Sterility Testing Market By Product (Kits and Reagents, Instruments, Services), By Test (Membrane Filtration, Direct Inoculation, Other Sterility Tests), By Application (Pharmaceutical and Biological Manufacturing, Medical Devices Manufacturing, Others Applications), By Geography, Size Share, Global Industry Analysis Report, Forecast, 2021-2030

Published On: May-2022 Base Year: 2021 No Of Pages: 135 Historical Data: 2017 - 2020 Formats: PDF Report ID: 00865575

Industry Report and Statistics

The global sterility testing market will witness a robust CAGR of 12.6%, valued at $161.18 million in 2021, expected to appreciate and reach $469.0 million by 2030, confirms Strategic Market Research. Sterility testing is carried out by pharmaceutical, biotechnological, and medical device firms to examine the raw material quality, process control, and end-product validation. The presence or absence of live bacteria capable of reproducing and replicating under favorable conditions is determined through sterility testing. Moreover, bulk and finished medicinal products, cell banks, and raw materials are subjected to undergo sterility testing. According to the Indian Economic Survey 2021, the domestic market is predicted to rise thrice in the next decade. In 2021, India's domestic pharmaceutical market was valued at US$ 42 billion, and it is expected to grow to US$ 65 billion by 2024 and then to US$ 120-130 billion by 2030.

The sterility testing market is poised to grow in the near future due to increased demand for sterilized items. Also, the growth media must be correctly prepared and tested to ensure that the microbial growth is as efficient as possible during sterility testing. Over the projected period, the increasing innovations in sterility testing technologies are expected to help the development of the industry. According to Mckinsey and Company, between 2014 and 2018, more than 580 healthcare technological agreements worth more than $10 million were completed in the United States, adding up to more than about $83 billion.

Market Drivers - Increase in Research and Development in the Field of Life Sciences

The expanding research and development in life sciences, combined with significant public and private financing, is a primary driver that is fuelling the expansion of the sterility testing industry.

According to Chemical and Engineering News, the Indian Ministry of Science and Technology allocated a budget of INR 35 billion for the Department of Biotechnology (DBT) of India in the Union Budget for the year 2021-2022, a 25% increase from the previous year. It is primarily for biotechnology research and development, as well as industrial and entrepreneurship development in the country, which will boost the market growth significantly.

Major industry players are working on business tactics such as mergers, acquisitions, collaborations, and developing new goods to stay ahead of the competition. Furthermore, new firms are engaging in the kit testing market since it provides a steady stream of revenue from the clients.

Furthermore, due to the yield of more positive sterility testing results as compared to the negative ones, the rise in the demand for pharmaceutical sterility testing market and the need for various types of sterility testing like b/f testing sterility, sterility testing medical devices, sgs sterility testing, hypothesis testing, Vaporized Hydrogen Peroxide (VHP) Ingress Testing, etc. is propelling the overall industry growth.

Restraints - Stringent Government Regulations

A rise in the sterility testing unit price and the scarcity of qualified sterility test professionals due to strict government rules are highly obstructing the market growth.

High levels of consolidation, as well as rigid regulatory frameworks and lengthy licensing processes, are significant barriers to new market entrants.

Trends and Opportunities - Emerging Markets and Increasing Pharmaceutical Outsourcing

Industry players in the pharmaceutical and biopharmaceutical industries are ensuring that environmental monitoring (EM) program is implemented to avoid sterility test failures in the future. The sterilization of the product assures safety and detects early concerns quickly. This aids the firms in maximizing their market position in the service industry. According to India Brand Equity Foundation, Biopharmaceuticals, Bio Services, Bio-agriculture, Bioindustry, and Bioinformatics makeup India's biotechnology industry. In 2020, the Indian biotechnology industry was valued at $70.2 billion; by 2025, it is predicted to be worth $150 billion.

Further, the governmental bodies are spending a hefty amount of money on the improvisation of the testing procedure. Apart from that, they have also introduced some of the notable FDA guidelines for sterility testing, which is expected to cater to ample growth opportunities for the market in due course of time. According to India Brand Equity Foundation, in FY20, India's medical device market was valued at US$ 10.36 billion. From 2020 to 2025, the industry is predicted to grow at a CAGR of 37%, reaching US$ 50 billion.

