The global cell and gene therapy market is rapidly expanding, with its size estimated at USD 25.03 billion in 2025 and projected to reach USD 117.46 billion by 2034, at a healthy CAGR of 18.7% from 2025 to 2034. This surge reflects increasing demand for advanced therapies targeting cancer, genetic disorders, and rare diseases.
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Cell and Gene Therapy Market Trends and Insights
🔹 In terms of revenue, the cell and gene therapy market was valued at USD 21.28 billion in 2024.
🔹 It Is projected to surpass USD 117.46 billion by 2034.
🔹 The market is expected to expand at a notable CAGR of 18.7% from 2025 to 2034.
🔹 In terms of region, North America led the market in 2024 with a dominant 49.75% revenue share.
🔹 Asia Pacific is expected to expand at a notable CAGR of 19.2% from 2025 to 2034.
🔹 Country-wise, The U.S. cell and gene therapy market size has been calculated at USD 11.74 billion in 2025.
🔹 Cell therapy segment accounted for 86.76% of total therapy revenue in 2024.
🔹 Infectious diseases segments held the largest therapeutic class share at 28.87% in 2024.
🔹 In vivo delivery methods captured 79.35% of the revenue share in 2024.
🔹 The cancer care centres segment contributed the major revenue share of 40.40% in 2024.
Cell and Gene Therapy Market Revenue Analysis, By Therapy Type 2022-2024 (USD Million)
Therapy Type |
2022 |
2023 |
2024 |
Cell Therapy |
13,396.01 |
15,621.48 |
18,250.90 |
Gene Therapy |
2,067.97 |
2,502.14 |
3,029.70 |
Cell and Gene Therapy Market Revenue Analysis, By Therapeutic Class 2022-2024 (USD Million)
Therapeutic Class |
2022 |
2023 |
2024 |
Cardiovascular Disease |
744.36 |
882.84 |
1,049.07 |
Genetic Disorder |
1,643.41 |
1,922.21 |
2,252.53 |
Oncology |
1,936.87 |
2,272.26 |
2,670.73 |
Hematology |
1,196.56 |
1,396.75 |
1,633.49 |
Ophthalmology |
835.60 |
972.46 |
1,133.87 |
Infectious Disease |
4,420.18 |
5,206.30 |
6,143.76 |
Neurological Disorders |
658.61 |
777.29 |
919.08 |
Others |
4,028.39 |
4,693.50 |
5,478.08 |
Cell
and Gene Therapy Market Revenue Analysis, By Delivery Method 2022-2024 (USD
Million)
By Delivery Method |
2022 |
2023 |
2024 |
In Vivo |
12,221.99 |
14,352.68 |
16,886.51 |
Ex Vivo |
3,241.99 |
3,770.93 |
4,394.09 |
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Market Overview and Industry Potential
Targeting the Root Cause: A New Era in Disease Treatment Begins
The cell and gene therapy market is expected to see steady growth owing to the increased need for the potential to treat diseases at the genetic level in the current period. Moreover, by playing an ideal role in fixing the root causes of major conditions such as cancer, immune diseases, and genetic disorders, cell and gene therapy have gained immense market attention in the past few years. Also, the advancements in technology advancements other modern equipment are increasingly seen supporting these types of therapy, and also the fast-paced approvals for clinical trials and drug systems have majorly contributed to the industry confidence.
What are the Major Trends in Cell and Gene Therapy Market?
🔹Increased use of the CAR-T cell therapies is spearheading industry growth in the current period. As these therapies have been seen in most successful approaches in treating major diseases such as lymphoma and leukemia. Moreover, several companies and healthcare specialists are now adopting these therapies as per recent observations.
🔹The shift from autologous to allogenic therapies is driving industry growth in recent years. Also, the autologous therapies use the patient's own cells to cure, which is time-consuming and reflects delays, but now in the allogenic therapy, patients can use the healthy donor cells, which are seen as cost-effective and can diagnose more patients faster, as per the recent report.
