The market size of the Global Cell & Gene Therapy Raw Material Testing Market in the year 2021 is valued at 12.29 billion and is predicted to reach 59.04 billion by the year 2030 at 19.18 % CAGR during the projected period.
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.
Based on Service, the sterility testing segment is accounted as a major contributor to the Cell & Gene Therapy Raw Material Testing Market.
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.
Based on Type, the cell therapy segment is accounted as a major contributor to the Cell & Gene Therapy Raw Material Testing Market.
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.
The North America Cell & Gene Therapy Raw Material Testing Market holds a significant revenue share in the region.
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.
The key players in the Cell & Gene Therapy Raw Material Testing Market have shifted their focus towards bio-based components for product manufacturing and are initiating significant strategies such as mergers, acquisitions, and through partnerships with regional and international companies to expand their product offerings and expand their global market presence. Some of the major key players in the Cell & Gene Therapy Raw Material Testing Market are Thermo Fisher Scientific, Merck KGaA, Catalent Inc., Charles River, Agilent Technologies, Pace Analytical Life Sciences, Element Material Technology, Intertek Group PLC, and Eurofins Scientific.