R&D Strategies of Pharmaceutical Companies and Current Status of CRO/SMO 2022
Product Code No:
Pharmaceutical Companies, CRO, SMO
Pharmaceutical Companies, CRO, SMO
I R&D Strategies of Pharmaceutical Companies & Actual Status and Outlook of CRO & SMO
1. R&D Strategies of Pharmaceutical Companies
- R&D investment continues to expand for new drug development. Japanese pharmaceuticals also seek large-scale M&A for the purpose of globalization and generating R&D expenses.
- Driven by the government’s initiatives to invigorate clinical trials, submissions for conducting clinical trials are on the rise again. In view of the submissions by medicinal property, clinical trials of cancer drugs account for 40% of the total, and it is still increasing.
- Pharmaceuticals aim to improve productivity of drug discovery by concentrating resources on priority areas, which are currently prioritize cancer, central nervous system, and immune system. The companies are expanding their pipeline compound and activating collaborative research.
- To achieve greater efficiency and speed in drug discovery, pharmaceuticals seek to reengineer R&D operation.
2. CRO Market
- A total sales of Japan CRO Association (JCROA) member companies in 2021 increased by 20.8% YoY to 225,600 million yen. The CRO market size including non-member companies is estimated at 260,000 million yen.
- CRO market is expected to grow stably, although growth rate may slowdown compared to previous years.
- Industry is transitioning from labor-intensive to knowledge-intensive. The number of monitors will no longer be the sole determinant of sales.
- Decentralized Clinical Trial (DCT) gathers attention as a test method in the post-Corona era.
- While global CRO companies are reinforcing business of Japanese subsidiary, Japanese companies also work on business development overseas.
- The first phase of industry restructuring in Japan has been completed. Alliances and acquisitions for the purpose of overseas expansion and new service development are expected to increase.
- CMIC Holdings' CRO business assists domestic market entrance of foreign companies, while supporting domestic non-medical businesses to enter the healthcare market, for the purpose of promoting business development in the area with increasingly diversifying needs such as biopharmaceuticals and regenerative medicine products.
- In addition to growing its current CRO business, EPS Holdings is considering a new business model to adapt to the changes in the business environment as well as provision of an operation that utilizes new technology.
- EPS Holdings aims to become a leader of CRO business in Asia-Pacific region through establishing robust business foundation in Japan, China, and other Asian countries.
3. SMO Market
- A total sales of Japan SMO Association (JASMO) member companies in fiscal 2021 decreased by 10.0% from the preceding year to 34,366 million yen. The SMO market size including non-member companies is estimated at around 4 million yen.
- In line with the shift in main target of clinical studies from lifestyle disease to diseases that require higher degree of difficulty in treatment, the number of clinical study protocols have been falling since FY2017. The number of clinical trial agreement (clinical study agreement) has been declining.
- Utilizing its business size, EPS Holdings develops growth strategy by region and by facility.
- EPS Holdings intends to increase the number of clinical trial agreement per Clinical Research Coordinator (CRC) through the dispatch of Clinical Research Associate (CRA) to play the role of Site Data Manager (SDM), as it will allow CRC to focus more on physicians and trial patients.
- CMIC Holdings’ SMO reinforces services in the field of oncology and is expanding new services.
- While the SMO market cannot expect considerable growth, there is a potential for market expansion if the outsourcing of in-hospital CRC tasks increases. The total number of companies in the market is diminishing due to industry restructuring.
- To ensure the reliability (validity) of clinical trial data, industry-wide efforts are required.
II R&D Strategies at Leading Pharmaceutical Enterprises
1. Astellas Pharma Inc.
2. AstraZeneca K.K.
3. Eisai Co., Ltd.
4. Otsuka Holdings Co., Ltd.
5. ONO PHARMACEUTICAL CO., LTD.
6. Kyowa Hakko Kirin Co., Ltd.
7. Sanofi K.K.
8. SHIONOGI & CO., LTD.
9. Sumitomo Pharma Co., Ltd.
10. DAIICHI SANKYO COMPANY, LIMITED
11. Takeda Pharmaceutical Company Limited.
12. Mitsubishi Tanabe Pharma Corporation
13. CHUGAI PHARMACEUTICAL CO., LTD.
14. Eli Lilly Japan K.K.
15. Novartis Pharma K.K.
16. Bayer Yakuhin, Ltd
III Strategies of CRO/SMO Enterprises
1. EPS Holdings, Inc.
2. M3, Inc.
3. CMIC HOLDINGS Co., Ltd.
*Plus, brief profiles of 29 CRO and 24 SMO enterprises