日本基因治疗市场：依类型、载体、基因转殖方法、应用、给药途径、最终使用者、地区、机会、预测，2018-2032

根据预测，2025-2032年预测期内，日本基因治疗市场规模将以22.79%的复合年增长率扩大，从2024年的4.1941亿美元成长到2032年的21.5179亿美元。市场成长的推动因素包括遗传疾病和慢性病患者数量的增加、小型生物技术公司和製造商之间的合作增加、支持研究活动的投资增加以及个性化医疗，其中包括患有遗传病和慢性病的人数的增加。

在过去的十年里，国家彻底修改了各种基因治疗法规，以促进更有效、更快速的研究和开发。该国更新了法律，为公司创造一条更快的途径获得新细胞和基因疗法的监管批准。 《药品和医疗器材法》允许新产品在临床试验证明其安全性和造福患者的潜力后在该国销售。

此外，随着各个生物医学组织的不断努力，用于增强日本细胞和基因治疗製造的新技术的可用性将会增加，预计将对市场扩张产生积极影响。 2024年9月，PHC控股公司生物医学部门在国际细胞与基因治疗学会（ISCT）2024年欧洲区域会议上展示了其新型细胞生长系统LiCellGrow的原型。此细胞生长系统的设计目的是让製药公司能够监测细胞的代谢变化并调整培养条件以优化生长。

本报告调查了日本基因治疗市场，并提供了市场概况，以及按类型、载体、基因转移方法、应用、给药途径、最终用户、地区和市场趋势划分的趋势。

目录

第1章专案范围与定义

第2章研究方法

第 3 章执行摘要

第 4 章日本基因治疗市场展望，2018-2032

• 市场规模分析与预测
• 市占率分析与预测
• 2024 年市场地图分析
  • 依类型
  • 按向量
  • 透过基因导入方法
  • 依用途
  • 依给药途径
  • 按最终用户
  • 按地区

第5章供需分析

第6章导入汇出分析

第7章价值链分析

第 8 章波特五力分析

第9章PESTLE分析

第10章价格分析

第 11 章市场动态

第12章市场趋势与发展

第 13 章监理架构与创新

第14章专利状况

第 15 章个案研究

第16章竞争态势

• 市场领导者的竞争矩阵
• 主要公司的 SWOT 分析
• 主要市场参与者状况
  • 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 章策略建议

第18章查询及免责声明

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

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