Sterility Testing Market Trends

Global Sterility Testing Market Overview

Sterility Testing Market Size was valued at USD 28.29 Billion in 2023. The Sterility Testing market industry is projected to grow from USD 31.88 Billion in 2024 to USD 73.62 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 11.03% during the forecast period (2024 - 2032). 

A growing number of pharmaceutical companies and an increase in product innovations and developments by market players are the key market drivers enhancing the growth of the studied market.

Source Secondary Research, Primary Research, MRFR Database, and Analyst Review

May 2024: Merck KGaA, a company located in Darmstadt, Germany, has launched the M-Trace Software & Mobile App. This application is intended to digitize sterility testing in the field of microbial quality control. Sterility testing is an essential element of the pharmaceutical industry's quality control procedure, guaranteeing that products like vaccines and injectables are free of contaminants. Microbial contamination is a significant risk, as it has the potential to expose patients to harmful pathogens or toxins, resulting in severe health consequences or even mortality. 

It can also lead to substance degradation, which can compromise the product's effectiveness. The M-Trace software offers pharmaceutical manufacturers a means to resolve safety concerns by notifying them of any errors that are identified during the testing process. Additionally, it provides a completely digital solution for document compliance. 

The software generates comprehensive reports that enhance data analytics capabilities, simplifying investigations into out-of-specification results and facilitating the monitoring of trends. AI-powered software for digital chemistry and drug discovery, including AIDDISON and SYNTHIA retrosynthesis software, is included in the company's portfolio.

In September 2021, Nelson Labs and Sterigenics Germany GmbH, comprehensive laboratory testing and sterilization service leaders worldwide, announced that Wiesbaden, Germany-based facilities have opened for a newly expanded center for microbiological laboratory testing and improved sterilization capacity. This progress will address the soaring demand for such services in the medical device and pharmaceutical industry.

In March 2021, Charles River Laboratories International, Inc. revealed that they had acquired Retrogenix Limited, which is a start-up CRO providing specialized bioanalytical services using its own cell microarray technology.

In June 2022, STEMart unveiled comprehensive microbiology and sterility testing programs for sterile non-pyrogenic medical devices.

In June 2022, Berkshire Sterile Manufacturing opened its sterility testing isolator (that) conducts site sterility tests of its GMP batches. It provides sterile injectable drug filling; most of them are in clinical trials or have small commercial needs.

In July 2022, US scientists developed the rapid methylene blue test (RMT), called USP71> sterility test by West Virginia Press. It is known as the “gold standard” in sterility tests. However, EU Pharmacopoeia (EP-2.6.1-Sterility) and Japanese Pharmacopeia (JP-4.06-Sterility Test) account for over (>90%) of the standardized test procedures used to determine if a specific product is sterile.

In May 2021, Charles River Laboratories International, Inc. disclosed that it has purchased Vigene Biosciences, Inc., a leading U.S.-based gene therapy contract development manufacturing organization (CDMO) focused on viral vectors. In this regard, an agreement has been reached to take over these gene delivery solutions company-based.

Rapid Micro Biosystems announced the Growth Direct Rapid Sterility application launch by mid-2024 during January 2024

August 2023 witnessed Pace Analytical Services enhancing its capabilities with the acquisition of Alpha Analytical, which included advanced hydrocarbon analytical support and expanded sediment & tissue testing.

In May 2023, Thermo Fisher Scientific will open a sterile drug facility in Singapore. This would enhance the delivery of new vaccines and drugs in the Asia-Pacific market.

Sterility Testing Market Trends

• 
  

  Growing healthcare industry is driving the market growth

  
  

The growing healthcare industry driven by government initiatives is driving Market CAGR for Sterility Testing. The market is anticipated to be driven by government investments in the healthcare sector, expanding R&D activity, an increase in drug releases, and a growing emphasis on quality and sterility. There is still a need to develop a safe and efficient COVID-19 treatment for all the new viral variations, hence clinical research on COVID-19 vaccines are still being done. The market in the post-pandemic period is likely to benefit from a sizable amount of research being done for COVID-19 medicines.

