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The Global Cell & Gene Therapy Raw Material Testing Market is estimated to reach over USD 59.04 billion by 2030, exhibiting a CAGR of 19.18% during the forecast period.

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The market has been primarily driven by an exponential increase in the clinical pipeline and the number of regulatory approvals for innovative medicines. Participants in the market are concentrating their efforts on increasing their market presence in light of the attractive growth possibilities in the contract development of cellular and gene-modified medicines. Additionally, to speed up the R&D of their candidate programs, bio manufacturers are forming strategic collaborations with contract manufacturers. Increased demand for CMO/CDMO services has prompted the entry of a number of new competitors and the increase of product development capacities, both of which have a favourable effect on market revenue. In order to enhance the production of cell and gene therapies, several innovative techniques are being introduced. For instance, the makers are investigating the potential of single-use technology in manufacturing workflows. This method is becoming more popular in this field since it may expedite development while also cutting costs and production times. In the upcoming years, market growth is predicted to be supported by such technical products in space.

List of Prominent Players in the Cell & Gene Therapy Raw Material Testing Market:

Thermo Fisher Scientific

Merck KGaA

Catalent Inc.,

Charles River

Pace Analytical Life Sciences

Agilent Technologies

Intertek Group PLC

Element Material Technology

Eurofins Scientific

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Market Dynamics:


The high frequency of cancer and other target diseases, the accessibility of reimbursements, and the rising financing for gene therapy research all contribute to the market’s expansion. The biopharmaceutical business has seen tremendous change as a result of the commercialization of highly sophisticated treatments, which has also altered how many severe and uncommon ailments are treated. The increasing rise of the advanced treatment background is one factor fueling the market expansion for cell and gene therapy manufacturing. For cellular products and gene-modified medicines, the healthcare sector has observed an ideal ratio of clinical success to the number of clinical studies during the previous few years. This is due to the advancements in clinical and technical understanding of the security hazards associated with the use of these products.


The development of the global cell and gene therapy raw material testing market may be constrained in the following years due to the high cost of bioassay services. Despite product development and technological advancement over the past ten years, the market has been hampered by a dearth of skilled workers who can operate sophisticated devices like flow cytometers and multi-mode readers. Modern, very complicated flow cytometers and spectrophotometers produce a variety of data outputs that call for specialized interpretation and analysis. Therefore, there is a global shortage of competent workers.

Regional Trends:

During the forecast period, the North American region is anticipated to account for the highest share of the global market for evaluating raw materials for cell and gene therapy. The North American area will rule the global market for evaluating raw materials for cell and gene therapies due to a growth in healthcare-related research. A few factors that influence the market in the United States include an improvement in the standard of life and new innovations in the medical field. The United States is a centre for complicated medical treatments for many individuals worldwide because it is one of the world’s most developed countries. For instance, a large number of allogeneic transplant recipients are housed in a research facility in the United States. With the improved facilities and a wide range of treatments, the cell and gene therapy raw material testing market in the US has been vital.

Recent Developments:

  • In November 2021, WuXi Advanced Therapies (US) opened a 140,000-square-foot cell and gene therapy testing centre. By tripling the company’s prior testing capacity, this facility will further strengthen the contract testing, development, and manufacturing organization (CTDMO) business model and fulfil the growing demands of clients in the cell and gene therapy industries.
  • In April 2021, PPD, Inc., a multinational contract research organization (CRO), is enlarging its GMP laboratory in Athlone, Ireland, increasing the size of its current facility, and extending the operation’s range of services to include cell and gene therapy testing. With the growth, PPD will be better able to fulfil the increasing demand from clients in Europe, the Middle East and Africa, and the Asia-Pacific area for worldwide scientific and technical knowledge.

Segmentation of Cell & Gene Therapy Raw Material Testing Market –

By Service

  • Sterility Testing
  • Mycoplasma Detection Assays
  • Endotoxin Detection
  • Bioburden Testing
  • Others

By Type

  • Cell Therapy
  • Gene Therapy

By Region-

North America-

  • The US
  • Canada
  • Mexico


  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe


  • China
  • Japan
  • India
  • South Korea
  • South East Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of Middle East and Africa

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