Cell and Gene Therapy CRO Market

Cell and Gene Therapy CRO Market (4th Edition): Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Cell Therapy (CAR-NK, CAR-T, TCR-T, and Others), Type of Genetic Modification (Ex vivo and In vivo), Stage of Development (Discovery, Preclinical, and Clinical), Therapeutic Area (Blood Disorders, Cardiovascular Disorders, Dermatological Disorders, Immunological Disorders, Infectious Diseases, Metabolic Disorders, Musculoskeletal Disorders, Neurological Disorders, Oncological Disorders, Rare Diseases, and Other disorders), End-Users (Industry Players and Non-Industry Players) and Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World)

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Cell and Gene Therapy CRO Market Overview

The global cell and gene therapy CRO market is estimated to grow from $1,653 million in 2024 to $3,513 million by 2035, representing a CAGR of 7.1% during the forecast period 2024-2035.

Cell and Gene Therapy CRO Market Size, by Stage of Development, 2024-2035 (USD Billion)

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The new research study consists of industry trends, detailed cell and gene therapy CRO market analysis, key market insights, market impact analysis, market forecast and opportunity analysis. The rise in the opportunity for contract research organizations over the next decade is likely to be the result of the anticipated rise in the demand for cell and gene therapies.

Cell and gene therapy candidates have demonstrated the potential to treat rare and complex diseases, including indications, for which no effective treatment is currently available. It is important to mention that, in case of cell therapy, human cells are transplanted to repair or replace the damaged cells / tissues, thereby enabling their treatment through alteration or restoration of certain set of cells; the cells may originate from the patient (autologous cells) or a donor (allogeneic cells). On the other hand, gene therapy aims to correct the underlying genetic problem to ensure the treatment, as well as prevention of diseases, by replacing, inactivating or introducing genes into cells, either inside or outside of the body. It is worth highlighting that some therapeutic interventions can be considered both cell and gene therapies. The mechanism of action of such therapies usually involves alteration of genes in specific types of cells and subsequently, their insertion into the patient body.

Presently, over 90 cell and gene therapies have been approved globally. Notable examples of recently approved therapies include (in reverse chronological order of year of approval) Fucaso (2023; developed by IASO Bio) for the treatment of multiple myeloma, Elvediys, (2023; developed by Sarepta Therapeutics) for the treatment of duchenne muscular dystrophy and Vyjuvek (2023; developed by Krystal Biotech) for the treatment of dystrophic epidermolysis bullosa. Additionally, more than to 3,500 clinical studies are currently evaluating cell and gene therapies across 16 therapeutic areas.

In addition to the biotechnology companies developing cell and gene therapies, there are several stakeholders in the market that are defining the success of these immunotherapies. In addition to the CROs, there are companies that are providing suitable clinical trial software solutions for clinical trial management. These platform providers are also working on exploring novel platforms that can allow decentralized / virtual clinical trials for cell and gene therapies. One such company is the US based Jeeva Clinical Trials, which is developing a SaaS platform aimed at reducing the travel burden for participants. In addition, there are companies developing cell and gene therapy supply chain software to allow the drug developers and CROs to manage the supply chains.

With rapidly evolving cell and gene therapy landscape, CROs bring expertise in navigating complex regulatory frameworks, optimizing study designs, and supporting seamless transition from preclinical to clinical success. The aforementioned factors are likely to present lucrative market growth opportunities for contract service providers during the forecast period.

Cell and Gene Therapy CRO Market Share Insights

The market research report presents an in-depth analysis of the various firms / organizations in the cell and gene therapy CRO market, across different segments, as defined in the table below:

Cell and Gene Therapy CRO Market: Report Attributes / Market Segmentations

Key Report Attribute Details
Historical Trend 2018-2023
Base Year 2023
Forecast Period 2024-2035
Market Size Value in 2024 $1,653 Million
Growth Rate CAGR of 7.1% from 2024 to 2035
Type of Cell Therapy
  • CAR-NK
  • CAR-T
  • TCR-T
  • Others
Type of Genetic Modification
  • Ex vivo
  • In vivo
Stage of Development
  • Discovery
  • Preclinical
  • Clinical
Therapeutic Area
  • Blood Disorders
  • Cardiovascular Disorders
  • Dermatological Disorders
  • Immunological Disorders
  • Infectious Diseases
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Neurological Disorders
  • Oncological Disorders
  • Rare Diseases
  • Other Disorders
End Users
  • Industry Players
  • Non- Industry Players
Key Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
Leading Market Players
  • Altasciences
  • Allucent
  • CMIC
  • Labcorp
  • Linical
  • Medpace
  • PPD
  • Precision for Medicine
  • QPS
  • Syneos Health
  • CMED
  • ICON
  • Pharmalex
  • Novotech
PowerPoint Presentation
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Customizatin Scope 15% Free Customization
Excel Data Packs
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  • Market Landscape Analysis
  • Benchmark Analysis
  • Partnerships and Collaborations
  • Mergers and Acquisitions
  • Key Acquisition Targets
  • Clinical Trial Analysis (Cell Therapy)
  • Clinical Trial Analysis (Gene Therapy)
  • Total Cost of Ownership
  • Market Sizing and Opportunity Analysis

