Market Highlights

According to MRFR analysis, the global Pharmaceutical Sterility Testing Market Size is expected to register a CAGR of 6.10% from 2020 to 2030 and hold a value of USD 900 million by 2030.

Sterility can be defined as the non-appearance of viable microorganisms, dust, fibers, foreign particles, and other biological agents. Pharmaceutical sterility testing is performed on a wide range of biological medicinal products, including blood products, vaccines, biotechnology products, cell products, and tissue products, in accordance with WHO sterility requirements. Sterility testing is carried out by companies such as pharmaceutical companies, biotechnology companies, and medical device manufacturers to assess process control, raw material quality, and product validity.

The industry players focus on technological developments to dominate the global Pharmaceutical Sterility Testing Market. In addition, the key players are involved in new product launches, acquisitions, and joint ventures to augment their market positions. For instance, in July 2020, Neogen Corporation (US) has launched Soleris, an advanced test system that can rapidly detect a wide variety of microorganisms in a fraction of the time.

Pharmaceutical Sterility Testing Market Overview

Pharmaceutical Sterility Testing Market Overview: by Sample (Sterile Drugs, Medical Devices, and Biologics), by Product Type (Instruments, Kits Reagents, and Services), by Type (In-house and Outsourcing), by Test Type (Sterility Testing, Bioburden Testing, and Bacterial Endotoxin Testing), by End User (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, and Others), and by Region (North America, Europe, Asia-Pacific, and Rest of the World)—Forecast to 2027

Key Players

Some of the key players in the global pharmaceutical sterility testing market are

Merck KGaA (Germany), Rapid Micro Biosystems (US), Sartorius AG (Germany), Solvias AG (Switzerland), SGS SA (Switzerland), Boston Analytical (US), bioMérieux, Inc. (France), Charles River Laboratories International, Inc. (US), Thermo Fisher Scientific, Inc. (US), Pace Analytical Services, LLC (US), Toxikon, Inc. (US), Sotera Health (US), Pacific Biolabs Inc. (US), STRERIS Corporation (US), WuXi AppTec (China).

Segmentation

The global Pharmaceutical Sterility Testing Market Report has been segmented based on sample, product type, type, test type, and end user. By sample, the market has been segregated into sterile drugs, medical devices, and biologics. The sterile drugs segment is expected to witness high growth in 2020, Owing to the high adoption of several techniques adopted for product safety across the globe.

• Based on product type, the global pharmaceutical sterility testing market has been classified into instruments, kits reagents, and services. Kits reagents held the largest segment share in 2020, owing to the repetitive purchase of these products by end users all around the world. In addition, cost efficiency and ease of use are related to the product.
• Based on type, the global pharmaceutical sterility testing market has been classified into in-house and outsourcing.
• Based on test type, the global pharmaceutical sterility testing market has been classified into sterility testing, bioburden testing, and bacterial endotoxin testing. The bacterial endotoxin testing segment held a major market share in 2020 due to the ongoing technological advancements in this segment.
• Based on end user, the pharmaceutical sterility testing market is classified into compounding pharmacies, medical devices companies, pharmaceutical companies, and others. Pharmaceutical companies held the largest market share in 2020 due to the high growth of pharmaceutical and biological industries across the globe, and new drug approvals will boost the pharmaceutical sterility testing market during the forecasting period.

Regional Analysis

North America is anticipated to dominate the global Pharmaceutical Sterility Testing Market Outlook, owing to the presence of several key players in the region and the rise in RD investments by public and private players in the healthcare sector. Moreover, the increase in the number of pipeline products and the launch of advanced drugs based on the biopharmaceutical that requires unique pharmaceutical sterility testing processes are also propelling the market growth.

The European pharmaceutical sterility testing market has been categorized into Germany, France, the UK, Italy, Spain, and the rest of Europe. Increasing government initiatives and extensive availability of research grants in the European countries are expected to propel the growth of the pharmaceutical sterility testing market in the region. Furthermore, the presence of outsourcing companies for pharmaceutical sterility testing is also supporting the growth of the pharmaceutical sterility testing market.

Asia-Pacific is anticipated to be the fastest-growing regional market over the forecast period due to the increasing harmonization of the regulatory standards with the International Council for Harmonisation (ICH) standards in developing nations, technological advances, and increasing investment in healthcare infrastructure. In addition, growing investment by governments from the China and India for offering cost-effective medications is providing lucrative opportunities for the growth of the pharmaceutical sterility testing market over the forecast period.

 In the Middle East, the UAE is the largest market due to the healthcare industry's development. Developing countries such as Argentina, Brazil, and Colombia, among others in Latin America, are also key contributors to the growth of the pharmaceutical sterility testing market.

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