日本のCAR-T細胞療法市場：2025年～2033年

日本のCAR-T細胞療法の市場規模は、2024年に3億4,600万米ドルとなりました。同市場は、2033年には13億5,015万米ドルに達すると予測され、予測期間の2025年～2033年のCAGRは16.3%と予測されています。

CAR-T細胞療法（キメラ抗原受容体T細胞療法）は、主にがん治療に用いられる先進免疫療法です。免疫細胞の一種である患者のT細胞を、キメラ抗原受容体（CAR）を発現するように改変することで、これらの細胞が特定のがん細胞を認識して攻撃できるようにするものです。CAR-T細胞療法は、急性リンパ芽球性白血病（ALL）やある種のリンパ腫など、特定の血液がんに対して特に有効です。

しかし、CAR-T細胞の有効性を制限する可能性のある、より抑制的な腫瘍微小環境など、異なる課題を持つ固形がんにこのアプローチを適応させるための調査が進行中です。CAR-T細胞療法の需要は、進行した血液がんを治療する可能性と個別化治療の成果をもたらす能力によって、急速に伸びています。

日本では、多発性骨髄腫、白血病、リンパ腫などの血液がんの罹患率が上昇しており、CAR-T細胞療法市場の成長を大きく牽引すると期待されています。日本の高齢化が進むにつれ、これらの血液関連がんの有病率は着実に増加しており、高度で効果的な治療オプションに対するニーズが高まっています。例えば、国際がん研究機関のデータによると、日本では2022年に約6,988例の多発性骨髄腫が新たに報告されました。2025年には7,350人に達すると予想されています。また、日本における多発性骨髄腫の罹患率は、2030年までに7,535人に達すると推定されています。

従来の治療法では、再発または難治性の症例では成功が限られることが多く、CAR-T細胞療法のような革新的なソリューションへの需要が高まっています。がん細胞を標的として破壊するように患者の免疫細胞を再プログラムするこの最先端のアプローチは、標準治療を使い果たした患者に新たな希望をもたらします。CARVYKTIのような最近の承認に見られるように、認知度が高まり、規制当局の支援が強化されるにつれて、日本はアジア太平洋地域におけるCAR-T細胞療法の重要な市場になる準備が整っています。このように、上記の要因が市場成長の原動力となっています。

CAR-T細胞療法は高額であるため、患者やヘルスケアシステムにとって利用しやすく手頃な価格ではないことから、市場成長の妨げとなっています。特に包括的な保険償還の枠組みがない国では、コストの壁が患者のアクセスを制限し、同療法の市場浸透を制限しています。多くのヘルスケアプロバイダーや保険会社は、長期的な費用対効果のデータがないためCAR-T細胞療法の保険適用をためらっており、臨床的な有効性にもかかわらずその導入が制限されています。

当レポートでは、日本のCAR-T細胞療法市場について調査し、市場の概要とともに、治療タイプ別、薬剤タイプ別、標的抗原別、用途別、地域別動向、競合情勢、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 市場のイントロダクションと範囲

第2章 経営者の洞察と重要なポイント

第3章 市場力学

• 影響要因
  • 促進要因
  • 抑制要因
  • 機会
  • 影響分析

第4章 戦略的洞察と業界展望

• 市場のリーダーとパイオニア
• CXOの視点
• 最新の開発とブレークスルー
• ケーススタディ/進行中の調査
• 北米の規制と償還の情勢
• ポーターのファイブフォース分析
• サプライチェーン分析
• 特許分析
• SWOT分析
• アンメットニーズとギャップ
• 市場参入と拡大のための推奨戦略
• シナリオ分析ベストケース、ベースケース、ワーストケースの予測
• 価格分析と価格動向
• キーオピニオンリーダー

第5章 CAR-T細胞療法市場（治療タイプ別）

• 自家CAR-T細胞療法
• 同種CAR-T細胞療法

第6章 CAR-T細胞療法市場（薬剤タイプ別）

• アベクマ
• ブレヤンジ
• カルヴィクティ
• テカルトゥス
• キムリア
• イエスカルタ

第7章 CAR-T細胞療法市場（標的抗原別）

• CD19
• BCMA（B細胞成熟抗原）
• CD20
• CD22
• CD30
• その他

第8章 CAR-T細胞療法市場（用途別）

• 急性リンパ性白血病（ALL）
• 非ホジキンリンパ腫
• 慢性リンパ性白血病
• 多発性骨髄腫（MM）
• 濾胞性リンパ腫
• その他

第9章 競合情勢と市場ポジショニング

• 競合状況の概要と主要市場参入企業
• 市場シェア分析とポジショニングマトリックス
• 戦略的パートナーシップ、合併・買収
• 製品ポートフォリオとイノベーションにおける主な発展
• 企業ベンチマーク

第10章 企業プロファイル

• Gilead Sciences, Inc.
• 会社概要
• 製品ポートフォリオ
• 財務概要
• 主な発展
• SWOT分析
• Bristol Myers Squibb Company
• Johnson &Johnson Services, Inc.
• Novartis AG
• Takara Bio Inc

第11章 仮定と調査手法

第12章 付録

The Japan CAR-T cell therapies market reached US$ 346.00 million in 2024 and is expected to reach US$ 1,350.15 million by 2033, growing at a CAGR of 16.3% during the forecast period 2025-2033.

