Biologics Safety Testing Market by Product (Consumables, Instruments, and Services), Test Type (Endotoxin, Mycoplasm, Sterility Test, and Others), Application (Vaccine & Therapeutics, Monoclonal Antibodies, Blood Based Products, Cell & Gene Therapy, and Others), End-User (Hospitals, Pharmaceuticals & Biotechnology and Research & Academia) and Region (North America, Europe, Asia Pacific, Middle East & Africa, and South America) — Industry Trends and Forecast to 2030

The Global Biologics Safety Testing Market has been estimated to reach a value of USD 3.0 billion in 2021 and is projected to grow at a CAGR of 12.3% during the forecast period from 2021-2030. Factors like rising investments in clinical research and drug development, increasing numbers of testing laboratories, and high prevalence of diseases will drive the market growth in the coming years. The present COVID-19 pandemic situation is further increasing vaccine testing and trials to develop corona vaccines. Government initiatives and vaccine production for the same will, therefore, drive the market.

Biologics safety testing is conducted on drugs, vaccines, therapeutics, stem or tissue cells, and other blood derived products. The testing ensures contamination-free products. Furthermore, the growth in biopharmaceutical product pipelines will accelerate the market growth. The presence of various organizations like FDA and CDC for approvals and testing of drugs has a huge impact on the biologics safety testing market.

Technological innovations and continuous development of products by key players and patents regarding safety testing will provide a major stimulus to the market. For instance, in April 2021, Lonza expanded its robotic solution for endotoxin testing. However, lack of skilled professional can be a challenge for market growth. Also, high costs of testing equipment can hamper the growth of the market.




The global biologics safety testing market report has been segmented by product, test type, application, end-user, and region.


Global Biologics Safety Testing Market, By Product

Based on product, the market for biologics safety testing is divided into consumables, instruments, and services. The instruments and services segments will grow significantly in the market during the forecast period. The instruments used for biologics safety testing include test kits and reagents, whose rising demand in the coming years will drive the market. Rising prevalence of diseases will further increase the demand for instruments and services. The adoption of digitalization will also have a positive impact on biologics safety testing services.

Global Biologics Safety Testing Market, By Test type

Based on the test type, the market for biologics safety testing is segmented into endotoxin, mycoplasm, sterility test, and others. The mycoplasm test will have a significant impact on market growth. The test is related to the measurement of antibodies in blood. Sterility test will also grow due to its demand for testing of pharmaceutical drugs and biopharmaceutical therapeutics. The increasing demand for injectable products and implantable devices in contact with blood requires the testing of bacterial endotoxins and hence, will drive the market.

Global Biologics Safety Testing Market, By Application

Based on application, the market is divided into vaccine & therapeutics, monoclonal antibodies, blood based products, cell & gene therapy, and others. Vaccine & therapeutics and monoclonal antibodies segments will grow significantly during the analysis period. The vaccine is the most efficient way to treat viruses.

The testing and trials of vaccine is an important aspect for safety check. Organizations like Food and Drug Administrative (FDA) and Centers for Disease Control and Prevention (CDC) check the potency, purity, sterility, reliability, and safety of drugs or vaccines, and then approve them accordingly. The rising prevalence of diseases and government initiatives regarding monoclonal drugs will drive the market.

Global Biologics Safety Testing Market, By End-User

Based on the end-user, the biologics safety testing market is segmented into hospitals, pharmaceuticals & biotechnology, and research & academia. The pharmaceutical and biotechnology companies will lead the market during the analysis period. Continuous research & development activities and product launches in the healthcare industry will enhance the market growth. Drug development, gene or culture line development, and testing products will influence the market. Developing countries like India are emerging in the biotechnology sector by focusing on vaccine development and other drug discoveries, which will boost the market growth during the forecast period.

The research & academia segment will also witness significant growth in the coming years. Increasing research and development activities will raise the demand for biosafety guidelines and sophisticated testing equipment. This will accelerate market growth over the forecast period.

Global Biologics Safety Testing Market, By Region

Based on regions, the global biologics safety testing market is segmented into North America, Europe, Asia Pacific, the Middle East & Africa, and South America. North America is expected to dominate the market during the forecast period. The presence of key players in this region and technological advancements in the biopharmaceutical industry will promote the growth of the market. Furthermore, increasing research & development activities and government approvals will improve the market growth.

Asia Pacific is expected to witness significant growth during the forecast period. The presence of the fastest growing countries like China, South Korea, and Japan, and developments in the medical industry will drive the market in this region. Furthermore, resource availability, low labour wages, and industrial regulations will also provide a major impetus to the market.



