Biological Safety Testing Market to USD 8.92 Billion in 2030

Ram dige Ram dige 09 December 2022 Follow

The global Biological Safety Testing Market is forecasted to grow at a rate of 12.1% from USD 3.59 Billion in 2020 to USD 8.92 Billion in 2030. This can be mainly associated with the increasing predominance of lifestyle-associated chronic diseases such as diabetes and cancer that serve as an essential contributing factor towards improving drug development and their subsequent commercialization, which are expected to drive the market growth. This is supposed to increase the need to study and ensure the safety of targeted and specific therapies, circumvent probable shortcomings, and evaluate their outcomes.

As a result of high manufacturing effectiveness, pharmaceutical and biotechnology companies are including biological safety testing tools to offer highly effective and contamination-free biologics to provide to the large population experiencing from target diseases.

Biologics are products manufactured from living organisms and has a unique set of features. The safety of biologics and specialized evaluation of the same is of the highest importance. Biological safety testing is essential for new products launching. Biological safety testing is performed to assure the safety quality and non-contamination of vaccines and biopharmaceuticals. The market is gaining traction to fight against possible biological warfare.

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Biologics are products manufactured from living organisms and has a unique set of features. Safety of biologics and specialized evaluation of the same is of the highest importance. Biological safety testing is essential for new products launching. Biological safety testing is performed to assure a safe quality and non-contamination of vaccines and biopharmaceuticals.

Accelerated growth in biotechnology and pharmaceutical industries, increasing prevalence of chronic diseases, rise in population, rise in R&D investment in life sciences, increasing number of innovative product launches, and increasing government support for biotechnology and pharmaceutical industries are some important factors for the North America region to account for the largest share of 37.3% of the market in 2020.

Product Outlook:

Due to increasing demand from biological safety testing laboratories, the instruments product segment is estimated to reach USD 2.18 billion by 2030 at a CAGR of 12.1% during the forecast period. The increasing demand is due to the growing influence of regulatory bodies to implement safety guidelines by the biopharma companies. Instruments are used to perform bioburden and toxicology tests among the other type of tests.

Application Outlook:

The market is witnessing increased demand due to the rise in the stem cell market. The market is witnessing an increased growth owing to the high number of clinical trials across the globe. Stem cells are used in regenerative medicine, especially in the field of dermatology. However, the stem cell applications in oncology will witness higher growth due to a large number of pipeline projects present for the treatment of cancer or tumors. Development of advanced genomic analysis technique, the introduction of effective guidelines for cell therapy manufacturing, a huge amount of research by cancer societies and proven effectiveness of transplants are some of the primary growth stimulants for the market

Test Type Outlook:

Endotoxin test type accounted for the largest share of 27.6% of the market in 2020. The abundant share is due to the increasing incorporation of these tests in an extensive range of areas of drug manufacturing to decrease the threat of endotoxins during the biopharmaceutical manufacture.

Moreover, the availability of different types of endotoxin tests, such as turbidimetric method, USP chromogenic endotoxin testing, and gel clot endotoxin testing, which is expected to suit different requirements. This is anticipated to propel the growth of this segment. Due to the predominance of a vast number of new entrants, established manufacturers, and suppliers in the market, the industry is extremely competitive.

Regional Outlook:

The developing prosperity of countries such as Indonesia, Taiwan, China, and India is inviting new international ventures in these countries, thereby leading to the growth of various industries in the APAC region. Asia Pacific is forecasted to witness the fastest CAGR of 12.6% during the forecast period. Rising healthcare expenditure and increasing concerns due to the various benefits of these tools are the significant growth drivers for the market in this region.

Economic development, coupled with continually increasing per capita healthcare investment in emerging countries such as India, China, and Singapore, is expected to create high growth opportunities. Innovations and technological trends in treatment and increased healthcare facilities are expected to drive growth further.


