The Changing Face of Global Clinical Trials:
Asia-Paciﬁc as an Ideal Destination for Specialty Biopharma
Pharmaceutical Market Trends

4.5% 4.2%

Slowdown expected in pharma industry
growth rate to 4.2% (2016-2020) from
4.5% (2012-2015)

Expansion to emerging
countries for access tonew markets

Regulatory& pricingpressures

Patent cliff of blockbusters and personalized
medicine trend shifting R&D focus to orphan
drugs and biologics

forecast market forBiologics drugs by 2022

Lengthy trial time due to differences in US Federal, State andInstitutional policies
Rising cost of drug discovery & development, and lack ofextensive in-house R&D talent and infrastructureLong and challenging recruitment of desired patients due tohigh penetration of clinical trials in the US
Laborious task to hire most sought-after investigators forsmall and mid-size pharmaceutical companies

Asia-Paciﬁc is fast becoming the preferred
destination for clinical trials

Areas to Watch: Global Biologics and Orphan
Drugs Market Revenue Growth*

USD220billion

USD375billionClinical Trials Outsourcing: Key Drivers for smalland mid-sized companies in the US

forecast market forOrphan drugs by 2022

2021F USD12.3 B

2021F USD52.3 B

2021F USD64.6 B

ASIAPACIFICREST OFTHE WORLDGLOBALAT 20.3%
CAGR

AT 11.4%
CAGR

AT 12.8%
CAGR

2016 USD4.89 B

2016 USD30.5 B

Fast-growing
pharma market

20%of orphan drugs expected to capture
prescription drug sales by 2020.

50%of the top 20 Orphan pipeline drugs will
be from mid to small biotech companies
based on net present value in 2015

*Source: The Economic Intelligence Unit; BMI Research;
Frost & Sullivan, Global Orphan Drug Market, Nov 20162016 USD35.4 B
Strong IP protection andlow legal barriers

Regulatory harmonization with international guidelines(i.e., ICH E17; AFTA) with fast-track options
High resource availability andaccess to state-of-the-art
facilities

Large treatment-naïve
patient pool across many
disease profiles

5 KEY PARAMETERS TO SELECTING THE RIGHT CRO PARTNER

123

45

Global support andscalability

Significant presence inAsia with deep local
market knowledge

Strong relationshipwith local regulators,investigators and KOLs

Exemplary regulatory
track record

Therapeuticexpertise aligned tospecialty pharma

CMIC: THE LARGEST JAPANESE INTEGRATED SERVICEPROVIDER PROVIDING FULL RANGE OF SERVICES
Extensive presence inJapan, US, and Asia (33bases in Japan, 12 overseas
bases, 16 Asian afﬁliates)

1000 clinical research
associates, 600 medical
representatives, and 50
regulatory consultants

Vast expertise in legal,
IP, manufacturing, andcommercialization

Excellent Regulatory Track Record
Supported >80% of drug approvals in Japan
Strong relationship with PMDA and Ministry of Health,Labour and Welfare (MHLW) and other regulatory
bodiesDeep understanding of cross-border pre-clinicalbioanalysis in US and Europe (FDA+EMEA), Japan, andAsia-Pacific

Vast Therapeutic Area Expertise
Focus on Oncology, Neurology, and Rare Diseases
CMIC’s regenerative medicine group has executed 50projects from >20 companies since 2015

“Pharmaceutical Value Creator" model tosupport full-range services
CRO: Supporting drug development
CDMO: Supporting both drug development-stage andcommercial-stage manufacturing
CSO: Supporting pharmaceutical sales
Healthcare: Supporting medical institutions (SMO) andelevating the health of individuals
IPM: Innovative pharma model, including
OrphanPacific, a dedicated subsidiary on rare diseases

To learn more about Asia as a preferred destination forCRO, its advantages and how CMIC can support small
and mid-sized pharmaceutical companies in theirinnovation journey download the white paper here.
www.cmicgroup.com