2024

A DVA N C I N G B I O T E C H N O L O GY
& GENOMICS IN SAUDI AR ABIABest practice strategies
to develop the sector &maximize its impact

CONTENTE XECUTIVE SUMMARY
1.

3

THE GLOBAL GROW TH OF BIOTECHNOLO GY& GENOMICS

2.

6C U R R E N T S TAT U S O F B I O T E C H N O L O G Y& GENOMIC S IN SAUDI AR ABIA3.

A C C E L E R AT I N G P R O G R E S S W I T H I N
SAUDI AR ABIA

4.

8

12

K E Y S U C C E S S FA C T O R S T O D E V E L O P
SEC TOR IN SAUDI AR ABIA

CONCLUSION

1620

VIK AS KHARBANDA

DR. ANKITA GULATI

Partner, Healthcare & Life Sciences PracticeLead for Middle East and South East Asia
Riyadh/Dubai

Principal, Healthcare & Life Sciences PracticeDubai

DR. PATRICK LINNENBANKHARSHA AGARWAL

Partner, Healthcare & Life Sciences Practice
Riyadh/Dubai

Consultant
New Delhi

We would like to acknowledge all those who contributed in the review of this Report, especially:
Dr. Ulrica Sehlstedt, Farhan Mirza, and Dr. Ali Ayach.

2

ARTHUR D. LITTLEEXECUTIVE SUMMARYHAR N ESS I N G T H E BE NEFITS OF
BI OT ECHN OLO GY IN SAUDI ARABIA
Fueled by advances in emerging technologies suchas precision medicine,1 ultra-targeted therapies,“omics,”2 and many more, the global biotechnology

and genomics sector is expected to expand at a

double-digit growth rate going forward. Having

understood the potential of the sector, governments
across the world are making concerted efforts

to harness and develop their own biotechnology
industries.

Recognizing the opportunity, The Kingdom of Saudi
Arabia (KSA) has already launched multiple initiatives
to encourage the sector’s growth within the country.
While KSA’s biotechnology industry is still at a relatively
nascent stage, it is already seeing activity fromdifferent players, along with collaboration on projects
such as the Saudi Genome Program, which provide a
promising foundation for the future.
However, while these efforts are a step in the right
direction, success requires a clear vision with specificpriority areas outlined. This includes identifying andtargeting three key segments of the biotechnology
value chain (sampling, analysis, and application) as highpriorities based on the country’s current capabilities andrequirements, as well as developing capacity across aminimum of four thematic areas to further foster growth:12

According to the European Federation of Pharmaceutical Industries and Associates (EFPIA),“Precision medicine is a healthcare approach that utilizes molecular information (genomic,transcriptomic, proteomic, metabolomic, etc.), phenotypic and health data from patientsto generate care insights to prevent or treat human disease resulting in improved healthoutcomes”; see: “Precision Medicine.” European Federation of Pharmaceutical Industries andAssociates (EFPIA), accessed March 2024.
The term “omics” encompasses the scientific field of collecting, quantifying, and analyzinglarge pools of biologic molecules, from single cells to whole organisms such as the human
body, in both normal health and with disease (e.g., cancer). Molecules can be DNA (genomics),
all kinds of RNA (transcriptomics), proteins (proteomics), metabolites (metabolomics), lipids(lipidomics), and sugars (glycomics), as well as their interactions (interactomics).

3

R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A(1) genomic data repository set up, (2) widespreadgenomics adoption, (3) omics and precision medicine
research and application, and (4) AI/machine learning(ML) utilization.
Adopting best practices from other countries is an
essential approach to catalyze the creation of an
indigenous biotechnology and genomics innovation
hub. Successful nations have already designed andimplemented a range of programs and practices to solve
potential challenges and ensure a seamless realizationof their visions for biotechnology and genomics. These
include: the creation of talent pools through anchoring
institutions and innovation hubs; enhanced, active
collaboration between the public and private sector;delivering a supportive pro-business environment andregulations, including enhanced intellectual property (IP)protection; the creation of specific innovation-themed
environments and ecosystems; setting a clear target
picture of all research efforts; and providing start-ups
with fast and easy access to public and private funds.
As this Report explains, these best practices are allimperative to helping KSA achieve its objective of
becoming a regional leader in the biotechnology andgenomics space, delivering clear benefits in termsof public health, economic development, reputation,and overall competitiveness.

4

ARTHUR D. LITTLE

5

R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

1. THE GLOBAL GROWTH OF
BIOTECHNOLOGY & GENOMIC S

Thanks to ongoing advances, the fields ofThese include a shift toward precisionbiotechnology and genomics are set to play

healthcare, including the rise of CAR-T cella major role in mankind’s future wellness andtherapy and companion diagnostics and thehealthcare journeys. Modern biotechnology

growth of ultra-targeted therapies, particularly

provides breakthrough products and technologies

in oncology, using genomic data, with ato combat debilitating and rare diseases,

consequent focus on more precise patientdelivering personalized and more effective

population segments. The trends are driving newtreatments often based on genomic data.

business models based on close collaboration

Globally, the market is growing rapidly as
nations and governments recognize its value for
their citizens and tremendous transformative
potential for their economies and healthcare
systems. As of 2023, the worldwide biotechnology

among players across the entire healthcare
ecosystem; these models are critical for the
successful development and implementationof novel approaches for preventive and curative
care.

