2022 Global Life Sciences Outlook 
Digitalization at scale: Delivering 
on the promise of science

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
2
Introduction	
3
Accelerating R&D productivity and industry collaboration	
4
Transforming the patient experience	
18
Transforming the talent experience	
29
Regulatory: Mastering external forces	
36
The digital enterprise at scale: A CEO imperative for 2022	
45
Future-proofing manufacturing and supply chains	
58
Environmental, Social, and Governance (ESG): Another CEO imperative	
67
Contacts	
80
Learn more	
82
Endnotes	
84
Contents

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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While valuations for the life sciences sector in this past year have been mixed, the underlying performance and outlook for the 
sector is healthy. We saw many companies’ growth buoyed by COVID-19 therapeutics, and the majority of others remaining 
fairly immune to some of the pandemic impacts initially feared (e.g., slowdown in patient recruitment and trial execution). We 
anticipate further growth in the industry as life sciences companies continue to transform.
Some companies, especially those with limited legacy ways of working, are coming out of the pandemic adopting a digital-first 
model and challenging norms across their enterprise. Those that made significant digital investments prior to the pandemic 
are benefitting from their bold vision as digital transformation accelerates every part of the life sciences value chain. In 2022, 
visionary leaders will continue to drive investments focused on long-term, strategic digital objectives—using automation, 
smart factories, and artificial intelligence to transform manufacturing and using new technologies to build supply chain 
resilience. 
Uncertain times will require a greater commitment to enterprise agility. The new world of virtual and hybrid work demands 
flexibility, and most life sciences companies will still be adjusting to new norms and a highly competitive talent landscape in the 
near future. Reimagining work with a focus on corporate and working culture is a CEO strategic priority and meeting the needs 
of humans—and human-centered experience in the workplace—has never been more important. 
The last two years of the pandemic saw unprecedented collaboration across life sciences and with stakeholders. Everyone 
was mobilized in the interest of patients, including regulatory agencies around the world digitally sharing research.1 Over the 
next year, more patient-centric, co-created experiences will evolve to make patients more equal partners in decision-making 
throughout their journeys and help life sciences deliver better, more personalized outcomes. We anticipate more diversity in 
clinical trials driven by patients and a greater focus on health equity, enabled by decentralized trials among other strategies.
In 2022, data-driven scientists, armed with new sources of insights and real-world evidence, will be solving problems for 
diseases that were once thought intractable.2 Scientific breakthroughs, like the mRNA technologies behind the COVID-19 
vaccines and cell and gene therapies, have many potential use-cases for the future. The new processes adopted to expedite 
COVID-19 vaccines and therapeutic products are now also being applied to speed up the development of other drugs and 
treatments—and companies cannot revert back to old ways.
ESG is expected to remain front and center in 2022, as companies face enhanced disclosures and new global standards. 
Watchdogs, investors, and customers will be scrutinizing life sciences’ progress.3 In the year ahead, life sciences leaders 
will be expected to focus on material ESG factors for the sector such as access to medicines, drug pricing, environmental 
sustainability, health and race equity, and diversity in leadership. 
Change will persist through 2022 and beyond. Many life sciences companies have experienced growth and are emboldened 
with stronger balance sheets from which to invest. We anticipate investments in their portfolios, including next generation 
therapies and investments, to capitalize on their digital progress. With access to a myriad of tools to gather and analyze data, 
it’s time for life sciences companies to employ digitalization at scale. A new bar has been set, and agile companies, willing 
to move beyond convention to solve the toughest challenges, stand to reap the biggest benefits. The greatest challenge 
for leaders in 2022 will be how to ensure they accelerate the progress made—and not revert to pre-pandemic norms. Bold 
leaders with a clear, cohesive vision will continue to take advantage of the many opportunities the pandemic has surfaced and 
accelerated.
Introduction

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Driving productivity, a need for speed
Currently, many life sciences companies are showing a ‘need for speed’ as their focus is on driving research and development (R&D) 
productivity. New processes adopted to expedite vaccines and therapeutic products to tackle COVID-19 are now being applied 
to other drugs. In 2022, pressures are expected to be on optimizing processes to fundamentally change the drug development 
paradigm.1
Collaboration and digitalization have played fundamental roles 
in bringing COVID vaccines and therapies to market at an 
unprecedented rate, saving an estimated 750,000 lives in the United 
States and Europe alone. As an industry, we must bring the same 
speed and sense of urgency to all our efforts.
Paul Hudson, CEO, Sanofi 2
Accelerating R&D productivity and 
industry collaboration

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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0
5
10
15
20
25
Months
0
5
10
15
20
25
NVO
GSK
LLY
MRK
SNY
Overall
AZN
ABBV
PFE
BMY
RHHBY
NVS 
Months
Healthy Participants
COVID-19
Bone Disease
Infectious Disease
Diabetes/Obesity
Hepatitis
Dermatology
Respiratory
Pain Management
Women’s Health
Liver Disease
Opthalmology
Cardiovascular/Renal
CNS
Rheum/Inﬂamm/Immuno
Non-Malignant hem
MS
Alzheimer’s
Other
Epilepsy
Rare Disease
Oncology
GI/Ulcer
Impact on timelines
While some worried that life sciences companies would see a negative impact on timelines during the pandemic, others were 
more bullish about the degree of change life sciences companies were going to embrace and mobilize to accelerate timelines. 
At large, timelines didn’t change.
What are typical timelines? Research conducted by Cowen analyzed the performance of 11 leading pharmaceutical companies 
over more than 15,000 clinical trials across five categories. The time period analyzed was 2012-2021, unless otherwise noted.3 
	• Pipeline pace:  Average time to reach approval, almost 5 years
	• Recruiting speed: Average time to enroll patients in trials, almost 19 months
	• R&D efficiency (2016-2021): Average R&D spend per active trial, US$35 million, US$66 million per active Phase III trial (may 
reflect a proclivity to in-license late stage assets)
	• Trial push-outs: Average percentage of trials not delayed, 52%
	• Delay duration: Average change in primary completion rate, 57-day delay 4
If we look at the results for recruiting speed, (see figure 1)5 for example, the data show how timelines for recruiting vary by 
company and therapeutic area. While it may take only about 4 months to enroll healthy participants, it may take almost 30 
months to enroll participants for studies concerning ulcers and the gastrointestinal tract.6 
Figure 1: Trial recruiting speed by company and therapeutic area, 2012-2021
Source: “R&D Pentathlon: Which Pharma’s R&D is faster, higher, stronger —ahead of the curve,” Cowen, 26 July 2021.
Weighted average enrollment time in months by company (left) and by therapeutic area (right)

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Overall, the leading companies averaged about 19 months to enroll patients, and the best recruiting speed—significantly 
leading the rest—was Novo Nordisk, with a phase-weighted average of 9.6 months. However, the company’s absence in 
oncology trials was a tailwind. The average oncology trial took 27.6 months to enroll, compared to non-oncology trials at 14.9 
months. Second-place GlaxoSmithKline (GSK) and third-place Eli Lilly also had limited exposure to oncology.7
Pharma R&D recruiting timelines were not slowed down by the pandemic. However, clinical trial starts actually increased and 
are back on track.8 Where we did see shortened timelines, companies are keen to replicate, if possible. 
Deloitte’s analysis of R&D cycle times for 15 leading pharmaceutical companies shows that, prepandemic, average cycle time 
was 6.64 years in 2019, followed by an increase to 7.14 years in 2020, a 7-year high. A slight improvement came in 2021—6.9 
years—a decrease driven by the expedited completion of studies for COVID-19 therapies and vaccines.9 
Some accelerated paths for improving productivity include focusing on continued digital transformation, quality and safety, 
and working in tandem and across geographies with regulators for earlier approvals.10   
Return on pharmaceutical innovation
Deloitte has been tracking return on pharmaceutical innovation since 2010. Up until 2020, companies we tracked experienced 
a decade-long decline in R&D productivity. But in 2021, Deloitte’s analysis of 15 large pharmaceutical companies shows a 
significant uptick for the cohort’s internal rate of return (IRR)—7%, up from 2.7% in 2020. COVID-19 related assets buoyed by 
emergency approvals played a significant role. Excluding those assets, the projected IRR is still higher, at 3.2% (see figure 2).11 
Figure 2: Uptick in R&D returns for biopharma cohort for 2021
15 biopharma companies were analyzed by Deloitte
Source:  Nurturing growth, Measuring the return from, pharmaceutical innovation 2021,  
Deloitte Centre for Health Solutions UK, January 2022.
0
2
4
6
8
2013
2014
2015
2016
2017
2018
2019
2020
2021
R&D returns have seen a large uptick in 2021
IRR is the highest it has been since 2014

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Pharmaceutical companies expect to advance scientific breakthroughs and manufacture innovative  
products in an effort to fulfill unmet needs and stay ahead of the competition. In 2021, the average  
cost to develop an asset for this group, including the cost of failure, decreased US$70 million  
from 2020, to approximately US$2 billion. This decrease is mainly due to the increase in the  
number of assets in the late-stage pipeline for the companies analyzed. In 2021, the group had a total number of  
242 late-stage assets, an increase from 210 in 2020.12 
We can’t revert to our old ways.
Paul Hudson, CEO, Sanofi 13  
Tracking R&D spend
Drug Discovery & Development analyzed the R&D spend for leading pharmaceutical companies’ annual reports. Spending for 
the top 15 companies ranged from almost US$4 billion to more than US$13.5 billion for the year (see figure 3).14 For R&D spend as 
a percentage of revenue, Incyte led the industry with an R&D spend of US$2.2 billion that constituted a whopping 83.10% of its 
revenue. Regeneron Pharmaceuticals spent almost US$2.4 billion on R&D, or 32.19% of revenue, to claim the number two spot.15  
When allocating R&D spend for an asset, a pharmaceutical company is often influenced by:
	• Anticipated lifetime global revenues from the new drug
	• Expected costs to develop the drug
	• Policies and programs influencing supply of and demand for prescription drugs16 
	• Pressure to innovate17 
Pharmaceutical companies face greater pressure to innovate because of the time-limited patent protection of their name-brand 
drugs. When a patent expires, companies expect to take a big hit to sales from generics and biosimilars and plan accordingly.18 
Source: Drug & Discovery 2021
Figure 3:  Pharma companies’ total R&D spend in 2020
Company
USD for 2020
1
Merck
$13,558,000,000
2
Roche Pharmaceuticals (division of Roche Group)
$12,164,234,743
3
Bristol Myers Squibb
$11,143,000,000
4
Janssen (Johnson & Johnson’s pharmaceutical segment)
$9,563,000,000
5
Pfizer
$9,405,000,000
6
Novartis
$8,980,000,000
7
AbbVie
$6,557,000,000
8
GlaxoSmithKline
$6,509,126,400
9
Sanofi
$6,303,060,000
10
Eli Lilly
$6,086,000,000
11
AstraZeneca
$5,991,000,000
12
Gilead Sciences
$5,039,000,000
13
Takeda Pharmaceutical
$4,611,350,440
14
Amgen
$4,207,000,000
15
Biogen
$3,990,900,000

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Investing in the research lab of the future
Accelerated advancements in drug discovery and 
delivery are expected to fuel industry growth and 
demand for lab space in the near term.19 In the R&D 
lab of the future, an interconnected ecosystem of data, 
platforms, instruments, and advanced analytical tools 
supports scientists across teams and geographies 
to rapidly discover breakthrough therapies. In 2021, 
Deloitte surveyed 150 leaders across the value chain 
from large biopharma companies (revenue of US$1 
billion and above) across the United States, Europe, and 
Asia. Survey respondents say that their organizations are 
currently prioritizing investments in AI (81%) and cloud 
(71%). A much smaller percentage believes that over the 
next five years their organizations are likely to invest in 
AR/VR (19%) and IoT (24%), both of which are essential 
for the lab of the future.
Source: NIH Clinical Trials
7,299
total 
COVID-19 trials 
(as of 17 Jan 2022)
998
Not yet 
recruiting
2,908
Recruiting
199
Enrolling by
invitation
743
Active, 
not recruiting
1,990
Completed
461
Other
Establishing new norms
Revamping the clinical trial model
Changes brought about as a result of the COVID-19 pandemic are 
shaping a new era in clinical trials. Restrictive norms and outdated 
processes are falling away. With digital and virtual tools, constraints 
such as geography and set ‘business hours’ are no longer barriers to 
participation. Researchers are finding new ways to bring more people 
into trials through new models that are adaptive, decentralized, and 
hybrid. Participants expect more personalized care and real-time 
access, no matter where they are.20 
Remote monitoring and remote visits were top strategies for keeping 
clinical trials open during the pandemic.21 Research shows that there 
were more study starts across the board by the end of 2021 than ever 
before, with an increase of almost 18% from 2020 to 2021, including 
more non-COVID trials. Oncology saw the biggest increase at almost 
1,300 trial initiations in 2021, a 23% increase.22 Two years after the 
pandemic started, more than 7,000 clinical trials had been initiated 
related to COVID-19 in the NIH Clinical Trials database (see figure 4).23 
Figure 4. Total number of clinical trials related to COVID-19 vaccines and treatments as of January 17, 2022

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Reducing patient burden through decentralized trials
New types of trials are already proving to be more productive. In particular, research shows that decentralized trials (DCTs) that 
rely on remote strategies are showing return on investment and are here to stay.28 Digitization is reducing patient burden and 
reporting subjectivity, while increasing outcome accuracy.29 In developing MyPath for Clinical, Deloitte found that an end-to-
end digital platform for decentralized trials was a more streamlined way to address many patient challenges—such as traveling 
to sites, confusion about treatment protocols, and access to medical teams in real time.30 
The pace of change in trial design and execution will continue to 
accelerate through adaptive trial design, which allows monitoring 
of incoming data and modifying the trial protocol based on interim 
review. Amgen has implemented these tools in clinical programs in 
inflammation, cardiovascular disease, and others disease areas.
Elliott M. Levy, MD, Senior Vice President, R&D Strategy and Operations, Amgen 27
In a fully decentralized clinical trial, 
patient recruitment, delivery of trial medication and supplies, and 
acquisition of trial outcomes data is enabled through virtual and real-time 
tools—essentially eliminating the need for in-person contact between the 
study team and the trial participant.31
Many hospitals and research institutions shifted from in-person clinical trials to home-based reporting and the clinical trial 
process was rapidly digitalized with tools such as telemedicine, sensor-based technologies, and wearable medical devices. 
Many trial participants were able to receive direct-to-patient shipment of investigational products and trial supplies, and 
remote consent was enabled via mobile—further modernizing the clinical trial process.24 
Adapting trials to patient response 
Adaptive clinical trials are using the potential of AI to discover the best possible treatments. An adaptive trial can be modified 
according to a patient’s response. For example, if a drug is not working, it might be pulled, and another treatment readily 
started in its place.25 Researchers used adaptive trials to discover and compare potential COVID-19 treatments during the 
pandemic. The World Health Organization and groups like the Bill & Melinda Gates Foundation are showing increasing support 
for adaptive trial designs, particularly as a way to evaluate therapies during epidemics.26

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Improving access to trials and technology 
through hybrid trials
Decentralized trials and remote monitoring may 
address convenience and diverse populations in 
distant locations, but underserved and minority 
populations are still likely to experience disparities. For 
example, access to broadband, caregivers, and home 
health care, may present a challenge.33   
Not all trials can be fully decentralized. Hybrid trials, 
that also reach patients through the community where 
they live, are another growing solution.34 Researchers 
should be aware of the logistical difficulties that 
some necessary in-person provider interactions and 
laboratory tests may pose for some pariticipants. 
For example, some may face travel constraints (e.g., 
access and cost), nonacceptance of job absences for 
study activities, and mobility challenges due to medical 
comorbidities.35  
Tufts’ study finds 5x to 14x financial return on decentralized 
trials investment
A recent study from the Tufts Center for the Study of Drug Development 
compared published benchmarks on trial cycle times and costs with data from 
more than 150 decentralized trials conducted by software firm Medable. The 
study reports that, on average, decentralized clinical trials (DCTs) are associated 
with reduced clinical trial timelines, recruitment, and higher retention rates. For 
example, decentralized phase 2 studies were completed 1 to 3 months faster 
than traditional trials, a net benefit up to five times greater than the upfront 
investment required; phase 3 was 14 times greater.32
CVS Health expands access to clinical trials through retail 
locations
CVS Health Clinical Trial Services was initially launched in response to 
the pandemic with the goal of providing greater access to clinical trials 
across the communities it serves. Collaborating with the pharmaceutical 
industry, CVS Health helped facilitate clinical trials for investigational 
COVID-19 vaccines and treatments. Using a specially designed digital 
model and screening protocols, the company engaged more than 300,000 
volunteers for COVID-19 vaccine trial consideration, connecting them to 
studies close to where they live.36
By creating a more efficient, convenient experience to improve participant 
retention and research effectiveness, CVS Health believes its new clinical 
trial experience benefits participants, health care providers, clinical 
research organizations, and study sponsors. The business is initially 
focused on scaling three core capabilities: precision patient recruitment, 
clinical trial delivery, and real-world evidence generation and studies.37 
Localizing in-person visits and providing digital tools to make it easier for 
patients to participate in their own communities may be all that is needed.
By making the clinical trial process more convenient for enrollment and participation, industry leaders stand to gain better 
research results, fewer failed trials, and more trust from physicians and patients. More accessible trials for diverse populations 
may provide deeper insights, enabling more tailored drug therapies to be developed and more productive R&D.38 
Defining goals for clinical trial diversity
The Pharmaceutical Research and Manufacturers of America (PhRMA) is an industry organization committed to enhancing 
diversity in clinical trial participation. In last year’s Life Sciences Outlook, we introduced PhRMA’s industry-wide “Principles on 
conduct of clinical trials and communication of clinical trial results”.39

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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39%
42%
19%
We have deﬁned goals and objectives, identiﬁed best practices, 
and begun to incorporate these across some of our trials
We have deﬁned goals and objectives and working to identify 
best practices 
We are working on deﬁning our goals and objectives
Note: N=31 PhRMA member companies
In 2021, PhRMA and the Deloitte US Center for Health Solutions conducted extensive research  
on clinical trial diversity, including a survey with 31 PhRMA’s member companies and a workshop  
with more than 500 stakeholders from more than 150 organizations. The survey of PhRMA  
members showed 61% of respondents have defined goals and objectives to enhance clinical  
trial diversity, and all respondents have or are planning to address trial access issues (see figure 5).40 
Figure 5:  PhRMA member companies survey on clinical trial diversity
All respondents have or are planning to address trial access issues and are considering the needs of 
diverse populations in clinical trial design
Percentage of respondents with defined goals and objectives 
for increasing clinical trial diversity
We are taking speciﬁc measures to address trial access issues ( e.g., transportation costs, event scheduling, 
remote/decentralized data collection, patient apps and data access, etc.) 
Yes
No
We are considering the needs of diverse populations in clinical trial design (e.g., taking a patient-centric approach 
to protocol design and incorporating patient input) 
We are identifying sites where diverse patients may be located, identifying health care providers that treat undeserved 
or underrepresented populations, and collaborating with investigators to address the goals of enrolling a diverse population 
We are enhancing education on the role of clinical trials throughout the medical community 
We are increasing clinical trial awareness and diversity by improving individual health literacy and community outreach 
We are enhancing information about diversity and inclusion in clinical trial participation (e.g., developing and 
maintaining policies and procedures, making these publicly available) 
We are using real-world data to enhance information on diverse populations beyond product approval 
We are enhancing diversity among clinical investigators 
We are broadening eligibility criteria to increase diversity in enrollment when scientiﬁcally and clinically appropriate 
Note: N=31 PhRMA member companies
97%
3%
71%
29%
71%
23%
61%
29%
58%
29%
52%
29%
52%
29%
52%
35%
45%
42%
Source: “Enhancing clinical trial diversity,” Deloitte Center for Health Solutions, 2021.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Most surveyed PhRMA member companies identified areas to address internally to enhance clinical trial diversity—such as 
legacy processes and systems, data on demographics of disease by race/ethnicity, and protocol design flexibility. Five key 
strategies were identified for enhancing clinical trial diversity and are discussed in the ESG section of this report.
Evolution of real-world evidence 
Amount and types of data rapidly accelerating
Life sciences companies strive for consistent, regulatory-quality clinical 
trial data to prove the effectiveness of treatments, and researchers are 
expected to gather, analyze, and curate many streams of structured 
and unstructured data. The amount of data being collected by digital 
health technologies—telemedicine, mobile devices, wearables, and other 
sensor-based technologies—is rapidly accelerating due to decentralized 
trials and remote monitoring.41  
In addition to clinical data, genomic information and improvements in 
technology—like AI and quantum computing—are evolving the way 
life science organizations approach drug discovery and development. 
Real-world data (RWD) and real-world evidence (RWE) collected today 
have the potental to better inform clinical trial design/execution and 
deliver insights never before thought possible. In Deloitte’s annual 
survey of C-suite biopharma leaders, 100% identified RWE as strategically 
important.42
At the end of 2021, the US Food and Drug Administration (US FDA) issued 
draft guidance for using digital health technologies to acquire data 
remotely from participants in clinical trials. In addition to sponsors and 
investigators, developers and manufacturers have the opportunity to 
benefit by reviewing this guidance.44  
Selecting digital tools for better clinical trials
When selecting digital and virtual tools for clinical investigations, sponsors should ensure they are “fit-for-purpose” or 
sufficient to support their use and interpretability in the study. Data transmission with manufacturers and end-user licensing 
agreements should be designed to secure data collected and transmitted.45
Getting better data from devices in clinical trials:
	• When validating instruments for trials, collect sufficient data to understand how each tool really works. Some tools may not 
transfer to a virtual platform.46 
	• Ensure that digital tools have user-friendly interfaces for supervisors and patients.47 
	• Wearables help take subjectiveness out of the data, but wearables are not always accurate. Always question data, and how 
you are interpreting the data.48  
	• Check that tools are measuring what you need them to measure. Is the data being collected clinically relevant and relevant to 
the patient?49 
Teams designing trials should have a clinical expert involved, not just statisticians. These experts have the ability to bring 
clinical analysis a priori and to look at outliers for clinical relevance. Value is expected to come from human-enabled AI—
expert clinical knowledge coupled with AI and machine learning (ML) analysis.50 
Verana Health: Building a vast database of 
RWE for clinical R&D 
Verana Health is building an extensive database of 
real-world clinical evidence curated from organizations 
like the American Academy of Ophthalmology, the 
American Academy of Neurology, and the American 
Urological Association. Life sciences companies 
and health care providers can mine the platform 
for insights from the electronic health record (EHR) 
systems of more than 20,000 health care providers. 
Their population health analytics tool, VeraQ, uses 
AI to automatically sift through those data, helping 
drug and device developers with their research and 
speeding up clinical trial recruitment. The startup has 
recently garnered support and funding from Johnson & 
Johnson, Novo Nordisk, and Merck.43

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Through AI & ML, life sciences companies have also been able to select investigators and countries for their clinical trials as 
well as predict their performance.51  
Lessons from the COVID-19 experience
In 2022, biopharma companies are looking to apply some of the more successful COVID-19 development measures to plan, 
design, and execute studies more efficiently by:
	• Enabling at-risk development for high-priority programs, allowing them to bypass certain stage-gates 
	• Expanding collaborative dialogue with regulators, using data-sharing infrastruture and harmonizing across geographies
	• Limiting the number of relevant endpoints, to streamline trial protocol design
	• Enabling the rapid assessment and development of therapies with master protocols and adaptive trial design
	• Accelerating the use of digital technologies, for conducting decentralized and hybrid studies, optimizing site selection, 
recruiting diverse study populations, and remotely collecting data and monitoring patients52 
During the pandemic, it became both difficult and potentially dangerous for some clinical trial patients to go to the hospital. 
According to Badhri Srinivasan, head of global development operations for Novartis, his teams worked to set up solutions such 
as in-home nursing programs or direct to patient shipments of their study medication. “These are options that patients may 
prefer, regardless of restrictions, and many trial sites have now expanded their capabilities to accommodate these services. 
Therefore, we need to prioritize building assessment of decentralized clinical trial elements, such as home nursing,” he says.53 
New therapeutic modalities are the future of R&D productivity
Highly anticipated biopharma research
The science of therapeutics is maturing with new and compelling modalities. Scientists are now focusing on diseases that were 
once thought intractable.54 Technology and science are converging, and the modality landscape is evolving—from sporadic 
disease, small molecules, biologics, and protein targets to genetic disorders, Antisense Oligonucleotides, siRNA, gene therapy, 
and nucleic acid targets, according to Anabella Villalobos, PhD, senior vice-president at Biogen.55 
Villalobos says that protein degraders are an emerging therapeutic modality showing encouraging results.56 Targeted protein 
degradation (TPD) tackles disease-causing proteins that have historically been highly challenging to target with conventional 
small molecules. In the future, this modality is expected to expand the use of ubiquitin ligases to enable precision medicine 
and move beyond oncology.57 
Dr. Jay Bradner oversees 5600 scientists and 325 discovery programs over 8 disease areas as president of Novartis Institutes 
for Biomedical Research (NIBR).58 He says that it is ironic that returns are diminishing when our understanding of disease has 
never been better and more granular. He believes R&D productivity can grow thanks to new modalities.
My least favorite term in our field is ‘undruggable target.’
Dr. Jay Bradner, President, Novartis Institutes for BioMedical Research, Novartis

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What’s next for cell & gene therapies?
Globally, cell and gene therapies (CGTs) are transforming how humans treat genetic and intractable diseases as well as 
altering the entire pharmaceutical ecosystem.59 As of Q1 2021, there were 2,261 ongoing global cell, gene, and tissue clinical 
trials—1,129 were industry-sponsored and 1,132 were academic/government-sponsored trials (see figure 6). In 2022, there 
will be more opportunities to expand cell and gene therapies, especially in rare disease, and more interest in allogeneic 
therapies.60  
Figure 6:  Cell and Gene clinical trials in development, March 2021
1,129 Industry-Sponsored Clinical Trials
1,132 Academic & Government Sponsored Trials
Gene Therapy: 222
43
47
132
Gene Therapy: 84
57
24
3
Gene-Based IO: 465
225
31
209
Gene-Based IO: 377
3
187
187
Cell Therapy: 424
62
130
232
Cell Therapy: 656
433
156
67
Tissue Engineering: 18
11
6
1
Tissue Engineering: 15
6
1
8
Ph 1
Ph 2
Ph 3
Data as of March 2021 by Global Data
Source: ARM, 10 January, 2022
We need to listen because ideas come from anywhere in the 
organization. We just need to evaluate and see what we can fund. 
Whether we do that internally or externally is another question. But 
we need to make sure that we listen to the project teams who are 
driving the science.
Anabella Villalobos, PhD, Senior Vice-President, Biotherapeutics and Medicinal Sciences, Biogen

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Unprecedented collaboration
Growing global ecosystem
During the pandemic, many life sciences companies that had been competitors came together to solve scientific problems to 
address the urgent need for treatments, vaccines, diagnostics, and medical devices (see figure 7).61 Companies, including those 
in other other industries, also joined the effort to help fill raw materials shortages, digitalize more of the drug development 
process, and enhance manufacturing at high capacities at different locations worldwide.62 	
Figure 7: Life sciences’ global collaborations
Currently, life sciences companies are partnering to develop digital medicine products, playing to their strengths in regulatory 
science and market access, while leveraging partner expertise in software development.63 Digital product development is an 
iterative process, and pharmaceutical companies are expected to demonstrate a willingness to be adaptive and nimble.64 Most 
technology companies are interested in a meaningful commercial relationship and not just running pilots.65  
Source:  “Never the same again, How COVID-19 created seismic change in life sciences regulations,” Deloitte, 2021.
Japan
Switzerland
India
Brazil
China
European Union
USA
United Kingdom
Takeda, JP
Drug and 
vaccine 
LS company
AstraZeneca signed  
an agreement with  
BioKangtao in China
BioKangtai, China 
A business integrating R&D, 
production, and sales of  
biological products in CN
Production scale of 
J&J vaccine
Biological E, India 
First private-sector 
biological products 
company in India
Johnson & Johnson, USA
Drug and vaccine  
LS company
Production scale-up of 
HGCO19, India’s first  
mRNA vaccine
HDT Biotech 
Corporation, Seattle 
Science-led, innovative 
biopharmaceutical business
Genova, India 
Biotherapeutics to address  
life-threatening diseases
Clinical trials and production  
scale-up of Covishield vaccine
AstraZeneca and  
Oxford, UK 
Science-led, innovative 
biopharmaceutical 
business 
Production scale of 
Sputnik V vaccine
Russia’s COVID-19  
Sputnik V
Dr Reddy’s 
Laboratories 
Development and 
production  
of a vaccine
Novavax, US
Clinical trials in EU and US; 
and production scale-up of 
Pfizer mRNA vaccine
Pfizer, US 
Drug and vaccine 
LS company
BioNTech, Germany 
Next generation 
immunotherapy 
powerhouse
Active ingredient for the  
COVID-19 Moderna vaccine is 
produced in Switzerland
Moderna, US  
Drugs and vaccine 
LS company
R&D-license agreement of  
research tech. for COVID-19 
therapeutic drugs*
Chugai, Japan 
Antibody engineering 
technology LS company
Eli Lily, US 
Drugs and vaccine 
development LS company
R&D—s­haring best  
practice in consortium** 
(Drug and vaccine LS companies)
AMGEN  
and 5 
companies,  
US
Bayer and 6 
companies, 
EU
Astellas 
and 
Shionogi, JP
AstraZeneca 
and 3 
companies, 
UK
	
