Biologics Safety Testing Market Size by Product & Service (Instruments, Consumables, Services), Application (mAbs, Vaccine, Cell & Gene Therapy), Test Type (Sterility Test, Endotoxin, Mycoplasma, Bioburden), End User (Biopharma, CDMO) & Region - Global Forecast to 2027
The size of global biologics safety testing market in terms of revenue was estimated to be worth $3.6 billion in 2022 and is poised to reach $6.8 billion by 2027, growing at a CAGR of 13.3% from 2022 to 2027. The research study consists of an industry trend analysis, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.
The growth of the global market is driven by factors such as the growing development of biologics and biosimilars, growing concerns over cell culture contamination, and rising biopharmaceutical R&D investments. Additionally, emerging markets and increasing outsourcing of biopharmaceutical activities to CROs are expected to provide significant growth opportunities for players in the market. However, a shortage of skilled professionals is expected to limit the growth of this market to a certain extent during the forecast period.
Global Biologic Safety Testing Market Trend
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Biologics Safety Testing Market Dynamics
Driver: Rising investment in biopharmaceutical R&D
Over the years, the prevalence of chronic diseases, such as cancer, diabetes, and neurological and cardiovascular diseases, has increased rapidly worldwide. The research and demand for various drugs, cell therapies, diagnostics, and active biological products are expected to grow due to the increasing incidence and prevalence of such diseases. Considering the regulatory mandates of testing, every biological sample during R&D would be tested for the presence & elimination of various contaminants (such as mycoplasma, endotoxins, and viruses), thereby driving the uptake of biologics safety testing products and services. The growing R&D expenditure by pharmaceutical & biotechnology companies, coupled with the increasing focus on life science projects for developing new therapeutic and diagnostic products, is expected to drive the growth of the overall market.
Opportunity: Increased outsourcing of biopharmaceutical activities to CROs
Contract research organizations (CROs) act as outsourcing partners for pharmaceutical & biotechnology companies and academic institutes. CROs provide several services, such as cell and virus bank characterization, genetic stability testing, raw material testing, bulk-lot release testing, final product release testing, sterility testing services, analytical services for biologics, biodistribution studies, cell-based assay services, cleaning validation studies, biorepository services, next-generation sequencing, and endotoxin determination. Several pharmaceutical & biotechnology companies and academic institutes opt to outsource numerous core functions like manufacturing, clinical trial management, and portions of drug discovery to CROs as the emergence of new technologies have made it unfeasible for companies to undertake all testing functions in-house.
Moreover, CROs can afford to invest in extensive drug discovery infrastructure as they cater to multiple clients. This makes investing in advanced techniques, such as rapid mycoplasma tests and fully automated robotic systems for endotoxin detection, a cost-effective option for CROs. With the increasing outsourcing of various functions to CROs, pharmaceutical and biotechnology companies can reduce their operational costs and R&D budgets. Cost savings, commercial sustainability, and optimal staffing are key advantages driving the outsourcing of safety testing services for large companies. The expanding pipelines of pharmaceutical & biopharmaceutical companies are further expected to drive the outsourcing of biologics safety testing to CROs.
Challenge: High Cost of Biologics
Biologics and biosimilars are medications made from living cells to treat various ailments such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. Biologics are extremely targeted and effective for treating various diseases. However, the manufacturing process of biologics is extremely tedious and requires a lot of R&D expenditure. Biologics are manufactured using various natural sources from living organisms, animals, and humans. The final drug comprises proteins, sugar, DNA, and living cells, an extremely complex manufacturing process. The average cost of biologics drugs treatment ranges from USD 10,000 to 30,000 per year and can exceed USD 500,000 for the most expensive biologics. The cost of biologics is much higher when compared to other drugs like conventional DMARDs, which have been chemically synthesized. The high cost of biologics negatively impacts market growth by reducing the manufacturing requirements and demand in the highly price-sensitive market.
By product & service segment, the consumables segment accounted for the second largest share of the biologics safety testing industry in 2021.
