Biological Safety Testing Market Size
| Study Period | 2019 - 2029 |
| Base Year For Estimation | 2023 |
| CAGR | 12.40 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Need a report that reflects how COVID-19 has impacted this market and its growth?
Biological Safety Testing Market Analysis
The biological safety testing market is expected to witness a CAGR of 12.4% during the forecast period.
With the emergence of COVID-19, many pharmaceutical and biotechnology companies began developing novel treatments and vaccines against COVID-19. These rising R&D activities impacted positively the biological safety testing market studied. For instance, in March 2020, Regeneron and Sanofi initiated the development of their biologic Kevzara for the treatment of patients with COVID-19. Kevzara (Sarilumab), jointly developed by Regeneron and Sanofi, also inhibits the IL-6 pathway. Biological safety testing plays a major role in ensuring the purity of vaccines and other biological products. Thus, with the development of new treatments for COVID-19, the demand for biological safety testing has also increased.
Some of the major factors that are driving the market growth are rapidly growing pharmaceutical and biotechnology industries, along with increasing investments, and rising production of new biologics due to the high disease burden. For instance, in 2021, biologics accounted for second of the top-eight drugs in terms of revenue. Humira (adalimumab), which was developed by AbbVie for the treatment of rheumatoid arthritis, psoriasis, Crohn's, and other autoimmune diseases, led to USD 20.7 billion sales, as per the Top 15 Best-selling Drugs of 2021 report. Humira was also the fastest-growing biological drug.
Further, biotechnology-derived products or biologicals have effectively made their way into various aspects of healthcare, including diagnoses, prevention, and treatments of diseases. However, there remain certain potential safety concerns, which generally arise from the manufacturing processes and complex biological and structural characteristics of these products. Therefore, these products need detailed and systematic biological safety testing, that eventually enables the adequate assessment of safety, before any kind of clinical investigation. Hence, the market is expected to thrive over the forecast period.
However, the biological safety process is quite time-consuming and complex which is expected to hinder the market growth.
Biological Safety Testing Market Trends
This section covers the major market trends shaping the Biological Safety Testing Market according to our research experts:
Bioburden Testing Segment is Expected to Hold Significant Share in the Test Segment of the Market Over the Forecast Period
Bioburden Testing Segment is expected to hold a significant share in the test segment of the market over the forecast period. Organizations like the World Health Organization have also released instructions for health managers and health workers on required infrastructures and standard procedures for effective sterilization, and decontamination of medical devices. These factors are expected to increase the demand for proper sterilization, which is expected to boost the demand for Bioburden testing as it acts as an efficient tool in the validation of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes to ensure safety.
Bioburden testing is an integral part of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes, monitoring of raw materials, components, or packaging, and overall environmental monitoring programs. The high adoption rate determines bioburden limits in wide-ranging biologics and medical devices. Further, the development of new products in the market is expected to accelerate the market studied. For instance, in December 2019, the company launched the BD Kiestra IdentifA system in Europe and Canada, which is used for microbial identification. It has incorporated automated sample processing steps that ensure accuracy and minimal error.
Furthermore, there are high bioburden and microbial contamination rates during pharmaceutical and biologics manufacturing, which is expected to drive government and private organizations to improve underlying biological safety practices. Hence, all these practices performed might drive the overall market.
North America Dominates the Market and is Expected to do the Same in the Forecast Period
North America Dominates the Market and is expected to do the same in the forecast period. The United States is expected to contribute majorly to the market growth of this region. Due to the outbreak of COVID-19, the rising R&D activities related to COVID-19 have impacted the market growth positively.
The growth of the biological safety testing market in this region can be directly attributed to the growing biotechnology and pharmaceutical industries in the region. The high growth of these industries is further attributable to factors, such as innovative technologies and the presence of favorable government initiatives. Also, the emerging need for validation of drugs and devices process of manufacturing is expected to boost the demand for the market studied. According to the United States Food & Drug Administration (FDA) report, in 2021, the United States had about 4,814 manufacturing sites for drugs.