*	Chugai sold the right to see  
         antibody engineering technology 
         to Eli Lily, and Eli Lily acquired 
         the right to develop and sell  
         antibody drugs by using this  
         technology
	 **	Best practices of clinical trials  
         under pandemic have been  
         shared among 20 companies in  
         “TransCelerate BioPharma Inc.”
	*** “COVID R&D alliance” was 
         founded for drugs of COVID-19. 
         AMGEN and  Takeda have  
         started clinical trials.
R&D—form of consortium 
“COVID R&D alliance”***
AMGEN, 
US  
Drug LS  
company
AstraZeneca, UK 
Science-led, innovative 
biopharmaceutical business 
AdvaMed  
Advanced Medical Technology 
Association—the world’s 
largest trade organization 
representing medical 
technology companies
PhRMA 
Pharmaceutical Research and 
Manufacturers of America 
represents US leading 
innovative biopharmaceutical 
research companies devoted  
to discovering and  
developing medicines
DIA Global  
Drug Information 
Association—members 
come together to 
collaborate and solve 
problems, discuss global 
and local challenges facing 
the life sciences field
US COVID R&D consortium  
Life science companies collaborate 
to accelerate therapies and 
vaccine for COVID-19

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
16
New partnerships filling the demand for digital therapeutics 
Last year, we saw pharma companies forming partnerships with digital therapeutics startups.
	• Boehringer Ingelheim partnered with Click Therapeutics to develop a digital therapeutic for patients with schizophrenia
	• Sanofi partnered with Happify Health to build a digital therapeutic to help multiple sclerosis patients manage their mental 
health66
In 2022, as the demand for digital therapeutics grows across the ecosystem, new business models will likely emerge beyond 
the traditional commercialization approaches. We expect to see a shift in favor of insourcing some of this technology as life 
sciences companies gain more experience in the field.67 
Mergers & Acquisitions (M&A) for R&D pipelines
COVID-19 negatively impacted the degree of M&A in 2020, with a slight rebound in 2021—but overall activity remained 
subdued. There were fewer, smaller deals, and we saw companies shifting their portfolio toward rare diseases through their 
smaller-scale M&A activity.68  
Pfizer was particularly active in 2021. Flush with cash from its hugely successful COVID-19 vaccine with BioNTech, Pfizer 
invested in other pipeline-boosting deals, including a US$2.4 billion licensing deal for an Arvinas cancer drug. The success of 
COVID-19 vaccines from Pfizer/BioNTech and Moderna put mRNA platforms into the spotlight. Sanofi paid US$3.2 billion for 
Translate Bio and its mRNA platform for expressing proteins.69  
In our outlook, we expect continued focus on bolt-on acquisitions aimed at bulking up R&D pipelines.70 WIth smaller firms, 
talent, tools, and intellectual property may be ported to the parent, adding value in many ways.71 When smaller bolt-on 
acquisitions dominate, the number of deals may be high,72 and deal-making activity is expected to pick up this year.
As smaller biotechnology firms and larger pharmaceutical companies position themselves for opportunities to acquire assets, 
we expect to see many more types of collaborative relationships maximizing new technologies. Pfizer kicked off 2022 with a 
US$300 million multi-target research collaboration with gene-editing firm Beam Therapeutics. The deal makes Beam eligible 
to receive future milestone payments of up to US$1.05 billion—a potential total consideration of up to US$1.35 billion. Pfizer 
looks to leverage Beam’s proprietary in vivo delivery technologies, which use mRNA and lipid nanoparticles (LNP) to deliver 
base editors to target organs.73   
More investments in cell & gene therapies
Mergers and acquisitions dominated the funding for cell and gene therapies in 2021, and it appears the trend will continue. 
CGT represents roughly a third of all private investment in life sciences.74 Total funding from all sources for cell and gene 
companies in 2021 exceeded US$70.8 billion last year, including:
	• IPO and FPO Deals
	• SPAC Deals
	• Venture Capital and Private Funding
	• Strategic Investments
	• Mergers & Acquisitions (M&A)
	• Technology and Research Collaborations
	• Licensing Deals
	• 	Manufacturing and Supply Chain Deals
	• Public Outreach, Consumer Education, & Philanthropy
	• Distribution & Co-marketing Deals
	• 	Restructurings, Joint Ventures, Terminations and Spinoffs
	• Other Types of Deals Impacting Cell and Gene Therapy75

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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More than 50 partnership deals were executed between pharma and promising CGT companies before the first therapy was 
even approved in 2017.76 Tools such as CRISPR and next-generation sequencing have lowered the barriers to entry,77 and early 
approvals are paving the way for new entrants in this nascent market, where CGT represents only 7% of the approved 340 
biologics.78 A record number of regulatory decisions are upcoming in 2022-2023 (see figure 8).79  
Figure 8: Upcoming cell & gene therapy regulatory decisions, 2022-2023
Gamida Cell 
Blood Cancer + HSCT
BioMarin 
Hemophilia A
PTC Therapeutics 
AADC Deficiency
PTC Therapeutics 
AADC Deficiency
Atara Bio 
EBV + PTLD
Iovance 
Melanoma
Janssen/Legend 
Multiple Myeloma
BioMarin 
Hemophilia A
Orchard 
Wiskott-Aldrich
Janssen/Legend 
Multiple Myeloma
GenSight Bio 
LHON
uniQure/CSL 
Hemophilia B
Krystal Bio 
Epidermolysis Bullosa
CARsgen 
Multiple Myeloma
Bluebird bio 
Beta thalassemia
Adaptimmune 
Synovial Sarcoma
Atara Bio 
EBV + PTLD
CRISPR/Vertex 
Sickle Cell & Beta Thal
uniQure/CSL 
Hemophilia B
Orchard 
MLD
Bluebird bio 
Cerebral ALD
Bluebird bio 
Sickle Cell Disease
United States
Europe
2022
2023
BLA/MAA submitted
BLA/MAA planned
Source: ARM, 10 January, 2022
A significant amount of future success hinges on whether approved treatments are allogeneic or autologous. Since autologous 
treatments are based on a patient’s own cells and made to order, they represent more complexity and cost in treatment 
planning, manufacturing, and supply chain. Allogeneic treatments are based on cells from a donor, fitting more into the 
traditional model of distribution.80 
Currently, as the number of therapies is small and the volume of patients is large, payers have been open to innovative 
approaches to reimbursements, including annuity and installment-based payments and outcomes-based reimbursement. 
Experts say it is unclear how these approaches might scale as the numbers rise.81  
However, the future promise of cell and gene therapies is making companies with strong cell or gene therapy pipelines and the 
most promising technologies, researchers, and intellectual property attractive targets.82

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Patients at the center, taking charge of their health
The pandemic put patients at the center of every conversation, and innovation was catalyzed. Over the last two years, collaboration 
across life sciences and with stakeholders was unprecedented—all mobilizing in the interest of patients. 
Communication between patients, sites, sponsors, and supply partners increased.1 As of 14 December 2021, sponsors are enrolling 
or have enrolled more than 90 million people in 775 COVID vaccine-related clinical trials, including 50 million estimated for a post-
marketing safety study for the Moderna mRNA-1273 vaccine.2  
The pandemic helped to create more patient-centric channels. Digital technologies, in particular, were globally adopted, and 
telemedicine became broadly available. Digital is allowing companies to collaborate with patients to develop therapies with endpoints 
that the patients care about—including quality of life measures.3 Collaborating with health systems is enabling insights from data, and 
patients are now taking charge of more of their health.4  	
Patient engagement has been an essential part of biopharma research and development and disease management.5 However, as one 
patient advocate told a pharma executive—“We’ve been engaged for a long time, it’s time to get married.”6 
How will life sciences take advantage of this momentum and become truly patient-centric in 2022?
Transforming the patient experience

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Becoming a more patient-centric organization
Co-creating with patients, the heart of patient centricity
The concept of patient-centricity is decades old—but remains a challenge to master.8 Patient input to life sciences companies’ 
designs is increasingly more sophisticated and widespread. But some patient advocates believe that patients should be equal 
partners in the process with the patient at the center of decision-making.9 
According to Dana Lewis, patient advocate and founder of OpenAPS, 
the health care system doesn’t have the patient as an equal partner 
all along. She says that there is a huge gap, and we really need to think 
about redesigning the system, not just having patients as an add-on to 
the system.10
From concept to launch, patient “co-creation” would change many of 
the micro and macro decisions life sciences companies make along that 
journey, including—what to research, how to develop, how to package 
and distribute, how to get into patients’ hands, and ultimately, how to 
measure patient outcomes (see figure1).
Pharma companies are starting to adjust their enterprise decisions 
by reflecting the patient needs in more decisions, and health tech and 
other ecosystem companies are gaining traction filling this need.
Integrating engagement, fully partnering with patients 
According to Dr. Freda C. Lewis-Hall, former chief patient officer for 
Pfizer,13 life sciences organizations need to stop trying to solve problems 
themselves, and instead, they should fully partner with patients. “Get insights into what patients’ preferences and needs are, 
what their current skills are, and how they can help us shape ourselves as companies and industries. Let them know that 
their input is important for what we are ultimately going to offer to them. When we bring the solution, they’ll know that we’ve 
worked on it together to provide it,” she says.14 
Figure 1: The patient and life sciences co-creation process
Voice tech captures the true voices of 
patients providing trial sponsors with deeper 
insights
TrialPulse is a patient insights platform helping 
hundreds of pharmaceutical companies better listen 
to the true voices of patients. Using voice technology, 
patients provide insights on various parts of the R&D 
process, including patient experience, disease burden, 
unmet needs, trial design, recruitment, and retention 
optimization.11 Language analysts and advanced natural 
language processing (NLP) tools are used to process, 
evaluate, and analyze multiple aspects of each patient’s 
response, including emotion which may provide deeper 
insights for the sponsor.12
Patient-centricity is more than providing good quality care. It means making 
patients equal partners who are at the center of health care decisions.7
Co-ideation 
Co-evaluation 
Co-design
Co-test
Co-launch
Source: “Patient co-creation is a tall, but worthwhile, order for health innovators,” MobiHealthNews, 27 November 2019.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
20
For accurate patient insights, it is important that life 
sciences companies are proactive, involving patients 
early, and not waiting until there is a final product such as 
an app or website for patients to review.15 Begin with the 
initial brainstorming through to the launch of the product 
(see figure 1).16 Be flexible—see the process of co-creation 
as an open dialogue and change direction based on the 
feedback you receive.17 
In addition, life sciences companies need to plan for 
the investment required to really involve patients, 
including patient compensation. When patients aren’t 
compensated for their time, sponsors risk bias by design 
and lack of diversity, because only patients who are able 
to—can afford to and have the time to—be involved, will.18 
Enhancing engagement, creating value
Digital and data solutions can help embed patient centricity across the value chain.20 Digital health, medicine, or therapeutic 
technologies offer many ways to provide value:
	• Empowering patients to monitor and self-manage their health
	• Increasing access to therapies which are clinically effective and safe, with side effects that are typically less severe than in 
traditional pharmacological interventions
	• Improving medication management and patient adherence
	• Helping alleviate the limited access to therapy
	• Providing updates on outcomes through regular 
monitoring
	• Reducing medication dosages for patients who adopt 
healthier lifestyle habits as a consequence of tracking 
their symptoms and health status
	• Reducing the number of face-to-face interventions, e.g., 
through digital cognitive behavioral therapies
	• Enhancing patient experience by receiving care in a 
more convenient setting, e.g., in the comfort and privacy 
of patients’ homes or wherever a patient may be
	• Increasing access to interventions for underserved 
populations
	• Enabling more predictive, preventative, personalized, 
and participatory care21
Just ask patients: Savvy Cooperative digital health 
startup
Companies and innovators are likely to waste time and money 
creating products and services that don’t meaningfully impact 
patients’ lives. Often, this is because developers never bothered to 
ask patients. They create products for patients and not with patients. 
Savvy Cooperative is an online marketplace for patient insights. 
The platform allows innovators to connect directly to patients and 
caregivers that match their objectives. Companies post a “Savvy Gig’, 
and patients choose gigs that they want to participate in or that are 
relevant for a particular disease. Patients have the opportunity to earn 
rewards. The goal is to co-create a product or service that offers a 
better patient experience and brings real value to patients.
Creating an end-to-end screening, scheduling, and 
results delivery platform
In the early days of the pandemic, both public and private 
organizations were forced to develop fast, piecemeal solutions to 
tackle the challenges of outbreaks. But Quebec’s Ministry of Health 
and Social Services (MSSS) had a vision to proactively combat these 
outbreaks by optimizing the testing and screening processes for its 
citizens. The goal was to reduce complexity, improve connectivity, 
automate manual tasks, and create a more efficient patient 
experience. Deloitte worked with the Canadian Ministry to create a 
centralized platform that gives citizens their appointments and results 
faster and provides ministry workers the tools they need for getting 
ahead of the virus in their community.22
In life sciences, we have brilliant people. We have technology and 
deep science. But what we often don’t have, is deep patient insight. 
We really have an opportunity now to build that in by creating an 
end-to-end partnership with patients. 
Freda C. Lewis-Hall, M.D., DFAPA, MFPM, former Chief Patient Officer, Pfizer, Inc.19

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
21
Monitoring value and use of products and services
Tracking consumer interest and actual use of technologies enables life sciences companies to be more patient-centric. For 
example, consumer use of risk assessment and early intervention products and services is increasing. These products and 
services provide early warnings regarding infectious diseases, genetic diseases, and cancer, among others. According to a 
survey of Chinese consumers’ preferences by Deloitte, higher utilization of these products was among those with chronic 
disease (see figure 2).23   
Figure 2:  Consumer preferences for products or services for disease risk analysis and early intervention in China
Mass market
consumers
New middle
class cusumers
Chronically illed
consumers
Online risk
assessment
Genetic testing
services
Test kits
No disease risk 
analysis has been 
conducted
Online health
report
interpretation
service
Disease risk
analysis
Health indicator
monitoring and
disease risk
prediction
Source: Integrating digital health care solutions to better serve and protect consumers, Deloitte China, 2021.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Shaping clinical trial design with patient insights 
Patient-focused drug development 
Patient-focused drug development incorporates patient experiences, needs, and outcomes to further drug development 
and evaluation—with greater emphasis being put on quality of life measurements.24 The SF-36v2 (36-Item Short Form Health 
Survey, version 2) is a widely used and validated instrument for patient-reported outcome (PRO) measures.25 Patients answer 
questions regarding their quality of life and overall physical and mental health (see figure 3).26
Sage Therapeutics, Inc. and Biogen Inc. were able to receive patient feedback on a clinical trial for zuranolone for major 
depressive disorder (MDD) with the SF-36v2. The assessment reported rapid improvement in quality of life and overall health 
for patients across all domains at Day 42 of the trial27 (see figure 3).28 
Figure 3: SF-36v2 Day 42 clinical trial PRO with Zuranolone treatment for MDD
Co-creating patient-friendly outcome measures
Pharmaceutical companies should consider more patient-friendly outcome measures and functional outcomes, as opposed to 
just regulatory or clinical outcomes, according to Gautam Gupta, senior vice president and head of strategy for Pfizer. He says 
that when selecting metrics for clinical trials, you should involve the patient, and consider: 
	• What metrics does the patient care about? 
	• What outcomes does the patient want to see? 
	• Is the medicine making the patient’s daily functioning easier?
	• Is it increasing mobility, if relevant to the disease?
 
Adding the endpoints patients care about should become part of the clinical trial.
Physical Health
Physical 
Function
Role
Physical
Bodily
Pain
General 
Health
Mental Health
Vitality
Social 
Functioning
Role 
Emotional
Mental 
Health
2
0
Physical
Functioning
3.5
2.2
Role
Physical
Bodily
Pain
General
Health
Vitality
Social
Functioning
Social
Functioning
Mental
Health
6
4
10
8
14
12
18
16
5.1
3.7
5.1
3.7
4.8
3.6
13.0
10.5
15.4
13.5
15.4
13.5
15.9
13.3
CFB in SF-36v2 Domain Score,mean (norm adjusted)
Zurannolone 30/50 mg
Placebo
Source: Sage Therapeutics, Inc.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Predictive engagement, using data for personalized experiences
Anticipating needs and meeting expectations 
Transforming clinical trials and patient services often requires catching up to other consumer experiences. Patients have a 
mental picture of expectations, that they may not even be aware of, shaped from other experiences.29 For example, when 
someone has a great customer service experience in retail or online, or a seamless experience with a tech giant’s app, they 
expect no less from their health care app, website, or consultation.30  
A leading customer service experience is provided by the Ritz-Carlton, whose goal is to ‘delight’ customers by anticipating the 
unexpressed wishes of their guests. Customer data is used to shape a personalized experience, and an innovation database 
stores ideas to share across properties.31 In health care, we can anticipate adverse health events by using data and digital 
tools to predict and prevent, according to Gilles Marrache, senior vice president in Europe for Amgen.32 For example, building 
algorithms from Electronic Medical Records (EMRs) may predict who is likely to have a second heart attack, and we can work 
with that patient to prevent it.33
Sparing patients an unpleasant experience with synthetic control arms 
Sparing patients an unpleasant experience is also valuable. According to Alicia Staley, vice president of patient engagement 
for Medidata, synthetic control arms essentially enable running a clinical trial with data. “With the evolution of what can be 
done with data, and particularly with AI, you are perhaps sparing the patient the actual experience of taking the medicine 
and living through side effects. You can figure out what a potential response would be,” she says. Staley suggests companies 
continuously look at data sources and act upon the signals they provide.35
This shift to predictive health and using data also requires trust. Trust by the patient that their data is being used responsibly 
and for their benefit. It requires pharma and device companies to invest in building that trust, to communicate openly and to 
be transparent.37
Everyone aspires to be healthy and happy.
Christophe Jauquet, author of Healthusiasm.34
Life sciences and medtech companies need to build a company 
culture around the patient experience and the data they’re 
learning about the patient. Data without analysis is just ones and 
zeros. If you’re not looking at the data and acting on that data, it’s 
useless and has no value.
Alicia Staley, Vice President, Patient Engagement, Medidata.36

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Enhancing engagement with leading-edge technology 
Life sciences companies can drive purposeful digital innovation by creating precision experiences with leading-edge 
technology (see figure 4).38 AI-driven engagement, connected patient, and health care provider (HCP) platforms may provide 
patients and partners timely access to content and treatments that are relevant and personalized.39
Figure 4:  Sample digital innovations powering precision experiences
Investing in more patient-centric digital capabilities
Digital becoming a strategic priority
Digital health, digital medicine, and digital therapeutics offer life sciences and stakeholders an opportunity to create more 
personalized experiences and new ways to become patient-centric. In the coming year, life science and medtech companies 
plan to grow investments in digital capabilities for more personalized therapies and patient support (see figure 5).40 
According to a recent study by Deloitte, executives from life sciences, technology, payer, and provider organizations expect 
digital medicine products to become a strategic priority. Digital therapeutics, in particular, are starting to impact patient 
outcomes and show clinical validation.41  
Digital innovations
Description
360-degree view of patients 
and partners  
(cloud/data lakes)
	• By combing behavioral and socioeconomic patient data (e.g., buying propensities, 
workout tendencies) with marketing data (interactions with online ads, impressions, 
conversions) in data lakes or the cloud, companies create 360-degree view of patient 
behavior across digital and physical footprints.
	• Similarly, data on how physicians interact with the company ad affiliate web ads, 
email, and social media content is aggregated to provide a view of their engagement 
across channels and platforms and can be cross-referenced to specific patients.
Al-based engagement 
recommendations (Al)
	• AI marketing solutions analyze patient datasets to recommend how, when, and with 
what customized content to engage patients and partners (such as personalized 
ads, tailored medicatio regimens, and adherence programs) across channels and the 
patient journey.
Next gen HCP portals  
(chatbots, NLP)
	• Next generation HCP portals with NLP and AI chatbots enable on-demand access 
to information and seeking peer opinion to improve care delivery, while broadening 
access opportunities for companies.
Connected  patient platforms 
(cloud/wearables)
	• Cloud-based connected patient platforms aggregate data from patient wearables 
and medical devices , track and analyze patient outcomes, and link patients to 
physicians and support groups to create longitudinal engagement.
Proactive market intelligence  
(Al/cloud)
	• Al enables curation and analysis of unique information sources to sense changes 
in the marketplace (such as likely changes to reimbursement practices, regulations, 
competitor tactics) that could affect launch strategies and competitive dynamics.
Source: Biopharma digital transformation: Gain an edge with leapfrog digital innovation. Deloitte, 2021.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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The need for education around these solutions is intensifying. If physicians are not educated on what digital therapeutics are 
and how they may help patients, they are unlikely to prescribe them. Staying up to date on regulations, the types of solutions 
available, clinical applications, digital biomarkers, etc. will remain an on-going need as technology evolves exponentially.42
Figure 5:  Differences between digital health, digital medicine, and digital therapeutics
Digital health venture funding boom
In 2021, US-digital health startups aimed at R&D in biopharma and medtech received funding totaling US$5.8 billion. Investor 
interest was fueled by the COVID-accelerated adoption of real-world evidence and decentralized trials. Overall, 2021 was a 
blockbuster year for US-based digital health startups, raising US$29.1 billion across 729 deals—nearly double the US$14.9 
billion raised in 2020, a previous record. There were nearly 23 exits via merger or acquisition monthly, almost double 2020’s 
monthly average of 12.43
2021 was also a big year for digital health in Europe. Europe had 34 digital health company exits in 2021 alone—half of the 68 
exits in Europe over the past decade. Babylon became the first European digital health company to list on public markets in a 
SPAC (Special Purpose Acquisition Company) in deal worth US$4.2 billion.44  
Digital Health 
Digital health includes technologies, platforms, and systems that engage consumers for lifestyle, wellness, and 
health-related purposes; capture, store or transmit health data; and/or support life science & clinical operations.
Digital Medicine 
Digital medicine includes evidence-based software and/or hardware products that 
measure and/or intervene in the services of human health.
Digital Therapeutics 
Digital therapeutic (DTx) products deliver evidence-
based therapeutic interventions to prevent, 
manage, or treat a medical disorder or disease.
Measurement products
No clinical evidence
Clinical evidence required
Clinical evidence and real-world outcomes reauired
Measurement & 
intervention products
Monotherapy
Adjunctive
Data & information 
capture, storage, and 
display
Data & information 
transmission 
	• User-facing technologies
	• Health Information 
Technology (HIT)
	• Consumer health 
information
	• Digital diagnostics
	• Digital biomarkers
	• Electronic clinical outcome 
assessments
	• Remote patient monitoring
	• Decision support software
	• Digital companions
	• Digital products that measure 
and intervene, and do not 
require human intervention 
to serve primary purpose
	• Designed to treat a disease 
by delivering therapeutic 
intervention digitally
	• Mostly used in mental 
heaIth as Cognitive 
Behavior Therapies (CBT) 
that can be digitally 
delivered to patients to 
treat several conditions
	• Designed to improve the 
effectiveness, management 
or treatment of a 
prescribed pharmacological 
intervention
	• Usually prevalent in 
complex indications such 
as diabetes, obesity and 
hypertension
	• Telehealth
	• Decision support software
	• Enterprise support Clinical 
care administration & 
management tools
Source: Digital therapeutics, Deloitte, 2021.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Merging different data silos from digital health partnerships or acquisitions remains a challenge 
 for many health care and life sciences companies. There should also be a better flow of data  
across payers, providers, and even manufacturers. Regulators are requiring data to become  
more transparent and user-friendly for patients.45 Enabling patients to provide feedback and  
concerns, allows patients to have more of a voice regarding how data is being captured and actioned upon.
Building holistic patient services experiences
Developing patient services in-house 
Life sciences companies typically manage patient services programs by therapy or therapeutic area. As patient engagement 
becomes more comprehensive—potentially with more value to the patient over a lifetime—an increasing number of life 
sciences companies are moving patient services in-house. An important first step to proving value for an in-house platform is 
starting small—with one or a limited number of therapies. A comprehensive program typically includes five areas:
Operationalizing a patient services program and moving it in-house requires integrating with internal and external systems 
and refining operations and processes. Service offerings should be modelled toward excellence in patient support. Innovating 
means analyzing key interactions to generate strategic insights that will inform the patient journey (see figure 6).47 
Figure 6:  Four stages to operationalizing a patient services program
Source:  Building patient services programs to deliver better patient experiences, therapy adherence, and improved health 
outcomes, Deloitte Digital, 2020.
Stabilize
Mature/evolve
Innovate
	• Refine service offerings
	• Refine operations and processes
	• Evaluate service delivery model 
(in-house vs. outsourced)
	• Establish governance and 
reporting
	• Evaluate service offerings and 
model toward excellence in 
patient support
	• Enable via process, technology, 
data for proactive measurement 
and monitoring
	• Optmize processes based on 
analytics
	• Analyze key interactions to 
generate insights and inform a 
data-driven patient journey
	• Augment and operationalize 
program based on strategic 
insights
	• Enable continuous improvement
STAGE  1
STAGE  3
STAGE  2
STAGE  4
Establish foundation
	• Define services and operating 
model
	• Enable foundational cloud-
based platform
	• Integrate with internal and 
external systems
	• Financial
	• Clinical 
	• Engagement
	• Education
	• Access to therapy46

