Pharmaceutical Sterility Testing Market – By Product (Kits & Reagents), Test (Membrane Filtration, Rapid Microbial [ATP Bioluminescence, Fluorescent-based]), Sample (Sterile Drugs, Biologics & Therapeutics), Type, End-user, Global Forecast (2024 – 2032)

Pharmaceutical Sterility Testing Market – By Product (Kits & Reagents), Test (Membrane Filtration, Rapid Microbial [ATP Bioluminescence, Fluorescent-based]), Sample (Sterile Drugs, Biologics & Therapeutics), Type, End-user, Global Forecast (2024 – 2032)

Pharmaceutical Sterility Testing Market Size

Pharmaceutical Sterility Testing Market size was valued at USD 741.3 million in 2023 and is anticipated to witness growth at a CAGR of 10.8% between 2024 and 2032. The market is experiencing growth driven by increased demand for sterile products and biologics, such as vaccines and gene therapies.

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The market is expanding as pharmaceutical companies strive to comply with stringent regulatory requirements and quality standards. In addition, advances in testing methods, such as rapid microbiological testing and automated systems, enhance efficiency and accuracy, encouraging wider adoption and investment in these technologies. These factors collectively contribute to the expansion of this market. Furthermore, stringent regulatory requirements, increasing focus on patient safety, and the globalization of pharmaceutical supply chain supports the market growth.

Pharmaceutical sterility testing is a quality assurance process used to confirm that pharmaceutical products such as injectable drugs, biologics, vaccines, ophthalmic preparations, and medical devices are free from viable microorganisms. This testing is essential for ensuring the safety, efficacy, and integrity of pharmaceutical products, as well as compliance with regulatory standards.
 

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Pharmaceutical Sterility Testing Market Trends

• The rising prevalence of infectious diseases worldwide is a significant driver fueling the growth of the market, by increasing the demand for safe and sterile pharmaceutical products, such as vaccines and other sterile medications.
• The accelerated development of vaccines and therapies to combat infectious diseases, further contributes to this demand.
• Sterility testing plays a crucial role in ensuring the safety and efficacy of pharmaceutical products by detecting and preventing the presence of harmful microorganisms.
• Thus, with the increasing demand for sterile pharmaceuticals to combat infectious diseases, the market is expected to experience robust growth in the coming years.

Pharmaceutical Sterility Testing Market Analysis

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Based on product, the market is segmented into kits & reagents, services, and instruments. The kits & reagents segment held a significant market share of 52.1% in 2023.

• The kits and reagents segment dominates the market due to the comprehensive and convenient solutions it provides. These pre-packaged kits contain all the necessary materials for sterility testing, such as culture media and buffers, streamlining the testing process and reducing preparation time.
• Additionally, other factors such as ease of use, convenience, efficiency, compatibility with automated systems, broad applications, quality assurance, and cost-effectiveness of kits and reagents significantly drives its adoption, thereby fueling the growth of this segment.

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Based on test, the pharmaceutical sterility testing market is classified into membrane filtration, direct inoculation, rapid microbial method, and other tests. The rapid microbial method segment is further classified into ATP bioluminescence, fluorescent -based, solid-phase cytometry, and other rapid microbial methods. The membrane filtration segment accounted for highest market share and was valued at USD 307.7 million in 2023.

• Membrane filtration is a versatile and widely applicable test, making it suitable for testing injectable drugs, vaccines, biologics, and other sterile liquids. The test provides rapid and quantitative results, allowing for efficient processing of large sample volumes and quick identification of potential contaminants.
• Moreover, membrane filtration is known for its ease of use and cost-effectiveness, making it an accessible and economical option for pharmaceutical companies.
• Further, it is also a well-established method accepted by regulatory authorities worldwide and complies with international guidelines and standards. Such aforementioned factors drive the growth of this segment.

Based on type, the pharmaceutical sterility testing market is categorized into in-house testing and outsourced testing. The in-house testing segment dominated the market in 2023 and is anticipated to grow at CAGR of 10.5% between 2024 – 2032.

• In-house testing allows for faster turnaround times, enabling quicker product release and lesser time-to-market new products.
• Moreover, in-house testing provides customization and flexibility, allowing companies to tailor testing methods to specific products or needs, resulting in improved accuracy and efficiency. These benefits collectively contribute to the dominance of the in-house segment in the market.

Based on sample, the pharmaceutical sterility testing market is divided into sterile drugs and biologics and therapeutics. The biologics and therapeutics segment was valued at USD 386.2 million and is anticipated to reach USD 948.5 million by 2032.

• The sterile drugs segment dominates the market due to the critical need to ensure the safety and efficacy of products such as injectables, vaccines, and biologics.
• These drugs must meet stringent regulatory standards to ensure they are free from microbial contamination, which is essential for patient safety. The high risk of contamination during manufacturing, packaging, and distribution drives the demand for rigorous sterility testing to safeguard public health.
• Additionally, the growing demand for injectable drugs, driven by the increasing prevalence of chronic diseases and the need for vaccines and biologics, contributes to the dominance of the sterile drugs segment.