🔹The increased usage of gene editing tools has contributed to the industry's growth in the past few years. Scientists are using tools like CRISPR-based gene editing, which is capable of editing faulty genes that are responsible for diseases. Also, these initiatives have gained major industry attention in the current period.
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Why CDMOs Are Essential for Cell and Gene Therapy Market’s Expansion?
1. Enabling Scalable Manufacturing:
🔹Over 80% of advanced therapy medicinal products (ATMPs), including cell and gene therapies, are developed by small-to-mid-size biotech firms that often lack in-house GMP manufacturing.
🔹 CDMOs provide GMP-compliant facilities capable of producing viral vectors (e.g., AAV, lentivirus) and engineered cell therapies at clinical and commercial scales.
🔹 For autologous therapies, CDMOs help manage patient-specific batch production, which can involve 50–100+ unique batches per trial phase.
2. Accelerating Time-to-Clinic:
🔹Cell and gene therapy CDMO help reduce the average time from preclinical to clinical stage from 18–24 months to as little as 12 months, by offering integrated development and manufacturing services.
🔹 They provide ready-to-use platforms for cell expansion, viral transduction, purification, and cryopreservation, significantly cutting development timelines.
Explore our https://www.precedenceresearch.com/rare-diseases-treatment-market
Personalized Gene Therapies Unlock a New Era of Precision Medicine
The development of personalized game therapies is expected to create significant industry opportunities in the coming years. These personalized therapies can diagnose disease with its root cause. By offering precision solutions without the side effects, manufacturers can gain substantial industry share in the coming years.
🔹 Gene therapies, particularly those using CRISPR-Cas9 and AAV (Adeno-Associated Virus) vectors, have demonstrated editing efficiencies above 70–80% in controlled environments, which marks a major advancement in precision medicine.
Moreover, these therapies can provide diagnostic solutions to rare genetic and specific cancer diseases, which can be a significant move during the forecast period as per future expectations. Moreover, technological advances can play a crucial role in making personalized gene therapies.
🔹 Technological advances, such as next-generation sequencing (NGS), which has dropped in cost from $10,000 per genome in 2011 to less than $200 today, play a crucial role in enabling personalized gene therapies by making rapid, affordable, and accurate genome analysis possible.
Also Read: How Advances in DNA Sequencing Are Powering Biotech Innovation and Precision Medicine
What are Major Challenges for Cell and Gene Therapy Market?
🔹 One of the primary hurdles is the complexity and high cost of manufacturing, particularly for autologous therapies, which require personalized, patient-specific production.
🔹 The limited availability of viral vectors, especially high-quality AAV and lentiviral vectors, has created supply bottlenecks that hinder scalability.
🔹 Additionally, stringent regulatory requirements across different regions increase the complexity and duration of product approval. Many therapies also face logistical challenges, including cold chain storage and timely delivery, which are critical for maintaining cell viability.
🔹 Moreover, reimbursement
uncertainties and uneven healthcare infrastructure,
especially in low- and middle-income countries, restrict patient access and
limit widespread adoption.
Also Read: Why Cold Storage Infrastructure Is
Critical for Biotech, Pharma, and Vaccine Supply Chains
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Also Read:
How the Cold Chain Market
Is Safeguarding Biologics, Cell & Gene Therapies, and Vaccine Integrity
Cell and Gene Therapy Market Coverage
Report Attribute |
Key Statistics |
Market Size in 2024 |
$ 21.28 Billion |
Market Size in 2025 |
$ 25.03 Billion |
Market Size in 2030 |
$ 58 Billion |
Market Size in 2032 |
$ 82.24 Billion |
Market Size by 2034 |
$ 117.46 Billion |
CAGR (2025-2034) |
18.7% |
Largest Market Region |
North America (49.75% share in 2024) |
Fastest Growing Region |
Asia Pacific (CAGR 19.2% 2025-2034) |
Dominant Country |
United States (USD 11.74 Billion in 2025) |
Base Year |
2024 |
Historic Years |
2020-2023 |
Forecast Years |
2025 to 2034 |
Segments Covered |
Therapy Type, Therapeutic class, End User, Delivery Method, Region |
Top Therapeutic Class |
Infectious Diseases (28.87% market share in 2024) |
Most Preferred Delivery Method |
In Vivo (79.35% revenue share in 2024) |
Key End-User Segment |
Cancer Care Centers (40.40% share in 2024) |
Regions Covered |
Asia Pacific, North America, Europe, Latin America, Middle East and Africa |
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Which Region Dominated the Cell and Gene Therapy Market in 2024?
North America held the dominant share of the cell and gene therapy market in 2024, owing to having advanced healthcare infrastructure and technology growth in the current period. Moreover, several private and government bodies are seen in creating high funding for the technology advancements in cell and gene therapies in the region nowadays. Also, the region has a strong patient awareness and the adoption of the latest therapies, which is providing a competitive edge to the market.
“Globally, the cell and gene therapy space has attracted over $30 billion in funding since 2020, led by increased government R&D spending in Asia Pacific and private biotech investment in North America.”
Can United States Maintain its Lead as the World Biotechnology Hub?
The United States is the major contributor to the cell market, akin to a huge investment in the research and development activities of the healthcare industry. Moreover, the country is considered the biotechnology hub globally, which is giving a major consumer base from all over the world, as per recent observations. Also, the countries have an advantage from having strong regulatory bodies like the FDA and others.
Also Read: Inside the Rapid Growth of Cell and Gene Therapy Clinical Trials: What It Means for Biotech and CROs
How Big is the U.S. Cell and Gene Therapy Market
The U.S. cell and gene therapy market is experiencing significant
growth. According to Precedence Research, the market was valued at USD 9.97
billion in 2024 and is projected to reach USD 55.47 billion by 2034, expanding
at a CAGR of 18.8% from 2025 to 2034.
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What to Expect from Asian Countries for Cell and Gene Therapy Market?
Asia Pacific is seen to grow at a rapid CAGR in the cell and gene therapy market. Countries like China and Japan lead in clinical trials and regulatory frameworks, while South Korea and Singapore are establishing themselves as regional hubs for manufacturing and innovation. Emerging economies such as India are also gaining traction through public-private partnerships and rising medical tourism. A surge in government funding, regulatory fast-tracking, and cross-border collaborations are driving a highly competitive landscape.
China
🔹 Largest contributor in the region with 400 active CAR-T trials.
🔹 Backed by “Made in China 2025” and NMPA’s fast-track approval.
Japan
🔹Pioneer in cell and gene therapy approvals; first to approve iPSC therapies.
🔹PMDA offers conditional approvals post-Phase II.
🔹Aging population drives demand for neurodegenerative therapies.
South Korea
🔹Major manufacturing and clinical trial hub.
🔹Invested KRW 1.3 trillion in biotech R&D.
🔹GIFT framework enables expedited gene therapy approvals.
India
🔹Emerging CGT player supported by BIRAC and National Biopharma Mission.
🔹Growing ecosystem for affordable CAR-T and stem cell therapies.
🔹Strategic interest in becoming a CGT manufacturing base.
Singapore
🔹Leading R&D center; S$25 billion allocated under RIE2025 initiative.
🔹Strong adoption of decentralized clinical trials (DCTs).
🔹Supports cell therapy manufacturing innovation via ACTRIS and Agilent partnership.
Also Read: Why Bioanalytical Testing Services Are Pivotal to Advancing Cell and Gene Therapy Trials
Europe Cell and Gene Therapy Market Trends:
Europe is expected to expand at a considerable rate during the forecast period, owing to technology-integrated healthcare infrastructure. The region is gaining substantial benefits akin to the supporting government initiatives from the stronger bodies like the European Union and others. Also, the countries in the region are observing an increase in clinical trials, which is providing an advantage for the market, as per a recent regional survey.