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
27
Takeda’s OnePath is an example of a comprehensive in-house services program. OnePath is a dedicated ‘patient support 
manager” that provides one-on-one service to make sure patients have access to their prescribed therapy and a personalized 
product support plan. Services include navigating insurance, managing costs, getting prescriptions filled, and arranging 
training from a nurse. There is a dedicated website for the OnePath journey that also includes a library of resources for the 
patient.48
There are specialized solutions along the patient journey, with which companies will want to partner (vs. seek to build 
themselves). Services to facilitate scheduling, pharmacy e-commerce, drone distribution of medical supplies, best in class 
Natural Language Understanding, and the plethora of digital applications enhancing a specific touchpoint are all capabilities 
life sciences companies can harness and integrate to their in-house services programs. 
Working with partners in the ecosystem 
Partnerships across the ecosystem are also key. According to Betül Susamis Unaran, chief strategy and digital officer for Zur 
Rose, Europe’s largest e-commerce pharmacy. When different companies deliver different parts of the journey, everyone 
needs to come together to create ‘one experience’ for the patient.49 
Enabling many companies to come together to create a unified experience for the patient, Deloitte’s ConvergeHEALTH 
Connect platform prioritizes supporting patient journeys within connected ecosystems (see figure 7). Whether for 
observational studies, clinical trials, or therapy support, the patient service workflows extend beyond a single life sciences or 
health care enterprise. ConvergeHEALTH Connect drives standardization of workflows, like enrollment, benefits checks, and 
authorizations through a set of interfaces and APIs. Wherever opportunity exists, it eliminates manual workflows through 
automation.50 
In addition, the platform provides personalization and enables the “whenever, wherever” paradigm of patient access by 
providing seamless integration of communication channels like phone calls, secure messaging, and video chats. In each 
scenario —standard workflows, communication channels, or automation—the ConvergeHEALTH product team builds 
partnerships with best-in-class vendors for joint innovation.
Figure 7: Delivering effective patient/health consumer experiences in connected systems 
Convergence of Enterprise and Consumer
Health requires inﬁnite engagement loops...
....within connected digital health ecosystems.
Health 
Enterprise
transforming
itself
Health 
Consumer
transforming
itself
Study/Trial
Participant
Decentralized
Clinical Trials
Patient Services
and Engagement
Connected Care/ 
Remote Monitoring
Workplace Health
Wellness
Patient
Consumer
Enterprise
Customer
Ecosystem
Stakeholder
Employee
BioPharma
Public Sector
Payers
Providers
Medtech
Source:  Deloitte analysis.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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In 2022, it’s time to fully partner with patients as longitudinal partners to better understand their disease and improve care 
outcomes.54 Successful life sciences companies and stakeholders will be involving patients in co-creation, making investments 
in patient-centric digital capabilities, and working to create holistic experiences whether in-house or with partners in the 
ecosystem. Organizations that reimagine their business models, and put the consumer-patient at the center, are likely to 
succeed in transforming the patient’s journey of care and deliver better outcomes.55
Ping An Good Doctor and Chugai Pharma China strategic partnership for osteoporosis
Ping An Good Doctor (Ping An Healthcare and Technology Company Limited) and Chugai Pharma China (Chugai Pharma 
China Co., Ltd.) are establishing a whole course management system for osteoporosis patients, including an osteoporosis 
clinic. Approximately 20% of the population over 50 years of age suffer from osteoporosis in China, but only 7% are aware 
of the disease. The treatment is complex—involving multiple medical departments including orthopedics, endocrinology, 
rheumatology, and immunology, etc.—but lacks a professional full-cycle care management platform.51  
Ping An Good Doctor is a health care platform working with pharmaceutical company, Chugai Pharma China, to enhance 
drug accessibility, medication guidance management, and sharing of pioneering academic findings to benefit more patients. 
The clinic is integrating services for osteoporosis patients, including health education, disease prevention, consultation, drug 
purchasing, and rehabilitation etc.—optimizing the online and offline closed-loop management system. Ping An Good Doctor 
is offering personalized solutions for patients and adjusting treatment strategies by tracking health data.52  
There are more than 400 million users on Ping An Good Doctor’s health care platform, and China’s health care sector is 
projected to grow by more than 10% annually. Ping An Good Doctor is forging many alliances, including offline-to-online co-
operation deals with 189,000 pharmacies, over 4,000 hospitals, around 1,700 checkup centers and more than 1,800 medical 
institutions, a network that keeps growing every month.53

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The COVID-19 pandemic permanently altered society’s view of work. The biggest transformational shift came from, not “where” work 
was done, but “how”—a wholly digital way of working.1 Life sciences companies are still optimizing virtual ways of working, and other 
issues of concern for life science leaders in 2022 include: 
	• What is our talent acquisition strategy? How do we secure in-demand skills and capabilties in a competitive market?
	• What are the “Great Resignation” effects on our company? How can we create a more meaningful talent experience? 
	• How can we become a more agile and adaptable organization?
Life sciences companies that want to succeed in the future of work will need to be flexible in how work is done and how talent is 
sourced, trained, and managed.2 Human resources is also undergoing a massive transformation. Instead of trying to predict the 
future, leaders might consider how they can develop an open culture of experimentation, learning, and iteration.3 
Developing new talent strategies will be a challenge for Human Resources (HR) in 2022. Leaders will need to find competitive 
advantages to address skills and talent shortages (e.g., digital and data analytics skills).4 Competition for workers will grow as the 
effects of the “Great Resignation” are now being felt at every level. Many older workers chose early retirement, and more than 40% of 
the global workforce is looking for new jobs, including 54% of Gen Z.5 Even high-level executives, including the C-suite, are quitting their 
jobs to spend time with their families.6 
Transforming the talent experience

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Aggressive hiring practices are poaching talent at all levels—potentially inflating titles and compensation. Rising inflation poses 
more challenges. Recent Deloitte research looks at a variety of potential inflation scenarios and key decisions executives 
will need to consider going forward. In the worst case scenario, inflation rises to 8-9% and becomes embedded in worker 
expectations and a “wage-price spiral” takes off. Companies may need to seriously consider cost-saving labor models—
offshore, automation, and labor-as-a-service.7 
Throughout the next year, many life sciences companies will continue to grapple with how to solve these issues, and each will 
land in a different place on the spectrum. The “Great Resignation” is calling for a “Great Re-imagination”, and a winning strategy 
includes creating value for workers as whole human beings and key stakeholders—including internal and external workers.8 
In a technological world, meeting the needs of humans has never been more important.9 By harmonizing technology and 
worker preferences, life sciences companies can deliver more flexible and meaningful talent experiences and become more 
adaptable organizations.10
Massive shifts in talent models
Successful companies are no longer concentrating on just hiring the 
smartest people, but rather on having access to the smartest people.12 
New workforce ecosystems include in-house employees combined 
with a diverse mix of external contributors—e.g., contractors, app 
developers, other gig workers, external partners and suppliers, and 
even software bots.13 According to recent research from MIT Sloan 
Management Review and Deloitte, only 28% of global managers feel 
they are sufficiently preparing to manage a workforce that will rely more 
on external participants.14 
One agile strategy is to shift from a hierarchical structure to a more 
team- and networked-based approach that may combine internal and 
external workers into specialized or cross-functional teams. To support 
cross-functional engagement, organizations might consider sharing 
owned facilities with suppliers and partners.15 
An agile work environment allows for choice and flexibility. Teams 
are formed to address specific problems, such as launching a new 
product, optimizing a process, analyzing market trends, understanding 
customers and their needs, and so on.16 In 2022, effective leaders in 
team environments will be mentors—more than managers—and digital 
enablers, embracing role mobility and job agility.17
In a business-as-usual environment, HR is a trusted partner to the 
business but, in a pandemic, we are leading the fight. The future of 
work remains undefined, I believe it will be marked by continuous 
organizational change with HR orchestrating transformation from within.
Agnieszka Romanczuk, Director, Human Resources, Japan and Asia-Pacific, AbbVie11
Helping people thrive in a large organization, 
ditching hierarchy for teams
Roche Pharmaceuticals, based in Basel Switzerland, is 
moving away from traditional hierarchy to autonomous, 
self-organizing teams—putting people and patients 
first.  According to Roche’s pharma CEO, William (Bill) 
Anderson, with a team approach, workers are much 
more accountable to their teams.  Anderson says that 
Roche is allowing teams to request the funds necessary 
to fulfill an objective or to solve a problem. “We only ask 
that they: 1) drive medical advances, 2) thrill customers 
and patients, and 3) make best use of company 
resources. We talk about how they did later,” says 
Anderson. The team approach is proving to be much 
more efficient. “Spending actually went down,” he says. 
There is more team pressure to deliver on an objective 
and use company resources wisely.19

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The workplace is now a virtual place 
As organizations are reimagining work, physical space and the need for facilities, and who needs to be in the office,21 they 
might start thinking about the workplace as a virtual place—a digital office for working. A virtual office is where team members 
gather digitally and use collaborative tools to solve problems in the pursuit of organizational goals—no matter where anyone is 
physically located (see figure 1).22 
Figure 1: Concepts for thinking differently about the workplace
Term
Definition
The digital workplace
The digital overlay that enables the physical work experience (typically in an office), including 
smart building technology, digital user interfaces (apps, portals), data collection, predictive 
technology.
Working digitally
Work that is agnostic of physical space or place, as it is done digitally (rather than physically) and 
so adheres to different rules and norms.
The virtual office
A “digital” place to work: the technologies (tools and media) that allow people to work individually 
and as a team anywhere, anytime, anyhow.
Digital offers a way to unbundle the workplace and create new solutions. For example, the pandemic caused some 
employees to feel isolated with remote work, in addition to experiencing loneliness in everyday life.24 Workers may also 
want to set boundaries between work and homelife for virtual work. A return to the office may not be the only option for 
someone unhappy working from home. Organizations might provide a co-working space close to home for the desired work 
environment, along with the benefit of a shorter commute.25 Empowering workers to work from a location that suits them 
promotes a better work/life balance.26 
Supporting flexible, hybrid work 
Offering workers a choice
Every life sciences organization must determine the work environment best-suited to its various operations and teams. 
Processes that require labs, such as clinical research or toxicology, are not viable for remote work, but many other 
pharmaceutical processes can be executed remotely.27 
Deloitte research finds employee engagement—which is directly correlated 
with productivity—is at its highest among employees who spend 60-80% of 
their time working remotely.28 
Source: Reconstructing the workplace: The digital-ready organization, Deloitte, 2021.23
I strongly believe when you invite folks to co-create a 
transformational process from the beginning, they’re more likely to 
contribute to the longer-term effort required to make it a reality.
Eva McLellan, Head of Business Strategy, Transformation, and Innovation, Roche Pharmaceuticals20

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Almost half of employees29 and a majority of millennials report they would give up some work benefits for a more flexible 
working space.30 As the workforce shrinks, attracting and retaining young talent by offering a choice of work style may be a 
competitive advantage.31 
Before the pandemic, it was rare to ask: “What would be your preference, if your role allowed for greater flexibility?”32 However, 
the success of a hybrid model depends on researching preferences. In Japan, despite being offered a choice of work style, 
many still carry the belief that an office presence is required. These workers may need to be encouraged to take a remote or 
hybrid option by companies asserting that the choice is acceptable, and maybe even preferred.33 
In Germany, ‘modern rules for mobile working in Germany’ are in development, creating a legal right to work from home. With 
this change, all employees would be allowed to work from home, so long as their presence isn’t necessarily required at the 
office; employers would only be allowed to refuse for compelling reasons.34 
We believe that the key to an energized work environment is 
recognizing individual needs and supporting a healthy work-life 
balance. That’s why we offer flexible workspaces and benefits, with 
some of our sites organizing volunteer activities, while others offering 
a range of initiatives that include gyms and sports events.
AztraZeneca in China35
Culture, collaboration, and co-location 
Can life sciences’ company culture evolve and thrive?
New ways of working are testing whether life sciences company culture can evolve and thrive. Work may never revert to pre-
pandemic culture, and preserving collaboration is central to life sciences companies. Challenges of hybrid and virtual work 
may become a source of tension between an organization and its workforce as they try to figure out how to build community, 
culture, and engagement—critical for retaining talent. 
Geographical differences also complicate global strategies for remote work and employment models. For example, Swiss 
global life sciences companies must consider tax compliance risks. Switzerland has separate tax agreements with different 
countries regarding frontier workers—workers who typically return to their foreign place of residence every day. The 
pandemic’s working-from-home arrangments prompted new cross-border agreements, but in 2022, Switzerland is expected 
to clarify post-pandemic terms for frontier workers.36

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Reevaluating the need to keep workers in “expensive” locations 
While considering administrative and operational implications and tax compliance risks,  
life sciences organizations are also reevaluating their location strategies for various teams  
and individuals and the need to keep people in “expensive” geographies. Some office-centric, knowledge-based work does not 
need to be in legacy locations.
Global life sciences enterprises should consider: 
	• What are the reasons to maintain or retain talent in those areas? 
	• How can we be more targeted in getting the best talent where it’s needed most? 
	• How can some tactical, less-knowledge centric work be moved to a better location or to remote work to suit talent 
preferences and growth needs?
The culture for the type of work also matters, and organizations should facilitate different types of collaboration tailored to the 
specific work to be done. Certain specialized team members, like data scientists, may benefit from co-located teams and face-
to-face collaboration. Organizations should create a space for a data-driven and connected community.
Fierce competition for digital and data science talent 
Data is changing life sciences. New products with greater digitization—such as next-gen therapies and software-powered 
medical devices—require an understanding of customer needs and feedback through data. Life sciences companies need 
digital talent, software engineers, and data scientists who understand how to design a digital product and solution that meets 
patient needs.
Hiring data science talent is completely different from how the sector has hired in the past. Organizations will need to 
differentiate hiring practices because these specialists are difficult to source. There are also so few people that are true 
data scientists. Organizations should consider retraining existing employees who already have the necessary scientific 
background.38 
In addition, data scientists in enterprise offices differ from data scientists in the Research & Development (R&D) lab. R&D relies 
more heavily on data to drive towards specific outcomes—requiring intricate and deep skill sets (see figure 2).
Incorporating data science into everything we do is transforming 
the way that our organization answers the question of ‘what is 
possible,’ including the way we conceive of, develop, and provide 
treatment options to our patients.
Mathai Mammen, Global Head of R&D, Janssen Pharmaceutical Companies of Johnson & Johnson 37

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
34
Figure 2: Data science in biopharma
Trends Driving Investment in Data Science
Common Data Science Applications
Patient
Centricity
Data
Liquidity
Regulatory
Guidance
Shift to Value
Growing Cost
of R&D
Patients moving to the 
center as a consumer 
of health care and 
owner of data
Explosion of patient 
health data, available 
from new sources and 
accessible for research 
from new pathways
Growing interest from 
regulators (e.g., FDA) 
supporting use of RWE 
in regulatory ﬁlings
Transforming 
reimbursement model, 
value-based models 
underpinned by RWE
Costs to develop a 
new drug rapidly 
approaching $2.6B, 
and overall care costs 
continue to rise
Biopharma Objective 
Data Science Support 
Accelerate discovery & development 
processes 
Expand access to disparate sources of existing data (e.g., patent data sets, 
publications ' clinical trial data RWD) 
Improve data quality & robustness of 
insights
Apply emerging digital enablers (e.g., AI, machine/deep learning, NLP; blockchain; 
and cloud) to expanding ﬂow of data 
Serve targeted populations w/ 
precision medicine
Gain complete/nuanced picture of the patient journey to enable development of 
targeted medicines for sub-groups
Increase trial eﬃciency
Harness big data to identify patient sub-populations (e.g., responders, non-re-
sponders) and optimize recruitment 
Accelerate drug approvals 
Combine clinical data and RWD to support novel regulatory pathways
Expand patient access to therapies
Use RWD to drive new reimbursement models and novel payment agreements 
Improve drug delivery "in the wild" 
Analyze RWD to understand patient behavior/ inform targeted services for 
speciﬁc demographics or at-risk patients 
Proactively monitor patient safety
Utilize real-time, unstructured data (e.g., social media) to identify signals of 
potential safety/operational risks 
Source: Deloitte analysis
Future-proofing data science roles in life sciences 
The skills in demand in biopharma companies are rapidly changing, and the types of new skills needed are growing. R&D 
organizations are posting 7 times more data science positions than they did 5 years ago. In addition to overall data science, the 
skills growing in most demand are python and machine learning.
Roles are also evolving, and anticipating change is critical to future-proofing an organization. For example, the worker 
profile for a Statistical Programmer or Biostatistician may evolve into a Data Strategy Manager role. To prepare, life sciences 
organizations can start by developing future proficiencies now (see figure 3).

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Figure 3: Biostatistician to Data Strategy Manager, current skills and future proficiencies 
Current Proficiency
Future Proficiency
Critical Thinking &  
Problem Solving
Managing Diverse 
& Virtual Teams
Operational tasks
HUMAN
Machine Learning 
and AI
Data Visualization
Data Protection & 
Integrity
Data Entry
TECH
TOP SKILLS
Source: Deloitte analysis
Reimagining work is a CEO strategic priority 
According to a recent Fortune/Deloitte CEO Survey, attracting and retaining talent in a tight labor market has ascended to the 
top of CEOs’ list of strategic priorities. Companies should reimagine work as a landscape of tasks and skills that dynamically 
evolves with business priorities.39 
By 2025, an estimated 40% of core skills will change for workers.40 Life Sciences will be competing from within and outside the 
industry for the same digital and data talent (see figure 4).41 The dearth of talent to support digital transformation initiatives is 
one of the biggest barriers to overcome, and expanding and upskilling talent should be a top investment priority.42 
Figure 4: Digital Job growth acceleration, 2020 to 2025
Virtual work, recruiting from wider geographies, and acquiring talent outside of the industry (e.g., consumer-tech companies 
with different perspectives and skill sets) are strategies for expanding the digital talent pool.43 Life sciences companies 
should also clearly define career pathing options and tasks, provide opportunities for all colleagues to improve their digital 
and data literacy, and implement scalable technology. A new distributed work model coupled with efficient, secure network 
communication tools will be essential to an organization’s success.44 
Source: Microsoft
Cloud and data roles
23M
new jobs 
by 2025
2020
41M
2022
66M
2024
127M
2021
51M
2023
90M
2025
190M
Job capacity
149M
Privacy and trust
1M
Data analysis, machine 
learning, and AI
20M
Cybersecurity
6M
Software development
98M

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Seismic changes in the life sciences regulatory landscape
Responses to the pandemic varied by country but still drove significant, broad-reaching change in the regulatory landscape. Public- 
and private-sector actors engaged in wide-scale collaboration, cooperation, and information sharing. Research and regulatory 
processes were digitalized and accelerated and may never be the same again.1
Reducing timelines from 10 years to 10 months
The speed at which vaccines were able to be developed and approved through expedited regulatory processes was unprecedented, 
and the focus remained on safety and efficacy despite the speed. The 10 months it took for the Pfizer-BioNTech COVID-19 vaccine to 
be developed, and to gain Emergency Use Authorization, is in direct contrast to the 10 plus years it takes for a typical cancer drug. As 
a result, the pandemic created a paradigm shift in expectations, and regulatory processes will likely become more streamlined going 
forward.
Getting medicines to patients quicker while maintaining safety is a priority for regulatory agencies as well as stakeholders. Tools such 
as Accelerated Approval, Priority Review, Breakthrough Therapy, Fast Track, and Rolling Submissions (see figure 1)2 expedited approval 
of COVID-related vaccines and treatments.3  
Regulatory: Mastering external forces

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What is a rolling submission or rolling review?
A regulator receives key portions of a drug application as it becomes available, 
instead of waiting for the full data package. Regulators can request additional 
information and get clarification quicker. Being able to review data in waves 
expedites timelines.7 
Growing trend in rolling submissions fueled by Real World Data
In the coming year, more companies are likely to accelerate regulatory approvals through rolling submissions and clinical, 
production, and distribution activities done in parallel as these practices became more widely accepted.4 For example, Canada 
never used the rolling submission or rolling review process before the pandemic.5 The option is now available under Canada’s 
Federal Drug Regulations.6 
Rolling submissions illuminate the power of real-time, real world evidence as a critical tool for regulators. More innovation is 
expected in 2022 as companies adopt data management tools that automate and speed up the work of ingesting, aggregating 
and cleaning data so that it’s easier to analyze, report on, and share with regulators.8
In the United States, the FDA is committed to understanding the full potential of RWD and RWE in regulatory decision-making. 
The agency is engaging with sponsors on the topic and creating mobile and web applications that can collect RWD.9 
While emergencies demand speedy responses, regulatory agencies cannot operate on a permanent emergency footing. Many 
life sciences and medtech companies will be working with regulators to see how some of the processes utilized during the 
pandemic may be maintained for non-COVID submissions as well.
In 2022, automating manual processes, finding new ways to process information, and simplifying data management systems 
will be part of improving patient safety and maintaining compliance. Modernizing pharmacovigilance data management to 
streamline safety operations and allowing safety departments to focus on the opportunity of managing their end-to-end 
pharmacovigilance processes more holistically and compliantly is expected to have a significant impact on speed throughout 
the regulatory process.10
Source:  Certara
Figure 1:  Example of rolling submission timeline
Feb
Apr
June
Mar
May
July
Aug
(Nonclinical)
NDA Part 1
(CMC)
NDA Part 2
(Clinical)
NDA Part 3

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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‘Lightspeed’ paradigm: Raising the end-to-end 
clinical success rate
The cost of failure is a significant challenge for the biopharma 
industry, making success rate a crucial driver of R&D 
productivity.11 For example, developing new cancer drugs is 
considerably difficult and expensive. Between 2000 and 2020, 
1,481 cancer drugs were selected for clinical trials, and only 115 
were approved—at an average cost of US$650 million per drug.12  
Vaccines have higher chances of being approved than other 
categories, but the failure rate is still high.13 
A decade ago, Pfizer began its journey to improve its R&D 
productivity—which was lagging industry benchmarks—without 
compromising scientific innovation.14 Improving its asset success 
rate is a Key Performance Indicator (KPI) for Pfizer and a ’bold 
move’ initiative to deliver first-in-class science.15 The company 
was able to raise its end-to-end clinical success rate (First-in-
Human to regulatory approval) from 2% in 2010 to 21% in 2020—
when the peer average was 11%. Pfizer credits its lightspeed 
paradigm as the driver behind the success of the Pfizer-BioNTech 
COVID-19 vaccine.16  
In December 2021, Pfizer published its paradigm for achieving 
end-to-end success in the clinic to share information with 
other biopharmaceutical R&D organizations. Deloitte spoke 
with Gautam Gupta, Pfizer’s senior vice president and head of 
strategy, for insights on the lightspeed paradigm and its role in 
regulatory approvals.
What can you tell us about Pfizer’s lightspeed 
process for maximizing R&D productivity?
Gupta: Lightspeed is more than a mindset, it’s also an investment 
approach. It’s how you make decisions around the progression 
of assets and which activities you do at risk before you have 
the data versus when you have data and certainty. It’s doing 
certain activities in parallel versus sequentially (e.g. starting 
commercial manufacturing while late phase trials are still 
ongoing) and having a very different governance process for 
how decisions are made. 
All of these things contribute to the speed at which we were able 
to move for the vaccine and our COVID antiviral pill, Paxlovid®. We 
plan to bring this approach to other key assets in our pipeline—
oncology, rare diseases, and even follow-on mRNA programs in 
the vaccine space. We designate an asset for lightspeed, if there 
is a significant medical need to move quickly, and often, there 
is competitive pressure as well.
How do you not revert?
Gupta: It’s always tricky to be honest. But there are three 
imperatives. In large companies, you do need top-down push 
and sponsorship. Our CEO, Albert Bourla, or one of his direct 
reports, has to almost personally be championing a program 
or the default mechanism is to go back to traditional ways of 
working. Senior leadership is meeting regularly, asking for 
updates. They’re not accepting anything less than lightspeed in 
terms of timelines and project plans, etc. That’s one way. 
Another is making sure funding follows that intent to move 
quickly and to do things differently with these programs. You 
need to prioritize how you’re going to deploy your capital and 
your R&D budget, making sure these programs are absolutely 
getting the right amount of resourcing. Then, everything else gets 
funded and resourced.
Third, is a very proactive dialogue with regulators, making sure 
external stakeholders are coming along for that speedy journey 
where possible. Regulators need to move equally quickly—
whether it’s approving R&D plans, reviewing data, rolling 
submissions, etc. We make sure to invest the time with them and 
bring them along the journey.
What is a key learning from lightspeed in the vaccine 
process?
Gupta: Real world data, real-time analytics, real world evidence 
were critical, especially in the early days of the pandemic. 
Determining where outbreaks were going to happen, how the 
virus was mutating, and how it is affecting certain populations 
and comorbidities. Also, using the predictive power of AI to 
try and predict where we should be opening clinical sites or 
recruiting globally.
What is it like to drive strategy through uncertainty?
Gupta: The pure strategist part of me is very excited because 
you get to do strategy work that you wouldn’t necessarily need 
to do if the world was very, very certain. The other part that’s 
exciting—and maybe this is a bit more about being at Pfizer and 
the success we’ve had—is that it’s encouraging us to be bigger 
and bolder in our thinking, in terms of our future ambitions and 
our goals.
Comments edited for brevity.
We had an interesting experiment 
collaborating with Israel to 
exclusively use the Pfizer-BioNTech 
vaccine across the entire country. 
It was almost a controlled clinical 
trial, but for the whole country. We 
received unmatched real world data 
about efficacy and safety that is still 
yielding essential insights on the 
fast changing virus—what’s needed, 
what’s effective and what’s not—for 
boosters, children, and variants.
Gautam Gupta 
Senior Vice President and Head of Strategy, Pfizer

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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New levels of international collaboration
Weekly virtual meetings for international regulators 
International and regional collaboration—among national and international regulators, stakeholders, and industry—has never 
been as important to medicines lifecycle development as it proved to be over the last 18 months.17 International collaborations 
among regulators focused mainly on expanding pre-existing collaborative working groups, creating clusters of technical 
experts, sharing research results, leveraging inspection reports, and disseminating information on how to help health care 
workers treat patients and stay safe (see figure 2).18   
Figure 02: Examples of regulators’ global collaborations 
Source: Never the same again: How COVID-19 created seismic change in global life sciences regulations, Deloitte, 2021
Japan
Canada
Australia
World Health Organization (WHO)
Regulators involved with  
the US FDA/EMA collaborations
	• Switzerland: Swissmedic
	• India: Indian Council of Medical 
Research, Health Ministry’s Screening 
Committee (HMSC), and Indian Council  
of Medical Research (ICMR) 
	• Brazil: ANVISA
	• Japan: Japanese regulators 
(PMA/MHLW) have been involved in 
collaborating with foreign nationals through 
international health initiatives, such as 
International Council for Harmonization of 
Technical Requirements for Pharmaceuticals 
for Human Use (ICH) and International 
Coalition of Medicines Regulatory 
Authorities (ICMRA), Pharmaceutical and 
Medical Devices Agency
China National Medical  
Products Administration (NMPA)
	• Chinese regulators soon shared the research results with 
WHO for worldwide research
	• China NMPA has also participated in an international 
collaboration initiative launched to accelerate the 
development of vaccines and medicines for COVID-19
Virtual meetings
 
US FDA
EMA
Clusters—expert  
technical groups
Mutual Recognition 
Agreement (MRA)—
Pharmaceutical Annex
International Coalition 
of Medicines Regulatory 
Authorities (ICMRA)
28 regulatory authorities

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In 2022, as technology accelerates and more digital processes and real-time sources of data are adopted by regulators, this 
international collaboration is expected to grow with ripple effects throughout the life sciences sector. The willingness to 
provide support and cooperation among regulators globally enhances the ability of work done by one authority to extend 
its reach— ultimately, harmonizing and speeding up the work of other regulators and approvals, getting patients access to 
medicines quicker, and driving even more innovation in R&D.19  
Modifying regulatory processes across the globe
Regulatory agencies across the globe came up with accelerated approval pathways for COVID-19 vaccines. Some changes 
affected long-term policy or opened the door to new processes.20 However, regulators missed developing an accelerated 
pathway for post-approval changes which is now a necessity.21 The following examples showcase modifications by country or 
territory.
United States: Operation Warp Speed (OWS) provided strong government financial and logistical support to accelerate 
vaccine development, distribution, and countermeasures such as the Coronavirus Treatment Acceleration Program (CTAP).22  
Regulators relaxed some requirements. For example, requirements for good manufacturing practices (GMP) for non–life 
sciences companies were relaxed, especially for ventilators and Personal Protective Equipment (PPE). Also, regulators allowed 
parallel processing of activities that are usually done sequentially to fund production before clinical trials were approved. This 
process also allowed phases of clinical trials to proceed before prior steps were approved.23    
Other regulatory modifications included issuing guidance to industry, closer interactions between regulators and life 
sciences companies to deliver real time scientific advice, waivers of certain application periods, improving engagement and 
communications pathways, and postponing and changing inspection processes.24 Inspections also moved virtually and/or 
international inspections relied on other regulatory bodies inspection results. 
China: Regulators accelerated the process for vaccines and drugs by offering priority conditional approval and priority review 
and approval, with the medical affairs department quickly generating clinical evidence after launch. The government also 
established the National Bureau of Disease Control and Prevention elevating the status of public health and the importance of 
disease prevention, a major shift in policy.25 
European Union: The European Medicines Agency established a pandemic Task Force (COVID- ETF) that provided, for 
example, rapid scientific advice, rolling reviews, expedited marketing authorizations and extensions, and compassionate use.26 
India: A rapid regulatory framework was created to fast-track regulatory approvals for vaccines, diagnostics, prophylactics, 
and therapeutics designed to prevent or treat COVID-19. India relaxed import requirements and amended clinical trial 
requirements, steps that helped India to obtain remdesivir.27  
Australia: The Therapeutic Goods Administration (TGA) does not have an ‘Emergency Use Authorization’ pathway for 
COVID-19 vaccines but does accept rolling data.28 Through the International Coalition of Medicines Regulatory Authorities 
(ICMRA), the TGA meets regularly with 30 international medicines regulators to address potential COVID-19 vaccines.29 
In 2022, regulators and life sciences companies might consider: 
	• 	Where did relaxing requirements present no, or extremely limited, new risks? 
	• Where might it make sense to permanently modify requirements? 
	• How can we develop a framework to be more flexible in the future?
Over the next year, finding ways to make drug development, manufacturing, 
distribution, and approval process timelines faster across the board while 
ensuring safety of users is likely to save money, time, and resources—and 
most importantly, benefit patients.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Impacts on ‘business as usual’
The pandemic did not have the huge impact on non-COVID regulatory approvals many feared, and concerns are likely to 
dissipate further in 202230 (see figure 3). ‘Normal business’ became a lower priority and experienced some setbacks. There 
was minimal disruption in clinical trials for non-COVID-19 products and a reduction in regulatory inspections and oversight. 
Figure 3:  Impacts on ‘business as usual’ in the United States, China, EU, Japan, and India
What’s next? Continued digitalization and collaboration
Embracing new ways of working: digital, virtual, and remote
Regulators adopted digital and virtual ways of working and collaborating as did the rest of the world during the pandemic. 
In the coming year, regulators are looking to improve data integrity of real-world evidence and are expected to continue 
embracing digital technologies and sharing worldwide research.31 
Remote approaches were adapted to conduct GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) regulatory 
oversight. Remote oversight is utilized to:
	• Share documents
	• Access relevant electronic systems and review data
	• Interview subject matter experts
	• Conduct facility tours and inspections32  
Regulators found video conferencing to be a valuable tool to develop an experience as close as possible to an on-site 
Source: Never the same again: How COVID-19 created seismic change in global life sciences regulations, Deloitte, 2021
US
China
EU
Japan
India
Approvals 
for non-
COVID-related 
products: 2019
91
Drugs: 45
MDs: 46
1,779
Drugs: 53
MDs: 1,726
Drugs: 66
MDs: N/A
167 
(all product 
approvals)
336
Approvals 
for non-
COVID-related 
products: 2020
112
Drugs: 53
MDs: 59
1,620
Drugs: 48
MDs: 1,572
Drugs: 97
MDs: N/A
153 
(all product 
approvals)
61 
(through Q1)
Regulatory 
inspections of 
LS companies 
by country 
regulators: 2019
4,770
No public data
643
155
453
Regulatory 
inspections of 
LS companies 
by country 
regulators: 2020
2,788
19,900
185 
(Q1 & Q2)
Unknown
113 
(through Q1)