Recent Developments in the Global Biologics Safety Testing Market

  • In May 2021, Clean Biologics, biopharmaceutical company has announced the acquisition of Biodextris, a contract and manufacturing organization in Canada. Biodextris provides quality control testing services, early phase clinical manufacturing, and process development.
  • In May 2021, Roche Diagnostics has announced its partnership with Canadian Blood Services for serology tests, i.e., Elecsys Anti-SARS-CoV-2-S and Elecsys Anti-SARS-CoV-2, to understand the immune response by comparing the level of COVID-19 virus after natural infection and COVID-19 vaccine.
  • In May 2021, Moderna has announced the supply of 0.025 billion doses to Australia, including 0.010 billion doses of Moderna’s mRNA-1273 ancestral strain and 0.015 billion of updated variant booster.
  • In March 2021, Rapid Micro Biosystems announced the funding of about USD 0.081 billion to improve the safety and data integrity of vaccines, cell & gene therapy, and expansion of automated platform for pharmaceutical tests.
  • In November 2020, PathoQuest SAS, in strategic partnership with Charles River Laboratories International, announced the establishment of its subsidiary PathoQuest, Inc for NGS-based testing laboratory.
  • In January 2020, Lonza Bioscience launched the PyroCell MAT system, a reliable and sustainable solution for in vito pyrogen testing. The system will ensure the safety of parental pharmaceuticals during product development, manufacture, and release.

What Does This Report Provide?

This report provides a detailed understanding of the global biologics safety testing market from qualitative and quantitative perspectives during the forecast period. The report also provides dynamic indicators with potential impact on the market during the forecast period and an in-depth analysis of the leading companies operating in the market. The major market drivers, challenges, and opportunities for the global biologics safety testing market have been covered in the report. This report further includes the market shares of the leading companies operating in the global market, along with their production capacities and the growth strategies adopted by them.

Market Segmentation:

By Product:

  • Consumables
  • Instruments
  • Services

By Test type:

  • Endotoxin
  • Mycoplasm
  • Sterility Test
  • Others

By Application:

  • Vaccine & Therapeutics
  • Monoclonal Antibiotics
  • Blood Based Products
  • Cell & Gene Therapy
  • Others

By End-User:

  • Hospitals
  • Pharmaceuticals & Biotechnology
  • Research & Academia

By Region:

North America Biologics Safety Testing Market

  • North America, by Country
    • U.S.
    • Canada
    • Mexico
  • North America by Product
  • North America by Test type
  • North America by Application
  • North America by End-User

 Europe Biologics Safety Testing Market

  • Europe, by Country
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe 
  • Europe by Product
  • Europe by Test type
  • Europe by Application
  • Europe by End-User

Asia Pacific Biologics Safety Testing Market

  • Asia Pacific, by Country
    • China
    • India
    • Japan
    • South Korea
    • Australia
    • Rest of Asia-Pacific 
  • Asia Pacific by Product
  • Asia Pacific by Test type
  • Asia Pacific by Application
  • Asia Pacific by End-User

Middle East and Africa Biologics Safety Testing Market

  • Middle East and Africa, by Country 
    • UAE
    • Saudi Arabia
    • Qatar
    • South Africa
    • Rest of Middle East and Africa
  • Middle East and Africa by Product
  • Middle East and Africa by Test type
  • Middle East and Africa by Application
  • Middle East and Africa by End-User

South America Biologics Safety Testing Market

  • South America, by Country 
    • Brazil
    • Argentina
    • Rest of South America
  • South America by Product
  • South America by Test type
  • South America by Application
  • South America by End-User

Major Companies: In this report, the major companies studied are: Maravai Lifesciences, Associates of Cape Cod, Inc., bioMérieux SA, Sartorius AG, F. Hoffmann-La Roche Ltd., Nelson Laboratories, LLC, Bio-Rad Laboratories, Inc, Agilent Technologies, Inc., Microcoat Biotechnologie GmbH, PromoCell GmbH, Almac Group, Lonza, Thermo Fisher Scientific, Inc., Merck KGaA, SGS SA, and WuXi AppTec   

Objectives of this Report:

  • To estimate the market size for the biologics safety testing market on a regional and global basis.
  • To identify major segments in the biologics safety testing market and evaluate their market shares and demand.
  • To provide a competitive scenario for the market with major developments observed by the key companies in the historic years.
  • To evaluate key factors governing the dynamics of biologics safety testing market with their potential gravity during the forecast period.
  • To evaluate the leading company-wise pricing analysis for the mentioned applications.

Key Questioned Answered in the Study:

  • What are major growth drivers and market trends that are impacting on the global biologics safety testing market?
  • What is the market size both in terms of value and volume for the global biologics safety testing market?
  • Who are the leading market players and who are the new market players that operate in the global market with an estimated market share?
  • What are the future investment pockets and opportunity in the global biologics safety testing market?
  • Major list of customers and potential futuristic customer list along with an estimated buying volume
  • Impact of COVID-19 on the global biologics safety testing market


This study is customized to meet your specific requirements:

  • By sub-segment
  • By client-specific country, type, and application market analysis
  • Pricing analysis along with the potential list of customers
  • Product-specific competitive anlysis

For more information, contact: