Sterility Testing Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global sterility testing market growth forecasted to transform from USD 1.1 billion in 2023 to USD 1.9 billion by 2028, driven by a CAGR of 10.5%. Factors such as expanding pharmaceutical & biotechnology production capacities, increasing development of novel biopharmaceutical products, and rising investments in life sciences research are expected to drive market growth. However, the growing adoption of single-use technology and stringent regulatory guidelines for product approval are expected to restrain market growth to a certain extent.

Sterility Testing Market Trends

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Sterility Testing Market Dynamics

Driver: Rising expansion of pharmaceutical & biopharmaceutical production capacities

In pharmaceutical and biopharmaceutical industries, sterility testing is conducted at all manufacturing stages to minimize the risk of product contamination. Subsequently, the growth of this end-use industry in the coming years will considerably boost the utilization of sterility testing.

The production capacity expansion of pharmaceuticals and biopharmaceuticals worldwide will augment the demand for sterility testing products and services. Sterility testing is mandatory during the production process of pharmaceuticals and biopharmaceuticals. Therefore, the rising production capacities of pharmaceutical & biopharmaceutical companies will drive the adoption of additional kits, reagents, and instruments for sterility tests.

For instance:

• In 2022, Novartis (Switzerland) invested USD 300 million to bolster the capacity and capabilities for next-generation bio-therapeutics across Switzerland, Slovenia, and Austria.
• In 2022, Eli Lilly and Company (US) invested USD 1.5 billion to establish two new manufacturing facilities: Concord, NC, and Limerick, Ireland. Of the total investment, the company aims to invest USD 500 million, specifically in Limerick, to create a new biologics active ingredients site.

Restraint: Growing adoption of single-use technology

Single-use technology substitutes the stainless-steel and hard-piped configurations used in aseptic processing and sterile manufacturing. Gamma-irradiated pre-assembled process systems are used under single-use technology. Such technology is used for aseptic filling as well as upstream & downstream processing. The main benefit of SUT is that time and money are not invested in labor-intensive and expensive cleaning, sterilization validation tests, or their recurring revalidation. Moreover, it eliminates system cleaning and sterilization requirement between batches. Adopting such technologies will hamper the demand for sterility testing products and services.

However, the chances of human error will continue, even if closed systems and single-use technology are used more frequently. Personnel continues to be the principal source of contamination for pharmaceutical & biopharmaceutical formulations that cannot be terminally sterilized. Thus, a thorough training program is essential. When adhering to GMP and quality standards, operator comprehension is a crucial factor.

Opportunity: Emerging markets

Emerging markets such as Brazil, India, and China are expected to present significant opportunities for the growth of the market. This can mainly be attributed to increased R&D funding for research in these countries. For instance, China's current healthcare expenditure (% of GDP) went from 5.1% in 2017 to 5.4% in 2019. Similarly, for India, the healthcare expenditure rose from 2.9% in 2017 to 3.0% in 2019, while for Brazil, it was 9.5% in 2017 and increased to 9.6% in 2019. (Source: World Bank)

Moreover, CDMOs and CROs based in emerging markets offer cost-efficient development and manufacturing services to pharma & biotech companies. Sterility testing is a mandatory step in pharmaceutical drug discovery & development. Therefore, the growing production capacities of CROs and CDMOs in emerging nations will augment the demand for sterility testing products and services. A few examples of such capacity expansions are as follows:

• In August 2022, Samsung Biologics announced plans to build a second biopharmaceutical campus, named Bio Campus II, at Songdo, Incheon, South Korea
• In July 2022, Wuxi Biologics announced a USD 1.4 billion investment for expanding its research, development, and large-scale drug substance and drug product manufacturing capacity and capabilities in Singapore.

Challenge: Shortage of skilled professionals

The success of sterility tests depends mainly on the expertise of the analysts on the same par as the environmental conditions under which the test is performed. For optimal efficacy, sterility testing needs to be conducted by skilled professionals with sufficient knowledge of the nuances of this field. Handling the instruments used in sterility testing also requires expertise. Consequently, the shortage of a sufficiently skilled workforce poses a key challenge to the growth of the market.

In 2022, by product & service segment, the consumables segment accounted for the largest share of the sterility testing industry

Based on product, the sterility testing market is segmented into membrane filtration, direct inoculation, and other tests. In 2022, the kits & reagents segment accounted for the largest share of the global market. The large share of this segment can primarily be attributed to ease of use, recurring purchase, and growing preference associated with kits & reagents.

In 2022, by test type, the membrane filtration segment accounted for the largest share of the sterility testing industry

On the basis of type, the sterility testing market is segmented into membrane filtration, direct inoculation, and other tests. In 2022, the membrane filtration segment accounted for the largest share of the global market. Factors responsible for the large share of this segment are the growing demand for liquid formulations coupled with the suitability of such tests with samples containing preservatives and bacteriostatic & fungistatic compounds.

In 2022, North America accounted for the largest share of the sterility testing industry

In 2022, North America accounted for the largest share of the sterility testing market. Increasing drug approvals are expected to boost the market in the region. Additionally, the rising prevalence of diseases and the growing patient pool are increasing the demand and production for medicines in North America. The pharmaceutical & biotechnology industries in North America invest heavily in R&D and are expected to witness significant growth in the coming years, which in turn, is expected to drive the growth of the market.

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The sterility testing market is dominated by a few globally established players such as Charles River Laboratories (US), Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), WuXi AppTec (China), Nelson Laboratories, LLC (US), Pacific BioLabs (US), Sartorius AG (Germany), Thermofisher Scientific Inc. (US), and Samsung Biologics (South Korea).

Sterility Testing Market Report Scope

The study categorizes the sterility testing market into the following segments & sub-segments:

By Product & Service

• Kits & Reagents
• Services
• Instruments

By Test Type

• Membrane Filtration
• Direct Inoculation
• Other Tests

By Application

• Pharmaceuticals And Biologicals
• Medical Devices
• Other Applications

By End User

• Pharmaceutical Companies
• Biotechnology Companies
• Others

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • Italy
  • Spain
  • UK
  • France
  • Rest of Europe
• Asia
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia
• Rest of the World
  • Africa
  • Pacific and Oceania
  • South America, Central America, and the Caribbean

Recent Developments of Sterility Testing Market

• In November 2022, Merck KGaA (Switzerland) invested USD 306.5 million in expanding its biosafety testing capacity at Rockville, Maryland, US. This site will provide biosafety testing and analytical development services in the US.
• In September 2022, Merck KGaA (Switzerland) opened its viral clearance (VC) laboratory as the first phase of the China Biologics Testing Center. This site is set to operate in China and will locally conduct viral clearance studies across pre-clinical development to commercialization.
• In June 2022, Charles River Laboratories, Inc. (US) opened a new facility of High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech's Alderley Park in Cheshire, UK. The 16,000 sq. ft facility will provide plasmid DNA manufacturing services.
• In May 2022, bioMérieux SA (France) acquired Specific Diagnostics (US). With this acquisition, bioMérieux will improve its presence in antimicrobial resistance while expanding its market-leading position globally in clinical microbiology.

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