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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inspection, including building rapport with inspectees. The way regulatory inspections may be conducted evolved into several 
models, and models are determined case by case (see figure 4). Direct access to documentation—electronic or otherwise—is 
expected, whether the inspection is on-site or remote.33  
In 2022, some on-site manufacturing inspections are, once again, being paused—now as a result of the Omicron variant. In 
the United States, the US FDA accrued a backlog of manufacturing inspections over the past two years. Prior to Omicron, the 
agency had been on track to complete its backlog of domestic drug plant inspections in 2022.34 
Figure 4: New models for regulatory inspections
Expanding Software as a Medical Device (SaMD) with AI
Technology giants continue to disrupt Life sciences and MedTech, including how work is done with regulators. Starting in 2017, 
Apple35 and Google’s Verily participated in the development of the US FDA’s Software Precertification (Pre-Cert) Pilot Program, 
an initiative to iteratively build and test a reimagined framework to regulate software-based products. The proposed approach 
aims to look first at the software developer or digital health technology developer, rather than primarily at the product, which 
is what US FDA currently does for traditional medical devices.36  
In 2022, SaMD is expected to evolve with a boom in AI/ML-based medical devices, and new policies are emerging:
United States: In 2021, the US FDA recently issued new guidance, the AI/ML-based SaMD Action Plan, to address the 
development, safety and effectiveness, and post-market monitoring of AI/ML tools. The agency is encouraging public input.37  
United Kingdom: The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is working on making software 
and AI devices more accessible, while protecting consumers from harm. A bold change is expected this year for a regulatory 
framework that will ensure that the United Kingdom is the home of responsible innovation for medical device software.38  
European Union: The Medical Device Coordination Group (MDCG) is defining regulatory standards for all EU member states 
through the development of a first-ever legal framework dedicated to ensuring trustworthy AI, including products qualified as 
medical device software (MDSW) with AI-driven functionalities.39 
Japan: The number of AI-based medical devices approved in Japan is still relatively low. Japan’s Ministry of Health, Labour and 
Welfare is implementing a five-year program for industry, academia, and government to work together on policy for AI-based 
medical devices, including the predictability of models and quality of data.40  
Term
Definition
On-site inspection
An inspection conducted physically on-site.
Remote inspection/distant 
assessment/evaluation
The process of conducting inspections, evaluations or assessments at a distance/virtually, 
supported by technology for communicating, sharing, reviewing, accessing systems, without 
the inspectors being physically present at the sites where they activities subject to an 
inspection have taken place/where the inspection would routinely be hosted.
Hybrid Inspection/
assessment
An inspection/assessment performed using a combination of on-site and remote means.
Collaborative inspections
Inspections involving two or more regulatory authorities.
Source:  Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 Pandemic, ICMRA, 
December 2021

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Over the next year, as agencies review and authorize a growing number of AI- and ML-based  
medical devices, regulators and manufacturers will likely gain new and important insights.41  
These devices will also help move the burden of many practical tasks from skilled physicians  
to clinical engineers, nurses, and other staff. Providers, as well as regulators, are likely to  
need additional skills and training.42
AI algorithms are different than conventional software. In order for regulators and providers around the world to trust the 
decisions and answers that AI-powered tools provide and allow their use for patients, manufacturers and developers will need 
to provide transparency and protect against errors and bias. Bias in training data may present not only ethical concerns, but 
the safety and performance of a medical device.43 
Changing policies for digital therapeutics
Regulators are enabling changes that will contribute to speeding up the adoption of digital therapeutics (DTx), with the United 
States, Germany, and Belgium leading the way. DTx are software-based products that provide clinical, real-world and, often, 
real-time evidence. They are most frequently SaMD, but not all DTx products qualify as SaMD.44 
United States: The Pre-Cert Pilot Program will help inform the development of a future regulatory model/process that will 
provide a more streamlined and efficient regulatory oversight of software-based medical devices. As the US FDA continues 
to identify, evaluate, and improve on Pre-Cert Pilot Program approaches to assure safety and effectiveness of products that 
require marketing authorization, the US FDA’s marketing authorizations for these products will continue under the US FDA’s 
existing regulatory pathways.45 
Germany: The Digital Healthcare Act 2019 (Digitale-Versorgung-Gesetz, DVG) paved the way for reimbursement for digital 
therapeutics (Digitale Gesundheitsanwendungen, or DiGA). Through DVG’s ‘Fast-Track Process’, digital therapeutics undergo 
a streamlined review in order to be included in a central registry of apps that can be prescribed by health care practitioners 
(HCPs) and psychotherapists and reimbursed by Germany’s statutory health insurance providers.46
Belgium: The National Institute for Health and Disability Insurance is approving digital therapeutics for reimbursement, 
provided the criteria for the top level of Belgium’s mobile health (mHealth) validation pyramid is met. This includes: CE marking 
as a medical device and meeting GDPR requirements, interoperability and connectivity tests, and demonstration of clinical and 
socio-economic added value.47 
Meeting the moment for consumers
Consumerism is driving the rapid growth of digital health technologies. Regulators, along with life sciences and medtech 
organizations, are starting to meet the moment. Actions taken by governments, regulators, and organizations during the 
pandemic accelerated innovation in products and supply chains and increased the adoption of new technologies and 
processes. 
New entrants were also welcomed into the life sciences market to meet consumer needs. In 2022, tech giants, as well as 
startups, are expected to continue to threaten the status quo. The sector must continue to collaborate with regulators and 
other stakeholders to make sure that the positive changes driven by digital technology innovation during the pandemic are 
preserved and improved upon for the future (see figure 5).

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Figure 5: Digital technology adoption at full tilt (US, China, EU, Japan, India)
United 
States
The FDA used digital platforms for reviews and approvals of products and clinical trials and for remote 
inspections. The Center for Medicare and Medicaid Services (CMS) issued temporary measures for 
people enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) to receive 
telehealth services during the public health emergency. Changes allowed providers to conduct 
telehealth visits in patients’ homes, practice remote care across state lines, and bill for telehealth 
services as if provided in person. Many individual states also relaxed telemedicine restrictions and 
allowed out-of-state professionals to provide telehealth services.
Accelerated use of technologies: 
	• Wearables for real-time vital signs monitoring
	• Electronic diaries for real-time data capture
	• Image harvesting through smartphone cameras
	• Telemedicine technology and advanced analytics
	• Electronic signatures for patient consent forms
	• Use of electronic health records as a source of truth for remote monitoring
China
The National Healthcare Security Administration (NHSA) and National Health Commission (NHC) issued 
guidance on “Internet +” medical insurance services during the pandemic. This guidance enables medical 
institutions to provide online follow-up for diseases and obtain insurance reimbursements.
The government also proposed relaxing the scope of internet diagnosis and treatment, including 
qualified services in the scope of medical insurance reimbursement, and unifying internet medical 
examination and approval standards.
European 
Union
The EMA expanded the types of trials that may use remote source data verification (rSDV) in addition to 
onsite, centralized, and offsite trial monitoring. 
As needed, remote site inspections of facilities were to be carried out, with onsite inspection to follow 
when circumstances permit. EU governments approved remote working for life sciences companies 
where possible. 
To enable business continuity, in April 2020, the EMA issued guidance on regulatory expectations related 
to processes such as remote batch certification, remote audits, and remote inspections.
Japan
Regulators conducted remote GCP inspections. In April 2020, MHLW deregulated the ban on use of 
telemedicine for first-time visits to hospitals and permitted prescriptions using fax.
Although that is temporary, MHLW promised to enact telemedicine as a new form of health care based 
on expert opinion. MHLW will also likely consider promoting a system to complete interactions online, 
including medical examinations, electronic prescriptions, online medication guidance, and drug delivery.
India
Clinical trial sponsors and contract research organizations (CROs) employed a number of initiatives 
to minimize disruptions to clinical trials. Key among these is use of telemedicine and virtual media 
by doctors to track the well-being of clinical trial patients and remote monitoring of data by the trial 
sponsors and CROs to ensure data quality.
Bangalore-based Cardiac Design Labs developed its Telemetric Patient Monitoring System, which is a 
vital signs monitoring system, to monitor multiple patients remotely and simultaneously from a central 
location. The system, which uses wearable devices, can monitor a patient’s ECG, respiration, blood 
oxygen level, body temperature, and blood pressure.
Source: Never the same again: How COVID-19 created seismic change in global life sciences regulations, Deloitte, 2021

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Digital becomes our reality
Continued accelerated growth and record investment 
A recent Deloitte and Fortune report shows that 77% of CEOs across 15 industries say the COVID-19 crisis accelerated digital 
transformation, and CEO optimism about the year ahead remains strong.1 The digital transformation trend is expected to accelerate in 
2022 with a renewed drive towards more long-term strategic digital objectives.2
Digital innovation has been accelerated 10 years by what 
has happened over the course of the last 18 months.
Manoj Raghunandan, President, Global self-care and consumer experience for Johnson & Johnson.3
The digital enterprise at scale: A CEO 
imperative for 2022

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Deloitte also surveyed biopharma executives, and 82% believe that this trend will continue post-pandemic. Almost half believe 
they will need a better digital innovation strategy.4 For the first time, digital transformation spending is forecast to exceed 
US$10 trillion worldwide over the next five years, according to IDC (see figure 1).5 
Figure 1: Global digital transformation spending forecast, 2019-2025
Scaling digital for end-to-end transformation
More holistic and enterprise digital transformation in the life sciences sector is no longer a question of if or when, but how  
(see figure 2).6 As companies push digital at scale across the value chain, we are seeing digital transformation being tackled 
head-on by executive leadership—not just by the Chief Information Officers (CIO) or Chief Digital Officers (CDO), but by 
management teams at large.7 The digital imperative is being embedded in every business function—R&D, manufacturing, 
supply chain, and commercial—as well as core functions such as HR.8  
Source:  “IDC Spending Guide shows continued growth for digital transformation,” IDC, 9 November 2021.
Note:  DX represents digital transformation
$7.84
$10.55
$8.69
$10.12
$8.01
$9.70
$9.08
$9.06
$9.14
$9.74
$10.68
$9.59
$10
$9
$8
$7
$6
$5
V1 2019
(2018 - 2022)
V2 2019
(2019 - 2023)
Trillions
V1 2020
(2019 - 2023)
V2 2020
(2020 - 2024)
V1 2021
(2020 - 2024)
V2 2021
(2021 - 2025)
DX
Non-DX
DX
Non-DX
COVID-19 Impact

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Scaling digitalization and utilizing AI are likely to produce novel insights across the organization. According to Raghunandan, 
Johnson & Johnson’s focus is on connecting the organization end-to-end to create an improved and more transparent 
experience for consumers, customers, and suppliers. “This requires connecting all the data from the very beginning of 
research & development, through the supply chain, to our retail customers, and through to the consumer,” he says.9 
Figure 2: From ‘molecule to market’, digitalization across the value chain
Source: “Biopharma digital transformation: Gain an edge with leapfrog digital innovation”, Deloitte Insights, 8 December 2021.
Source:  MedTech commercial transformation: Moving from “doing digital” to “being digital”, Deloitte, 2020
Shifting from ‘doing digital’ to ‘being digital’
A scattershot approach to digital will no longer work for those who want to succeed in driving business value and delivering 
customer- and patient-centric experiences. Biopharma and medtech companies are expected to evolve from just doing 
digital—to being digital.10 Companies that ‘do digital’ still apply digital capabilities in an ad hoc manner without a cohesive 
vision. “Being digital” means designing and implementing a differentiating digital strategy and incorporating it into the 
organization’s DNA (see figure 3).11 
Figure 3:  Progression of ‘doing digital’ to ‘being digital’
Digital
innovation
north stars
Sample
innovations
Research
Development
Manufacturing
Supply chain
Commercial
• Virtual data
  assistants
• Interoperable
  data ecosystems
• AI-driven drug
  discovery
• Longitudinal
  engagement
  models
• Digital data ﬂow
• Digital patient
  monitoring
• AI-driven asset
  uptime
• Digital batch
  disposition
• Site command
  centers
• Predictive yield
  optimization
• Control towers
• Real-time tracking
  and tracing
• AI-based
  engagement
  recommendations
• Connected patient
  platforms
• Proactive market
  intelligence
Lab of the 
future
Patient-
centered and 
seamless trials
Predictive and
autonomous
supply chain
management
Precision
experiences
for patients
and partners
Smart factory
Powered by common technology capabilities
Exploring
Leverage traditional 
technologies to automate 
existing capabilities. Dabbling 
with digital. No real change to 
the organization
Doing
Leverage digital technologies 
to extend current capabilities, 
but largely same ways of 
organizing, operating & 
behaving
Becoming
Leverage digital 
technologies—becoming 
more synchronized and less 
siloed—with more advanced 
changes to ways of organizing, 
operating & behaving
Being
Ways of organizing, operating & 
behaving are optimized for 
digital and profoundly diﬀerent 
from prior ways of doing things
Don’t get stuck here in 
an illusion of ‘being’ 
digital with “Random 
acts of Digital”

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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What does “being digital” at scale really mean?
Digital at scale means companies are investing in agility, analytics, and automation—and integrating data. Without a plan for 
strategic use of data, tools are not likely to deliver the full value of digitalization.12 
At the core, being digital involves:
	• 	Moving beyond transactions creating a meaningful, differentiated, and personalized experience for customers and patients
	• Enabling more evidence-based decision-making for health care and payment
	• Modernizing processes/systems across the entire value chain and in core functions
	• Leveraging data/analytics to create actionable insights that drive growth and operational efficiency
	• Breaking down functional silos to create empowered and accountable multi-disciplinary teams that drive and track 
investment decisions and performance13 
	• Enhancing business agility to keep pace with the constant sea of changes14 
In the next 12 to 18 months, we will see more companies taking on the challenge of scaling digital and moving out of the trial 
and error phase. In China, favorable long-term policies, infrastructure upgrades, abundant capital markets, and the pandemic 
are promoting digitalization across Life Sciences and Health Care (see figure 4).15 
Figure 4:  Going digital in life sciences and health care
Source: Deloitte analysis
Digitalization
Medical
Services
Health Monitoring
Online consultations
Online diagnosis
Online prescription
Online retail
AI drug development
Health
Insurance
Medicine
Online payment
Online reimbursement

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Bringing enterprise agility to scale  
Fully transforming and scaling digital requires being agile and adaptable—one of the  
biggest challenges large, enterprise life sciences and medtech companies are struggling with  
in 2022. For many, becoming an adaptable organization represents a fundamental shift in operating and  
management philosophy.16  
Adopting a team-based approach to meet changing needs
Adopting enterprise agility enables large-scale global organizations to operate with a start-up mindset through empowered 
networks of teams that can pivot to meet changing needs.17 Team-based design focuses less on who people work for and 
more on who people work with.18 Organizing work along informal systems in the way people naturally behave helps maximize 
opportunities to drive experimentation, innovation, and idea generation—and makes for a happier workplace (see figure 5).19  
Figure 5:  Top-down formal structure vs. cross-functional collaboration
Leading transformational change with continuous improvement
In life sciences, we are seeing more companies adopting agility-rooted models throughout their organization—requiring 
leaders to know how to be more agile themselves. Agile leaders know how to lead through a crisis with resilience, and the 
pandemic tested these capabilities.20  
Those proven to be the most resilient were digitally savvy and adaptive—doing things differently.21 In a rapidly changing world, 
these capabilities will continue to be challenged, and winning life sciences enterprises will have the capacity for change and 
continuous improvement.
Source:  “The Adaptable Organization, Harnessing a networked enterprise of human resilience,” Deloitte, 2018.
How we think an organization 
works…
How it actually  
works…
Cross-Functional Informal Network
Functional Formal Structure

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Sustainable, scalable agility requires leaders who embrace an agile way of working—creating an environment for people to 
be great and a culture that fosters curiosity and learning.22 It requires leaders to think thematically to communicate across 
functions.23 Open and honest communication enables leaders to stay responsive to their workforce and the broader, still 
uncertain, pandemic landscape.24
As individuals in the workforce navigate this change, they are also solving for change in their personal lives. Successful leaders 
ensure that teams are supported with empathy and optimism, and that they provide psychological safety—allowing individuals 
to also communicate openly and safely.25
For Roche, being agile and displaying organizational agility means 
having a creative mindset and striking the right balance between 
speed, flexibility, and stability. Our investment in building creative 
leadership skills and a creative mindset has recently enabled us 
to overcome tremendous challenges during the pandemic and to 
find innovative ways to develop and deliver products urgently to 
patients and health care professionals.
Cris Wilbur, Chief People Officer, Roche.  
Leaders of multi-functional agile teams
Provide a clear vision
Lead with empathy and optimism
Comfortable in showing vulnerability
Communicate openly and transparently
Provide psychological safety
Orchestrate vs command and control (pull, not push)

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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51
51
How do you want to change the world?
Enterprise agility starts with a clear vision. Leaders need a clear vision to connect with their workforce and to convince 
others to align with that vision. The V2MOM (Vision, Values, Methods, Obstacles, and Measures) framework can help 
leaders clarify and communicate their vision and plot a course forward (see figure 6).
Figure 6: V2MOM framework to guide enterprise agility
The VRMOM framework is also a guide to decomposing an organization’s vision into actionable methods and measures. 
Metrics are established before anything else to track levels of customer value (not costs) and to drive decision-making. 
Four metrics to measure how change is making an impact include:
	• Are we better? Tracking reduction in production incidents and increased resilience
	• Are we delivering sooner? Tracking flow and increases in delivery times (from idea to delivery)
	• Are we safer? Tracking compliance issues and incidence rates
	• Are we happier? Tracking if employees and customers are happier
VISION
What do you 
want?
METHODS
How do you
get it?
VALUES
What’s important 
about it?
OBSTACLES
What might stand 
in the way?
MEASURES
How will you know 
you have it?
Source:  Deloitte analysis

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Large, legacy organizations vs. nimble, digitally-native organizations
Legacy life sciences organizations are being challenged by nimble startups—digitally-native companies that are already digital 
across the board. These companies are not tied to legacy systems, are more cloud ready, and have a different mindset.26 
Adopting more digitally-strategic objectives
Unlike traditional pharma companies, startups are likely to challenge the way things have historically been done. New players 
may question “why” problems are approached a certain way, jump right in to solve them, and then, get other players such as 
regulators on board—establishing new frontiers. Legacy organizations tend to focus on all the barriers to solving the problem, 
not the opportunity.27
By leveraging enterprise digital transformation, life sciences companies are starting to connect and elevate existing digital 
efforts into wider enterprise digital strategies for greater business value.28 Digitally-native companies are strategic in many 
ways that large enterprises can learn from and adapt, to become more insight- and experience-driven (see figure 7).29
Figure 7:  Digital strategic objectives
Currently, startups and legacy organizations are swapping executive talent to close their opposing experience gaps. Startups 
are looking for traditional pharma expertise to navigate an unfamiliar ecosystem, in particular, regulatory. Traditional pharma is 
looking to tech companies for consumer and digital experience, and agility.
Source:  “Enterprise digital transformation as a competitive necessity,” Deloitte, 2021.
Customer-in-focus models:
Drive business strategies and 
operations from the patient and HCP
Always-on agility: 
Rapid, nonlatent responses to planned or 
unforeseen environmental conditions
Fully connected community: 
Enterprise insights from democratized 
data and a fully connected business 
Intelligent optimization:
Management by exception and continually 
optimized processes enabled by more extensive 
data (e.g., loT), intelligent workﬂow, and 
human-machine decision-making
Predictive, holistic,
insight-driven analytics: 
Accelerated and improved insights and 
decision-making across the enterprise 
Flexible, virtual, unbounded
workforce and workplace: 
Leverage talent wherever it is

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Moderna: A peek into some processes of a digitally native biotech
One of the first digitally native biotech companies, Moderna, is unshackled from legacy  
organizational structures and norms, and building its digital infrastructure from the  
ground up. Its strategy is the enablement of parallel progress and shared learning. As a result,  
it is advancing its mRNA medicines at a breadth, speed, and scale uncommon in the life sciences industry. The startup 
has demonstrated its ability to rapidly and seamlessly move mRNA medicines from concept through research and clinical 
development to delivering for patients.30 
Moderna’s digital building blocks include: Cloud enablement, Integration of processes and data, smart interconnected 
devices, automation, analytics, and AI. Its scientific digital environment prioritizes two goals, the rational design of mRNA 
medicines and the acceleration of programs through research.
Technical development requires a broad spectrum of digital capabilities including electronic notebooks, structured data 
capture, integrated equipment, and high throughput testing. Early stage analytical development is performed using off-
the-shelf analytical software. When possible, Moderna leverages the same systems between Analytical Development and 
Quality Control to accelerate the transfer of testing methods to production—including a shared, cloud based HPLC (High-
Performance Liquid Chromatography) management system and integrated laboratory execution system. 
Clinical trial documentation is digitized using Veeva’s eTMF (electronic trial master file) system, and for clinical data 
collection, Moderna standardized on Medidata’s suite of products. Separate apps were designed for IMO (Investigational 
Medicines Office), Supply, Regulatory, and Toxicology.
In Norwood, MA, Moderna’s fully-digital manufacturing site was designed to be integrated and paperless without silos of 
legacy systems or data. Data is synchronized from dozens of source databases and systems into a single data warehouse 
using Amazon’s Redshift database. Moderna scientists run queries and discover insights from data collated from dozens 
of ongoing experiments stored in the cloud to refine their mRNA sequence designs. Then, its automated manufacturing 
facilities convert these sequences into physical mRNA for further experimentation and use in clinical trials. 
The company’s commercial engine is in its early stages and developing with the view that digitally-savvy patients will be 
looking for more than medicines, wanting digital solutions to better understand and manage their conditions.
Moderna’s core business functions (HR, Finance, Legal, Infrastructure) also take advantage of the cloud and a bevy of SaaS 
(software-as-a-service) applications. In addition to digital technologies, Moderna’s productivity is based on its platform 
technology and the ‘software-like’ nature of mRNA when used as a drug.31

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Establishing new ventures to gain agility
In medtech, the ability to translate customer sentiment and desires into new product development is becoming more critical 
as startups also challenge incumbents. Software-oriented products and consumer-focused technology companies utilize 
rapid development and iteration— a direct contrast to the more linear way medtech companies have historically engineered 
hardware products. Being agile allows startups to continuously create value and perfect what target users want.32 
To gain agility, some large medtech companies are acquiring or forming partnerships with smaller technology companies. 
However, a startup that comes into a legacy culture may not survive or thrive when absorbed into the larger parent company. 
The preferred path may be to establish a completely separate venture—underpinned by a growth- and transformation-
oriented mindset.33  
A small, nimble new venture might be better equipped to:
	• Capitalize on rapid shifts 
	• Enter new markets
	• Monetize growing data assets 
	• Execute on bold new ideas
	• Navigate nontraditional competitors
	• Leverage changing customer needs, demographics, and behaviors
	• Extend boundaries of the business, while building a legacy of 
leadership34 
Also key for success is selecting the right person to run the new venture. 
This individual should be both a realist and a visionary, have the trust 
of the CEO and board, and be confident enough to champion the 
entity’s independence, rather than trying to shoehorn it into an existing 
business unit.35 
Scaling AI across the value chain
Being agile means anticipating and responding to changes in market 
conditions, and digital technologies such as AI enable leaders to react 
and respond with more informed and tailored decision-making. AI is 
now widely recognized as a strategic business issue in Life Sciences and 
actively discussed at the board and C-suite levels.39 While AI is becoming 
mainstream, enterprise AI at scale remains a challenge for many 
organizations. 40
Integrating AI into the organization, top outcomes and challenges
Companies are prioritizing building AI capabilities for improving innovation across the organization.41 According to a recent 
Deloitte survey about the use of AI in life sciences globally, respondents expect top outcomes for AI will include enhancing 
existing products, creating new products and services, and making processes more efficient.42 Top challenges include difficulty 
in identifying business cases with the highest value, managing data, and integrating AI into the organization.43
In the year ahead, life sciences companies are expected to integrate AI more holistically into all processes—from preliminary 
research and clinical trials, to manufacturing, supply chain, and commercialization.44 
Startups leading medtech 
Deloitte teamed up with MedTech Innovator (MTI) to 
look through the lens of 1,000 medtech innovators 
participating in MTI’s global accelerator program in 
2021.36 These startups are developing a new class of 
digitally-enabled technologies—including Software 
as a Medical Device (SaMD), bespoke algorithms, 
wearables, and other connected devices. About 70% of 
their technologies include a digital-health component, 
and nearly 30% that identify as digital say they employ 
artificial intelligence (AI) and machine learning.37 
Most of these companies are focused on prevention, 
wellness, and diagnosis rather than treatment. Over the 
last three years, the share of point-of-care products has 
grown significantly—from 62% to 70%—among start-
up companies that have diagnostic products. Because 
site of care is shifting away from traditional inpatient 
settings, many early-stage innovators are designing 
products for use in outpatient locations or in the home. 
These products address diverse populations and 
accessibility, and 67% say they are designing products 
with health equity in mind.38

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Need for high quality data
For most organizations, the single most important AI building block is data. Getting access to the rich data that AI systems 
require and managing that data in a coordinated way across the enterprise are critical.45 Often, that means overcoming 
historically separate and siloed organizational structures that impede the accessibility of high quality data.46 Data scientists 
rely on having high quality, standardized, and referenceable data to produce the best insights.47
Advanced data collection and analysis is essential to:
	• Shortening the R&D cycle
	• Meeting the needs of patients
	• Transforming surgery from an isolated event to a connected, 
data-driven endeavor51  
	• Deepening the understanding of access issues across the 
globe
	• Creating tailored experiences for health care providers
	• Anticipating key challenges across the ecosystem, including 
those of suppliers and manufacturers52 
AI has the potential to expedite drug development, provide 
better decision-making for diagnosis and surgeries, help 
companies launch and market products more effectively, 
and make supply chains smarter and more responsive. With 
robust data, the potential use cases for AI in life sciences are 
nearly limitless,53 and the breadth of AI applications and rate of 
innovation are only expected to increase.54
Asking the right questions to reimagine medicine 
for the 21st century 
Data42 is Novartis’s research & development platform and 
one of the pharmaceutical industry’s largest data pools, 
hosting clinical data from nearly one million patients. The big 
data system—equipped with AI and “The Map of Life”—allows 
Novartis’ more than 20K researchers and developers access to a 
treasure trove of curated and linked data sets.49
Today, if a researcher has a question about cardiovascular 
disease, they are not limited to only cardiovascular data. They 
can explore links between all the data in 500 disease indications 
over decades of research through data that is clean and 
connected in one environment. The challenge of such a rich 
data set is that you need to ask the right questions to extract 
meaningful data. data42 works with their scientists on asking 
the right questions and finding new and creative uses for the 
data such as using already approved drugs for new uses.50
All the data needs to be cleaned and curated to make it 
machine-learnable. This is hard and cumbersome work, but it 
frees up our data scientists to focus on answering questions 
with data. Once all the data is curated, the potential to 
generate new insights is likely to be enormous.
Peter Speyer, Head of Products, data42 at Novartis.48