Additionally, the advanced healthcare infrastructure and rising R&D spending are expected to increase the revenue size further. According to the data of Pharmaceutical Research and Manufacturers of America (PhRMA), in the United States, about USD 83 billion were spent by the pharmaceutical industry on the R&D. Thus, this is expected to boost the market growth over the forecast period.
Biological Safety Testing Industry Overview
The biological safety testing market is highly competitive and consists of a few major players. Companies, like Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, and WuXi AppTec, among others, hold a substantial share in the market.
Biological Safety Testing Market Leaders
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Eurofins Scientific
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Lonza
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Merck KGaA
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Promega Corporation
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Thermo Fisher Scientific
*Disclaimer: Major Players sorted in no particular order
Biological Safety Testing Market News
- In April 2021, Lonza expanded its product ''PyroTec PRO Automated Robotic Solution'' for endotoxin testing. It is compatible with the company's product PYROGENT-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, Kinetic-QCL Chromogenic LAL Assay, and the PyroGene rFC Assay.
- In December 2020, Redberry introduced a new product ''Red One Automated Bioburden Detection'' that enables instantaneous bioburden detection of microorganisms and has been designed for water and pharmaceutical testing.
Biological Safety Testing Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Growth in the Pharmaceutical and Biotechnology Industries, along with Increasing Investments
- 4.2.2 Rising Production of New Biologics due to High Disease Burden
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4.3 Market Restraints
- 4.3.1 Time Consuming Approval Process
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4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size - Value in USD million)
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5.1 By Product
- 5.1.1 Reagents and Kits
- 5.1.2 Instruments
- 5.1.3 Other Products
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5.2 By Application
- 5.2.1 Vaccines and Therapeutics
- 5.2.2 Cellular and Gene Therapy
- 5.2.3 Blood and Blood-based Therapy
- 5.2.4 Other Applications
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5.3 By Test
- 5.3.1 Sterility Tests
- 5.3.2 Bioburden Tests
- 5.3.3 Endotoxin Tests
- 5.3.4 Other Tests
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5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Avance Biosciences
- 6.1.2 Cytovance Biologics
- 6.1.3 Eurofins Scientific
- 6.1.4 Lonza
- 6.1.5 Merck KGaA
- 6.1.6 Promega Corporation
- 6.1.7 Thermo Fisher Scientific
- 6.1.8 Toxikon
- 6.1.9 WuXi AppTec
- 6.1.10 Biomerieux SA
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityBiological Safety Testing Industry Segmentation
Biological safety testing refers to the testing procedures that are carried out to ensure the non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. This includes various types of sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and residual host contamination detection tests, among others. The Biological Safety Testing market is segmented by Product (Reagents and Kits, Instruments, Other Products), by Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, Other Applications), by Test (Sterility Tests, Bioburden Tests, Endotoxin Tests, Other Tests), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.
| By Product | Reagents and Kits | |
| Instruments | ||
| Other Products | ||
| By Application | Vaccines and Therapeutics | |
| Cellular and Gene Therapy | ||
| Blood and Blood-based Therapy | ||
| Other Applications | ||
| By Test | Sterility Tests | |
| Bioburden Tests | ||
| Endotoxin Tests | ||
| Other Tests | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Biological Safety Testing Market Research FAQs
What is the current Global Biological Safety Testing Market size?
The Global Biological Safety Testing Market is projected to register a CAGR of 12.40% during the forecast period (2024-2029)
Who are the key players in Global Biological Safety Testing Market?
Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation and Thermo Fisher Scientific are the major companies operating in the Global Biological Safety Testing Market.
Which is the fastest growing region in Global Biological Safety Testing Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Global Biological Safety Testing Market?
In 2024, the North America accounts for the largest market share in Global Biological Safety Testing Market.
What years does this Global Biological Safety Testing Market cover?
The report covers the Global Biological Safety Testing Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Biological Safety Testing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Biologics Safety Testing Industry Report
Statistics for the 2024 Biologics Safety Testing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Biologics Safety Testing analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
