Pharmaceutical Sterility Testing Market - Forecast(2024 - 2030)

Pharmaceutical Sterility Testing Market Overview

Pharmaceutical Sterility Testing Market size is estimated at $1.1 billion in 2020, projected to grow at a CAGR of 11.3% during the forecast period 2021-2026. Microorganisms are investigated during pharmaceutical sterility research. Fungistasis and bacteriostasis monitoring were used in this sterility procedure. This test guarantees that the test article has an antimicrobial property that prevents microbial organisms from being detected. This test is carried out in a clean environment according to the instructions or using membrane filtration methods or Direct Inoculation with an isolator. 

Growing regulatory approvals are hastening the release of new products to meet market demand. The acceptance of pharmaceutical sterility testing is increasing, Bacterial Endotoxin Testing, and the pharmaceutical sterility testing industry is expected to expand as a result of these product launches. 

The global pharmaceutical industry spent about $149.8 billion on R&D activities in 2017, according to a study released by the International Federation of Pharmaceutical Manufacturers and Associations aiding growth towards pharmaceutical sterility testing industry. According to the Pharma and Annual Review 2019 survey, 1,273 new drugs were introduced to the global market in 2019, up 6.2 percent from the previous year.

Pharmaceutical Sterility Testing Market Report Coverage

The report: “Pharmaceutical Sterility Testing Market Forecast (2021-2026)”, by Industry ARC, covers an in-depth analysis of the following segments of the Pharmaceutical Sterility Testing Market.

By Type: In-house and Outsourcing.
By Test Type: Sterility Testing, Membrane Filtration, Direct Inoculation, Bioburden Testing and Bacterial Endotoxin Testing.
By Service: Sterile Drugs, Medical Devices and Biologics & Therapeutics.
By Geography: North America (U.S, Canada and Mexico), Europe (Germany, UK, France, Italy, Spain, Russia and Rest of Europe), Asia Pacific (China, Japan India, South Korea, Australia & New Zealand, and Rest of Asia Pacific), South America (Brazil, Argentina and Rest of South America) and RoW (Middle East and Africa).

Key Takeaways

• Technological advances in sterility testing methods resulted in a decrease in procedural time and human interaction, increasing the test's efficiency and accuracy, thereby, driving the Pharmaceutical Sterility Testing Industry.
• Geographically, North America Pharmaceutical Sterility Testing Market held the largest revenue share of 40% in 2020 owing to government investments in the healthcare sector, increased R&D activities and drug launches, and a growing emphasis on quality and sterility.
• Increased pharmaceutical outsourcing, the healthcare spending, and technical advancements in rapid sterility testing are all assisting the market's development.
• The Pharmaceutical Sterility Testing market is being driven by increased focus on safety and sterility, as well as increased R&D activities in the pharmaceutical sector and increased development and launch of drugs and medical device

 Pharmaceutical Sterility Testing Market: Market Share (%) by Region, 2020

Pharmaceutical Sterility Testing Market Segment Analysis – By Type:

Based on Type, Pharmaceutical Sterility Testing Market is segmented into In-house and Outsourcing. Outsourcing accounted for the largest revenue market share in 2020 as customers are willing to spend more on health and wellness. Since some businesses lack the necessary resources to perform high-quality sterility testing, they tend to outsource these services. Outsourcing often saves time and money by eliminating the need for staff training and the procurement of sterility testing equipment. 

The quality of sterility testing services, on the other hand, is dependent on the outsourced lab, as a poorly designed lab can produce inaccurate test results. As a result, the market for high-quality sterility testing laboratories is increasing, propelling the segment forward. In-house is anticipated to grow with the fastest CAGR of 11.9% in the forecast period 2021-2026. For manufacturers of pharmaceuticals, biopharmaceuticals, and medical devices, in-house sterility checking is an important part of quality assurance and Good Manufacturing Practices (GMP). Each batch must pass sterility testing before being released, allowing the segment to expand.

Pharmaceutical Sterility Testing Market Segment Analysis – By Test Type:

Based on Test Type, Pharmaceutical Sterility Testing Market is segmented into Sterility Testing, Membrane Filtration, Direct Inoculation, Bioburden Testing and Bacterial Endotoxin Testing. Bacterial Endotoxin Testing accounted for the largest revenue market share in 2020 owing towards ongoing technological advancements in this segment. 

