Global Cell and Gene Therapy Market Size Likely to Surpass at a CAGR of 18.79% By 2034

Market Size and Growth

As per the Cell And Gene Therapy Market size analysis conducted by the CMI Team, the global Cell and Gene Therapy Market is expected to record a CAGR of 18.79% from 2025 to 2034. In 2025, the market size is projected to reach a valuation of USD 25.20 Billion. Experts anticipate the valuation to reach USD USD 118.63 Billion by 2034.

Overview

According to industry experts at CMI, the implementation of new strategies and technologies by the manufacturers presents lucrative opportunities for players in the Cell and Gene Therapy Market during the forecast period. Furthermore, the growing significance of organized retailing is expected to drive the future growth of the market.

Key Trends & Drivers

• Advancements in Gene Editing Technologies: The development of precise gene editing tools such as CRISPR-Cas9, TALENs, and zinc finger nucleases is reshaping the gene therapy market. These technologies help in the accurate fixing of the mutations in the genetic material along with reducing the off-target effects and enhancing the safety. Especially CRISPR is expected to gain popularity owing to its efficiency, relatively cheap method, and application across varied genetic disorders. With the evolution of these tools, more clinical programs are now involved in integrating them, including therapies for inherited diseases and certain cancers. Continuous innovations in editing precision, delivery systems, and regulatory oversight are catapulting gene editing to the forefront of gene therapy applications in the future and expanding its commercial scope.

• Expansion into Rare and Orphan Diseases: The expansion of gene therapy is proceeding by leaps and bounds into rare and orphan diseases, many of which have no known treatments. These conditions often tend to have a well-defined genetic cause, making them apt candidates for gene intervention. Regulatory incentives such as orphan drug designations, priority review, and extended marketing exclusivity provide more encouragement for development in this arena. Emerging therapies are targeting spinal muscular atrophy, Duchenne muscular dystrophy, and inherited retinal disorders, while inroads by their success have contributed to the further increase in research. This trend is addressing several pressing unmet medical needs while also providing for quicker entry into the marketplace with comparatively less competition, thereby fueling the rapid growth of the gene therapy sector.

• Increasing Regulatory Support and Fast-Track Approvals: Increasingly, worldwide regulatory bodies such as the FDA and EMA are bestowing fast-track designations, breakthrough therapy statuses, and conditional approvals for promising gene therapies. These pathways are meant to fast-track development and review of treatments for serious or life-threatening illnesses. Such a regulatory change indicates the growing confidence in gene therapy regarding safety and efficacy and also the urgency of putting new treatment modalities on the market. With more therapies entering the clinical success phase, regulatory agencies are now actively working with developers to update and revise the guidance on manufacturing, trial design, and post-market surveillance. Hence, a forward regulatory approach accelerates approvals and enhances investor confidence in the field.

• Growth in Strategic Partnerships and M&A Activity: The gene therapy market is currently witnessing an increase in strategic collaborations, licensing deals, mergers, and acquisitions between biotech startups and large pharma companies. The partnerships then translate into commercialization of innovation by bringing together innovative research and development with the regulatory, manufacturing, and distribution capabilities of big pharma. The big players are essentially looking to pump life into their pipeline while the smaller players are getting capital infusion and technical know-how. The notable M&A activities give a similar indication of confidence in the long-term value of gene therapies. Therefore, it promotes the efficiency of R&D, speeds up the arrival of products to the market, and shapes a competitive landscape, which in turn helps drive the growth of the market and increase the availability of new proposed treatments.

• Innovations in Delivery Mechanisms: The successful gene therapy needs the efficient delivery of the genetic materials inside the target cells. The innovations in the delivery systems like adeno-associated viruses, lentiviral vectors, lipid nanoparticles, and non-viral systems are ushering in better therapeutic outcomes and have fewer side effects. These delivery systems are being fine-tuned for specific tissues and diseases, thereby increasing precision while reducing immune responses to the vector. Better platforms also consider vector re-dosing, increased tissue distribution, and efficacy, with more straightforward manufacturing. Moving toward better delivery technologies, the newer ones are more capable of affecting a wider variety of conditions and ensuring greater patient safety, thus facilitating the full utilization of gene therapy and supporting its widespread clinical acceptance.