  • Reagents are a significant element in biological safety testing, and so are used extensively in clinical and research laboratories.
  • Growing advancements and modifications in the formulation of reagents and kits will encourage laboratory technicians to include these products, specifically in toxicology assessment.
  • Reagents and kits product segment accounts for the largest share of 38.8% of the market in 2020.
  • These reagents are attachments and matrix factors, freezing and dissociation reagents, antibiotics, biological buffers, and miscellaneous reagents.
  • Vaccine and therapeutic application account for the largest market share of 39.3% in 2020.
  • The growing demand for this segment is due to clearly defined guidelines ensuring the safety of developed vaccines along with the unaltered therapeutic value and decreased toxicity.
  • Regulatory organizations are working towards implementing relevant standards for biological safety to ensure the patient’s safety.
  • The market has growing importance and a potential for growth in the coming future.
  • However, stringent regulations and the complicated procedure to receive FDA approval may be a restraining factor for the market.
  • Market leaders perform extensive research for the development of technologically advanced and cost-efficient testing products.
  • Also, strategies to increase market presence, such as mergers and acquisitions, initiated by these companies are anticipated to provide the market with profitable growth opportunities during the forecast period.

Companies considered and profiled in this market study

Charles River Laboratories International Inc., SGS SA, Lonza Group, Sigma-Aldrich Corporation, WuXiPharmaTech Inc., Avance Biosciences Inc., BSL Bioservice, Merck KGaA, Cytovance Biologics Inc., Toxikon Corporation.

The players operating in the market have undertaken a number of strategies related to the market in the period 2017-2020. The key highlight is:

  • In May 2020, Beckman Coulter Life Sciences launched RNA extraction Kit for the usage in the research of the COVID-19 virus. The kit can also be used in real-time PCR and infectious disease research.
  • In January 2020, a group of investors founded a new company, i.e., ProKidney, by raising USD 75 million and spent USD 62 million to acquire the cell ¬therapy company inRegen and its manufacturing affiliate, Twin City Bio to develop kidney stem-cell therapies.

Start-Up Traction

The industry offers numerous growth opportunities. Thus, a number of startups providing innovative products and technologies have been entering the market. Some of them include Vitargent, Front Range Biosciences, FungiAert, and Trace Genomics, among others.

Deals Landscape

Mergers and Acquisitions are an integral part of the Biological Safety Testing industry. Along with the companies operating in the market, other key market players have also been entering the industry.

  • In February 2018, MPI Research was acquired by Charles River. The acquisition cost the company USD 800 Million. The deal strengthened the company’s ability to partner with several clients worldwide.
  • In December 2018, Kineta Immuno-Oncology, LLC (KIO), a subsidiary of Kineta Inc, entered into a research collaboration and license agreement with Pfizer Inc. to develop RIG-I agonist immunotherapies for cancer treatment.
  • The Merger and Acquisition (M&A) deal between CSL Behring and Calimmune Inc., took effect on August 2017 will provide CSL Behring with Calimmune's pre-clinical asset, CAL-H, an HSC gene therapy for the treatment of sickle cell disease and β-thalassemia, which complements CSL Behring's current product portfolio and deep expertise in hematology.

Expert Insights:

Reports and Data forecast promising developments for increased adoption of Biological Safety Testing. According to industry experts, new manufacturers are expected to enter the market, which is likely to provide enhanced market products. New Biological Safety Testing companies entering the industry would focus on innovating and providing through advanced technologies, thereby reducing complexity and lowering the overall total cost of operation. Experts also believe that increase in the adoption of the latest technology in emerging nations would be a key development area for the industry.

Segments Covered in the report

This report forecasts revenue growth at a global, regional & country level, and provides an analysis of the market trends in each of the sub-segments from 2020 to 2030. The scope of the report can be defined as:

For the purpose of this report, Reports and Data have segmented the global Biological Safety Testing Market on the basis of Product, Application, Test Type, and region:

Biological Safety Testing Market Report Scope

Segments covered By Product Outlook, Application Outlook, Test Type Outlook, Regional Outlook

By Product Outlook       

Reagents & kits



By Application Outlook

Vaccines & therapeutics

Stem cell

Tissue & tissue-based products

Gene therapy

Blood & blood-based therapy

By Test Type Outlook    

Endotoxin tests

Bioburden tests

Adventitious agent detection tests

Residual host contamination detection tests

Sterility tests

Cell line authentication and characterization tests


Regional scope

North America


Asia Pacific

Latin America

Middle East & Africa

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