sector was estimated to be worth US $1.5 trillion,

At the same time, new treatment paradigms

with an expectation that it will grow at a double

have emerged. Advanced therapeutics such

digit CAGR to reach between $3.5-$4 trillion by

as gene editing through CRISPR-Cas9 provide

2030, according to Grand View Research.

highly personalized and targeted therapies that

3This rapid growth will be driven by both demandside factors (including rising demand for betterand more efficient healthcare diagnostics andtreatment services and an increasing focus
on wellness and prevention) and supply-side
aspects, such as an increasing governmental
focus on the sector, along with rising private

are curing once-fatal diseases such as cancer
and rare genetic disorders, while gene therapy,
cell therapy, and immunotherapy are rapidly
shifting the focus from mortality to morbidity.
This brings implications for all players in thehealthcare ecosystem, including developers,
payors, providers, and patients.

sector investments and rapid technologicalThanks to advances in next-generation

advances.

sequencing (NGS) technologies, we are rapidly
moving toward a future where generating andE MERGI N G T R EN D S
I N T HE SECTOR
Both the public and private sectors are
exploring a range of biotechnology use cases
along the wellness and healthcare value chain.
Demonstrating this, a study of funding patternsfor AI/ML-powered digital health companies
reflects multiple emerging trends.

3
4

6

analyzing the whole human genome will beroutine for any laboratory.4 Alongside this,gathering large-scale biological informationand data from other pools of molecules (such asproteomics, metabolomics, and transcriptomics)
will help generate insights related to diseasedevelopment and treatment effects. Genome
data analysis using sophisticated technologies
such as AI and ML is also a major emerging trendwith several start-ups focusing on this segment.

“Biotechnology Market Size, Share & Trend Analysis by Technology (Nanobiotechnology, DNA Sequencing, Cell-Based Assays), by Application(Health, Bioinformatics), by Region, and Segment Forecasts, 2024–2030.” Grand View Research, accessed March 2024.
Green, Eric D., et al. “Strategic Vision for Improving Human Health at the Forefront of Genomics.” Nature, 28 October 2020.

ARTHUR D. LITTLE

G ROW T H I N G EN OM I C
DATA BAS E S TO SUPPO RT
RE S E A RC H

CRITICALITY OF SECTOR TO
NATIONAL GROWTH AGE NDA

Global priorities are shifting toward citizen-

rise of new diseases and pandemics mean that acentered and patient-friendly genomic
collaboration and research. This is leading
to countries increasing their investments inbiotechnology. In particular, they are actively
working to create diverse genome data sets,
fostering equitable genomics and driving

Changing global geopolitical dynamics and thestrong biotechnology sector is increasingly vitalto ensuring a country’s competitiveness, selfsufficiency, and health. Clearly, at a basic level,
investing in the sector is essential to providing
countries with rapid, immediate access to thelatest innovative and cost-effective treatments.

innovation to address health disparities:

Globally, around $162 billion was invested in the-

The US National Institute of Health (NIH) All

for approximately 35% of total global funding. 8

set of nearly 100,000 genome sequences,

A strong biotechnology industry also catalyzes

of Us Research Program now boasts a data
supplemented by participants’ electronic
health records, Fitbit data, and survey
responses, all accessible through a cloudbased platform.

5- The EU’s 1+ Million Genomes Initiative,

supported by over 25 signatory countries, isdedicated to establishing a European genomic
data infrastructure and facilitating federated
data access through common national
regulation.6- In the UK, the National Health Service (NHS)
is taking steps to integrate genomics into its

biotech sector in 2023, with the US accounting

growth in capability development acrossresearch and innovation, increasing jobs andinvestments and boosting the country’s GDP.
Demonstrating this, the biosciences sector hasoutperformed the wider US economy postCOVID, contributing to around 10% of US GDP
in 2021. Additionally, the industry generated
2.1 million direct jobs, with employees earning
85% more than the average private sector
salary. 9 A strong biotech sector provides a
reputational boost that enhances a country’s
competitiveness in terms of acquiring talent,innovations, and investment.

regular operations by offering whole genomics
sequencing as standard to those with rarediseases or cancers.7

5
6
7
8
9

“NIH’s All of Us Research Program Releases First Genomic Dataset of Nearly 100,000 Whole Genome Sequences.” National Institutes of Health,17 March 2022.
“European ‘1+ Million Genomes’ Initiative.” European Commission, accessed March 2024.
Floden, Evan. “US Sets Bioeconomy Goals and Confronts Data Challenges.” Genetic Engineering & Biotechnology News, 1 September 2023.
Buntz, Brian. “The Global Biotech Funding Landscape in 2023: US Leads While Europe and China Make Strides.” Drug Discovery & Development,
5 January 2024.
“The US Bioscience Industry: Fostering Innovation and Driving America’s Economy Forward.” TEConomy/BIO, 2022.

7

R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

2 . C U R R E N T S TAT U S O F
BIOTECHNOLOGY & GENOMIC S
IN SAUDI AR ABIA
While KSA accounts for 1.3% of global GDP,

Along similar lines, Saudi Arabia has

it only currently makes up 0.2% of the global

demonstrated a strong commitment toward

genomics sector.10 This demonstrates thatdeveloping its R&D agenda. Its “RDI (Research,

the industry is still early in its development.

