PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1454103
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1454103
Pharmaceutical Sterility Testing Market size was valued at USD 1,456.54 Million in 2023, expanding at a CAGR of 10.9% from 2024 to 2032.
Sterility testing is a method that determines whether or not live bacteria exist in a medicinal product. The purpose is to guarantee that the product fulfils sterility criteria, therefore reducing the danger of microbiological contamination that might endanger patient safety.
Pharmaceutical Sterility Testing Market- Market Dynamics
Increasing R&D and drug launches to propel market demand
Increased expenditure in research and development (R&D) and a rise in medication launches are the main factors driving growth in the pharmaceutical sterility testing industry. Preserving sterility during the drug-making process is essential to avoid contamination and guarantee that the drugs don't contain living microbes. Notably, the UK government committed to developing the pharmaceutical industry in March 2022 by pledging a sizeable $347 million for research and development projects aimed at creating novel therapies and instruments. In addition, IQVIA's research from December 2021 predicts a notable increase in expenditure on new products over the next five years, along with an increase in the launch of new pharmaceuticals, especially in the specialty, niche, and orphan drug categories. Thus, the aforementioned facts drive the pharmaceutical sterility testing market.
Pharmaceutical Sterility Testing Market- Key Insights
As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 10.9% over the forecast period (2024-2032)
Based on product type segmentation, the Kits & Reagents segment dominates the market
Based on sample segmentation, the pharmaceuticals sector dominates the market
Based on region, North America was the leading revenue generator in 2023
The Global Pharmaceutical Sterility Testing Market is segmented based on Type, Product Type, Test Type, Sample, End-use, and Region.
The market is divided into two categories based on product type: Instruments, Kits & Reagents and Services. The Kits & Reagents segment dominates the market. The segment growth is attributed to the increasing technological advancements.
The market is divided into four categories based on sample: Medical Devices, Pharmaceuticals and Biopharmaceuticals. The Pharmaceuticals sector dominates the market and is likely to maintain its dominance during the forecast period. Sterile testing is essential to guarantee adherence to regulatory standards like Good Manufacturing Practices (GMP), as the pharmaceutical business is subject to stringent regulatory regulations. Pharmaceutical businesses can achieve these strict regulatory criteria without incurring significant costs for specialist facilities and staff by outsourcing sterility testing to specialized laboratories. Pharmaceuticals include a wide range of dosage forms, including aerosols, ointments, eye drops, parenteral solutions, and other formulations.
Pharmaceutical Sterility Testing Market- Geographical Insights
Geographically, this market is widespread in the regions of North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. These regions are further divided as per the nations bringing business. North America is expected to hold the largest market share over the forecast period. This is explained by the proliferation of pharmaceutical businesses and the existence of several significant market participants in the United States and Canada. The market's growth can be attributed to the presence of technologically sophisticated CROs and CDMOs as well as an increase in grant distribution. Over the anticipated timeframe, additional funds would be invested in clinical research due to the rising frequency of various diseases. In addition, increased efforts toward medication development, strategic initiatives such as innovation and acquisitions, the existence of biotech and pharmaceutical companies, and an increase in the number of clinical studies in the area are important drivers of market expansion.
Several major businesses are implementing some strategic efforts to improve their market position and provide a wide range of services to customers. To boost market presence and revenue and obtain a competitive edge, organizations frequently engage in partnerships and agreements, joint ventures, service launches, and other tactics that fuel market growth.
In May 2023, Thermo Fisher Scientific, Inc. declared the opening of a Singaporean sterile pharmaceuticals factory. It would assist in supplying the Asia Pacific market with novel vaccinations and medications.
GLOBAL PHARMACEUTICAL STERILITY TESTING MARKET KEY PLAYERS- DETAILED COMPETITIVE INSIGHTS
Sotera Health Company (Nelson Labs)
Boston Analytical
Steris Plc
Pacific Biolabs
Sartorius Ag
Solvias Ag
SGS SA
Pace Analytical
Labcorp
Thermo Fisher Scientific, Inc.
Charles River Laboratories
Almac Group
Rapid Micro Biosystems, Inc.
Labor LS SE & Co. KG