Japan Biosimilars Market Assessment, By Product Class [Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-Inflammatory Agents, Others], By Indication [Oncology, Growth Hormone Deficiency, Blood Disorders, Chronic and Autoimmune Disorders,

Japan biosimilars market is projected to witness a CAGR of 9.33% during the forecast period FY2026-FY2033, growing from USD 543.52 million in FY2025 to USD 1109.50 million in FY2033. The Japan biosimilars market is being propelled by the growing need for affordable healthcare solutions and government policies promoting biosimilar adoption. The oncology segment is witnessing significant expansion, driven by the increasing burden of cancer and the approval of biosimilar monoclonal antibodies. Strategic partnerships between domestic and global companies are further strengthening market penetration and product availability.

Rising Demand for Cost-Effective Therapies Fueling Biosimilar Adoption in Japan

The biosimilars market in Japan is experiencing significant growth driven by the increasing need for cost-effective treatment alternatives, especially in the fields of oncology and chronic disease management. As the population ages and healthcare expenses rise, biosimilars present a financially viable option compared to biologic therapies, maintaining both efficacy and safety. The Japanese government is actively encouraging the adoption of biosimilars through supportive policies and reimbursement incentives, with the goal of alleviating the national healthcare burden. Hospitals and cancer treatment facilities are progressively integrating biosimilars to enhance patient access to treatment. Additionally, public awareness initiatives that emphasize the equivalence of biosimilars to their reference biologics are facilitating market growth. For example, in December 2023, Biocon Biologics, a subsidiary of Biocon, announced a partnership with Sandoz, granting Sandoz exclusive rights to market, sell, and distribute the Adalimumab biosimilar for subcutaneous administration in Japan.

Increasing Oncology Focus Enhancing the Biosimilars Segment Growth

The increasing incidence of cancer cases in Japan has resulted in a notable surge in the demand for biosimilar monoclonal antibodies. Oncology biosimilars, especially those aimed at breast cancer, lymphoma, and colorectal cancer, are becoming essential for hospitals that are looking for cost-effective treatment options. Regulatory bodies in Japan are expediting the approval processes for oncology biosimilars, thereby enhancing the range of available therapeutic alternatives. Furthermore, collaborations between local pharmaceutical firms and international biosimilar developers are improving access to innovative biosimilar treatments. The heightened emphasis on oncology-specific biosimilars is fostering significant growth in this sector and establishing Japan as a prominent biosimilars market within Asia. For instance, in January 2025, Celltrion announced that its biosimilar therapy for breast and gastric cancer, Herzuma (trastuzumab), has achieved a 74 percent market share in Japan, a key pharmaceutical market in Asia, as of November. After surpassing the original product in market share during the second quarter of 2021, Herzuma has sustained its leading status for three consecutive years and is now increasing its lead over competitors.

Strategic Collaborations Strengthening Japan’s Position in the Global Biosimilars Landscape

The strategic partnerships between Japanese pharmaceutical companies and global biosimilar firms are driving market growth. These collaborations are centered on the joint development, production, and marketing of biosimilars that meet the specific regulatory and clinical requirements of Japan. Firms are making significant investments in local manufacturing facilities to adhere to Japan's stringent quality regulations, thereby enhancing the domestic supply chain. Additionally, these partnerships are enabling Japanese companies to launch highly competitive products in both local and international markets. This movement is positioning Japan as a key center for biosimilar innovation and commercialization. For instance, in February 2025, Biocon Biologics revealed its collaboration with Janssen to launch a biosimilar medication targeting autoimmune diseases in Europe, the United Kingdom, Canada, and Japan. As a subsidiary of Biocon Ltd, the company has successfully negotiated a settlement and licensing agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson, which supports the commercialization of its proposed biosimilar Bmab 1200, intended as an alternative to Stelara.

Future Market Scenario (FY2026 – FY2033F)

The biosimilars market in Japan is set for substantial growth in the upcoming years, fueled by rising healthcare expenses, an increasingly aging demographic, and a heightened demand for affordable biologic therapies. Government initiatives aimed at fostering biosimilar adoption, along with expedited regulatory approvals, will further propel market development. The growing prevalence of oncology, autoimmune diseases, and chronic conditions is generating a significant demand for cost-effective therapeutic options. Moreover, domestic pharmaceutical firms are progressively partnering with global entities to enhance the biosimilars pipeline and launch innovative products. Improvements in manufacturing technologies and quality assurance processes will also boost the competitiveness of biosimilars in Japan. With the expansion of indications and the introduction of new products, Japan is anticipated to become a prominent biosimilars market within the Asia-Pacific region.

Key Players Landscape and Outlook

Key players in the biosimilars industry utilize strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing big-cap industry players to increase their presence and, therefore, find new opportunities in this market.

For instance, Owen Mumford's exclusive partnership with NIPRO CORPORATION, based in Osaka, for the distribution of the UniSafe drug delivery device, has experienced significant early growth in the sales of combination products in Japan. Since its introduction in late 2023, the product has rapidly captured a substantial portion of the market, including the original biologic combination product. This achievement within the initial three months of its commercial release has surpassed the expectations of both NIPRO and Owen Mumford.