Pharmaceutical Sterility Testing Market

The global Pharmaceutical Sterility Testing Market is valued at USD 0.67 Billion in 2024 and is projected to reach a value of USD 1.208 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 5.55% between 2025 and 2035.

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The increasing cases of chronic and infectious diseases have raised the demand for strict sterility testing of drugs and medical devices to ensure product and appliance safety. According to the World Health Organization (WHO), the worldwide incidence of tuberculosis was estimated to be around 10.6 million people in 2021, with 1.2 million children. This burden of diseases is expected to drive the demand for pharmaceuticals and consequently support the need for Pharmaceutical Sterility Testing. Emerging countries have shortened their regulatory schedules for drug approval and accelerated drug launches to meet the growing demand for healthcare. These regulatory adjustments are expected to accelerate market expansion. Furthermore, introducing biopharmaceutical products like Elagolix and Lanadelumab, which require unique sterility testing, will significantly contribute to the markets growth. Ongoing clinical studies on COVID-19 vaccines to find safe and effective treatments for all new virus variants will positively impact the market in the post-pandemic period. Moreover, increasing research and development efforts in the life sciences field and substantial public and private funding fuel the markets growth. The biopharmaceutical industrys annual research and development spending is notably higher than that of other industries, such as the aerospace and defense industry, chemicals industry, and software and computer services, according to data published by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

• Factors such as increasing R&D activities in the pharmaceutical industry, the growing number of pharmaceutical products in the market, the 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 largest 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 largest 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 dominates global sales owing to its well-established healthcare infrastructure, the presence of key market players, and high demand for pharmaceutical products in the region

Top Market Trends

1. Technological advancements have led to the development of automated sterility testing systems, which offer higher accuracy and efficiency than manual methods. These systems help minimize human error and improve the productivity of pharmaceutical manufacturing processes. For instance, the Milliflex Quantum system by Merck is an automated microbial detection system that can significantly shorten the incubation time.
2. Traditional sterility testing methods have certain limitations, such as their inability to detect certain microorganisms. This has led to the development and adopting of alternative methods, such as the rapid microbial method (RMM), which can provide faster and more accurate results. The GeneDisc system by Pall Corporation is an example of an RMM that uses real-time polymerase chain reaction (PCR) technology for microbial detection.
3. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have implemented strict guidelines for Pharmaceutical Sterility Testing to ensure the safety and efficacy of drugs. This has led to an increased focus on sterility testing, driving market growth. For example, the FDAs cGMP requirements state that all sterile drug products must undergo sterility testing before release.
4. 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.
5. The rising global population and the growth in chronic and infectious diseases have raised the need for pharmaceutical products. This, in turn, drives the development 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.

Economic Insights

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 drug discovery and development activities, as reported by the CBO in February 2022. According to Statistics Canada, Canadas in-house spending on drug discovery and development 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 the countrys biotechnology research and development and industrial and entrepreneurship development, further fuelling 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 Segmentation

The Global Pharmaceutical Sterility Testing Market can be broadly classified across the segments as mentioned below:

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Based on Product Type

Kits and Reagents to Lead Maximum Market Share Due to Its Wide Usage for Conducting Sterility Tests in Pharmaceutical Laboratories and Manufacturing Facilities

In 2022, Kits and Reagents dominated the market. This increase is attributable to the accessibility of several items that reduce the possibility of false adverse and false positive outcomes. Another example is the integration of sterility testing pumps, which can be effortlessly incorporated into any testing setting, facilitating the enhancement of safety measures and optimizing productivity. Over the anticipated period, segmental growth will be aided by the rising demand for comparable products.

Based on Test Type

Bacterial Endotoxin Testing Segment Expects Dominion Owing to The Increasing Demand for Pharmaceutical Products and The Growing Emphasis on Product Quality and Safety

The Bacterial Endotoxin Testing category generated the most income in 2022. For all medications delivered parenterally, bacterial endotoxin testing is necessary. Medical items like implants are also tested using these procedures. The sector market is expanding due to the rising demand for parenteral medications and implants. Along with an increase in drug and medical device launches, there is a growing emphasis on product quality.

Based on End-Use

Pharmaceutical Companies to Lead Maximum Market Share Due to The Strict Regulatory Requirements and Quality Control Measures Imposed on Pharmaceutical Products

The Pharmaceutical Companies segment is expected to witness significant growth in the Pharmaceutical Sterility Testing market over the forecast period. The main factors responsible for the development of the segment are the rising demand for drugs, vaccines, and high-growth pharmaceutical manufacturing industries. Sterility testing aims to reduce the likelihood of contamination in pharmaceutical and biological products during manufacturing. With the rising demand for medication and improved medical outcomes for various health conditions, the frequency of sterility testing in industries is also increasing. This trend is expected to impact the market positively.

Based on Region

North America to Dominate Global Sales Owing to The Increasing Number of Pharmaceutical Industries Within the U.S. And Canada

Europe dominated the market in 2022 due to the increasing number of pharmaceutical industries within the U.S. and Canada. Many major market players in this region are anticipated to contribute significantly to the industry growth. Stringent regulatory requirements for the sterility testing of pharmaceuticals and medical devices in this region further support the development of the regional market. For instance, PreHevbrio was introduced by VBI Vaccines Inc. in March 2022 for the treatment of persons aged 18 years old. It is for those at risk of contracting any recognized subtypes of the hepatitis B virus (HBV). In November 2021, the FDA authorized this vaccine as the exclusive adult 3-antigen HBV vaccine.

The Pharmaceutical Sterility Testing industry in Asia Pacific is rapidly gaining popularity. This results from emerging countries increasingly harmonizing their regulatory norms with ICH standards. Additionally, several of the regions developing nations are adopting various steps to expand the domestic pharmaceutical industry and are enticing corporations to establish operations there (collaborations that promote outsourcing activities). Such efforts are probably going to help with regional development.

Competitive Landscape

The global Pharmaceutical Sterility Testing market is highly competitive, with major players focusing on collaborations, M&A activity, and new product launches to gain a competitive edge. Some key players in the market include Pacific Biolabs, STERIS, Boston Analytical, Nelson Laboratories LLC, and Sartorius AG. For Instance, to conduct on-site sterility testing for its GMP batches, Berkshire Sterile Manufacturing opened a sterility testing isolator. The business provides sterile filling of injectable medications, most of which are undergoing clinical studies or have little commercial demand.

The key players in the global Pharmaceutical Sterility Testing market include - Pacific Biolabs (U.S.) among others.

Recent Market Developments

• 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.

Segmentation of the Global Pharmaceutical Sterility Testing Market