R&D Strategies of Pharmaceutical Companies

Pharmaceutical, CRO, and SMO Companies

I. Pharmaceutical R&D Strategies and the Current Status and Outlook of Clinical Research Organizations (CROs) and Site Management Organizations (SMOs)

1. R&D Strategies of Pharmaceuticals

• R&D investments have advanced in pursuit of innovative new drugs. To strengthen their global competitiveness and secure a drug pipeline, major domestic pharmaceutical companies have accelerated their mergers and acquisitions with overseas companies, as well as external alliances.
• The challenges posed by a slowdown in clinical trial notifications and drug losses are being addressed; Clinical testing is flourishing through streamlined procedures and the creation of an ecosystem.
• To improve the productivity of drug discovery research, companies are allocating resources to priority areas; Priority areas include cancer, the central nervous system, and the immune system.
• To streamline and accelerate drug discovery research, the R&D organizational consoidation is underway.

2. CRO Market Status and Outlook

• Total sales of Japan CRO Association member companies dropped by 5.7% from the preceding year.
• The CRO market is projected to remain stable in terms of scale, though growth rates are flattening.
• The industry is transitioning from labor-intensive to knowledge-intensive.
• Decentralized Clinical Trials (DCT) are gaining attention.
• Global CRO companies are advancing the 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: Supports overseas companies entering the Japanese market and cross-industry players entering the healthcare market; Addresses the need for biopharmaceuticals and regenerative medicine.
• EPS: Explores new CRO business models to be able to cope with changes in the business environment, while securing basic growth; Plans to provide operations leveraging new technologies; The overseas operation provides the Innovative Research Organization (IRO) business, which provides a total solution that exceeds the traditional CRO operations.

3. The SMO Market Status and Outlook

• Total sales of Japan SMO Association member companies in fiscal 2025 increased by 6.8% year-on-year.
• The development focus has shifted from lifestyle-related diseases to more challenging ones.
• The number of protocols and contracted cases has continued to increase, since rebounding in fiscal 2020.
• Companies aim to dispatch clinical research associates (CRAs) to SMOs and appoint them as site data managers (SDMs). Clinical research coordinators (CRCs) are focusing more on physicians and test subjects to increase the number of tests they oversee.
• CMIC: propels cutting-edge technology and civic participation in its clinical support business and plans to advance and differentiate SMOs.
• SMOs are facing market maturity and restructuring. They are reorganizing the support in the era of cancer and rare diseases.

II. R&D Strategies of Leading Pharmaceutical Companies

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. 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 and SMO Companies

1. EPS Holdings, Inc.
2. M3, Inc.
3. CMIC HOLDINGS Co., Ltd.

• Leading CRO Companies: 26 companies
• Leading SMO Companies: 20 companies