일본의 유전자 치료 시장 규모는 2025-2032년의 예측 기간 중 22.79%의 CAGR로 확대하며, 2024년 4억 1,941만 달러에서 2032년에는 21억 5,179만 달러로 성장할 것으로 예측됩니다. 유전성 질환 및 만성질환 환자 수 증가, 소규모 바이오 기업 및 제조업체간의 제휴 증가, 연구 활동 지원을 위한 투자 증가, 맞춤형 의료로의 전환 증가, 정부 지원 정책 도입 등이 시장 성장을 촉진하고 있습니다.
지난 10년간 중국은 보다 효과적이고 신속한 연구개발을 촉진하기 위해 유전자 치료와 관련된 각종 규제를 전면적으로 재검토했습니다. 중국은 기업이 새로운 세포치료제 및 유전자 치료제에 대한 약사 승인을 받을 수 있는 신속한 경로를 구축하기 위해 법률을 개정했습니다. 의약품의료기기법은 임상시험을 통해 안전성과 환자들에게 혜택을 줄 수 있는 가능성이 입증된 후 국내 판매를 허용하고 있습니다.
또한 다양한 생물 의학 단체의 노력이 활발해짐에 따라 일본에서는 세포 및 유전자 치료제 제조를 강화하기 위한 새로운 기술의 가용성이 높아져 시장 확대에 긍정적인 영향을 미칠 것으로 예상됩니다.2024년 9월, PHC Holdings Corporation의 바이오메디컬 부문은 2024년 국제세포-유전자치료학회(ISCT) 유럽지역 회의에서 새로운 세포증식 시스템인 LiCellGrow의 프로토타입을 발표했습니다. 이 세포 증식 시스템은 제약회사가 세포의 대사 변화를 모니터링하고 배양 조건을 조정하여 증식을 최적화할 수 있도록 설계되었습니다.
일본의 유전자 치료 시장에 대해 조사했으며, 시장의 개요와 유형별, 벡터별, 유전자 도입 방법별, 용도별, 투여 경로별, 최종사용자별, 지역별 동향 및 시장에 참여하는 기업의 개요 등을 제공하고 있습니다.
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.
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.