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Gaining an edge requires ongoing 
transformation
Life Sciences is in a stage of continuous improvement and ongoing 
transformation. Technology isn’t an end in itself but enables the 
capabilities essential for surviving an uncertain future.57 
Those who made investments prior to the pandemic— ahead of a known clear benefit—benefited from their bold vision and 
conviction. By doing things differently, they proved to be the most resilient.59 Through the pandemic, investments in AI and 
digitizing trial operations enabled most of the top 20 companies by R&D spend to keep pivotal trials moving without affecting 
anticipated launch timings.60  
In 2022, as life sciences executives address the urgency for more investments and take more risks, digital technology and 
AI are expected to come together to change the status quo and transform functional areas and value streams.61 It’s time to 
take advantage of this technological momentum and lessons learned from the pandemic—operating by being digital and 
competing by being agile. 
While some life sciences companies may remain ill-equipped to win in an environment teeming with disruptive forces,62 others 
will be positioning themselves to win with a capacity for change (see figure 8).63 The ability to sense, interpret, and execute 
strategic responses to major swings in the market and operating environment is enabled by bold strategic investments aligned 
to clear and compelling long-term ambitions.64 
Transforming digital surgery and colonoscopy 
with artificial intelligence 
Data and analytics, machine learning, and artificial 
intelligence are also advancing a more holistic digital 
surgery ecosystem. Johnson & Johnson Medical Device 
Companies are looking beyond robotic-assisted surgery 
systems to reimagine the entire care pathway. Data and 
analytics are being used to turn learnings from surgeons 
who have performed countless surgeries into insights and 
technologies that bring informed decision-making across 
the continuum of care.55 
Medtronic was given de novo clearance from the US 
FDA for its artificial intelligence system for colonoscopy. 
The company’s GI Genius intelligent endoscopy module 
uses advanced AI as a second observer (compatible 
with colonoscope video) to highlight the presence of 
precancerous lesions with a visual marker in real-time. 
Algorithms are used to identify and mark abnormalities 
consistent with cancerous polyps. Compared to 
colonoscopy alone, the GI Genius module demonstrated a 
14% absolute increase in adenoma detection rate (ADR).56
Technological innovation is 
continuous and accelerating, and 
technology needs to be applied to 
the very core of how a company 
operates and competes. The stakes 
are very high, and there is no finish 
line. Continuous transformation 
requires a growth mindset, a different 
way of leading an organization.
Rich Nanda, Principal, Deloitte Consulting, and 
Author, “The Transformation Myth”58

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Figure 8:  Triumphant traits: Ability to win and capacity for change
Long-term ambition
A clear and 
compelling vision and 
goals that remain 
stable over time
Resonant purpose
A mission and core 
values that custom-
ers, capital providers, 
and talent believe in 
and support
“Always-on” strategy 
and transformation
Dedicated resources and 
well-deﬁned processes for 
sensing, interpreting, and 
executing strategic 
responses to near- and 
long-term shifts in the 
market and operating 
environment
Diverse 
stakeholders
A diverse and wide 
range of ﬁnancial and 
nonﬁnancial 
stakeholders to fund 
initiatives, fuel 
responsive R&D, and 
accrue value across 
multiple time 
horizons
Unique intellectual 
property
Truly unique and 
diﬀerentiated assets, 
capabilities, ad 
resources that are 
not easily replicated 
or commoditized by 
competitors
Strategic 
nimbleness
The ability to sense, 
interpret, and 
respond advanta-
geously to change 
and disruption 
through organic and 
inorganic means
Operational
scalability
The ability to handle 
unanticipated 
increases (or 
decreases) in 
demand without a 
commensurate 
increase in cost
Organizational 
optionality
The ability to 
integrate new 
capabilities and 
redirect the value 
chain through 
ecosystem 
partnerships
Performance 
stability
The ability to 
maintain 
operational 
excellence and 
results orientation, 
particularly during 
periods of disruption
Ability to win
Strategic positioning
Distinctive advantages enabling the enterprise 
to maintain focus and compete for market 
leadership in the long term
Capacity for change
Strategic activation
The operating model enabling the enterprise to 
adapt advantages quickly and eﬀectively to shifts in 
the market and operating  environment

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Today’s headwinds, and the uncertainty that is expected to continue, will require life sciences companies to have agile manufacturing 
processes and resilent supply chains. This includes retooling technology and transforming environments.1
Scaling smart factory transformation
In 2022, more life science organizations are scaling smart factory capabilities to boost agility. Biopharma and medtech companies are 
investing in fully digitizing and integrating information technology (IT) and operational technology (OT) capabilities in manufacturing.2  
As smart factories scale, manufacturing organizations are looking for ways to:
	• 	Improve performance 
	• 	Make data integration sustainable
	• 	Upskill workers’ digital and data skills
	• Transform infrastructure and culture
	• Minimize cyber risk
Future-proofing manufacturing and 
supply chains

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Deloitte believes there are four drivers of performance for life sciences companies looking to get the most out of smart factory 
investments:
1.	 Human performance, reducing error rates on the production floor 
2.	 Process performance, getting that extra yield, extra gram of product 
from the current processes 
3.	 Asset performance, getting more up time from manufacturing 
assets
4.	 Network performance, optimizing the performance that you need 
across the entire manufacturing network3 
A high-performing smart factory empowers shop floor personnel with 
predictive analytics to take productivity and quality to the next level. As 
they analyze reams of data, asset performance issues can be revealed, 
allowing for more proactive and corrective optimization. The optimized 
processes, in turn, result in cost-effective production.4  
Making data integration sustainable 
Smart factories employ data-driven technologies—like artificial 
intelligence (AI), machine learning (ML), and the Internet of Things (IOT). 
(see figure 1).  By seamlessly connecting and integrating disparate 
manufacturing systems and processes, companies increase visibility 
and performance capabilities. Figure 1 shows the level of business case-
based opportunities for various medtech capabilities.
For example, on a digitized shop floor, machine intelligence is able to 
monitor processes and provide actionable insights for floor staff to 
reduce errors, deviations, and production losses.7 For biopharma, AI 
can predict asset maintenance requirements based on operational and 
maintenance history data stored in the cloud to prevent disruptions and 
loss of expensive APIs (Active Pharmaceutical Ingredients).8 
Figure 1: Smart factory digital transformation 
Estimating the net value of a smart factory 
investment
After a rapid assessment and identification of where 
digital capabilities could be scaled more effectively, 
a leading biotech/pharmaceutical manufacturer put 
numbers against a smart factory’s expected benefits. 
The company combined top-down financial analyses 
with bottom-up evaluations of the impact of the 
proposed use cases on operational key performance 
indicators (KPIs) at two pilot sites. The company then 
scaled the opportunities across the network at full 
potential to determine which benefits were recurring 
and which were one-offs. Finally, the company validated 
the scaling and clustering approach and confirmed 
business case input parameters such as duration, rate of 
return, and cost of capital.5  
The net value of the smart factory platform was 
projected to be at $50 million to $75 million year-over-
year in operational expense reduction on a baseline of 
$700 million—a direct bottom-line impact. This approach 
also created additional capacity that effectively negated 
the need for $500 million in capital expenditures over a 
five-year period.6
	• Dynamic Inventory 
Management/Fulfillment
	• RT Optimization of Product 
Parameters
	• Production Balancing – 
Capacity Sharing 
	• Scheduling/Resource 
Optimization
	• Vision/Sensor Tracking & 
Optimization
	• Asset Tracking – 
Equipment, Fixtures, Tools
	• Sensor Driven Inventory 
Tracking & Optimization
	• Smart Anomaly Detection
	• Continuous Product 
Inspection
Factory Synchronization 
and Dynamic Scheduling 
(including asset tracking)
Quality Sensing & Detection
	• XR Guided Manufacturing
	• XR Training 
	• Process Design & 
Simulation
	• Digital 3P (Production 
Preparation Process)
	• Real-time Asset 
Monitoring/ OEE insights
	• Pitch Chart
	• Real-time Process Analytics
	• Predictive Maintenance
	• Do Not Make, Do Not Ship
	• Perf Tuning/ML/Opt. for 
Env. Conditions
Augmented Worker 
Efficiency & Safety Solutions 
Engineering Collaboration/ 
Digital Twin 
Factory Asset Intelligence & 
Performance Management

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Figure 2: Business case-based oppportunities for medtech capabilities
Source: Deloitte analysis
Augmented 
Worker 
Eﬃciency & 
Safety Solutions 
Factory Asset
Intelligence and 
Performance Management 
Industry Sector
Overall MedTech Capabilities
Electromechanical Implantables
Mechanical Implantables
External Electromechanical Devices
Capital Equipment
Disposables
Instruments
Implant/Implant Support
Tissue/Biologic 
Factory Synchronization &
Dynamic Scheduling 
(Including Asset Tracking)
Engineering
Collaboration/
Digital Twin
Quality Sensing & 
Detection
XR Guided Mfg.
XR Training 
Real-time Asset 
Pitch Chart
Monitoring/OEE
 
Real-time
Process Analytics
Predictive 
Maintenance
Do Not Make,
Do Not Ship
Process Design & 
Digital 3P 
Simulation
insights
Perf Tuning/ML/ 
Opt. for Env. 
Conditions
Continuous 
Product 
Smart Anomaly 
Detection
Sensor Driven 
Inventory Tracking 
and Optimization
Asset Tracking – 
Equipment, 
Fixtures, tools
Vision/Sensor 
Tracking and 
Optimization
Scheduling/ 
Resource 
Optimization
Production 
Balancing – 
Capacity Sharing 
Dynamic Inventory 
Management/
RT Optimization of 
Prod. Parameters
Fulﬁllment
Inspection
LEGEND: Business Case-based Opportunity
High
Medium
Low
Legacy biopharmaceutical companies have grown and proliferated 
sources of data by establishing different systems across their operations. 
One of the fundamental challenges for a smart factory transformation is 
integrating those data sets from different sources—and making sense of 
them—with the least possible effort and investment.
Laks Pernenkil, Principal, Life Sciences Operations, Deloitte.9
Data integrity, a global issue for regulators
While investments already made represent huge opportunities, too often, they are impeded by manual and disconnected 
processes and documentation, especially if paper-based. Data integrity issues are a risk for life sciences companies,10 and a 
global issue for regulators. Poor documentation is a top data integrity concern covered in the US FDA’s Compliance Program 
7356.002M implemented 1 October 2021.11  
Regulatory intelligence platform REDICA Systems analyzed US FDA warning letters to manufacturing sites for 23 countries over 
a five-year period (see figure 3).12 Their research identified letters that included data integrity issues, and they were surprised 
to find that Canada led the list by percentage of issues.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Figure 3: Country comparison: Manufacturers with US FDA warning letters (WL) and letters identifying data integrity (DI) issues, 
2014-2019.
Automated processes still require upskilling workers’ digital and data skills 
Solutions that automate batch records and other documentation processes are designed to prevent incorrect, missing, or out-
of-date entries, but automation tools can be deployed with greater speed by less-technical people and that may pose a risk.14  
As companies pursue automation capabilities, they should develop a flexible, mature validation strategy to implement controls 
that support regulatory compliance and product safety.15 
Insufficient training and awareness is one of the factors that has made data integrity challenging for a while. Staff members are 
expected to fully understand all the requirements and standards relating to data integrity, and today’s environment requires 
upskilling workers’ digital and data capabilities.16  
If work is outsourced, life sciences companies maintain responsibility for the integrity of all data involved.17 Two clinical 
research organizations in India were recently told by regulators that studies would need to be redone due to data integrity 
issues—affecting an untold number of drug makers.18 
Transforming infrastructure and culture
In 2022, as life sciences companies look to change the innovation-averse DNA in some manufacturing organizations, they 
are also looking at ways to transform their infrastructure and culture. Companies might adopt a think-digital-to-be-digital 
mindset—considering how digital technologies augment human capabilities and change execution of processes. Shifting 
away from siloed manufacturing systems and processes requires building connectivity for the flow of information, data, and 
actionable insights.19 
Minimizing cyber risk
As connectivity expands, cyber risk increases. In 2020, manufacturing moved up the list of most targeted industries from 
8th to 2nd—a rise of 300% globally, according to the 2021 Global Threat Intelligence Report.20  Over the year, attacks against 
manufacturing increased from 7% to 22%; health care increased from 7% to 17%.21 
Organizations should have clear agreement on which data is most critical, who has access to that data, and an understanding 
about the potential impact if it is compromised. While no amount of money can make the risk completely disappear—and the 
long-term costs associated with data breaches can be difficult to quantify—brand reputation, supply chain, patient safety, and 
consumer trust may all be affected.22 
n-gram: Natural Language Processing (NLP) identifies a series of n items in text, in this case, data integrity issues.
Source: “What can regulatory data tell us about data integrity trends?” REDICA Systems, 31 August 2021.
Country
Number WLs with DI n-grams
Total Number of WLs
Percent with DI Issues
Canada
10
11
97
India
40
51
78
Japan
5
7
71
USA
9
13
69
China
40
62
65
South Korea
7
14
50

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Building supply chain resilience
Starting with a global suppply chain strategy
As disruptions to logistics and transportation impacted the timely delivery of products during the pandemic, life sciences 
companies rapidly digitalized their supply-chain operations. IoT solutions tracked and traced product shipments in real time 
and plugged gaps in supply-chain visibility.23 The ability to anticipate and react to disruptions and shifts quickly requires a 
resilient global supply chain strategy (see figure 4).24   
Figure 4: Building a resilient global supply chain strategy
Regionalizing supply and continuous manufacturing
The pandemic created new urgency to reduce dependence on bulk active ingredients and generic drugs sourced from India 
and China. Manufacturers in Europe and the United States are building new in-country API development and manufacturing 
capabilities.25 In addition to reshoring and regionalizing the supply of critical materials, companies are using innovative, 
continuous manufacturing to mitigate supply chain risks.26 
Raw Material 
Supplier
MANAGE
SUPPLY RISK
USE A PATIENT-
CENTRIC APPROACH
STRENGTHEN 
PUBLIC-PRIVATE 
PARTNERSHIPS
ENHANCE E2E VISIBILITY
THROUGH DIGITIZATION
Manufacturer
Distributor
Hospital
Provider
Patient
Government /
 Health Authorities
Conduct 
thorough supply 
and supplier risk 
assessments
Increase supply 
redundancy 
through 
multi-source 
awards
Increase safety 
stock of critical 
materials
Regionalize the 
supply of critical 
materials where 
possible
Resilience
!2
!4
!3
1
Build digital 
capabilities to 
support changing 
consumer 
behaviors
 
Implement risk 
sensing solutions 
to gain real time 
understanding of 
consumer needs 
and pain points
12
Identify 
collaboration 
opportunities 
with federal, state 
and local 
governments
Engage with the 
public sector to 
solve chronic 
shortages of 
critical products
14
15
13
5
6
7
8
Develop forward-sensing abilities to improve demand prediction
Leverage analytics and establish control towers to gain greater E2E visibility
Increase data sharing and transparency with customers and partners
Explore opportunities to harvest cutting edge technologies
BOOST SUPPLY
CHAIN AGILITY
9
10
11
Stress-test business continuity plans to prepare for the next crisis
Build redundancy into operations
Empower teams through increased workforce ﬂexibility
Source:  “The Semiconductor Chip Shortage Hits MedTech: Strategies to Build Resilient Supply Chains,” AdvaMed/Deloitte, 2021.
Continuous manufacturing is a way for drug manufacturers to more easily adapt  
supply to demand
Fully end-to-end systems, like CONTINUUS’ Integrated Continuous Manufacturing (ICM) platform, seek to encompass 
both API and final dosage form manufacturing in one integrated system. More cost-effective manufacturing for small 
molecules can be performed at CONTINUUS sites or even clients’ facilities through a Mobile Pharmaceutical (MoP) 
offering.
GlaxoSmithKline says its agile, continuous flow chemistry manufacturing has smaller operations that are more efficient 
and environmentally friendly. In Singapore, the company’s commercial continuous API manufacturing process requires a 
facility approximately one-ninth the size (100 m2) of a facility required for a batch process (900 m2).27 
Continuity Pharma, a start-up out of Purdue University, is using flow chemistry to develop a system for continuously 
manufacturing multiple APIs with shorter turnaround times and higher volume. Innovative, streamlined, and automated 
systems are needed to compete with offshore API manufacturing.28

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In 2022, as life sciences companies conduct risk assessments, data analytics tools can be leveraged for deeper insights 
across the supply chain. These tools are designed to improve demand prediction and support data sharing with customers 
and partners.29 Other digital innovations, like AI, can predict or forecast supply chain-related events (e.g., logistics challenges, 
geopolitical issues, and supply disruptions), either executing actions autonomously or recommending actions stakeholders 
should take—ultimately, helping life sciences companies build resilience and gain competitive advantage (see figure 5).30  
Figure 5: Sample innovations driving predictive and autonomous supply chain management
Addressing external forces disrupting supply chains
Research shows that the life sciences sector expects to experience continued disruption in 2022 to its supply chains from 
external factors, including inflation and labor shortages.31 We see the pandemic, global volatility,32 and the semiconductor 
shortage (affecting two-thirds of the medtech industry)33 continuing to be major supply chain issues.34  
Pandemic-era inflation linked to supply chain constraints
Today’s economic climate and inflationary pressures present challenges not seen since 2008.35 But pandemic-era inflation is 
different36—attributed mostly to constraints connected to transportation and supply chain bottlenecks.37  
Access to raw materials is a factor.38 Global ocean freight rates increased substantially in 2021 (see figure 6),39 and trucking 
spot rates increased by 20%.40 Air freight rates in January 2022 were ahead of last year.41 According to Abbott CFO Bob Funck, 
inflation and the supply chain are really linked together.42
Digital innovations
Description
Control towers 
(data lakes)
	• By building control towers or data hubs, organizations can merge internal data (such 
as production and inventory data) with data from intermediaries and partners to 
provide real-time longitudinal visibility into material and product flow.
Machine-assisted business 
response (Al)
	• As part of day-to-day operations, self-healing Al solutions analyze supply chain, 
manufacturing, and market data to highlight potential issues (e.g., stockout of a raw 
material), analyze their root causes (inability of a vendor to make a delivery due to 
logistics issues) and suggest next steps to supply chain operators (ordering from an 
alternative supplier or changing production schedules).
Machine-driven resilience 
management   
(AI)
	• Al predicts or forecasts events (such as logistics challenges, geopolitical issues, and 
supply disruptions) to execute actions either autonomously or recommend actions to 
stakeholders to respond to long-term risk/disruptions.
Market and product tracking 
(Al, loT, blockchain)
	• Companies track and analyze nontraditional data such as consumer sentiment, 
competitor, product user, and experience data along with traditional data (such as 
order patterns, demand signals) to optimize supply chain planning.
	• As more next generation therapies enter the market, loT, and blockchain are 
increasingly applied to track and trace product movement and temperature and 
coordinate timely delivery of such therapies to treatment centers.
The global supply chain has not been able to keep up with strong 
demand out there. So, like others, we’re seeing some increased input 
costs across areas of our business. We’re experiencing some higher 
shipping costs and, in some cases, higher commodity costs.
Bob Funck, CFO, Abbott.43

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Figure 6:  Year-on-year global container freight rates, Feb 2020 – January 2022
Today’s market headwinds are different; inflation is higher, but also more volatile,44 and inflation is not likely to go back to pre-
pandemic levels.45 While price increases did not significantly impact the financial results of many sector companies in 2021, 
change could come when Q4 2021 reports are released in early 2022.46 Going forward, companies will need to look holistically 
across a range of levers—analyzing people, financial, and operational data—for effective inflation margin management.47 
Addressing volatility
Increasing global trade friction, on top of the global pandemic, have, in places, led to disruption in tariffs, regulatory changes, 
diminished access to suppliers/vendors, limitations on cargo capacity, and shortages of products.48  
Some life sciences companies are looking to minimize trade uncertainties and reduce customs taxes by rethinking operations 
and diversifying supply chains. Diversification or business model changes can lead to unintended tax costs or presence. Tax 
leaders should be engaged early to analyze potential impacts.49 
Semiconductor chip shortage
It took the chip shortages of 2020 and 2021 for semiconductors to cement their “critical” status. In 2022, Deloitte expects the 
global semiconductor chip industry to grow 10% to over US$600 billion for the first time ever. Shortages and supply chain 
issues are likely to remain front and center for the first half of the year, hopefully easing by the back half, but with longer lead 
times for some components stretching into 2023, possibly well into 2023.50 
Whether explicitly or inadvertently, it is unknown which sectors could be prioritized if chip shortages persist. Many medical 
devices are chip-dependent, including ventilators and defibrillators; imaging machines; glucose, ECG, EEG, and blood pressure 
monitors; implantable pacemakers; and more. Patients who rely on these technologies for lifesaving and life enhancing care 
may be at risk.51  
Freightos Baltic Index (FBX) Global Container Index
Year on Year: FBX Global Container Freight Index
Feb 2021–Jan 2022
Feb 2020–Jan 2021
28-Jan-22
$12,500
$10,000
$7,500
$5,000
$2,500
$0
Feb
Apr
Jun
Sep
Nov
Source: Freightos, 28 January 2022.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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The issue is industry-wide for the hundreds of diagnostics, therapeutics, and capital equipment companies that produce 
essential medical technologies. An Advanced Medical Technology Association (AdvaMed) study conducted by Deloitte found 
that two-thirds of medical technology companies surveyed say semiconductors, firmware, and/or embedded software are 
required for at least half of the medical devices they produce for patients.52  
Deloitte found that half of semiconductors for the majority of those surveyed (mostly with over US$1 billion in revenues) are 
single source—raising the stakes for supply chain disruption. All experienced chip supply chain disruption ranging from two 
weeks to more than a year, mostly from delays, order cancellations, and short orders.53 Disruptions were all across the supply 
chain, many affecting the bottom line—e.g, increased shipping costs, decreased revenue from shortages, or negative impacts 
on working capital (see figure 7).54  
Figure 7: Have you experienced any of the following disruptions to your overall supply chain in the last 12 months?
Medtech’s primary needs are 2nd or 3rd generation chips,55 and the use of chips in life sciences and health care will likely grow. 
Regulators are approving new connected home health care devices such as wearables and smart patches whose use may 
span hundreds of millions of units, especially given the rise in virtual visits and decentralized clinical trials.56
The United States is looking for companies to onshore larger portions of the semiconductor supply chain.57 In October 2021, 
the US Department of Commerce established the Microelectronics Early Alert System to coordinate government resources 
and help companies resolve supply chain bottlenecks due to the chip shortage.58 Intel is spending $20 billion on a cutting-
edge, 1000-acre chip manufacturing campus in Ohio which would make it one of the largest chip manufacturing facilities in the 
world. Production is scheduled to start in 2025.59 
Source:  “The Semiconductor Chip Shortage Hits MedTech: Strategies to Build Resilient Supply Chains,” AdvaMed/Deloitte, 2021.
Expected freight to keep 
supply lines ﬂowing
Inability for existing suppliers 
to meet new operational/
virtual requirements
Brand damage stemming 
from supply issues (i.e. quality 
employee, shortage)
IP/cyber – attacks aﬀecting 
continuity of supply
Contract compliance failures 
leading to penalties
Lost revenue from supply 
shortages/constraints
Negative impact on working 
capital
Existing suppliers bankrupted 
or severely hampered
Loss of critical talent
Weakened controls / oversight 
from lack of on-site operation
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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In addition to the chip shortage there is a growing demand for software skills required to program  
and integrate chips—and an overall labor shortage—that will likely exacerbate the situation for the near future.60 
Growing popularity of RNA therapies and short-term plasmid shortage
Increased demand has led to an industry shortage of plasmid starting material, prompting a growing number of viral vector 
facilities to consider manufacturing plasmid in-house to avoid potential supply-chain issues. The shortage may continue for 
the next couple of years.61 
Demand increased with the rise of viral vector and gene therapy facilities, and is further complicated by increased interest in 
mRNA manufacturing. Plasmids are the raw material for both viral vector and in vitro-transcribed (IVT) mRNA manufacturing.62  
Expanding the supply chain ecosystem in 2022
A business is only as strong as its chain of suppliers,63 and the pandemic highlighted the need to transform traditional supply 
chain models.64 According to a recent Fortune/Deloitte survey, the majority of LSHC CEOs say that supply chain disruption has 
resulted in higher costs of doing business and margin impacts,65 and continued challenges will influence and disrupt business 
strategy over the next 12 months (see figure 8).66 
Figure 8:  Winter 2022 Fortune/Deloitte CEO Survey, LSHC CEO responses
According to the survey, half of LSHC CEOs plan to expand their supply chain ecosystem with more partners in 2022, with a 
majority planning changes to profit/pricing models (see figure 8).67 The research further shows that a new normal appears to 
be setting in, wherein leaders expect new challenges to arise continuously, but are confident they can manage through them 
to achieve positive business results.68  
Source:  Winter 2022 Fortune/Deloitte CEO survey, Deloitte, 2022.
What supply chain challenges has your organization experienced?
What supply chain actions do you expect to take in the next 12 months?
Challenge
% of LSHC CEOs
Input/raw material shortages
33%
Labor shortages
92%
Maintaining quality standards
8%
Production and/or logistics issues
50%
Reduced logistics capacity (any mode)
33%
Reduced manufacturing capacity
0%
Other
8%
Action
% of LSHC CEOs
Change product portfolio and roadmap
25%
Change profit/pricing model (e.g., higher prices)
67%
Expand sustainability/climate change initiatives
17%
Expand the supply chain ecosystem with more partners
50%
Update/change the logistics network and modes
33%
Vertical integration acquisitions
25%
Other
8%

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Life sciences companies face distinct challenges with their very visible role in drug pricing and access to medicines, and the pandemic 
only underscored this focus. During the pandemic, life sciences companies came closer to their purpose—expanding environmental 
and diversity/inclusion goals and recommitting to social issues and health equity.1 ESG (environment, social, and governance) at large 
is growing in importance as investors, partners, communities, customers, and employees increasingly scrutinize the companies they 
support.2
In 2022, ESG performance is expected to come under even more monitoring, and life sciences companies will need to home in on the 
material factors affecting the sector.3 Work is also underway for new global ESG standards,4 and companies will need to determine 
how best to demonstrate their progress with robust measures and enhanced disclosures.5 
Environmental, Social, and Governance 
(ESG): Another CEO imperative

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Materiality, measuring what matters most 
Materiality for life sciences
Materiality in ESG defines what is important to stakeholders as well as what is important for business success.6 Leading 
material factors for the life sciences sector include:
	• Environmental sustainability, making medicines more sustainable and reducing greenhouse gas emissions, in particular, 
Scope 3 emissions of a company’s supply chain7 
	• 	Drug pricing—balancing the need for innovation with the needs of policymakers8—and the broader effect from new ESG 
regulations9 
	• Access to medicines globally and supporting innovation in medicines and treatments with the greatest need10
	• 	Health and race equity, including enhancing diversity in clinical trials11 
	• Diversity in leadership and income equality, including a gender pay gap in scientific research and the pharmaceutical 
industry12 
Material issues may sway public perception, ESG ratings, and company valuations,13 and companies that conduct materiality 
assessments have been shown to achieve significantly higher disclosure scores.14 In addition to positive societal impact, 
companies with strong ESG propositions and materiality may benefit from quantifiable business value.15 
E, S, and G issues increasingly intertwined
Environmental, social, and governance issues are becoming progressively intertwined. For example, making medicines 
sustainable protects the environment and has a social impact on the broader access to medicines. As a result, more 
companies are realizing that ESG metrics and business metrics are inextricably linked.16
At the executive committee, when we review where we are and 
how we are progressing towards our objectives, we don’t look at 
the ESG metrics separate from everything else, but rather, key 
elements of our ESG goals are an integral part of the broader set of 
operational goals and metrics that we review on a regular basis—
they contribute to each other. For example, our ability to attract, 
retain and develop a diverse workforce contributes to our overall 
success and business results.
Anat Ashkenazi, CFO, Eli Lilly and Company17

