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Cell and Gene Therapy Market Size, Growth, Share by 2031

Cell and Gene Therapy Market Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Type [Cell Therapy (Allogeneic, Autologous, and Viral Vectors) and Gene Therapy (Non-Viral Vectors, and Viral Vectors)], Services (Process Development, cGMP Manufacturing, Regulatory Services, and Bioassay Services), Scale (Pre Commercial/R and D Manufacturing and Commercial Scale Manufacturing), Service Providers (CDMOs and CMOs), End User (Contract Research Organizations, Pharmaceutical and Biopharmaceutical Companies, and Academic and Research Institutes), and Geography

  • Report Code : TIPRE00020854
  • Category : Life Sciences
  • No. of Pages : 232
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The cell and gene therapy market size is projected to reach US$ 28,050.39 million by 2031 from US$ 4,485.00 million in 2023. The market is expected to register a CAGR of 25.8% during 2023–2031. Integration of artificial intelligence (AI) and automation technologies is likely to bring new trends in the market during the forecast period.

Cell and Gene Therapy Market Analysis

The increase in the number of approvals of cell and gene therapies and the rapid popularity of outsourcing cell and gene therapy manufacturing are the factors favoring the cell and gene therapy market progress. Strategic initiatives by companies are also expected to benefit the market in the coming years.

Cell and Gene Therapy Market Overview

The advancements in biotechnology have led to the adoption of personalized treatments for a wide range of indications. Stem cell therapies are being used to treat cancer, neurological disorders, genetic disorders, and other chronic diseases. Further, the advantages of cell therapy include targeted treatment, rapid and efficient recovery, and reduced side effects. Cell therapies are widely adopted worldwide owing to the availability of Food and Drug Administration (FDA) approved products. A few of the cell and gene therapy products approved by the FDA in recent years are mentioned below:

  • In April 2024, the FDA approved BEQVEZ for use by Pfizer Inc. to treat adults suffering from moderate to severe hemophilia B who are on factor IX (FIX) prophylaxis therapy. A FIX deficiency causes people with hemophilia B, a rare genetic bleeding illness, to bleed more frequently and for longer periods than healthy people. The disease hinders normal blood clotting.
  • In 2023, the FDA approved VYJUVEK, manufactured by Krystal Biotech, Inc., for the treatment of wounds in patients ages 6 months and above with dystrophic epidermolysis bullosa, showing mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Therefore, the increasing number of approvals of cell and gene therapies enhances manufacturing capabilities, which fuels the cell and gene therapy market growth.

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Cell and Gene Therapy Market: Strategic Insights

Market Size Value inUS$ 4,485.00 Million in 2023
Market Size Value byUS$ 28,050.39 Million by 2031
Growth rateCAGR of 25.8% from 2023 to 2031
Forecast Period2024-2031
Historic Period2021-2022
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Cell and Gene Therapy Market Drivers and Opportunities

Rapid Popularity of Outsourcing Cell and Gene Therapy Manufacturing Favors Market

Cell and gene therapy manufacturing is a complex process, which makes the proper execution and monitoring of the operation crucial. Cell and gene therapy manufacturers have a limited number of qualified personnel who know biological and process engineering. Moreover, for experienced teams, managing the attempts to reach the first clinical trial using a manual and open manufacturing method, as well as building a more commercially suitable process, can be challenging. Therefore, these manufacturers choose to work with contract development and manufacturing organizations (CDMOs) to accelerate their clinical studies and commercialization process. CDMOs support product development, manufacturing, clinical trials, and commercialization services to cell and gene therapy companies on a contract basis. Under the partnership with a CDMO, cell and gene therapy manufacturers support scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies.

Strategic Initiatives by Companies to Create Market Opportunities

Many companies involved in manufacturing cell and gene therapy products focus on collaborations, expansions, agreements, partnerships, new product launches, and other strategic developments. These strategic initiatives help them improve sales, expand geographic reach, and enhance capacities to cater to a large customer base. A few of the significant developments in the cell and gene therapy market are mentioned below.

  • In September 2023, Agilent Technologies Inc. signed a Memorandum of Understanding (MOU) with the Advanced Cell Therapy and Research Institute, Singapore (ACTRIS). This agreement aims to improve cell and gene therapy advancements over the next three years.
  • In March 2022, Cellevolve Bio partnered with Seattle Children’s Therapeutics to develop and commercialize new multiplex CARs for pediatric cancers. With this collaboration, the companies will focus on the BrainChild research program—a suite of five multiplex CARs—to treat pediatric central nervous system (CNS) malignancies. They aim to leverage the Seattle Children’s Cure Factory facility to conduct early clinical GMP research on new CARs.

The initiation of new businesses to remain competitive in the market through collaborations and partnerships can help accelerate the development of new platforms for cell and gene therapy manufacturing services. Thus, these strategic initiatives by key players are anticipated to create substantial growth opportunities in the cell and gene therapy market during the forecast period.

Cell and Gene Therapy Market Report Segmentation Analysis

Key segments that contributed to the derivation of the cell and gene therapy market analysis are product type, application, and end user.

  • Based on type, the cell and gene therapy market is segmented into bifurcated into cell therapy and gene therapy. The cell therapy segment held a larger market share in 2023.
  • By services, the market is segmented into process development, cGMP manufacturing, regulatory services, and bioassay services. The process development segment held the largest share of the market in 2023.
  • By scale, the market is bifurcated into pre commercial/R and D manufacturing and commercial scale manufacturing. The pre commercial/R and D manufacturing segment held a larger share of the market in 2023.
  • By service provider, the market is divided into CDMOs and CMOs. The CDMOs segment dominated the market in 2023.
  • Based on end user, the market is segmented into contract research organizations, pharmaceutical and biopharmaceutical companies, and academic and research institutes. The pharmaceutical and biopharmaceutical companies segment dominated the market in 2023.

Cell and Gene Therapy Market Share Analysis by Geography

The geographic scope of the cell and gene therapy market report is mainly divided into five regions: North America, Asia Pacific, Europe, the Middle East & Africa, and South & Central America. North America dominated the market in 2023. The North America cell and gene therapy market has been analyzed on the basis of the US, Canada, and Mexico. The cell and gene therapies market growth in the US is attributed to the growing adoption of cell therapies such as stem cell, gene, and immune therapies. Growing incidences of genetic and cellular disorders are leading to increasing demand for cell therapies. According to the American Society of Gene & Cell Therapy (ASGCT), there are currently 3,633 therapies in the pipeline—55% are gene, 22% are non-genetically modified cells, and 23% are RNA—from preclinical through pre-registration. These are focused on various diseases and conditions, varying from cancer to genetic disorders to neurological conditions. As of February 2024, 19 cell and gene therapy products have been approved in the US for treating cancer, eye diseases, and rare hereditary diseases. Also, the country is experiencing an increasing number of start-ups innovating cell therapies. In addition, growing support from the government is promoting the growth of cell therapies, influencing the development of the market. For instance, the American Society of Gene & Cell Therapy (ASGCT), a public organization, offers memberships to scientists, physicians, professionals, and patient advocates who are engaged in gene and cell therapies. ASGCT aims to enhance knowledge, education, and awareness regarding the clinical application of cell and gene therapies.

Cell and Gene Therapy Market Report Scope

Cell and Gene Therapy Market News and Recent Developments

The cell and gene therapy market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the cell and gene therapy market are listed below:

  • South Korean CDMO Lotte Biologics and Merck KGaA have signed a partnership deal focused on expanding biopharmaceutical production and process development. (Source: Lotte Biologics, Company Website, June 2024)
  • Catalent launched a new case management service specifically designed to address the unique challenges associated with the safe and timely delivery of advanced therapies to patients by providing professional supply chain oversight from program start to finish. The supply chain logistics for advanced therapy medicinal products (ATMPs), such as cell and gene therapies, is complex because of their inherent sensitivity, high value, and certain patient-specific complexities of delivering each dose. (Source: Catalent, Company Website, January 2023)

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 key opportunities
  • Detailed PEST and SWOT analysis
  • Cell and gene therapy market analysis covering key market 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
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered

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to segments covered.

Regional Scope

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

Country Scope

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to country scope.

Frequently Asked Questions


Which region dominated the cell and gene therapy market in 2023?

North America dominated the market in 2023.

What are the driving factors impacting the cell and gene therapy market?

Key factors that are driving the market are the increase in number of approvals of cell and gene therapies and rapid popularity of outsourcing cell and gene therapy manufacturing.

What are the significant future trends in the cell and gene therapy market?

Integration of artificial intelligence and automation technologies is likely to remain a key trend in the market.

Which are the leading players operating in the cell and gene therapy market?

Thermo Fisher Scientific, Inc.; Merck KGaA; Charles River Laboratories; Cell and Gene Therapy Catapult; Lonza; WuXi AppTec; Takara Bio Inc.; Bristol Myers Squibb; FUJIFILM Holdings Corporation; F. Hoffmann-La Roche Ltd.; and Catalent Biologics are among the key players operating in the market.

What would be the estimated value of the cell and gene therapy market by 2031?

The cell and gene therapy market value is estimated to reach US$ 28,050.39 million by 2031.

What is the expected CAGR of the cell and gene therapy market?

The cell and gene therapy market is anticipated to record a CAGR of 25.8% during 2023–2031.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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