日本のバイオシミラー市場：製品クラス別、適応症別、流通チャネル別、地域別、機会、予測、2019年～2033年

日本のバイオシミラーの市場規模は、2026年～2033年の予測期間中に9.33%のCAGRで拡大し、2025年の5億4,352万米ドルから2033年には11億950万米ドルに成長すると予測されています。日本のバイオシミラー市場は、手頃な価格のヘルスケアソリューションに対するニーズの高まりと、バイオシミラーの採用を促進する政府の政策によって後押しされています。がん領域は、がん罹患率の増加とバイオシミラーモノクローナル抗体の承認に牽引され、大幅な拡大が見られます。国内企業と世界企業の戦略的提携により、市場への浸透と製品の供給がさらに強化されています。

当レポートでは、日本のバイオシミラー市場について調査し、市場の概要とともに、製品クラス別、適応症別、流通チャネル別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 米国の関税の影響

第4章 エグゼクティブサマリー

第5章 日本のバイオシミラー市場の見通し、2019年～2033年

• 市場規模分析と予測
• 市場シェア分析と予測
  • 製品クラス別
    • モノクローナル抗体
    • 組み換えホルモン
    • 免疫調節薬
    • 抗炎症剤
    • その他
  • 適応症別
    • 腫瘍学
    • 成長ホルモン欠乏症
    • 血液疾患
    • 慢性疾患および自己免疫疾患
    • 感染症
    • その他
  • 流通チャネル別
    • 病院
    • がんケアセンター
    • その他
  • 地域別
    • 北部[北海道・東北]
    • 中部（関東・中部）
    • 南部[関西、中国、四国、九州・沖縄]
  • 企業別市場シェア分析（上位5社およびその他- 金額ベース、2025年）
• 2025年の市場マップ分析

第6章 需要供給分析

第7章 バリューチェーン分析

第8章 ポーターのファイブフォース分析

第9章 PESTLE分析

第10章 価格分析

第11章 市場力学

• 市場の促進要因
• 市場の課題

第12章 市場動向と発展

第13章 規制枠組みとイノベーション

• 規制当局の承認
• 臨床試験

第14章 特許の情勢

第15章 ケーススタディ

第16章 競合情勢

• 市場リーダートップ5の競合マトリックス
• 参入企業トップ5のSWOT分析
• 市場の主要企業トップ10の情勢
  • FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd.
  • Daiichi Sankyo Company, Limited
  • Mochida Pharmaceutical Co., Ltd
  • Teva Japan Private Limited
  • Eli Lilly and Company (Japan) Pvt. Ltd.
  • Pfizer Japan Inc.
  • Celltrion Healthcare Japan Private Limited
  • JCR Pharmaceuticals Co Ltd
  • LG Life Sciences Inc.

第17章 戦略的提言

第18章 調査会社について・免責事項

List of Tables

• Table 1. Competition Matrix of Top 5 Market Leaders
• Table 2. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 3. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. Japan Biosimilars Market, By Value, In USD Million, FY2019-FY2033F
• Figure 2. Japan Biosimilars Market Share (%), By Product Class, FY2019-FY2033F
• Figure 3. Japan Biosimilars Market Share (%), By Indication, FY2019-FY2033F
• Figure 4. Japan Biosimilars Market Share (%), By Distribution Channel, FY2019-FY2033F
• Figure 5. Japan Biosimilars Market Share (%), By Region, FY2019-FY2033F
• Figure 6. By Product Class Map-Market Size (USD Million) & Growth Rate (%), FY2025
• Figure 7. By Indication Map-Market Size (USD Million) & Growth Rate (%), FY2025
• Figure 8. By Distribution Channel Map-Market Size (USD Million) & Growth Rate (%), FY2025
• Figure 9. By Region Map-Market Size (USD Million) & Growth Rate (%), FY2025

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.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Impact of U.S. Tariffs

4. Executive Summary

5. Japan Biosimilars Market Outlook, FY2019-FY2033F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Product Class
    • 5.2.1.1. Monoclonal Antibodies
      • 5.2.1.1.1. Adalimumab
      • 5.2.1.1.2. Infliximab
      • 5.2.1.1.3. Rituximab
      • 5.2.1.1.4. Trastuzumab
      • 5.2.1.1.5. Others
    • 5.2.1.2. Recombinant Hormones
      • 5.2.1.2.1. Insulin
      • 5.2.1.2.2. Erythropoietin
      • 5.2.1.2.3. Others
    • 5.2.1.3. Immunomodulators
    • 5.2.1.4. Anti-Inflammatory Agents
    • 5.2.1.5. Others
  • 5.2.2. By Indication
    • 5.2.2.1. Oncology
    • 5.2.2.2. Growth Hormone Deficiency
    • 5.2.2.3. Blood Disorders
    • 5.2.2.4. Chronic and Autoimmune Disorders
    • 5.2.2.5. Infectious Diseases
    • 5.2.2.6. Others
  • 5.2.3. By Distribution Channel
    • 5.2.3.1. Hospitals
    • 5.2.3.2. Cancer Care Centers
    • 5.2.3.3. Others
  • 5.2.4. By Region
    • 5.2.4.1. North [Hokkaido and Tohoku]
    • 5.2.4.2. Central [Kanto and Chubu]
    • 5.2.4.3. South [Kansai, Chugoku, Shikoku, and Kyushu & Okinawa]
  • 5.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, FY2025)
• 5.3. Market Map Analysis, FY2025
  • 5.3.1. By Product Class
  • 5.3.2. By Indication
  • 5.3.3. By Distribution Channel
  • 5.3.4. By Region

6. Demand Supply Analysis

7. Value Chain Analysis

8. Porter's Five Forces Analysis

9. PESTLE Analysis

10. Pricing Analysis

11. Market Dynamics

• 11.1. Market Drivers
• 11.2. Market Challenges

12. Market Trends and Developments

13. Regulatory Framework and Innovation

• 13.1. Regulatory Approvals
• 13.2. Clinical Trials

14. Patent Landscape

15. Case Studies

16. Competitive Landscape

• 16.1. Competition Matrix of Top 5 Market Leaders
• 16.2. SWOT Analysis for Top 5 Players
• 16.3. Key Players Landscape for Top 10 Market Players
  • 16.3.1. FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd.
    • 16.3.1.1. Company Details
    • 16.3.1.2. Key Management Personnel
    • 16.3.1.3. Products and Services
    • 16.3.1.4. Financials (As Reported)
    • 16.3.1.5. Key Market Focus and Geographical Presence
    • 16.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 16.3.2. Daiichi Sankyo Company, Limited
  • 16.3.3. Mochida Pharmaceutical Co., Ltd
  • 16.3.4. Teva Japan Private Limited
  • 16.3.5. Eli Lilly and Company (Japan) Pvt. Ltd.
  • 16.3.6. Pfizer Japan Inc.
  • 16.3.7. Celltrion Healthcare Japan Private Limited
  • 16.3.8. JCR Pharmaceuticals Co Ltd
  • 16.3.9. LG Life Sciences Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

17. Strategic Recommendations

18. About Us and Disclaimer