日本の抗体治療薬市場：製品タイプ別、適応疾患別、投与経路別、エンドユーザー別、地域別、機会、予測、2019年～2033年

日本の抗体治療薬の市場規模は、2025年～2033年の予測期間中に10％のCAGRで拡大し、2025年の193億3,000万米ドルから2033年には414億4,000万米ドルに成長すると予測されています。日本の抗体治療薬市場は、最近の技術動向と効果的な治療ソリューションの緊急ニーズにより大きく成長しています。市場拡大の主な要因のひとつは、がんや心血管疾患などの慢性疾患の頻度が増加し、製造業務が増加していることです。

例えば、エプキンリー（TM）（一般名：エプコリタマブ）は厚生労働省から承認を取得し、特定の再発または難治性の大細胞型B細胞リンパ腫（LBCL）の成人患者の治療薬として、日本で最初で唯一のT細胞関与二特異性抗体として承認されました。これには、びまん性大細胞型B細胞リンパ腫（DLBCL）、高悪性度B細胞リンパ腫（HGBCL）、原発性縦隔大細胞型B細胞リンパ腫（PMBCL）、濾胞性リンパ腫グレード3B（FL3B）が含まれます。エプコリタマブは、GenmabとAbbVieのがん領域における共同開発品です。

当レポートでは、日本の抗体治療薬市場について調査し、市場の概要とともに、製品タイプ別、適応疾患別、投与経路別、エンドユーザー別、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 エグゼクティブサマリー

第4章 日本の抗体治療薬市場の見通し、2019年～2033年

• 市場規模分析と予測
• 市場シェア分析と予測
• 2025年市場マップ分析
  • 製品タイプ別
  • 適応疾患別
  • 投与経路別
  • エンドユーザー別
  • 地域別

第5章 需要供給分析

第6章 バリューチェーン分析

第7章 ポーターのファイブフォース分析

第8章 PESTLE分析

第9章 価格分析

第10章 市場力学

• 市場の促進要因
• 市場の課題

第11章 市場動向と発展

第12章 規制状況

第13章 臨床試験の概要

第14章 ケーススタディ

第15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
• 市場トップ10の主要企業の情勢
  • AbbVie Inc.
  • Bristol-Myers Squibb Co.
  • F. Hoffmann-La Roche Ltd.
  • Johnson & Johnson Services Inc.
  • Amgen Inc.
  • Merck KGaA
  • Novartis AG
  • Pfizer Inc.
  • AstraZeneca plc
  • Eli Lilly and Company

第16章 戦略的提言

第17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 Antibody Therapeutics Market, By Value, In USD Billion, FY2019-FY2033F
• Figure 2. Japan Antibody Therapeutics Market Share (%), By Product Type, FY2019-FY2033F
• Figure 3. Japan Antibody Therapeutics Market Share (%), By Disease Indication, FY2019-FY2033F
• Figure 4. Japan Antibody Therapeutics Market Share (%), By Route of Administration, FY2019-FY2033F
• Figure 5. Japan Antibody Therapeutics Market Share (%), By End-user, FY2019-FY2033F
• Figure 6. Japan Antibody Therapeutics Market Share (%), By Region, FY2019-FY2033F
• Figure 7. By Product Type Map-Market Size (USD Billion) & Growth Rate (%), FY2025
• Figure 8. By Disease Indication Map-Market Size (USD Billion) & Growth Rate (%), FY2025
• Figure 9. By Route of Administration Map-Market Size (USD Billion) & Growth Rate (%), FY2025
• Figure 10. By End-user Map-Market Size (USD Billion) & Growth Rate (%), FY2025
• Figure 11. By Region Map-Market Size (USD Billion) & Growth Rate (%), FY2025

Japan antibody therapeutics market is projected to witness a CAGR of 10% during the forecast period FY2025-FY2033, growing from USD 19.33 billion in FY2025 to USD 41.44 billion in FY2033. Japan market for antibody therapeutics has grown significantly because of recent developments in technology and the urgent need for effective therapeutic solutions. One of the main reasons for driving market expansion is the increasing frequency of chronic diseases such as cancer and cardiovascular disorders, which has increased manufacturing operations.