Development and Innovation) National

Backing this up, the projected growth rate for

Aspirations and Priorities” for the next two

the genomics sector across MENA (Middle East

decades include “Health and Wellness” andand North Africa) between 2022–2030 is around“Economies of the Future.” 11 Backing this up,

9.5% CAGR, which is much lower than the overall

multiple initiatives have been planned andglobal growth rate of approximately 16.5%. Thisannounced in KSA, such as the creation of thehighlights the opportunity and indicates the

National Biotechnology Strategy Committee

potential for the region to direct additional

and Riyadh Biotechnology City.12 The Saudi

focus and resources toward the sector.

Genome Project 2.0 has also set ambitious
objectives including enhancing the country’s

C LEAR TARGETS G I V E
I MPET US & D I R ECT I ON
Globally, multiple countries’ economies haveoutlined specific goals and targets for theirbiotechnology and genomics sectors. For
example, in the US, the White House Office of
Science and Technology Policy report “Bold
Goals for US Biotech and Biomanufacturing,”
published in March 2023, highlights concrete
objectives to strengthen the US bioeconomy,
including collaboration with the private sector
to advance innovation throughout the full
healthcare value chain.

position as the leader in genomics and genetics
within the MENA region.13
Objectives are being backed by investment in
R&D to build a knowledge-based sustainableeconomy, as part of Saudi Arabia’s National
Vision 2030 and National Transformation
Program. KSA has dedicated substantial funding
for R&D, totaling $3.9 billion in 2021,14 equivalent
to 0.46% of GDP 15 (see Figure 1). While this R&D
intensity 16 is currently much lower than the
typical 1.5%-3.5% spent by regional and large
global economies, this is set to change as
Saudi Arabia aims to become a global leader in
research, development, and innovation throughan annual investment equivalent to 2.5% of GDP
by 2040. This is expected to not only add $16
billion to the economy, but also create highvalue jobs in science and technology.17

10
11
12
13
14
15
16
17

8

“GDP Based on PPP, Share of World.” International Monetary Fund (IMF), accessed March 2024.
“Saudi Crown Prince to Prioritize Research, Development, and Innovation to Address Global Challenges.” The Embassy of The Kingdom of Saudi
Arabia, 1 July 2022.
Riyadh Global Medical Technology Summit 2023 website, accessed March 2024.
Objectives also include establishing KSA as a global hub for world-class collaborations on prevalent genetic diseases and ensuring genomics playa vital role in delivering high-quality healthcare to all Saudi citizens; see: “Saudi Genome Project.” Kingdom of Saudi Arabia Vision 2030, accessed
March 2024.
“Saudi R&D Spending Tops $3.9bn.” Arabian Business, 8 February 2023.
“Research and Development Expenditure (% of GDP).” The World Bank, 27 November 2023.
“EU Investment in R&D Increased to €328 Billion in 2021.” Eurostat, 29 November 2022.
“Saudi Arabia’s Leap in Research and Development Excellence.” Elsevier/Research, Development, and Innovation Authority (RDIA), 2023.

ARTHUR D. LITTLE

Figure 1. R&D intensity vs. health & biotech innovation focus
across countries
Figure 1. R&D intensity vs. health & biotech innovation focus across countries

5.5

Israel

R&D investment as % GDP

5.0South Korea

4.5
4.0

Sweden3.5
3.0

Switzerland
Germany

2.5

China

FranceUAE
Turkey

1.5
1.0

Italy

Iran
India

0.5

The Netherlands

Singapore

2.0

0.0

Belgium

US

Japan

CanadaUK

Australia

GDP (size)

Spain

Other
Hong Kong

CyprusMiddle EastUS

Saudi Arabia

0

20

40

Europe

60

80

100

120

140

160

180

260

280

300

320

Citations across health & biotech (1996–2021) per 1,000 capita
Source: Arthur D. Little, World Bank, World Intellectual Property Organization (WIPO), Capital IQ, Preqin, IBISWorld,
European Medicines Agency (EMA), International Monetary Fund, and SCImago Journal Rank (SJR)S U P P O RT I VE R EGULAT I O N S
ACC E LE RATE G RO WT H

Source: Arthur D. Little

In the biotechnology sector, major economies
have introduced regulations to encouragetransparency and expedite clinical trial
approvals. For instance, the UK is looking
to introduce the Future Clinical Trials Bill,18
while its Medicines and Healthcare products
Regulatory Agency (MHRA) has introduced
guidelines to expedite low-risk clinical trials.19
Along similar lines, Saudi Arabia is developing
and setting up a clear regulatory andgovernance mechanism for R&D. The Saudi
Food and Drug Authority (SFDA) has proposed
new guidelines for clinical trials with the aim toregulate, support, and enhance collaboration
between the different entities involved in
them,

20

while the Research, Development andInnovation Authority (RDIA) is aiming to act
as an enabler, legislator, and regulator 21 going
forward.

