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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2022 – 2035
Area of Expertise
|Cell Therapy, Gene Therapy
Scale of Operation
|Clinical, Preclinical and Discovery
|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:
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.