The global Sterility Testing Market in terms of revenue was estimated to be worth $1.1 billion in 2023 and is poised to reach $1.9 billion in 2028, growing at a CAGR of 10.5% from 2023 to 2028. Factors responsible for the growth in the market are mainly the rising expansion of pharmaceutical & biopharmaceutical production capacities, increasing development of novel biopharmaceutical products, and rising investments in life science research. However, the growing adoption of single-use technology is a major factor restraining the market growth.

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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), Samsung Biologics (South Korea), GenScript (US), Pace Analytical (US), Rapid Micro Biosystems Inc (US), Tentamus Pharma (Germany). Singota Solutions (US), Neopharm Labs Inc. (Canada), LexaMed (US), Astell Scientifc (UK), HiMedia Laboratories (India), Pall Corporation (US), Boston Analytical (US), Solvias AG (Switzerland), and Becton, Dickinson, and Company (US).

In 2022, by product & service segment, the consumables segment accounted for the largest share of the sterility testing market
Based on product, the 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.

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

In 2022, by test type, the membrane filtration segment accounted for the largest share of the sterility testing market
On the basis of type, the 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.

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