For example, the Japan Ministry of Health, Labour and Welfare has granted approval to EPKINLY(TM) (epcoritamab), making it the first and only T-cell engaging bispecific antibody approved in Japan for the treatment of adult patients with certain relapsed or refractory large B-cell lymphoma (LBCL) types. This includes diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B), after two or more prior lines of systemic therapy. Epcoritamab is co-developed by Genmab and AbbVie under their oncology collaboration.

Increasing Prevalence of Chronic Diseases and Aging Population Driving Market Demand

Japan has one of the world's oldest populations, with more than 28% of its residents aged 65 and older. This demographic shift has led to a surge in age-related diseases, particularly cancer, autoimmune disorders, and neurological conditions, which are major targets for antibody therapeutics. The rising burden of these diseases is increasing the demand for monoclonal antibodies (mAbs) and polyclonal antibodies, as they offer targeted treatment with fewer side effects compared to traditional therapies. Additionally, the high prevalence of rheumatoid arthritis, multiple sclerosis, and inflammatory diseases in Japan is further driving the adoption of antibody-based treatments. For instance, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Roche's Polivy (polatuzumab vedotin) for the first-line treatment of diffuse large B-cell lymphoma (DLBCL) in combination with chemotherapy. In December 2024, Roche presented five-year follow-up data from the phase III POLARIX study, reinforcing the potential of Polivy in combination with R-CHP to provide durable and lasting remissions in previously untreated DLBCL. This approval marked a significant advancement in the antibody therapeutics space, providing a new treatment option for a disease that accounts for 30-40% of all non-Hodgkin lymphoma cases in Japan. The increasing number of such approvals is expected to propel the growth of the antibody therapeutics market, as more patients gain access to life-saving biologics.

Rising Investments and Collaborations in Antibody Drug Development

Japan's pharmaceutical sector is witnessing substantial investments and strategic collaborations to advance antibody drug discovery and development. Leading pharmaceutical firms and biotech companies are expanding their biologics research and development (R&D) activities in Japan to leverage the country's expertise in biotechnology and precision medicine. With government support for biopharmaceutical innovations, the market for antibody therapeutics is experiencing rapid expansion. For instance, in August 2023, ImmunoGen, Inc. entered into an exclusive collaboration with Takeda Pharmaceutical Company Limited to develop and commercialize ELAHERE (mirvetuximab soravtansine-gynx) in Japan. ELAHERE is an antibody-drug conjugate (ADC) targeting folate receptor alpha (FRa)-positive, platinum-resistant ovarian cancer. Under the terms of the agreement, ImmunoGen received a USD 34 million upfront payment and is eligible for additional regulatory and commercial milestone payments, as well as double-digit royalties on future net sales in Japan. This collaboration underscores Takeda's commitment to bringing innovative oncology therapies to the Japanese market, addressing significant unmet medical needs.

Increasing Adoption of Subcutaneous Antibody Therapeutics for Patient Convenience

Among the different routes of administration, subcutaneous antibody therapies are gaining popularity in Japan due to greater patient convenience, reduced hospital visits, and lower healthcare costs. Intravenous (IV) infusion, the traditional method of delivering antibody drugs, often requires long hospital stays and high administration costs. However, the introduction of subcutaneous formulations has allowed patients to receive antibody-based treatments at home or in outpatient settings, improving compliance and accessibility. A major development in this segment occurred in January 2024, when Johnson & Johnson's Janssen Pharmaceuticals received approval in Japan for DARZALEX SC (daratumumab), a subcutaneous formulation of its blockbuster multiple myeloma drug. This new version offers shorter administration time and improved patient comfort compared to the intravenous form. With such advancements, subcutaneous antibody therapies are expected to gain a larger market share in Japan, particularly for chronic conditions like cancer, autoimmune diseases, and hematological disorders. As more subcutaneous antibody drugs receive regulatory approvals, the segment will continue to expand, driving overall market growth.

