R&D Strategies of Pharmaceutical Companies and Current Status of CRO/SMO 2025
Language:
Japanese
Product Code No:
C67113400
Issued In:
2025/09
#of Pages:
156
Publication Cycle:
Annual
Format:
PDF
Geographic Coverage:
Japan
Industry:
Jump to the Japanese Page:
Coverage: (Product/service)
Drug Development
Research Target:
Pharmaceutical Companies, CRO, SMO
Research Content:
I. R&D Strategies of Pharmaceuticals and Actual Status & Perspective of CRO/SMO
1. R&D Strategies of Pharmaceuticals
- M&A Continued expansion of R&D investment, large-scale M&A
- Number of clinical trial plan notifications trending downward, pressing need for streamlining clinical trial procedures
- Concentrating resources on key areas (cancer, central nervous system, immunology)
- To boost drug discovery productivity, collaborative research intensifies, moves to reorganize R&D structures underway
2. Actual Status & Perspective of CRO
- Total sales of Japan CRO Association member companies dropped by 9.3% from preceding year
- The CRO market projected to continue at a stable scale but growth rates flatten
- Transition from labor-intensive to knowledge-intensive industry.
- Decentralized Clinical Trials (DCT) gaining attention
- Global CRO companies advancing provision of broader and more sophisticated services
- Domestic industry consolidation has largely concluded; partnerships and acquisitions aimed at overseas expansion and new service development are increasing
- CMIC: Supporting overseas companies entering the Japanese market and cross-industry players entering the healthcare market; Addressing needs for biopharmaceuticals and regenerative medicine
- EPS: Explores new business models, operations leveraging new technologies; accelerates overseas operations and Innovative Research Organization (IRO) business
3. Actual Status & Perspective of SMO
- Total sales of Japan SMO Association member companies in fiscal 2024 decreased by 2.6% year-on-year
- Development focus shifted from lifestyle-related diseases to more challenging diseases
- Number of protocols and contracted cases showing rebounding trends
- Aiming to dispatch CRAs to SMOs and entrust them as Site Data Manager (SDM) / CRC focus on physician and subject interactions to increase the number of trials
- CMIC Holdings promotes advanced technology and citizen participation in clinical trial support, challenging the advancement and differentiation of SMOs
- SMOs face market maturity and restructuring/ Support systems for cancer and rare diseases
II. R&D Strategies of Leading Pharmaceuticals
1. Astellas Pharma Inc.
2. AstraZeneca K.K.
3. Eisai Co., Ltd.
4. Otsuka Holdings Co., Ltd.
5. ONO PHARMACEUTICAL CO., LTD.
6. Kyowa 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. CHUGAI PHARMACEUTICAL CO., LTD.
13. Eli Lilly Japan K.K.
14. Novartis Pharma K.K.
15. Bayer Yakuhin, Ltd.
III. Strategies of CRO Companies and SMO Companies
1. EPS Holdings
2. M3, Inc.
2. CMIC HOLDINGS Co., Ltd.
Plus, brief profiles of:
- leading CROs (26 enterprises)
- leading SMOs (20 enterprises)