• Increasing Investment and Funding Activities: As there has been a surge in the venture capital, private equity, and public market investments coming into the fold, gene therapy is becoming more promising for the research and commercialization. The existence of several high-profile IPOs, funding rounds, and government grants serves as proof of investor confidence in gene therapy and in its ability to bring about a kind of transformation. The finances allow companies to delve deeper into the R&D, conduct clinical trials, and upgrade manufacturing facilities. Furthermore, there are also public and philanthropic organizations supporting early-stage innovations. This stream of capital enables developers to undertake a wider variety of diseases, invest in new technologies, and set their sights on global market entry. Continued funding is a requisite to keep the momentum going and to ensure the long-term sustainability of the gene therapy sector.

Report Scope

SWOT Analysis

• Strengths: A primary strength of cell and gene therapies lies in their ability to move beyond symptomatic treatment to address the fundamental causes of diseases, offering the profound possibility of a one-time treatment for conditions that were previously considered incurable. The CGT market is experiencing exponential growth, with projections consistently indicating continued rapid expansion. The CGT market is propelled by ground-breaking technological advancements that enhance both the precision and potential of therapies.

• Weakness: A significant weakness of the Cell and Gene Therapy market is the exorbitant cost associated with manufacturing these advanced therapies, which currently renders them financially inaccessible for many patients. Scaling the manufacturing of cell and gene therapies to meet increasing global demand presents a formidable challenge. The supply chain for cell and gene therapies is exceptionally intricate and highly vulnerable, primarily due to the delicate nature of the products and strict logistical requirements.

• Opportunities: The rising global burden of chronic disorders, including various cancers, cardiovascular diseases, and diabetes, alongside a growing prevalence of genetic disorders such as sickle cell anemia and cystic fibrosis, serves as a powerful driver for the demand for innovative treatments. Governments worldwide are increasingly recognizing the transformative potential of cell and gene therapies and are actively supporting their development through significant initiatives and funding. The development and adoption of value-based payment models represent a crucial opportunity to mitigate the primary threat of high upfront costs.

• Threats: The most immediate and significant threat to the Cell and Gene Therapy market stems from the exorbitant upfront costs of these therapies, which create substantial reimbursement hurdles. A considerable threat to the CGT market’s sustained growth and broader adoption is the inherent uncertainty surrounding the long-term efficacy and durability of these novel therapies. The intellectual property (IP) landscape surrounding cell and gene therapies presents a complex and formidable barrier to competition, potentially limiting market access and perpetuating high costs.

List of the prominent players in the Cell and Gene Therapy Market:

• Amgen Inc.
• Biogen Inc.
• Biomarin Pharmaceutical Inc.
• Bluebird Bio Inc. (Celgene Corporation)
• Bristol-Myers Squibb Company
• Freeline Therapeutics Ltd.
• Gene Biotherapeutics
• Gilead Sciences Inc.
• Horama S.A.
• JCR Pharmaceuticals Co. Ltd.
• Kolon TissueGene Inc.
• MeiraGTx Limited
• Novartis International AG
• Orchard Therapeutics Plc.
• Organogenesis Inc.
• Others

The Cell and Gene Therapy Market is segmented as follows:

By Therapy Type

• Cell Theray
• Gene Therapy

By Therapeutic Class

• Cardiovascular Disease
• Cancer
• Genetic Disorder
• Rare Diseases
• Oncology
• Hematology
• Ophthalmology
• Infectious Disease
• Neurological Disorders
• Others

By Delivery Method

• In Vivo
• Ex Vivo

By End-User

• Hospitals
• Cancer Care Centers
• Others

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America