Cell and Gene Therapy CRO Market Size was valued at USD 1.46 Bn in 2023 and is predicted to reach USD 2.43 Bn by 2031 at a 6.7% CAGR during the forecast period for 2024-2031.
Cell and gene therapy involves manipulating a patient's cells to introduce, remove, or alter specific genes in order to correct genetic problems. By getting to the bottom of hereditary disorders like cystic fibrosis and cancer, this treatment approach has promise. Clinical trials have revealed promising outcomes, and it holds potential for individualized therapy. Correction of genetic defects or modification of gene expression to improve cardiac and vascular function is the main goal of gene therapy in the treatment of coronary artery disease.
One approach to cell and gene therapy that makes use of viral vectors is the delivery of therapeutic genes to cells in the cardiovascular system. Increased awareness of gene therapy and substantial investments in research and development are driving forces behind the cell and gene therapy CRO market's rapid expansion. Cell and gene therapy is anticipated to have a significant impact on the cancer treatment industry due to several variables, including rising cancer rates, ethical acceptance of the treatment, and more support from the government. The rising incidence of long-term diseases, including cancer, rare genetic disorders affecting a wide range of uncommon diseases, and others, is a major force propelling the gene therapy market forward.
However, the market growth is hampered by the high-cost criteria for the safety and health of the call and gene therapy market. The product's inability to prevent fog in environments with dramatic temperature fluctuations or high call and gene therapy due to complex manufacturing, long clinical trials, strict regulatory requirements, and gene therapy incurs high R&D expenses. These monetary roadblocks cause businesses trouble because they reduce their investment potential, which in turn reduces development and market accessibility. If gene therapy is to advance and become more accessible to patients, the prohibitive expense must be addressed. Due to the COVID-19 pandemic, which has affected the worldwide market and forced the closure of numerous factories in an effort to protect their personnel from contracting the virus, the expansion of the industry may be hindered.
Cell and gene therapy CRO market is segmented based on type of cell therapy, stage of development, type of genetic modification, therapeutic area, and end-users. Based on type, the market is segmented into Ex vivo and In vivo. Based on the stage of development, the market is segmented into discovery, preclinical, and clinical. Based on therapeutic area, the market is segmented into blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders. On the basis of type of cell therapy, market segmented into CAR-NK, CAR-T, TCR-T, and others. Type of genetic modification includes ex-vivo and in-vivo. By end-users, the market is segmented into industry players and non-industry players.
The cardiovascular disorders segment of the cell and gene therapy CRO market is expected to hold a major global market share in 2023. The need for pharmaceutical compounds to treat arterial and cardiovascular ailments is rising globally. With more and more people suffering from heart conditions, the pharmaceutical chemicals market is seeing growth in cardiovascular applications.
Cell and gene therapies are groundbreaking treatments, but require rigorous testing before reaching patients. Due to this, the clinical segment dominates the CRO market in this field. CROs, or Contract Research Organizations, handle clinical trials for pharmaceutical and biotech companies. These trials involve multiple stages with increasing numbers of participants to assess safety and effectiveness. CROs with clinical expertise understand the strict regulations for cell and gene therapies and guide their clients through the approval process. With the focus on safety and navigating regulations, the clinical segment is crucial. Even though the gene therapy segment itself is projected to grow, the clinical segment will likely remain on top as companies develop and test these innovative therapies.
The North American cell and gene therapy CRO market is expected to register the highest market share in revenue in the near future. It can be attributed to the prevalence of chronic diseases, high and rising healthcare expenditure, an advanced healthcare infrastructure, available reimbursements, and the presence of major market players. In addition, Asia Pacific is projected to grow rapidly in the global cell and gene therapy in market due to the huge amount of registered clinical trials linked to the treatments. The significant focus on government funding and reforms is another factor expected to contribute to expanding the region's chimeric antigen gene therapy market in the coming years.
| Report Attribute | Specifications |
| Market Size Value In 2023 | USD 1.46 Bn |
| Revenue Forecast In 2031 | USD 2.43 Bn |
| Growth Rate CAGR | CAGR of 6.7% from 2024 to 2031 |
| Quantitative Units | Representation of revenue in US$ Million and CAGR from 2024 to 2031 |
| Historic Year | 2019 to 2023 |
| Forecast Year | 2024-2031 |
| Report Coverage | The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
| Segments Covered | By Type of Cell Therapy, By Stage of Development, By Type of Genetic Modification, By Therapeutic Area, By End-users and By Region |
| Regional Scope | North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
| Country Scope | U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; Southeast Asia; South Korea |
| Competitive Landscape | Altasciences, Allucent, CMIC, Labcorp, Linical, Medpace, PPD, Precision for Medicine, QPS, Syneos Health, CMED, ICON, Pharmalex, and Novotech. |
| Customization Scope | Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
| Pricing And Available Payment Methods | Explore pricing alternatives that are customized to your particular study requirements. |
Cell and Gene Therapy CRO Market- By Type of Cell Therapy
Cell and Gene Therapy CRO Market- By Type of Genetic Modification
Cell and Gene Therapy CRO Market-By Stage of Development
Cell and Gene Therapy CRO Market-By Therapeutic Area
Cell and Gene Therapy CRO Market-By End-Users
Cell and Gene Therapy CRO Market-By Region
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
This study employed a multi-step, mixed-method research approach that integrates:
This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.
Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.
Secondary data for the market study was gathered from multiple credible sources, including:
These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.
Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.
Primary interviews for this study involved:
Interviews were conducted via:
Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.
All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.
The data validation process included:
This ensured that the dataset used for modelling was clean, robust, and reliable.
The bottom-up approach involved aggregating segment-level data, such as:
This method was primarily used when detailed micro-level market data were available.
The top-down approach used macro-level indicators:
This approach was used for segments where granular data were limited or inconsistent.
To ensure accuracy, a triangulated hybrid model was used. This included:
This multi-angle validation yielded the final market size.
Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.
Given inherent uncertainties, three scenarios were constructed:
Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.