Japan Biosimilars Market Research Report, 2030

Biosimilars are pharmaceutical medications that are highly similar to an existing biological reference product, known as the originator or reference biologic. Biosimilars are designed to be comparable in quality, safety, and efficacy to the reference product while being less expensive. They are an alternative to costly biologic therapeutics, providing patients with greater access to treatments while potentially saving healthcare systems money. Despite a sluggish start, Japan’s biosimilar market looks set for accelerated growth. The country’s patient co-pay dynamic, financial incentives, and commercial model will be keys to success. The increasing chronic disease prevalence, government initiatives for streamlined approvals, aging population demands, strong pharmaceutical company involvement, cost containment efforts, heightened awareness, and expanding product pipelines represent some of the key factors driving the market. In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW). The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese regulatory agency, working together with MHLW. PMDA’s Office of Biologicals provides consultations concerning the clinical trials of new drugs and medical devices and handles biotechnology medicines, including biosimilars. Cost-effectiveness, patent expirations of reference biologics, increasing demand for biologic medicines, a supportive regulatory environment, and increased acceptance by healthcare professionals are all main drivers in the biosimilars market. According to the research report, “Japan Biosimilars Market Research Report, 2030” published by Actual Market Research, the Japan Biosimilars market is projected to add USD 1.79 Billion from 2025 to 2030. The Japanese government's initiatives to promote the use of biosimilars, and the introduction of a regulatory framework to expedite the approval process, are significantly fueling the market growth. Moreover, the rising geriatric population in Japan underscores the demand for affordable healthcare solutions, such as biosimilars, strengthening the market growth. Besides this, the strong presence of established pharmaceutical companies investing in biosimilar research and development (R&D) is providing an impetus to the market growth as these companies leverage their expertise and resources to expedite the production and commercialization of biosimilar products. Concurrently, extensive collaborations and partnerships between domestic and international pharmaceutical firms stimulate innovation and widen the scope of biosimilar offerings, which is contributing to the market's growth. Along with this, the push for healthcare cost containment, driven by economic factors, further bolsters the biosimilar market in Japan, as these products provide an avenue for achieving significant cost savings without compromising on treatment efficacy. Additionally, the increasing awareness and acceptance of biosimilars among healthcare professionals and patients, fostering a positive perception of these alternatives, is presenting lucrative opportunities for the market expansion. Furthermore, the growing emphasis on personalized medicine and targeted therapies and the expanding pipeline of biosimilar products encompassing a diverse range of therapeutic areas are creating a positive outlook for the market growth.

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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. 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. 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. 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.

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Nikita Jabrela

Business Development Manager

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 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. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

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By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.