As a result of the rising prevalence of chronic and infectious diseases, there is an increasing demand for pharmaceuticals on a  scale. For instance, the World Health Organization (WHO) announced in February 2021 that cardiovascular illnesses remain among the leading causes of mortality worldwide, killing 17.9 million people year. Future illness load is anticipated to increase demand for pharmaceuticals, supporting the need for pharmaceutical sterility testing.

Many developing nations have sped up drug introductions and shortened regulatory approval timelines in response to the rising demand for healthcare. These regulatory changes are projected to quicken market expansion. Additionally, because biopharmaceutical goods like Elagolix and Lanadelumab require specific sterility testing, their debut is strongly assisting the market's growth.

Drug companies are concentrating on creating biologics and biosimilars in the post-pandemic period since they are very effective in treating some major illnesses like cancer, psoriasis, and Alzheimer's disease. For instance, in June 2021, Lonza teamed up with Pint on Therapeutics, a biotechnology business that specializes in creating Alzheimer's disease treatments.

By the terms of their collaboration agreement, Lonza chose to produce PNT001, a novel tau antibody developed by Pinteon Therapeutics for the treatment of traumatic brain injury and Alzheimer's disease. The burden of these diseases is predicted to increase ly, which should boost therapeutic R&D and production. In the aftermath of the pandemic, this is anticipated to increase demand for sterility testing. Thus, driving the Sterility Testing market revenue.

Sterility Testing Market Segment Insights

Sterility Testing Type Insights

The  Sterility Testing market segmentation, based on product type, includes instruments, and services. Services category held the biggest share while instruments are expected to hold the fastest CAGR in the anticipated period. Many medical and pharmaceutical companies are involving themselves in research & development activities to enhance sterility testing services.

Sterility Testing Test Type Insights

The  Sterility Testing market segmentation, based on the test type, is divided into Membrane filtration, and Direct transfer. Due to technological breakthroughs in membrane filtration design and operation, which boost filtration effectiveness and enable filtration processes to run at low temperatures with less energy consumption, membrane filtration has dominated the industry. According to Bit Rebels, 47% of organizations are expected to increase their use of linked health solutions over the next few years. According to 71% of doctors, personal sensor technologies like wearable devices will likely have a positive effect on health.

Sterility Testing End-User Insights

Based on the end-user of Sterility Testing, the  Sterility Testing market segmentation includes Pharmaceutical Companies, Hospitals & clinics, and Academic, and Research Laboratories. The market is dominated by pharmaceuticals companies. Owing to the increasing demand for medications and vaccines, the booming pharmaceutical industry, and more regulatory interventions like the requirement for equipment sterility testing, this dominates the market. Pharmaceutical items undergo sterility testing during production to lower the risk of contamination. The market for sterility testing is rising as a result of the increased frequency of sterility tests due to advances in medicine. Therefore, it is anticipated that over time, these rising R&D investments will accelerate market expansion.

Figure 1  Sterility Testing Market, by End-User, 2022 & 2032 (USD Billion)

Source Secondary Research, Primary Research, MRFR Database, and Analyst Review

Sterility Testing Regional Insights

By region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. During the projected period, the North American Sterility Testing market is expected to dominate over the course of the forecasted period. The market is expanding due to the presence of leading market players and strict government regulations monitoring that support the market’s growth.

Further, the major countries studied in the market report are The US, Canada, German, France, the U.K., Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2  STERILITY TESTING MARKET SHARE BY REGION 2022 (USD Billion)

Source Secondary Research, Primary Research, MRFR Database, and Analyst Review

Asia Pacific Sterility Testing market accounts for the fastest market share. This is a result of emerging countries increasingly harmonizing their regulatory norms with ICH standards. Additionally, several of the region's growing economies are adopting a variety of steps to expand their domestic pharmaceutical industry and are enticing  corporations to establish facilities there. Moreover, the China Sterility Testing market held the largest market share, and the India Sterility Testing market was the quickest-growing market in the Asia-Pacific region.