 

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential for the contract research organizations serving the cell and gene therapy industry, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2024-2035.

The market report also features the likely distribution of the current and forecasted opportunity within the cell and gene therapy CRO market across various segments, such as type of cell therapy (CAR-NK, CAR-T, TCR-T, and others), type of genetic modification (ex vivo and in vivo), stage of development (discovery, preclinical, and clinical), therapeutic area (blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and  other disorders), end-users (industry players and non-industry players) and key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World).

In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in the cell and gene therapy CRO market. In addition, the research report features detailed transcripts of interviews held with the following industry stakeholders (arranged on the basis of designation):

  • Business Development Executive, Large Company, France
  • Clinical Trial Manager, Small Company, US
  • Former Director, Marketing and Sales, Large Company, US 
  • Former President, Large Company, US

Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Cell and Gene Therapy CRO Market Segmentation Overview

Market Share by Type of Cell Therapy

The overall cell therapy market is segmented into CAR-NK, CAR-T, TCR-T, and others. The CAR-T cell therapy market segment occupies the highest share in 2024 and is expected to remain dominant during the forecast period. This can be attributed to the fact that CAR-T cell therapies have resulted in profound clinical responses in the treatment of various disease indications, such as CD19-positive haematological malignancies, acute lymphoblastic leukemia and multiple myeloma.

Market Share by Type of Genetic Modification

This section highlights the overall gene therapy CRO market across ex vivo and in vivo. The ex vivo segment occupies the highest share in 2024 and is expected to dominate during the forecast period. This can be primarily attributed to the fact that ex vivo techniques involve the use of viral vectors, which are effective in delivering and integrating modified genetic material into cells.

Market Share by Stage of Development

This section segments the cell and gene therapies on the basis of their stage of development (discovery, preclinical and clinical) in the cell and gene therapy CRO market. The clinical segment occupies the highest share in 2024 and expected to be dominant during the forecast period. This can be attributed to the fact that the therapies undergo rigorous clinical testing to meet regulatory standards before reaching the market. Further, majority (47%) of the trials evaluating cell and gene therapies are currently in phase II.

Market Share by Therapeutic Areas

This section segments the global cell and gene therapy CRO market based on therapeutic area into blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders. The oncological disorders segment occupies the highest share in 2024 and this trend (in terms of market share) is likely to remain same during the forecast period. In addition, the favorable clinical outcomes for  oncological-based studies has contributed to the increase in the development of cell and gene therapies, thereby leading to a higher market share as compared to other therapeutic areas.

Market Share by End-users

Based on end-users, the global cell and gene therapy CRO market is segmented into industry and non-industry players. Presently industry players generate the maximum revenues, thereby capturing majority of the market share in this domain and this trend (in terms of market share) is likely to remain same during the forecast period.

Market Share by Key Geographical Regions

This segment highlights the distribution of cell and gene therapy CRO market across various geographies, namely North America, Europe, Asia-Pacific and Rest of the World. According to our projections, North America is likely to capture majority (59%) of the cell and gene therapy CRO market share, and this trend is unlikely to change in the future. It is worth highlighting that the market in Asia-Pacific is expected to grow at a relatively healthy CAGR (8.1%), during the period 2024-2035.

Cell and Gene Therapy CRO Market: Key Insights

The Cell and Gene Therapy CRO Market (4th Edition): Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Cell Therapy (CAR-NK, CAR-T, TCR-T, and Others), Type of Genetic Modification (Ex vivo and In vivo), Stage of Development (Discovery, Preclinical, and Clinical), Therapeutic Area (Blood Disorders, Cardiovascular Disorders, Dermatological Disorders, Immunological Disorders, Infectious Diseases, Metabolic Disorders, Musculoskeletal Disorders, Neurological Disorders, Oncological Disorders, Rare Diseases, and  Other disorders), End-users (Industry Players and Non-Industry Players) and Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World)  market report features an extensive study of the current market landscape, market size, market share, market analysis, market forecast and future opportunities for the cell and gene therapy CROs. Key takeaways of the market report are briefly discussed below:

Competitive Landscape of Cell and Gene Therapy Contract Research Organizations

The cell and gene therapy CRO market features over 105 large, mid-sized and small contract research organizations that are engaged in offering services for cell and gene therapy across preclinical, clinical, and commercial scales of operation. Currently, 80% of the contract research organizations offer their expertise for the advancement of cell and gene therapies to drug developers in order to ensure efficiency, from initial research and development to clinical trials and regulatory approvals; notable examples (in alphabetical order) include Absorption Systems, Accelera, Advanced BioScience Laboratories, and Advanced Cell Diagnostics. In addition, majority of these companies are actively involved in offering clinical trial management services, followed by clinical research monitoring services.

It is worth highlighting that, in recent years, ATMPs have emerged as one of the potential therapeutic modalities that are likely to change the standardized management in order to control the onset of chronic diseases. Thus, the growing demand for novel cell and gene therapies, approvals from various regulatory bodies and technological advancements in order to streamline the drug discovery and clinical research processes, are expected to drive the cell and gene therapy CRO market growth during the forecast period.

Clinical Trials Analysis: Over 3,500 Trials are Evaluating Cell and Gene Therapies to Treat Myriad of Disease Indications

Over the years, cell and gene therapy contract research organizations have made significant efforts to conduct clinical trials for evaluating the efficacy of these therapies for targeting various disorders, including oncological disorders, neurological disorders, and cardiovascular disorders. Majority (49%) of these trials were registered in North America. Further, the maximum number of patients (110,585) have been enrolled in clinical trials conducted in North America, which account for 32% of the overall patient enrollment. It is worth mentioning that Chongqing Precision Biotech is conducting the maximum number of trials in this industry for various therapeutic areas, including oncological disorders, autoimmune / inflammatory disorders and liver disorders. This is followed by Chia Tai Tianqing Pharmaceutical with majority of its therapy candidates in the phase II clinical trials.

Market Trends Analysis: Partnerships and Collaborations have Fueled Cell and Gene Therapy CRO Market Growth

Several stakeholders have been forging alliances with other industry / non-industry players in the cell and gene therapy CRO industry. It is worth highlighting that, since 2015, over 65 strategic partnerships have been established in this domain. Interestingly, most of the agreements signed between the stakeholders were instances of acquisitions. This can be attributed to the fact that the rapid advancements in the cell and gene therapy market has created a competitive landscape, thereby leading to acquisitions of specialized firms by leading players in order to enhance their capabilities and stay at the forefront of innovation. For instance, in October 2023, QHP Capital acquired Applied Stem Cell, a US based company. The primary purpose of this acquisition was to utilize Applied Stem Cell’s technology and capabilities combined with QHP’s strategic network and deep industry knowledge in order to accelerate the development of regenerative medicines.

This is followed by clinical trial agreements and service alliances signed between various stakeholders in this domain. Notable examples of players that have adopted the service alliance partnership model (in reverse chronological order) include Obio Technology and Tofflon (August 2023), Parexel and Partex (August 2023), Labcorp and Forge Biologics (May 2023) and Syneos Health and Cryoport (January 2023).

Cell and Gene Therapy CRO Market Drivers: Complexity of the Drug Modality and Expertise Offered by CROs

It is a well-known fact that the development and clinical evaluation of cell and gene therapies is both challenging and cost intensive, and only a few therapeutic developers have the required technical expertise to carry out in-house clinical research. This can be attributed to the peculiar requirements associated with acquiring the necessary infrastructure and capabilities to carry out research, along with advanced product development expertise. The aforementioned challenges are believed to be the key factors for driving the outsourcing of research operations to a cell and gene therapy CRO.

CROs play a pivotal role in advancing healthcare innovations through preclinical and clinical development stages. For instance, in the preclinical phase, CROs aid in conducting rigorous assessments of potential therapies in laboratory settings, evaluating safety, and refining protocols before human trials.

Further in the clinical stage, CROs facilitate the execution of trials, ensure adherence to regulatory standards, effective monitoring and management of clinical trial-related patient data.

Market Analysis: Global Cell and Gene Therapy CRO Market Size

The global cell and gene therapy CRO market is estimated to be worth $1,653 million in 2024. Driven by the increase in potential of these therapies to treat myriad of disease indications, the market is anticipated to grow at a CAGR of 7.1% during the forecast period. Specifically, in terms of type of cell therapy, majority of the market share is anticipated to be captured by CAR-T cell therapy segment.

Further, by 2035, in terms of stage of development, majority of the market share is anticipated to be captured by the clinical segment.

Regional Analysis: North America Emerged as the Hub of Cell and Gene Therapy CRO Market; Asia Pacific to be the Fastest Growing Market

Majority of the cell and gene therapy CRO are headquartered in North America, followed by companies based in Europe. Currently, North America and Europe capture over 80% of the market share of the overall cell and gene therapy CRO market.

In recent years, demand for cell and gene therapies in the North America region has witnessed a tremendous increase owing to increasing R&D investments and number of clinical studies pertaining to the development of cell and gene therapy-based products. However, in the coming years, Asia-Pacific region is likely to grow at a much faster rate as compared to other geographies.

Key Companies Involved in Cell and Gene Therapy CRO Market

Examples of key cell and gene therapy CRO (which have also been profiled in this market report; the complete list of companies is available in the full report) include Altasciences, Allucent, CMIC, Labcorp, Linical, Medpace, PPD, Precision for Medicine, QPS, Syneos Health, CMED, ICON, Pharmalex and Novotech. This global cell and gene therapy CRO market research report includes an easily searchable excel database of all the companies that offer contract research services for cell and gene therapy worldwide.

Cell and Gene Therapy CRO Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market report includes:

  • A preface providing an introduction to the full report, Cell and Gene Therapy CRO Market, 2024-2035.
Cell and Gene Therapy CRO Market List Cell and Gene Therapy CRO Market, Distribution by Area of Expertise Cell and Gene Therapy CRO Market, Partnerships and Collaborations
  • An outline of the systematic research methodology adopted to conduct the study on cell and gene therapy CRO industry, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • An overview of economic factors that impact the overall cell and gene therapy CRO industry, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
  • An executive summary of the key insights captured during our research, offering a high-level view on the current landscape of the cell and gene therapy CRO market and its likely evolution in the short to mid and long term.
  • A general introduction to CROs, featuring insights on the historical evolution of such organizations, legacy and contemporary trends in outsourcing activity. It provides a brief introduction to the concept of CROs, featuring a discussion on the historical evolution of contract research services market in this domain. Additionally, the chapter includes details on the various types of services offered by different types of CROs. Further, the chapter highlights the advantages and risks associated in partnering with contract service providers, and their role in the development of ATMPs. 
  • A detailed discussion on the business models that are commonly adopted by the biopharmaceutical industry for outsourcing cell and gene therapies. In addition, it includes information on various factors that drive sponsors towards outsourcing and key parameters that sponsors must consider while choosing CROs at each phase of drug development process.  
  • A comprehensive assessment of the overall market landscape of contract research service providers in cell and gene therapy market, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, area of expertise (cell therapy and gene therapy), scale of operation (discovery, preclinical, clinical and commercial), type of preclinical services offered (toxicology studies, in-vivo testing, safety studies, PK / ADME studies, bioanalytical studies, and other preclinical services), type of clinical services offered (clinical trial management / clinical project management, clinical research monitoring, data management, safety and pharmacovigilance, and other clinical services), type of regulatory services offered (legal representation, GAP analysis, Technical Dossier Submission, and  IND Preparation) and type of general support services offered (consulting, training, biostatistics, post-market assessment, and  re-imbursement).
  • Elaborate profiles of cell and gene therapy CROs (large contract research organizations offering both cell and gene therapy services at preclinical, clinical and commercial scale) based in North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, details related to its cell and gene therapies-related service portfolio, recent developments, and an informed future outlook.
  • A detailed benchmark analysis of the various players involved in this domain. It highlights the capabilities of the companies (in terms of their expertise across various services related to the development of cell and gene therapies). The analysis allows companies to compare their existing capabilities within and beyond their peer groups and identify opportunities to become more competitive in the industry.
  • A detailed analysis of the partnerships inked between stakeholders in the cell and gene therapy contract research industry, based on several relevant parameters, such as year of partnership, type of partnership, area of expertise, most active players (in terms of number of partnerships inked) and regional distribution of partnership activity that have taken place in this domain, during the period 2015-2023.
Cell and Gene Therapy CRO Market Acquisitions Cell and Gene Therapy CRO Market, Distribution by Study Design Cell and Gene Therapy CRO Market, Geographical Distribution
  • A detailed analysis of the various mergers and acquisitions in this domain during the period 2015-2023, based on several relevant parameters, such as year of agreement, type of agreement, key value drivers of the deal, most active players (in terms of number of agreements signed) and geographical location of companies. In addition, the chapter provides information on the financial terms of the deals (if available) in order to enumerate the deal multiples (in terms of annual revenues of the acquired firm (at the time of acquisition) and years of experience in this domain).
  • A detailed analysis of acquisitions that have taken place in the cell and gene therapy domain, taking into consideration the historical trend of the activity of players that have acquired other firms since 2015, and offering a means for other industry stakeholders to identify potential acquisition targets. The primary purpose of this analysis was to develop a better understanding of the overall potential and capabilities of companies involved in this domain, that are likely to be acquired in the recent future.
  • A comprehensive analysis of completed, ongoing, and planned clinical studies of various cell and gene therapies, based on several relevant parameters, such as trial registration year, trial status, trial phase, enrolled patient population, type of sponsor, most active industry players (in terms of number of registered trials), study design, therapeutic area and key geographical regions.
  • A detailed analysis of the total cost of ownership for large / very large cell and gene therapy contract research organizations, highlighting the expenses associated with establishment and maintenance of a CRO facility, in the short to long term. The chapter features insights generated from a detailed analysis of the total cost of ownership for cell and gene therapy contract research organizations, during the period Y0-Y20. 
  • A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution highlighting the relative effect of each SWOT parameter on the overall cell and gene therapies research services industry
  • A detailed market forecast analysis in order to estimate the existing market size and future opportunity for cell and gene therapy CRO over the next decade. Based on multiple parameters, such as likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the cell and gene therapy CRO market. Further, in order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
  • Detailed projections of the current and future cell & gene therapy CRO market across different type of cell therapy, such as CAR-NK, CAR-T, TCR-T, and others. 
  • Detailed projections of the current and future cell and gene therapy CRO market across different type of genetic modification, such as ex vivo and in vivo.
  • Detailed projections of the current and future cell and gene therapy CRO industry across different stages of development, such as clinical, preclinical and discovery.
  • Detailed projections of the current and future cell and gene therapy CRO market across different therapeutic area, such as blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and  other disorders.
  • Detailed projections of the current and future cell & gene therapy CRO market across different end users, namely industry players and non-industry players.
  • Detailed projections of the current and future cell and gene therapy CRO industry across various geographies, namely North America, Europe, Asia-Pacific and Rest of the World.
Cell and Gene Therapy CRO Market, Key Offerings Cell and Gene Therapy CRO Market, Key Parameters Cell and Gene Therapy CRO Market, Emerging Players

