Biological Safety Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

Market Overview

The biological safety testing market is expected to witness a CAGR of 12.4% during the forecast period, 2021-2026. 

With the emergence of COVID-19, many pharmaceutical and biotechnology companies began developing novel treatments and vaccines against COVID-19. These rising R&D activities impacted positively on the biological safety testing market studied. For instance, in March 2020, Regeneron and Sanofi initiated the development of their biologic Kevzara for the treatment of patients with COVID-19. Kevzara (Sarilumab), jointly developed by Regeneron and Sanofi, also inhibits the IL-6 pathway. Biological safety testing plays a major role in ensuring the purity of vaccines and other biological products. Thus, with the development of new treatment for COVID-19, the demand for biological safety testing has also increased.

Some of the major factors that are driving the market growth are rapidly growing pharmaceutical and biotechnology industries, along with increasing investments, and rising production of new biologics due to the high disease burden. For instance, in 2019, biologics accounted for six of the top-eight drugs in terms of revenue. Humira (adalimumab), which was developed by AbbVie for the treatment of rheumatoid arthritis, psoriasis, Crohn’s, and other autoimmune diseases, led to USD 19 billion sales, as per the Top 15 Best-selling Drugs of 2019 report. Humira was also the fastest-growing biological drug.

Further, the biotechnology-derived products or biologicals have effectively made their ways into various aspects of healthcare, including diagnoses, prevention, and treatments of diseases. However, there remain certain potential safety concerns, which generally arise from the manufacturing processes and complex biological and structural characteristics of these products. Therefore, these products needs detailed and systematic biological safety testing, that eventually enables the adequate assessment of safety, before any kind of clinical investigation. Hence, the market is expected to thrive over the forecast period.

However, the biological safety process is quite time consuming and complex which is expected to hinder the market growth.

Scope of the Report

Biological safety testing refers to the testing procedures that are carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. This includes various types of sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and residual host contamination detection tests, among others. The Biological Safety Testing market is segmented by Product (Reagents and Kits, Instruments and Other Products), by Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy and Other Applications), by Test (Sterility Tests, Bioburden Tests, Endotoxin Tests, Other Tests), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The report offers the value (in USD million) for the above segments.

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Key Market Trends

Bioburden Testing Segment is Expected to Hold Significant Share in the Test Segment of the Market Over the Forecast Period

Bioburden Testing Segment is expected to hold a significant share in the test segment of the market over the forecast period. Organizations like the World Health Organization have also released instructions for health managers and health workers on required infrastructures and standard procedures for effective sterilization, and decontamination of medical devices. These factors are expected to increase the demand for proper sterilization, which is expected to boost the demand of Bioburden testing as it acts as an efficient tool in the validation of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes to ensure safety. 

Bioburden testing is an integral part of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes, monitoring of raw materials, components, or packaging, and overall environmental monitoring programs. The high adoption rate, to determine bioburden limits in wide-ranging biologics and medical devices. Further, the development of new products in the market is expected to accelerate the market studied. For instance, in December 2019, the company has launched the BD Kiestra IdentifA system in Europe and Canada, that is used for microbial identification. It has incorporated automated sample processing steps that ensures accuracy and minimal error. 

Furthermore, there are high bioburden and microbial contamination rates during pharmaceutical and biologics manufacturing, which is expected to drive government and private organizations to improve underlying biological safety practices. Hence, all these practices performed might drive the overall market. 

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