Cell and Gene Therapy CRO Market

Cell and Gene Therapy CRO Market (3rd Edition): Distribution by Area of Expertise (Cell Therapy and Gene Therapy), Scale of Operation (Clinical, Preclinical and Discovery), Therapeutic Area (Oncological Disorders, Neurological Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Autoimmune Disorders, Blood Disorders, Rare / Genetic Disorders, Ophthalmological Disorders, and Other disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts, 2022-2035

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Cell and Gene Therapy CRO Market

The cell and gene therapy CRO market is estimated to be worth $713 million in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 18% during the forecast period. Cell and gene therapy have been demonstrated to have the potential to treat complex and rare diseases, including indications, for which no effective treatment is currently available. In this context, 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 sets 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 then, their insertion into the patient body.

How is the research and development (R&D) activity evolving in the cell and gene therapy industry?

At present, cell and gene therapy industry is one of the fastest growing therapeutic segments, already having contributed to some of the most significant disruptions in the biopharmaceutical domain. Till date, 23 cell and gene therapies have been approved by the Food and Drug Administration (FDA) in the US, while more than 1,000 IND applications have been filed for candidates being evaluated in ongoing clinical studies. This further indicates a remarkable scientific progress and therapeutic promise of these breakthrough drug candidates. 

This image highlights the context of Cell and Gene Therapy CROs Market report. Characterized by high prevalence rate of rare and genetic disorders, and rise in demand for effective novel ATMPs, the cell and gene therapy contract research industry is likely to witness evolutionary advancements, in the coming years This image provides list of Cell and Gene Therapy Contract Research Organizations. More than 105 CROs claim to provide a wide range of preclinical and clinical services for the development of advanced therapy medicinal products This image presents current market landscape of Cell and Gene Therapy Contract Research Organizations. The current market landscape features the presence of established and emerging players, majority of the service providers offer research and analytical services for both cell and gene therapies at different scales of operation

What is the need for contract research organizations (CROs) in the cell and gene therapy domain?

At present, only a few therapeutic developers have the required technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the necessary infrastructure and capabilities to carry out research. Other key concerns shared by contemporary innovators include limited availability of expertise, high rate of attrition of pipeline drugs / therapies and prolonged development timelines. The aforementioned challenges are believed to be the key factors for driving the outsourcing of research operations to a cell and gene therapy CRO, which claim to be well-aware of the nuances of advanced therapy medicinal products (ATMPs) design and development, as well as cell and gene therapy manufacturing process. 

What are the current opportunities in the cell and gene therapy CRO market?

Due to the upsurge in the research and development related to genetic engineering, there has been a considerable increase in the development of cell and gene therapies. Consequently, there has been a parallel rise in outsourcing of services as more clinical studies are anticipated to start. Specifically, cell therapy companies and gene therapy companies have made significant investments to support the development / adoption of advanced tools, technologies and platforms, to generate more robust and evidence based clinical data, which is required for gaining the marketing authorizations across different geographies. For instance, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain. Further, CROs are believed to play a significant role in the successful approval of these drugs in a highly evolving regulatory environment. Since 2005, over 40 CROs have been established in cell and gene therapy CRO market. It is worth mentioning that cell and gene therapy CROs are bolstering their existing capabilities to offer a wide range of services to their clients. 

What are the recent developments and expected trends in the cell and gene therapy industry?

Presently, more than 3,570 cell and gene therapies are being evaluated across various stages of clinical development for a myriad of disease indications. Given that the demand for cell and gene therapies is indubitably rising, more than 53% mergers and acquisitions have been undertaken by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall cell and gene therapies market, we believe that the cell and gene therapy CRO market is likely to witness a consistent growth, till 2035.

What are the key challenges faced by cell and gene therapy CROs?

One of the key challenges faced by cell and gene therapy CROs is the lack of understanding of the standard operating procedures (SOPs). In addition, various regulatory guidelines render therapies subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives.

What are the key value drivers in the cell and gene therapy market?

A significant rise in healthcare expenditure, R&D spending and booming research have emerged as key value drivers in the cell and gene therapy domain. 

How is the revenue generation potential associated with cell and gene therapy CROs likely to evolve in the coming years?

The cell and gene therapy CRO market is likely to witness a substantial market growth in the coming years. It is worth mentioning that, presently in terms of area of expertise, the market is likely to be driven by cell therapies, and this trend is unlikely to change in the foreseen future as well. Further, based on scale of operation, majority of the revenue share is likely to be associated with clinical operations. Specifically, in terms of global regions, the cell and gene therapy market in Asia-Pacific is likely to grow at a relatively faster pace (21%), in the long term. 

Who are the key players engaged in the cell and gene therapy CRO market?

The key players engaged in cell and gene therapy CRO market (which have also been capture in this report) include Altasciences, Allucent, Accelera Charles River Laboratories, Creative Biolabs, CMIC, Evotec, ICON, IQVIA, Labcorp, Medpace, PPD, Precision For Medicine, QPS and Syneos Health.

This image highlights benchmark analysis of players engaged in the domain of Cell and Gene Therapy CROs Market. In order to meet the rising demand for cell and gene therapies, stakeholders are striving to upgrade / expand their capabilities to enhance their respective service portfolios This image highlights the partnership activity undertaken by players engaged in Cell and Gene Therapy contract research. In pursuit of a competitive edge and to eventually establish themselves as one-stop shops, stakeholders have actively entered into mutually beneficial partnerships This image provides information on mergers and acquisitions of various stakeholders engaged in the development of Cell and Gene Therapies. The rising interest in this domain is reflected in the number of mergers and acquisitions reported in the last few years; 53% of such initiatives were focused on geographical consolidation and portfolio expansion

Key Cell and Gene Therapy CRO 

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 (formerly known as CATO SMS), Accelera, Charles River Laboratories, CMIC Group, Creative Biolabs, Evotec, ICON, IQVIA, Labcorp, Medpace, PPD, Precision for Medicine, QPS and Syneos Health. This market report includes an easily searchable excel database of all the contract research organizations providing cell and gene therapy CRO services, worldwide.

Recent Developments in Cell and Gene Therapy CRO Market:

Several recent developments have taken place in the field of cell and gene therapy CRO. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In August 2023, a research article published in the New England Journal of Medicine revealed that stem cell gene therapy might have the potential for the treatment of Sickle Cell Disease (SCD). The data is backed by the Novartis’ Phase I/II clinical trial for the use of cryopreserved stem cells to reduce vaso-constriction. 
  • In August 2023, Rentschler Biopharma entered into a collaboration with Cell and Gene Therapy Catapult and Refeyn for the development of a novel / improvised process to manufacture adeno-associated viruses in gene therapy production. 
  • In August 2023, a research study conducted by the University College London (UCL) and the NIHR Great Ormond Street Hospital Biomedical Research Centre revealed a gene therapy having the potential to mitigate hearing loss associated with Norrie disease.

Scope of the Report

The Cell and Gene Therapy CRO Market (3rd Edition), 2022-2035: Distribution by Area of Expertise (Cell Therapy and Gene Therapy), Scale of Operation (Clinical, Preclinical and Discovery), Therapeutic Area (Oncological Disorders, Neurological Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Autoimmune Disorders, Blood Disorders, Rare / Genetic Disorders, Ophthalmological Disorders, and Other disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa) market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities for the cell and gene therapy CRO market, during the forecast period. The detailed segmention is highlighted in the below table.

Market Segmentation

Report Attribute Details

Forecast Period

2022 – 2035

Area of Expertise

Cell Therapy, Gene Therapy

Scale of Operation

Clinical, Preclinical and Discovery

Therapeutic Areas

Oncological disorders, neurological disorders, cardiovascular disorders, infectious diseases, metabolic disorders, autoimmune disorders, blood Disorders, rare / genetic disorders, ophthalmological disorders, other disorders
Key Geographical Regions North America, Europe, Asia-Pacific, MENA, Latin America and Rest of the World

The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the market research report features: 