Based on end-user, the pharmaceutical sterility testing market is categorized into pharmaceutical & biotechnology companies, Contract Research Organizations (CROs) and contract testing laboratories, compounding pharmacies, and other end-users. The pharmaceutical & biotechnology companies’ segment is projected to reach USD 913.6 million by 2032.

• High volume of production of pharmaceutical products and the necessity of ensuring product safety and regulatory compliance is a major factor driving the segmental growth.
• Pharmaceutical & biotechnology companies produce a large variety of sterile drugs, biologics, and vaccines, that require extensive sterility testing to maintain high quality and safety, thereby driving the growth of this segment.
• Further, rising number of innovations and development of new therapies, such as gene and cell therapies, increasing demand of biopharmaceuticals, rising prevalence of infectious diseases contributes to the growth of this segment.

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North America pharmaceutical sterility testing market size in 2023 was valued at USD 317.3 million and is predicted to grow at a CAGR of 10.7% over the analysis timeframe.

• North America dominates the market due to its strong pharmaceutical industry and stringent regulatory environment.
• The region also benefits from significant investment in research and development within the pharmaceutical and biotech sectors, fueling the demand for advanced sterility testing methods.
• Further, the region leads in the adoption of technologies like rapid microbiological methods and automation, enhancing testing efficiency and accuracy, thereby propelling the growth of this market.

U.S. pharmaceutical sterility testing market is anticipated to grow at CAGR of 10.6% to reach USD 713.7 million by the end of forecast timeframe.

• The rising prevalence of infectious diseases in U.S. are raising the demand for biologics, vaccines, and other sterile drugs in the country, thereby boosting the need for robust sterility testing to ensure product safety and efficacy.
• For instance, according to Centers for Disease Control and Prevention, the number of new tuberculosis cases and salmonella cases in U.S. were reported around 8,916 and 58,371 in 2019.

Germany pharmaceutical sterility testing is projected to grow remarkably in the coming years.

• The growth of this market is driven by a robust pharmaceutical industry, stringent regulatory standards, and a strong focus on research and development.
• Germany's adoption of advanced testing technologies enhances efficiency and accuracy, while specialized contract testing laboratories offer reliable outsourcing options. The emphasis on quality assurance and patient safety further supports the demand for rigorous sterility testing, contributing to the growth of the market in the region.

Japan is experiencing high market growth in the pharmaceutical sterility testing market.

• The increasing demand for pharmaceutical products, coupled with stringent regulations regarding product safety and quality, has led to a greater emphasis on sterility testing in the country.
• Additionally, the growing prevalence of chronic diseases and the aging population in Japan have boosted the demand for sterile pharmaceuticals. For instance, as per a study published by the National Institute of Health (NIH), in Japan, over 90% of adults aged 75 or older have 1 chronic disease, and, of those, approximately 80% have multiple chronic diseases.
• Furthermore, advancements in pharmaceutical manufacturing technologies and the rise of contract manufacturing organizations (CMOs) in the region have contributed to the expansion of the sterility testing market.

Pharmaceutical Sterility Testing Market Share

The pharmaceutical sterility testing industry is characterized by the presence of several established and emerging players that offer a variety of products and services across the globe. The market players compete based on factors such as product quality, innovation, regulatory compliance, customer service, and pricing strategies.

Pharmaceutical Sterility Testing Market Companies

Prominent players operating in the pharmaceutical sterility testing industry include

• Alcami Corporation
• bioMerieux SA
• BA Sciences
• Charles River Laboratories
• Nelson Laboratories, LLC
• Merck KGaA
• Pacific BioLabs Inc.
• Rapid Micro Biosystems Inc.
• SGS Societe Generale de Surveillance SA.
• STERIS Corporation
• Thermo Fisher Scientific Inc.

Pharmaceutical Sterility Testing Industry News

• In April 2023, STEMart launched bioburden and sterility testing services for medical devices under the guidance of the ISO 11731 method. This strategic launch has helped them to improve their product portfolio and increase their customer base.
• In October 2019, Alcami Corporation launched new rapid sterility testing services to deliver significantly faster testing results to clients. They invested in Milliflex Rapid System for the rapid sterility test, that uses adenosine triphosphate (ATP) bioluminescence for detection of microorganism. This strategic initiative helped the company to enhance their offerings and generate revenue.

The pharmaceutical sterility testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 - 2032 for the following segments

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Market, By Product

• Kits & reagents
• Services
• Instruments

Market, By Test

• Membrane filtration
• Direct inoculation
• Rapid microbial method
  • ATP bioluminescence
  • Fluorescent-based
  • Solid-phase cytometry
  • Other rapid microbial methods 
• Other tests

Market, By Type

• In-house testing
• Outsourced testing

Market, By Sample

• Sterile drugs
• Biologics and therapeutics

Market, By End-user

• Pharmaceutical & biotechnology companies
• CROs and contract testing laboratories
• Compounding pharmacies
• Other end-users

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa