Sterility Testing Market: By Product Type (Instruments, Kits and Reagents, And Services), By Test Type (Membrane Filtration, Direct Inoculation, And Others), By Application (Pharmaceutical and Biological Manufacturing, Medical Devices Manufacturing, And Others) and Geography

Purchase Option

$ 4400
$ 6600
$ 8900

Sterility Testing Market size was valued at USD 1,425.7 million in 2023 and is expected to grow at a CAGR of 11.8%  from 2024 to 2030. Sterility testing is used to determine the presence or absence of live bacteria or any other microorganisms that are capable of reproduction and replicating. Sterility testing is mainly carried out in pharmaceuticals, medical devices, and biotechnological to examine the raw material quality, process control, and end product validation. The increasing demand for sterilized products in the future, increasing innovations and developments in sterility testing technologies, and rising incidence of chronic disease among the population are expected to increase the demand for the sterility testing market and thus are expected to drive the growth of the sterility testing market.

Sterility Testing Market

In addition, the expansion and increasing investments in research and developments in life sciences along with private and public funding is expected to fuel the growth of the sterility testing market in the forecasted years. Major market key players are focusing on business tactics like acquisitions, mergers, and collaborations, and the development of new technologies is expected to propel the market growth over the forecasted period. Furthermore, the increasing number of pharmaceutical products and increasing demand for sterile parenteral dosage forms are expected to provide opportunities to the key market players in the forecasted years. However, the lack of skilled people and highly trained professionals in handling sterility tests and high prices are expected to challenge the sterility testing market growth over the forecasted years. In addition, strict laws and regulations imposed by the government in regulatory frameworks, their delayed approvals, and the entry of new key players in the market are expected to hinder the growth of the sterility testing market in the forecasted years.

Sterility Testing Market Key Developments:
  • In June 2022, STEMart launched comprehensive microbiology and sterility testing for sterile, non-pyrogenic medical devices.
  • In March 2022, AUSTAR launched an isolator workstation for sterility testing in two models, Uni-Directional Air Flow, and Turbulent.

Sterility Testing Market Summary

Study Period

2024-2030

Base Year

2023

CAGR

11.8%

Largest Market

North America

Fastest Growing Market

Asia Pacific
Sterility Testing Market Dynamics

The sterility testing market is expected to grow over the forecasted period owing to the increasing demand for sterilized products, rising incidence of chronic diseases caused by infections, increasing pharmaceutical industries across the globe, and increasing demand for parenteral dosage forms in the market are expected to drive the sterility testing market over the forecasted years. In addition, increasing number of product launches and advancement of technologies and increasing investment in the research and development by the key market players is expected to boost the growth of sterility testing market over the forecasted years. However, the high cost and lack of skilled and trained professionals are expected to hinder the market growth over the forecasted period.

Key Features of the Reports

  • The sterility testing market report provides granular level information about the market size, regional market share, historic market (2019 to 2023) and forecast (2024 to 2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments and startup’s details that are actively working in the market
  • The report provides plethora of information about market entry strategies, regulatory framework and reimbursement scenario
  • The report analyses the impact of socio-political environment through PESTLE Analysis and competition through Porter’s Five Force Analysis in addition to recent technology advancements and innovations in the market

Sterility Testing Market Segmentation

By Product Type
  • Instruments
  • Kits and Reagents
  • Services
By Test Type
  • Membrane Filtration
  • Direct Inoculation
  • Others
By Application Type
  • Pharmaceutical and Biological Manufacturing
  • Medical Devices Manufacturing
  • Others
By Geography
  • North America
  • Europe
  • The Asia Pacific
  • Latin America
  • MEA

Frequently Asked Questions

Sterility Testing market was valued at USD 1,425.7 million in 2023.

Rising pharmaceutical industries across the globe, increasing development of products and new launches are expected to drive the market growth in this region.

The leading players in the global Sterility Testing market are Pacific Bio Labs, STERIS, Boston Analytica, Nelson Laboratories LLC, Sartorius AG, SOLVIAS AG, Laboratory Corporation of America Holding, STEMart, Charles River Laboratories, AUSTAR, Rapid Micro Biosystems, Inc.

Lack of skilled and highly trained professionals, and high cost are expected to hinder the sterility testing market growth over the forecasted years.

