Sterility Testing Market by Product (Kits & Reagents, Instrument, Services), Test (Membrane Filtration, Direct Inoculation), Application (Pharma, Biological Manufacturing, Medical Device Manufacturing), End User (Pharma, Biotech) & Region - Global Forecasts to 2028
Updated on : March 14, 2023
The global sterility testing market in terms of revenue was estimated to be worth $1.1 billion in 2023 and is poised to reach $1.9 billion in 2028, growing at a CAGR of 10.5% from 2023 to 2028. Factors responsible for the growth in the market are mainly the rising expansion of pharmaceutical & biopharmaceutical production capacities, increasing development of novel biopharmaceutical products, and rising investments in life science research. However, the growing adoption of single-use technology is a major factor restraining the market growth.
Global Sterility Testing Market Trends
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Sterility Testing Market Dynamics
Drivers: Rising expansion of pharmaceutical & biopharmaceutical production capacities
In pharmaceutical and biopharmaceutical industries, sterility testing is conducted at all manufacturing stages to minimize the risk of product contamination. Subsequently, the growth of this end-use industry in the coming years will considerably boost the utilization of sterility testing.
The production capacity expansion of pharmaceuticals and biopharmaceuticals worldwide will augment the demand for sterility testing products and services. Sterility testing is mandatory during the production process of pharmaceuticals and biopharmaceuticals. Therefore, the rising production capacities of pharmaceutical & biopharmaceutical companies will drive the adoption of additional kits, reagents, and instruments for sterility tests.
- In 2022, Novartis (Switzerland) invested USD 300 million to bolster the capacity and capabilities for next-generation bio-therapeutics across Switzerland, Slovenia, and Austria.
- In 2022, Eli Lilly and Company (US) invested USD 1.5 billion to establish two new manufacturing facilities: Concord, NC, and Limerick, Ireland. Of the total investment, the company aims to invest USD 500 million, specifically in Limerick, to create a new biologics active ingredients site.
Restraints: Growing adoption of single-use technology
Single-use technology substitutes the stainless-steel and hard-piped configurations used in aseptic processing and sterile manufacturing. Gamma-irradiated pre-assembled process systems are used under single-use technology. Such technology is used for aseptic filling as well as upstream & downstream processing. The main benefit of SUT is that time and money are not invested in labor-intensive and expensive cleaning, sterilization validation tests, or their recurring revalidation. Moreover, it eliminates system cleaning and sterilization requirement between batches. Adopting such technologies will hamper the demand for sterility testing products and services.
However, the chances of human error will continue, even if closed systems and single-use technology are used more frequently. Personnel continues to be the principal source of contamination for pharmaceutical & biopharmaceutical formulations that cannot be terminally sterilized. Thus, a thorough training program is essential. When adhering to GMP and quality standards, operator comprehension is a crucial factor.
Opportunities: Emerging markets
Emerging markets such as Brazil, India, and China are expected to present significant opportunities for the growth of the market. This can mainly be attributed to increased R&D funding for research in these countries. For instance, China's current healthcare expenditure (% of GDP) went from 5.1% in 2017 to 5.4% in 2019. Similarly, for India, the healthcare expenditure rose from 2.9% in 2017 to 3.0% in 2019, while for Brazil, it was 9.5% in 2017 and increased to 9.6% in 2019. (Source: World Bank)
Moreover, CDMOs and CROs based in emerging markets offer cost-efficient development and manufacturing services to pharma & biotech companies. Sterility testing is a mandatory step in pharmaceutical drug discovery & development. Therefore, the growing production capacities of CROs and CDMOs in emerging nations will augment the demand for sterility testing products and services. A few examples of such capacity expansions are as follows:
- In August 2022, Samsung Biologics announced plans to build a second biopharmaceutical campus, named Bio Campus II, at Songdo, Incheon, South Korea
- In July 2022, Wuxi Biologics announced a USD 1.4 billion investment for expanding its research, development, and large-scale drug substance and drug product manufacturing capacity and capabilities in Singapore.