Based on product and service, the biologics safety testing market is segmented into consumables, services, and instruments. In 2021, the consumables segment accounted for the second largest market share. This segment comprises the assays, kits, and reagents used for testing/detection and elimination of various contaminants (viruses, bacteria, fungi, mycoplasma, and toxins, among others) in test samples. Assays, kits, and reagents are used in various biologics safety testing applications, such as process & product validation, process monitoring and quality control, raw material testing, bulk lot release testing, and final product release testing. Kits are widely used in biopharmaceutical companies primarily due to ease of use, long shelf life, and the premeasured nature of the components of these kits. The reagents market is experiencing growth due to the growing applications of biosciences and biotechnology within pharmaceutical and healthcare.
By test type, the mycoplasma tests segment accounted for the second largest share of the biologics safety testing industry in 2021.
Based on test type, the biologics safety testing market is segmented into residual host-cell proteins and DNA detection tests, endotoxin tests, sterility tests, mycoplasma tests, bioburden tests, virus safety tests, and other biologics safety testing. In 2021, the mycoplasma tests segment accounted for the second largest market share. Mycoplasma detection and removal are critical for biologics produced for clinical studies and licensed products for human use. The testing is complicated, as microbes have different and often fastidious requirements for growth. These are the major factors driving the growth of this segment.
By application, the vaccine development and manufacturing segment registered for the highest CAGR of the biologics safety testing industry in 2021.
Based on application, the biologics safety testing market is segmented into monoclonal antibodies development and manufacturing, vaccines development and manufacturing, blood and blood products development and manufacturing, cellular and gene therapy products development and manufacturing, and other applications. In 2021, the vaccine development and manufacturing segment registered the highest CAGR. Vaccine development and manufacturing is expected to grow at the highest rate due to the growing number of infectious diseases; and the necessity of biologics safety testing for quality assurance measure to ensure patient safety.
North America accounted for the largest share of the biologics safety testing industry in 2021.
North America accounted for the largest share of the biologics safety testing market in 2021. Fast paced growth in the biopharmaceutical industry is the major factor driving the growth of the North American market. This region is also witnessing an increase in the development of structure-based drug designs, growing academic & government investments, rising demand for high-quality research tools for data reproducibility, and growing consumer awareness of product safety. Such factors are expected to drive market growth for biologics safety testing in the coming years.
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Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), Labcorp (US), and Eurofins Scientific (Luxembourg). The key players in this market are focusing on strategic expansions, partnerships, and product & service launches to expand their presence in the market.
Scope of the Biologics Safety Testing Industry:
|
Report Metric |
Details |
|
Market Revenue Size in 2022 |
$3.6 billion |
|
Projected Revenue Size by 2027 |
$6.8 billion |
|
Industry Growth Rate |
Poised to Grow at a CAGR of 13.3% |
|
Market Driver |
Rising investment in biopharmaceutical R&D |
|
Market Opportunity |
Increased outsourcing of biopharmaceutical activities to CROs |
The study categorizes the biologics safety testing market to forecast revenue and analyze trends in each of the following submarkets:
By Product & Services
- Consumables
- Instrument
- Services
By Application
- Vaccine Development and Manufacturing
- Monoclonal Antibodies Development and Manufacturing
- Cellular & Gene Therapy Products Development and Manufacturing
- Blood and Blood Products Development and Manufacturing
- Other Application
By Test Type
- Endotoxin Test
- Sterility Test
- Mycoplasma Tests
- Bioburden Tests
- Residual Host-cell Proteins & DNA Detection Tests
- Virus safety Test
- Other Biologics safety Tests
By Region
-
North America
- US
- Canada
-
Europe
- UK
- Germany
- France
- Italy
- Spain
- Rest of Europe
-
Asia Pacific
- China
- Japan
- India
- Rest of Asia Pacific
- Latin America
- The Middle East and Africa
Recent Developments of Biologics Safety Testing Industry:
- In November 2022, Merck KGaA (Germany) invested in expanding its biosafety testing capacity at Rockville, Maryland, US. This site will provide biosafety testing and analytical development services in the US.
- In July 2022, Eurofins Scientific (Luxembourg) acquired Wessling Hungary, a food, environmental, and BioPharma product testing laboratory in Hungary. This acquisition helped expand Eurofins' biopharma testing business in Europe.
- In June 2022, Lonza (Switzerland) launched the PyroCell Monocyte Activation Test to detect non-endotoxin pyrogens and reduce interferences from complex drug products, such as biologics-based pharmaceuticals.
- In March 2021 Charles River Laboratories, Inc. (US) launched a new detection tool, EndoScan-V, a validated endotoxin detection and measurement software used to generate and report quantitative test data. The software performed the requisite measurements and calculations and created test reports with the convenience of digital signature report approval.
- In January 2021, Charles River Laboratories, Inc. (US) partnered with JADE Biomedical to expand its biological testing solutions capabilities geographically and cater to the increasing demand for biologics therapeutics, especially cell and gene therapies. This strategic relationship enabled JADE to expand its current global Good Manufacturing Practice (GMP) product testing operations in Shanghai into a second facility and further build upon its current offering of comprehensive biologics quality management and testing services.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global biologics safety testing market?
The global biologics safety testing market boasts a total revenue value of $6.8 billion by 2027.
What is the estimated growth rate (CAGR) of the global biologics safety testing market?
The global biologics safety testing market has an estimated compound annual growth rate (CAGR) of 13.3% and a revenue size in the region of $3.6 billion in 2022.
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This market research study involved the extensive use of secondary sources, directories, and databases to identify and collect information useful for this technical, market-oriented, and financial study of the global biologics safety testing market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, among other experts, to obtain and verify critical qualitative and quantitative information and to assess market prospects. The size of the biologics safety testing market was estimated through various secondary research approaches and triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
The secondary sources referred to for this research study included publications from government sources such as the Biotechnology and Biological Sciences Research Council (BBSRC), United States Food and Drug Administration (FDA), National Center for Biotechnology Information (NCBI), World Bank, World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Organisation for Economic Co-operation and Development (OECD), National Institutes of Health (NIH), and American Society for Microbiology (ASM).
Secondary sources also include corporate and regulatory filings (such as annual reports, SEC filings, investor presentations, and financial statements); business magazines and research journals; press releases; and trade, business, and professional associations, among others. Secondary data was collected and analyzed to arrive at the overall size of the global biologics safety testing market, which was validated through primary research.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the global biologics safety testing market scenario through secondary research. Several primary interviews were conducted with market experts from both the demand (such as personnel from research centers, government and academic institutes, and pharmaceutical & biopharmaceutical companies) and supply sides (such as C-level and D-level executives, product managers, marketing and sales managers of key manufacturers, distributors, and channel partners) across five major regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. Approximately 80% and 20% of primary interviews were conducted with supply-side and demand-side participants, respectively. This primary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
Breakdown of Primary Participants
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Data Triangulation
After arriving at the overall size of the biologics safety testing market through the methodology mentioned above, this market was split into several segments and subsegments. Market breakdown procedures were employed, wherever applicable, to arrive at the exact market value for the key segments and subsegments. The extrapolated market data was triangulated by studying various macroindicators and regional trends from both demand and supply-side participants.
Report Objectives
- To define, describe, and forecast the biologics safety testing market on the basis of product & service, application, test type, end user, and region
- To provide detailed information regarding the factors influencing the market growth (such as drivers, opportunities, restraints, and challenges)
- To strategically analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall biologics safety testing market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To profile the key players in the global biologics safety testing market and comprehensively analyze their core competencies2 and market rankings
- To forecast the size of the market segments in North America, Europe, the Asia Pacific (APAC), Latin America, and the Middle East and Africa
- To track and analyze competitive developments such as product & service launches, expansions, acquisitions, partnerships, collaborations, and agreements in the biologics safety testing market
Available Customizations:
With the given market data, MarketsandMarkets offers customizations as per your company’s specific needs. The following customization options are available for the report:
Geographical Analysis
- Further breakdown of the European oligonucleotide synthesis market into RoE countries
- Further breakdown of the Asia Pacific oligonucleotide synthesis market into RoAPAC countries
Company Information
- Detailed analysis and profiling of additional market players (up to 5)
Future Growth Drivers for Biosafety Testing Market
- Increasing demand for biopharmaceuticals: The demand for biopharmaceuticals is rapidly increasing due to the aging population and the rise of chronic diseases. Biosafety testing is an essential component of the biopharmaceutical manufacturing process, as it ensures the safety and efficacy of these products.