Germany: Power Ahead in Cell & Gene Therapy with Strong Pharma Backbone
Germany is expected to rise as a dominant country in the European region in the coming years, owing to the presence of a heavy pharmaceutical industry. Also, Germany has advanced clinical research centers, which are contributing to the industry's growth in recent years. Moreover, the country has well-funded public healthcare systems, which are able to adopt high-cost and high-impact therapies that can create lucrative opportunities during the projected years.
Cell and Gene Therapy Market Segmentation Analysis:
By Therapy Analysis:
Why Did the Cell Therapy Segment Dominate the Cell and Gene Therapy Market in 2024?
The cell therapy segment held the largest share of the cell and gene therapy market in 2024, owing to its recent success in diseases like blood cancers and genetic diseases. Moreover, these types of therapies are mostly approved and are in use to treat current major diseases, which gives them an industry advantage in the current period. Also, the cell therapies are seeing wide adoption in global hospitals, akin to ts success rate and understanding, which provides the heavy consumer base to segment in recent years.
On the other hand, the gene segment is expected to grow significantly during the forecast period due to these therapies offering long-lasting and most curable solutions for the diseases. Also, by improving the delivery methods with minimum side effects, gene therapy has gained immense popularity in recent years. As the genetic disorder increases and the need for effective cancer therapies is expected to drive the gene therapy demand in the coming years.
Also Read: How Innovation in Cancer Diagnostics Is Reshaping Early Detection and Precision Oncology
By Therapeutic Class Analysis:
Why Is the Infectious Diseases Segment Leading the Cell and Gene Therapy Market in 2024?
The infectious diseases segment held the largest share of the cell and gene therapy market in 2024, owing to the urgent need for effective treatments, especially after the COVID-19 pandemic. Cell and gene therapies have been explored for fighting serious infections, including viral diseases. The rising threat of antibiotic-resistant infections has also pushed researchers to look at advanced therapies like these. Funding from governments and health organizations for new treatment methods against infections has been high. These factors have helped the infectious disease segment hold a strong position in the market in recent years, especially in clinical research and emergency healthcare setups.
On the other hand, the cancer segment is expected to grow at a notable rate because of the rising number of cancer cases globally and the strong effectiveness of cell and gene therapies in treating it. Therapies like CAR-T have already shown major success in blood cancers. Now, research is expanding into solid tumors, which opens a large potential market. With continued clinical trials and regulatory approvals, more advanced therapies are likely to be available.
Also Read: Breakthroughs in Blood Cancer Diagnostics Fuel Advances in Hematology and Personalized Treatment
By Delivery Method Type Analysis:
Why Is In Vivo Therapy Leading the Cell and Gene Therapy Market in 2024?
The in vivo segment led the cell and gene therapy market in 2024, owing to its more direct and often simpler approach than other methods. In vivo therapy means the gene material is delivered straight into the patient's body, without needing to remove or modify cells outside. This approach has been widely used in gene therapy trials for genetic and metabolic disorders. It also reduces time, cost, and risks linked with cell handling outside the body. Because of its relatively simpler process and success in early trials, in vivo remains the preferred delivery method in current therapeutic approaches.
On the other hand, the ex vivo segment is seen to grow at the fastest rate during the forecast period. In this method, cells are removed from the patient, genetically modified in a lab, and then reintroduced. This allows scientists to better control the genetic changes, making the therapy safer and more precise.
Ex vivo methods are especially useful in personalized therapies, like CAR-T for cancer, which is showing great clinical results. As technology advances and lab processes become faster and cheaper, more therapies will use this method. This will likely make ex vivo delivery dominant in the coming years.
Also Read: T-cell Therapy Market Momentum: Transforming Cancer Treatment and Driving Next-Gen Immunotherapies
By End User Analysis:
Why Are Hospitals the Primary Drivers of the Cell and Gene Therapy Market in 2024?
The hospitals segment held the largest share of the cell and gene therapy market in 2024, owing to hospitals having the medical teams and infrastructure needed to perform complex procedures like infusions or stem cell transplants. Many of the currently approved therapies are provided in hospitals under expert supervision due to the risk of side effects. Also, hospitals are often the first to adopt new treatments because of their role in clinical trials. These reasons make hospitals the main access point for patients needing advanced therapies, giving them the largest market share today.
On the other hand, the cancer care centres segment is expected to grow at a notable rate. These centres specialize in oncology and are increasingly adopting advanced therapies like CAR-T and gene editing treatments. As more cancer-focused therapies receive approval, patients are likely to receive treatment in these specialized centers. With rising cancer cases and growing demand for targeted treatment, these centers are expected to become the primary providers of gene and cell therapies for cancer patients, boosting their market share in the coming years.
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Top 10 Companies in Cell and Gene Therapy Market and Their Contribution:
🔹Alnylam Pharmaceuticals Inc. – Pioneers RNA interference (RNAi) therapies targeting rare genetic diseases at the gene-silencing level.
🔹Amgen Inc. – Developed the first FDA-approved oncolytic virus therapy and invests heavily in CAR-T and gene delivery technologies.
🔹Biogen Inc. – Leads in neurological gene therapies, notably with Spinraza® for spinal muscular atrophy.
🔹CORESTEM Inc. – Specializes in autologous stem cell therapies for neurodegenerative diseases like ALS.
🔹Dendreon Pharmaceuticals LLC – Introduced Provenge®, the first FDA-approved autologous cell therapy for prostate cancer.
🔹Helixmith Co. Ltd. – Develops non-viral gene therapies like VM202 for diabetic neuropathy and nerve regeneration.
🔹JCR Pharmaceuticals Co. Ltd. – Innovates in gene-modified enzyme replacement therapies for lysosomal storage diseases.
🔹Kolon TissueGene Inc. – Developed Invossa®, a gene-cell combination therapy for knee osteoarthritis.
🔹Novartis AG – Leads the CGT market with Kymriah® and Zolgensma®, advancing both CAR-T and AAV gene therapies.
🔹Pfizer Inc. – Focuses on scalable AAV gene therapies for rare genetic diseases like hemophilia and DMD
What is Going Around the Globe?
🔹 In 2024, Bharat Biotech introduced the latest cell and gene therapy in Hyderabad and had a production facility in Genome Valley in Hyderabad, India. The production facility aims to produce major material for anticancer and genetic disorders, which is high-titer viral vectors.
🔹 In 2024, Novartis created a partnership with Voyager Therapeutics with a signed capsid license agreement. The motive of the collaboration is to develop and research gene therapies for Huntington's disease. Similarly, their expert team is expected to research the development of gene therapy for spinal muscular atrophy (SMA).
🔹 In 2024, the first gene therapy was approved on 25 April by Pfizer, named Fidanacogene elaparvovec-dzkt (Beqvez). This treatment is mainly for adults with moderate to severe hemophilia B. This gene therapy is available for limited patients who do not have antibodies to fight the virus called serotype Rh74var (AAVRh74var) capsid.
🔹 In 2025, the first cell therapy, CAR T, was unveiled in India. This cell therapy will be used in treating adult B-cell Non-Hodgkin Lymphoma, which is similar to blood cancer that maintains affects the lymphatic system.
Cell and Gene Therapy Market Segmentation:
By Therapy Type
• Cell Therapy
o Stem Cells
o T Cells
o Dendritic Cells
o NK Cells
o Tumor Cells
• 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
By Geography
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
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About Us
Precedence Research is a global market intelligence and consulting powerhouse, dedicated to unlocking deep strategic insights that drive innovation and transformation. With a laser focus on the dynamic world of life sciences, we specialize in decoding the complexities of cell and gene therapy, drug development, and oncology markets, helping our clients stay ahead in some of the most cutting-edge and high-stakes domains in healthcare. Our expertise spans across the biotech and pharmaceutical ecosystem, serving innovators, investors, and institutions that are redefining what’s possible in regenerative medicine, cancer care, precision therapeutics, and beyond.
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