Sterility Testing Market: Current Analysis and Forecast (2021-2027)


Emphasis on Test Type (Membrane Filtration, Direct Inoculation, Others); Product Type (Reagents & Kits, Instruments, Services); Application (Pharmaceutical & Biological Manufacturing, Medical Device Manufacturing, Others); Region/Country









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Report Description
Table of content
Research Methodology

Report Description

Sterility Testing Market 2
Sterility Testing Market 2

Global Sterility Testing Market is anticipated to grow with an elevated CAGR of more than 11% over the forecast period (2021-2027). Sterility testing is done to check the presence or absence of viable microorganisms capable of developing and multiplying under favorable growth conditions. Many pharmaceutical and biotechnology companies carry out sterility testing to examine the quality of the raw materials as well as the end product.

With rapid technological advancement and rising investment in research & development of pharmaceutical & biotechnology companies, the sterility testing market is witnessing an uptick all over the globe. For instance, the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group represents the leading biopharmaceutical research companies in the United States. In 2019, the research and development (R&D) expenditure of its member companies reached USD 83 billion worldwide, up from USD 79.6 billion in 2018. Furthermore, the growing focus on the launch of new drugs owing to the support by the government for research and investments is propelling the growth of this market.

Furthermore, the growing safety concerns regarding the product and the manufacturing process has also fueled the need to carry out the sterility testing of all the raw materials, finished product as the demand for pharmaceutical and medical products is on the surge. Thus, many industry leaders are also expanding their services in this field. For example, in 2019, Alcami Corporation announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster-testing results to its clients. The company invested in the Milliflex Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for the detection of microorganisms after five days.

Current & Projected Total Global Spending on Pharmaceutical R&D, 2016-2026 (in USD billion)

Sterility Testing Market 1
Sterility Testing Market 1

Merck KGaA, Thermo Fisher Scientific, Inc., Charles River Laboratories International, Inc., Biomérieux SA, SGS S.A., Danaher Corporation, Sartorius AG, WuXi AppTec, Toxikon Corporation, Sotera Health LLC, are some of the prominent players operating in the sterility testing market. Several M&As along with partnerships have been undertaken by these players to facilitate customers with new varieties of sterility testing.

Insights Presented in the Report

“Amongst Test Type, Membrane Filtration segment holds the major share”

Based on test type, the sterility testing market is segmented into membrane filtration, direct inoculation, and others. The membrane filtration segment accounted for the significant market share in 2020 and it is estimated that it will exhibit the highest CAGR during the forecast period. This is because this method is the most preferred method used for sterility test as it separates the product from the potential microbial contaminants which reduces or eliminates the inhibitory properties of the drug.

“Amongst Product Type, Reagents & Kits segment holds the major share”

Based on product type, the sterility testing market is divided into reagents & kits, instruments, and services. The reagents & kits segment occupied the major share of the sterility testing market in 2020 and it is expected to grow with substantial CAGR in the upcoming years. The growth of this segment is attributed to the increase in number of sterility testing procedures and thus, requirement of the repeat purchase of these products. Also, the increasing preference for kit-based testing has led to the launch of new and innovative testing kits.

“Amongst Application, Pharmaceutical & Biological Manufacturing segment holds the major share”

Based on application, the market is fragmented into pharmaceutical & biological manufacturing, medical device manufacturing, and other applications. In 2020 pharmaceutical & biological manufacturing segment grabbed the considerable market share, and it is expected to grow at the significant CAGR during the forecast period as sterility testing is caried out for raw materials as well as final product at all levels in various pharmaceutical & biological manufacturing units to avoid any type of the contamination. However, the medical device manufacturing segment is also expected to grow at a significant pace in the forthcoming years.

“North America represents one of the largest markets of sterility testing market”

For a better understanding of the market dynamics of the sterility testing market, a detailed analysis was conducted for different regions across the globe including North America (the U.S, Canada, and the Rest of North America), Europe (Germany, France, Spain, United Kingdom, Italy, and Rest of Europe), Asia-Pacific (China, India, Australia, Japan, and Rest of APAC), Rest of World has been conducted. North America constitutes a major market for the sterility testing market industry and generated revenue of USD XX Million in 2020 owing to the presence of well-established market players in the region.

Reasons to buy this report:

  • The study includes market sizing and forecasting analysis validated by authenticated key industry experts
  • The report presents a quick review of overall industry performance at one glance
  • The report covers an in-depth analysis of prominent industry peers with a primary focus on key business financials, product portfolio, expansion strategies, and recent developments
  • Detailed examination of drivers, restraints, key trends, and opportunities prevailing in the industry
  • The study comprehensively covers the market across different segments
  • Deep dive regional level analysis of the industry

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1.1Market Definitions
1.2Objective of the Study
1.4Stake Holders
1.5Currency Used in Report
1.6Scope of the Global Sterility Testing Study
2.1Research Methodology for the Global Sterility Testing Market
 2.1.1Main Objective of the Global Sterility Testing Market




7.1Membrane Filtration
7.2Direct Inoculation
8.1Reagents & Kits
9.1Pharmaceutical & Biological Manufacturing
9.2Medical Device Manufacturing
9.3Other Applications
 10.1.1United States
 10.1.3Rest of North America
 10.2.3United Kingdom
 10.2.6Rest of Europe
 10.3.5Rest of Asia Pacific
11.1Market Drivers 
11.2Market Challenges
11.3Impact Analysis
15.1Demand Side Analysis
15.2Supply Side Analysis
 15.2.1Top Product Launches
 15.2.2Top Business Partnerships
 15.2.3Top Merger & Acquisitions


