Cell and Gene Therapy Market Growth & Future Trends 2031

The Cell and Gene Therapy Market size is projected to reach US$ 25.78 billion by 2031 from US$ 5.30 billion in 2024. The market is expected to register a CAGR of 25.5% during 2025–2031.

Cell and Gene Therapy Market Analysis

The​‍​‌‍​‍‌​‍​‌‍​‍‌ cell and gene therapy market is experiencing robust growth due to rising chronic and genetic diseases, expanding funding and biotech investments, increased support from regulations, and technological innovations such as CRISPR and CAR-T. Partnerships among various players in the industry and their investment in more clinical programs speed up the process of getting advanced therapeutics out in the market.

Cell and Gene Therapy Market Overview

Innovative treatments target unmet needs across oncology, rare diseases, and personalized medicine. Advances in gene editing, scalable manufacturing technologies, and automated production systems thereby make the therapy less expensive and easier, and attract public and private investments. Researchers, through the collaboration of academic and industrial sectors, get their research done and increase the number of clinical trials in the pipeline. Positive regulatory regulations and quicker approval routes hasten the entrance of new therapies into the market. The worldwide knowledge of regenerative treatments is increasing, and the demand for curative treatment rather than traditional ones is driving wider acceptance and long-term growth of the industry.

Cell and Gene Therapy Market: Strategic Insights

Cell and Gene Therapy Market Drivers and Opportunities

Market Drivers:

• Increasing Prevalence of Chronic and Genetic Diseases: The global increase in the incidence of cancer, autoimmune, and inherited genetic disorders is driving the need for advanced, targeted, and curative treatments, thus putting cell and gene therapies as an alternative to long-term disease management.
• Rapid Popularity of Outsourcing Cell and Gene Therapy Manufacturing: The production of cell and gene therapy has become so complex that it is now a common practice for developers to outsource manufacturing to the specialized CDMOs, which leads to cost efficiency, scalability, regulatory compliance, and faster clinical and commercial timelines.
• Surging Regulatory Approvals and Commercialization: The use of accelerated regulatory pathways, orphan drug designations, and supportive approval frameworks allows for the quicker commercialization of cell and gene therapies, which raises market confidence, increases investment flow, and gives patients more access to innovative treatments.

Market Opportunities:

• Strategic Initiatives by Companies: Pharmaceutical and biotechnology companies are resorting to partnerships, acquisitions, and technology collaborations as a means of expanding their pipelines, bolstering manufacturing capabilities, and hastening the commercialization of cell and gene therapy innovations.
• Supportive Government Initiatives: The governments of different nations are using a variety of strategies, such as favorable policies, funding programs, tax incentives, and expedited regulatory pathways, thus improving patients’ accessibility to advanced therapeutic technologies.
• Rising Investments in Research and Development and Clinical Trials: The rising public and private investment in research and clinical trials is promoting the exploration, verification, and scaling of new cell and gene therapies, which is making treatments more effective.

Cell and Gene Therapy Market Report Segmentation Analysis

The cell and gene therapy market is segmented into distinct categories to provide a clearer understanding of its operations, growth potential, and current trends. Below is the standard segmentation approach used in industry reports:

By Type:

• Cell Therapy: Cell therapy demand is driven by increasing adoption in oncology and regenerative medicine, proven clinical outcomes, expanding stem cell research, and continuous advancements in cell processing and manufacturing technologies.
• Gene Therapy: Gene therapy adoption is supported by progress in gene editing tools, rising approvals for rare disease treatments, strong clinical pipelines, and growing demand for long-term or curative therapeutic solutions.

By Service:

• Process Development
• cGMP Manufacturing
• Regulatory Services
• Bioassay Services

By Scale:

• Pre-commercial/R and D Manufacturing
• Commercial Scale Manufacturing

By Service Providers:

• CDMOs
• CMOs

By Transfection Reagents:

• Polymer-based Transfection Reagents
• Lipid-based Transfection Reagents
• Viral Transduction Enhancers
• Others

By End User:

• Contract Research Organizations
• Pharmaceutical and Biopharmaceutical Companies
• Academic and Research Institutes

By Geography:

• North America
• Europe
• Asia Pacific
• South & Central America
• Middle East & Africa

Cell and Gene Therapy Market Regional Insights

The regional trends and factors influencing the Cell and Gene Therapy Market throughout the forecast period have been thoroughly explained by the analysts at The Insight Partners. This section also discusses Cell and Gene Therapy Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

Cell and Gene Therapy Market Report Scope

Cell and Gene Therapy Market Players Density: Understanding Its Impact on Business Dynamics

The Cell and Gene Therapy Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Cell and Gene Therapy Market Share Analysis by Geography

Asia Pacific is expected to grow the fastest in the next few years. Emerging markets in South America, the Middle East, and Africa have untapped opportunities for cell and gene therapy providers to expand.

