Biological Safety Testing Products & Services Market Analysis Report By Product (Reagents & Kits, Instruments, Services), By Application (Vaccines & Therapeutics, Gene Therapy, Stem Cell), By Test By Region, And Segment Forecasts, 2019 - 2026

Industry Insights

The global biological safety testing products & services market size was valued at USD 2.77 billion in 2018 and is expected to grow at a CAGR of 12.3% over the forecast period. The market is primarily driven by the increasing production of new-generation biologics by major pharmaceutical and biotechnology companies. The high prevalence of target diseases globally has encouraged companies to increase the production of advanced biologics.

The rising need for biologics has resulted in unprecedented growth in the number of biopharmaceutical companies. Increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve aspects of manufacturing processes such as productivity and cost-efficiency. Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of the production cycle, thereby aiding the market growth.

The rising number of government initiatives to promote biological safety testing products and services is anticipated to drive overall growth over the forecast period. The high rate of microbial contamination and bioburden while manufacturing pharmaceuticals and biologics is expected to drive government and private organizations to improve underlying biological safety practices.

Moreover, the presence of regulatory authorities to enforce significant safety standards is anticipated to boost the adoption of testing tools. Stringent guidelines and recommendations issued by these authorities increase the incorporation of these tools by quality assurance technicians, thus fueling the market growth.

Biological safety testing services are used to ensure the safety of vaccines and biopharmaceuticals by confirming the absence of bacterial contaminants. Companies are offering services such as toxicology testing, bioburden testing, and analytical testing, which assess products on parameters such as accuracy, specificity, linearity, and range.

Product Insights

Reagents and kits accounted for the largest market share, based on the product, in 2018. Reagents are a major component in biological safety testing and hence are extensively used in research and clinical laboratories. These reagents are antibiotics, attachments & matrix factors, biological buffers, freezing & dissociation reagents, and miscellaneous reagents. Rapid advancements and modifications in the formulation of reagents and kits are expected to increase their adoption by laboratory technicians, especially in toxicology assessment.

The instruments segment is expected to grow during the forecast period due to rising demand in biological safety testing laboratories. Besides, rising pressure from regulatory bodies on biopharmaceutical companies to implement safety guidelines is also boosting the demand for instruments. These are used in biological assays to perform toxicology and bioburden tests, among others.

Application Insights

Vaccine and therapeutics held the largest share, based on application, in 2018. Clearly defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity are among the factors responsible for the largest share held by this segment. Several guidelines and recommendations issued by regulatory authorities such as the U.S. FDA about characterization and qualification of materials used in the production of vaccines for infectious disease indications are expected to fuel segment growth.

This segment is also anticipated to grow at a lucrative rate during the forecast period owing to factors such as a significant increase in disease outbreaks over the years. The increasing need for vaccines to prevent diseases is supporting the adoption of biological safety tools. Moreover, gene therapy is expected to exhibit growth at a significant rate during the forecast period owing to the high risk of contamination with residual DNA. Residual DNA might be considered to pose a potential risk to the final product due to high infectivity potential.

Test Type Insights

Endotoxin tests dominated the biological safety testing products and services market in terms of revenue in 2018. The substantial share can be attributed to the rising usage of these tests in various areas such as the manufacturing and production of drugs to reduce the threat of endotoxins. Also, the availability of numerous types of endotoxin tests, such as gel clot endotoxin testing, turbidimetric method, and USP chromogenic endotoxin testing, which are designed to meet different requirements, is likely to boost segment growth.

The bioburden tests segment is expected to grow at a lucrative rate over the forecast period. This can be attributed to the high adoption of these tests to determine the bioburden limit in a wide range of biologics and medical devices. Moreover, the integration of advanced colorimetric methods and computation has enabled the rapid generation of results and precise bioburden quantification. Rapid advancements in this segment are further expected to aid in segment growth.

Regional Insights

North America held the largest share of the global market in 2018. The dominant share can be attributed to high investments in biotechnology, increased adoption in cancer research, and the development of new biologics, vaccines, & drugs. Moreover, an increasing number of R&D investments by companies is one of the factors responsible for growth.

The presence of major market players undertaking extensive expansion strategies is also expected to boost the market. Moreover, the increasing burden of chronic diseases in this region is anticipated to increase the usage of advanced technologies by researchers and healthcare professionals. This is further anticipated to widen the scope for growth.

The Asia Pacific market is anticipated to grow at a lucrative CAGR over the forecast period. Various factors such as rising healthcare spending and increasing awareness about the benefits of these products are expected to contribute to growth. Also, Asia‐Pacific Biosafety Association trains concerned professionals across the region on biosafety principles and practices, thus widening growth prospects in this region.

Biological Safety Testing Products & Services Market Share Insights

The market is highly competitive and a considerable number of players dominate the market. Some of the key market players are Charles River Laboratories, Lonza Group, MilliporeSigma, and Sartorius Stedim BioOutsource Limited. These players hold considerable market shares owing to their wide product offerings.

Market leaders are involved in extensive R&D for producing cost-efficient and technologically advanced testing products. Besides, various strategies, such as mergers & acquisitions, being undertaken by these companies to improve market presence are expected to create lucrative growth opportunities over the forecast period. For instance, in 2018, Charles River Laboratories, Inc. acquired MPI Research, expanding its ability to provide drug discovery and development services.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, & country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2015 to 2026. For this study, Grand View Research has segmented the biological safety testing products & services market report based on the product, application, test type, and region:

• Product Outlook (Revenue, USD Million, 2015 - 2026)

  • Reagents & kits

  • Instruments

  • Services

• Application Outlook (Revenue, USD Million, 2015 - 2026)

  • Vaccines & Therapeutics

  • Blood & Blood-based Products

  • Gene Therapy

  • Tissue & Tissue-based Products

  • Stem Cell

• Test Type Outlook (Revenue, USD Million, 2015 - 2026)

  • Endotoxin Tests

  • Sterility Tests

  • Cell Line Authentication & Characterization Tests

  • Bioburden Tests

  • Adventitious Agent Detection Tests

  • Residual Host Contamination Detection Tests

  • Others

• Regional Outlook (Revenue, USD Million, 2015 - 2026)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE