Regional Market Research on CRO
The CRO market in China is growing at a CAGR of 20.32% and is driven by pharmaceutical companies spending more on R&D, with an increase in the number of new drugs approved and favorable policies.
The country’s large pool of patients and its sizeable and growing pharmaceutical market, complemented with lower cost of conducting trials, has made it one of the most sought out destinations in Asia Pacific.
Domestic Chinese CROs will be benefited by the outsourcing from Chinese pharmaceutical companies, focusing on innovation, and conducting China-only trials (90% growth), while the growth of global CROs will be driven by steady reduction in the drug lag, leading to more multinational trials.
The CRO market in China is growing at a CAGR of 20.32% and is driven by pharmaceutical companies spending more on R&D with an increase in the number of new drugs approved and favorable policies.
Country’s large pool of patients and its sizeable and growing pharmaceutical market complemented with lower costs of conducting trials has made it one of the most sought out destinations in Asia Pacific.
CRO Industry Trend
- AvvVie, Novartis, GSK, and Eli Lilly and Company have closed or are about to close or sell their R&D centers in China.
- With the growing world economy, pharmaceutical companies will be increasing their R&D budget gradually, up to an estimated global R&D spend of USD 160 billion by 2021
- Bright prospects of CRO industry and favorable policies in China have attracted many enterprises into the field.
- Reliance on CRO enterprises for new drug research activities will increase promoting the development of CRO industry specially local CRO enterprises
- R&D spend in china will increase up to USD 29.2 billion, which will drive the development of CRO industry from supply side.Dian Diagnostics, Xinjiang Baihuacun, Quantum Hi-Tech (China) Biological, and Xiamen Academy of Building Research Group have shown interest in the Chinese market, thus promoting the development of CRO industry in China.
To reduce the drug approval lag and timely inclusion of China in MRCTs, China is hiring more reviewers (approximately 1,200 by 2020) and is improving procedural activities of the China Food and Drug Administration (CFDA) and the Center for Drug Evaluation (CDE).
- The CFDA is the national authority that approves and reviews clinical research
- The sponsor should prepare and submit the dossier and drug samples to the CFDA, which consults with the CDE before issuing a clinical trial approval letter
- New clinical trial must also be granted approval from the Ethics Committee (EC), submitted in written form to the CFDA before the review of the clinical trial application is completed
- The process takes from 7-8 months to 1 year
- Submissions for regulatory approval and EC approval are sequential, not parallel
- EC approval takes a further of 2 to 3 months
- Clinical trials are only permitted with doctors and hospitals that have been approved by the government and must be conducted according to Chinese GCP
- Fast track review is available for clinical trials of drugs that treat serious or life-threatening illness, innovative products, and drugs that are the same kind of drug as one that has already been approved
- Several months of reduction in the clinical trial application timeframe is also possible in certain cases in which China is part of an international multicenter study
Clinical Trial Environment
- Only medical institutions, not independent sites, are certified to conduct clinical trials
- A principal investigator must be a medical practitioner
- All clinical trials must receive government approval, not merely those used to support product marketing approval
- Phase I clinical trials are generally not recommended in China because lead times are long and cost savings are not very significant
- There are certain exceptions for proof of concept trials or if China is expected to play a significant sales role after the drug’s development
- Multi-country trials can generally only start in China after the drug has completed Phase II trials outside of China
- It recently implemented a ‘four-color-light’ strategy, where different drugs are classified into redefined categories of innovative and generic drugs, with priority being given to approval decisions concerning innovative drugs
Domestic Chinese CROs will be benefited by the outsourcing from Chinese pharmaceutical companies focusing on innovation and conducting China-only trials (90% growth), while the growth of global CROs will be driven by steady reduction in the drug lag, leading to more multinational trials.
- Leading Chinese CRO companies include WuXi AppTec, Pharmaron, Shanghai Medicilon, Shanghai ChemPartner, Hangzhou Tigermed Consulting, and JOINN Laboratories
- Major global players are IQVIA, Labcorp, PPD, Parexel, ICON, INC-InVentiv and Charles River Laboratories
- WuXi AppTec is one of the most comprehensive service platforms integrating discovery, research and development of small-molecule chemical drugs, with the strongest R&D strength and the largest (domestically) and a leading (globally) small-molecule pharmaceutical R&D service business
Ease in vendor management, audits, and scale of economies are the major benefits of engaging with a global supplier, whereas low sub-contracting risk and lesser management costs are the advantages of engaging with a regional player.
Engagement and Pricing Model
Chinese culture is driven by relationships and hence, they prefer to work with people whom they know, hence, developing networks is important for long-term commitments.
Companies in general prefer to work with Chinese partners, as they have their own infrastructure.