Future Market Scenario (FY2026 - FY2033F)

Many factors claim the growth of Japan antibody therapeutics market. Technological and infrastructural advancements give better results after the diagnosis of the disease. For instance, Astellas has committed USD 256 million to expand its antibody and cell therapy operations in both Japan and the United States. The investment will support the company's future pipeline by building two multi-modality facilities in Japan and relocating a regenerative medicine plant in Massachusetts. The expansion, which includes sites in Toyama and Tsukuba (Japan) and Massachusetts (U.S.), will enhance both R&D and manufacturing capabilities to advance the development and commercialization of Astellas' portfolio. Opportunity also lies in the increasing number of viral infections that the Japan is facing today. Promising moves of the government that provide healthcare infrastructure, funds to carry on research and development on a large scale, and a reliable distribution channel that ensures the solution reaches everyone is testimonial.

Key Players Landscape and Outlook

Key players in the antibody therapeutics 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, in order to improve and broaden the use of ADCs for patients with various cancer types, the partnership combines Merck KGaA's extensive oncology knowledge and clinical development skills with Daiichi Sankyo's demonstrated ADC expertise and DXd technology. With the exception of Japan, where Daiichi Sankyo maintains exclusive rights, Daiichi Sankyo and Merck will jointly develop and market patritumab deruxtecan, ifinatamab deruxtecan, and raludotatug deruxtecan globally.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Japan Antibody Therapeutics Market Outlook, FY2019-FY2033F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Product Type
    • 4.2.1.1. Monoclonal Antibodies
    • 4.2.1.2. Polyclonal Antibodies
    • 4.2.1.3. Others
  • 4.2.2. By Disease Indication
    • 4.2.2.1. Oncology
    • 4.2.2.2. Hematology
    • 4.2.2.3. Immunology
    • 4.2.2.4. Autoimmune and Inflammatory Diseases
    • 4.2.2.5. Neurology
    • 4.2.2.6. Others
  • 4.2.3. By Route of Administration
    • 4.2.3.1. Intravenous
    • 4.2.3.2. Subcutaneous
    • 4.2.3.3. Other Routes of Administration
  • 4.2.4. By End-user
    • 4.2.4.1. Hospitals
    • 4.2.4.2. Long-term Care Centers
    • 4.2.4.3. Others
  • 4.2.5. By Region
    • 4.2.5.1. North [Hokkaido and Tohoku]
    • 4.2.5.2. Central [Kanto and Chubu]
    • 4.2.5.3. South [Kansai, Chugoku, Shikoku, and Kyushu & Okinawa]
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, FY2025)
• 4.3. Market Map Analysis, FY2025
  • 4.3.1. By Product Type
  • 4.3.2. By Disease Indication
  • 4.3.3. By Route of Administration
  • 4.3.4. By End-user
  • 4.3.5. By Region

5. Demand Supply Analysis

6. Value Chain Analysis

7. Porter's Five Forces Analysis

8. PESTLE Analysis

9. Pricing Analysis

10. Market Dynamics

• 10.1. Market Drivers
• 10.2. Market Challenges

11. Market Trends and Developments

12. Regulatory Landscape

13. Overview of Clinical Trials

14. Case Studies

15. Competitive Landscape

• 15.1. Competition Matrix of Top 5 Market Leaders
• 15.2. SWOT Analysis for Top 5 Players
• 15.3. Key Players Landscape for Top 10 Market Players
  • 15.3.1. AbbVie Inc.
    • 15.3.1.1. Company Details
    • 15.3.1.2. Key Management Personnel
    • 15.3.1.3. Products and Services
    • 15.3.1.4. Financials (As Reported)
    • 15.3.1.5. Key Market Focus and Geographical Presence
    • 15.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 15.3.2. Bristol-Myers Squibb Co.
  • 15.3.3. F. Hoffmann-La Roche Ltd.
  • 15.3.4. Johnson & Johnson Services Inc.
  • 15.3.5. Amgen Inc.
  • 15.3.6. Merck KGaA
  • 15.3.7. Novartis AG
  • 15.3.8. Pfizer Inc.
  • 15.3.9. AstraZeneca plc
  • 15.3.10. Eli Lilly and Company

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

16. Strategic Recommendations

17. About Us and Disclaimer