Forecast
Period
|
2025-2029
|
Market
Size (2023)
|
USD
3.98 Billion
|
CAGR
(2024-2029)
|
9.10%
|
Fastest
Growing Segment
|
Reagents
& Kits
|
Largest
Market
|
North America
|
Market
Size (2029)
|
USD
6.73 Billion
|
Market Overview
Global Biological Safety Testing Products and
Services Market was valued at USD 3.98 Billion in 2023 and is anticipated to witness
a steady growth in the forecast period with a CAGR of 9.10% through 2029. Biological Safety Testing Products and
Services refer to a broad range of tools, methodologies, and services used to
assess the safety, quality, and purity of biological products, pharmaceuticals,
medical devices, and various other materials that meet living organisms. These
products and services are critical for ensuring that biological substances, including
vaccines, biologics, drugs, medical devices, and research materials, meet
stringent safety and quality standards. Specialized equipment, such as
automated liquid handling systems, microbiological incubators, and analytical
instruments, is used for sample preparation and analysis in biological safety
testing. Various consumable items, including culture media, microplates,
pipettes, and filtration membranes, are essential for conducting biological
safety tests. Testing laboratories offer analytical services to assess the
quality and safety of products, from pharmaceuticals to medical devices. These
services may include potency testing, stability testing, and method validation.
Custom method development and validation services are essential for creating
and verifying testing protocols tailored to specific products and materials.
Increasing healthcare spending and a growing
emphasis on patient safety worldwide drive demand for biological safety
testing, particularly in the quality control of medical devices and
pharmaceuticals. Advances in testing technologies, such as rapid
microbiological methods, molecular biology techniques, and high-throughput
screening, enhance the efficiency and accuracy of biological safety testing. As
biopharmaceutical companies expand their global presence, they require reliable
biological safety testing services and products in multiple regions. There's a
growing emphasis on sustainable practices and reducing the environmental impact
of laboratory testing, influencing the choice of testing products and services.
The continuous development of new drugs and vaccines, including personalized
medicine, drives demand for biological safety testing in research and clinical
trials.
Key Market Drivers
Technological Advancements
Rapid Microbiological Methods (RMMs) have reduced
the time required for traditional microbiological testing, such as sterility
testing and microbial limit testing. Techniques like polymerase chain reaction
(PCR), real-time PCR, and next-generation sequencing (NGS) enable faster and
more accurate detection of microorganisms. Automation and robotics have
streamlined high throughput screening processes, allowing for the testing of
many samples simultaneously. This has increased the efficiency and throughput
of biological safety testing. Advanced testing platforms permit the
simultaneous measurement of multiple parameters, such as multiple analytes or
different biological safety indicators, in a single assay. This reduces the
time and resources required for testing. Label-free assays, such as surface
plasmon resonance (SPR) and biolayer interferometry (BLI), enable real-time
monitoring of binding interactions without the need for labeling molecules,
making them valuable in affinity testing. Automated liquid handling, sample
preparation, and data analysis systems have improved testing accuracy and
reproducibility while reducing the risk of human error.
Mass spectrometry has become a powerful tool for
high-throughput analysis of biochemical activities and binding interactions.
Innovations in MS technology have made it a versatile platform for various
types of biological safety testing. High-resolution imaging and microscopy
techniques provide detailed insights into the structure and behavior of
microorganisms, cells, and other biological components, enhancing testing
capabilities. AI and machine learning algorithms are being used to analyze
large datasets, identify patterns, and predict outcomes in biological safety
testing. They improve decision-making and data interpretation. Cloud-based
platforms and remote monitoring tools allow for real-time access to testing
data, enhancing collaboration, and enabling more efficient data analysis and
reporting.
Biosensor technologies, including surface plasmon
resonance sensors, optical sensors, and electrochemical sensors, offer
real-time monitoring and quantitative measurement of biological interactions,
making them valuable for safety testing. Techniques like nuclear magnetic
resonance (NMR) and Fourier-transform infrared (FTIR) spectroscopy are used to
analyze the chemical composition of samples, aiding in safety assessment. Microfluidics
and lab-on-a-chip technologies have led to smaller, more portable testing
devices, reducing the sample size required and allowing testing in a wider
range of settings. Technology is advancing in the realm of data security and
compliance management to meet regulatory requirements, ensuring data integrity
and traceability. This factor will help in the development of the Global
Biological Safety Testing Products and Services Market.
