Biologics Safety Testing Market Size with Growth Opportunities, Top Countries Data, Future Trends and Share with Revenue Forecast 2022-2031

Kenneth Research recently added a report on ‘Biologics Safety Testing Market’ in its database of market research reports which provides its readers an in-depth analysis on the latest trends, growth opportunities and growth drivers that are associated with the growth of the market. The report additionally shares critical insights on the COVID-19 impacts on the Biologics Safety Testing Market, along with the compound growth rate (CAGR) of the market for a projected period between 2022 and 2031. The report also includes analysis of the market by utilizing different analytical tools, such as PESTEL analysis and Porter’s five forces analysis. These tools also provide an in-depth analysis on the micro and macro-environmental factors that are associated with the growth of the market during the forecast period.

U.S. Market recovers fast; In a release on May 4th 2021, the U.S. Bureau and Economic Analsysis and U.S. Census Bureau mentions the recovery in the U.S. International trade in March 2021. Exports in the country reached $200 billion, up by $12.4 billion in Feb 2021. Following the continuous incremental trend, imports tallied at $274.5 billion, picked up by $16.4 billion in Feb 2021. However, as COVID19 still haunts the economies across the globe, year-over-year (y-o-y) avergae exports in the U.S. declined by $7.0 billion from March 2020 till March 2021 whilest imports increased by $20.7 billion during the same time. This definitely shows how the market is trying to recover back and this will have a direct impact on the Healthcare/ICT/Chemical industries, creating a huge demand for Biologics Safety Testing Market products.

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In 2021, the global market size of biosafety testing products and services is estimated to achieve ~USD 3 billion, and it is expected to grow at a compound annual growth rate of 13% during the forecast period 2022-2030. The market is mainly driven by the increase in the production of new generation biologics from major pharmaceutical and biotech companies. The high prevalence of target diseases globally encourages companies to increase the production of advanced biologics. The increasing demand for biologics has led to an unprecedented increase in the number of biopharmaceutical companies. The increasing competition for large-scale development of advanced therapeutic drugs has forced manufacturers to improve various aspects of the production process, such as productivity and profitability. Therefore, the company is implementing good manufacturing practices, including extensive biological testing at all levels of the production cycle to help the market grow.

It is expected that during the forecast period, more and more government initiatives to promote biosafety testing products and services will drive overall growth. The high rate of microbial contamination and bioburden in the manufacturing of pharmaceuticals and biological products is expected to prompt governments and private organizations to improve basic biosafety practices.

In addition, the existence of important safety standards implemented by regulatory agencies is expected to drive the adoption of testing tools. The strict guidelines and recommendations issued by these authorities have increased the adoption of these tools by quality assurance technicians, thereby driving market growth.

The biosafety testing service is used to ensure the safety of vaccines and biopharmaceuticals by confirming the absence of bacterial contaminants. The company provides services such as toxicology testing, bioburden testing, and analytical testing to evaluate products based on parameters such as accuracy, specificity, linearity, and range.


Reagents and kits accounted for the largest market share of products in 2018. Reagents are an important part of biosafety testing, so they are widely used in research and clinical laboratories. These reagents are antibiotics, matrix additives and factors, biological buffers, dissociation and freezing reagents, and other reagents. The rapid advancement and modification of reagents and kit formulations are expected to increase their adoption by laboratory technicians, especially in toxicological assessments.

Due to the increased demand for biosafety testing laboratories, it is expected that the instrument part will grow during the forecast period. In addition, regulatory agencies are increasingly putting pressure on pharmaceutical companies to implement safety guidelines, which has also driven the demand for instruments. These are used for biological testing to perform toxicology and bioburden tests, among others.


According to the application, the participation of vaccines and therapeutics was the highest in 2018. Clearly defined guidelines ensure the safety of developing vaccines, the therapeutic value remains unchanged, and the toxicity is reduced, which is one of the biggest factors in this market segment.

Various guidelines and recommendations on the characteristics and identification of materials used in the production of vaccines for infectious diseases issued by regulatory agencies such as the US FDA are expected to promote the growth of this market segment.

Due to factors such as a significant increase in disease outbreaks over the years, it is expected that this market segment will also grow at a profitable rate during the forecast period. The growing demand for vaccines to prevent disease is supporting the adoption of biosafety tools. In addition, due to the high risk of residual DNA contamination, gene therapy is expected to increase at a significant rate during the prognosis period. Residual DNA can be considered as a potential risk to the final product because it is highly infectious.


In terms of revenue in 2018, endotoxin testing dominated the market for biosafety testing products and services. A considerable share can be attributed to the increasing use of these tests in various fields, such as manufacturing and drug production, to reduce the threat of endotoxins. In addition, the availability of many types of endotoxin testing, such as gel clot endotoxin testing, turbidimetry, and USP chromogenic endotoxin testing, are designed to meet different requirements and may drive the growth of this market segment.

At a profitable rate during the forecast period. This can be attributed to the high adoption of these tests to determine bioburden limits in various biological products and medical devices. In addition, the integration of advanced calculations and colorimetric methods can quickly generate results and accurately quantify bioburden. In addition, the rapid development of this segment is expected to contribute to the growth of this segment.


North America occupied the largest share of the global market in 2018. The main share can be attributed to high investment in biotechnology, increased adoption of cancer research, and the development of new biologics, vaccines and drugs. In addition, the compans increasing R&D investment is one of the factors driving growth.

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