  • A detailed overview of the overall market landscape of the cell and gene therapy CROs, 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 (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operation (discovery, preclinical, clinical and commercial) and types of services offered, including [A] preclinical services (bioanalytical services, in-vivo studies, pharmacokinetic and ADME services, preclinical safety studies, toxicology studies and other preclinical services), [B] clinical services (clinical research monitoring, clinical trial management/ clinical project management, data management, safety and pharmacovigilance, and other clinical services), [C] regulatory services (GAP analysis, IND preparation, legal representation and technical dossier submission) and [D] general support services (biostatistics, consulting, post-market assessment, re-imbursement and training).
  • A detailed analysis 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 developers towards outsourcing and key parameters that sponsors must consider while choosing CROs at each phase of drug development process.  
  • Elaborate profiles of key industry players (very large and large companies) based in North America, Europe and Asia-Pacific that offer contract research services for both cell and gene therapies across both preclinical and clinical scales of operation. Each profile features a brief overview of the company, along with details related to its cell and gene therapies-related service portfolio, recent developments, and an informed future outlook.
  • A benchmark analysis of the various players engaged in cell and gene therapy CRO market. 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 gain a competitive edge in the industry.  
  • An analysis of the recent collaborations within 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 deals inked) and regional distribution of partnership activity that have been undertaken in cell and gene therapy CRO market, during the period 2015-2022.
  • A detailed analysis of the various mergers and acquisitions that have taken place in cell and gene therapy CRO market, during the period 2015-2022, based on several parameters, such as year, type of agreement, area of expertise, geographical location of the companies and key value drivers.
  • A detailed acquisition target analysis, taking into consideration 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.
  • A list of over 310 cell therapy companies that are anticipated to partner with cell therapy CROs. These players have been shortlisted based on several relevant parameters, such as developer strength (based on company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development), and availability of other cell therapy capabilities.
  • An in-depth analysis of nearly 235 gene therapy companies that are anticipated to partner with gene therapy CROs and have been shortlisted on the basis of several relevant parameters, such as developer strength (based on company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other gene therapy capabilities.
  • An in-depth analysis of completed, ongoing, and planned clinical studies of various cell and gene therapies, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), 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. It features an informed estimate of direct and indirect expenses taking into consideration various relevant parameters, over a span of 20 years.
  • 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.
This image provides information about key acquisition targets. Our proprietary analysis highlights several potential acquisition partners for cell and gene therapy service providers across different geographies This image provides information about various factors that are likely to influence the pricing of gene therapies. Our proprietary total cost of ownership model provides an informed estimate of direct and indirect expenses for setting up a contract research facility in different regions, over a span of 20 years This image highlights the market segments of Cell and Gene Therapy CROs Market. The market is expected to grow at a CAGR of over 21% in the coming decade; the opportunity is likely to be well distributed across areas of expertise, therapeutic areas, scales of operation and key geographical regions

The key objective of cell and gene therapy CRO market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for cell and gene therapy CRO market over the forecast period. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the forecast period 2022-2035. The market research report also features the likely distribution of the current and forecasted opportunity across important parameters, such as [A] area of expertise (cell therapy and gene therapy), [B] scale of operation (clinical, preclinical and discovery), [C] therapeutic area (oncological disorders, neurological disorders, cardiovascular disorders, infectious diseases, metabolic disorders, autoimmune disorders, blood disorders, rare / genetic disorders, ophthalmological disorders, and other disorders), and [D] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa).  

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.

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

Frequently Asked Questions

Question 1: What are cell and gene therapies?

Answer: Cell therapies and gene therapies aim to alleviate or prevent the chances of genetic and acquired disorders. Cell therapies restore certain sets of cells in the body using external sources, whereas gene therapies introduce new genes within the body to treat the disease.

Question 2: What is the cell and gene therapy CRO market size?

Answer: The cell and gene therapy CRO market size is estimated to be worth $713 million in 2022.

Question 3: What is the projected market growth of the cell and gene therapy CRO market?

Answer: The cell and gene therapy CRO market is expected to grow at compounded annual growth rate (CAGR) of 18% during the forecast period 2022 - 2035.

Question 4: Who are the leading companies in the cell and gene therapy CRO market?

Answer: Examples of key companies engaged in cell and gene therapy CRO services market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Altasciences, Allucent (Formerly Known as CATO SMS), Accelera, Charles River Laboratories, CMIC Group, Creative Biolabs, Evotec, ICON, IQVIA, Labcorp, Medpace, PPD, Precision for Medicine, QPS and Syneos Health.

Question 5: How many cell and gene therapies have been approved worldwide?

Answer: Close to 40 cell and gene therapies have been approved across various geographic regions.

Question 6: Which region is the hub for players providing cell and gene therapy CRO services?

Answer: North America presently harbors the majority of the players providing cell and gene therapy CRO services, with close to 60% of the companies established in this region.

Question 7: How many clinical trials have been conducted in the cell and gene therapy CRO market?

Answer: Since 2017, close to 295 clinical trials have been conducted in the cell and gene therapy CRO market, highlighting the ongoing research in the field.

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