Moreover, scientists from all across the globe are toiling hard in their field of research. They have successfully developed some of the critical sterility testing methods in microbiology, which is expected to extensively fuel market growth.

sterility testing market by product 2020-2030

Market Analysis Of Different Segments Covered in the Report

Based on Product

Kits and Reagents
Instruments
Services

Based on Test

Membrane Filtration
Direct Inoculation
Other Sterility Tests

Based on Application

Pharmaceutical and Biological Manufacturing
Medical devises Manufacturing
Others Applications

Regional Coverage Analysis

North America

U.S.
Canada

Europe

Germany
France
U.K.
Italy
Spain
Rest of Europe (RoE)

Asia

China
Japan
India
Rest of Asia (RoA)

Product Analysis & Insights

Kits and Reagent segment dominated the market in 2020, and it is predicted to grow significantly. This rise is due to the availability of a wide range of products that help in minimizing the risk of false-negative and false-positive results. Sterility testing pumps are also available, which are designed to fit seamlessly into all the testing facilities that aid in maximizing safety & streamlining workflow. Over the forecasted period, the rising demand for similar items is expected to enhance this segmental growth.

Type Analysis & Insights

Membrane filtration dominated the market, owing to technological advancements in membrane filtration design and operations, which increases the filtration efficiency and allows the filtration processes to operate at low temperatures with less energy consumption. According to Bit Rebels, Over the next few years, 47% of businesses is anticipated to increase their usage of connected health solutions. Personal sensor technologies such as wearable gadgets are expected to have a favorable impact on health, according to 71% of physicians.

Application Analysis & Insights

The Pharmaceutical and Biological Manufacturing segment is expected to grow and hold a significant proportion of the sterility testing market, which is primarily due to the increased regulatory intervention. According to the India Brand Equity Foundation, with a CAGR of 16.4 percent, the Indian biotechnology industry is predicted to grow from US$ 63 billion in 2019 to US$ 150 billion by 2025. The Indian biotechnology industry will contribute 19 percent of the global biotechnology market by 2025.

Region Analysis & Insights

North America had the largest market of sterility testing. The primary reason behind possessing the largest industry share is due to the rise in the research and innovation in the biotechnology and pharmaceutical industries, increased investment in life sciences, rise in the research & development activities of medical technology, and favorable government initiatives in the entire region. According to the Government of Canada's Industrial Research and Development, in-house R&D expenditure by Canadian businesses reached a new landmark of USD 21.7 billion in 2019. By data from seed scientific, the global biotechnology market value is anticipated to reach $727.1 billion by 2025. Moreover, the experts believe that the employment rate in biotech will grow by 5% between the years 2019 and 2029. On the contrary, the Asia-Pacific region is the fastest growing market for sterility testing throughout the forecasted period, which is primarily due to the rise in the expenditure on life science research & the rising trend of pharmaceutical outsourcing to Asian countries like China and India. According to the India Brand Equity Foundation, the Indian pharmaceutical industry supplies more than half of the global demand for vaccines, including 40% of the generic demand in the United States and 25% of all medicine in the United Kingdom. India is the world's third-largest producer of drugs by volume and the fourteenth-largest producer by value. A network of 3,000 medicinal businesses and 10,500 manufacturing units make up the domestic pharmaceutical sector.

Sterility Testing Market Report Coverage

Report Attribute	Details
Forecast Period	2020-2027
The market size value in 2021	USD 161.18 Million
Revenue Forecast in 2030	USD 469.0 million
Growth Rate	CAGR of Approximately 12.6%
The base year for estimation	2021
Historical Data	2017 - 2020
Unit	USD Million, CAGR (2021-2030)
Segmentation	By Product, By Test, By Application, By Region
By Product	Kits and Reagents, Instruments, and Services
By Test	Membrane Filtration, Direct Inoculation, and Other Sterility Tests
By Application	Pharmaceutical and biological manufacturing, Medical Devices Manufacturing, and Other Applications.
By Region	North America, Europe, and Asia
Country Space	US, Canada, Germany, France, UK, Japan, China, India, etc.
Company Usability Profiles	BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, and Thermo Fisher Scientific

Global Sterility Testing Market Competitive Landscape Analysis

The competitive landscape analysis provides information about the crucial competitors prevailing in the global environment. The comparison is performed based on overall revenue generation, market initiatives, company overview, investment in R&D, company financials, company strengths and weaknesses, global presence, production capacity, production sites and facilities, market potential, etc.