Rising Global Healthcare Expenditure
As
healthcare spending increases, there is a growing emphasis on ensuring the
safety, efficacy, and quality of medical products and treatments. Biological
safety testing is essential for maintaining high standards and quality
assurance in the healthcare sector. Patient safety is a top priority in
healthcare. Ensuring that medical devices, pharmaceuticals, vaccines, and
diagnostic tools are free from harmful contaminants and pathogens is essential
to prevent harm to patients. Regulatory agencies, such as the FDA in the United
States and equivalent bodies in other countries, enforce strict safety and
quality standards for healthcare products. Compliance with these regulations
necessitates extensive biological safety testing throughout the product
development and manufacturing process. With increased healthcare expenditure,
there is more investment in research and development for new medical products,
including drugs, biologics, and medical devices. These products require
rigorous biological safety testing to reach the market.
The demand
for diagnostic tools and tests continues to rise as healthcare becomes more
personalized and precision oriented. These diagnostics must undergo rigorous
testing to ensure accurate and reliable results. Healthcare spending drives the
pharmaceutical and biotechnology industries, which depend on biological safety
testing to ensure the safety and efficacy of drugs, biologics, and vaccines. The
growing use of medical devices in healthcare, ranging from simple instruments
to complex equipment, necessitates biological safety testing to meet regulatory
and quality control standards. Preventing the spread of healthcare-associated
infections is a key focus in healthcare. Biological safety testing is crucial
in assessing the effectiveness of infection control measures and products used
in healthcare facilities.
With the increasing interconnectedness of global
healthcare, concerns over global health threats, such as pandemics or emerging
infectious diseases, highlight the need for biological safety testing in
diagnostics, treatment, and research. Expanding healthcare expenditure supports
innovation in the development of new medical treatments, which, in turn,
requires extensive research and testing, including biological safety testing. Growth
in healthcare expenditure is not limited to one region, it's a global phenomenon.
Therefore, biological safety testing products and services have a broad
international market. Clinical trials, a crucial step in bringing new
treatments and medical products to market, rely on rigorous biological safety
testing to ensure the safety of study participants and the efficacy of
interventions. This factor will pace up the demand of the Global Biological
Safety Testing Products and Services Market.
Global Expansion of Biopharmaceutical Companies
Biopharmaceutical companies conduct extensive
research and development activities to develop new drugs, biologics, vaccines,
and medical devices. As they expand globally, these companies require
biological safety testing to ensure the safety and efficacy of their products,
both in their home countries and in new international markets. Regulatory
agencies in different countries have their own specific requirements for
product safety and quality. Global biopharmaceutical companies must adhere to
these diverse regulatory standards, which often involve thorough biological
safety testing to obtain product approvals. The expansion of biopharmaceutical
companies into new regions increases the demand for biological safety testing
products and services. These companies need to meet the safety and quality
standards of local markets where they operate or sell their products. Biopharmaceutical
companies often have diverse product portfolios, ranging from pharmaceuticals
to biologics, vaccines, and medical devices. Each of these product categories
requires specific biological safety testing tailored to its characteristics. Many
biopharmaceutical companies outsource aspects of their research, development,
or manufacturing processes to contract research organizations (CROs) or
contract manufacturing organizations (CMOs). These service providers rely on
biological safety testing to meet their clients' demands.
The biopharmaceutical industry is expanding rapidly
in emerging markets such as Asia, Latin America, and the Middle East. These
markets offer significant growth opportunities for global biopharmaceutical
companies, further driving the need for biological safety testing in these
regions. Global biopharmaceutical companies often collaborate with research
institutions, academic centers, and biotech startups around the world.
Collaboration frequently involves biological safety testing for research and
development projects. Biopharmaceutical companies lead in advanced research and
innovation, such as the development of biologics, personalized medicine, and
gene therapies. These cutting-edge products require sophisticated biological
safety testing. Expanding globally necessitates launching and distributing
products in different markets. Each market has specific requirements for
biological safety testing before product distribution. Collaborations with
governments and healthcare organizations to address public health issues, such
as vaccination campaigns or outbreak responses, require robust biological
safety testing for diagnostics, vaccines, and treatments. This factor will
accelerate the demand of the Global Biological Safety Testing Products and
Services Market.

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Key Market Challenges
Cost Pressures
Meeting the stringent regulatory requirements for
biological safety testing can be costly. Companies must invest in staff
training, quality control measures, and documentation to ensure compliance with
various regulations, in addition to operational expenses. To stay competitive
and meet evolving testing needs, companies in the industry must continually
invest in cutting-edge laboratory equipment, instrumentation, and advanced
technologies. These investments can be substantial and impact on the overall
cost structure. Skilled professionals, such as microbiologists, biochemists,
and quality control experts, are essential for biological safety testing.
