The global biologics safety testing market size is projected to reach USD 11.2 billion by 2030 from USD 4.4 billion in 2021, at a CAGR of 12.4% during the forecast period. Major pharmaceutical and biotechnology companies’ growing production of new generation biologics is a high-impact rendering growth driver of the market. The subsequent increase is a consequence of the high global prevalence of target diseases, which has triggered the companies to produce advanced biologics. Consequently, the high need for biologics resulted in extraordinary growth in biopharmaceutical companies.
Moreover, the increasing number of R&D investments initiated by the companies is one of the key potential growth factors that will drive the market. Furthermore, the increasing chronic disease burden present over this region is anticipated to drive researchers and healthcare professionals’ inclination toward advanced technologies, which in turn is further anticipated to widen the scope for growth.
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Global Biological Safety Testing Market Definition
Biological tests describe the standardized experiments that determine the toxicity of a substance or material by evaluating its result on living organisms.
Tests are designed to use suitable organisms and sensitive effect measurements in the media of interest for a specified test duration.
Global Biological Safety Testing Market Dynamics
Drivers: Rising number of government initiatives and recommendations
The rising number of government initiatives to promote biological safety testing products is presumed to drive the overall market growth during the forecast period. The high microbial contamination rates and bioburden during pharmaceutical & biologics manufacturing are key factors driving the government and private organizations to improve the underlying biological safety practices. Microbial contamination is known to exert a huge impact on biologics & pharmaceuticals manufacturing, generally arising in product variability, significant loss of potency, early degradation due to high levels of bacterial endotoxins. In addition, laboratory-based contamination has stimulated the development and refinement of workstations by incorporating biological safety testing tools.
Restraints: Time-consuming approval process
The significant cost associated and time taken during the approval process for medical devices, biologics, and pharmaceutical is the most critical restraining factor for the industry. Moreover, the high amount of R&D investment involved in developing new technology of these systems is a key factor contributing to their high costs. Furthermore, the lack of availability & funding opportunities to new players in the emerging economies restricts these players from investing more in research and development. Moreover, low awareness levels associated with the biological safety testing procedures and their benefits in emerging economies are also anticipated to exert a negative impact on the global level and are considered one of the growth-restraining drivers for the market.
Global Biological Safety Testing Market Research Report Segmentation
The study categorizes the biological safety testing market based on product, test type, and application at the regional and global levels.
By Product Outlook (Sales, USD Million, 2017–2030)
- Reagents & kits
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By Test Outlook (Sales, USD Million, 2017–2030)
- Sterility Tests
- Cell Line Authentication & Characterization Tests
- Bioburden Tests
- Endotoxin Tests
- Adventitious Agent Detection Tests
- Residual Host Contamination Detection Tests
By Application Outlook (Sales, USD Million, 2017–2030)
- Stem Cell
- Tissue & Tissue Based Products
- Gene Therapy
- Blood & Blood Based Products
- Vaccines & Therapeutics