Cell and Gene Therapy Market
Report ID: SQMIG35D2325
Report ID: SQMIG35D2325
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Report ID:
SQMIG35D2325 |
Region:
Global |
Published Date: June, 2025
Pages:
194
|Tables:
96
|Figures:
71
Global Cell & Gene Therapy Market size was valued at USD 29.44 Billion in 2024 and is poised to grow from USD 34.88 Billion in 2025 to USD 135.62 Billion by 2033, growing at a CAGR of 18.5% during the forecast period (2026–2033).
The increasing global burden of chronic illnesses such as cancer, cardiovascular diseases, and rare genetic disorders is a critical driver for the cell and gene therapy market. Traditional treatments often fall short in providing long-term cures for these complex diseases. This unmet medical need pushes healthcare providers and pharmaceutical companies to explore innovative therapies that offer targeted, personalized treatment. As the number of diagnosed patients rises due to better screening and aging populations, demand for advanced cell and gene therapies grows, encouraging investments, clinical trials, and commercialization efforts worldwide.
Technological breakthroughs in biotechnology, especially gene editing tools like CRISPR-Cas9, have been key trends driving the global cell and gene therapy market. These tools enable precise, efficient modification of DNA, allowing scientists to correct genetic defects or engineer immune cells to better fight diseases. Enhanced accuracy reduces off-target effects and improves patient safety, making therapies more viable for regulatory approval. This progress accelerates R&D timelines, lowers costs, and increases the likelihood of successful outcomes, thereby attracting more investment and expanding the pipeline of innovative treatments in the global market.
What are the Key Challenges in Integrating AI with Cell and Gene Therapy R&D Pipelines?
AI accelerates the development of cell and gene therapies by analyzing vast molecular and patient data to identify novel therapeutic targets and optimize gene editing, such as CRISPR. This precision reduces off-target effects and enhances treatment efficacy. Furthermore, AI-driven algorithms streamline clinical trial design by selecting ideal patient cohorts and predicting responses, leading to faster, cost-efficient trials. For example, AstraZeneca’s collaboration with Immunai uses AI models of the immune system to improve cancer therapy trials, increasing success rates and speeding up market entry. Consequently, AI drives innovation and market growth in this sector.
In September 2024, AstraZeneca entered into a multi-year collaboration with Immunai, a New York-based biotechnology firm specializing in artificial intelligence. The partnership, valued at $18 million for its initial phase, aims to enhance the efficiency of cancer drug trials by leveraging Immunai's AI model of the immune system. This collaboration focuses on optimizing clinical decision-making processes, including dose selection, elucidating mechanisms of action, patient responder analysis, and biomarker identification.
Market snapshot - 2026-2033
Global Market Size
USD 20.97 Billion
Largest Segment
Cell Therapy
Fastest Growth
Gene Therapy
Growth Rate
18.50% CAGR
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The global cell and gene therapy market is segmented based on therapy type, therapeutic class, end-users, and region. In terms of therapy type, the market is bifurcated into cell therapy and gene therapy. Based on therapeutic class, the market is segmented into cardiovascular disease, cancer, genetic disorder, rare diseases, oncology, hematology, ophthalmology, infectious disease, neurological disorders, and others. Based on end-users, the market is trifurcated into hospitals, cancer care centers, and others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Central & South America and the Middle East & Africa.
Based on the global cell and gene therapy market forecast, cell therapy, particularly autologous treatments like CAR T-cell therapy, is leading the industry. These therapies involve modifying a patient's own cells to treat diseases such as cancer and autoimmune disorders. Their dominance is attributed to their personalized nature, which minimizes immune rejection risks, and their proven efficacy in treating previously untreatable conditions. Advancements in gene editing technologies, automation in manufacturing processes, and supportive regulatory frameworks are further accelerating their development and accessibility, solidifying their market leadership.
Gene therapy is emerging as the fastest-growing segment in the global cell and gene therapy market due to its transformative potential in treating previously untreatable diseases. Advancements in gene editing technologies, such as CRISPR-Cas9, have enabled precise modifications of genetic material, leading to effective treatments for conditions like sickle cell disease and beta-thalassemia.
The infectious disease therapeutic class dominates the global cell and gene therapy market due to the rising burden of diseases like HIV and hepatitis. Innovations such as CRISPR-based gene editing enable precise targeting of viral genomes, offering potential cures where conventional treatments fail. Continuous advancements and streamlined regulatory approvals accelerate the development and adoption of these therapies, making infectious diseases a leading focus area and driving sustained market growth in this segment.
The oncology therapeutic class is poised to be the fastest-growing segment in the global cell and gene therapy market due to the escalating global cancer burden and advancements in targeted therapies. Innovations such as CAR T-cell therapies and oncolytic virotherapy offer personalized, precise treatments with improved efficacy and reduced side effects compared to traditional methods.
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As per the global cell and gene therapy market analysis, North America leads the industry due to its robust healthcare infrastructure, significant R&D investments, and presence of major biotech companies. The U.S. dominates with strong regulatory support and numerous clinical trials accelerating therapy approvals. Increasing prevalence of chronic diseases and government initiatives further boost adoption. Advanced manufacturing capabilities and strategic collaborations enhance innovation, solidifying North America’s position as a key growth hub in the global market.
The U.S. dominates North America’s cell and gene therapy market with extensive biotech infrastructure and innovation. It leads clinical trials and regulatory approvals, including pioneering CRISPR-based therapies like Casgevy for sickle cell disease. Substantial investments and collaborations between academia and industry drive rapid therapy development, making the U.S. the primary growth engine in the region’s advanced therapy landscape.
Canada is an emerging player in the North America’s cell and gene therapy market, focusing on innovative treatments for rare diseases and cancers. Government initiatives support research and clinical trials, while biotech hubs in Toronto and Montreal foster collaboration. With growing regulatory support and investment in advanced manufacturing, Canada is strengthening its position as a key contributor to North America’s expanding cell and gene therapy ecosystem.
Europe’s cell and gene therapy market is rapidly growing, driven by strong government funding, advanced research institutions, and a favorable regulatory environment. Countries like Germany, the UK, and France lead with significant clinical trials and manufacturing capabilities. Collaborative initiatives and public-private partnerships accelerate innovation, particularly in oncology and rare diseases. Increasing healthcare investments and patient access programs further boost adoption, positioning Europe as a vital hub in the global cell and gene therapy landscape.
Germany is a leading European hub for cell and gene therapy, supported by advanced biotech infrastructure and robust R&D funding. The country excels in clinical trials, particularly in oncology and rare genetic disorders. Strong government support and collaborations between academic institutions and industry foster innovation. Germany’s advanced manufacturing facilities and streamlined regulatory processes further enhance its contribution to the global market’s growth and therapy accessibility.
France is a key player in the Europe cell and gene therapy market, with strong government investment in biotechnology and life sciences. It focuses on developing innovative treatments for rare diseases and cancers. French research centers and hospitals actively participate in clinical trials, supported by collaborative networks and favorable reimbursement policies. These factors, combined with growing manufacturing capabilities, position France as a significant contributor to advancing global cell and gene therapies.
The UK drives innovation in the Europe cell and gene therapy market through substantial public and private funding, world-class research institutions, and strong clinical trial activity. It leads in developing CAR-T and gene-editing therapies, supported by progressive regulatory frameworks. The government’s commitment to life sciences and extensive collaboration between academia and industry accelerates therapy development and commercialization, making the UK a major global contributor to this fast-evolving market.
Asia Pacific’s cell and gene therapy market is rapidly expanding, fueled by increasing healthcare investments, rising disease burden, and growing biotech innovation hubs in China, Japan, and South Korea. Government support, improving regulatory frameworks, and collaborations with global companies accelerate clinical trials and therapy development. Expanding manufacturing capabilities and raising patient awareness further drive adoption, positioning Asia Pacific as a vital growth region in the global cell and gene therapy market.
Japan is a major contributor to the Asia Pacific cell and gene therapy market, driven by strong government support and advanced regenerative medicine research. With multiple approvals of innovative therapies like CAR-T and CRISPR-based treatments, Japan fosters rapid clinical development. Its efficient regulatory framework and investment in biotechnology infrastructure boost therapy commercialization, solidifying Japan’s role as a leader in Asia Pacific’s cell and gene therapy growth.
South Korea’s cell and gene therapy market is rapidly growing due to proactive government policies and robust biotech innovation. The country has approved several cell and gene therapies, supported by streamlined regulations under the Advanced Regenerative Medicine Act. Strong investments in R&D and collaborations with global firms enhance South Korea’s manufacturing and clinical trial capabilities, positioning it as a key player in Asia Pacific’s expanding advanced therapy landscape.
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Rising Prevalence of Genetic Disorders
Advancements in Biotechnology
Long Development Timelines
Limited Infrastructure in Emerging Markets
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The global cell and gene therapy market outlook is highly competitive and dynamic, with key players like Novartis, Gilead Sciences, Bristol Myers Squibb, and bluebird bio leading innovation. Companies focus on strategic partnerships, acquisitions, and expanding clinical pipelines. For example, Novartis invests heavily in CAR-T therapies, while Gilead leverages acquisitions like Kite Pharma to strengthen its oncology portfolio. These strategies aim to accelerate development, enhance market reach, and maintain competitive advantage.
As per the global cell and gene therapy industry analysis, the startup landscape is rapidly evolving, driven by innovative technology and growing investment. Startups focus on overcoming delivery challenges, improving gene editing precision, and developing novel therapeutic targets. By combining advanced biotech with AI and machine learning, these young companies accelerate therapy development and reduce costs. Their agility and innovation fill gaps left by larger firms, playing a pivotal role in advancing personalized medicine and regenerative treatments worldwide.
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the global cell and gene therapy industry is rapidly evolving due to rising chronic disease burdens and technological breakthroughs like CRISPR. Personalized medicine and AI-driven innovations are accelerating therapy development, improving precision and safety while shortening clinical timelines. Despite challenges such as lengthy regulatory processes and infrastructure gaps in emerging regions, strong investments and collaborations by leading biotech firms and startups drive sustained growth.
Regional markets like North America and Europe lead with robust ecosystems, while Asia Pacific emerges through increasing healthcare investments. With continuous advancements in gene editing and delivery technologies, the global cell and gene therapy market strategies are poised to deliver transformative therapies for previously untreatable diseases, ultimately improving patient outcomes and expanding access worldwide.
| Report Metric | Details |
|---|---|
| Market size value in 2024 | USD 29.44 Billion |
| Market size value in 2033 | USD 135.62 Billion |
| Growth Rate | 18.5% |
| Base year | 2024 |
| Forecast period | 2026-2033 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
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| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Cell and Gene Therapy Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Cell and Gene Therapy Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
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