1. Executive Summary
2. Global Sterility Testing Market Introduction 
2.1.Global Sterility Testing Market  - Taxonomy
2.2.Global Sterility Testing Market  - Definitions
2.2.1.Product Type
2.2.2.Test Type
2.2.3.Application 
2.2.4.Region
3. Global Sterility Testing Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4. Global Sterility Testing Market Analysis, 2019 - 2023 and Forecast 2024 - 2030
4.1.  Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5. Global Sterility Testing Market  By Product Type, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
5.1. Instruments
5.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
5.2. Kits and Reagents
5.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.2.3. Market Opportunity Analysis 
5.3. Services
5.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.3.3. Market Opportunity Analysis 
6. Global Sterility Testing Market  By Test Type, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
6.1. Membrane Filtration
6.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. Direct Inoculation
6.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
6.3. Others
6.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.3.3. Market Opportunity Analysis 
7. Global Sterility Testing Market  By Application , 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
7.1. Pharmaceutical and Biological Manufacturing
7.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.1.3. Market Opportunity Analysis 
7.2. Medical Devices Manufacturing
7.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.2.3. Market Opportunity Analysis 
7.3. Others
7.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.3.3. Market Opportunity Analysis 
8. Global Sterility Testing Market  By Region, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
8.1. North America
8.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.1.3. Market Opportunity Analysis 
8.2. Europe
8.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.2.3. Market Opportunity Analysis 
8.3. Asia Pacific (APAC)
8.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.3.3. Market Opportunity Analysis 
8.4. Middle East and Africa (MEA)
8.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.4.3. Market Opportunity Analysis 
8.5. Latin America
8.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.5.3. Market Opportunity Analysis 
9. North America Sterility Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
9.1. Product Type Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.1.1.Instruments
9.1.2.Kits and Reagents
9.1.3.Services
9.2.  Test Type Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.2.1.Membrane Filtration
9.2.2.Direct Inoculation
9.2.3.Others
9.3.  Application  Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.3.1.Pharmaceutical and Biological Manufacturing
9.3.2.Medical Devices Manufacturing
9.3.3.Others
9.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.4.1.United States of America (USA)
9.4.2.Canada
10. Europe Sterility Testing Market, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
10.1. Product Type Analysis and Forecast by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.Instruments
10.1.2.Kits and Reagents
10.1.3.Services
10.2.  Test Type Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.Membrane Filtration
10.2.2.Direct Inoculation
10.2.3.Others
10.3.  Application  Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.3.1.Pharmaceutical and Biological Manufacturing
10.3.2.Medical Devices Manufacturing
10.3.3.Others
10.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.4.1.Germany
10.4.2.France
10.4.3.Italy
10.4.4.United Kingdom (UK)
10.4.5.Spain
10.4.6.Rest of EU
10.4.7.
11. Asia Pacific (APAC) Sterility Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
11.1. Product Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.Instruments
11.1.2.Kits and Reagents
11.1.3.Services
11.2.  Test Type Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Membrane Filtration
11.2.2.Direct Inoculation
11.2.3.Others
11.3.  Application  Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.3.1.Pharmaceutical and Biological Manufacturing
11.3.2.Medical Devices Manufacturing
11.3.3.Others
11.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.4.1.China
11.4.2.India
11.4.3.Australia and New Zealand (ANZ)
11.4.4.Japan
11.4.5.Rest of APAC
12. Middle East and Africa (MEA) Sterility Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
12.1. Product Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.1.1.Instruments
12.1.2.Kits and Reagents
12.1.3.Services
12.2.  Test Type Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.2.1.Membrane Filtration
12.2.2.Direct Inoculation
12.2.3.Others
12.3.  Application  Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.3.1.Pharmaceutical and Biological Manufacturing
12.3.2.Medical Devices Manufacturing
12.3.3.Others
12.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.4.1.GCC Countries
12.4.2.South Africa
12.4.3.Rest of MEA
13. Latin America Sterility Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
13.1. Product Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.1.1.Instruments
13.1.2.Kits and Reagents
13.1.3.Services
13.2.  Test Type Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.2.1.Membrane Filtration
13.2.2.Direct Inoculation
13.2.3.Others
13.3.  Application  Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.3.1.Pharmaceutical and Biological Manufacturing
13.3.2.Medical Devices Manufacturing
13.3.3.Others
13.4.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.4.1.Brazil
13.4.2.Mexico
13.4.3.Rest of LA
14. Competition Landscape
14.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
14.2.1.Pacific Bio Labs
14.2.2.STERIS
14.2.3.Boston Analytical
14.2.4.Nelson Laboratories, LLC
14.2.5.Sartorius AG
14.2.6.SOLVIAS AG
14.2.7.Laboratory Corporation of America Holding
14.2.8.STEMart
14.2.9.Charles River Laboratories
14.2.10.AUSTAR
14.2.11.Rapid Micro Biosystems Inc.
15. Research Methodology 
16. Appendix and Abbreviations 
  • Pacific Bio Labs
  • STERIS
  • Boston Analytical
  • Nelson Laboratories, LLC
  • Sartorius AG
  • SOLVIAS AG
  • Laboratory Corporation of America Holding
  • STEMart
  • Charles River Laboratories
  • AUSTAR
  • Rapid Micro Biosystems Inc.

Adjacent Markets