Challenges: Shortage of skilled professionals
The success of sterility tests depends mainly on the expertise of the analysts on the same par as the environmental conditions under which the test is performed. For optimal efficacy, sterility testing needs to be conducted by skilled professionals with sufficient knowledge of the nuances of this field. Handling the instruments used in sterility testing also requires expertise. Consequently, the shortage of a sufficiently skilled workforce poses a key challenge to the growth of the market.
In 2022, by product & service segment, the consumables segment accounted for the largest share of the sterility testing market
Based on product, the market is segmented into membrane filtration, direct inoculation, and other tests. In 2022, the kits & reagents segment accounted for the largest share of the global market. The large share of this segment can primarily be attributed to ease of use, recurring purchase, and growing preference associated with kits & reagents.
In 2022, by test type, the membrane filtration segment accounted for the largest share of the sterility testing market
On the basis of type, the market is segmented into membrane filtration, direct inoculation, and other tests. In 2022, the membrane filtration segment accounted for the largest share of the global market. Factors responsible for the large share of this segment are the growing demand for liquid formulations coupled with the suitability of such tests with samples containing preservatives and bacteriostatic & fungistatic compounds.
In 2022, North America accounted for the largest share of the sterility testing market
In 2022, North America accounted for the largest share of the market. Increasing drug approvals are expected to boost the market in the region. Additionally, the rising prevalence of diseases and the growing patient pool are increasing the demand and production for medicines in North America. The pharmaceutical & biotechnology industries in North America invest heavily in R&D and are expected to witness significant growth in the coming years, which in turn, is expected to drive the growth of the market.
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The sterility testing market is dominated by a few globally established players such as Charles River Laboratories (US), Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), WuXi AppTec (China), Nelson Laboratories, LLC (US), Pacific BioLabs (US), Sartorius AG (Germany), Thermofisher Scientific Inc. (US), and Samsung Biologics (South Korea).
sterility testing Market Report Scope:
Market Size Available for Years
Base Year Considered
Value (USD Billion)
Product & Service, Test Type, Application, End User, and Region
North America, Europe, Asia, and the Rest of the World
The major market players include Charles River Laboratories (US), Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), WuXi AppTec (China), Nelson Laboratories, LLC (US), Pacific BioLabs (US), Sartorius AG (Germany), Thermofisher Scientific Inc. (US), Samsung Biologics (South Korea), GenScript (US), Pace Analytical (US), Rapid Micro Biosystems Inc (US), Tentamus Pharma (Germany). Singota Solutions (US), Neopharm Labs Inc. (Canada), LexaMed (US), Astell Scientifc (UK), HiMedia Laboratories (India), Pall Corporation (US), Boston Analytical (US), Solvias AG (Switzerland), and Becton, Dickinson, and Company (US).
The study categorizes the sterility testing market into the following segments & sub-segments:
By Product & Service
- Kits & Reagents
By Test Type
- Membrane Filtration
- Direct Inoculation
- Other Tests
- Pharmaceuticals And Biologicals
- Medical Devices
- Other Applications
By End User
- Pharmaceutical Companies
- Biotechnology Companies
- Rest of Europe
- South Korea
- Rest of Asia
Rest of the World
- Pacific and Oceania
- South America, Central America, and the Caribbean
- In November 2022, Merck KGaA (Switzerland) invested USD 306.5 million in expanding its biosafety testing capacity at Rockville, Maryland, US. This site will provide biosafety testing and analytical development services in the US.
- In September 2022, Merck KGaA (Switzerland) opened its viral clearance (VC) laboratory as the first phase of the China Biologics Testing Center. This site is set to operate in China and will locally conduct viral clearance studies across pre-clinical development to commercialization.
- In June 2022, Charles River Laboratories, Inc. (US) opened a new facility of High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech's Alderley Park in Cheshire, UK. The 16,000 sq. ft facility will provide plasmid DNA manufacturing services.
- In May 2022, bioMérieux SA (France) acquired Specific Diagnostics (US). With this acquisition, bioMérieux will improve its presence in antimicrobial resistance while expanding its market-leading position globally in clinical microbiology.
