Japan Cell and Gene Therapy Market

Japan Cell and Gene Therapy Market Size and Share:

The Japan cell and gene therapy market size was valued at USD 727 Million in 2024. Looking forward, IMARC Group estimates the market to reach USD 2,016 Million by 2033, exhibiting a CAGR of 12% from 2025-2033. The market in Japan is driven by advancements in biotechnology, a growing focus on personalized medicine, and increased government support for regenerative therapies. The widespread adoption of novel cell and gene therapies is further accelerated by an aging population, the increasing frequency of hereditary and chronic diseases, and significant investments in research and development (R&D).

Notable scientific breakthroughs in biotechnology and a growing emphasis on customized care are pushing the market for cell and gene therapy in Japan. Advanced technologies, including CRISPR and CAR-T therapy, allow for precise genetic alterations and novel treatments for diseases that were thought to be incurable in the past. For instance, in December 2023, Bristol-Myers Squibb K.K. announced that it has received manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma® (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy. This is particularly for patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The nation's proactive regulatory structure promotes innovation and speeds up the commercialization of products, particularly the Act on the Safety of Regenerative Medicine's (ASRM) accelerated approval process for regenerative medicine. Furthermore, government assistance in the form of grants and collaborations with research institutions advances the development of gene and cell therapies, establishing Japan as a world leader in regenerative medicine.

In Japan, the demand for cell and gene therapies is further fueled by the aging population and the increasing incidence of hereditary and chronic illnesses. Patients are seeking cutting-edge treatment alternatives that have the potential to be curative due to the rising prevalence of diseases including cancer, heart disease, and uncommon genetic abnormalities. Both domestic and foreign pharmaceutical companies make significant investments in R&D, which supports a strong pipeline of cutting-edge treatments. For instance, in March 2024, The CiRA Foundation, a public interest group for the transfer of induced pluripotent stem (iPS) cells to industry, and Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, announced a collaboration aimed at advancing the widespread use of iPS cells for a variety of novel treatments. With the help of Terumo BCT's enabling technologies and cell therapy manufacturing expertise, as well as CiRA Foundation's leading iPS cell knowledge, the companies aim to create an automated and clinically relevant workflow for iPS cell-derived therapies, which could be a game-changer for the field of cell and gene therapy (CGT). Furthermore, industry-academia partnerships are essential for accelerating clinical studies and ensuring the availability of innovative therapies, which propels the expansion of the cell and gene therapy market in Japan.

Japan Cell and Gene Therapy Market Trends:

Significant Advancements in Biotechnology

Advanced technologies such as gene editing, CRISPR, and CAR-T propel the creation of targeted, novel treatments. These developments established Japan as a leader in cell and gene therapy and allowed for the efficient treatment of chronic and hereditary illnesses. For instance, in December 2023, the synthetic biology startup, Synplogen Co., which is also a part of Kobe University's Graduate School of Science, Technology, and Innovation that provides custom DNA synthesis and Gene Therapy Biofoundry services, and Ginkgo Bioworks, and is currently engaged in building the leading platform for cell programming and biosecurity, announced that they had signed a non-binding Memorandum of Understanding (MOU). Synplogen and Ginkgo aim to work collaboratively to expedite the global development of gene therapy platform services and DNA production in Japan.

Rising Prevalence of Chronic and Genetic Diseases

High incidences of cancer, cardiovascular disorders, and rare genetic conditions in Japan create a strong demand for curative therapies. Cell and gene therapies address unmet medical needs, offering transformative options for patients with limited traditional treatments. For instance, in September 2024, Biomedical Division, a part of PHC Corporation, announced the commercial launch of a live cell metabolic analyzer, LiCellMo, that allows researchers to visualize metabolic changes in cell cultures, thus granting a more complete picture of cell activity for research uses in cell and gene therapies (CGT). LiCellMo utilizes PHC’s proprietary high-precision In-Line monitoring technology, which assists endless measurement of cellular metabolites in a culture medium without requiring any interruption of the experiment for sampling.

Government and Industry Investments

Substantial government funding, academic collaborations, and industry partnerships drive research and development. These efforts expand the therapeutic pipeline, advance clinical trials, and ensure the availability of innovative treatments, boosting Japan’s position in the global regenerative medicine market. For instance, in January 2024, the Development Bank of Japan Inc. (DBJ) announced an investment agreement with the biotech venture fund, 4BIO Ventures III LP, managed by 4BIO Partners LLP. This endeavor focuses primarily on early-stage biotech ventures that utilize innovative modalities to explain treatments resulting in solutions for unmet medical needs. Headquartered in London and with a global network spanning regions, including North America, Europe, Japan, and other parts of Asia, the firm was founded in 2014 and has since been instrumental in investing in biotech ventures developing novel drug discovery modalities involving cell and gene therapy, RNA-based medicine, targeted therapies, and the microbiome.

