INTERPRETATION

Leading Contract Research Organizations (CRO) in China

by Grace Wang
May 31, 2022

China's CRO Market Size

In 2020, China's CRO market grew to 522 billion yuan1 (circa 77.22 billion USD), increasing by 9.43% year on year. By estimation, the Chinese CRO market size will leap to 1,500 billion yuan (circa 221.91 billion USD) by 2025.

China's Regulatory Reforms Spur CRO Growth

  • China's Good Clinical Practices (GCP), effective since 2003, permits clinical trial sponsors to entrust trial-related tasks to CROs.

  • In 2015, China started requiring generic drugs to pass the Quality and Therapeutic Equivalence Evaluation with originator drugs/reference listed drugs. Thus, many generic manufacturers turn to CRO for bioequivalence (BE) studies to provide essential evidence for therapeutic equivalence.

  • The revised Drug Administration Law revised in 2019 allows the separation between marketing authorization holder (MAH) and manufacturer. Thus, R&D institutions, including CROs, get incentives to develop new drugs because they can be MAHs of their self-developed drugs rather than selling R&D results to manufacturers.

  • The Administrative Measures for Drug Registration, effective in 2020, sets up four programs for expediting marketing approval, which favor the R&D of innovative drugs with high clinical value.

China's drug regulatory reforms generally encourage innovation. During the process, CROs thrive as innovative drug R&D service providers.

Leading Chinese CROs

The following is a list of leading Chinese CROs, which all realized revenue growth in 2021.

CRO

Revenue (RMB mm)

Growth

Service Summary

1

2

3

2020

2021

Notes: 1,2,3 refers to service scopes: 1. Compound discovery; 2. Pre-clinical study; 3. Clinical study.

Wuxi AppTec2

16,535.43

22,902.39

38.50%

Biology; small molecule (CRDMO); drug   R&D and medical device testing; clinical research; oligonucleotide (CRDMO); peptide (CRDMO); cell therapy and gene therapy, etc.

ü

ü

ü

Pharmaron3

5,133.60

7,443.77

45.00%

Laboratory chemistry; biosciences; chemistry, manufacturing & control (CMC); safety assessment; radiolabeled sciences; clinical development; biologics, cell & gene therapy, etc.

ü

ü

ü

Hangzhou Tigermed4

3,192.30

5,213.50

63.30%

Regulatory affairs; clinical operations; biometrics; integrated technology services; medical devices/IVD; post-marketing/real world evidence/vaccine, etc.


ü

ü

Asymchem Laboratories5

3,136.72

4,632.12

47.67%

R&D and cGMP production of advanced intermediates, APIs, chemical drug products, and biologics; regulatory affairs, etc.



ü

Porton Pharma Solutions6

2,071.88

3,105.15

49.87%

Small molecule API and intermediate CDMO services; drug product CDMO services; biologics CDMO services; client-oriented program management; global licensing & partnering, etc.


ü

ü

ChemPartner7

1,481.59

1,690.68

14.11%

Discovery chemistry; biology & pharmacology; DMPK/Tox studies; discovery biologics; small molecule CMC; biologics CMC, etc.

ü



Joinn Laboratories8

1,075.90

1,516.68

40.97%

Research animals & models; discovery services; R&D and production; safety assessment; clinical trials; laboratory services; pharmacovigilance, etc.

ü

ü

ü

Shanghai Medicilon9

665.96

1,167.23

75.27%

Drug discovery; CMC research; preclinical research, etc.

ü

ü


Boji Medical Technology10

260.47

324.2

24.47%

Clinical research; CMC study; drug evaluation; technology transfer; data management; MAH and CDMO; NMPA &   FDA application, etc.


ü

ü

Obio Technology11

142.31

254.55

78.87%

CDMO services across plasmid, adeno-associated virus, lentivirus, adenovirus, oncolytic viruses, and cell therapy products, etc.


ü

ü

 

Grace Wang
ChemLinked Regulatory Analyst
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