MULTIP LE LARGE-SCALE
INITIATIVE S ALREADYLAUNCH E D
Understanding the opportunity, multiple
entities within KSA’s R&D ecosystem are working
toward enhancing the biotechnology agenda,
launching a range of initiatives. As part of this,
there has been an increase in academic researchand initiatives by Saudi institutions and a focus
on developing the local talent pool in scienceand technology:- Research organizations- King Abdullah International Medical

Research Center’s (KAIMRC), launchedin 2006, focuses on applied sciences
research and works with leading academic
institutions around the world in areas suchas vaccines, genetic research, therapeutics,
and drug screening. For example, working
with the University of Oxford, KAIMRC led
The Kingdom’s first phase I clinical trial ofa vaccine into the MERS-CoV virus.22 The
institution is currently focused on multiple
initiatives, including the Saudi Biobank,
Cord Blood Bank, Research Trauma Project,and Saudi Stem Cell Donor Registry.

18
19
20
21
22

Eckford, Catherine. “New Bill Could Enhance UK Clinical Trial Regulation.” European Pharmaceutical Review, 27 October 2023.
Medicines and Healthcare Products Regulatory Agency. “New Streamlined Notification Scheme for Lowest-Risk Clinical Trials Marks Start of MHRA
Overhaul of Regulation.” Gov.UK, 12 October 2023.
“SFDA’s New Contract Research Organization Draft Guideline.” Al Tamimi & Co., 24 March 2022.
“Saudi Crown Prince to Prioritize Research, Development, and Innovation to Address Global Challenges.” The Embassy of The Kingdom of Saudi
Arabia, 1 July 2022.
Nature Research Custom Media. “KAIMRC Leads The Kingdom into the First Phase I Clinical Trial.” Nature Portfolio, accessed March 2024.

9

R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

M U LT I P L E E N T I T I E S
W I T H I N K S A’ s R & D
ECOSYSTEM AREWO R K I N G TOWA R D
ENHANCING THE
BIOTECHNOLO GY
AGENDA- Academic institutions- The King Abdullah University of Scienceand Technology (KAUST) and King Abdulaziz
City for Science and Technology (KACST) are
fostering research in the fields of genomics
and biosciences through memorandumsof understanding (MoUs) and collaboration
with industry bodies, with a deep focus on
biotechnology.

- The National Biotechnology Center, a joint

effort between King Faisal Specialist Hospitaland Research Centre (KFSH&RC) and KACST is
focused on enhancing medical research andbiotechnology. Over 110 projects have been
approved, and 67 are ongoing.23- Government initiatives- The Saudi National Institute of Health,launched by the Ministry of Health (MOH),
is focused on supervision and backing oftranslational research and clinical trials in
the health domain by providing funds andsupport to research personnel.24- Nonprofit organizations- The Hevolution Foundation, a non-profit
organization, is focused on longevity

medicine and receives up to $1 billion funding
per year from the Saudi government.25- Pharmaceutical manufacturing companies- Lifera, a Public Investment Fund entity,

Additionally, Saudi Arabia has built strong
partnerships with many global pharmaceuticaland biotech companies that are helping growlocal capabilities:- Partnerships- KAUST signed two MoUs in 2023 withmultinational firms (Boehringer Ingelheim
and Novo Nordisk) focused on enhancing
cooperation in the biotechnology andmedicine sector.26- The Ministry of Investment (MISA)
has partnered with Novartis tofurther strengthen Saudi Arabia’s
biopharmaceutical capabilities. Thispartnership involves local investments incell and gene therapy, technology transfer,and clinical research, aiming to alleviate
healthcare budget pressures. Novartis’s
involvement is anticipated to contribute
approximately $857 million to Saudi Arabia’s
GDP by 2024.27- In 2023, Lifera, Sanofi, and Arabio signed an
MoU to manufacture and supply vaccines

in Saudi Arabia, boosting local production
with a new state-of-the-art manufacturing
facility.
However, while these agreements are a stepin the right direction to bring big pharma
and multinational biotech companies to
Saudi Arabia, there is a long way to go fordeveloping local capabilities across thevalue chain. Recognizing this, academic andresearch institutes have put in place a range ofaccelerator and incubator programs to train
and support entrepreneurs:- Research organizations- KAIMRC’s Medical Biotechnology Park (MBP)
provides a supportive environment to newand emerging medical and biomedical
technology ventures and compatible

is a pharmaceutical manufacturingbusinesses. This environment is designed tocompany set up in June 2023 to focus on

assist them during their start-up phase andmanufacturing life-saving and essential

enhance their prospects for local success.

pharmaceutical products. To date,
Lifera has established three platforms:
Biologics & Innovation, Manufacturing, andCommercialization.
23
24
25
26
27

10

“National Biotechnology Center.” King Faisal Specialist Hospital & Research Centre, accessed March 2024.
“Mechanisms and Incentives to Transform the Health Research into Discoveries and Knowledge with Health and Economic Benefits.” Saudi National
Institute of Health (NIH), accessed March 2024.
Hevolution website, accessed March 2024.
“Investment Ministry Signs 2 Deals to Enhance Biotechnology, Pharmaceutical Sector in Saudi Arabia.” Arab News, 27 January 2023.
“Novartis Signs Deal to Help Saudi Arabia Expand Its Biopharma Capabilities.” Arab News, 2 June 2022.

ARTHUR D. LITTLE- Academic institutions- KAUST’s accelerator programs include
TAQADAM, one of the longest-running

accelerator programs in Saudi Arabia. It
provides six-month programs to innovatorsand entrepreneurs offering mentorship,
funding, and targeted workshops.