Attracting and retaining these experts can be costly due to the high demand for
their specialized skills. Biological safety testing often requires the use of
specialized reagents, consumables, and test materials, which can be expensive.
Additionally, the labor-intensive nature of some testing procedures contributes
to operational costs. Ensuring the accuracy and reliability of testing results
necessitates comprehensive quality control and validation processes, which can
be resource intensive.
Complex Sample Types
Complex samples can be highly heterogeneous, with
variations in composition, concentration, and physical properties. This
heterogeneity complicates testing and may require more extensive testing
procedures to account for potential variations. Complex samples may contain
substances that interfere with the accuracy of testing methods. Interfering
substances can lead to false positives or false negatives, making it essential
to develop testing methods that can distinguish and quantify multiple components.
Preparing complex samples for testing can be time-consuming and
labor-intensive. Specialized sample preparation techniques may be necessary to
extract, concentrate, or purify specific analytes or components of interest. Complex
samples may carry a higher risk of cross-contamination during testing, which
can compromise the integrity of results. Careful handling and containment
measures are required to avoid contamination. Complex samples often necessitate
multiplex testing, where multiple analytes or parameters are tested
simultaneously. This requires advanced equipment and methodologies to ensure
accurate and reliable results. The matrix of complex samples can influence the
performance of analytical methods. Matrix effects can lead to biased or
inaccurate results, and compensation strategies may be required.
Key Market Trends
Customization and Outsourcing
Customization involves tailoring biological safety
testing services to the specific requirements of clients or projects. Businesses
are increasingly seeking customized testing solutions that address their unique
needs, whether related to the type of samples, the parameters being tested, or
specific regulatory considerations. Customized services can range from assay
development to adapting testing methodologies to accommodate complex or
atypical sample types. Many companies are outsourcing their biological safety
testing needs to specialized contract testing organizations (CROs). Outsourcing
offers several advantages, including access to specialized expertise,
state-of-the-art equipment, and cost-effectiveness. CROs often offer a range of
testing services, from endotoxin testing to mycoplasma testing, sterility
testing, and bioburden testing. This trend aligns with the growing emphasis on
cost-efficiency, streamlined processes, and access to the latest testing
technologies.
Segmental Insights
Product Insights
Based on Product, Reagents & Kits have emerged as the fastest growing segment in the Global Biological Safety Testing Products and Services Market in 2023. Reagents & kits are fundamental components used in a wide range of biological
safety testing procedures. They include materials for various tests, such as
endotoxin testing, mycoplasma testing, and sterility testing. Their essential
nature in the testing process contributes to their market dominance. Many
biological safety tests, such as those required for pharmaceuticals, vaccines,
and medical devices, are performed regularly as part of quality control and
safety assurance in the manufacturing process. This leads to a consistent
demand for reagents and kits. The pharmaceutical and biotechnology industries
are highly regulated, with stringent requirements for product safety and
quality. Compliance with these regulations often necessitates the use of
standardized reagents and kits for testing. Reagents and kits are versatile and
can be used across various types of biological safety testing, making them
attractive to laboratories and manufacturers seeking a one-stop solution for
different testing needs.
Test Type Insights
Based on Test Type, Endotoxin Tests have emerged as the dominating segment in the Global Biological Safety Testing Products and Services Market in 2023. Endotoxin testing is a critical component of
quality control and safety assessment in the biopharmaceutical and medical device
industries. Regulatory agencies such as the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA) mandate rigorous testing for
endotoxins to ensure the safety of pharmaceutical products, medical devices,
and vaccines. This regulatory requirement drives significant demand for
endotoxin testing services and products. Endotoxins, which are components of
the cell walls of Gram-negative bacteria, can be harmful when introduced into
the human body. They are known to cause severe adverse reactions, including
fever, sepsis, and even death. Consequently, ensuring that endotoxin levels are
within safe limits is vital to product safety and patient well-being. Endotoxin
testing is used in a wide range of applications, including testing of drugs,
vaccines, medical devices, and biotechnology products. As these industries
continue to expand and develop new products, the demand for endotoxin testing
remains consistently high. The pharmaceutical industry relies on endotoxin
testing to validate the quality of drugs and pharmaceutical products. Any
failure to meet endotoxin limits can lead to product recalls and regulatory
issues, making it a top priority for pharmaceutical companies. With a growing
emphasis on patient safety, pharmaceutical manufacturers and healthcare
providers place a significant focus on ensuring that endotoxin levels are
within safe limits to prevent harm to patients who use these products.