- Stringent government regulations: The government regulations and guidelines are becoming increasingly strict to ensure the safety of patients and the environment. Biosafety testing is mandated by these regulations to ensure that biopharmaceuticals and other products are safe for use.
- Advancements in technology: The advancements in technology, such as next-generation sequencing, are enabling the development of more sensitive and accurate biosafety testing methods. These technologies are improving the speed and efficiency of biosafety testing, leading to reduced costs and increased throughput.
- Increasing investment in R&D: The increasing investment in research and development activities is driving the growth of the biosafety testing market. As biopharmaceutical companies develop new drugs and therapies, they require extensive biosafety testing to ensure the safety and efficacy of these products.
- Growing focus on quality control: The focus on quality control is increasing in the biopharmaceutical industry, as companies strive to improve their manufacturing processes and reduce the risk of contamination or other issues. Biosafety testing plays a critical role in quality control, ensuring that products meet strict safety and quality standards.
Top 20 Use Cases including Existing and Futuristic for Biosafety Testing Market
- Testing of biopharmaceutical products for contamination and impurities
- Testing of medical devices for safety and efficacy
- Detection of viral infections in blood and tissue samples
- Quality control of food and agricultural products to ensure safety for consumption
- Environmental monitoring to detect pathogens and other contaminants in air, water, and soil
- Identification of antibiotic resistance in bacteria
- Screening of stem cell therapies for safety and efficacy
- Testing of cosmetics and personal care products for safety and toxicity
- Monitoring of microbial communities in industrial settings, such as bioreactors and wastewater treatment plants
- Testing of vaccines for safety and efficacy
- Detection of mycotoxins in food products
- Identification of emerging infectious diseases in humans and animals
- Testing of cell and gene therapies for safety and efficacy
- Quality control of raw materials and intermediates used in biopharmaceutical manufacturing
- Monitoring of water quality in swimming pools and other recreational areas
- Testing of blood and plasma products for safety and purity
- Detection of foodborne pathogens in fresh produce and meat products
- Monitoring of air quality in hospitals and other healthcare facilities
- Screening of genetically modified organisms for safety and compliance with regulatory guidelines
- Testing of packaging materials for safety and compatibility with products.
Niche Threats / Restraints for Biosafety Testing Market in Enterprise
- High cost: Biosafety testing can be expensive due to the equipment, reagents, and trained personnel required. This can be a barrier for smaller companies or those with limited budgets.
- Regulatory hurdles: Regulatory approval is required for many biosafety tests, which can be a lengthy and expensive process. In addition, regulations can vary by country or region, making it difficult for companies operating in multiple locations to comply with all requirements.
- Limited expertise: Biosafety testing requires specialized knowledge and skills, which can be in short supply. Companies may struggle to find qualified personnel to perform the tests or interpret the results.
- Limited sample availability: Some biosafety tests require access to live pathogens or other hazardous materials, which may be difficult to obtain or handle safely. This can limit the scope of testing that can be performed.
- Limited testing capacity: Biosafety testing can be time-consuming and labor-intensive, which can limit the number of samples that can be processed at a given time. This can be a bottleneck for companies with high testing volumes or those facing urgent deadlines.
- Competition from alternative methods: Some companies may opt for alternative methods to biosafety testing, such as in silico modeling or computer simulations. While these methods may be faster or less expensive, they may not be as accurate or reliable as biosafety testing.
- Data privacy and security concerns: Biosafety testing generates large amounts of sensitive data, which must be stored and transmitted securely to protect patient privacy and prevent unauthorized access or tampering. Companies must invest in robust security measures to ensure the integrity of their data.
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Growth opportunities and latent adjacency in Biologics Safety Testing Market
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