- KACST has an agreement with King Salman

Youth Center to carry out a training project
for entrepreneurs. This boosts KSA’s
ongoing efforts to fully realize the potentialof Saudi youth by promoting their active
participation in the development process.

- In 2022, Dammam Valley, owned byImam Abdulrahman bin Faisal University,
established the Biotech Startups Program,a first-of-its-kind initiative designed
to support and incentivize health andbiotechnology entrepreneurs. Over 130
projects from various fields of genomics

TH E SAUDI GENOME
P ROGRAM: A BLUEP RINTFOR SUCCESS
Joint efforts and strong collaboration between
public and private entities will bolster thedevelopment of the Saudi Arabian biotechnology
sector. The Saudi Genome Program represents
a significant stride in this direction, specificallyin the fight against genetic disorders. The
program was developed through partnerships
with international organizations to establish an
extensive genetic repository. To date, 63,000
genetic samples have been gathered, and7,500 pathogen variants have been detected.
This is a result of cross collaboration between
institutes, including KACST, KAIMRC, KFSHD,
and MOH. 28 However, a stronger coordinatedpush is critical to ensure rapid innovation andcommercialization in The Kingdom.

and therapeutics have participated since
the program’s inception.
Entrepreneurship initiatives have so far primarily
come from leading institutions such as KAIMRC,
KAUST, and KACST. However, as these institutes
and their programs are independent of eachother, this can limit collaboration and result ininefficient utilization of resources and facilities.

28“Saudi Genome Project.” Kingdom of Saudi Arabia Vision 2030, accessed March 2024.

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R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

3 . A C C E L E R AT I N G P R O G R E S S
WITHIN SAUDI AR ABIA

For development of KSA’s biotechnology sector

1. Sampling. Saudi Arabia can easily develop

to gather pace, there needs to be a focus on

local capabilities in this area, given thatthree segments of the value chain (sampling,

there is a low dependence on highly trained

analysis, and applications) and four thematicclinicians or existing transportation

growth areas (creating a population-level

infrastructure. While this component has agenomic data repository, the widespread

relatively low financial value compared to otheradoption of genomics as a screening/diagnostic

steps, developing local capabilities will create

tool, omics/precision medicine, and AI/ML-

a strong foundation for developing presence inenhanced genomics).

more complex processes.
2. Sequencing. Large, high-tech equipment

T HE VALUE CHAI N :C O N CEN T R AT E O N
3 S EGM EN TS

is essential for sequencing work. Developed

The genomics value chain comprises five steps,

revenues. Establishing competitive equipment

economies such as the US and UK havealready built a strong presence in this area
based on their high-tech manufacturing

each of which requires different capabilities

capability, tapping into the high potential for
manufacturing facilities within KSA would be(see Figure 2). 29 To enhance Saudi Arabia’s
competitiveness in the biotechnology market,
it is vital to identify which of these steps bestalign with the country’s core capabilities. As
highlighted in the figure, KSA should increase its
focus particularly across three segments in the

CAPEX-intensive and technically challenging
given a lack of local knowledge and skilledlabor. Consequently, Saudi Arabia should focus
on importing sequencing machines at thisstage.

value chain: sampling, analysis, and application

Figure 2.—Genomic
value
chain: potential focus areas for KSA
due to the following
reasons:
Figure 2. Genomic value chain: potential focus areas for KSA
SAMPLING

SEQUENCINGANALYSIS

INTERPRETATIONAPPLICATION

Collection & packaging
of DNA samples,shipping & storage

Determining sequence ofgenome (e.g., NGS);
target sequencing, wholegenome & whole exome

Bioinformatics:
processing & analyzing
genomic data using
software solutions

Translating (i.e., clinicalinterpretation ofobserved variations
into insights)

Applying genomics datafor diagnosis & treatment(companion diagnostics& drug discovery)

Extraction

Data cleansing

Reporting

Drug development-

Consumables

Variant calling

Link with EHRs

Clinical services

Instruments

Data service

Tailoring results

Diagnostics

Subcomponents•

Key players •involved invalue chain•

Potential focus
area for KSA

Sample collectors
Storage & shipment/
logistics managementcompanies
Diagnostics labs



•

•

Sequencing
equipment
manufacturers
Diagnostics/
research labs



•
•
•

Data analytics &management firms
Government &research institutes
Diagnostic labs



•
•
•
•

Clinicians
Data analytics &management firms
Pharma companies
Research institutions

Source: Arthur D. Little, Thailand Center of Excellence for Life Sciences (TCELS)
29

12“Genomics Value Chain.” Thailand Center of Excellence for Life Sciences (TCELS), accessed March 2024.

•••

Providers
Pharma & biotech
companies
Research institutions

ARTHUR D. LITTLEI T I S V I TA L T O I D E N T I F Y
WHICH STEPS BESTALIGN WITH THE
COUNTRY’S COREC A PA B I L I T I E S

FOCUS ON 4 TH EMATIC
AREAS TO DRIVE GROWTH
The biotechnology sector has seen crucial
advances that are shaping the genetic researchand healthcare landscape, including:- The increasing utilization of high-throughput
sequencing technologies, which are enabling

3. Analysis. Bioinformatics plays a crucialrole in processing and analyzing genomic
data. Developing software capabilities isa prerequisite for growth in this space; forexample, comparison with various phenotypes
can reveal meaningful data about diseases andthe rapid and cost-effective analysis ofentire genomes. This has accelerated ourunderstanding of genetic variation and its
implications in health and disease.