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Transparently tackling ESG challenges with stakeholders
Forward-looking companies should welcome diverse stakeholders and incorporate their perspectives into strategic decision-
making to solve ESG challenges. Communicating challenges promotes transparency, and working together with stakeholders 
may provide:
	• A better understanding of the implications of decisions
	• Support that minimizes risk
	• 	A social license to act 
	• More trust and a better reputation18 
Biopharma companies are often held to an unparalleled standard when it comes to motive and profit, although continued 
innovation and product availability depend on it. Building trust is a vital pathway to demonstrating the true value that 
biopharma companies and the rest of the health care system bring to society while also being accountable to shareholders 
and stakeholders.19
While investor relations is available to communicate with shareholders on concerns, Jim Greffet says that a large part of his 
role, as Head of ESG for Eli Lilly, is determining what is important to stakeholders by having an open door for discussion.20
Climate disclosure mandates ramping up
The impacts of the environment and climate change are increasingly viewed as a growing financial risk—both in terms of a 
company’s exposure to impacts as well as their contribution to increased global warming.22 As more robust data is being 
sought on environmental issues,23 climate mandates are ramping up, especially in Asia.24
In 2021, New Zealand became one of the first countries to formally legislate the mandatory assessment and reporting of 
climate change risks by publicly listed companies, banks, investors, and insurers.25 The Securities and Exchange Board of India 
rolled out a series of rules in 2021,26 and Thailand’s SEC (Securities and Exchange Commission) will soon require companies to 
annually disclose ESG impacts and policies, including the level of greenhouse gases emitted.27 
Non-financial ESG reporting is further along in the European Union, but the first set of reporting standards—the Commission’s 
proposal for a Corporate Sustainability Reporting Directive (CSRD)—is expected in October 2022.28 In the United States, the 
SEC recently proposed new rules to standardize climate-related disclosures for US-listed companies.29
The best way to understand what’s on your stakeholders’ 
minds is to talk to them.
Jim Greffet, Head of ESG, Eli Lilly and Company 21

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Growing focus on Scope 3 emissions 
Investors are particularly interested in “Scope 3” disclosures—greenhouse gas emissions (GHG) that also include a company’s 
suppliers and other partners. Under the US SEC’s new proposed rules, registrants would be required to disclose Scope 3 
GHG emissions, if material or if the registrant has set a GHG emissions target or goal that includes Scope 3 emissions. The 
proposed rules would provide a safe harbor for liability from Scope 3 emissions disclosure and an exemption from the Scope 3 
emissions disclosure requirement for smaller reporting companies.30 Digital solutions for measurement and optimization (that 
include Scope 3) are a core component of a successful Net Zero strategy. 
Some life sciences companies are setting ambitious Scope 3 targets led by AstraZeneca (see figure 1).31 In addition to its 
long-term target, AstraZeneca commits to reducing absolute scope 3 GHG emissions from fuel and energy related activities, 
upstream leased assets and downstream leased assets—80% by FY2030; from use of sold products—95% by 2030; and from 
upstream transportation and distribution, waste generated in operations, business travel, employee commuting and end of 
life treatment of sold products—46% by FY2030. All commitments are from a 2019 base year. AstraZeneca also commits to 
science-based targets by FY2025 for 95% of its suppliers by spend covering purchased goods/services and capital goods, and 
50% of its suppliers by spend covering upstream transportation and distribution and business travel.32 
Figure 1: Life sciences companies’ absolute Scope 3 GHG Net-Zero commitments 
Company
Target 
Target Year
Base Year
Notes
AstraZeneca
90% reduction
2045
2019
Long-term target in addition to other shorter-
term targets
Illumina, Inc.
46% reduction
2030
2019
From purchased goods and services, 
capital goods, upstream transportation 
and distribution, business travel, employee 
commuting and investments
Novartis
35% reduction
2030
2016
Merck & Co., Inc.
30% reduction
2030
2019
Target boundary includes biogenic emissions 
and removals from bioenergy feedstocks
Pfizer Inc.
10% reduction
64% reduction
2025
2025
2019
10% from upstream transportation and 
distribution
64% of its suppliers by spend covering 
purchased goods & services
Target boundary includes biogenic emissions 
and removals from bioenergy feedstocks
Johnson & 
Johnson
20% reduction
2030
2016
Target boundary includes biogenic emissions 
and removals from bioenergy feedstocks
GlaxoSmithKline
16% reduction
2030
2017
Takeda
15% reduction
2025
2018
Through educating and influencing suppliers33  
and commits 67% of its suppliers by emissions 
covering purchased goods and services, capital 
goods and upstream transportation and 
distribution will have science-based targets by 
2024
Sanofi
14% reduction
2030
2019
Target boundary includes biogenic emissions 
and removals from bioenergy feedstocks
Source:Science-Based Targets Initiative, 2021.

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Broader effects on the supply chain and drug pricing
Additional costs are typically involved with meeting ESG criteria, and changes may have an  
effect on pharmaceutical pricing policies. Drug pricing is increasingly becoming a broader  
ESG topic, cutting across corporate governance, the investment community, and global access to medicines.  
But new ESG requirements may focus on the degree of influence a supplier has within the supply chain beyond Scope 3 
greenhouse gas emissions.34
For example, the recently approved Supply Chain Due Diligence Act in Germany introduces new obligations for German 
companies with regard to protecting human rights in supply chains globally. The entire supply chain, from the extraction of raw 
materials to the delivery to customers, is covered by the new act—which will apply to companies with at least 3,000 employees 
in Germany in 2023, and those with at least 1,000 employees in 2024.35 
Statutory health insurance funds in Germany are also introducing ethical considerations into pharmaceutical supply 
contracts. One tender for the supply of five antibiotics was part of the discount contract system that included a number of 
ESG conditions—including protections for workers’ rights and environmental standards. Those with higher environmental 
standards had a better opportunity to win the contracts, while in the past, the main criteria was price.36 
Collectively making medicines sustainable 
The non-profit Sustainable Medicines Partnership (SMP) endeavors to bring the biopharma industry together on a single 
initiative—reducing waste in medicines. The biopharma industry produces 4.5 trillion medicines annually—and many are 
never used. For example, US$37 billion in medicines are lost every year due to failures in cold chain logistics alone.37
Another reason for waste is shelf life given to a medicine is typically based on the information available when it went through 
the approval process. But it may actually be twice as long before it is no longer effective.38 
I saw the magnitude of the problem as well as the 
opportunities to deal with it. I wanted action
Dr. Nazneen Rahman, Founder, YewMaker and Sustainable Medicines Partnership, 
Non-executive Director, AstraZeneca39

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Source: Deloitte analysis
SMP is a four-year program designed to deliver evidence-based, scalable, and sustainable solutions that address six pillars 
to make medicines sustainable (see figure 2).40 The organization is not only looking to rally the biopharma industry, but also 
collaborating with the ‘Big 4’, the NHS, health care, the medicines supply chain and packaging, government bodies, academia, 
researchers, designers, entrepreneurs, and patient groups.41
Figure 2: 6 pillars of the Sustainable Medicines Partnership
Improving access to medicines
Overall, pharmaceutical companies are making incremental progress in improving access to medicines globally and supporting 
innovation for treatments with the greatest need.42 But the impact of these ESG factors was clearly highlighted by the 
pandemic.43
According to the Access to Medicines Foundation, 5 billion people have access to medicines, but there are 2 billion people to 
go.44 The Access to Medicines Index is a tool designed to drive change in the pharma industry by tracking its progress.45 The 
Foundation’s new strategic direction for 2022-2026 expands the range of companies and healthcare sectors to mobilize in the 
fight against health care inequality.46
2021 Access to Medicines Index results
The 2021 Index analyzed how the world’s top 20 pharmaceutical companies addressed access to medicine in 106 low- and 
middle-income (LMIC) countries for 82 diseases, conditions, and pathogens (see figure 3).47 Companies were measured and 
ranked overall and in individual categories for:
	• Governance of access
	• Research & development
	• Product delivery48
Of the 20 companies analyzed in 2021, GlaxoSmithKline (GSK) took first place overall as well as first place in the governance 
1. Transparent environmental impact
•  Carbon footprint based on C02e not expenditure
•  Practical, comparative tools & metrics
•  lncentivised disclosure and reduction
2. End-to-end traceability
•  Track sourcing, production, use and disposal
•  Immutable record with integrated C02e
•  Responsible, resilient, agile supply chain
3. Long shelf life
•  Shelf life based on stability not approval timing
•  Cost-eﬀective, scalable shelf life extension process
•  Standardised, simpliﬁed, incentivised
4. Digital patient information
•  Digital by default, accessible to all
•  Improved patient experience and adherence
•  Substantial decrease in C02e and costs
5. Every dose used
•  Quality assured, pre-expiry meds as standard
•  Uncollected prescriptions
•  Integrated with equitable access programs
6. Recyclable packaging
•  Take-back packaging as standard
•  Safe, cost-eﬀective alternatives to incineration
•  Reduce single-use with closed loop recycling
SMP
Projects

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Source: “Access to Medicine Index 2021,” Access to Medicine Foundation, 2021.
of access and research and development categories. GSK leads governance due to its clear access-to-medicine strategy 
embedded in its overall corporate strategy and CEO remuneration tied to access objectives. In R&D, GSK is undertaking 22% of 
the total number of priority R&D projects, followed by Johnson & Johnson with 13.6%.49
Novartis was the first to begin mainstreaming access planning across its pipeline50 and attained first place for product delivery 
in the 2021 index, leading consistently across all access strategies.51 In 2021, 8 companies adopted processes to systematically 
address access to medicine for all new products, and 12 out of 20 make access to medicines a direct board level responsibility. 
Sanofi was recognized for its approach to access strategies for supranationally procured products (procured through 
international organizations like The Global Fund).52 
Figure 3 :Access to Medicines Index 2021, top 20 pharma companies
1.   GlaxoSmithKline plc
2.   Novartis AG
3.   Johnson & Johnson
4.   Pﬁzer Inc.
5.   Sanoﬁ
6.   Takeda Pharmaceutical Co. Ltd.
8.   Merck KGaA (Merck)
7.   AstraZeneca plc
9.   Roche Holding AG
10.   Novo Nordisk A/S
11.   Eisai Co. Ltd.
12.   Boehringer Ingelheim GmbH
13.   Bayer AG
14.   Astellas Pharma Inc.
14.   Gilead Sciences Inc.
15.   Merck & Co., Inc. (MSD)
16.   Daiichi Sankyo Co. Ltd.
17.   AbbVie Inc.
18.   Eli Lilly & Co.
19.   Bristol Myers Squibb Co.
4.23
4.18
3.76
3.65
3.47
3.31
3.09
3.30
3.07
2.96
2.87
2.84
2.63
2.33
2.33
1.88
1.80
1.73
1.59
1.55
0
1
2
3
4
Governance of Access
Research & Development
Product Delivery
Large research-based pharmaceutical companies have a critical role 
to play in preparing for the next pandemic. While academic groups 
and small biotechs can pioneer new research ideas, big companies 
are essential in ensuring rapid development and access.
Access to Medicines Foundation53

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Taking actions to improve access performance
Pfizer’s performance in planning for access improved from previous years, helping the company move into a top 5 overall 
position for the 2021 Index.54 Some actions Pfizer took to improve access include:
	• Expanding access planning during development from vaccines to all products
	• Launching a Global Pricing and Access Strategy that requires access planning for all products to commence two years pre-
launch
	• Sharing many IP assets with third-party researchers, e.g. for malaria and TB via research institutions and via the COVID-19 
Therapeutics Accelerator
	• Completing a sustainability bond whose proceeds are used for social (e.g. for COVID-19 and AMR Action Fund)and 
environmental projects55 
	• Reaching nearly 700,000 patients in 2020 through its ex-US patient assistance programs, some of whom may not have 
otherwise been reached through traditional commercial channels56
	• Linking CEO remuneration to access performance.57
The Methodology Report for the 2022 Access to Medicines Index lays out the metrics by which companies will be assessed this 
coming year.58 A greater weight will be put on R&D in 2022, focusing on indicators that measure outcomes, rather than polices 
and processes.59 The 2021 Access to Medicines Index found that despite major gaps in the pediatric drugs pipeline, only 6% of 
R&D projects targeted children under 12 years of age.60 
Leading health equity
Strategies for enhancing diversity in clinical trials
A material factor for life sciences under the social umbrella, or “S” in ESG”, is diversity in clinical trials. COVID-19 brought existing 
social inequalities to the fore, and ensuring clinical trials better reflect patient populations will expand access to potentially life-
saving therapies, build trust, and promote innovation.61 
In the report, Five Key Strategies for Enhancing Diversity in Clinical Trials, the Pharmaceutical Research and Manufacturers of 
America (PhRMA) and the Deloitte US Center for Health Solutions (CFHS) outline five critical strategies for enhancing diversity 
in clinical trials during the research and development of new medicines.62
	• Create a network of clinical trial sites in underserved communities. Establish research sites in locations where potential 
participants already receive care, including non-traditional locations such as community health centers and pharmacies.
	• Develop a racially and ethnically diverse pool of investigators and staff. These key community ambassadors can ensure 
that trials are culturally competent and mindful of unconscious/implicit bias.
	• Establish long-term relationships and invest in the community. Prioritize long-term and sustainable community building 
efforts, like investing in health education or supporting the next generation of diverse health practitioners and investigators.
	• Engage the community in conversations. Sponsors should communicate and work toward shared understanding with the 
community and seek input into the elements of design that might impact community members’ ability to participate.
	• Provide sustainable support and standardized platforms. Build a data infrastructure that leverages real world data and 
includes baseline measurements to improve data on race and ethnicity.63 
A community-based clinical trial infrastructure may be the most effective way to sustainably accomplish the goals of enhancing 
access to clinical trials and promoting health equity. Shifting the paradigm will likely require substantial cross-stakeholder 
commitment and collaboration.64

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Principles of health equity for medtech
Medtech makes the technologies and tests that are responsible for the accurate diagnosis  
of disease and improved patient outcomes. AdvaMed (Advanced Medical Technology Association) is a global trade 
association advancing the interests of the medtech industry and is working to ensure the industry is doing its part to 
mitigate the adverse impacts of health disparities among people and communities of color.65
AdvaMed’s board-created and board-approved set of principles are designed to guide the industry in addressing racial 
health disparities. The principles call on industry to: 
	• Promote inclusion and equity and health care. Promoting unbiased treatment of patients likely requires partnerships 
to educate the industry and others on identifying, acknowledging, and addressing bias.
	• Partner in education with stakeholders. Outreach to, and partnership with, clinicians to educate them regarding 
disparate trends in patient care, including access technologies.
	• Advocate for and facilitate patient access to innovative technology. Develop and disseminate materials for use by 
patients, providers, and facilities.
	• Promote research equity in the medtech industry. Require engagement and partnership with other caregivers and 
groups to bridge the gap, and promote the need for, involvement in studies and research to include more diversity 
among investigators.66 
Health equity is covered extensively in Deloitte’s 2022 Global Health Care 
Sector Outlook.67
Advancing diversity and women in leadership
Women appointed CEOs globally rose to 13% in 1H 2021, compared to 6% 
in the previous 6-month period.69 In the Fortune 500, there were 41 women 
CEOs in 2021, an all-time record, but just 8.1% of the total.70 In the Fortune 
Global 500, women accounted for 23% of the chief executives in 2021, 
including 6 women of color, also an all-time high.71 As of January 2022, women 
hold 31 (6.2%) of CEO positions at S&P 500 companies.72 Women of color hold 
only 1 percent of CEO positions across the Fortune 1000.73 
Some notable new CEO appointments in 2021 for Life Sciences and Health 
Care include: Karen Lynch, CVS Health (the $268 billion health care giant is 
now the largest company ever to be run by a female chief executive); Roz 
Brewer, Walgreens Boots Alliance (the only Black woman currently running a 
Fortune 500 company); Reshma Kewalramani, Vertex Pharmaceuticals,74 and 
Tan Sin Yin (Jessica Tan), co-CEO, Ping An Insurance.75 
China capitalizes on digital platforms for 
health equity
For decades, China has strived to achieve health 
equity nationwide. During the pandemic, with 
many outpatient clinics closed and medical supplies 
low, patients with non-COVID-19 symptoms were 
among the hardest hit groups. Digital health care 
proved to be a promising solution to this issue, 
and the pandemic accelerated the development of 
many digital health platforms, including WeDoctor 
and Alibaba Health. These platforms facilitated 
online health care consultations and the delivery of 
medicine from health care institutions to patients—
providing more accessibility. Digital accessibility 
was also encouraged in rural regions, where more 
patients delayed treatments than in urban areas.68
We’re seeing more intentionality. We’re seeing a focus on women of 
color. And we’re seeing a recognition that diversity and women in 
leadership is even more important.
Lorraine Hariton, CEO, gender equality organization Catalyst76

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Research shows that eﬃciency gains from having a larger female representation in ﬁrm leadership can be quite large.77 Women 
CEOs exhibited a different leadership style than men during the COVID-19 crisis—leaning toward empathy, adaptability, 
accountability, and diversity. 
Women’s more positive communication style scored higher for words expressing trust and anticipation, according to S&P 
Global.78 They report that female CFOs are more profitable and have produced superior stock price performance compared to 
the market average. Women may be the most underutilized source of growth.79 
According to the Women Business Collaborator, there are 10 accelerators for advancing women to the CEO role:
1.	 Recognize women’s experience, talent and acumen to be CEO Leaders
2.	 Generate board support for women in the pipeline
3.	 Create shareholder and stakeholder value
4.	 Sponsor and advocate for women leaders
5.	 Include diverse women
6.	 Celebrate and affirm the men who are building pipelines
7.	 Use successful Women CEO role models as examples and advocates 
8.	 Pay equal or better compensation 
9.	 Search Firms to include women in their slates
10.		Join and support women’s organizations focused on position, pay and power for all women80 
There is also a gender pay gap that needs to be addressed in the overall scientific research community and pharmaceutical 
industry.81 A significant imbalance between genders was found by the British Gender Pay Gap Report.82 It is interesting to note 
that GSK, the leader in access to medicines, had no gap in distribution of pay—and also appointed the first female to CEO of a 
leading pharma company, Emma Walmsley in 2016.83
In 2022, companies are expected to face continuing external pressures from institutional investors, activist shareholders, 
potential employees, and customers to increase the representation of women on corporate boards, in C-suite positions, and 
across executive leadership, as well as equal compensation and mobility for women and people of color.84 If life sciences 
companies are to be truly understanding of the diverse patient population they seek to serve, executive and board members 
should also be truly representative.85 
ESG ratings and raising levels of public trust
More than 150 ESG ratings and data providers
Rating agencies and data providers are useful tools for measuring an organization’s positive or negative impact on ESG issues. 
But the sheer number of firms to consider—each using its own methodology—is often a challenge.86
There are at least 600 products from more than 150 organizations providing ESG data to corporations and asset managers. 
Leaders in the field include MSCI, Sustainalytics, ISS ESG, Bloomberg, and S&P Global (TRUCOST). Some data providers are 
specific to industries—like the Access to Medicines Index.87 Chinese ratings providers come from many diverse viewpoints, 
ranging from traditional index/data providers, fintech companies, asset managers/owners and academic/non-profit 
institutions to consulting companies.88

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As a result, rankings from the many data firms assessing ESG performance vary.89 Novartis, an ESG leader in the sector, 
publishes its performance ratings provided by various agencies (see figure 4).90 
Figure 4: Novartis performance ratings across ESG ratings providers, updated January 2022
Source: Novartis, January 2022.
1. Published every 2nd year. Result shown shows 2020/20218 scores   2. 2021/2020 scores   3. Published every 2nd year. Updated December 
2021.    4. Updated December 2021   5. Updated December 22, 2021. Novartis has been a DJSI World member since 2022   6. Updated 
April 2021   7. 0-10 scale, 0 being most severe controversy   8. Leadership as defined by rating agencies   9. Climate: Novartis received a B 
(Management band), same as the Biotech & pharma sector average, Water: Novartis received a A-(Leadership band), higher than the Biotech 
& pharma sector average   10. Novartis is in the top 5 Pharmaceuticals   11. Pharmaceuticals subindustry group. 
ESG is central to the Novartis strategy and is critical to delivering on 
our purpose to reimagine medicine to improve and extend people’s 
lives. Looking ahead, we are renewing our focus on our ESG material 
topics, redoubling our efforts on improving access to medicines and 
accelerating our journey toward a zero-carbon future.
Vas Narasimhan, CEO, Novartis91
Bridging the ESG perception/reality gap
There is an overuse of cliches in ESG reporting, and stakeholders expect to see evidence of action, not empty words.92 
However, despite actions, more than 90% of 250 public companies studied by data company RepTrak have a perception/
reality gap between public opinion and ESG actions/ratings.93 With this gap, a company may be judged more harshly in a crisis 
scenario,94 and the pandemic demonstrated the importance of anticipating and managing risk.95
To mitigate this risk, biopharma companies might consider working together on specific ESG initiatives to build more trust and 
raise public opinion of the industry96—especially since biopharma ranks as one of the least trusted industries according to 
many consumer polls.97 While public opinion improved during the pandemic, recent Deloitte research found the lowest levels 
of trust for biopharma to be in the United States and the highest in India.98
Agency
Rating
Current
Previous
Industry perspective
Access to  
Medicine Index1
Score
4.18
3.2
2 / 20
CDP2
Climate score
B
A-
Management band B/B-9
Water score
A-
A
Leadership band A/A-9
FTSE4Good2
ESG score
4
4.7
n/a10
ISS ESG2,3
ESG score
B
B
4 / 473
MSCI2,4
ESG score
A
A
Best rated peers: AAA 
(3 PharmaCos), AA (10 
PharmaCos)
MSCI Global Compact
Pass
Watchlist
Controversy7
3
1
S&P Global 2,5
ESG score
83
73
5 / 91 in Pharmaceuticals 
(97th percentile)
Sustainalytics 2,6
Risk score
17
21
1 / 432 in Pharmaceutical 
subindustry group11
Controversy level
3
3

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Preparing for new global standards 
A significant challenge—for ratings’ agencies, asset managers, and 
companies themselves—is that ESG information is not reported in a 
standardized way.101 The IFRSF (International Financial Reporting Standards 
Foundation) formed the International Sustainability Standards Board (ISSB) 
to provide the global financial markets with high-quality disclosures on 
climate and other sustainability issues. Consolidation of several standard-
setters is expected by June 2022, with the release of the first batch of 
climate-related disclosure standards.102
The World Economic Forum’s International Business Council welcomes 
the arrival of the new IFRSF standards that the IFRSF has indicated103 
and suggests companies consider its Stakeholder Capitalism Metrics 
framework to prepare.104 Life sciences companies should not wait for 
mandates and can begin by:
	• Identifying the metrics most relevant to their own company’s strategy 
and stakeholders as well as those relevant to the life sciences sector105 
	• Identifying a full list of individuals and groups whose interests are affected or could be affected by its company’s activities106 
	• Monitoring and evaluating how new and existing third-party relationships impact the company’s ESG priorities
	• Collaborating across the ecosystem to simplify data collection, synthesis, and reporting 
	• Looking for ways to transform business models and innovate solutions to move toward goals 
	• Communicating the company’s ESG vision and strategy early to win support107 
Gathering data for better ESG reporting
It is important that corporations measure and report on the results of their ESG efforts to live up to the purpose set for the 
enterprise. This enhances integrity and authenticity of the environmental and social goals.108 Selective reporting that does not 
connect narrative information and financial information can lead to greenwashing.109  The temptation can be great for being 
seen as ethical, as this may drive profitability. But the risks remain, even if unintentional, with bad data and communications.110 
Watchdogs are analyzing ESG reports, questioning the substance of companies’ pledges and looking for evidence of 
greenwashing.111 By utilizing better data and analytics, companies can have a more systematic, quantitative, objective, and 
financially relevant approach to key ESG issues—providing ESG reporting with data integrity.112
Demonstrating performance for ESG reporting starts with:
	• Knowing what needs to be collected
	• Knowing who needs to be involved in the process
	• Knowing where the data is in the business
	• Developing a robust, future-proof data collection process113 
In addition to data management, Deloitte research finds that organizations could likely improve the efficiency and 
effectiveness of ESG reporting processes with an integrated and automated platform approach. Strong governance and 
internal controls in ESG measurement and disclosure are part of establishing a comprehensive strategy for integrating ESG 
considerations into business processes.114 
Financial vs non-financial ESG 
communications
Sustainability reporting is expected to be a trusted, 
credible, and relevant resource for stakeholders–
making a clear link between financial and non-financial 
information.99 Some companies may create problems 
by repurposing technical financial investor information 
into other public communications geared to a less 
technical audience. While at times this may be a 
matter of resources, life sciences companies should 
consider the effects on public perception, and opt for 
more authentic messaging targeted to each specific 
audience.100

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Investor focus on ESG reporting 
ESG now accounts for 10% of global fund assets, and 2021 was a record 
year for investment. US$649 billion poured into ESG-focused funds 
worldwide thru 30 November 2021, up from US$285 billion in 2019.116 
Experts say US$4 of every US$10 moving into global equity funds is being 
diverted to ESG funds.117 From the US$6.1 trillion held in ESG funds, 59% 
is held in Europe, Middle East, and Africa, according to Refinitiv Lipper 
Research.118 
While inflows in European ESG funds decreased in 2021, this was more 
than offset by rising flows into US and Asian ESG funds. In China, RMB 250 
billion (US$39.3 billion) was invested in ESG funds through Q3 2021,119and 
the number of funds surged to 48—close to the total of the previous 5 
years.120
Foreign investors in Chinese assets have to meet their fund domicile 
standards on ESG when investing in China, which is driving improved 
reporting by Chinese firms.121 Researchers studied a novel dataset that 
showed ESG performance in China positively associated with the short-
term cumulative returns of CSI 300 stocks around the COVID-19 crisis. 
They concluded that investors may interpret ESG performance as a signal 
of future stock performance and/or risk mitigation in times of crisis.122 
Investors are looking for demonstrative ESG reporting to compare 
a company’s ESG risks and opportunities to their business strategy, 
operations, and financials.123 In 2022, as the velocity of ESG investments 
rise124 and investor focus on ESG practices grows, more board members 
are considering whether ESG measures should be incorporated into 
executive incentive plans to hold management accountable for ESG 
results.125 ESG is expected to remain front and center for 2022.126 
New sustainability-linked bonds (SLB) tied to 
climate, access to medicines, biodiversity
Since Novartis became the first pharma to create an 
SLB in 2020, SLBs have become a growing trend.127 In 
November 2021, a global pharma manufacturer linked 
both climate and access to medicine targets to an SLB. 
Their US$5 billion bond is the largest of its kind from 
any sector and the first issued by a generic medicines 
company. They are committing to access to medicine 
targets with a 150% increase in both the number of 
registrations and products provided through access 
programs in LMICs.128
In addition to access to medicines and other ESG 
concerns, part of Eli Lilly’s sustainability bond is tied to 
a specific category addressing terrestrial and aquatic 
biodiversity conservation—using their skills in genetic 
engineering and recombinant technology to avoid 
testing on animals. Since 7 out of 8 manufacturing 
plants have transitioned, there is larger effect on 
the environment and conservation. For example, by 
eliminating testing on horseshoe crabs, an endangered 
species, Eli Lilly also protects the birds that feed on the 
crab’s eggs.129
In 2022, companies can expect more scrutiny for SLBs. 
While SLBs are linked to Key Performance Indicators 
(KPIs), there are no standards. Penalties for missing 
KPIs are often less serious. Another issue is that the 
maturity date of the bond and the measurement of the 
KPIs often coincide, potentially enabling the issuer to 
redeem early if KPIs are going to be missed.130 
As a board member, it’s also my responsibility to ensure that ESG 
reporting is not a marketing exercise but one that transparently lays out 
a set of goals that leadership is measuring its performance against.
Jamere Jackson, CFO of AutoZone, Audit Committee Chair, Eli Lilly and Company115