The Bacterial Endotoxins Test (BET) is an in vitro assay that detects and quantifies bacterial endotoxins, which are a part of gram-negative bacteria's cell wall. The BET is used in lot release testing for medical devices that come into contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid directly or indirectly contributing to the segment's rise thereby, driving the Pharmaceutical Sterility Testing Industry. 

International segment is anticipated to grow with the fastest CAGR of 11.6% during the forecast period 2021-2026 owing towards rising emphasis on product quality, along with the rising number of drug and medical devices launches. GMP needs bioburden monitoring, as well as sterilization process validation, to ensure the safety of end products. Prior to the sterilization process, bioburden testing is performed on medical devices or their components to assess the total viable microorganism count, enabling the growth of these segments, thereby, expanding the Pharmaceutical Sterility Testing Market.

Pharmaceutical Sterility Testing Market Segment Analysis - By Geography:

Based on Geography, North America Pharmaceutical Sterility Testing Market accounted for the 40% revenue share in 2020 owing towards the presence of several key players in the region. For instance, Nelson Laboratories (US) announced the addition of a Technical Consulting Services division for MedTech companies to its service offerings in June 2014. Product production, facility and process validation, Bacterial Endotoxin Testing, product performance testing, Membrane Filtration, Direct Inoculation and regulatory support are among the services offered. 

Furthermore, the involvement of regulatory bodies in this region is high which fuel the market growth. For instance, Nelson Laboratories (US) announced the addition of a Technical Consulting Services division for MedTech companies to its service offerings in June 2014. Product production, facility and process validation, product performance testing, and regulatory support are among the services offered driving the Pharmaceutical Sterility Testing Industry. 

Asia-Pacific is predicted to be the fastest growing region during the forecast period 2021- 2026 owing towards technological advances and rising disposable income levels in developing countries such as China and India. Pharmaceutical Sterility Testing Industry is expanding in this region owing to developed countries growing regulatory standards harmonization with ICH standards. Furthermore, many developing economies in the region are taking steps to improve the domestic pharmaceutical market and are attracting multinational companies to set up shop in the region. Such programs would almost certainly lead to regional growth.

Pharmaceutical Sterility Testing Market - Drivers

The Growing Number Of Drug Launches & Growth Of Pharmaceutical Companies:

The key growth factors for the pharmaceutical sterility testing market are pharmaceutical company evolution, an increasing number of drug introductions, the escalating incidence of chronic diseases, government assistance for pharmaceutical. For instance, Merck KGaA introduced Steritest Symbio Pump systems accessories in September 2016. In any atmosphere, the accessories allow for faster and safer sterility checking. 

According to the Centers for Disease Control and Prevention (CDC), about 117 million people in the United States had one or more chronic illnesses in 2012. Pharmaceutical outsourcing is increasing, healthcare spending is increasing, Membrane Filtration, Direct Inoculation and rapid sterility test technology is improving like Bacterial Endotoxin Testing all of which are assisting the pharmaceutical sterility testing market's development.

Pharmaceutical Sterility Testing Market Challenges

Time-Consuming Approval Procedures And Strict Regulatory Structures:

The market's growth is being stifled by certain stringent regulations placed on the regulatory system, as well as the need of lengthy approval processes. The approval process for a new player in the market is lengthy. Apart from that, the need for a large initial investment is likely to be a roadblock for new entrants, restricting market development.  Also, the shortage of skilled professionals further hinders the market growth.

Pharmaceutical Sterility Testing Market Landscape:

The Pharmaceutical Sterility Testing Market's main strategies include product releases, mergers and acquisitions, joint ventures, and regional expansion. Pharmaceutical Sterility Testing Market top 10 companies are Pace Analytical Services, LLC, Toxikon, Inc., Merck KGaA, Rapid Micro Biosystems, Sartorius AG, Solvias AG, SGS SA, Boston Analytical, bioMérieux, Inc. and Charles River Laboratories International, Inc.

Acquisitions/Product Launches

• In August 2020, Pace Analytical Services, LLC acquired Emerson Resources Inc., which is a contract production and manufacturing organization (CDMO) that specializes in drug form development and clinical trial substance manufacturing for pharmaceutical companies. From early-stage research and development to phase 2 clinical trial materials processing, this acquisition helps pharmaceutical and biopharmaceutical clients.

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