Austin, TX, USA, June 25, 2025 (GLOBE NEWSWIRE) — Custom Market Insights has published a new research report titled “Cell and Gene Therapy Market Size, Trends and Insights 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), and By Region – Global Industry Overview, Statistical Data, Competitive Analysis, Share, Outlook, and Forecast 2025–2034” in its research database.
“According to the latest research study, the demand of global Cell and Gene Therapy Market size & share was valued at approximately USD 21.23 Billion in 2024 and is expected to reach USD 25.20 Billion in 2025 and is expected to reach a value of around USD 118.63 Billion by 2034, at a compound annual growth rate (CAGR) of about 18.79% during the forecast period 2025 to 2034.”
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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, we expect the growing significance of organized retailing 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 mutations in the genetic material, along with reducing off-target effects and enhancing safety. We expect CRISPR to gain popularity due to its efficiency, cost-effectiveness, and versatility in treating various 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.
- Gene therapy: is rapidly expanding into rare and orphan diseases, many of which lack established 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 made 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 growing confidence in gene therapy regarding safety and efficacy, as well as 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 the 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.
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- 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, along with more straightforward manufacturing. As we develop better delivery technologies, the newer ones can treat more types of conditions and keep patients safer, making it easier to use gene therapy widely and helping it gain acceptance in clinics.
- 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 further investigate the R&D, conduct clinical trials, and upgrade manufacturing facilities. Furthermore, there are also public and philanthropic organizations supporting early-stage innovations. This source of funding empowers developers to explore a broader range of diseases, invest in innovative technologies, and aim for global market penetration. Continued funding is a requisite to keep the momentum going and to ensure the long-term sustainability of the gene therapy sector.
Report Scope
| Feature of the Report | Details |
| Market Size in 2025 | USD 25.20 Billion |
| Projected Market Size in 2034 | USD 118.63 Billion |
| Market Size in 2024 | USD 21.23 Billion |
| CAGR Growth Rate | 18.79% CAGR |
| Base Year | 2024 |
| Forecast Period | 2025-2034 |
| Key Segment | By Therapy Type, Therapeutic Class, Delivery Method, End-User and Region |
| Report Coverage | Revenue Estimation and Forecast, Company Profile, Competitive Landscape, Growth Factors and Recent Trends |
| Regional Scope | North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America |
| Buying Options | Request tailored purchasing options to fulfil your requirements for research. |
(A free sample of the Cell and Gene Therapy report is available upon request; please contact us for more information.)
Our Free Sample Report Consists of the following:
- The updated report for 2024 includes an Introduction, an Overview, and an in-depth industry analysis.
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- About 220+ Pages Research Report (Including Recent Research)
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- Updated Regional Analysis with a Graphical Representation of Size, Share, and Trends for the Year 2025
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- Custom Market Insights (CMI) research methodology
(Please note that the sample of the Cell and Gene Therapy report has been modified to include the COVID-19 impact study prior to delivery.)
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SWOT Analysis
- Strengths: A key advantage of cell and gene therapies is that they can go beyond just treating symptoms to tackle the root causes of diseases, providing the exciting chance for a single treatment for conditions that were once thought to be untreatable. 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 increasing number of people suffering from long-term illnesses like different types of cancer, heart diseases, and diabetes, as well as a rise in genetic disorders such as sickle cell anemia and cystic fibrosis, is a strong reason for the growing need for new 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.
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Key questions answered in this report:
- What is the size of the cellular and gene therapy market, and what is its expected growth rate?
- What are the primary driving factors that push the Cell and Gene Therapy market forward?
- What are the Cell and Gene Therapy Industry’s top companies?
- What are the different categories that the Cell and Gene Therapy Market caters to?
- What will be the fastest-growing segment or region?
- In the value chain, what role do essential players play?
- What is the procedure for getting a free copy of the Cell and Gene Therapy market sample report and company profiles?
Key Offerings:
- Market Share, Size & Forecast by Revenue | 2025−2034
- Market Dynamics – Growth Drivers, Restraints, Investment Opportunities, and Leading Trends
- Market Segmentation – A detailed analysis by Types of Services, by End-User Services, and by regions
- Competitive Landscape – Top Key Vendors and Other Prominent Vendors
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Regional Analysis
The Cell and Gene Therapy Market is segmented into various regions, including North America, Europe, Asia-Pacific, and LAMEA. Here is a brief overview of each region:
- North America: North America dominates cell and gene therapy (CGT) markets due to strong health infrastructure, substantial R&D investments, and a supportive regulatory landscape. Leading biotech entities present and contributed to the creation and growth of excellent clinical trial networks that stimulate innovation and commercialization. The U.S. is a pivotal market for early adoption of therapies like CAR-T. Strong governmental support, acceptance by the patient populace, and insurance reimbursements act as factors that augment market growth. The FDA’s accelerated approval pathway and breakthrough therapy designations also allow the availability of treatments years before commercialization.
- Europe: Cell and gene therapy market in Europe is witnessing rapid growth with increasing investments in biotechnology and favorable regulatory initiatives such as the PRIME scheme by the European Medicines Agency. Countries such as Germany, the UK, and France are flower centers of research and clinical trials augmented by strong collaborative partnerships between public and private organizations. The rising incidence of chronic and rare diseases is further driving market demand. However, heterogeneous healthcare systems and reimbursement procedures act as hurdles in market access. Several initiatives have been set to harmonize the regulatory framework and set up an efficient infrastructure for manufacturing.
- Asia-Pacific: Considered an emerging and fast-growing market for cell and gene therapies, this region sees rising healthcare expenditure, development of biotechnology sectors, and an increasing prevalence of various diseases as high growth factors. Besides China, Japan has invested heavily in CGT research, clinical trials, and manufacturing setups; South Korea, too, is gradually forging ahead. Regulatory bodies have increasingly adapted to facilitate faster approvals, while growing awareness among clinicians and patients is also contributing to market growth. Although infrastructural and reimbursement constraints exist in some pockets, expanding government schemes and international collaborations further bolster the market growth.
- LAMEA: The LAMEA cell and gene therapy market is at an early stage but is expected to grow at a significant rate owing to the increasing burden of diseases along with the improving healthcare infrastructure. Latin America, the Middle East, and Africa have witnessed heightened activity in biotechnology and clinical research but remain limited in market penetration due to regulatory hitches, absence of specialized facilities, and reimbursement issues. The increasing partnership with the international biotech players along with the increasing initiatives from the government for better healthcare accessibility is expected to propel the market growth. Enhancements in awareness and infrastructure will establish LAMEA as a promising region for CGT, particularly in addressing unmet medical needs related to rare and genetic diseases.
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Browse the full “Cell and Gene Therapy Market Size, Trends and Insights 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), and By Region – Global Industry Overview, Statistical Data, Competitive Analysis, Share, Outlook, and Forecast 2025–2034” Report at https://www.custommarketinsights.com/report/cell-and-gene-therapy-market/
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
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The We have segmented the Cell and Gene Therapy Market 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
Click Here to Get a Free Sample Report of the Global Cell and Gene Therapy Market @ https://www.custommarketinsights.com/report/cell-and-gene-therapy-market/
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
This cell and gene therapy market research and analysis report contains answers to the following questions:
- Which Trends Are Causing These Developments?
- Who Are the Global Key Players in This Cell and Gene Therapy Market? What are the company profiles, product information, and contact details for these key players?
- What Was the Global Market Status of the Cell and Gene Therapy Market? What Was the Capacity, Production Value, Cost and PROFIT of the Cell and Gene Therapy markets?
- What Is the Current Market Status of the Cell and Gene Therapy industries? What’s the market’s competition in this industry, both company-wise and country-wise? What’s the Market Analysis of Cell and Gene Therapy Market by Considering Applications and Types?
- What Are Projections of the Global Cell and Gene Therapy Industry Considering Capacity, Production, and Production Value? What Will Be the estimate of Cost and Profit? What Will Be Market Share, Supply, and Consumption? What about imports and exports?
- What Is Cell and Gene Therapy Market Chain Analysis by Upstream Raw Materials and Downstream Industry?
- What Is the Economic Impact On Cell and Gene Therapy Industry? What are Global Macroeconomic Environment Analysis Results? What Are Global Macroeconomic Environment Development Trends?
- What Are Market Dynamics of Cell and Gene Therapy Market? What Are Challenges and Opportunities?
- What Should Be Entry Strategies, Countermeasures to Economic Impact, and Marketing Channels for Cell and Gene Therapy Industry?
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Reasons to Purchase Cell and Gene Therapy Market Report
- Cell and Gene Therapy Market Report provides qualitative and quantitative analysis of the market based on segmentation involving economic and non-economic factors.
- Cell and Gene Therapy Market report outlines market value (USD) data for each segment and sub-segment.
- This report indicates the region and segment expected to witness the fastest growth and dominate the market.
- Cell and Gene Therapy Market Analysis by geography highlights the consumption of the product/service in the region and indicates the factors affecting the market within each region.
- The competitive landscape incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled.
- The report includes extensive company profiles, which include company overviews, insights, product benchmarking, and SWOT analyses for the major market players.
- The Industry’s current and future market outlook concerning recent developments (which involve growth opportunities and drivers as well as challenges and restraints of both emerging and developed regions).
- Cell and Gene Therapy Market Includes in-depth market analysis from various perspectives through Porter’s five forces analysis and offers context for the market through Value Chain.
Reasons for the Research Report
- The study provides a thorough overview of the global Cell and Gene Therapy market. Compare your performance to that of the market as a whole.
- Aim to maintain competitiveness while innovations from established leaders drive market growth.
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What does the report include?
- Drivers, restrictions, and opportunities are among the qualitative elements covered in the worldwide Cell and Gene Therapy market analysis.
- The competitive environment of current and potential participants in the Cell and Gene Therapy market is covered in the report, as well as those companies’ strategic product development ambitions.
- According to the component, application, and industry vertical, this study analyzes the market qualitatively and quantitatively. Additionally, the report offers comparable data for the important regions.
- We have provided actual market sizes and forecasts for each of the aforementioned segments.
Who should buy this report?
- Participants and stakeholders in the worldwide Cell and Gene Therapy market should find this report useful. The research will be useful to all market participants in the Cell and Gene Therapy industry.
- Managers in the Cell and Gene Therapy sector are interested in publishing up-to-date and projected data about the worldwide Cell and Gene Therapy market.
- Governmental agencies, regulatory bodies, decision-makers, and organizations want to invest in Cell and Gene Therapy products’ market trends.
- Market insights are sought by analysts, researchers, educators, strategy managers, and government organizations to develop plans.
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