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
80
Contacts
Ashley Theophanides 
Deloitte Africa 
atheophanides@deloitte.co.za 
Charu Sehgal 
Deloitte India 
csehgal@deloitte.com
Mike Delone 
Deloitte United States 
mdelone@deloitte.com 
Rohan Hammett 
Deloitte Asia Pacific 
rhammett@deloitte.com.au
Alex Arias 
Deloitte S-LATAM 
alarias@deloittemx.com
Michael Dohrmann 
Deloitte Germany 
mdohrmann@deloitte.de
Nico Kleyn 
Deloitte North South Europe 
nikleyn@deloitte.ch
Accelerating R&D 
Productiving and industry 
collaboration
Transforming the patient 
experience
Colin Terry 
Partner 
Deloitte United Kingdom 
colterry@deloitte.co.uk
Neil Lesser 
Principal 
Deloitte United States 
nlesser@deloitte.com
Patricia Gee 
Director 
Deloitte Switzerland 
pgee@deloitte.ch
Carol Klein 
Principal 
Deloitte United States 
caklein@deloitte.com
Hanno Ronte 
Partner 
Deloitte United Kingdom 
hronte@deloitte.co.uk
Vicky Levy 
Deloitte Global Life Sciences Sector Leader 
vlevy@deloitte.com
Author
Contacts & Acknowledgements
Regional/Country Contacts
Chapter contacts & Acknowledgements
We would like to thank Angela Dunn, Terry Koch, Karen Taylor, and Sonal Shah for their overall 
contributions to this outlook.
We would like to thank the following individuals for their 
contribution to this chapter: Amarinder Sidhu, Holly Darov, Carrie 
Xiao and Frances Yu.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
81
Transforming the talent 
experience
Future-proofing 
manufacturing and supply 
chains
Regulatory: Mastering 
external forces
Environmental, social, and 
Governance (ESG): Another 
CEO imperative
The digital enterprise at 
scale: A CEO imperative for 
2022
Veronica Melian 
Partner 
Deloitte Switzerland 
vcmelian@deloitte.ch
Marty DiMarzio 
Principal 
Deloitte United States 
mdimarzio@deloitte.com
Matt Humphreys 
Principal 
Deloitte United States 
mhumphreys@deloitte.com
Tom Van Wesemael 
Partner 
Deloitte Belgium 
tvanwesemael@deloitte.com
Frits Stulp 
Partner 
Deloitte Netherlands 
fstulp@deloitte.nl
Oliver Steck 
Principal 
Deloitte United States 
osteck@deloitte.com
James Gregson 
Partner 
Deloitte United Kingdom 
jgregson@deloitte.co.uk
Neil Lesser 
Principal 
Deloitte United States 
nlesser@deloitte.com
Deborshi Dutt 
Partner 
Deloitte United Kingdom 
deborshidutt@deloitte.co.uk
Johnathan Fox 
Managing Director 
Deloitte United States 
jonfox@deloitte.com
Todd Konersmann 
Principal 
Deloitte United States 
tkonersmann@deloitte.com
Aditya Kudumala 
Principal 
Deloitte United States 
akudumala@deloitte.com
We would like to thank the following individuals for their 
contribution to this chapter: Jenny Ahn and Chloe Domergue.
We would like to thank the following individuals for their 
contribution to this chapter: Lieven Comeyne and Laks Pernenkil.
We would like to thank the following individuals for their 
contribution to this chapter: Gautam Gupta (Pfizer), George Van 
Antwerp, Malka Fraiman, William Greenrose, and Paul Silver.
We would like to thank the following individuals for their 
contribution to this chapter: Anat Ashkenazi (Eli Lilly), Jim Greffet (Eli 
Lilly), Josh Lee, and John Mennel.
We would like to thank the following individuals for their 
contribution to this chapter: Cris Wilbur (Roche), Dawn Anderson, 
Ryan Hoffmeister, Bill Murray, Rich Nanda, Amarinder Sidhu, Glenn 
Snyder, Carrie Xiao, Frances Yu and Chris Zant.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
82
Learn more
Interested in learning more about accelerating R&D productivity and industry collaboration in life sciences? Check out these 
Deloitte publications:
Nurturing growth: Measuring the return from pharmaceutical innovation 2021
Intelligent biopharma: Intelligent clinical trials: Transforming through AI-enabled engagement
Never the same again: How COVID-19 created seismic change in global life sciences regulations: A global report for 
life sciences executives and regulators
Personalized therapies in the Future of Health: Winning with digital medicine products
Digital therapeutics: Catalyzing the future of health
Interested in learning more about transforming the patient experience in life sciences? Check out these Deloitte publications:
Digital transformation: From a buzzword to an imperative for health systems
Biopharma digital transformation: Gain an edge with leapfrog digital innovation
Personalized therapies in the Future of Health: Winning with digital medicine products
Digital therapeutics: Catalyzing the future of health
Digital health: Integrating digital healthcare solutions to better serve and protect consumers
Building patient services programs to deliver better experiences, therapy adherence, and improved health outcomes
Interested in learning more about the changing talent experience in life sciences? Check out these Deloitte publications:
Reconstructing the workplace: The digital-ready organization
Marketers disrupted: Turning marketing talent into a competitive force
Workforce ecosystems: A new strategic approach to the Future of Work
Designing adaptive workplaces: How the public sector can capitalize on lessons learned from COVID-19
Driving the future of work with workforce ecosystems
Winter 2022 Fortune/Deloitte CEO Survey: CEOs eye 2022 with optimism and a dash of uncertainty
Digital transformation: From a buzzword to an imperative for health systems

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
83
Interested in learning more about the changing regulatory landscape in life sciences? Check out these Deloitte publications:
Never the same again: How COVID-19 created seismic change in global life sciences regulations: A global report for 
life sciences executives and regulators
Digital therapeutics: Catalyzing the future of health
Interested in learning more about the digital enterprise at scale in life sciences? Check out these Deloitte publications:
Biopharma digital transformation: Gain an edge with leapfrog digital innovation
AI in biopharma
Digital transformation: From a buzzword to an imperative for health systems
New business models in health care: Building platform-enabled ecosystems
Earning digital trust: Where to invest today and tomorrow
Interested in learning more about future-proofing operations, manufacturing and the supply chain in life sciences? Check 
out these Deloitte publications:
Securing trust in the global COVID-19 supply chain
How can CFOs prepare for supply chain diversification?
Supply chain resilience in the face of geopolitical risks
Interested in learning more about Environmental, Social, and Governance in life sciences? Connect with the Deloitte Center for 
Climate and Sustainability, and check out these Deloitte publications:
2022 Deloitte CxO Sustainability Report
Tectonic shifts: How ESG is changing business, moving markets, and driving regulation
Your big agenda just got bigger

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
84
Endnotes
1.	
Haley Dixey, et al., “MHRA and US FDA tackle challenging data 
integrity,” Gov.UK MHRA Inspectorate Blog, September 2021.
2.	
Pharma R&D Week, “Novel Drug Modalities & Integrated 
Platforms to Transform R&D Productivity Webinar”, July 16, 
2020.
3.	
Kristen Sullivan et al., Incorporating ESG measures into 
executive compensation plans, Deloitte, 2021.
1.	
Maria João Cruz, PhD et al, “Seeds of change: Measuring the 
return from pharmaceutical innovation 2020,” Deloitte UK, 
July 20, 2021.
2.	
Paul Hudson, “Pharma’s sense of urgency must outlast the 
pandemic,” Fortune, February 22, 2022. 
3.	
R&D Pentathlon: Which Pharma’s R&D is faster, higher, 
stronger —ahead of the curve, Cowen, 26 July 2021.
4.	
Ibid.
5.	
Ibid.
6.	
Ibid.
7.	
Ibid.
8.	
David Borasky et al, “Clinical Research Trends & Insights for 
2022,” WCG CenterWatch, January 3, 2022. 
9.	
Maria João Cruz, PhD et al, “Seeds of change: Measuring the 
return from pharmaceutical innovation 2020.”
10.	 Ibid.
11.	 Ibid.
12.	 Ibid.
13.	 Paul Hudson, “Pharma’s sense of urgency must outlast the 
pandemic.”
14.	 Brian Buntz, “Pharma’s top 20 R&D spenders in 2020,” Drug 
Discovery and Development, May 13, 2021. 
15.	 Ibid.
16.	 Phillip L. Swagel, Research and Development in the 
Pharmaceutical Industry, Congressional Budget Office, April 
2021. 
17.	 Matej Mikulic, “Total global pharmaceutical R&D spending 
2012-2026,” Statistica, August 27, 2021. 
18.	 Ibid.
19.	 2021 Life Sciences Lab Real Estate Outlook, JLL. 15 September 
2021.
20.	 Stacey Rivkin, “The Post-pandemic future of clinical trials: 
How recruiting, participating and monitoring are changing,” 
MedCity News, September 7, 2021. 
21.	 WCG Clinical, “Clinical Trial Insights from the WCG Knowledge 
Base,” August 13, 2021. 
22.	 Lindsay McNair et al, “A Look Ahead in 2022: Trends and 
Insights from Leading Experts,” WCG Clinical, January 18, 
2022. 
23.	 ClinicalTrials.gov, “Search of: COVID-19,” accessed January 17, 
2022.
24.	 WCG Clinical, Clinical Trial Insights from the WCG Knowledge 
Base.
25.	 Karen Taylor et al, Intelligent drug launch and commercial, 
Deloitte Insights, 2021. 
26.	 Casey Ross, “International trial uses AI to rapidly identify 
optimal Covid-19 treatments,” STAT, April 9, 2020. 
27.	 PharmaVoice, “A New Era of Clinical Trials,” June 1, 2020. 
28.	 Gareth Macdonald, “Not just for a pandemic: Decentralized 
clinical trials pay off financially, study finds,” FierceBiotech, 
January 12, 2022. 
29.	 ObvioHealth, “4 Clinical Trial Trends for 2022,” accessed March 
16, 2022. 
30.	 Amazon Web Services, Inc., “Deloitte’s MyPath Uses AWS to 
Enable Decentralized Clinical Trials at Scale,” 2020. 
31.	 Gail A. Van Norman, MD, “Decentralized Clinical Trials: The 
Future of Medical Product Development?” PubMed Central 
(PMC), March 27, 2021. 
32.	 Gareth Macdonald, “Not just for a pandemic: Decentralized 
clinical trials pay off financially, study finds.” 
33.	 Manasi Vaidya, “Trial diversity-it’s time to quit talking and start 
doing,” Pharmaceutical Technology, March 14, 2022. 
34.	 Gareth Macdonald, “Not just for a pandemic: Decentralized 
clinical trials pay off financially, study finds.”
Accelerating R&D productivity and industry collaboration

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
85
35.	 Gail A. Van Norman, MD, “Decentralized Clinical Trials: The 
Future of Medical Product Development?”.
36.	 Tammy Arnold, “CVS Health introduces Clinical Trial Services,” 
CVSHealth, May 20, 2021. 
37.	 Ibid.
38.	 Stacey Rivkin, “The Post-pandemic future of clinical trials: How 
recruiting, participating and monitoring are changing.”
39.	 PhRMA, Principles on Conduct of Clinical Trials: 
Communication of Clinical Trial Results, January 14, 2020. 
40.	 Christine Change et al., Enhancing clinical trial diversity, 
Deloitte, 2021.
41.	 Allison Fulton et al, “FDA Releases Guidance for Digital Health 
Tech Used in Clinical Investigations,” The National Law Review, 
January 7, 2022. 
42.	 Karen Taylor, “Episode #6: Real World Evidence, Life Sciences 
Connect,” Deloitte UK, accessed March 16, 2022.
43.	 Andrea Park, “Verana Health lands J&J, Novo backing in 
$150M round to fund real-world database for drug, device 
development,” FierceBiotech, January 14, 2022. 
44.	 US FDA, Real-World Data: Assessing Electronic Health Records 
and Medical Claims Data To Support Regulatory Decision-
Making for Drug and Biological Products, September 2021. 
45.	 Allison Fulton et al, “FDA Releases Guidance for Digital Health 
Tech Used in Clinical Investigations.” 
46.	 David Borasky et al, “Clinical Research Trends & Insights for 
2022.”
47.	 Dr. Stephanie Allen et al, “Digital health technology,” Deloitte 
Insights, March 31, 2019. 
48.	 David Borasky et al, “Clinical Research Trends & Insights for 
2022.” 
49.	 Ibid.
50.	 Ibid.
51.	 IQVIA, Improving Decision-Making through Connected 
Intelligence, February 28, 2022. 
52.	 Maria João Cruz, PhD et al, “Seeds of change: Measuring the 
return from pharmaceutical innovation 2020.” 
53.	 Badhri Srinivasan, “6 key clinical trial trends that we should 
embrace and build on,” Endpoints News, September 2, 2021. 
54.	 Tomi K Sawyer, PhD, “Novel Drug Modalities & Integrated 
Platforms to Transform R&D Productivity,” Pharma Week, July 
16, 2020. 
55.	 Ibid.
56.	 Ibid.
57.	 Miklós Békés et al, “PROTAC targeted protein degraders: the 
past is prologue,” PubMed, January 18, 2022. 
58.	 Novartis, “Novartis Institutes for BioMedical Research,” 
accessed March 16, 2022. 
59.	 David Xie et al, Winning in the cell and gene therapies market 
in China, Deloitte, 2020. 
60.	 Janet Lambert et al, “Cell & Gene State of the Industry 
Briefing,” Alliance for Regenerative Medicine,” January 13, 
2022. 
61.	 Terence Yifan Cai et al, Never the same again: How COVID-19 
created seismic change in global life sciences regulations, 
Deloitte US, 2021. 
62.	 Ibid.
63.	 Brett Davis et al., “Personalized therapies in the Future of 
Health,” Deloitte Insights, March 4, 2021.
64.	 Ibid.
65.	 Ibid.
66.	 Johann Meyer-Christian et al., Digital therapeutics: Catalysing 
the future of health, Deloitte, 2021.
67.	 Brett Davis et al., “Personalized therapies in the Future of 
Health.”
68.	 Phil Taylor, “The top 10 biopharma M&A deals in 2021,” Fierce 
Pharma, January 18, 2022. 
69.	 Ibid.
70.	 Ibid.
71.	 Nate Nead, “Bolt-On Acquisitions: Growth From an 
Established Industry Platform,” InvestmentBank.com, 
Febraury 14, 2016. 
72.	 Marie Daghlian, “Biotech and Pharma M&A in 2020,” 
DealForma, February 17, 2021. 
73.	 Pfizer, “Pfizer and Beam Enter Exclusive Multi-Target Research 
Collaboration to Advance Novel In Vivo Base Editing Programs 
for a Range of Rare Diseases,” [Press release] January 10, 
2022. 
74.	 Stephen Kemler et al., RSM, “Cell & Gene Therapy Investment 
Outlook In 2022 & Beyond,” Cell & Gene, February 21, 2022. 
75.	 Kalorama Information, “Funding to Cell and Gene Therapies 
Exceeded 70 Billion Last Year: Kalorama Report,” [Press 
release], March 1, 2022. 
76.	 Stephen Kemler et al., “Cell & Gene Therapy Investment 
Outlook In 2022 & Beyond.”
77.	 Kalorama Information, “Funding to Cell and Gene Therapies 
Exceeded 70 Billion Last Year: Kalorama Report.”
78.	 Stephen Kemler et al., “Cell & Gene Therapy Investment 
Outlook In 2022 & Beyond.”
79.	 Janet Lambert et al, “Cell & Gene State of the Industry 
Briefing,” Alliance for Regenerative Medicine.”
80.	 Stephen Kemler et al., “Cell & Gene Therapy Investment 
Outlook In 2022 & Beyond.”
81.	 Ibid.
82.	 Ibid.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
86
Transforming the patient experience
1.	
marcus evans Group, “Driving Patient Centricity beyond the 
Pandemic,” Medium, January 15, 2021.
2.	
ClinicalTrials.gov, “Post-Marketing Safety Study of Severe 
Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) 
mRNA-1273 COVID-19 Vaccine in the United States,” July 12, 
2021.
3.	
Ryan Myers et al., Striving to become more patient-centric in 
life sciences, Deloitte Insights, January 30, 2020.
4.	
Ibid.
5.	
Guy Yeoman et al., “Defining patient centricity with patients 
for patients and caregivers: A collaborative endeavour,” 
PubMed, March 24, 2017.
6.	
FT LIVE, “2021 Global Pharmaceutical and Biotechnology 
Conference,” 2021.
7.	
Deloitte Switzerland, “Deloitte Health Connect Webcast - 
Patient Equality in Health,” YouTube, November 20, 2020.
8.	
Michael Stadler, “A Short History of Patient Centricity,” 
Clariness, April 6, 2016.
9.	
Deloitte Switzerland, “Deloitte Health Connect Webcast - 
Patient Equality in Health.”
10.	 Ibid.
11.	 inVibe Labs, “Pharmaceutical Companies Integrate Patient 
Insights into the Drug Development Process,” [Press Release], 
November 2, 2021.
12.	 Ibid.
13.	 The Foundation for the National Institutes of Health, “Freda C. 
Lewis-Hall, M.D., DFAPA,
14.	 FT LIVE, “2021 Global Pharmaceutical and Biotechnology 
Conference”.
15.	 Jon Hoggard, “The importance of co-creation with patients,” 
PMLive, February 22, 2019.
16.	 Jonah Comstock, “Patient co-creation is a tall, but worthwhile, 
order for health innovators,” MobiHealthNews, November 27, 
2019.
17.	 Jon Hoggard, “The importance of co-creation with patients,”
18.	 Jonah Comstock, “Patient co-creation is a tall, but worthwhile, 
order for health innovators
19.	 FT LIVE, “2021 Global Pharmaceutical and Biotechnology 
Conference”.
20.	 Ibid.
21.	 Gabriele Vanoli et al., Digital therapeutics, Deloitte 
Switzerland, 2021.
22.	 Susan Sterling et al., “How Quebec found relief in testing 
times,” Deloitte, accessed March 16, 2022.
23.	 Kevin Zhou et al., Digital Health Whitepaper, Deloitte China, 
2021.
24.	 US FDA, “CDER Patient-Focused Drug Development,” July 27, 
2021.
25.	 Sage Therapeutics, “ECNP Encore: Zuranolone Data Review,” 
October 4, 2021.
26.	 Ibid
27.	 Biogen, “Sage Therapeutics and Biogen Announce 
Consistent Clinically Meaningful Data for Zuranolone 
Across the LANDSCAPE and NEST Clinical Development 
Programs Presented at the European College of 
Neuropsychopharmacology (ECNP) Congress,” October 4, 
2021.
28.	 Sage Therapeutics, “ECNP Encore: Zuranolone Data Review.”
29.	 Fatimah Lateef, “Patient expectations and the paradigm shift 
of care in emergency medicine,” PubMed Central (PMC), April 
18, 2010.
30.	 Blackstone Equity Healthcare, “What Do We Mean When 
We Say that We Want Employees to Be Active Consumers of 
Healthcare?” March 21, 2012.
31.	 Catherine Morin, “How the Ritz-Carlton Creates a 5 Star 
Customer Experience,” CRM.org, December 13, 2019.
32.	 FT LIVE, “2021 Global Pharmaceutical and Biotechnology 
Conference”.
33.	 Dan Riskin et al., “Abstract 13797: Enabling Advanced 
Real-world Evidence in Heart Failure: A Pilot Study Defining 
Preferred Approaches to Electronic Health Record Data Use,” 
Circulation, November 12, 2020.
34.	 Christophe Jauquet, “Healthusiasm,” accessed March 16, 
2022.
35.	 FT LIVE, “2021 Global Pharmaceutical and Biotechnology 
Conference”.
36.	 Ibid.
37.	 Greg Reh et al., “Overcoming biopharma’s trust deficit,” 
Deloitte Insights, May 6, 2021.
38.	 Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation,” Deloitte 
Insights, December 8, 2021.
39.	 Ibid.
40.	 Brett Davis et al., “Personalized therapies in the Future of 
Health,” Deloitte Insights, March 4, 2021.
41.	 Gabriele Vanoli et al., Digital therapeutics, Deloitte 
Switzerland, 2021.
42.	 Healthware Group, “Life sciences predictions for 2022: digital 
health and transformation accelerates,” December 21, 2021.
43.	 Adriana Krasniansky et al., “2021 year-end digital health 
funding: Seismic shifts beneath the surface,” Rock Health, 
January 10, 2022.
44.	 Daria Gherghelas, “Digital Health Exits in Europe: End of 2021

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
87
Update,” Speedinvest, January 13, 2022.
45.	 Adriana Krasniansky et al., “2021 year-end digital health 
funding: Seismic shifts beneath the surface,” Rock Health, 
January 10, 2022.
46.	 Amarinder Sidhu et al., Building patient services programs to 
deliver better experiences, therapy adherence, and improved 
health outcomes, Deloitte Digital, 2020.
47.	 Ibid.
48.	 Takeda Pharmaceutical Company Limited, “OnePath,” 
accessed March 16, 2022.
49.	 FT LIVE, “2021 Global Pharmaceutical and Biotechnology 
Conference”.
50.	 Christopher Zant, “ConvergeHEALTH Connect—A Patient 
Engagement Solution Suite,” Deloitte US, 2019.
51.	 “Ping An Good Doctor and Chugai Pharma China Jointly 
Establish a Whole Course Management System for 
Osteoporosis,” [Press release], December 21, 2021.
52.	 Ibid.
53.	 Ping An Good Doctor, “’Easier, faster and more affordable’: 
Ping An Good Doctor’s new strategy builds on solid 
foundation,” [Press Release], October 24, 2021.
54.	 Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation.”
55.	 Brett Davis et al., “Personalized therapies in the Future of 
Health.”
Transforming the talent experience
1.	
Peter Evans-Greenwood et al., “Reconstructing the 
workplace.” Deloitte Insights, July 12, 2021.
2.	
Jennifer Veenstra, 2021 Global Marketing Trends, Deloitte 
Insights, 2020.
3.	
Ibid.
4.	
Anne Field, “From ‘the Great Resignation’ to ‘the Great 
Reimagination’,” WSJ and Deloitte, November 3, 2021. 
5.	
Sean Fleming, “Survey: 40% of employees are thinking of 
quitting their jobs,” World Economic Forum, June 2, 2021.
6.	
David Gelles, “Executives Are Quitting to Spend Time With 
Family... Really,” New York Times, February 16, 2022. 
7.	
Andrew Blau et al., ”The inflation outlook,” Deloitte, February 
10, 2022.
8.	
Anne Field, “From ‘the Great Resignation’ to ‘the Great 
Reimagination’.”
9.	
Elizabeth J. Altman, “Driving the future of work with workforce 
ecosystems,” Deloitte Insights, January 18, 2021.
10.	 Ibid.
11.	 Eri Sugiura et al., “Back to the office? How Japan might work 
after COVID-19,” Nikkei Asia, March 19, 2021. 
12.	 Steve Hatfield et al., “Workforce strategies in the era of the gig 
economy,” Deloitte US, August 3, 2021.
13.	 Elizabeth J. Altman, “Driving the future of work with workforce 
ecosystems.”
14.	 Ibid.
15.	 Ibid.
16.	 Peter Evans-Greenwood et al., “Reconstructing the 
workplace.”
17.	 Eri Sugiura et al., “Back to the office? How Japan might work 
after COVID-19.”
18.	 Jurriaan Kamer, “People and Patients First: How Roche BeLux 
is Reinventing Itself,” Medium, September 1, 2021. 
19.	 FT LIVE, “2021 Global Pharmaceutical and Biotechnology 
Conference,” 2021. 
20.	 Jurriaan Kamer, “People and Patients First: How Roche BeLux 
is Reinventing Itself,”
21.	 Laura Shact et al., “Creating a human-centric hybrid 
workplace,” Deloitte US, November 24, 2021. 
22.	 Peter Evans-Greenwood et al., “Reconstructing the 
workplace.”
23.	 Ibid.
24.	 Jack Kelly, “Survey: Nearly 100% Of Human Resources And 
72% Of Execs Said Corporate Culture Was Great During The 
Pandemic—Workers Disagreed,” Forbes, September 18, 2021. 
25.	 Peter Evans-Greenwood et al., “Reconstructing the 
workplace.”
26.	 Elizabeth J. Altman, “Driving the future of work with workforce 
ecosystems.”
27.	 Uwe Trinks, “Making ‘work from home’ work in pharma,” 
Pharma Manufacturing, August 4, 2021. 
28.	 Alexander Braier et al., “Designing adaptive workplaces,” 
Deloitte Insights, February 10, 2021.
29.	 Shreya Dutta, “Employee Benefits And Compensation Ideas: A 
Guide,” Vantage Circle HR Blog, March 4, 2022. 
30.	 Elizabeth J. Altman, “Driving the future of work with workforce 
ecosystems.”
31.	 Eri Sugiura et al., “Back to the office? How Japan might work 
after COVID-19.”
32.	 Laura Shact et al., “Creating a human-centric hybrid 
workplace.”
33.	 Eri Sugiura et al., “Back to the office? How Japan might work 
after COVID-19.”

