Sterility Testing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

The Sterility Testing Market is Segmented by Product Type (Instruments, Kits and Reagents, and Services), Test Type (Membrane Filtration, Direct Inoculation, and Other Sterility Tests), Application (Pharmaceutical and Biological Manufacturing, Medical Devices Manufacturing, and Other Applications) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Sterility Testing Market Snapshot

sterility testing market overview
Study Period: 2018 - 2026
Base Year: 2020
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 8.5 %
sterility testing market major players

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Market Overview

The sterility testing market is expected to register a CAGR of 8.5% during the forecast period (2021-2026).

The COVID-19 pandemic made most of the pharmaceutical and biotechnological companies focus on their research and development for the identification of leads that can diagnose and treat the SARS-CoV-2 infection and also, it forced them to look beyond just conventional medicine and therapy which led to the huge investment in the research and development activities by private as well as government entities, all across the world which significantly boosted the sterility testing market, and also, the severity and high infection rate of SARS-CoV-2 increased the demand for sterility testing products in the biologics manufacturing sector which in turn expected to fuel the growth of the studied market for next few years.

The major factor contributing to the growth of the sterility testing market is increasing research and development in the field of life sciences and huge public and private funding in the area. For example, as per the Union Budget for the year 2021-2020, the Indian Ministry of Science and Technology allocated budget of INR 3,502.37 crore for the Department of Biotechnology (DBT) of India, mainly for biotechnology research and development, and industrial and entrepreneurship development in the country which will boost the studied market. The other factor contributing to the growth of the studied market of sterility testing is the increasing number of drug approvals and new drug launches over the year. For instance, according to the April 2021 report from the Congressional Budget Office on “Research and Development in Pharmaceutical Industry, between 2010 and 2019, there was 60 percent increase in the number of new drugs for sales in the United States and in 2018, total 59 new drugs were approved in the country. Additionally, the new launches and development in the sterility testing market by the key market players in the area and strategic collaborations, mergers, and acquisitions will also complement the growth of the studied market. For instance, in November 2019, Reading Scientific Services Ltd. launched fast, responsive, and flexible sterility testing service for pharmaceutical and medical devices companies.

Furthermore, certain potential safety concerns that are associated with the products, which generally arise from the manufacturing processes and complex biological and structural characteristics of the products along with rise in demand for sterilized products around the world are some of the other factors which are expected to fuel the market growth of the studied market over the forecast period. Whereas the stringent regulatory policies and framework of different countries around the world is expected to impede the growth of the sterility testing market over the forecast period.

Scope of the Report

As per the scope of the report, Sterility testing is performed to reveal the presence of microorganisms such as bacteria, fungi, and yeast in pharmaceutical products or devices before the release and patent administration.The Sterility Testing Market is Segmented by Product Type (Instruments, Kits and Reagents, and Services), Test Type (Membrane Filtration, Direct Inoculation, and Other Sterility Tests), Application (Pharmaceutical and Biological Manufacturing, Medical Devices Manufacturing, and Other Applications) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

By Product Type
Instruments
Kits and Reagents
Services
By Test Type
Membrane Filtration
Direct Inoculation
Other Sterility Tests
By Application
Pharmaceutical and Biological Manufacturing
Medical Devices Manufacturing
Other Applications
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Pharmaceutical and Biological Manufacturing Segment is Expected to Occupy a Significant Share in the Sterility Testing Market Over the Forecast Period

Sterility testing is carried out at all levels of manufacturing pharmaceutical and biological products to minimize the risk of product contamination and the high growth of pharmaceutical and biological industries will considerably boost the overall use of sterility testing leading to the high demand for sterility testing products and solutions which will boost the growth of the studied market over the forecast period.