17.1Porter’s Five forces analysis
 17.1.1Bargaining power of Supplier
 17.1.2Bargaining power of Buyer
 17.1.3Industry Rivalry
 17.1.4Availability of Substitute
 17.1.5Threat of new Entrants
18.1Merck KGaA
 18.1.1Key Facts
 18.1.2Business Description
 18.1.3Key Product/Services Offerings
 18.1.4Growth Strategy
 18.1.5SWOT Analysis
 18.1.6Key Financials
 18.1.7Recent Developments
18.2Thermo Fisher Scientific, Inc.
18.3Charles River Laboratories International, Inc.
18.4Biomérieux SA
18.5SGS S.A. 
18.6Danaher Corporation
18.7Sartorius AG
18.8WuXi AppTec
18.9Sotera Health LLC
18.10Toxikon Corporation

Research Methodology

Analyzing the historical market, estimation of the current market, and forecasting the future market of the global sterility testing market were the three major steps undertaken to create and analyze the adoption of sterility testing in major regions globally. Exhaustive secondary research was conducted to collect the historical market numbers and estimate the current market size. Secondly, to validate these insights, numerous findings and assumptions were taken into consideration. Moreover, exhaustive primary interviews were also conducted, with industry experts across the value chain of the global sterility testing market. Post assumption and validation of market numbers through primary interviews, we employed a top-down/bottom-up approach to forecasting the complete market size. Thereafter, market breakdown and data triangulation methods were adopted to estimate and analyze the market size of segments and sub-segments the industry pertains to. Detailed methodology is explained below:

Analysis of Historical Market Size

Step 1: In-Depth Study of Secondary Sources:

Detail secondary study was conducted to obtain the historical market size of the sterility testing through company internal sources such as annual report & financial statements, performance presentations, press releases, etc., and external sources including journals, news & articles, government publications, competitor publications, sector reports, third-party database, and other credible publications.

Step 2: Market Segmentation:

After obtaining the historical market size of the sterility testing market, we conducted a detailed secondary analysis to gather historical market insights and share for different segments & sub-segments for major regions. Major segments included in the report as product type, test type, and application. Further country-level analyses were conducted to evaluate the overall adoption of sterility testing across the globe.

Step 3: Factor Analysis:

After acquiring the historical market size of different segments and sub-segments, we conducted a detailed factor analysis to estimate the current market size of the sterility testing. Further, we conducted factor analysis using dependent and independent variables such as rapidly growing pharmaceutical and biotechnology sector all over the globe. A thorough analysis was conducted for demand and supply-side scenarios considering top partnerships, merger and acquisition, business expansion, and product launches in the sterility testing sector across the globe.

Current Market Size Estimate & Forecast

Current Market Sizing: Based on actionable insights from the above 3 steps, we arrived at the current market size, key players in the sterility testing market, and market shares of the segments. All the required percentage shares split, and market breakdowns were determined using the above-mentioned secondary approach and were verified through primary interviews.

Estimation & Forecasting: For market estimation and forecast, weights were assigned to different factors including drivers & trends, restraints, and opportunities available for the stakeholders. After analyzing these factors, relevant forecasting techniques i.e., top-down/bottom-up approach was applied to arrive at the market forecast about 2027 for different segments and subsegments across the major markets globally. The research methodology adopted to estimate the market size encompasses:

  • The industry’s market size, in terms of value (US$) and the adoption rate of sterility testing across the major markets domestically
  • All percentage shares, splits, and breakdowns of market segments and sub-segments
  • Key players in the sterility testing market in terms of products offered. Also, the growth strategies adopted by these players to compete in the fast-growing market

Market Size and Share Validation

Primary Research: In-depth interviews were conducted with the Key Opinion Leaders (KOLs) including Top Level Executives (CXO/VPs, Sales Head, Marketing Head, Operational Head, and Regional Head, Country Head, etc.) across major regions. Primary research findings were then summarized, and statistical analysis was performed to prove the stated hypothesis. Inputs from primary research were consolidated with secondary findings, hence turning information into actionable insights.

Split of Primary Participants in Different Regions

Sterility Testing Market 3
Sterility Testing Market 3

Market Engineering

Data triangulation technique was employed to complete the overall market estimation and to arrive at precise statistical numbers of each segment and sub-segment of the sterility testing market. Data was split into several segments & sub-segments post studying various parameters and trends in the areas of product type, test type and application of the sterility testing market.

The main objective of the Sterility testing Market Study

The current & future market trends of sterility testing were pinpointed in the study. Investors can gain strategic insights to base their discretion for investments from the qualitative and quantitative analysis performed in the study. Current and future market trends were determined the overall attractiveness of the market at a regional level, providing a platform for the industrial participant to exploit the untapped market to benefit as a first-mover advantage. Other quantitative goals of the studies include:

  • Analyze the current and forecast market size of sterility testing in terms of value (US$). Also, analyze the current and forecast market size of different segments and sub-segments
  • Segments in the study include areas of of product type, test type and application
  • Define and analysis of the regulatory framework for the sterility testing industry
  • Analyze the value chain involved with the presence of various intermediaries, along with analyzing customer and competitor behaviors of the industry
  • Analyze the current and forecast market size of the sterility testing market for the major region
  • Major regions studied in the report include North America, Europe, Asia-Pacific and Rest of the world
  • Company profiles of the sterility testing market and the growth strategies adopted by the market players to sustain in the fast-growing market
  • Deep dive regional level analysis of the industry