CAR-T cell therapy, or Chimeric Antigen Receptor T-cell therapy, is an advanced immunotherapy used primarily in cancer treatment. It involves engineering a patient's T cells, a type of immune cell, by modifying them to express a chimeric antigen receptor (CAR) that allows these cells to recognize and attack specific cancer cells. CAR-T cell therapy has been particularly effective for certain blood cancers, such as acute lymphoblastic leukemia (ALL) and certain types of lymphoma.

However, research is ongoing to adapt this approach for solid tumors, which have different challenges, like a more suppressive tumor microenvironment that can limit CAR-T cell effectiveness. The demand for CAR-T cell therapy is growing rapidly, driven by its potential to treat advanced blood cancers and its ability to deliver personalized treatment outcomes.

Market Dynamics: Drivers & Restraints

Rising Incidence of Hematological Cancers

The rising incidence of hematological cancers in Japan, such as multiple myeloma, leukemia, and lymphoma, is expected to significantly drive the growth of the country's CAR-T cell therapy market. As Japan's population continues to age, the prevalence of these blood-related cancers has been steadily increasing, creating a greater need for advanced and effective treatment options. For instance, according to the data provided by the International Agency for Research on Cancer, around 6,988 new cases of multiple myeloma were reported in Japan in 2022. By 2025, the number is expected to reach 7,350. Also, it is estimated that the incidence of multiple myeloma in Japan is expected to reach 7,535 by 2030.

Traditional therapies often have limited success in relapsed or refractory cases, which is raising the demand for innovative solutions like CAR-T cell therapy. This cutting-edge approach, which involves reprogramming a patient's immune cells to target and destroy cancer cells, offers new hope for patients who have exhausted standard treatments. As awareness grows and regulatory support strengthens, as seen with recent approvals like CARVYKTI, Japan is poised to become a key market for CAR-T cell therapies in the Asia-Pacific region. Thus, the above factors are driving the market growth.

High Costs of Therapy

The high cost of CAR-T cell therapy significantly hampers its market growth by limiting accessibility and affordability for patients and healthcare systems. The cost barrier restricts patient access, especially in countries without comprehensive reimbursement frameworks, and limits the therapy's market penetration. Many healthcare providers and insurers hesitate to cover CAR-T cell therapy due to the lack of long-term cost-benefit data, thus constraining its adoption despite clinical efficacy.

Segment Analysis

The Japan CAR-T cell therapies market is segmented based on the therapy type, drug type, target antigen, and application.

Multiple myeloma in the application segment is expected to dominate the CAR-T cell therapies market

Multiple myeloma is projected to lead the application segment of Japan's CAR-T cell therapy market, driven by the rising number of cancer cases, increasing approval and launch activities from key industry players. For instance, in September 2022, Legend Biotech Corporation, a global biotechnology company focused on developing, manufacturing, and commercializing innovative therapies for life-threatening diseases, announced that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved CARVYKTI (ciltacabtagene autoleucel). This BCMA-targeted CAR-T cell therapy is now approved for the treatment of adult patients with relapsed or refractory multiple myeloma.

Additionally, in December 2023, Bristol Myers Squibb's idecabtagene vicleucel was approved in Japan for patients with relapsed or refractory multiple myeloma who had received at least two prior lines of therapy. The approval was supported by results from the phase 3 KarMMA-3 trial, which showed significant improvements in progression-free survival and objective response rates compared to standard therapies.

These developments underscore the growing focus on multiple myeloma within Japan's CAR-T therapy market. The increasing availability of approved CAR-T treatments is expected to meet the rising demand for effective therapies, solidifying multiple myeloma as a dominant application area in this market segment.

Competitive Landscape

The market players in the CAR-T cell therapies market are Gilead Sciences, Inc., Bristol Myers Squibb Company, Johnson & Johnson Services, Inc., and Novartis AG, among others.

Key Developments

• In April 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
• In January 2024, Bristol Myers Squibb announced three regulatory acceptances from the U.S. Food and Drug Administration (FDA) and Japan's Ministry of Health, Labour and Welfare (MHLW) for Breyanzi (lisocabtagene maraleucel).
• In April 2023, Takara Bio Inc. submitted a Clinical Trial Application (CTA) to Health Canada and the receipt of the No Objection Letter to initiate a Phase I/Ib clinical trial for CD19 JAK/STAT CAR-T therapy (TBI-2001). Once the necessary steps are taken, the investigator-initiated clinical trial will be started for patients with CD19-positive B-cell lymphoma.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming pharmaceutical advancements.
• Type Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient Type delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The Japan CAR-T cell therapies market report would provide approximately 42 tables, 33 figures, and 180 pages.

