Global Market Study on Biologics Safety Testing: Endotoxin Tests to Witness Surplus Demand during 2017-2022

Biologics Safety Testing  Market
  • Published On : Sep-2017 |
  • Pages : 170 Pages |
  • Format : Biologics Safety Testing  Market Biologics Safety Testing  Market Biologics Safety Testing  Market Biologics Safety Testing  Market

Large and complex molecules produced from genes of living organisms by using advanced DNA technologies are collectively identified as biologics. Theses biologics are actively incorporated in development of new medicines as well as improvement of existing drugs. Testing the safety of these biologics is critical for avoiding the inadvertent inclusion of unknown entities in drug manufacturing system. Untested and unsafe biologics can cause a greater harm to global population as drugs derived from them can create new abnormalities for patients, and further complicate their health conditions. Hence, government authorities from around the world are watchfully regulating these complex manufacturing processes, which include drug development, product testing, and efficacy evaluation.

According to Persistence Market Research, the global market for biologics safety testing is poised to grow at a robust pace during the forecast period, 2017-2022. Safety of biologics will continue to play a pivotal role in future drug developments, and products facilitating these tests will witness a significant uptake in the global pharmaceuticals industry. The report projects that by the end of 2022, the global biologics safety testing market will have reached a value of US$ 4,360 Mn.

biologics safety testing market Gain More Insights about this Report

The report anticipates North America as the most lucrative market for biologics safety testing. Presence of the FDA and robust healthcare marketplaces in the US and Canada will continue to bolster the presence of North America in the global market. The Asia-Pacific excluding Japan (APEJ) region is also expected to reflect robust growth in its biologics safety testing market. Favorable industrial regulations, coupled with low labor wages and ample resource availability, are anticipated to factor the growth of biologics safety testing market in the APEJ region.

Market Analysis by Test-Type

The report anticipates that on the basis of safety tests, endotoxin tests will register high upturns in the global biologics safety testing market. Currently, endotoxin tests are estimated to account for nearly one-third share of global market revenues, and are anticipated to procure more than US$ 1,400 Mn by the end 2022. During the forecast period, endotoxin tests will record largest revenue share as well as the fastest revenue growth in the overall biologics safety testing market.

Sterility tests and residual host contamination tests will register parallel growth by reflecting similar CAGRs through 2022. The demand for cell line authentication and characterization tests is also anticipated to gain traction, while bioburden tests are anticipated to create an incremental opportunity of over US$ 100 Mn between 2017 and 2022. Compared to the above, adventitious agent detection tests will exhibit a relatively low CAGR, indicating their limiting demand in the near future.

Market Analysis by Product-type & Applications

  • In 2017, nearly half of the revenues procured in the global market will be procured from sales of kits & reagents
  • Compared to products, testing services will record higher traction, and are expected to exhibit 9% CAGR over the forecast period
  • The report projects that vaccine and therapeutics development will remain the largest application for biologics safety testing
  • Application of biologics safety testing in cellular and gene therapy is anticipated to witness a gradual uptick, revenues from which are likely to touch US$ 710 Mn value by the end of 2022

Biological Safety Testing Market: Key Companies

Companies developing solutions on assessing the safety of biologics are anticipated to combine industry-leading expertise and operational excellence, which will ensure that critical drug development programs and manufacturing processes become successful. Companies such as Wuxi Apptec, Toxikon Corporation, Lonza Group Ltd., Pace Analytical Services Inc., BioMerieux SA, Genscript Biotech Corp., Thermo Fisher Scientific Inc., SGS S.A., Eurofins Scientific Se, Sigma-Aldrich Corporation (part of Merck KGaA), and Charles River Laboratories International, Inc.are observed to remain active in the global biologics safety testing market throughout the forecast period. 

Changing landscape of healthcare markets around the world have propelled the need for having a deep understanding before measuring the future of pharmaceutical manufacturing procedures such as biologics safety testing. Designing these genetically-engineered proteins called biologics, which are derived from human genes, involves a series of testing procedures to weigh their safety in treatment of various disorders, and their inclusion in production of drugs and medicine. Persistence Market Research has developed a market study, titled “Biologics Safety Testing Market: Global Industry Analysis (2012-2016), and Forecast (2017-2022),” which offers insights on the foreseeable future of global market for biologics safety testing. The report has analyzed key trends influencing the dynamics of biologics safety testing market, delivering global market size valuations over a five-year historical period. These assessments have been redirected as primary reference to construe estimations on the global biologics safety testing market for the forecast period, 2017-2022.

Report Synopsis

The first section in the report offers an executive summary, wherein the analyzed and anticipated expansion of global biologics safety testing market across various regions has been highlighted. The report offers a comprehensive overview of the market, which includes a formal introduction to the global biologics safety testing market, and a standard definition on biologics safety testing. This section offers market size estimations in metrics such as compounded annual growth rates (CAGRs) and Year-on-Year (Y-o-Y) growth rates.

The report further delivers an analysis on industry trends, cost structure, pricing, and supply chain. Factors impacting the growth of biologics safety testing market have also been analyzed, and the report also delivers an illustrative intensity map that plots the presence of market participants across all regions.

Key chapters in the report offer a segmented analysis and forecast on the global biologics safety testing market. The global market for biologics safety testing has been segmented on the basis of product-type, test-type, application, and region. These sections also provide cross-segmental data and country-wise market analysis & forecast. The report concludes by profiling key market players in detail. This section reveals the overall competitive landscape of the global biologics safety testing market, tracking all notable developments of companies and disclosing their current market standings.

Market Taxonomy

A concise taxonomy on the global market for biologics safety testing has been summarized in the table below:


Product Type

Test Type


North America

Kits & Reagents

Endotoxin Tests

Vaccine and Therapeutics Development

Latin America


Sterility Tests

Blood and Blood-related Products Testing



Cell Line Authentication and Characterization Tests

Cellular and Gene Therapy



Residual Host Contamination Detection Tests

Tissue and Tissue-related Products Testing



Adventitious Agent Detection Tests

Stem Cell Research



Bioburden Tests


Other Tests


Research Methodology

Our research methodology is underpinned by robust methodical approaches adopted by our analysts. Firstly, data on revenues of market participants is procured by secondary and primary resources, which include authoritative databases. This data is aggregated to generate market size estimations for the past five years. Quantitative data is further infused with qualitative insights to offer an assorted assessment on the future of biologics safety testing. Market size estimations have been quantified in US dollars (US$) by converting regional market evaluations with 2017 currency exchange rates. The report has also enlisted key mergers & acquisitions encompassing the global biologics safety testing market, underlining the strategic undertakings of market players towards product development and long-term remunerative gains. The scope of the report is to enable companies boost their presence in the overall biologics safety testing market by taking informed decisions. Research findings and market forecasts availed in this report can be used as guidelines for developing strategic goals in future market direction.

Companies covered in Biologics Safety Testing Market Report

Company Profiles

  • Charles River Laboratories International, Inc.
  • Eurofins Scientific Se
  • SGS S.A.
  • Thermo Fisher Scientific Inc.
  • Genscript
  • Biomérieux Sa
  • Pace Analytical Services Inc.
  • Lonza Group Ltd.
  • Toxikon Corporation
  • Wuxi Apptec
  • Others.

Biologics Safety Testing Market

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