Introduction to Strategic Focus on Autoimmune Diseases
According to a news article (大塚HD・井上社長兼CEO 自己免疫領域に８つの開発品 「中長期的視点に基づく戦略的投資」と位置付け | ニュース | ミクスOnline) published by MIX Online on July 18, 2025, Otsuka Holdings has strategically positioned the autoimmune disease area for the next-generation growth driver alongside CNS and oncology in the product development. The company aims to establish a robust business foundation by advancing research, licensing, and acquisitions, particularly in rare autoimmune indications with high unmet medical need and potential for life-cycle management (LCM) expansion.
Current Pipeline and Development Goals
Otsuka currently holds eight investigational assets in the autoimmune area. The company aims to achieve Proof of Concept (POC) by FY2030 and pursue regulatory approvals around FY2035. These assets are expected to contribute to medium- to long-term revenue, particularly from the 5th Mid-Term Management Plan (FY2029–FY2033) onward.
Key Pipeline Assets and Partnerships
Recent additions to the pipeline include:
These deals reflect Otsuka’s strategy to acquire promising assets with applicability to multiple autoimmune indications and high LCM potential.
Target Indications and Market Positioning
The targeted indications are primarily rare diseases or niche segments with clear unmet needs, making them suitable for agile development and differentiated market positioning. Examples include lupus nephritis, autoimmune myocarditis, and other inflammatory conditions.
Organizational and Investment Strategy
Otsuka emphasized the need for a flexible, balanced investment framework that allows continued R&D spending while achieving operational efficiency. The company also highlighted integration efforts with acquired companies such as Visterra (antibodies) and Jnana Therapeutics (small molecules) to enhance discovery capabilities and reinforce its autoimmune portfolio.
Conclusion
Otsuka Holdings is executing a long-term growth strategy centered on autoimmune diseases. With a pipeline of eight assets aimed at addressing rare conditions with high LCM potential, the company is positioning itself as a future leader in this field by integrating global capabilities and rapidly expanding its development portfolio. These developments may present partnership or investment opportunities for stakeholders in global pharmaceutical markets.