日本の遺伝子治療市場：タイプ別、ベクター別、遺伝子導入方法別、用途別、投与経路別、エンドユーザー別、地域別、機会、予測、2018年～2032年

日本の遺伝子治療の市場規模は、2025年～2032年の予測期間中に22.79％のCAGRで拡大し、2024年の4億1,941万米ドルから2032年には21億5,179万米ドルに成長すると予測されています。同市場の成長を後押ししているのは、遺伝性疾患や慢性疾患の患者数の増加、小規模バイオ企業やメーカー間の提携の増加、研究活動を支援するための投資の増加、個別化医療へのシフトの増加、政府による支援策の導入などです。

過去10年間、同国はより効果的で迅速な研究開発を促進するため、遺伝子治療に関わる様々な規制を抜本的に見直してきました。同国は、企業が新しい細胞治療や遺伝子治療の薬事承認を受けるための迅速なルートを構築するために法律を更新しました。医薬品医療機器法では、臨床試験で安全性と患者に利益をもたらす可能性が証明された後、国内での新製品の販売を許可しています。

さらに、さまざまな生物医学団体の取り組みが活発化していることから、日本では細胞治療や遺伝子治療の製造を増強するための新技術の利用可能性が高まり、市場の拡大にプラスの影響を与えると予想されます。2024年9月、PHC Holdings Corporationのバイオメディカル部門は、国際細胞・遺伝子治療学会（ISCT）の2024年欧州地域会議で、同社の新しい細胞増殖システムであるLiCellGrowのプロトタイプを発表しました。この細胞増殖システムは、製薬会社が細胞の代謝変化をモニターし、培養条件を調整して増殖を最適化できるように設計されました。

当レポートでは、日本の遺伝子治療市場について調査し、市場の概要とともに、タイプ別、ベクター別、遺伝子導入方法別、用途別、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 日本の遺伝子治療市場の見通し、2018年～2032年

• 市場規模の分析と予測
• 市場シェア分析と予測
• 市場マップ分析、2024年
  • タイプ別
  • ベクター別
  • 遺伝子導入方法別
  • 用途別
  • 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 輸出入の分析

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

第12章 市場の動向と発展

第13章 規制枠組みとイノベーション

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

• 市場リーダーの競合マトリックス
• 主要企業のためのSWOT分析
• 主要市場参入企業の情勢
  • Bristol-Myers Squibb Company
  • 2seventy bio, Inc.
  • Novartis AG
  • Gilead Sciences Inc. (Kite Pharma)
  • Spark Therapeutics, Inc.
  • Nipro Corporation
  • JCR Pharmaceuticals Co., Ltd.
  • Aurion Biotech
  • Johnson & Johnson Services, Inc.
  • Terumo BCT

第17章 戦略的提言

第18章 お問い合わせと免責事項

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. Japan Gene Therapy Market, By Value, In USD Million, FY2018-FY2032F
• Figure 2. Japan Gene Therapy Market, By Volume, In Thousand Therapies, FY2018-FY2032F
• Figure 3. Japan Gene Therapy Market Share (%), By Type, FY2018-FY2032F
• Figure 4. Japan Gene Therapy Market Share (%), By Vector, FY2018-FY2032F
• Figure 5. Japan Gene Therapy Market Share (%), By Gene Delivery Method, FY2018-FY2032F
• Figure 6. Japan Gene Therapy Market Share (%), By Application, FY2018-FY2032F
• Figure 7. Japan Gene Therapy Market Share (%), By Route of Administration, FY2018-FY2032F
• Figure 8. Japan Gene Therapy Market Share (%), By End-user, FY2018-FY2032F
• Figure 9. Japan Gene Therapy Market Share (%), By Region, FY2018-FY2032F
• Figure 10. By Type Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 11. By Vector Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 12. By Gene Delivery Method Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 13. By Application Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 14. By Route of Administration Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 15. By End-user Map-Market Size (USD Million) & Growth Rate (%), FY2024
• Figure 16. By Region Map-Market Size (USD Million) & Growth Rate (%), FY2024

Japan gene therapy market is projected to witness a CAGR of 22.79% during the forecast period FY2025-FY2032, growing from USD 419.41 million in FY2024 to USD 2,151.79 million in FY2032. The market's growth is bolstered by the rising cases of genetic and chronic diseases, increasing collaborations among small biotech companies and manufacturers, rising investments to support research activities, increasing shift towards personalized medicine, and the introduction of supportive measures by the government.