- The integration of genomics into precision

medicine, with customized treatments andbiomarkers. In terms of financial value, this is atherapies being developed based on an

lucrative segment where important value can

individual’s genetic profile.

be derived by creating a population database.
Marking this as an area of focus, institutes
such as KAUST and KACST are already creating
academic and industry partnerships to develop
AI and data analytics capabilities in KSA.
4. Interpretation. Genetic data interpretation
involves identifying clinically relevant genetic
variations and their implications for anindividual’s health. This segment is expected
to significantly increase in size as humangenome projects are completed, becoming acentral area of research for many countries.
However, to enter this area, KSA would need todevelop processes and train skilled clinicians
who can translate genomic data to predict anddiagnose genetic disorders.
5. Applications. Genomic applications acrossdiagnostics, drug development, and precision
medicine are relevant for pharmaceuticalcompanies, healthcare systems, andclinicians. This component of the value chain
is at a relatively early stage and thus presents
opportunities for KSA. The Kingdom should
continue to focus on developing the diagnostic
services component (i.e., genomics testing
services) and maximize value generation from it.

- The field of epigenomics has grown, shedding
light on how environmental factors caninfluence gene expression and impact health.

- The emergence of large-scale biobanks

and collaborative initiatives worldwide isfacilitating the sharing of genetic data,
promoting international collaboration, andenhancing our ability to tackle global healthchallenges.

- Furthermore, AI/ML are also playing a pivotal
role in genomics, aiding in data analysis
and the identification of novel genetic
associations.
These trends present crucial opportunities
that KSA can tap into to develop prevention,
monitoring, and treatment technologies
that reduce mortality and improve the entire
population’s quality of life. Foundations arebeing established through investment andregulatory framework setup, and now it isimperative to embark on specific actions aimed
at fostering the next stage of growth.
Globally, countries are selecting biotechnology
and genomics sector priorities based on their
population’s healthcare burden and trends,
existing capabilities, infrastructure, and themost promising emerging areas. KSA must
recognize the fast-evolving landscape andfocus on four specific themes going forward to
maximize value generation. These include:13

R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

1. A population-level genomic data repository.
Almost all major economies, including
KSA, have been working toward creating a
population-level genomic database. This is
the first step toward developing precision
medicine and is important for understanding
how diseases develop so better ways of
prevention and management can be devised.
2. Widespread adoption of genomics as aregular tool for screening and diagnostics.

C R E AT I N G A S T R O N GF O U N D AT I O N F O RGENOMIC RESEARCHA N D A N A LY S I S I S
A PREREQUISITEFOR SUCCESSFULI N N O VAT I O N

It is important to develop a nation-wide
underlying infrastructure and service networkthat facilitates adoption of genomics as astandard clinical diagnostic tool. Currently,
due to sociocultural norms, the incidence ofbirth defects is relatively high. Consequently,
30

genetic risk profiling, genetic screening, andnewborn genetic testing could be incorporated
as a standard clinical guideline for certain
cases. Over time, new clinical indications
for genomic testing should be introduced
in a phased manner based on the country’s
requirements.31
3. Omics and precision medicine. Considering
the keingdom’s disease burden, it isimperative to focus on this segment, andgather and analyze data to support withdiagnosis and management of diseases.
The burden of non-communicable diseases(NCDs) such as cardiovascular diseases anddiabetes on KSA’s economy is substantial.
NCDs accounted for 73% of all deaths in KSA
in 2018, higher than the global average of
71%.

32

Approximately 10% of the population

4. AI/ML in genomics. Advanced softwareand technologies are vital for rapidly andefficiently deriving insights from genetic
material. Countries across the globe areutilizing AI and ML for various use casessuch as mapping rare mutations or drafting
treatment regimes. 34
Overall, KSA will have to define and initiate
focused efforts to develop technologies andplatforms for a range of genomics applications.
Creating a strong foundation for genomic
research and analysis is a prerequisite forsuccessful innovation in the sector. This can beachieved by the development of biobanks andgenome databases for the Saudi population
while encouraging the use of AI/ML to enable
exhaustive research into genotypes and genevariations. It is also important to increase
research focus on precision medicine so that
tailored solutions based on the country’s
population characteristics and disease burden
can be created and delivered.

is at risk of developing cancer before theage of 75, a figure that is expected to risegoing forward. 33 By using biomarkers, omics
could support individuals in preventing or
effectively treating diseases, thus reducing
costs to the healthcare system as well as
increasing benefits to patients. In somecountries, selected data from omics is being
used in certain types of cancer treatments toscreen for drug responsiveness and likelihoodof adverse effects.

30
31
32
33
34

14

Majeed-Saidan, Muhammad Ali. “Effect of Consanguinity on Birth Defects in Saudi Women: Results from a Nested Case-Control Study.”
Birth Defects Research Part A: Clinical and Molecular Teratology, Vol. 103, No. 2, February 2015.
“Accelerating Genomic Medicine in the NHS: A Strategy for Embedding Genomics in the NHS Over the Next 5 Years.” National Health Service (NHS)
England, 2022.
Alqunaibet, Ada, et al. “Noncommunicable Diseases in Saudi Arabia Toward Effective Interventions for Prevention.” International Bank for
Reconstruction and Development/World Bank Group, 2021.
“Global Cancer Observatory.” World Health Organization (WHO), accessed March 2024.
“Genomics and Biotechnology R&D in Singapore.” Government of the Netherlands Ministry of Foreign Affairs, January 2022.

