Biologics Safety Testing Market Research Report - Forecast till 2027

Biologics Safety Testing Market Report: By Product (Kits & Reagents, Instruments, Services), Test (Sterility, Endotoxin, Cell Line Authentication), Application (Vaccine Development, Blood Products, Stem Cell Research)— Forecast till 2027

ID: MRFR/LS/5336-HCR | November 2022 | Region: Global | 100 Pages         

Biologics Safety Testing Market

Biologics Safety Testing market is anticipated to grow with USD 2.79 billion in 2017 at a CAGR of 13.6% exponentially during the forecast period.


By Product Kits & Reagents Instruments Services
By Test Sterility Endotoxin Cell Line Authentication
By Application Vaccine Development Blood Products Stem Cell Research

Key Players

  • Merck KGaA
  • Charles River Laboratories
  • Sartorius AG
  • Lonza Group Ltd.
  • SGS S.A.
  • Thermo Fisher Scientific Inc
  • Wuxi Apptec
  • Cytovance Biologics Inc.
  • Avance Biosciences Inc.
  • Eurofins Scientific


  • Growth in pharmaceutical and biotechnology industries
  • Increase in a number of drug launches
  • Increasing R&D investments
Speak to Analyst Request a Free Sample

Biologics Safety Testing Market Overview:

Over the projected period, the biologics safety testing market is predicted to increase considerably. The market was worth USD 2.79 billion in 2017 and is expected to grow at a CAGR of 13.6 percent over the forecast period. All biopharmaceutical goods and vaccines must undergo biological safety testing to guarantee that they are safe and free of contaminants. CDER recently authorized 46 new medicines in 2017, compared to 22 in 2016.

Considerations such as the expansion of the pharmaceutical and biotechnology sectors, an increase in the number of medication releases, and increased R&D spending in life science are likely to drive market growth. However, tight government rules for copycat licensing and the high cost of medication research are projected to stymie market expansion throughout the projection period.


The global biologics safety testing market has been segmented into product, test type, and application.

Based on product, the market is segmented into kits and reagents, services, and instruments. The kits and reagents segment accounted for the largest share of the market in 2017.

Based on test type, the market is segmented into sterility tests, endotoxin tests, cell line authentication and characterization tests, residual host contamination detection tests, adventitious agent detection tests, bioburden tests, and others.

Based on application, the market is segmented into vaccine and therapeutics development, blood and blood-related products testing, cellular and gene therapy, tissue and tissue-related products testing, and stem cell research.

The market has been segmented, by region, into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The market in the Americas has further been segmented into North America and South America, with the North American market divided into the US and Canada.

The European market has been segmented into Western Europe and Eastern Europe. Western Europe has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe.

The market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The market in the Middle East and Africa has been segmented into the Middle East and Africa.

Regional Market Summary

Global Biologics Safety Testing Market Share (%), by Region, 2017

Source: Annual Reports, Sec Filings, and Press Release

Geographically, the Americas is anticipated to dominate the global biologics safety testing market owing to a well-established player, new product launches, and increasing demand for biological products.

Europe is expected to hold the second largest position in the global market.

The biologics safety testing market in Asia-Pacific region consists of countries namely China, Japan, Republic of Korea, India, Australia and Rest of Asia-Pacific. The Asia-Pacific region is expected to be the fastest growing region owing to the growth in pharmaceutical and biotech industries.

The Middle East & Africa has the least share of the market. Majority of the market of this region is expected to be held by the Middle East region due to a well-developed healthcare sector.

Global Biologics Safety Testing Market, by Product

  • Kits & Reagents

  • Services

  • Instruments

Global Biologics Safety Testing Market, by Test Type

  • Sterility Tests

  • Endotoxin Tests

  • Cell Line Authentication and Characterization Tests

  • Residual Host Contamination Detection Tests

  • Adventitious Agent Detection Tests

  • Bioburden Tests

  • Others

Global Biologics Safety Testing Market, by Application

  • Vaccine and Therapeutics Development

  • Blood and Blood-Related Products Testing

  • Cellular and Gene Therapy

  • Tissue and Tissue-Related Products Testing

  • Stem Cell Research

Global Biologics Safety Testing Market, by Region

  • Americas

    • North America

      • US

      • Canada

    • South America

  • Europe

    • Western Europe

      • Germany

      • France

      • Italy

      • Spain

      • UK

      • Rest of Western Europe

    • Eastern Europe

  • Asia-Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Rest of Asia-Pacific

  • Middle East & Africa

    • Middle East

    • Africa

Key Players:

  • Merck KGaA

  • Charles River Laboratories

  • Sartorius AG

  • Lonza Group Ltd.

  • SGS S.A.

  • Thermo Fisher Scientific Inc

  • Wuxi Apptec

  • Cytovance Biologics, Inc.

  • Avance Biosciences Inc.

  • Eurofins Scientific

Recent Development

3D Systems is a pioneer in 3D printing for the general public. 3DS offers the most sophisticated and complete 3D design-to-manufacturing solutions available, including 3D printers, print materials, and cloud-sourced bespoke components. Its strong digital thread enables experts and individuals worldwide to bring their ideas to life in a variety of materials such as plastics, metals, ceramics, and foodstuffs. End-to-end simulation, training, and integrated 3D design and printing for tailored surgery and patient-specific medical and dental products are among 3DS' premier healthcare offerings.

EnvisionTEC is a prominent global provider of 3D printing solutions for the quick creation of customized items across a wide range of applications, leveraging its patented consumables. EnvisionTEC has created and distributed 3D print solutions such as 3D printers, print materials, replacement components, as well as training and other services since their initial patent filing in 1999. EnvisionTEC's patented, multi-platform technology provides high accuracy, surface quality, and functionality, as well as the flexibility to employ a wide range of materials at production.

Intended Audience

  • Biologics safety testing products manufacturers and vendors

  • Various research and consulting firms

  • Biologics safety testing Distributors

  • Biologics safety testing services providers

Report Scope:

Report Attribute/Metric Details
  Market Size   Significant Value
  CAGR   13.6%
  Base Year   2019
  Forecast Period   2027
  Historical Data   2018
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Product, Test Type, and Application
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   3D Systems Corporations, Stratasys Ltd., SLM Solutions Group AG, EnvisionTEC, Arcam AB, Organovo Holdings, Inc., Oxford Performance Materials, Inc., Materialise NV, Bio3D Technologies, Cyfuse Medical K.K.EOS GmbHConcept, Laser GmbH, Renishaw plc, Prodways Group, 3T RPD Ltd.
  Key Market Opportunities   Biologics safety testing products manufacturers
  Key Market Drivers

  • Increase in a number of drug launches
  • Increasing R&D investments in life science

  • Speak to Analyst Ask for Customization