The Japan biologics market was valued at USD 12.20 Billion in 2025 and is expected to grow at a CAGR of 6.50%, reaching USD 22.90 Billion by 2035. The market growth is driven by the rising demand for targeted therapies, strong government support for regenerative medicine, growing biosimilar adoption, and expanding domestic biomanufacturing capabilities.
Base Year
Historical Period
Forecast Period
AGC Biologics’ new Yokohama facility will enhance local manufacturing capacity and support sustained growth in Japan’s biologics production ecosystem.
Chugai’s 2025 approval of ELEVIDYS marks a turning point for regenerative therapies, boosting innovation in Japan’s biologics pipeline.
The launch of a subcutaneous ustekinumab biosimilar will drive biosimilar uptake and increase biologics accessibility for chronic disease patients in Japan.
Compound Annual Growth Rate
6.5%
Value in USD Billion
2026-2035
*this image is indicative*
The market is steadily expanding, driven by advancements in biotechnology, a growing aging population, and increased demand for targeted therapies. The country has established itself as a key player in Asia’s biopharmaceutical innovation ecosystem, with active government support for regenerative medicine and gene therapies. In the historical period, Japan accounted for approximately 7% of the global biologics market revenue, reflecting its strong industry presence. Continued investment in R&D and early adoption of cutting-edge biologics are expected to fuel market growth in the years ahead. The market is expected to grow at a CAGR of 6.50% during the forecast period of 2026-2035 and attain a market value of USD 22.90 Billion by 2035.
Biosimilar Expansion Set to Accelerate Biologics Market Growth in Japan
The rising demand for cost-effective biologic therapies and favorable biosimilar regulations are key drivers in Japan’s evolving biologics market. For instance, in May 2025, Biocon Biologics and Yoshindo launched a subcutaneous biosimilar version of Ustekinumab, used to treat psoriasis and Crohn’s disease, in Japan. This marks the first biosimilar launch of its kind in the country. By increasing access to high-cost monoclonal antibody therapies at reduced prices, this development is expected to significantly boost biosimilar adoption, reduce treatment costs, and drive overall biologics market growth in Japan during the forecast period.
Major market trends include biomanufacturing expansion and breakthrough approvals in regenerative therapies.
Biomanufacturing Infrastructure Expansion Driving the Japan Biologics Market Growth
Growing demand for biologics and the need for localized production capacity are reshaping Japan’s pharmaceutical manufacturing landscape. For instance, in May 2025, AGC Biologics announced plans to establish a new manufacturing facility in Yokohama, aimed at expanding its cell and gene therapy capabilities. This strategic investment enhances domestic biomanufacturing infrastructure, improves supply chain efficiency, and supports faster product delivery. The move is expected to strengthen Japan’s position as a biologic manufacturing hub, driving significant growth in the biologics market over the forecast period.
Regenerative Therapy Approvals Accelerating the Japan Biologics Market Demand
Japan’s progressive regulatory environment and focus on rare disease treatment are catalyzing innovation in the biologics space. For instance, in May 2025, Chugai Pharmaceutical received conditional approval from the MHLW for ELEVIDYS, an AAV-based gene therapy for Duchenne muscular dystrophy. As one of the first regenerative gene therapies cleared under Japan’s time-limited pathway, the approval signals regulatory confidence in advanced biologics. This milestone is set to accelerate investment, product launches, and development in Japan’s growing regenerative medicine and biologics markets.
Microbial Source Biologics Leading the Market Share
Microbial biologics are expected to maintain the largest share in the market, supported by their 60% revenue contribution in 2024. This dominance stems from their cost-effectiveness, scalability, and wide application in producing insulin, vaccines, and recombinant proteins. Microbial systems, such as E. coli and yeast, offer faster growth cycles and lower production costs compared to mammalian cells. Given Japan’s strong presence in biosimilar development and emphasis on affordable biologics, microbial-derived products are poised to continue leading the market over the forecast period.
The key features of the market report comprise funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
Pfizer Inc. is a key player with a robust portfolio in oncology, immunology, and rare disease biologics. Its offerings include monoclonal antibodies, vaccines, and recombinant proteins, supported by partnerships with Japanese firms for distribution and clinical trials. Pfizer leverages its global R&D capabilities to introduce innovative therapies, particularly in cancer treatment and autoimmune disorders, aligning with Japan’s growing demand for advanced biologics and personalized medicine solutions.
Novartis AG holds a strong presence in Japan’s biologics market through breakthrough therapies in oncology, ophthalmology, and immunology. Products like monoclonal antibodies, CAR-T cell therapies, and targeted biologics cater to unmet medical needs. The company invests heavily in local clinical research and collaborations to adapt treatments for Japan’s patient population. Its strategic focus on precision medicine and high-value biologics strengthens its market share, especially in complex diseases where biologic interventions outperform traditional treatments.
F. Hoffmann-La Roche dominates segments of Japan’s biologics market with leading oncology, immunology, and rare disease biologics. Flagship monoclonal antibodies and targeted therapies have strong uptake, supported by its diagnostics arm, which enables personalized treatment approaches. Roche’s collaborations with Japanese research institutions enhance local clinical validation and market access. Its emphasis on innovative cancer biologics and immune-based treatments aligns with Japan’s healthcare priorities, driving sustained growth and strong physician adoption in the biologics sector.
Amgen Inc. plays a significant role in Japan’s market through partnerships, notably with Astellas Pharma, to commercialize its biologic therapies. Its portfolio spans oncology, cardiovascular, and bone health biologics, including monoclonal antibodies and recombinant proteins. Amgen focuses on high-need therapeutic areas where biologics offer superior efficacy. Local manufacturing alliances and clinical development in Japan ensure product relevance and regulatory alignment, enabling Amgen to meet rising demand for innovative, targeted biologic treatments in the Japanese market.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other key players in the market include Eli Lilly and Company, Sanofi, and Bristol Myers Squibb Company.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Source
Market Breakup by Product
Market Breakup by Indication
Upto 15% Off
USD
$1999 $1799
$3099 $2789
$4599 $3909
$5999 $5099
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
Get in touch with us for a customized solution tailored to your unique requirements and save upto 35%!
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|
| Breakup by Source |
|
| Breakup by Product |
|
| Breakup by Indication |
|
| Market Dynamics |
|
| Supplier Landscape |
|
| Companies Covered |
|
Datasheet
One User
USD 1,999
USD 1,799
tax inclusive*
Single User License
One User
USD 3,099
USD 2,789
tax inclusive*
Five User License
Five User
USD 4,599
USD 3,909
tax inclusive*
Corporate License
Unlimited Users
USD 5,999
USD 5,099
tax inclusive*
*Please note that the prices mentioned below are starting prices for each bundle type. Kindly contact our team for further details.*
Flash Bundle
Small Business Bundle
Growth Bundle
Enterprise Bundle
*Please note that the prices mentioned below are starting prices for each bundle type. Kindly contact our team for further details.*
Flash Bundle
Number of Reports: 3
20%
tax inclusive*
Small Business Bundle
Number of Reports: 5
25%
tax inclusive*
Growth Bundle
Number of Reports: 8
30%
tax inclusive*
Enterprise Bundle
Number of Reports: 10
35%
tax inclusive*
How To Order
Select License Type
Choose the right license for your needs and access rights.
Click on ‘Buy Now’
Add the report to your cart with one click and proceed to register.
Select Mode of Payment
Choose a payment option for a secure checkout. You will be redirected accordingly.
Gain insights to stay ahead and seize opportunities.
Get insights & trends for a competitive edge.
Track prices with detailed trend reports.
Analyse trade data for supply chain insights.
Leverage cost reports for smart savings
Enhance supply chain with partnerships.
Connect For More Information
Our expert team of analysts will offer full support and resolve any queries regarding the report, before and after the purchase.
Our expert team of analysts will offer full support and resolve any queries regarding the report, before and after the purchase.
We employ meticulous research methods, blending advanced analytics and expert insights to deliver accurate, actionable industry intelligence, staying ahead of competitors.
Our skilled analysts offer unparalleled competitive advantage with detailed insights on current and emerging markets, ensuring your strategic edge.
We offer an in-depth yet simplified presentation of industry insights and analysis to meet your specific requirements effectively.
Share