The Europe Sterility Testing Market is expected to expand at the quickest CAGR from 2023 to 2032. Sterile devices have increased dramatically, which has boosted the region's growth. This is due to the rising incidence of infectious diseases and the introduction of the newest kits and reagents. Further, the Canada Sterility Testing market was the fastest-growing region in the market, and the German Sterility Testing market held a substantial share of the market.

Sterility Testing Key Market Players & Competitive Insights

Leading market players are investing capital and resources across research and development to extend their product offerings, this is expected to help the Sterility Testing market, grow even more. Market leaders and manufacturers are also adopting various strategies to expand their worldwide footprint, with important market developments including new product developments & launches, contracts & agreements, mergers & acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, the Sterility Testing industry must offer cost-effective items.

The manufacturers are making use of locally available resources to minimize the production costs which will aid the growth of the  Sterility Testing industry to benefit clients and increase the market sector. In recent years, the Sterility Testing industry has offered some of the most significant advantages to medicine. Major players in the Sterility Testing market, including SA of France, Thermo Fisher Scientific, Merck KGaA, Sartorius Ag, WuXi Apptec, Astell Scientific, BioLabs Inc, Bioquel, and others, are attempting to increase market demand by investing in research and development operations.

A biopharmaceutical firm called Merck & Co Inc. (Merck) is dedicated to the discovery, development, production, and marketing of prescription drugs, biologic therapies, vaccines, and animal health products. It provides products on prescription for the treatment of conditions like diabetes, cancer, immunological diseases, cardiovascular disease, and cancer. The business offers vaccinations, poultry, cattle, and aquaculture products, among other animal health items. Merck provides managed healthcare services to hospitals, government organizations, wholesalers, retailers, and hospitals. It also provides veterinarians, distributors, and animal producers with animal health products. In August 2022, As per a statement from the firm, Merck opened its first Microbiology Application and Training (MAT) Lab in Jigani, Bengaluru. The lab will provide resources and technical assistance to help the Indian life science community enhance its capacity for microbiological quality control.

Thermo Fisher Scientific Inc. (Thermo Fisher) provides pharma equipment, analytics instruments, reagents and consumables, software, and services to meet the requirements of analytical problems across research and laboratories. It offers solutions for flow cytometry, synthetic biology, and cellular biology. The business offers a variety of goods, such as mass spectrometry, genetic sequencing, electron microscopy, protein, and molecular biology research technology. The company offers services to academic and research institutions, government agencies, pharmaceutical and biotech firms, clinical diagnostic laboratories, and environmental, industrial quality, and process control sectors. In the Americas, Asia-Pacific, and Europe, it sells its goods and services through its direct sales force, online sales, and third-party distributors. In January 2022, With expanding manufacture and distribution in the US and Canada, Thermo Fisher Scientific produced culture media plates that combine quality-assurance technologies with a wide choice of pharmaceutical-specific formulations.

 Key Companies in the Sterility Testing market include

• SA of France


• Thermo Fisher Scientific


• Merck KGaA


• Sartorius Ag


• WuXi Apptec


• Astell Scientific


• BioLabs Inc


• Bioquel

Sterility Testing Industry Developments

June 2022 STEMart has started conducting thorough sterility and microbial tests for sterile, non-pyrogenic medical equipment.

June 2022 For its GMP batches, Berkshire Sterile Manufacturing opened a sterility testing isolator and conducts sterility testing there. The business provides sterile filling of injectable medications, the majority of which are undergoing clinical trials or have little commercial need.

Sterility Testing Market Segmentation

Sterility Testing Product Type Outlook (USD Billion, 2018-2032)

• Instruments


• Services

Sterility Testing, Test type Outlook (USD Billion, 2018-2032)

• Membrane filtration


• Direct transfer

Sterility Testing, End-user Outlook (USD Billion, 2018-2032)

• Pharmaceutical Companies


• Hospitals & clinics


• Academic


• Research Laboratories

Sterility Testing Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America