Target Audience 2024

• Manufacturers: Pharmaceutical, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Market Introduction and Scope

• 1.1. Objectives of the Report
• 1.2. Report Coverage & Definitions
• 1.3. Report Scope

2. Executive Insights and Key Takeaways

• 2.1. Market Highlights and Strategic Takeaways
• 2.2. Key Trends and Future Projections
• 2.3. Snippet by Therapy Type
• 2.4. Snippet by Drug Type
• 2.5. Snippet by Target Antigen
• 2.6. Snippet by Application

3. Dynamics

• 3.1. Impacting Factors
  • 3.1.1. Drivers
    • 3.1.1.1. Rising Incidence of Hematological Cancers
    • 3.1.1.2. Growing Demand for Personalized Therapies
  • 3.1.2. Restraints
    • 3.1.2.1. High Costs of Therapy
    • 3.1.2.2. Stringent Regulatory Framework
  • 3.1.3. Opportunity
    • 3.1.3.1. Rising Number of Clinical Studies
  • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

• 4.1. Market Leaders and Pioneers
  • 4.1.1. Emerging Pioneers and Prominent Players
  • 4.1.2. Established leaders with largest-selling Brand
  • 4.1.3. Market leaders with established Product
• 4.2. CXO Perspectives
• 4.3. Latest Developments and Breakthroughs
• 4.4. Case Studies/Ongoing Research
• 4.5. North America Regulatory and Reimbursement Landscape
• 4.6. Porter's Five Force Analysis
• 4.7. Supply Chain Analysis
• 4.8. Patent Analysis
• 4.9. SWOT Analysis
• 4.10. Unmet Needs and Gaps
• 4.11. Recommended Strategies for Market Entry and Expansion
• 4.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
• 4.13. Pricing Analysis and Price Dynamics
• 4.14. Key Opinion Leaders

5. CAR-T cell therapies Market, By Therapy Type

• 5.1. Introduction
  • 5.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy Type
  • 5.1.2. Market Attractiveness Index, By Therapy Type
• 5.2. Autologous CAR-T Cell Therapy*
  • 5.2.1. Introduction
  • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 5.3. Allogeneic CAR-T Cell Therapy

6. CAR-T cell therapies Market, By Drug Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
  • 6.1.2. Market Attractiveness Index, By Drug Type
• 6.2. Abecma*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Breyanzi
• 6.4. Carvykti
• 6.5. Tecartus
• 6.6. Kymriah
• 6.7. Yescarta

7. CAR-T cell therapies Market, By Target Antigen

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Target Antigen
  • 7.1.2. Market Attractiveness Index, By Target Antigen
• 7.2. CD19*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. BCMA (B-cell maturation antigen)
• 7.4. CD20
• 7.5. CD22
• 7.6. CD30
• 7.7. Others

8. CAR-T cell therapies Market, By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Acute Lymphoblastic Leukemia (ALL)*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Non-Hodgkin Lymphoma
• 8.4. Chronic Lymphocytic Leukemia
• 8.5. Multiple Myeloma (MM)
• 8.6. Follicular Lymphoma
• 8.7. Others

9. Competitive Landscape and Market Positioning

• 9.1. Competitive Overview and Key Market Players
• 9.2. Market Share Analysis and Positioning Matrix
• 9.3. Strategic Partnerships, Mergers & Acquisitions
• 9.4. Key Developments in Product Portfolios and Innovations
• 9.5. Company Benchmarking

10. Company Profiles

Established Players

• 10.1. Gilead Sciences, Inc.*
  • 10.1.1. Company Overview
  • 10.1.2. Product Portfolio
    • 10.1.2.1. Product Description
    • 10.1.2.2. Product Key Performance Indicators (KPIs)
    • 10.1.2.3. Historic and Forecasted Product Sales
    • 10.1.2.4. Product Sales Volume
  • 10.1.3. Financial Overview
    • 10.1.3.1. Company Revenue
    • 10.1.3.2. Geographical Revenue Shares
    • 10.1.3.3. Revenue Forecasts
  • 10.1.4. Key Developments
    • 10.1.4.1. Mergers & Acquisitions
    • 10.1.4.2. Key Product Development Activities
    • 10.1.4.3. Regulatory Approvals, etc.
  • 10.1.5. SWOT Analysis
• 10.2. Bristol Myers Squibb Company
• 10.3. Johnson & Johnson Services, Inc.
• 10.4. Novartis AG

Emerging Players

• 10.5. Takara Bio Inc

LIST NOT EXHAUSTIVE

11. Assumption and Research Methodology

• 11.1. Data Collection Methods
• 11.2. Data Triangulation
• 11.3. Forecasting Techniques
• 11.4. Data Verification and Validation

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us