WASHINGTON, Oct. 05, 2023 (GLOBE NEWSWIRE) -- As per Vantage Market Research, the Global Pharmaceutical Sterility Testing Market has been significantly growing over the years due to factors such as increasing R&D activities in the pharmaceutical industry, growing number of pharmaceutical products in the market, rising demand for quality control and assurance in drug manufacturing, and the increasing prevalence of chronic diseases.
According to Vantage Market Research, the Global Pharmaceutical Sterility Testing Market is estimated to be valued at USD 3.15 Billion by 2030 and is expected to exhibit a CAGR of 11.7% from 2023 to 2030. The global Pharmaceutical Sterility Testing market grew to USD 1.3 Billion in 2022.
Pharmaceutical Sterility Testing ensures that pharmaceutical products, including injectable drugs and medical devices, are free from harmful microorganisms. The testing is usually conducted in a controlled laboratory environment and involves using susceptible techniques to detect the presence of any viable microorganisms. This includes bacteria and fungi that could cause infection or harm to patients. Sterility testing aims to ensure that the products are safe for use and meet the stringent criteria of excellence set by regulatory authorities such as the FDA.
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Key Highlights
- Factors such as increasing R&D activities in the pharmaceutical industry, the growing number of pharmaceutical products in the market, rising demand for quality control and assurance in drug manufacturing, and the increasing prevalence of chronic diseases will bolster the market growth.
- North America accounted for the most significant growth, with a revenue share of 48.20% in 2022.
- Asia Pacific is expected to dominate the market during the forecast period.
- The Kits and Reagents segment accounted for the most enormous market growth in 2022 due to its wide usage for conducting sterility tests in pharmaceutical laboratories and manufacturing facilities.
- Based on End-Use, the Pharmaceutical Companies segment accounted for the potential market growth in 2022 due to the strict regulatory requirements and quality control measures imposed on pharmaceutical products.
- North America to dominate global sales owing to well-established healthcare infrastructure, the presence of key market players, and high demand for pharmaceutical products in the region.
The global Pharmaceutical Sterility Testing industry is expected to experience significant growth in the coming years. This boost can be attributed to the increasing demand for pharmaceutical products and the industry's need for strict quality control measures. Sterility testing plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, making it a vital aspect of the industry.
Top Companies in The Global Pharmaceutical Sterility Testing Market
- Pacific Biolabs (U.S.)
- STERIS (U.S.)
- Boston Analytical (U.S.)
- Nelson Laboratories LLC (U.S.)
- Sartorius AG (Germany)
- SOLVIAS AG (Switzerland)
- SGS SA (Switzerland)
- Laboratory Corporation of America Holding (U.S.)
- Pace Analytical (U.S.)
- Charles River Laboratories (U.S.)
- Thermo Fisher Scientific Inc. (U.S.)
- Rapid Micro Bio Systems Inc. (U.S.)
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Factors affecting the growth of the Pharmaceutical Sterility Testing Industry
Several factors can affect the growth of the Pharmaceutical Sterility Testing industry. Some of these factors include:
- Increasing demand for pharmaceutical products: The growing global population and the rise in chronic and infectious diseases have raised the need for pharmaceutical products. This, in turn, drives the growth of the Pharmaceutical Sterility Testing industry, as these products need to undergo strict testing to ensure their safety. As per the report 2022, over 202 billion was estimated to be spent worldwide on biopharmaceutical research and development.
- Stringent regulatory requirements: Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established strict guidelines and standards for pharmaceutical manufacturing and testing. Compliance with these regulations is crucial for pharmaceutical companies, thus driving the demand for sterility testing. The FDA's Current Good Manufacturing Practices (cGMP) and EMA's Good Manufacturing Practice (GMP) require pharmaceutical products to undergo sterility testing before release.
- Increasing generic drug production: The generic drug market is experiencing rapid growth, and sterility testing is crucial to ensure the safety and quality of these generic products. According to the U.S. FDA, generic drugs account for approximately 90% of prescriptions in the United States. Sterility testing plays a critical role in maintaining the quality and safety of these generic drugs.
- Technological advancements in sterility testing methods: The Pharmaceutical Sterility Testing industry has witnessed significant advances in testing methods that enhance efficiency, accuracy, and reliability. Rapid microbiological methods (RMM) such as polymerase chain reaction (PCR) and real-time PCR have gained popularity due to their quicker turnaround time and higher sensitivity.
Top Trends in Global Pharmaceutical Sterility Testing Market
The global Pharmaceutical Sterility Testing market is experiencing several key trends. Firstly, there is an increasing demand for advanced testing methods to guarantee the safety and efficacy of pharmaceutical products. This has led to the adoption of rapid sterility testing systems that provide accurate results in a shorter time frame. Moreover, there is a rising focus on using alternative testing methods, such as molecular-based approaches, to complement traditional culture-based methods. Furthermore, the rise of biologics and personalized medicine has necessitated the development of sterility testing techniques tailored explicitly for these products. For example, membrane filtration and direct inoculation are used to test biologics.
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Recent Development of the Global Pharmaceutical Sterility Testing Market
- In June 2022, STEMart introduced a comprehensive range of microbiology and sterility testing services specifically designed for sterile, non-pyrogenic medical devices.
- In June 2022, Berkshire Sterile Manufacturing opened a sterility testing isolator that performs onsite sterility testing for its GMP batches. The company offers sterile filling of injectable medicines, most in clinical trials or require a small commercial need.
