Press Release

Japan Biosimilars Market to Grow with a CAGR of 10.12% through 2030

Rising Healthcare Costs and Demand for Affordable Therapies and Technological Advancements in Biomanufacturing are expected to drive the Japan Biosimilars Market growth in the forecast period, 2026-2030

 

According to TechSci Research report, “Japan Biosimilars Market – By Region, Competition Forecast & Opportunities, 2030F”, the Japan Biosimilars Market stood at USD 502.09 Million in 2024 and is anticipated to grow with a CAGR of 10.12% in the forecast period through 2030.

Regulatory advancements are pivotal in driving the growth of the biosimilars market in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) has established a proactive regulatory framework that offers clear guidelines for the development and approval of biosimilars. This approach not only reduces uncertainty for manufacturers but also accelerates the entry of new biosimilars into the market, encouraging investment in research and development.

Also, Japan’s alignment with global regulatory standards, including those set by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), facilitates smoother international collaborations and market access. This harmonization fosters a competitive environment for biosimilars, enhancing their market presence and viability.

Government policies and incentives further support market growth. Tax breaks and grants for biosimilar development make it economically feasible for companies to engage in biosimilar projects, thereby stimulating the market and encouraging innovation.

The expiration of patents for several major biologics presents significant opportunities for biosimilars. As these patents lapse, biosimilar manufacturers are positioned to introduce competitive alternatives, enhancing market competition and expanding treatment options at reduced costs. This influx of biosimilars not only increases market share but also allows them to penetrate areas previously dominated by originator biologics, driving overall market growth.

                                                                                             

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The Japan Biosimilars Market is segmented into product, application, distribution channel, regional distribution, and company.

Based on distribution channel, the Hospital Pharmacies segment has emerged as the predominant market leader, Hospital pharmacies benefit from centralized procurement systems that streamline the acquisition of medications, including biosimilars. This centralization allows for bulk purchasing, which often results in cost savings through negotiated discounts. As biosimilars are typically positioned as cost-effective alternatives to expensive biologics, hospital pharmacies are well-positioned to leverage these savings, making them a primary channel for biosimilar distribution.

Hospital pharmacies are integral to the healthcare delivery system within hospitals. They are closely connected with the clinical departments that prescribe biosimilars, such as oncology, rheumatology, and internal medicine. This integration ensures that hospital pharmacies are the primary dispensers of biosimilars for in-patient and outpatient care, particularly for treatments requiring specialized administration and monitoring. The ability to manage and dispense biosimilars directly to patients under the hospital's care contributes to their dominant role in the market. Hospital pharmacies are responsible for adhering to established treatment protocols and guidelines, which increasingly include biosimilars. These protocols often prioritize cost-effective treatments without compromising quality, aligning with the use of biosimilars as substitutes for reference biologics. By adhering to these protocols, hospital pharmacies drive the adoption of biosimilars, ensuring that they are consistently included in treatment regimens and formularies.

Hospital pharmacies provide specialized support and training for the use of biosimilars. This includes educating healthcare professionals about the equivalency of biosimilars to originator biologics, managing patient transitions from reference biologics to biosimilars, and ensuring proper administration techniques. This level of support fosters confidence in the use of biosimilars and enhances their acceptance within hospital settings. Regulatory and reimbursement policies in Japan also influence the dominance of hospital pharmacies. The Japanese government often supports the use of biosimilars through favorable reimbursement policies, which can be more readily managed and implemented through hospital pharmacies. These policies encourage the adoption of biosimilars in hospital settings, where the alignment with reimbursement practices and regulatory guidelines is crucial.

 

Major companies operating in Japan Biosimilars Market are:

  • Novartis AG
  • Pfizer Inc.
  • Amgen Inc
  • Coherus BioSciences, Inc
  • Viatris Inc
  • Samsung Bioepis Co., Ltd

 

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“the Japan biosimilars market is poised for substantial growth, underpinned by a supportive regulatory environment, increasing demand for cost-effective therapies, and significant advancements in biomanufacturing technologies. The proactive stance of the Pharmaceuticals and Medical Devices Agency (PMDA) and alignment with global regulatory standards facilitate the market entry and adoption of biosimilars. As patents for key biologics expire, opportunities for biosimilars expand, further driving market dynamics. Despite challenges such as market acceptance and pricing pressures, the market outlook remains positive, with ongoing innovations and supportive government policies expected to foster continued growth and integration of biosimilars into the Japanese healthcare system.,” said Mr. Karan Chechi, Research Director of TechSci Research, a research-based management consulting firm.

Japan Biosimilars Market, By Product (Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-inflammatory Agents, Other), By Application (Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, Oncology, Other), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, Competition Forecast & Opportunities, 2020-2030F”, has evaluated the future growth potential of Japan Biosimilars Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Japan Biosimilars Market.

 

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