Recent Developments in Cell and Gene Therapy CRO Market

Several recent developments have taken place in the field of contract research for cell and gene therapy, some of which have been outlined below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we have outlined in our analysis.

  • In December 2023, the Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients of twelve years and older.
  • In August 2023, Cellares, a US-based cell therapy company, raised USD 255 million in a series C round led by Bristol Myers Squibb. The company plans to use these funds to launch the world’s first commercial-scale IDMO Smart Factory in order to meet global demand for life-saving cell therapies.

Author(s): Simriti Gupta, Jasmeet Bhalla, Muskan Arora

Frequently Asked Questions

Question 1: What is the difference between cell and gene therapy?

Answer: Cell therapy is the transplantation of cells in tissues in order to replace or repair damaged tissues or cells in the body. The concentrated cells may then be injected into the patient directly. Whereas, gene therapy is a process that modifies the expression of a gene or alters the biological process of living cells for therapeutic use.

Question 2: How big is the cell and gene therapy CRO market?

Answer: The cell and gene therapy CRO market is estimated to be worth $1,653 million in 2024.

Question 3: How big is the cell therapy CRO market?

Answer: The cell therapy CRO market size is anticipated to be worth $1,185 million in 2024.

Question 4: What is the anticipated CAGR of cell and gene therapy CRO market?

Answer: The cell & gene therapy CRO market is anticipated to grow at a CAGR of 7.1% by 2035.

Question 5: Who are the leading CROs in the cell and gene therapy market?

Answer: Altasciences, Allucent, CMIC, Labcorp, Linical, Medpace, PPD, Precision for Medicine, QPS, Syneos Health, CMED, ICON, Pharmalex and Novotech are some of the leading cell and gene therapy CRO.

Question 6: What are the most common types of agreement signed by the cell and gene therapy contract research organizations?

Answer: Most of the companies offering contract research services for cell and gene therapy have adopted the acquisitions model, followed by clinical trial agreements and service alliances.

Question 7: What are the leading market segments in the cell and gene therapy CRO market?

Answer: Currently, in terms of stage of development, clinical segment captures the largest market share. Further, in terms of type of cell therapy, CAR-T is expected to capture a prominent market share of the global cell and gene therapy CRO market.

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