THE MARKET IS EXPECTED TO GROW AT AN ANNUALIZED RATE OF ~30% OVER THE COMING DECADE
Stringent regulatory guidelines pertaining to cell and gene therapies has made it mandatory for developer companies to conduct extensive preclinical and clinical research to generate the necessary body of evidence, validating the safety, efficacy and benefits of their proprietary products. As a consequence, capital investments required in R&D have increased substantially. It is worth highlighting that even the well-established players in the industry are gradually opting to outsource certain aspects of their early-stage product development operations, such as preclinical research, clinical development, assessment of regulatory compliance and certain parts of the commercialization process, to contract service providers. In fact, as mentioned earlier in the report, there are a number of companies offering a wide range of R&D-related services, specifically for cell and gene therapies.
Amongst the total players offering bioassay services for cell and gene therapies, most of the players engaged in this domain were established before 1995. Of these, nine are headquartered in North America, while eight are based in Europe. Further, the industry witnessed the establishment of nine players, post 2010. Of these, five are based in North America, three in Europe and one in the Asia-Pacific region. In addition to this, all of the bioassay service providers (100%) are offering pre-developed assay. This is followed by 89% players that offer customized cell therapy assay and gene therapy assay. Primarily driven by the need for technical and operational expertise, which are available with contract service providers, the cell and gene therapy bioassay services market is poised to witness substantial growth in the coming years.
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During our research, we estimated the market under conservative, base and optimistic scenarios. As per the base case forecast scenario, the global cell and gene therapy bioassay services market is likely to be growing at a CAGR of 30.1%, during the given time period.
Further, in terms of therapeutic area, the current market is dominated by oncological disorders, followed by infectious diseases. However, the clinical scale of operation is estimated to acquire a share of 65% in 2021, and this value is anticipated to grow at an annualized rate of 30% in the given time period.
In addition to this, North America is leading the current market estimated to capture ~60% shares of total market and anticipated to grow at an annualized rate of 49%, followed by Europe estimated to capture over 30% shares of the current market in 2021.
Besides this, it was observed that close to 60% of the total shares are captured by cell therapy domain and our estimates suggest that players offering services for cell therapies are likely to capture major share of the market. This can be attributed to the fact that a number of cell therapies have already been commercialized and cell therapies capture a larger share of the overall biopharmaceutical industry
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