Over the past decade, the country has overhauled various regulations governing gene therapies to facilitate more effective and faster research and development. The country has updated its legislation to create fast-track routes for companies to receive regulatory approval for new cell and gene therapies. The Pharmaceutical and Medical Devices Act allows the sale of new products in the country after the clinical trials have proved their safety and potential to benefit patients, after which the company has up to seven years to conduct more trials to confirm the claimed benefits and receive full regulatory approvals.

Furthermore, the rising efforts of different biomedical organizations are expected to bolster the availability of novel technologies in Japan to augment the manufacturing of cell and gene therapies, positively influencing the market's expansion. In September 2024, the biomedical division of PHC Holdings Corporation presented a prototype of LiCellGrow, their new cell expansion system, at the 2024 European Regional Conference of the International Society for Cell & Gene Therapy (ISCT). The cell expansion system was designed to allow pharma companies to monitor cellular metabolic changes and adjust cultural conditions to optimize their growth.

Increasing Investments to Support Market Expansion

The rising investments in pharmaceutical and biotech companies to bolster the development of gene therapies are positively influencing the market's expansion. Biotech and pharma companies are engaging in collaborating and partnering to validate potential gene therapies for various genetic diseases. For instance, in October 2022, Astellas Pharma Inc. invested USD 50 million in Taysha Gene Therapies, Inc. to advance their pipeline of novel therapies that target rare diseases. As part of the deal, Astellas took a 15% stake in Taysha Gene Therapies, Inc. and an exclusive option to license their therapy development program for genetic diseases that affect the central nervous system. Such investments and collaborations are expected to bolster the growth of Japan gene therapy market by accelerating the development of novel therapies with the help of infrastructure expansion, knowledge sharing, and focus on research activities.

Rising Collaborations to Bolster Market Growth

The growing emphasis on collaborations and partnerships to accelerate innovations in gene therapy and bolster the availability of different therapies by improving manufacturing capabilities augments the growth of Japan gene therapy market. Joint ventures between small biotech companies and large manufacturers allow the former to meet the rising demand for gene therapies and focus their efforts on product innovation and research activities. In December 2023, Synplogen Co., Ltd. and Ginkgo Bioworks, Inc. entered a Memorandum of Understanding (MoU) to enhance gene therapy platform services in the Japanese market and advance global DNA manufacturing. The companies are working together to extend Ginkgo's gene therapy services in the country with the help of Synplogen's marketing support and business development efforts. Such efforts and collaborations are expected to bolster the development of novel technologies and the advancement of the country's biotech sector.

Additionally, increasing partnerships between international biotech companies and Japanese research and development-oriented pharmaceutical organizations are bolstering the availability of gene therapies in the country, providing lucrative growth opportunities to the market. In February 2023, Nippon Shinyaku Co., Ltd. and Capricor Therapeutics, Inc. entered into a collaboration for exclusive distribution and commercialization of Capricor's CAP-1002 for treating duchenne muscular dystrophy in Japan. Under the partnership, Capricor received USD 12 million upfront from Nippon, and the former intends to carry out clinical development in Japan.

Oncological Diseases to Hold Major Market Share

The increasing burden of oncological diseases is one of the major factors bolstering the growth of the Japan gene therapy market. As per the estimates of the National Cancer Center of Japan, 1,019,000 new cases of cancer and 380,400 deaths related to cancer occurred in Japan in 2022. The major objective of gene therapy is to manage genetic diseases by administering foreign genomic material in the host tissue to modify the expression of the gene product or alter the biological properties of the cells for therapeutic applications. Over the past three decades, gene therapy for cancer treatment has shown significant progression and has shown better safety and tolerable adverse effects as compared to chemotherapy. In the coming years, assessment of host humoral and cellular immunity and tumor genomic analysis will facilitate the selection of appropriate patients for gene therapy. Additionally, gene therapies, with advanced biotechnologies and safe vectors, are expected to play a greater role in the management and prophylaxis of cancer in the near future by ensuring the provision of individualized cancer treatments.

Hospitals to Account for the Most Significant Market Share

The increasing investments by the government towards the development of the healthcare sector and rising efforts by hospitals to bolster the availability of novel and advanced therapeutic solutions, including gene therapies for patients, are bolstering the segment's expansion. Vectors are given intravenously or injected directly into the specific tissue in the body and are taken up by individual cells. Meanwhile, the patient's cell sample is removed and exposed to the vector, which is then administered to the patient. This complex process requires advanced equipment and qualified professionals to ensure the successful and safe completion of the therapy. Such resources and infrastructure are often available only at hospitals, thus propelling the segment's expansion.