Market Drivers
The growth of the pharmaceutical and medicine manufacturing industry is expected to drive the adoption of sterility testing, leading to an expansion in the market. In 2021, PhRMA members in the United States spent USD 102 billion on R&D activities, as reported by the CBO in February 2022. According to Statistics Canada, Canada's in-house spending on pharmaceutical R&D activities was USD 23.4 billion in 2021 and is projected to increase by 1.7% to USD 23.8 billion in 2022. This increased funding for R&D activities in both countries is expected to contribute to the growth of the sterility testing market.
Moreover, the field of life sciences is experiencing significant research and development advancements, supported by substantial public and private funding. In India, for example, the Union Budget for 2021-2022 allocated a budget of INR 35 billion to the Department of Biotechnology (DBT), representing a 25% increase from the previous year. This allocation aims to promote biotechnology research and development and industrial and entrepreneurship development in the country, further fueling market growth.
Overall, the anticipated rise in pharmaceutical and medicine manufacturing, increased R&D investments, and support in the life sciences sector are expected to drive the market growth for sterility testing.
Market Restraints
The Pharmaceutical Sterility Testing market faces significant challenges, including the high cost of tests and a shortage of skilled personnel to perform them. These limitations can result in errors or delays in testing. Strict regulatory guidelines and the lengthy approval process for sterility testing products further hinder market expansion.
Market Opportunities
The Pharmaceutical Sterility Testing market is projected to grow significantly, driven by the increasing demand for pharmaceutical products and the stringent regulatory guidelines for product safety. Additionally, the rising number of pharmaceutical manufacturing facilities, advanced technological advancements, and the growing emphasis on quality assurance measures further contribute to the market growth. Moreover, the increasing adoption of automation solutions for sterility testing and the development of rapid sterility testing methods present lucrative opportunities in the market.
Browse market data Tables and Figures spread through 150 Pages and in-depth TOC on Pharmaceutical Sterility Testing Market Forecast Report (2023-2030).
Report Segmentation of the Global Pharmaceutical Sterility Testing Market
Product Type Analysis
Kits and Reagents dominated the market with the largest share because of the increasing demand for efficient and accurate testing methods to ensure the sterility of pharmaceutical products. The global Pharmaceutical Sterility Testing market is based on product types segmented into kits and reagents, instruments, and services. Analysis kits and reagents provide a convenient and reliable solution for sterility testing by enabling the detection of microbial contamination. Additionally, technological advancements, such as the development of rapid sterility testing methods using kits and reagents, have further boosted the growth of this segment.
Test Type Analysis
The bacterial endotoxin testing market segment accounted for the highest in 2022. The global Pharmaceutical Sterility Testing market is based on the test type analysis segmented into sterility testing, bioburden testing, bacterial endotoxin testing, and other test types. Bacterial endotoxin testing is required for all drugs administered via parenteral routes. These tests are also used for testing medical devices such as implants. The growing demand for parenteral drugs and implants supports the segment market's growth. There is a rising emphasis on product quality and an increasing number of drug and medical device launches. This is anticipated to contribute towards the expansion of the segments.
End-Use Analysis
Pharmaceutical companies dominated the most significant share due to the strict regulatory requirements and quality control measures imposed on pharmaceutical products. The global Pharmaceutical Sterility Testing market is based on end-use analysis segmented into compounding pharmacies, medical device companies, and pharmaceutical companies. Since most of these medications are taken orally by patients, pharmaceutical companies must perform sterility testing to ensure product safety, particularly for oral dosage forms. The sterility tests needed for a particular drug are detailed in each country's pharmacopeia according to established norms.
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Global Pharmaceutical Sterility Testing Market Segmentation
By Product Type
- Kits and Reagents
- Instruments
- Service
By Test Type
- Sterility Testing
- Bioburden Testing
- Bacterial Endotoxin Testing
- Other Test Types
By End-Use
- Compounding Pharmacies
- Medical Devices Companies
- Pharmaceutical Companies
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
Scope of the Report:
| Report Attributes | Details |
| Market Size in 2022 | USD 1.3 Billion |
| Revenue Forecast by 2030 | USD 3.15 Billion |
| CAGR | 11.7% from 2023 to 2030 |
| Base Year | 2022 |
| Forecast Year | 2023 to 2030 |
| Key Players | Pacific Biolabs, STERIS, Boston Analytical, Nelson Laboratories LLC, Sartorius AG, SOLVIAS AG, SGS SA, Laboratory Corporation of America Holding, Pace Analytical, Charles River Laboratories, Thermo Fisher Scientific Inc., Rapid Micro Bio Systems Inc. |
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Regional Analysis
The North American Pharmaceutical Sterility Testing market had a significant share of 48.20% in 2022. This is credited to the presence of leading pharma and biopharma players, increasing R&D activities in the biotech and pharma industry, increasing number of product introductions, high occurrence of chronic ailments, and supportive government policies for setting up R&D facilities. Furthermore, solid healthcare policies, strict drug approval needs, increasing public consciousness of drug safety, increasing acceptance of pioneering technologies, and the launch of gene and cell therapies for treating more than a few hematologic malignancies resulted in the development of the regional industry. Consequently, Canada spent US$ 23,400 million internally on pharmaceutical research and development in 2021, reaching US$ 23,800 million in 2022, a 1.7% increase.
The Asia Pacific industry is the most lucrative due to several possible areas for future enlargement. This results from emerging countries increasingly harmonizing their regulatory norms with ICH standards. Moreover, China's Pharmaceutical Sterility Testing market held the largest revenue share, and the Indian market of Pharmaceutical Sterility Testing was the fastest-growing market in the Asia-Pacific region.
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