Frequently Asked Questions (FAQ):
What is the projected market value of the global sterility testing market?
The global market of sterility testing is projected to reach USD 1.9 billion.
What is the estimated growth rate (CAGR) of the global sterility testing market for the next five years?
The global sterility testing market is projected to grow at a Compound Annual Growth Rate (CAGR) of 10.5% from 2023 to 2028.
What are the major revenue pockets in the sterility testing market currently?
In 2022, North America accounted for the largest share of the market. Increasing drug approvals are expected to boost the sterility testing market in the region. Additionally, the rising prevalence of diseases and the growing patient pool are increasing the demand and production for medicines in North America. The pharmaceutical & biotechnology industries in North America invest heavily in R&D and are expected to witness significant growth in the coming years, which in turn, is expected to drive the growth of the sterility testing market.
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This research study involved extensive secondary sources, directories, and databases such as Hoovers, Bloomberg Business, and Factiva to identify and collect information useful for this technical, market-oriented, and commercial study of the sterility testing market. Primary sources included several industry experts from core and related industries and preferred suppliers, manufacturers, distributors, service providers, reimbursement providers, technology developers, alliances, and standards and certification organizations from companies and organizations related to all segments of this industry’s value chain. 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, to obtain and verify critical qualitative and quantitative information and assess prospects.
The secondary sources referred to for this research study include publications from organizations such as the World Bank, World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Cancer Institute (NCI), Food and Drug Administration (FDA), European Medicines Agency (EMA), National Comprehensive Cancer Network (NCCN), and National Institutes of Health (NIH). Secondary sources 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. Secondary data was collected and analyzed to arrive at the overall size of the global Sterility testing market, which was validated through primary research.
In the primary research process, various supply and demand sources were interviewed to obtain qualitative and quantitative information for this report. Primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing and sales directors, technology and innovation directors, and related key executives from various companies and organizations operating in the Sterility testing market. Primary sources from the demand side include industry experts such as software application specialists, product managers, medical device manufacturers, pharmaceutical firm R&D heads, packaging department heads, research scientists, and other related key opinion leaders. Primary research was conducted to validate the market segmentation, identify key players, and gather insights into key industry trends and market dynamics.
Breakdown of Primary Participants
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Market size Estimation
Segmental revenues were arrived at to calculate the global market value based on the revenue mapping of major players active in the Sterility testing market. This process involved the following steps:
- Generating a list of the major global players operating in the sterility testing market
- Mapping the annual revenues generated by major global players from the Sterility testing market or the nearest reported business unit/product category
- Identifying the revenues of the top five players in the sterility testing market
- Estimating the revenue of the key four players at 500-550 million in 2022 and adding up to 100% to derive the global value of the Sterility testing market
After arriving at the overall size of the sterility testing market through the methodology mentioned above, this market was split into several segments. Market breakdown procedures were employed, wherever applicable, to arrive at the exact market value for the key segments. The extrapolated market data was triangulated by studying various macro indicators and regional trends from both demand and supply-side participants.
- To define, describe, and forecast the sterility testing market based on product & service, test type, application, end-user, and region.
- To provide detailed information regarding the major factors influencing the growth of the market (such as drivers, restraints, opportunities, and industry-specific challenges)
- To strategically analyze micro markets concerning individual growth trends, future prospects, and contributions to the overall sterility testing market
- To analyze the opportunities in the market for stakeholders and provide details of a competitive landscape for market leaders.
- To profile key players and comprehensively analyze their market shares and core competencies regarding market development and growth strategies.
- To forecast revenue of the market segments concerning four main regional segments, namely, North America, Europe, Asia, and the Rest of the World
- To track and analyze competitive developments such as collaborations, mergers and acquisitions, product launches, and expansions in the sterility testing market.
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the report:
- Further breakdown of the European sterility testing market into RoE countries
- Further breakdown of the Asia sterility testing market into RoA countries
- Detailed analysis and profiling of additional market players (up to 5)
Growth opportunities and latent adjacency in Sterility Testing Market