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34.	 Abi Carter, “German Labour Minister plans permanent right to 
work from home,” IamExpat, January 13, 2022. 
35.	 AstraZeneca, “AstraZeneca in China,” accessed March 16, 
2022. 
36.	 David Wigersma et al, “New cross-border double taxation 
agreement between Switzerland and Italy,” Deloitte tax@
hand, March 2, 2022.
37.	 JNJ , “Applying Data Science for Real-World Impact,” accessed 
March 16, 2022. 
38.	 Bob Violino, “6 ways to deal with the great data scientist 
shortage,” CIO, May 22, 2019. 
39.	 Heather McBride Leef et al., “Winter 2022 Fortune/Deloitte 
CEO Survey,” Deloitte US, 2022. 
40.	 Saadia Zahidi et al., “The Future of Jobs Report 2020,” World 
Economic Forum, October 2020. 
41.	 Brad Smith, “Microsoft launches initiative to help 25 million 
people worldwide acquire the digital skills needed in a 
COVID-19 economy,” The Official Microsoft Blog, June 30, 
2020. 
42.	 Chuck Appleby et al., “Digital transformation,” Deloitte 
Insights, October 26, 2021.
43.	 Ibid.
44.	 Ronald Bannister, Solutions for the new distributed workforce, 
Deloitte, 2020.
Regulatory: Mastering external forces
1.	
Deloitte, Never the same again: How COVID-19 created 
seismic change in life sciences regulations, 2021.
2.	
Evan Richardson, “Rolling NDA and BLA Submissions: 
Accelerate Your Timeline for Review,” Certara, April 23, 2021.
3.	
Kate Goodwin, “FDA Works to Get New Drugs to Patients 
Faster with Multiple Approvals This Week”, BioSpace, 
December 2, 2020.
4.	
Evan Richardson, “Rolling NDA and BLA Submissions: 
Accelerate Your Timeline for Review,” Certara, April 23, 2021.
5.	
Maria Lily Shaw, et al., Shortening Approval Delays for New 
Drugs: A Safe, Straightforward Prescription, MEI, June 21, 
2021.
6.	
Government of Canada, Health Product InfoWatch: 
September 2021, September 2021.
7.	
Bruno Speder, Rolling reviews: A useful tool to speed up the 
regulatory review process, TOPRA, May 2021.
8.	
Kevin Robinson, Top tips for the pharmaceutical industry in 
2022,” Manufacturing Insights, December 21, 2021.
9.	
Ozlem Belen, et al., “FDA Approval Demonstrates the Role of 
Real-World Evidence in Regulatory Decision-Making on Drug 
Effectiveness,” US FDA, accessed March 15, 2022.
10.	 Kevin Robinson, “Top tips for the pharmaceutical industry in 
2022,” Manufacturing Insights, December 21, 2021.
11.	 Kathy Fernando et al., “Achieving end-to-end success in the 
clinic: Pfizer’s learnings on R&D productivity,” Drug Discovery 
Today, 27(3): 697-704, March 2022.
12.	 Predictive Oncology, “How Artificial Intelligence Can Boost 
FDA Approvals for Novel Cancer Treatments,” Nasdaq, 
December 16, 2021.
13.	 Gail Dutton, “Past Vaccine Failures May Reduce COVID-19 
Vaccination Rates,” BioSpace, June 10, 2020.
14.	 Kathy Fernando et al., “Achieving end-to-end success in the 
clinic: Pfizer’s learnings on R&D productivity,” Drug Discovery 
Today, 27(3): 697-704, March 2022.
15.	 Pfizer, Bold Moves, Pfizer 2020 Annual Review, 2020. 
16.	 Kathy Fernando et al., “Achieving end-to-end success in the 
clinic: Pfizer’s learnings on R&D productivity,” Drug Discovery 
Today, 27(3): 697-704, March 2022.
17.	 Haley Dixey et al., “MHRA and US FDA tackle challenging data 
integrity,” GOV UK, September 1, 2021.
18.	 Deloitte, Never the same again.
19.	 World Health Organization, “Regulatory collaboration,” WHO 
Drug Information, 30(4), 2016. 
20.	 Deloitte, Never the same again.
21.	 International Conference of Drug Regulatory Authorities 
(ICDRA), “Session: Local production to improve access: 
Lessons learnt from the Pandemic,” DCVMN, September 23, 
2021.
22.	 Deloitte, Never the same again.
23.	 Ibid.
24.	 Ibid.
25.	 Ibid.
26.	 Ibid.
27.	 Ibid.
28.	 Australian Government Department of Health, “Is it true? Get 
the facts on COVID-19 vaccines,” February 17, 2022.
29.	 Australian Government Department of Health, “COVID-19 
vaccine: International collaboration,” September 16, 2021.
30.	 Amy Brown, et al., Evaluate Vantage 2022 Preview, Evaluate, 
December 2021.
31.	 Haley Dixey et al., “MHRA and US FDA tackle challenging data 
integrity,” GOV UK, September 1, 2021.
32.	 ICMRA, Reflections on the regulatory experience of remote 
approaches to GCP and GMP regulatory oversight during the 
COVID-19 Pandemic, December 2021.
33.	 Ibid.
34.	 Fraiser Kansteiner, “FDA, working through pandemic backlog, 
pauses US factory inspections on omicron concerns,” 
FiercePharma, January 5, 2022.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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35.	 US FDA, “Digital Health Software Precertification (Pre-Cert) 
Program,” May 6, 2021.
36.	 Deloitte Global’s 2022 Global Life Sciences Outlook is an 
independent publication and has not been authorized, 
sponsored, or otherwise approved by Apple Inc.
37.	 US FDA, “Artificial Intelligence and Machine Learning (AI/ML)-
Enabled Medical Devices,” September 22, 2021.
38.	 GOV UK, Guidance: Software and AI as a Medical Device 
Change Programme, September 16, 2021. 
39.	 Vatsal Chhaya, et al., “The SaMD regulatory landscape in the 
US and Europe,” RAPS, August 6, 2021.
40.	 Shohei Nakano, “Policies to Promote Development of 
AI-Based Medical Devices in Japan,” Shohei Nakano Japan 
Association for the Advancement of Medical Equipment 
(JAAME), November 2021.
41.	 US FDA, “Artificial Intelligence and Machine Learning (AI/ML)-
Enabled Medical Devices,” September 22, 2021.
42.	 Shohei Nakano, “Policies to Promote Development of 
AI-Based Medical Devices in Japan,” Shohei Nakano Japan 
Association for the Advancement of Medical Equipment 
(JAAME), November 2021.
43.	 Dr. Abtin Rad, “AI in MedTech: Risks and Opportunities of 
Innovative Technologies in Medical Applications,” MedTech 
Intelligence, May 7, 2021.
44.	 Deloitte/GAIA AG, Digital therapeutics, Catalysing the future 
of health,” Deloitte, 2021.
45.	 Ibid.
46.	 Ibid.
47.	 Ibid.
The digital enterprise at scale: A CEO imperative for 2022
1.	
Heather McBride Leef, “Winter 2022 Fortune/Deloitte CEO 
Survey,” Deloitte US, 2022.
2.	
Michael Shirer, “New IDC Spending Guide Shows Continued 
Growth for Digital Transformation as Organizations Focus on 
Strategic Priorities,” IDC, November 9, 2021.
3.	
Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation,” Deloitte 
Insights, December 8, 2021.
4.	
Ibid.
5.	
Michael Shirer, “New IDC Spending Guide Shows Continued 
Growth for Digital Transformation as Organizations Focus on 
Strategic Priorities,” IDC, November 9, 2021.
6.	
Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation.”
7.	
Todd Konersmann et al, “Digital Transformation in Life 
Sciences,” Deloitte US, 2021.
8.	
Mike DeLone, “2022 Outlook for Life Sciences: 7 Important 
Trends to Watch,” Deloitte US, January 11, 2022.
9.	
Rich Nanda et al, “A new language for digital transformation,” 
Deloitte Insights, September 23, 2021.
10.	 Todd Konersmann et al, “Digital Transformation in Life 
Sciences,” Deloitte US, 2021
11.	 Jay Zhu et al, MedTech commercial transformation: Moving 
from “doing digital” to “being digital, Deloitte US, 2020.
12.	 Ibid.
13.	 Ibid.
14.	 Surinderpal S. Kumar, “DevOps - A Crucial Steppingstone for 
CXO’s Digital Transformation Aspirations,” Addteq, June 11, 
2019.
15.	 Deloitte China, “Deloitte explored digitalization in pharma 
industry with EUCCC,” accessed March 16, 2022.
16.	 Amir Rahnema et al, The Adaptable Organization, Harnessing 
a networked enterprise of human resilience, Deloitte, 2018.
17.	 Ibid.
18.	 Amir Rahnema et al, The Adaptable Organization, Harnessing 
a networked enterprise of human resilience.
19.	 Ibid.
20.	 Renee Cuzens, “Creating the Right Environment for People to 
be Agile,” Deloitte Australia, May 22, 2019.
21.	 Neil C. Hughes, “Rich Nanda from Deloitte Explores The 
Transformation Myth,” Neil C. Hughes, January 4, 2022.
22.	 Renee Cuzens, “Creating the Right Environment for People to 
be Agile.”
23.	 Rich Nanda et al, “A New Language for Digital Transformation,” 
Deloitte and WSJ, November 5, 2021.
24.	 Gaurav Lahiri et al, “Combating COVID-19 with an agile change 
management approach,” Deloitte India, May 2020.
25.	 Ibid.
26.	 Todd Konersmann et al, Enterprise digital transformation as a 
competitive necessity, Deloitte US, 2021.
27.	 Aaron Ferguson, “How Pharma Startups Can Remain 
Competitive in Today’s Market,” HIT Consultant Media, August 
30, 2021.
28.	 Todd Konersmann et al, “Enterprise digital transformation as 
a competitive necessity,”
29.	 Ibid.
30.	 Moderna, “How Moderna is Building a Digital Biotech,” March 
2, 2020.
31.	 Moderna, How Building a Digital Biotech’s  Mission-critical to 
Moderna, 2020.
32.	 Glenn Snyder, Deloitte US, August 10, 2021. How should 
Medtech companies respond to an increasingly consumer-
centric world?
33.	 Ibid.
34.	 Ibid.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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35.	 Ibid.
36.	 Glenn Snyder, “Viewing Medtech Through The Lens of 
Innovators,” Deloitte US, September 23, 2021.
37.	 Ibid.
38.	 Ibid.
39.	 Beena Ammanath et al, The AI Dossier, Deloitte AI Institute, 
2021.
40.	 Deloitte, IDC MarketScape: Worldwide AI Services 2021 
Vendor Assessment, May 2021.
41.	 Jennifer Hamel, “IDC MarketScape: Worldwide Artificial 
Intelligence Services 2021 Vendor Assessment,” IDC, May 
2021.
42.	 Beena Ammanath et al, The AI Dossier.
43.	 Ibid.
44.	 Mike DeLone, “2022 Outlook for Life Sciences: 7 Important 
Trends to Watch.”
45.	 Beena Ammanath et al, The AI Dossier.
46.	 Mike DeLone, “2022 Outlook for Life Sciences: 7 Important 
Trends to Watch.”
47.	 Karen Taylor et al, Intelligent drug launch and commercial, 
Deloitte Insights, 2021.
48.	 Goran Mijuk, “The data42 program shows Novartis’ intent to 
go big on data and digital,” Novartis, March 11, 2020.
49.	 Anisah Alyahya, “data42: Bridging the gap between preclinical 
research and clinical development,” Medium, December 13, 
2021.
50.	 Achim Plueckebaum and Gabriel Eichler, “data42 is coming of 
age,” Novartis, Live. Magazine, September 29, 2021.
51.	 JnJ Medical Device Business Services, Inc., “The Future of 
Digital Surgery,” accessed March 16, 2022.
52.	 Karen Taylor et al, Intelligent drug launch and commercial.
53.	 Beena Ammanath et al, The AI Dossier.
54.	 Aditya Kudumala et al, “Scaling up AI across the life sciences 
value chain,” Deloitte Insights, November 4, 2020.
55.	 JnJ Medical Device Business Services, Inc., “The Future of 
Digital Surgery.”
56.	 HealthTech, “U.S. FDA Grants De Novo Clearance for 
Medtronic Artificial Intelligence System for Colonoscopy: GI 
Genius Intelligent Endoscopy Module,” April 12, 2021.
57.	 Neil C. Hughes, “Rich Nanda from Deloitte Explores The 
Transformation Myth.”
58.	 Rich Nanda et al, “Deloitte book collaboration: The 
Transformation Myth,” Deloitte US, September 28, 2021.
59.	 Neil C. Hughes, “Rich Nanda from Deloitte Explores The 
Transformation Myth.”
60.	 Maria João Cruz, PhD et al, “Seeds of change: Measuring the 
return from pharmaceutical innovation 2020,” Deloitte UK, 
May 2021.
61.	 Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation,”
62.	 Rich Nanda, “The Key to Long-Term Success? Nonstop 
Transformation,” WSJ and Deloitte, February 4, 2022.
63.	 Ibid.
64.	 Ibid.
Future-proofing manufacturing and supply chains
1.	
SAP, “What Does Future-Proofing Actually Mean?” accessed 
March 16, 2022.
2.	
MasterControl, The ultimate guide to digitizing the shop floor, 
2020.
3.	
Laks Pernenkil et al., The biopharma factory of the future: 
Start the journey to smart manufacturing, Deloitte US, 2019.
4.	
Ibid.
5.	
Ibid.
6.	
Ibid.
7.	
MasterControl, The ultimate guide to digitizing the shop floor, 
2020.
8.	
Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation,” Deloitte 
Insights, December 8, 2021.
9.	
Executive Platforms: Thought Leader Series, “Digital 
Transformation and the Smart Factory – A Conversation with 
Laks Pernenkil of Deloitte Consulting LLP,” November 26, 
2019.
10.	 MasterControl, The ultimate guide to digitizing the shop floor.
11.	 US FDA, Chapter 56—Drug Quality Assurance, August 27, 
2021.
12.	 Rebecca Stauffer, What Can Regulatory Data Tell Us About 
Data Integrity Trends? REDICA Systems, August 31, 2021.
13.	 Ibid.
14.	 Srikanth Narayana Mangalam et al., Automating quality 
assurance in pharmaceutical, biotechnology, and medical 
devices, Deloitte US, 2019.  .
15.	 Ibid.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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16.	 David Hodgson et al., Under the spotlight: Data Integrity in life 
sciences, Deloitte UK, 2017.
17.	 Ibid.
18.	 Ed Silverman, “FDA tells drug makers to redo studies run by 
two contract research firms due to data integrity issues,” STAT, 
September 28, 2021.
19.	 Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation.”
20.	 Beth Sissons, “NTT Global Threat Intelligence Report: Up to 
300% Increase in Attacks from Opportunistic Targeting,” NTT, 
May 11, 2021.
21.	 Ibid.
22.	 Amry Junaideen, “For health and life sciences companies, 
cybersecurity is not just an IT issue,” Deloitte US, May 21, 
2019.
23.	 Aditya Kudumala et al., “Biopharma digital transformation: 
Gain an edge with leapfrog digital innovation.”
24.	 Bill Murray et al., “The Semiconductor Chip Shortage Hits 
MedTech: Strategies to Build Resilient Supply Chains,” Deloitte 
US, September 23, 2021.
25.	 Jennifer Markarian, “Advanced Manufacturing Technologies 
Shift Outside the Box,” PharmTech, April 2, 2021.
26.	 Bill Murray et al., “The Semiconductor Chip Shortage Hits 
MedTech: Strategies to Build Resilient Supply Chains.”
27.	 Jennifer Markarian, “Advanced Manufacturing Technologies 
Shift Outside the Box,” PharmTech, April 2, 2021.
28.	 Ibid.
29.	 Bill Murray et al., “The Semiconductor Chip Shortage Hits 
MedTech: Strategies to Build Resilient Supply Chains.”
30.	 Kendra Hann et al., Resilient supply chain strategies, Deloitte, 
2021.
31.	 Heather McBride Leef, “Winter 2022 Fortune/Deloitte CEO 
Survey,”
32.	 Kendra Hann et al., Resilient supply chain strategies.
33.	 Ibid.
34.	 John Ciacchella et al., 2022 Semiconductor Industry Outlook, 
Deloitte US, 2022.
35.	 Ed Johnson et al., “Effective margin management during 
inflation,” Deloitte US, accessed March 16, 2022.
36.	 Bryce Baschuk, “BlackRock Warns of New Era of Supply-Driven 
Inflation,” Bloomberg, January 31, 2022.
37.	 Stephanie Allen et al., 2022 Global Health Care Outlook, 
Deloitte, 2021.
38.	 Ibid.
39.	 Freightos, “Freightos Baltic Container Freight Index (FBX),” 
accessed January 28, 2022.
40.	 Lori Ann LaRocco, “How shipping and supply chain backlogs 
are impacting inflation,” MSN, February 2, 2022.
41.	 Damian Brett, “Airfreight rates remain elevated in January,” Air 
Cargo News, February 3, 2022.
42.	 Nick Paul Taylor, “Supply chain constraints, inflation weigh on 
medtech,” Supply Chain Dive, November 11, 2021.
43.	 Ibid.
44.	 Russ Koesterich, “Navigating the new world of inflation,” 
BlackRock, January 10, 2022
45.	 Bryce Baschuk, “BlackRock Warns of New Era of Supply-Driven 
Inflation,” Bloomberg, January 31, 2022.
46.	 Nick Paul Taylor, “Supply chain constraints, inflation weigh on 
medtech,”
47.	 Ed Johnson et al., “Effective margin management during 
inflation,” Deloitte US, accessed March 16, 2022.
48.	 Kendra Hann et al., Resilient supply chain strategies.
49.	 Ibid.
50.	 John Ciacchella et al., 2022 Semiconductor Industry Outlook.
51.	 Bill Murray et al., “The Semiconductor Chip Shortage Hits 
MedTech: Strategies to Build Resilient Supply Chains,” Deloitte 
US, September 23, 2021.
52.	 Ibid.
53.	 Ibid.
54.	 Ibid.
55.	 Ibid.
56.	 Duncan Stewart et al., “My kingdom for a chip: The 
semiconductor shortage extends into 2022,” Deloitte Insights, 
December 1, 2021.
57.	 Kayla Tausche, “Raimondo: Need companies to build factories 
in U.S.,” CNBC, September 28, 2021.
58.	 Gina M. Raimondo, “Commerce Department, Biden 
Administration Take Action on Semiconductor Chip Shortage,” 
US Department of Commerce, October 8, 2021.
59.	 Joel Khalili, “Intel to splash $20 billion on state-of-the-art chip 
factory the size of a village,” TechRadar, January 25, 2022.
60.	 John Ciacchella et al., 2022 Semiconductor Industry Outlook.
61.	 Emily Thompson, “Four trends to watch in pharma facility 
design for 2022,” Pharma Manufacturing, December 13, 2021.
62.	 Ibid.
63.	 Larry Kivett et al., Understanding risk management in the 
supply chain, Deloitte US, 2017
64.	 Jim Kilpatrick et al., COVID-19: Managing supply chain risk and 
disruption, Deloitte US, 2020.
65.	 Heather McBride Leef, “Winter 2022 Fortune/Deloitte CEO 
Survey.”
66.	 Ibid.
67.	 Ibid.
68.	 Ibid.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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Environmental, Social, and Governance (ESG): Another CEO imperative
1.	
Beth Snyder Bulik, “Call it a pandemic reckoning: New 
ESG expectations spur surge of pharma good deeds,” 
FiercePharma, April 15, 2021.
2.	
Brian Bacon, “Purpose Drives Performance in Organisations,” 
Oxford Leadership, June 29, 2017.
3.	
Anjul A. Shah et al., “ESG & Long-Term Disclosures: The State 
of Play in Biopharma,” Harvard Law School Forum, July 1, 2021.
4.	
Kristen Sullivan et al., Incorporating ESG measures into 
executive compensation plans, Deloitte US, April 2021.
5.	
Ibid.
6.	
Anuj A. Shah, “ESG & Long-Term Disclosures: The State of Play 
in Biopharma.”
7.	
Capital Monitor, “Capital Monitor,” accessed March 16, 2022.
8.	
Berkeley Center for Health Technology, “Pricing and Access for 
Pharmaceuticals,” accessed March 16, 2022.
9.	
Brendan Melck, “Germany’s ESG Law: A case study for new 
pharma pricing model,” Pharmaceutical Technology, July 19, 
2021.
10.	 Access to Medicine Foundation, “Worldwide 5 billion people 
have access to medicine,” accessed March 16, 2022.
11.	 PhRMA, “Five Key Strategies for Enhancing Diversity in Clinical 
Trials,” November 16, 2021.
12.	 Alexandra Charge, “Gender Equality in Science is Still Too Far 
Away,” LinkedIn, January 11, 2022.
13.	 Beth Snyder Bulik, “The top 10 ESG pharma companies in 
2021,” FiercePharma, June 21, 2021.
14.	 Ibid.
15.	 NYU Stern, “Return on Sustainability Investment 
Methodology,” accessed March 16, 2022.
16.	 Deloitte WSJ Pro Sustainability Business interview, Jim Greffet 
and Anat Ashkenazi, 2022.
17.	 Ibid.
18.	 Ivana Turjak-Čebohin, “Support in stakeholder engagement,” 
Deloitte Croatia, accessed March 16, 2022.
19.	 Greg Reh et al., “Overcoming biopharma’s trust deficit.”
20.	 Deloitte WSJ Pro Sustainability Business interview, Jim Greffet 
and Anat Ashkenazi.
21.	 Ibid.
22.	 Michael Mazengarb, “Why New Zealand could become global 
leader on corporate climate risk disclosures,” RenewEconomy, 
January 27, 2022.
23.	 Katanga Johnson, “FOCUS-Companies worry U.S. SEC climate 
rule may require broad emissions disclosures,” Nasdaq, 
January 19, 2022.
24.	 Michael Mazengarb, “Why New Zealand could become global 
leader on corporate climate risk disclosures,”
25.	 Ibid.
26.	 Dhwani Pandya, “ESG Rater Says Green Push Compliance 
Tough For Indian Companies,” Bloomberg, February 10, 2022.
27.	 The Securities and Exchange Commission, Thailand, “SEC to 
impose ESG training requirement on capital market business 
personnel to promote sustainable investment,” March 22, 
2021.
28.	 European Commission, “Corporate sustainability reporting,” 
September 15, 2021.
29.	 Unites States Securities and Exchange Commission, “SEC 
Proposes Rules to Enhance and Standardize Climate-Related 
Disclosures for Investors,” [Press release], SEC.gov, March 21, 
2022.
30.	 Ibid.
31.	 Science Based Targets, “Companies taking action - Science 
Based Targets,” accessed March 16, 2022.
32.	 Ibid.
33.	 Takeda Pharmaceutical Company Limited, “Commitment to 
Carbon Neutrality at Takeda,” accessed March 16, 2022.
34.	 Brendan Melck, “Germany’s ESG Law: A case study for new 
pharma pricing model,” Pharmaceutical Technology, July 19, 
2021.
35.	 Ibid.
36.	 Ibid.
37.	 Andrew Stone, “Making medicines sustainable,” Reuters 
Events, November 30, 2021.
38.	 Ibid.
39.	 Dr. Nazneen Rahman, “Healthier climate, healthier us,” 
Financial Times, January 19, 2022.
40.	 YewMaker, “Sustainable Medicines Partnership — YewMaker,” 
accessed March 16, 2022.
41.	 Ibid.
42.	 Access to Medicine Foundation, “Novartis AG,” accessed 
March 16, 2022.
43.	 Linda-Eling Lee et al, “2021 ESG Trends to Watch,” MSCI, 
December 7, 2020.
44.	 Access to Medicine Foundation, “Worldwide 5 billion people 
have access to medicine.”
45.	 Hans Hogerzeil et al, “Access to Medicine Index 2022,” Access 
to Medicine Foundation, 2022.
46.	 Suzanne Wolf, “Taking access to the next level: Mobilising five 
essential healthcare sectors,” Access to Medicine Foundation, 
December 14, 2021.
47.	 James Hazel, “Competition is close for top positions,” Access to 
Medicine Foundation, 2021.

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48.	 Access to Medicine Foundation, “Novartis AG.”
49.	 James Hazel, “Competition is close for top positions.”
50.	 James Hazel, “Eight companies adopt processes to 
systematically address access to medicine for all new 
products,” Access to Medicine Foundation, 2021.
51.	 Access to Medicine Foundation, “Novartis AG.”
52.	 James Hazel, “Competition is close for top positions.”
53.	 James Hazel, “R&D for COVID-19 has increased, yet other 
pandemic risks go unaddressed,” Access to Medicine 
Foundation, 2021.
54.	 James Hazel, “Competition is close for top positions,”
55.	 Ibid.
56.	 Pfizer, ESG Report 2020, 2021.
57.	 James Hazel, “Competition is close for top positions.”
58.	 James Hazel, “The Methodology for the 2022 Access to 
Medicine Index,” Access to Medicine Foundation, September 
22, 2021.
59.	 Ibid.
60.	 James Hazel, “Competition is close for top positions,”
61.	 PhRMA, “Five Key Strategies for Enhancing Diversity in Clinical 
Trials,” November 16, 2021.
62.	 Ibid.
63.	 Christine Chang et al., Enhancing clinical trial diversity, 
Deloitte Insights, 2021.
64.	 Ibid. 
65.	 AdvaMed, “Health Equity,” July 8, 2021.
66.	 AdvaMed, “Principles on Health Equity,” June 2021.
67.	 Stephanie Allen, 2022 Global Health Care Outlook, Deloitte, 
2021.
68.	 Bridge Beijing, “Health Equity in China,” April 7, 2021.
69.	 Bonnie Gwin et al., “Route to the Top 2021,” Heidrick & 
Struggles, July 5, 2021.
70.	 Emma Hinchliffe, “The female CEOs on this year’s Fortune 500 
just broke three all-time records,” Fortune, June 2, 2021.
71.	 Emma Hinchliffe, “The number of women running Global 500 
businesses soars to an all-time high,” Fortune, August 2, 2021.
72.	 Catalyst, “Women CEOs of the S&P 500,” February 1, 2022.
73.	 Marie Leech, “In pandemic, women at the top exhibited more 
empathetic and adaptable leadership,” The Business Journals, 
January 4, 2022.
74.	 Emma Hinchliffe, “The female CEOs on this year’s Fortune 500 
just broke three all-time records.”
75.	 Emma Hinchliffe, “The number of women running Global 500 
businesses soars to an all-time high.”
76.	 Emma Hinchliffe, “The female CEOs on this year’s Fortune 500 
just broke three all-time records,”
77.	 Luca Flabbi, “How do female CEOs affect their company’s 
gender wage gap?” World Economic Forum, April 27, 2015.
78.	 Marie Leech, “In pandemic, women at the top exhibited more 
empathetic and adaptable leadership,” The Business Journals, 
January 4, 2022.
79.	 Molly Mintz, “How Gender Fits into ESG?” S&P Global, 
February 24, 2020.
80.	 Women Business Collaborative, “Ten Accelerators to Driving 
Women into CEO Roles in America,” February 28, 2022.
81.	 Alexandra Charge, “Gender Equality in Science is Still Too Far 
Away,” LinkedIn, January 11, 2022.
82.	 Nicola J White, “Gender pay gap in the UK: 2021,” Office for 
National Statistics, October 26, 2021.
83.	 Alexandra Charge, “Gender Equality in Science is Still Too Far 
Away,”
84.	 Molly Mintz, “How Gender Fits into ESG?” 
85.	 Amanda Barrell, “Is the pharma gender gap starting to close?” 
pharmaphorum, December 4, 2018.
86.	 The Impact Investor, “8 Best ESG Rating Agencies - Who Gets 
to Grade?” December 10, 2021.
87.	 Francesca Livoti et al., “Knowing where your investors stand 
on ESG is more important than ever,” Georgeson, 2021.
88.	 Jessica Tan, “A new green wave of ESG investment is breaking 
in China,” World Economic Forum, December 4, 2020.
89.	 Ariel Pinchot et al., “What Investors Want from Sustainability 
Data,” World Resources Institute, February 12, 2019.
90.	 Novartis, “ESG Rating Performance,” March 2022.
91.	 Antonio Ligi et al., “Novartis accelerates efforts toward ESG 
targets to increase access to medicines, improve health equity 
and achieve net-zero carbon emissions,” Yahoo Finance, 
September 30, 2021.
92.	 Ollie Burch et al., Words that work: Effective language in 
sustainability communications, Radley Yeldar, 2019.
93.	 Reptrak, “VIDEO: The gap between ESG perception and 
reality,” September 22, 2021
94.	 Ibid.
95.	 David C. Broadstock et al., “The role of ESG performance 
during times of financial crisis: Evidence from COVID-19 in 
China,” PubMed Central (PMC), August 13, 2020.
96.	 Reptrak, “VIDEO: The gap between ESG perception and 
reality.”
97.	 Greg Reh et al., “Overcoming biopharma’s trust deficit,” 
Deloitte Insights, May 6, 2021.
98.	 Ibid.
99.	 Carmine Di Sibio et al., “Sustainability reporting: five ways 
companies should prepare,” World Economic Forum, June 21, 
2021.

2022 Global Life Sciences Outlook | Digitalization at scale: Delivering on the promise of science
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100.	Ollie Burch et al., Words that work: Effective language in 
sustainability communications.
101.	Ariel Pinchot et al., “What Investors Want from Sustainability 
Data,” World Resources Institute, February 12, 2019.
102.	The International Financial Reporting Standards Foundation, 
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Standards Board, consolidation with CDSB and VRF, and 
publication of prototype disclosure requirements,” November 
3, 2021.
103.	Bank of America et al., “Measuring Stakeholder Capitalism: 
Top Global Companies Take Action on Universal ESG 
Reporting,” World Economic Forum, November 5, 2021.
104.	Carmine Di Sibio et al., “Sustainability reporting: five ways 
companies should prepare,” World Economic Forum, June 21, 
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105.	Ibid.
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108.	Veronica Poole et al., “Globally Consistent ESG Reporting,” 
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109.	Ibid.
110.	Deena Robinson, “Greenwashing: What is it, Why is it a 
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111.	Ellie Duncan, “World’s largest companies’ climate pledges ‘lack 
real substance’,” Investment Week, February 7, 2022.
112.	MSCI, Introducing ESG investing, 2018.
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from the very basics | #3 What are the challenges in ESG 
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on ESG,” WSJ Pro Sustainable Business and Deloitte, March 
16, 2022. 
115.	Andy Marks, “At the Intersection of ESG Oversight and 
Strategy,” WSJ CFO Journal and Deloitte, January 14, 2022.
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ESG investing,” Reuters, December 23, 2021.
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ESG investing,” Reuters, December 23, 2021.
119.	Zoey Zhang, “What is ESG Reporting and Why is it Gaining 
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2022.
120.	Ibid.
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in China,” World Economic Forum, December 4, 2020.
122.	David C. Broadstock et al., “The role of ESG performance 
during times of financial crisis: Evidence from COVID-19 in 
China,” PubMed Central (PMC), August 13, 2020.
123.	Michael Mazengarb, “Why New Zealand could become global 
leader on corporate climate risk disclosures,”
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markets a lot more,’ Jefferies Global Head of ESG says,” Yahoo 
News, December 31, 2021.
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measures into executive compensation plans,” Deloitte US, 
April 2021.
126.	Brian Bacon, “Purpose Drives Performance in Organisations,”
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Pharmaceutical Company to Execute Sustainability-linked 
Bond Tied to both Climate and Access to Medicine Targets,” 
[Press release], November 3, 2021.
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January 24, 2022.

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