Cell and Gene Therapy Market is expected to reach US$ 25.78 billion by 2031

Cell Therapy Segment Drives Cell and Gene Therapy Market Growth

According to our new research study named "Cell and Gene Therapy Market Forecast to 2031 – Global Analysis – by Type, Service, Scale, Service Providers, Transfection Reagents, End User, and Geography," the market was valued at US$ 5.30 billion in 2024 and is projected to reach US$ 25.78 billion by 2031; it is expected to register a CAGR of 25.5% during 2025–2031. The increasing prevalence of chronic and genetic diseases, the rapid popularity of outsourcing cell and gene therapy manufacturing, and surging regulatory approvals and commercialization drive the adoption of cell and gene therapy. The development of next-generation gene editing tools is projected to bring new cell and gene therapy market trends in the coming years.

Cell and gene therapy modifies or replaces cells or genes to treat cancers, genetic disorders, diseases, and rare inherited conditions. The rising prevalence of genetic diseases, oncology demand, and technological advances are driving the global cell and gene therapy market growth. Additionally, regulatory approvals, investment growth, personalized medicine adoption, improved delivery systems, and expanding clinical pipelines worldwide are contributing to the rising cell and gene therapy market size.

Cell and Gene Therapy Market, by Region, 2024 (%)

Source: The Insight Partners Analysis

Cell and Gene Therapy Market Analysis Based on Segmental Evaluation:

Based on type, the cell and gene therapy market is bifurcated into cell therapy and gene therapy. The cell therapy segment held a significant cell and gene therapy market share in 2024. The segment is witnessing an upward trend due to its impressive clinical success, especially in oncology and regenerative medicine. CAR-T cell therapies have made most of the cancer cases that were once unreachable for treatment possible and have gained trust and support for their use through increased investments. Alongside the progress in cell engineering, there is the implementation of new manufacturing and automation technologies, which have brought about the reduction of costs and enhanced production capacity. Cases of cancer, autoimmune disorders, and degenerative diseases drive demand. The demand for cell-based therapies is being expedited by factors such as favorable regulations, a growing number of clinical trials, forming strategic partnerships, and receiving more funds from public and private investors.

The geographical scope of the cell and gene therapy market report encompasses an assessment of the market performance in North America, Europe, the Asia Pacific, South America, Central America, the Middle East, and Africa. North America dominated the cell and gene therapy market share in 2024. Research in genomics, vector engineering, and CRISPR-based gene editing has sped up the introduction of targeted and personalized treatments, which were once thought to be impossible for diseases to be treated. The FDA's RMAT, Fast Track, and Breakthrough Therapy designations have created a friendly atmosphere where the shortening of development timelines and investment encouragement go hand in hand, boosting the cell and gene therapy market growth.

North America's strong biotech and pharma scene, with its abundant venture capital and strategic partnerships, will help speed up clinical translation and commercialization. The increasing number of patients with genetic disorders and chronic diseases is driving the demand for innovative regenerative solutions, while the growing awareness and acceptance of personalized medicine are widening the patient pool.

Large academic medical centers and research institutions across the region make it possible to rapidly start and scale up clinical trials. The US FDA gave the green light to cell and gene therapies in 2023, one of which was gene-editing treatments aimed at rare diseases. Along with the gene therapies of exagamglogene autotemcel (Casgevy) and lovotibeglogene autotemcel, which are both for sickle cell disease, and of valoctocogene roxaparvovec, which is for severe hemophilia A, the FDA has approved these therapies, thus confirming the potential role of gene therapies in tackling the problems related to rare diseases. In 2024, Charles River Laboratories collaborated with the Gates Institute at the University of Colorado Anschutz Medical Campus to establish a CDMO for lentiviral vectors. The main goal of the partnership was to produce lentiviral vectors that are of GMP-grade and that will be used for the manufacturing of CAR T-cell therapies, making use of Charles River's long experience in the field of cell and gene therapy. Hence, the above-mentioned factors collectively support the growth of the global cell and gene therapy market.

Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories International Inc., Cell and Gene Therapy Catapult, Lonza Group AG, WuXi AppTec Co Ltd, Takara Bio Inc., FUJIFILM Holdings Corp, F. Hoffmann-La Roche Ltd, and Catalent Inc. are among the leading companies profiled in the cell and gene therapy market report.

Based on type, the cell and gene therapy market is divided into cell therapy and gene therapy. In terms of service, the market is segmented into process development, cGMP manufacturing, regulatory services, and bioassay services. Based on scale, the cell and gene therapy market is categorized into pre-commercial/R and D manufacturing and commercial scale manufacturing. By service providers, the market is bifurcated into CDMOs and CMOs. By transfection reagents, the market is classified into polymer-based transfection reagents, lipid-based transfection reagents, viral transduction enhancers, and others. In terms of end user, the cell and gene therapy market is segmented into contract research organizations, pharmaceutical and biopharmaceutical companies, and academic and research institutes. Geographically, the cell and gene therapy market is segmented into North America (US, Canada, and Mexico), Europe (France, Germany, UK, Spain, Italy, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific), the Middle East and Africa (Saudi Arabia, South Africa, the UAE, and the Rest of Middle East and Africa), and South and Central America (Brazil, Argentina, and the Rest of South and Central America).

Contact Us

Phone: +1-646-491-9876
Email Id: sales@theinsightpartners.com