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Japan Cell and Gene Therapy Manufacturing Market Forecast to 2035 | Market to Reach USD 5.15 Billion at 29.0% CAGR as Commercial-Scale Capacity and Gene Therapies Expand

globenewswire.com
TMO Thermo Fisher Scientific is mentioned as a participant in the Japan cell and gene therapy manufacturing market, indicating its involvement in this growing sector. The article does not provide specific sentiment towards the company's performance or outlook. CAT Catalent is listed as a participant in the Japan cell and gene therapy manufacturing market. The article does not offer specific details on Catalent's performance or future prospects within this market. CRL Charles River Laboratories is identified as a company active in the Japan cell and gene therapy manufacturing market. The article does not provide specific sentiment or performance indicators for the company. AMGN While not explicitly mentioned by ticker, Amgen is a major player in CAR-T therapies, which are a key focus of the Japan cell and gene therapy market discussed in the article. The article highlights growth in CAR-T, suggesting potential relevance. BMY While not explicitly mentioned by ticker, Bristol Myers Squibb is a major player in CAR-T therapies, which are a key focus of the Japan cell and gene therapy market discussed in the article. The article highlights growth in CAR-T, suggesting potential relevance. GILD While not explicitly mentioned by ticker, Gilead Sciences is a major player in CAR-T therapies, which are a key focus of the Japan cell and gene therapy market discussed in the article. The article highlights growth in CAR-T, suggesting potential relevance. AZN While not explicitly mentioned by ticker, AstraZeneca is involved in cell and gene therapy research and development, a key focus of the Japan market discussed. The article's focus on market expansion suggests potential opportunities for such companies. NVS While not explicitly mentioned by ticker, Novartis is a major player in CAR-T therapies, which are a key focus of the Japan cell and gene therapy market discussed in the article. The article highlights growth in CAR-T, suggesting potential relevance. MRK While not explicitly mentioned by ticker, Merck & Co. is involved in cell and gene therapy research and development, a key focus of the Japan market discussed. The article's focus on market expansion suggests potential opportunities for such companies. JNJ While not explicitly mentioned by ticker, Johnson & Johnson is involved in cell and gene therapy research and development, a key focus of the Japan market discussed. The article's focus on market expansion suggests potential opportunities for such companies. LLY While not explicitly mentioned by ticker, Eli Lilly and Company is involved in cell and gene therapy research and development, a key focus of the Japan market discussed. The article's focus on market expansion suggests potential opportunities for such companies. ABBV While not explicitly mentioned by ticker, AbbVie is involved in cell and gene therapy research and development, a key focus of the Japan market discussed. The article's focus on market expansion suggests potential opportunities for such companies.

Japan Cell and Gene Therapy Manufacturing Market Forecast to 2035 | Market to Reach USD 5.15 Billion at 29.0% CAGR as Commercial-Scale Capacity and Gene Therapies Expand Dublin, Oct. 06, 2026 (GLOBE NEWSWIRE) -- "Japan Cell and Gene Therapy Manufacturing Market: Industry Trends and Future Forecast, Till 2035 - Distribution by Type of Therapy, Type of Scale, Type of Mode, Type of Workflow, Type of Process, Type of Technology, End User and Leading Players" has been added to ResearchAndMarkets.com's offering.

The Japan cell and gene therapy market is projected to increase from USD 521 million in the current year to USD 5.15 billion by 2035, expanding at a CAGR of 29.0% during the forecast period. Market growth is supported by regulatory initiatives, biotechnology advancements, increasing R&D investment, and rising demand for treatments targeting cancer, rare genetic conditions, cardiovascular diseases, and degenerative disorders.

Japan Cell and Gene Therapy Manufacturing Market Growth and Trends

Japan has emerged as an important market for cell and gene therapy development and manufacturing. The country's regulatory framework supports accelerated pathways for innovative treatments, while its aging population is increasing demand for advanced therapeutic options. Government programs, private-sector investment, and collaboration among pharmaceutical companies, biotechnology developers, academic institutions, and contract manufacturing organizations are strengthening clinical translation and manufacturing capacity.

Technologies such as CRISPR, CAR-T therapies, and induced pluripotent stem cell platforms are advancing treatment development and supporting personalized medicine. Industry-academia partnerships are also improving iPS cell workflows, process development, analytical testing, and the progression of therapies from research to clinical and commercial production.

Market Growth Drivers

Advances in biotechnology are enabling more precise therapeutic development for diseases with limited treatment options. Japan's demographic profile is another major growth driver, with an aging population contributing to higher incidences of cancer, chronic conditions, and degenerative diseases. At the same time, government support for regenerative medicine, accelerated regulatory review, and expanding R&D expenditure are encouraging domestic and international companies to invest in the Japan cell and gene therapy manufacturing market.

Additional opportunities are emerging from stronger manufacturing partnerships, growing clinical pipelines, and increasing requirements for viral vectors, plasmid DNA, cell processing, quality testing, and fill & finish operations.

Key Market Challenges

Market expansion is constrained by high development and production costs, complex manufacturing workflows, and scalability limitations associated with autologous therapies. Reimbursement remains a significant consideration for high-price treatments within Japan's universal healthcare system. Manufacturers must also address shortages of specialized personnel, infrastructure requirements, stringent PMDA safety standards, and differences between domestic and international manufacturing and quality frameworks.

Cell Therapies Lead the Market

Cell therapies account for the largest share of the Japan cell and gene therapy manufacturing market, supported by growing development activity involving CAR-T cell therapy, stem cell therapy, and other cell-based approaches. Demand is particularly strong in oncology, where multiple programs are progressing through research and clinical evaluation.

Gene therapies are expected to record substantial growth during the forecast period. Continued research into gene mutations, inherited diseases, and targeted genetic treatments is expanding the development pipeline and increasing demand for specialized production capabilities.

Pre-commercial / R&D Scale Manufacturing Holds the Largest Share

Pre-commercial / R&D scale manufacturing currently represents almost 70% of the market. This position reflects the expanding pipeline of cell and gene therapy candidates and sustained investment in process development, clinical manufacturing, and scale-up preparation.

Commercial scale manufacturing is anticipated to expand at the highest CAGR as more products advance toward regulatory approval and market availability. Growth in viral vector and plasmid DNA production is also expected to increase demand for commercial manufacturing infrastructure and external production partnerships.

Japan Cell and Gene Therapy Manufacturing Market Segmentation

Companies Active in the Market

Selected participants in the Japan cell and gene therapy market include AGC, Astellas Pharma, Catalent, Charles River Laboratories, Cytiva, Fujifilm Cellular Dynamics, OmniAb, Rentschler Biopharma, Takeda Pharmaceutical, Thermo Fisher Scientific, and Wuxi AppTec.

Report Coverage

The report evaluates the current and projected Japan cell and gene therapy market size, competitive landscape, manufacturing ecosystem, segment-level revenue opportunities, growth drivers, regulatory considerations, and operational challenges. It examines how market opportunities are distributed by therapy, manufacturing scale, operating mode, workflow, process, technology, and end user.

The analysis helps established companies and new market entrants assess customer demand, identify investment opportunities, evaluate competitive positioning, and develop evidence-based business strategies. It also provides insight into leading manufacturers, emerging trends, market barriers, commercialization prospects, and factors expected to influence market development through 2035.

A selection of companies mentioned in this report includes, but is not limited to:

For more information about this report visit https://www.researchandmarkets.com/r/ncjbb6

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