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Regional Insights
Based on Region, North America have emerged as the dominating region in the Global Biological
Safety Testing Products and Services Market in 2023. North America,
particularly the United States, is home to a robust and highly developed
biopharmaceutical industry. This industry encompasses pharmaceuticals, biotechnology,
and medical device companies that require extensive biological safety testing
to ensure product safety and compliance. The presence of numerous
biopharmaceutical firms creates a significant demand for biological safety
testing products and services. The region is known for its cutting-edge
research and development activities in the life sciences sector. This research
includes drug discovery, vaccine development, and biotechnology advancements,
all of which necessitate rigorous biological safety testing. The United States
has a stringent regulatory environment governed by agencies like the U.S. Food
and Drug Administration (FDA) and the Environmental Protection Agency (EPA).
These agencies enforce strict safety and quality standards, which require
extensive testing of biopharmaceutical products, contributing to the demand for
testing services. North American companies and research institutions often lead
in the development and adoption of innovative testing technologies. This
emphasis on innovation and continuous improvement helps maintain the region's
leadership in biological safety testing. The region has access to a highly
skilled and educated workforce with expertise in biotechnology, biochemistry,
microbiology, and related fields, which is crucial for conducting complex
biological safety tests.
Recent Developments
- In August 2023, Lonza launched the Nebula Absorbance Reader, an innovative absorbance microplate reader that broadens the company's portfolio of optimized instruments for efficient endotoxin and pyrogen testing in quality control laboratories. This new reader features enhanced functionality with high-performance optics and monochromator-based wavelength selection, ensuring precise and accurate endotoxin measurements. Its compact design reduces laboratory space requirements and promotes workflow flexibility. Additionally, it integrates seamlessly with Lonza's latest WinKQCL Endotoxin Detection and Analysis Software (v6.4), enabling compliance with the latest data integrity standards. This integration minimizes the need for current WinKQCL Software users to adjust to new software when adopting the Nebula Absorbance Reader. Furthermore, the reader shares a similar design and structure with the Nebula Multimode Reader, utilizing the same user manual, service tools, and qualification procedures, thereby simplifying system maintenance.
Key Market
Players
- Charles River Laboratories International, Inc.
- BSL Bioservice Scientific Laboratories Munich GmbH
- Merck KGaA
- Samsung Biologics
- Sartorius AG
- Eurofins Scientific (Ireland) Limited
- SGS Société Générale de
Surveillance SA
- Thermo Fisher Scientific
Inc.
- BIOMÉRIEUX SA
- Lonza Group Ltd.
By Product
|
By Application
|
By Test Type
|
By Region
|
- Reagents & Kits
- Services
- Instruments
|
- Vaccines & Therapeutics
- Gene Therapy
- Monoclonal Antibodies
- Recombinant Protein
- Blood & Blood-based Products
- Tissue & Tissue-based Products
- Stem Cells
|
- Endotoxin Tests
- Sterility Tests
- Cell Line Authentication &
Characterization Tests
- Bioburden Tests
- Adventitious Agent Detection Tests
- Residual Host Contamination Detection
Tests
- Others
|
- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global Biological Safety
Testing Products and Services Market has been segmented into the following
categories, in addition to the industry trends which have also been detailed
below:
- Biological Safety Testing Products and Services
Market, By
Product:
o Reagents & Kits
o Services
o Instruments
- Biological Safety
Testing Products and Services Market, By Application:
o Vaccines & Therapeutics
o Gene Therapy
o Monoclonal Antibodies
o Recombinant Protein
o Blood & Blood-based Products
o Tissue & Tissue-based Products
o Stem Cells
- Biological Safety
Testing Products and Services Market, By Test
Type:
o Endotoxin Tests
o Sterility Tests
o Cell Line Authentication & Characterization
Tests
o Bioburden Tests
o Adventitious Agent Detection Tests
o Residual Host Contamination Detection Tests
o Others
- Biological Safety Testing Products and Services
Market, By Region:
o North America
§ United
States
§ Canada
§ Mexico
o Asia Pacific
§ China
§ India
§ South Korea
§ Australia
§ Japan
o Europe
§ Germany
§ France
§ United
Kingdom
§ Spain
§ Italy
o South
America
§ Brazil
§ Argentina
§ Colombia
o Middle
East & Africa
§ South
Africa
§ Saudi
Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Biological
Safety Testing Products And Services Market.
Available Customizations:
Global Biological Safety Testing Products and
Services Market report with the given market data, Tech Sci Research offers
customizations according to a company's specific needs. The following
customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
Global Biological Safety Testing Products and Services
Market is an upcoming report to be released soon. If you wish an early delivery
of this report or want to confirm the date of release, please contact us at [email protected]