The growth of the cell and gene therapy market varies across regions due to factors such as rising disease burden, government funding, biotechnology innovation, and expanding healthcare infrastructure. Below is a summary of market share and trends by region:

1. North America

• Market Share: Holds a significant portion of the global market
• Key Drivers:  Advanced R&D, strong regulatory support, and extensive clinical pipelines fueling the adoption of novel therapies.
• Trends: Rapid expansion of specialized clinical trials and manufacturing hubs.

2. Europe

• Market Share: Substantial market share
• Key Drivers: Collaborative EU funding, integrated regulatory pathways, and aging populations increasing demand for regenerative and rare‑disease treatments.
• Trends: Harmonization of approvals across countries boosting cross‑border therapy development.

3. Asia Pacific

• Market Share: Fastest-growing region with a rising market share every year
• Key Drivers: Rising healthcare spending, supportive government initiatives, and increasing clinical activity in China, Japan, and India.
• Trends: Domestic innovation and pro‑innovation policies.

4. South and Central America

• Market Share: Growing market with steady progress
• Key Drivers: Expanding healthcare access, rising clinical research, and partnerships improving local therapy adoption.
• Trends: Increasing public‑private collaborations enhance regional biotech infrastructure.

5. Middle East and Africa

• Market Share: Although small, it is growing quickly
• Key Drivers: Rising healthcare modernization, government investment, and expanding treatment centers, despite limited current infrastructure.
• Trends: Strategic partnerships with global biotech firms accelerate capability building.

Cell and Gene Therapy Market Players Density: Understanding Its Impact on Business Dynamics

High Market Density and Competition

Competition is strong due to the presence of established players such as Lonza Group AG and WuXi AppTec Co Ltd. Regional and niche providers add to the competitive landscape across regions.

The high level of competition urges companies to stand out by offering:

• Advanced Products and Services
• Product Approvals
• Compliance with Regulatory Guidelines

Opportunities and Strategic Moves

• Expanding manufacturing capacities and advanced technologies such as CRISPR, AI, and automated bioprocessing boost scalability, lowering costs and broadening global access.
• Companies pursue partnerships, acquisitions, and geographic expansion to accelerate R&D, diversify pipelines, and integrate end‑to‑end production for competitive advantage.

Other companies analyzed during the course of research:

1. Novartis AG
2. CRISPR Therapeutics AG
3. Bluebird Bio, Inc.
4. Oxford Biomedica plc
5. AGC Biologics Inc.
6. Evotec SE
7. Samsung Biologics Co., Ltd.
8. Rocket Pharmaceuticals
9. Krystal Biotech, Inc.
10. Adaptimmune Therapeutics.

Cell and Gene Therapy Market News and Recent Developments

• In October 2025, Lonza Group AG broadened its suite of cell and gene therapy manufacturing solutions with the launch of two new products: TheraPEAK AmpliCell Cytokines and TheraPEAK 293-GT Medium. The additions are aimed at enhancing the scalability and consistency of advanced therapy production under Good Manufacturing Practice (GMP) conditions.
• In December 2025, the US Food and Drug Administration (FDA) approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra is indicated for paediatric patients six months and older and adults with WAS. The approval was granted to Fondazione Telethon ETS, making this the first approved cell and gene therapy product from a non-profit applicant.

Cell and Gene Therapy Market Report Coverage and Deliverables

The "Cell and Gene Therapy Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering below areas:

• Cell and Gene Therapy Market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
• Cell and Gene Therapy Market trends, as well as market dynamics such as drivers, restraints, and opportunities
• Detailed PEST and SWOT analysis
• Cell and Gene Therapy Market analysis covering key trends, global and regional framework, major players, regulations, and recent market developments
• Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the cell and gene therapy Market
• Detailed company profiles