Japan Cell and Gene Therapy Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the Japan cell and gene therapy market, along with forecasts at the country and regional levels from 2025-2033. The market has been categorized based on therapy type, indication, delivery mode, and end user.

Analysis by Therapy Type:

• Cell Therapy 
  • Stem Cell
  • Non-Stem Cell
• Gene Therapy

Cell therapy holds a significant share due to its ability to treat various conditions, including cancer, autoimmune disorders, and degenerative diseases. Regenerative treatments including stem cell and CAR-T therapy are in high demand in Japan due to the country's aging population and increased chronic illness prevalence. The nation's robust research infrastructure and supportive regulatory environment, including the Act on the Safety of Regenerative Medicine's accelerated approvals, further promote the development and adoption of cell therapies and solidify their market leadership.

Gene therapy leads due to its potential to provide long-lasting or curative solutions for genetic and rare diseases. Advances in gene-editing technologies like CRISPR and the increasing prevalence of inherited disorders in Japan drive adoption. Market penetration is increased by government support for novel therapies and expanding clinical trial activity. With significant investment in R&D, gene therapy is broadening its therapeutic use, guaranteeing its leading position in the Japanese market for regenerative medicine.

Analysis by Indication:

• Cardiovascular Disease
• Oncology Disorder
• Genetic Disorder
• Infectious Disease
• Neurological Disorder
• Others

Cardiovascular diseases hold a large share due to their high prevalence in Japan’s aging population. Cell therapies, including stem cell treatments, provide regenerative solutions to fix damaged heart tissue and enhance the prognosis of long-term cardiac disorders. The need for novel and effective treatments is rising as cardiovascular diseases are one of the main causes of death. The use of cell and gene treatments for cardiovascular diseases is also fueled by government financing for regenerative medicine and growing clinical research in this field.

Oncology disorders dominate due to the rising incidence of cancers in Japan, particularly among its elderly population. Advanced treatments for complicated cancers, such as CAR-T and gene-editing technologies, offer individualized, tailored care that increases survival rates. Japan promotes innovation in oncology-focused cell and gene treatments through its strong regulatory environment and quick approvals. Increased R&D spending and partnerships between biotech companies and academic institutions also improve the accessibility and uptake of these innovative cancer medicines.

Genetic disorders hold a significant share due to the potential of gene therapies to address the root cause of inherited diseases. Treatments like CRISPR and other gene-editing technologies provide therapeutic treatments as rare and hereditary illnesses are being diagnosed in Japan. Government programs that fund genetic disease research and the expanding gene therapy pipeline fuel their commercial expansion. Enhanced diagnostic capabilities and targeted treatment approaches ensure gene therapy’s prominence in treating genetic disorders in Japan.

Analysis by Delivery Mode:

• In-Vivo
• Ex-Vivo

In-vivo gene therapies dominate due to their ability to deliver genetic material directly into patients’ cells, offering precise and effective treatments for conditions like genetic disorders, cancer, and rare diseases. Advances in viral and non-viral delivery systems, such as adeno-associated viruses (AAVs), enhance therapy efficiency and safety. Japan's supportive regulatory framework and increasing clinical trials focused on in-vivo therapies further drive adoption. The potential for long-term or curative outcomes solidifies their leading role in the market.

Ex-vivo therapies hold a significant share as they allow genetic modifications of cells outside the body before reintroducing them to patients, offering high precision and controlled therapeutic effects. CAR-T therapies for cancer are a notable example, showcasing remarkable efficacy. Japan's expertise in regenerative medicine and growing R&D investments bolster advancements in ex-vivo approaches. With increasing demand for personalized treatments and robust infrastructure for cell processing, ex-vivo therapies continue to expand their applications and maintain strong market prominence.

Analysis by End User:

• Hospitals
• Cancer Care Centers
• Pharmaceutical and Biotechnology Companies
• Others

Hospitals dominate due to their role as primary care providers for cell and gene therapy administration, particularly for complex treatments like CAR-T and stem cell therapies. Equipped with advanced infrastructure, hospitals handle the intricate processes involved in these therapies. Japan’s aging population and rising prevalence of chronic diseases drive the demand for hospital-based therapies. Collaborations with pharmaceutical companies for clinical trials and therapy delivery further enhance their share in the market.

Cancer care centers hold a significant share due to the rising cancer burden in Japan. Specialized centers are ideal for administering advanced therapies like CAR-T, which require expert handling and monitoring. These centers’ focus on oncology treatments makes them pivotal in delivering personalized and innovative solutions. Strong partnerships with biotech firms for clinical trials and therapy deployment ensure that cancer care centers remain critical hubs for cell and gene therapy adoption in oncology.

