The Cell & Gene Therapy Raw Material Testing Market Size is valued at 1462.5 Million in 2022 and is predicted to reach 6822.6 Million by the year 2031 at an 18.8 % CAGR during the forecast period for 2023-2031.
Cell and gene therapy is critical for treating life-threatening disorders such as cancer, leukemia, and cardiovascular disease. It is also necessary for advanced therapy medical products (ATMPs), which use genes and tissues as the basis for their medical therapies. These tissue-engineered medications can be altered according to the patient's needs, which aids in replacing dead cells. The market has been principally stimulated by an exponential rise in the clinical pipeline and an increase in regulatory approvals for novel medications. Additionally, bio manufacturers are establishing strategic partnerships with contract manufacturers to hasten the R&D of their candidate programs. A number of new rivals have entered the market due to the rising demand for CMO/CDMO services, and product development capacity has also increased. Both of these developments have a positive impact on market revenue. The prevalence of cancer and other target diseases, the simplicity of reimbursements, and the increased funding for gene therapy research are all factors that support the market's growth. One aspect driving the market expansion for cell and gene therapy manufacturing is the rising prevalence of advanced treatment backgrounds.
Despite product innovation and technological growth over the previous ten years, the market has been constrained by a lack of qualified personnel who can use complex equipment like flow cytometers and multi-mode readers. A multitude of data outputs from contemporary, very complex flow cytometers and spectrophotometers require specialist interpretation and analysis. Consequently, there is a lack of skilled labour on a global scale. The high cost of bioassay services may limit the growth of the global market for testing raw materials for cell and gene therapy in the upcoming years.
The Cell & Gene Therapy Raw Material Testing Market is segmented on the basis of Service and Type. Based on Service, the market is segmented as Sterility Testing, Mycoplasma Detection Assays, Endotoxin Detection, Bioburden Testing, and Others. Based on Type, the market is segmented into Cell Therapy and Gene Therapy.
During the forecast period, the sterility testing segment is anticipated to account for the most significant market share in the global cell & gene therapy raw material testing market. The estimated likelihood of the components used in the creation of gene and cell therapies is determined by sterility testing. Prior to being inserted into a patient's body, sterilization also forecasts the survival rate of the cells. Additionally, contamination-free microorganisms are filtered by sterility testing, propelling the market throughout the projection period. The need for sterility tests will increase along with developments in the pharmaceutical and medical fields. The global biotechnology industry is booming, and during the projected period, this development will also fuel the expansion of the sterility testing market. Concerns about the safety of biological pharmaceuticals are also growing. The sterility testing market will increase in the upcoming years due to these causes. Sterility testing has benefited from new technology advancements that have improved process efficiency, promoting market expansion.
During the projection period, the cell therapy segment is anticipated to hold the highest share in the global cell & gene therapy raw material testing market. Customers who suffer from cardiovascular problems may benefit from cell treatment because it supports healthy blood vessels and various cell functions. The healthy tissue assists the collagen regeneration process and stimulates healthy skin and hair. The market will experience growth during the forecast period because of the substantially quicker recovery rate following cell treatment. The existence of public and private financing organizations, which frequently provide funds to support initiatives across multiple stages of clinical trials, can be credited with the rise in the number of ongoing clinical trials.
In terms of revenue, North America topped the world market for producing cell and gene therapies with a significant market share. The essential driver for expanding the market is the sizeable number of ongoing clinical studies and the growing investment of businesses in gene and cell therapy R&D activities. With over 400 firms actively engaged in developing cell and gene therapy products for various diseases, North America has taken the top spot for having the highest number of gene therapy clinical trials. The United States operates as a hub for complex medical treatments for a large number of people worldwide due to its status as one of the world's most industrialized nations. The US's cell and gene therapy raw material testing market has been amazingly robust due to enhanced facilities and a wide range of therapies.
| Report Attribute | Specifications |
| Market Size Value In 2022 | USD 1462.5 Million |
| Revenue Forecast In 2031 | USD 6822.6 Million |
| Growth Rate CAGR | CAGR of 18.8 % from 2023 to 2031 |
| Quantitative Units | Representation of revenue in US$ Million and CAGR from 2023 to 2031 |
| Historic Year | 2019 to 2022 |
| Forecast Year | 2023-2031 |
| Report Coverage | The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
| Segments Covered | By Service, By Type |
| 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; The UK; France; Italy; Spain; China; Japan; India; South Korea; South East Asia; South Korea; South East Asia |
| Competitive Landscape | Thermo Fisher Scientific, Merck KGaA, Catalent Inc., Charles River, Agilent Technologies, Pace Analytical Life Sciences, Element Material Technology, Intertek Group PLC, and Eurofins Scientific |
| Customization Scope | Free customization report with the procurement of the report, 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. |
By Service
By Type
By Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
Rest of Middle East and 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.