In the manufacturing process of any pharmaceutical or biological product, the sterility testing is carried out for raw materials, finished product, and even before the releasing of the final product to ensure the absence of microorganisms as per the mandated regulations of the regulatory authority or institutions and as the demand for pharmaceutical and medical products for different health conditions is increasing, the frequency of sterility testing in the industries also increasing which is expected to boost the growth of the studied market. Also, the increasing investment in research and development along with growing approvals from the regulatory bodies for drugs and other biologics are surging the launch of new drugs and several products, which is expected to fuel the market in the coming years. For instance, as per the report of the European Federation of Pharmaceutical Industries and Associations, in 2019, the research and development expenditure in Europe increased to 37,500 as compared to 27,920 in 2010. Hence, these fctors are expected to contribute to the market growth.

sterility testing market trends

North America Dominates the Sterility Testing Market and is Expected to Follow the Same Trend During the Forecast Period

North America holds a major share in the sterility testing market and is expected to show a similar trend over the forecast period mainly due to the growing research and innovations in the biotechnology and pharmaceutical industries in the regions along with the increasing investment in the research and development activities in the area of life sciences and medical technology and favorable government initiatives. For instance, according to the Statistics Canada May 2021 report titled “The Canadian Research and Development Pharmaceutical Sector”, in 2018, the pharmaceutical sector added almost USD 15 billion in value-added to the Canadian economy and spent about USD 1.5 billion to USD 2 billion on research and development during the same period of time.

In the North American region, the United States will hold the largest market in sterility testing market in the region over the forecast period. The high share of the United States in the sterility testing market is attributed to the presence of a number of global pharmaceutical and biopharmaceutical companies and huge funding in research and development by the government as well as private entities in the country. For instance, as per the April 2021 report from the Congressional Budget Office on “Research and Development in Pharmaceutical Industry”, the pharmaceutical industry’s expenditure on research and development was USD 83 billion in 2019 and if this amount is adjusted for inflation, then this amount is about 10 times of what the industry spent per year in the 1980s. Also, the high-end research activities in the academics and research institutes will further drive the growth of the sterility testing market in the country over the forecast period.

sterility testing market growth

Competitive Landscape

The sterility testing market is moderately competitive and consists of several major players along with others. In terms of market share, few of the major players currently dominate the market. With growing opportunities in the biopharmaceutical segment, other new players are also expected to enter the studied market. Some of the major players of the market are BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, Thermo Fisher Scientific among many others.

Recent Developments

In December 2020, Redberry launched a fully automated rapid microbial detection platform for in-process control and industrial product release.

In October 2019, Alcami Corporation launched a rapid sterility testing service system, Milliflex Rapid System that uses adenosine triphosphate (ATP) bioluminescence for the detection of microorganisms after five days.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Research and Development in Life Sciences

      2. 4.2.2 Increasing Number of Drug Launches

      3. 4.2.3 Rise in Demand for Sterilized Products

    3. 4.3 Market Restraints

      1. 4.3.1 Stringent Regulatory Framework

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Product Type

      1. 5.1.1 Instruments

      2. 5.1.2 Kits and Reagents

      3. 5.1.3 Services

    2. 5.2 By Test Type

      1. 5.2.1 Membrane Filtration

      2. 5.2.2 Direct Inoculation

      3. 5.2.3 Other Sterility Tests

    3. 5.3 By Application

      1. 5.3.1 Pharmaceutical and Biological Manufacturing

      2. 5.3.2 Medical Devices Manufacturing

      3. 5.3.3 Other Applications

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 BioMerieux

      2. 6.1.2 Charles River Laboratories, Inc.

      3. 6.1.3 Merck & Co. Inc.

      4. 6.1.4 Sartorius AG

      5. 6.1.5 SGS S.A.

      6. 6.1.6 Sotera Health LLC

      7. 6.1.7 Steris PLC

      8. 6.1.8 Thermo Fisher Scientific Inc.

      9. 6.1.9 Toxikon Corporation

      10. 6.1.10 WuXi AppTec

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Sterility Testing Market market is studied from 2018 - 2026.

The Global Sterility Testing Market is growing at a CAGR of 8.5% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2020.

Charles River Laboratories, SGS S.A., Sotera Health LLC, bioMérieux SA, Merck KGaA are the major companies operating in Global Sterility Testing Market.

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