Future Market Scenario (FY2025 - FY2032F)

Japan gene therapy market is expected to grow owing to the rising prevalence of chronic and genetic diseases in the country. The increasing shift towards personalized medicine is expected to provide lucrative growth opportunities to the market in the coming years. Advancements in genomic sequencing can aid in tailoring therapies to the generic profiles of the patients, resulting in the availability of targeted and more effective treatment solutions. Personalized medicines are expected to improve patient satisfaction and adherence, propelling the Japan gene therapy market demand for addressing various genetic mutations. The influx of capital for facilitating research and development activities, commercialization, and manufacturing efforts is expected to allow the exploration and development of novel therapies in the country. Furthermore, the government's growing efforts to ensure the availability of gene therapies in the country are expected to strengthen the market position of the market.

Key Players Landscape and Outlook

The rising collaborations between leading healthcare and biotech companies across the globe and Japanese startups to advance gene therapy and bolster their availability in the country are expected to support the market's expansion. In July 2024, Merck & Co., Inc. signed a MoU with a Japanese-clinical stage biotech startup, Gene Therapy Research Institution (GTRI) to accelerate the development of viral vector-based gene therapy for Parkinson's disease. The startup plans to utilize Merck's SF-RVN Insect Cell Line platform to produce their viral vector-based therapies. Merck plans to support GTRI with its broad portfolio of products and services and equip the latter with tools to bolster the manufacturing and development process of gene therapies. Merck will support GTRI in building a robust adeno-associated virus (AAV) production platform for scaling up production and will include the use of their platform technologies for developing viral-vector-based gene therapies.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Japan Gene Therapy Market Outlook, FY2018-FY2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Type
    • 4.2.1.1. Gene Augmentation
    • 4.2.1.2. Gene Silencing
    • 4.2.1.3. Others
  • 4.2.2. By Vector
    • 4.2.2.1. Viral Vectors
    • 4.2.2.2. Non-Viral Vectors
  • 4.2.3. By Gene Delivery Method
    • 4.2.3.1. In vivo
    • 4.2.3.2. Ex vivo
  • 4.2.4. By Application
    • 4.2.4.1. Oncological Diseases
    • 4.2.4.2. Genetic Diseases
    • 4.2.4.3. Cardiovascular Diseases
    • 4.2.4.4. Neuromuscular Diseases
    • 4.2.4.5. Hematological Diseases
    • 4.2.4.6. Infectious Diseases
    • 4.2.4.7. Others
  • 4.2.5. By Route of Administration
    • 4.2.5.1. Intravenous
    • 4.2.5.2. Others
  • 4.2.6. By End-user
    • 4.2.6.1. Hospitals
    • 4.2.6.2. Cancer and Research Institutes
    • 4.2.6.3. Clinics
    • 4.2.6.4. Others
  • 4.2.7. By Region
    • 4.2.7.1. North [Hokkaido and Tohoku]
    • 4.2.7.2. Central [Kanto and Chubu]
    • 4.2.7.3. South [Kansai, Chugoku, Shikoku, Kyushu, Okinawa]
  • 4.2.8. By Company Market Share Analysis (Top Companies and Others - By Value, FY2024)
• 4.3. Market Map Analysis, FY2024
  • 4.3.1. By Type
  • 4.3.2. By Vector
  • 4.3.3. By Gene Delivery Method
  • 4.3.4. By Application
  • 4.3.5. By Route of Administration
  • 4.3.6. By End-user
  • 4.3.7. By Region

5. Demand Supply Analysis

6. Import and Export 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. Clinical Trials
• 13.2. Regulatory Approvals

14. Patent Landscape

15. Case Studies

16. Competitive Landscape

• 16.1. Competition Matrix of Top Market Leaders
• 16.2. SWOT Analysis for Top Players
• 16.3. Key Players Landscape for Top Market Players
  • 16.3.1. Bristol-Myers Squibb Company
    • 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. 2seventy bio, Inc.
  • 16.3.3. Novartis AG
  • 16.3.4. Gilead Sciences Inc. (Kite Pharma)
  • 16.3.5. Spark Therapeutics, Inc.
  • 16.3.6. Nipro Corporation
  • 16.3.7. JCR Pharmaceuticals Co., Ltd.
  • 16.3.8. Aurion Biotech
  • 16.3.9. Johnson & Johnson Services, Inc.
  • 16.3.10. Terumo BCT

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