Pharmaceutical and biotechnology companies lead in developing and commercializing cell and gene therapies. Their strong R&D capabilities, access to funding, and expertise in advancing innovative treatments drive the market. In Japan, these companies actively collaborate with hospitals and research institutions to expand clinical trials and regulatory approvals. Their role in manufacturing, distribution, and advancing technologies ensures their dominance in the cell and gene therapy market, catering to the growing demand for cutting-edge treatments.

Regional Analysis:

• Kanto Region
• Kansai/Kinki Region
• Central/ Chubu Region
• Kyushu-Okinawa Region
• Tohoku Region
• Chugoku Region
• Hokkaido Region
• Shikoku Region

The Kanto region, including Tokyo, drives the market with its advanced healthcare infrastructure, leading research institutions, and biotechnology hubs. The region attracts significant investment for clinical trials and the development of cell and gene therapies. With a high population density and demand for cutting-edge treatments, Kanto remains central to market growth.

Kansai, home to Osaka and Kyoto, is a biotech and pharmaceutical hub. Renowned universities and research institutes in the region foster innovation in regenerative medicine. The region’s strong focus on oncology and genetic disorder treatments supports its leadership in developing and implementing cell and gene therapies.

Chubu, which is well-known for its advanced manufacturing skills, provides research and production facilities to support the industry for cell and gene therapy. Major cities like Nagoya are making investments in biotechnology developments, which are improving product development and clinical research. The region's emphasis on innovation guarantees a rising role in the adoption of therapies.

Kyushu-Okinawa benefits from government support for regional healthcare advancements. With increasing research on regenerative medicine and specialized facilities for chronic disease treatment, this region is becoming a growing hub for cell and gene therapy development, particularly for addressing aging-related conditions.

Tohoku has a strong emphasis on regenerative medicine research, which is financed by the government and university partnerships. The region's emphasis on cutting-edge medical treatments, particularly for uncommon illnesses, helps explain why cell and gene therapies are becoming more and more popular in both urban and rural areas.

Chugoku is investing funds on cell and gene therapy research and development with an eye on expanding access to cutting-edge medicines. Growth is fueled by cooperation between regional organizations and biotech companies, especially in the treatment of cancer and cardiovascular illness.

Hokkaido emphasizes research and clinical trials, using its academic institutions to promote gene treatments for hereditary and rare disorders. The region's adoption of cutting-edge treatments is supported by local investments and growing healthcare awareness.

Shikoku is developing its medical system to facilitate the use of gene and cell therapies. The region is concentrating on providing its people with cutting-edge treatments for hereditary and chronic illnesses because of expanding partnerships between research institutes and biotech companies.

Competitive Landscape:

The Japan cell and gene therapy market is competitive, with leading players including Takeda Pharmaceutical, Astellas Pharma, and Fujifilm Cellular Dynamics, alongside global firms like Novartis, Bristol-Myers Squibb, and Gilead Sciences. These companies emphasize creating cutting-edge treatments for regenerative medicine, rare disorders, and cancer. Research institutes, businesses, and academia work together to drive innovation, which is aided by Japan's advantageous regulatory environment. While foreign businesses form alliances to increase their footprint, domestic businesses take advantage of local expertise and government assistance. The growing pipeline of therapies and rising clinical trial activity further intensify competition in this rapidly evolving market. For instance, in October 2024, Teijin Limited announced the signing of a Memorandum of Understanding to develop a strategic international commercial cooperation with Singapore-based biotechnology company Hilleman Laboratories. The purpose of this collaboration is to encourage the growth of the cell and gene therapy industry's contract development and manufacturing organization (CDMO) business.

Latest News and Developments:

• In September 2024, a partnership agreement was finalized between AGC, the parent company of AGC Biologics and MEDINET, in the cell therapy CDMO business. As a part of this partnership, AGC intends to send talents to MEDINET to develop knowledge of this business in Japan by supporting MEDINET's operations, which has extensive experience in associating with Japan-based start-ups and academia, and to prepare for the launch of cell therapy CDMO services in Japan at the AGC Biologics’ Yokohama site, scheduled for 2026 (Part of the service will begin in 2025).
• In July 2024, The National Cancer Center (Tokyo, Japan) and The University of Pennsylvania (Philadelphia, PA, USA) licensed patent rights directed to a chimeric antigen receptor T cell therapy that targets the chemokine receptor CCR4 (CCR4 CAR-T cell therapy) to ARC Therapies Inc., a startup originating from the National Cancer Center. This agreement marks the commencement of ARC Therapies, Inc.’s research and development of a cell therapy targeting T-cell cancers, including adult T-cell leukemia/lymphoma (ATLL)＊3, which is prevalent in Japan. Furthermore, the potential application of CCR4 CAR-T cell therapy to solid cancers will also be pursued.

Japan Cell and Gene Therapy Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the Japan cell and gene therapy market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the Japan cell and gene therapy market.
• Porter's Five Forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the Japan cell and gene therapy industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.