Pharmaceutical Sterility Testing Market Size, Share, and Analysis, By Product Type (Kits & Reagents (Biological Indicators, and Chemical Indicators) and Instruments (Steam Sterilizer, Heat Sterilizer, Low Temperature Sterilizer, Ionizing Radiation Sterilizer, and Filter Sterilization Instrument), By Test Type (Sterility Testing {Direct Inoculation, and Closed-System Membrane Filtration}, Bioburden Testing, Bacterial Endotoxin Testing, and Others), By End-User (Pharmaceutical Companies, Compounding Pharmacies, Contract Research Organizations, and Others), and Regional Forecast, 2024-2032

Sterility testing of pharmaceuticals is an imperative process to confirm the absence of viable microorganisms on products. This is applied to all biopharmaceutical, and pharmaceutical products before product approvals. There has been a significant increase in pharmaceutical and biopharmaceutical production globally, owing to various factors including the rising prevalence of chronic conditions, increasing emphasis on early diagnosis, and increasing healthcare expenditure, among others. For instance, according to JAMA Network Medicine, cardiovascular diseases were the most serious concern of death in the U.S. in October 2021. This increasing burden of diseases is expected to lead the pharmaceutical industries to launch new drugs to combat the situation. 

As a result of this, the key players are focusing to the rising R&D investment to introduce advanced drug products. There has been a significant rise in R&D spending in the pharmaceutical sector, with market players focusing on the introduction of innovative drugs in the market. This along with an increasing number of approvals for biologics and biosimilar has been instrumental in the rising demand for sterility testing products globally.

Moreover, a growing number of service providers for pharmaceutical sterile testing services such as contract manufacturing organizations (CMOs), and others due to a sudden boost in the market after the impact of COVID-19 is leading to the rising adoption of these practices in the market. This, along with the increasing focus on biologics and biosimilars among the population owing to the distinct benefits of these drugs is also contributing to the growth of the market. Biologics and biosimilar are largely available as pre-filled vials, containers or in a liquid form and thus, requires a stringent check on the absence of microorganisms.

• In July 2022, according to U.S. Food & Drug Administration guidelines, manufacturers of biological products must perform sterility testing of each lot of each biological product’s final container material or other material.


• In January 2022, Alembic Pharma received final approval from U.S. Food and Drug Administration (USFDA) for a generic drug named Entacapone for the treatment of Parkinson’s disease.

Therefore, increasing adoption of sterile practices and adherence to protocols for sterile testing among pharmaceutical companies along with the growing specialized service providers such as contract manufacturing organizations and others is to foster the growth of the market.

Impact of COVID-19 on the Pharmaceutical Sterility Testing Market 

The COVID-19 pandemic has positively impacted the pharmaceutical sterility testing market. The COVID-19 pandemic has shifted the focus of pharmaceutical companies towards highly stringent policies for sterile testing in pharmaceutical and biopharmaceutical drugs. This has led to increasing research and development investment among pharmaceutical companies and research institutions globally.

Also, the high infection rate observed in patients due to weaker immunity during the COVID-19 pandemic has increased the demand for sterility testing kits among pharmaceutical companies worldwide. This, along with an increasing focus on adherence of Good Manufacturing Practices (GMP) among pharmaceutical companies, boosted the market during the pandemic.

• For instance, In September 2020, according to an article published by the American Association for the Advancement of Science, it was reported that 14% patients infected with COVID-19 has shown immune weakness which leads to increased chances of infection in these patients. This allowed the key players in the market to focus on the introduction of sterile testing kits.

Key Insights: 

• Regulatory Scenario, Key Regions


• Guidelines: Sterilization Testing, Key Regions


• Advancements in Pharmaceutical Sterility Testing Kits


• Key Industry Developments- New Product Launches, Mergers, and Acquisitions


• Impact of COVID-19 on the Pharmaceutical Sterility Testing Market

Analysis by Product:

Based on the Sample, the Pharmaceutical Sterility Testing Market is bifurcated into Pharmaceuticals, Biopharmaceuticals. Amongst the sample, the pharmaceutical segment is anticipated to hold a dominant position in the market. This dominance is attributed to the large utilization of pharmaceutics such as oral drugs, parenteral formulations, topical medicines, modified-release formulations, and others among patients. The increased investment in research and development activities is contributing to the rising demand for sterility kits and reagents among pharmaceutical companies. Thus, the key players are introducing various sterile test kits, reagents, and instruments to introduce different tests for different microorganisms. This is expected to propel the growth of the segment in the market.

• For instance, according to an article published by National Center for Biotechnology Information, pharmaceutics utilization increased by 4.8% in 2021 compared to 2020.

On the other hand, the biopharmaceuticals segment is also anticipated to grow with a significant CAGR. This is attributed to the rising demand for biologics and biosimilars among the patient population owing to their benefits and efficacy in treating severe diseases such as cancer, neurological, and others. The increased demand for biopharmaceuticals is allowing the key players in the pharmaceutical testing market to introduce advanced and effective sterile testing kits with an aim to ensure the sterility of drugs prior to their introduction in the market.

Regional Analysis:

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North America market holds the largest share in the market due to rising awareness about the safety and quality associated with pharmaceuticals, and others. Also, the increasing number of pharmacies and pharmaceutical companies launching advanced sterile test kits, devices, and others is attributed to the region's growth in the market. Additionally, the availability of raw materials for the production of sterile test kits and reagents is leading to expansion of their distribution channel in Asia Pacific countries and thus, leading to the growth of the region in the market.

On the other hand, Asia Pacific is anticipated to register a significant CAGR. This is due to stringent compliance of sterile test practices among pharmaceutical companies and compounding pharmacies after the impact of COVID-19. Moreover, the rising healthcare expenditure, and demand for innovative products, are driving pharmaceutical companies to focus on research and development activities which include the sterility of pharmaceutical products.

Key Players:

The report will include the profiles of key players such as Pacific Biolabs, Thermo Fisher Scientific, Pace Analytical Life Sciences, SGS Société Générale de Surveillance SA, SOLVIAS AG, Sartorius AG, Boston Analytical, STERIS, Rapid Micro Biosystems, Inc.

Segmentation:

Key Industry Developments:

• In September 2021, Nelson Labs and Sterigenics Germany GmbH announced the opening of state-of-the-art and expansion of sterilization facilities to meet increasing consumer demand in Europe.


• In December 2020, Redberry announced the launch of the Red One platform for the instantaneous detection of microorganisms in water and pharmaceutical products.


• In October 2020, Thermo Fisher Scientific announced the expansion of sterile filling capacity for therapies and vaccines with a new facility in Singapore to strengthen the government’s ability to handle the future health crises.