Japan Gene Therapy Market Assessment, By Type [Gene Augmentation, Gene Silencing, Others], By Vector [Viral Vectors, Non-Viral Vectors], By Gene Delivery Method [In vivo, Ex vivo], By Application [Oncological Diseases, Genetic Diseases, Cardiovascular Diseases, Neuromuscular Diseases, Hematological Diseases, Infectious Diseases, Others], By Route of Administration [Intravenous, Others], By End-user [Hospitals, Cancer and Research Institutes, Clinics, Others], By Region, Opportunities and Forecast, FY2018-FY2032F

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.

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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.

Report Scope

“Japan Gene Therapy Market Assessment, Opportunities and Forecast, FY2018-FY2032F”, is a comprehensive report by Markets and Data, providing in-depth analysis and qualitative and quantitative assessment of the current state of Japan gene therapy market, industry dynamics, and challenges. The report includes market size, segmental shares, growth trends, opportunities, and forecast between FY2025 and FY2032. Additionally, the report profiles the leading players in the industry, mentioning their respective market share, business models, competitive intelligence, etc.

Report Attribute	Details
Base Year of the Analysis	FY2024
Historical Period	FY2018-FY2023
Forecast Period	FY2025-FY2032
Projected Growth Rate	CAGR of 22.79% between FY2025 and FY2032
Revenue Forecast in FY2032	USD 2,151.79 million
Segments Covered	Type, Vector, Gene Delivery Method, Application, Route of Administration, End-user
Regions Covered	North, Central, South
Key Companies Profile	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
Customization Scope	15% free report customization with purchase
Pricing and Purchase Options	Avail the customized purchase options to fulfill your precise research needs
Delivery Format	PDF and Excel through email (subject to the license purchased)

In the report, Japan gene therapy market has been segmented into the following categories: 

• By Type
  • Gene Augmentation
  • Gene Silencing
  • Others
• By Vector
  • Viral Vectors
  • Non-Viral Vectors
• By Gene Delivery Method
  • In vivo
  • Ex vivo
• By Application
  • Oncological Diseases
  • Genetic Diseases
  • Cardiovascular Diseases
  • Neuromuscular Diseases
  • Hematological Diseases
  • Infectious Diseases
  • Others
• By Route of Administration
  • Intravenous
  • Others
• By End-user
  • Hospitals
  • Cancer and Research Institutes
  • Clinics
  • Others
• By Region
  • North [Hokkaido and Tohoku]
  • Central [Kanto and Chubu]
  • South [Kansai, Chugoku, Shikoku, Kyushu, Okinawa]

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.

Key Players Operating in Japan Gene Therapy Market are:

• 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

Markets and Data report answers the following questions:

• What is the current and future market size of the product/service in question globally or specific to different countries?
• How are the markets divided into different product/service segments and the market size and growth of each segment?
• What is the market potential of different product segments and their investment case?
• How are the markets predicted to develop in the future and what factors will drive or inhibit growth?
• What is the business environment and regulatory landscape specific to the product/service?

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