ARTHUR D. LITTLE

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R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

4 . K E Y S U C C E S S FAC TO R S TO
DE VELOP SECTOR IN SAUDI AR ABIA

Saudi Arabia has embarked on multiple
initiatives aimed at fostering investment in
R&D and introducing legislation to support
innovation. Nonetheless, development of
KSA biotechnology and genomics industry iscurrently at an early stage, requiring a focus onsix key success factors to encourage progress.

E NSURE COLLABORATIO N
BE TWE EN P UBLIC & P RIVATESECTOR
Saudi Arabia has directed substantial investments
toward the development of fundamental
infrastructure, including laboratories andfacilities, which serves as the cornerstone for

C REAT E TALEN T PO O L

scientific research. To ensure continued growth,

The availability of a skilled and diverse talentedge research facilities that cultivate disruptive

pool to meet current and future needs acrossdifferent research areas is arguably the mostimportant success factor for innovation. This
makes it imperative for Saudi Arabia to embracea collaborative approach that bridges the gap
between academia and industry to formulate
programs aimed at nurturing clinicians,
engineers, scientists, and entrepreneurs.
This can be accomplished through thedevelopment of internships, apprenticeships,
and joint research projects. KSA should work
toward building synergies between the talentpipelines of leading institutions such that itserves the current and future needs of thetechnologies in intersecting and interdisciplinary
fields like AI and data analytics, which play apivotal role in genomics and bioinformatics.
Identifying opportunities for public-private
collaboration in these areas is essential tosuccessful patient-centric innovation in KSA.
Similarly, the establishment of biotech parks andinnovation campuses, designed to promote thecollaborative use of workspaces and researchfacilities, is of paramount importance for
fostering interdisciplinary innovation. A notable
example of such a hub is the partnership between
Karolinska Institutet and AstraZeneca (see “Casestudy: Sweden”). Other examples are Biohub andcountry.

Stevenage Bioscience Catalyst in the UK and

The US, one of the world’s foremost leaders inand the Mission Bay Innovation District in thebiotech innovations, employs a multifaceted
approach to address this challenge. In addition
to establishing innovation hubs anchoredaround major academic institutes, cooperative
agreements such as the one between NIH andthe Center for Disease Control and Prevention(CDC) to train public health workers in genetics
and genomics to strengthen their Human Genome
Program serve as exemplary strategies forbuilding a robust talent pipeline.

16

it is imperative to allocate resources to cutting-

BioLabs, Johnson & Johnson Innovation’s JLABS,
US, all of which are home to renowned research
institutions, biotech enterprises, and start-ups,
thereby serving as hotbeds of biotech innovation.

ARTHUR D. LITTLE

Case study: Sweden

Case study: Singapore

Karolinska Institutet/AstraZeneca Integrated

Singapore has worked for decades to

Cardio Metabolic Centre (KI/AZ ICMC), a joint

establish its healthcare and medical

center for research on cardiovascular andresearch ecosystem. The researchmetabolic diseases, was formed in 2013 byecosystem is led by its Ministry of Health,

Karolinska Institutet and AstraZeneca, withwhich oversees delivery of services, andthe aim of identifying and validating novela separate council for research-driven

targets within cardio-metabolic diseases.

innovation (National Medical Research

The center’s focus is mainly on cardiac

Council). The country’s leading public sector

regeneration, islet health (diabetes), andR&D agency — A*STAR (Agency for Science,diabetic nephropathy across modalities using

Technology and Research) — focuses

small molecules and biologics. It is staffedon bridging the gap between academia

with around 30 research scientists from bothand industry through collaboration andentities, led by a single director, and funded

open innovation. The country set up its

through a contribution from AstraZeneca

first R&D hub in biomedical sciencesof ~$100 million during the initial five-year(Biopolis) in the early 2000s; as a result,contract period. This collaboration has

many major pharmaceutical MNCs now

founded capabilities around translational

have research or manufacturing centers

medicine that enables seamless transitionin the country. Singapore offers a range ofof private sector developments into patient-incentives, including tax benefits, grants,

centric care in a real-world environment.

and simplified administrative processes
to promote R&D and innovation. It has

DE LI VE R S UPPO RT I V E PRO B U S IN E S S EN V I RO N M EN T
& R EG U LAT I O N S
While the launch of the RDIA is a positive step
toward creating legislation covering research,development, and innovation, it is imperative toestablish a regulatory framework that actively

also established a strong IP protection
framework, making it an attractive
destination for tech start-ups.

CREATE INNOVATIONE NVIRONME NTS &ECOSYSTEMS

nurtures innovation. Critical components of thisAs part of its Catapult Network initiative, theregulatory environment include safeguarding

UK has set up specific cell and gene therapy–

IP rights, facilitating market access throughfocused research centers, which bring together

international trade agreements, and simplifying

diverse public and private sector partners tobureaucratic procedures to foster a culture ofcreate rapid solutions for key challenges (seerisk-taking.