Merck KGaA
Baxter Healthcare Corporation
Boston Analytical
Neopharm Labs Inc.
LexaMed LTD
Danaher Corporation
Sartorius AG
Gibraltar Laboratories
Pace Analytical Services, Inc.
Sigma-Aldrich Co. LLC.
Nelson Laboratories
Pacific Biolabs
BioConvergence LLC
Thermo Fisher Scientific Inc.
Toxikon Corporation.
Wuxi Apptec
Rapid Micro Biosystems, Inc.

sterility testing market by region 2020-2030

Recent Developments

On July 25th, 2022, the West Virginia news revealed that U.S scientists had developed a unique and rapid sterility testing (RMT) method known as the USP<71>Sterility-test. It has been regarded as the “gold standard” for sterility tests. Along with the EU Pharmacopeia (EP-2.6.1-Sterility) & Japanese Pharmacopeia (JP-4.06-Sterility Test), they together represent (90+) % of harmonized test processes which is utilized for the identification of sterility for a particular product.

Charles River Laboratories International, Inc. announced on May 17, 2021, that it had signed a definitive agreement to acquire Vigene Biosciences, Inc., a leading gene therapy contract development and manufacturing organization (CDMO) in the United States that specializes in viral vector-based gene delivery solutions.

Thermo Fisher Scientific announced plans to build two additional sterile filling lines in Singapore in October 2020, allowing the company to expand its capacity in the APAC region for vaccine and therapy manufacturing and development.

Charles River Laboratories International, Inc. and Valence Discovery established a strategic agreement on April 6, 2021, to give clients access to Valence's artificial intelligence platform for molecular property prediction, generative chemistry, and multiparameter optimization.

In September 2021, Nelson Labs and Sterigenics Germany GmbH inaugurated a new center of excellence in Wiesbaden, with expanded sterilization capabilities and microbiological laboratory testing. The expansion will assist in terms of addressing the increased demand for these services among pharmaceutical and medical device businesses.

Charles River Laboratories International, Inc. announced the acquisition of Retrogenix Limited, an early-stage contract research organization (CRO) that offers specialized bioanalytical services using its unique cell microarray technology, on March 31, 2021.

Various Devices that the Market Leaders are Manufacturing

Name of the product	Function	Key Players
Filter Paper	Filter papers are often used in quantitative and qualitative analysis.	Sigma-Aldrich Co. LLC.
QuantStudio Real-Time PCR systems	Changes in gene expression as little as 1.5-fold can be detected with QuantStudio Real-Time PCR equipment.	Thermo Fisher Scientific Inc.
ProClin Preservatives	ProClinTM preservatives are water-soluble biocide formulations among the most effective biocides in the IVD sector and are utilized in over 1,000 FDA-approved IVD kits from leading diagnostic companies.	Sigma-Aldrich Co. LLC.
KingFisher Apex System	The KingFisher Apex of Thermo Scientific is the pinnacle of automated DNA, RNA, protein, and cell purification.	Thermo Fisher Scientific Inc.

Frequently Asked Question About This Report

b: The global sterility testing market is expected to grow at a compound annual growth rate (CAGR) of 12.6% from 2021 to 2030 to reach USD 469.0 billion by 2030.

b: The global sterility testing market size was $161.18 Mn in 2021 and is predicted to reach $469.0 Mn by 2030, representing a CAGR of 12.6% during 2021 - 2030.

b: BioMerieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, and Thermo Fisher Scientific, among others, are some of the markets key competitors.

b: Sterility testing is a GMP microbiological testing requirement that ensures the presence of sterile items before being released and administered to patients. Membrane filtration, Direct Transfer and Product Flush are the various types of sterility tests.

b: Fluid thioglycolate medium (FTM) is used for sterility testing.

b: Sterility testing usually requires two weeks of long incubation time as there exists some bacteria which are very slow in terms of growth, such as Propionibacterium acnes. P. acne is gram-positive, rod-shaped, slow-growing bacteria which is found in the acne of homosapians.

b: The global market is predicted to reach USD 469.0 million by 2030.

Sources

https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/the-next-wave-of-healthcare-innovation-the-evolution-of-ecosystems

https://economictimes.indiatimes.com/news/science/union-budget-2022-23-ministry-of-science-and-technology-allocated-rs-14217-crore/articleshow/89280245.cms?from=mdr

https://www.ibef.org/blogs/india-a-global-biotech-market

https://www.ibef.org/download/Medical-Devices-March-2021.pdf

https://ised-isde.canada.ca/site/industrial-technological-benefits/en