日本基因治療市場：依類型、載體、基因轉殖方法、應用、給藥途徑、最終使用者、地區、機會、預測，2018-2032

根據預測，2025-2032年預測期內，日本基因治療市場規模將以22.79%的複合年增長率擴大，從2024年的4.1941億美元成長到2032年的21.5179億美元。市場成長的推動因素包括遺傳疾病和慢性病患者數量的增加、小型生物技術公司和製造商之間的合作增加、支持研究活動的投資增加以及個性化醫療，其中包括患有遺傳病和慢性病的人數的增加。

在過去的十年裡，國家徹底修改了各種基因治療法規，以促進更有效、更快速的研究和開發。該國更新了法律，為公司創造一條更快的途徑獲得新細胞和基因療法的監管批准。 《藥品和醫療器材法》允許新產品在臨床試驗證明其安全性和造福患者的潛力後在該國銷售。

此外，隨著各個生物醫學組織的不斷努力，用於增強日本細胞和基因治療製造的新技術的可用性將會增加，預計將對市場擴張產生積極影響。 2024年9月，PHC控股公司生物醫學部門在國際細胞與基因治療學會（ISCT）2024年歐洲區域會議上展示了其新型細胞生長系統LiCellGrow的原型。此細胞生長系統的設計目的是讓製藥公司能夠監測細胞的代謝變化並調整培養條件以優化生長。

本報告調查了日本基因治療市場，並提供了市場概況，以及按類型、載體、基因轉移方法、應用、給藥途徑、最終用戶、地區和市場趨勢劃分的趨勢。

目錄

第1章專案範圍與定義

第2章研究方法

第 3 章執行摘要

第 4 章日本基因治療市場展望，2018-2032

• 市場規模分析與預測
• 市佔率分析與預測
• 2024 年市場地圖分析
  • 依類型
  • 按向量
  • 透過基因導入方法
  • 依用途
  • 依給藥途徑
  • 按最終用戶
  • 按地區

第5章供需分析

第6章導入匯出分析

第7章價值鏈分析

第 8 章波特五力分析

第9章PESTLE分析

第10章價格分析

第 11 章市場動態

第12章市場趨勢與發展

第 13 章監理架構與創新

第14章專利狀況

第 15 章個案研究

第16章競爭態勢

• 市場領導者的競爭矩陣
• 主要公司的 SWOT 分析
• 主要市場參與者狀況
  • 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 章策略建議

第18章查詢及免責聲明

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