“Case study: UK”). KSA can set up a similar

Singapore’s biotech research ecosystem is a good
example of this (see “Case study: Singapore”).
Led by the country’s Ministry of Health and a

network for hereditary disorders, where diverse
companies, clinicians, and patients can cometogether to solve key challenges.

council for research, the state is known for its
pro-business environment. Using regulation andsupportive government infrastructure, as well as
centralized government coordination, has madeSingapore a regional powerhouse in medical
research. To compete, KSA must design andimplement appropriate governance arrangements
in addition to devising strong underpinning
regulations and infrastructure to support anddirect efforts toward the country’s chosen
biotechnology priorities.

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R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

Case study: UK
The UK has set up the Catapult Network, afocused network of research centers. The
Catapult Network is the evolution of thetechnology and innovation center initiative. A
Catapult is a physical business center wherebusinesses work alongside around 50-300
Catapult-employed scientists, engineers, andcommercialization support staff. Catapults
aim to occupy a gap in translational researchby providing the following:- Open access facilities — state-of the-art-

kit and business accommodation

Technical experts — skilled technical

Catapult example:
The Cell and Gene Therapy (CGT) Catapult
focuses on supporting acceleration of celland gene therapy to market throughout
development, manufacturing, and clinicaladoption by fostering collaborations between
industry, government, research organizations,academia, and others. Nearly 170 companies
have collaborated with CGT Catapult on
advanced therapy medicinal products (ATMP)
innovation, contributing to the UK emerging
as a global leader in the development ofadvanced therapies.

resource and domain experts- Business know-how — commercialization,routes to funding, networking, and IP

Key features include:- Tailorization — to address a particularmarket failure- Critical mass in one location — potentially

C ATA P U LT S A I M
TO OCCUPY A GAPI N T R A N S L AT I O N A L
RESEARCH

with satellites- Collaboration among organizations —from different domains

FO CUS O N CLEAR TARGETPI C T UR E FO R ALL R ESE ARCH

The UK’s CGT Catapult (see “Case study: UK”)

Delivering biotechnology success requires acommercial manufacturing, by ensuring that theclear target picture and the right operating
model to centrally coordinate and promote
the right research network with academia. This
will streamline innovation from research
to business. Technology-transfer offices

play a pivotal role in the biotech industry byemphasizing the commercialization of researchoutcomes. They incentivize research andmaximize research impact by providing accessto markets and industry and protecting therights of innovators.

35

18

remains focused on commercialization byfocusing both on supporting clinical trials 35 andcountry has the necessary infrastructure, skills,
and capacity. CGT Catapult’s manufacturing
facility aims to accelerate large-scale
manufacturing of ATMPs.
Emerging economies such as Lithuania are also
investing in the health and biotech arena witha clear focus on driving commercialization. An
early integration of commercial functions to
prepare for launch can accelerate technology
transfer, thereby reducing time to market.

Over 175 ATMP clinical trials were reported as ongoing in the UK in 2023; see: Cameron, Isabel. “UK Maintains Status as an Attractive Destination for
Advanced Therapy Clinical Trials.” BioPharmaReporter, 18 January 2024.

ARTHUR D. LITTLEP ROVI DE START- UPS
ACC E S S TO PR I VAT E& P U B LIC F UN D I N G
Adequate sources of funding, including venture

INITIAL CAPEX AND TIMEREQUIREMENTS ARES I G N I F I C A N T LY H I G H E R
THAN FOR OTHER FIELDS

capital, angel investors, and public grants, arecrucial for start-ups and innovative projects
to thrive. Given the complex nature of the R&D
and regulatory hurdles for commercializationof any biotechnology product, initial CAPEX
and time requirements are significantly higher
than other fields. This means that early-stage
biotechnology companies almost always requirelarge amounts of capital and resources to fundMost developed economies have public bodies
such as the UKRI (UK Research & Innovation),
Innovate UK, and the Biotechnology Innovation
Organization (BIO). These catalyze and direct
research and innovation funding to start-ups.
Similar bodies should be created within KSA.

and fuel their R&D programs, which take years
before they reach the market.

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R E P O R T: A D VA N C I N G B I O T E C H N O L O G Y & G E N O M I C S I N S A U D I A R A B I A

CONCLUSIONM OV I N G FO R WAR D WITH
B I OTECHN O LO GY I N KSA
Given the opportunities and potential benefits
it provides, countries across the world arefocusing on fostering innovation and setting
national targets for the biotechnology andgenomics sector. While the sector is at an earlystage in KSA, the country understands the large
untapped potential that exists and is ramping
up its efforts. While various entities such as
KAIMRC, Hevolution Foundation, and Lifera arefocusing extensively on the sector and forging
partnerships to drive growth, a strong andcoordinated push is necessary to achieve KSA’s
biotechnology potential. Learnings from provenand successful strategies across the globe
must be rapidly adapted in KSA to achieve its
objective of becoming a regional leader in the
genomics and genetics space, benefiting its
people, economy, and overall reputation.

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C O U N T R I E S AC R O S S
THE WORLD ARE
FOCUSING ON FOSTERINGI N N OVAT I O N A N D
S E T T I N G N AT I O N A L
TA R G E T S F O R T H E
B I O T E C H N O L O GY
AND GENOMICS SECTORARTHUR D. LITTLE

NOTES

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ARTHUR D. LITTLE

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