Overview and Scope
Pharmaceutical sterility testing refers to a test that is intended to show if biological parenteral made for human use contain extraneous, viable contaminating microorganisms or not. All pharmaceutical items used on patients by medical professionals must be of the highest quality and extremely safe. Otherwise, it could harm the patients. Testing for sterility assures that the offered product is suitably sterile.
Sizing and Forecast
The pharmaceutical sterility testing market size has grown strongly in recent years. It will grow from $1.41 billion in 2023 to $1.54 billion in 2024 at a compound annual growth rate (CAGR) of 9.0%. The growth in the historic period can be attributed to rising demand for quality pharmaceutical products, growing emphasis on drug safety and efficacy, growing demand for biologics and biosimilar drugs, increasing prevalence of infectious diseases, rising investments in life science research.
The pharmaceutical sterility testing market size is expected to see strongly grown in the next few years. It will grow to $3.18 billion in 2028 at a compound annual growth rate (CAGR) of 20.0%. The growth in the forecast period can be attributed to biopharmaceutical growth, personalized medicine, growing trend of outsourcing, quality assurance emphasis, pandemic preparedness. Major trends in the forecast period include rapid microbiological methods, combination products, data integrity and digitalization, automation and robotics, advanced analytical techniques.
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Segmentation & Regional Insights
The pharmaceutical sterility testing market covered in this report is segmented –
1) By Sample: Sterile Drugs, Medical Devices, Biologics and Therapeutics
2) By Product Type: Instruments, Kits and Reagents, Services
3) By Type: In- house, Outsourcing
4) By Test Type: Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing
5) By End- User: Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies
North America was the largest region in the pharmaceutical sterility testing market in 2023. The Middle East is expected to be the fastest-growing region in the global pharmaceutical sterility testing market share during the forecast period. The regions covered in the pharmaceutical sterility testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.
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Major Driver Impacting Market Growth
An increase in the number of drug launches and rising investment in research and development (R&D) contributed to the growth of the pharmaceutical sterility testing market. Sterility is an important step in the manufacture of drugs to avoid product contamination and make the drugs free from any viable microorganisms. For instance, in March 2022, according to an article shared by Pharmaceutical Technology, a US-based independent source for information, insight, and analysis on bio/pharmaceutical formulation, the UK government announced a $347 million (£260 million) commitment to advance research and development (R&D) and the creation of innovative treatments, tools, and diagnostics. Additionally, in December 2021, according to a report shared by IQVIA, a US-based provider of advanced analytics, technology solutions, and clinical research services, Over the next five years, until 2026, a total of 300 new medications are anticipated to be introduced; this is a large increase over the level observed on average over the previous ten years, and the drugs are anticipated to tilt toward specialty, niche, and orphan drugs. In the next five years, there will be a $196 billion increase in spending on new products, which will be roughly offset by a $188 billion decrease in brand spending owing to loss of exclusivity.
Key Industry Players
Major companies operating in the pharmaceutical sterility testing market include Pacific Biolabs Inc., STERIS Corporation, Boston Analytical Inc., Gibraltar Laboratories Inc., Sartorius AG, Solvias AG, SGS S.A., Toxikon Inc., Pace Analytical Services LLC, Charles River Laboratories International Inc., Nelson Laboratories Inc., Rapid Micro Biosystems Inc., bioMérieux Inc., Merck KGaA, WuXi AppTec, Sotera Health LLC, Dynalabs LLC, Infinity Laboratories, Eurofins Scientific SE, Avomeen Analytical Services, Microbac Laboratories Inc., Analytical Lab Group LLC, North American Science Associates Inc., Medical Device Testing Services Inc., Microtest Laboratories Inc., BioScreen Testing Services Inc., Microchem Laboratory Inc., Bactolac Pharmaceutical Inc., Micro Quality Labs Inc., Boston Microfluidics Inc., BioPharma Services Inc., Microbiology Research Associates, BioScience Laboratories Inc.
The pharmaceutical sterility testing market report table of contents includes:
1. Executive Summary
2. Pharmaceutical Sterility Testing Market Characteristics
3. Pharmaceutical Sterility Testing Market Trends And Strategies
4. Pharmaceutical Sterility Testing Market – Macro Economic Scenario
5. Global Pharmaceutical Sterility Testing Market Size and Growth
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31. Global Pharmaceutical Sterility Testing Market Competitive Benchmarking
32. Global Pharmaceutical Sterility Testing Market Competitive Dashboard
33. Key Mergers And Acquisitions In The Pharmaceutical Sterility Testing Market
34. Pharmaceutical Sterility Testing Market Future Outlook and Potential Analysis
35. Appendix
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