U.S. Pharmaceutical Sterility Testing Market To Reach $1.70 Billion By 2033

U.S. Pharmaceutical Sterility Testing Market Growth & Trends

The U.S. pharmaceutical sterility testing market size is expected to reach USD 1.70 billion by 2033, registering a CAGR of 11.04% from 2025 to 2033, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 10.9% from 2022 to 2030. Supportive government investment in the healthcare industry, increasing R&D activities, and growing demand for new therapeutics in the country are the key factors driving the growth. The majority of clinical trials worldwide are performed in the U.S. alone.

According to ClinicalTrials.gov, as of October 2022, over 31% of global clinical trials were registered in the U.S. alone. This is due to the significant number of initiatives taken by public organizations in the country to support R&D activities. The presence of technologically advanced infrastructure and an increase in R&D investment by pharmaceutical companies are also supporting clinical trials in the country. This is expected to improve the number of new medications and medical devices in the coming years in the U.S. and support the market in the post-pandemic period.

The government is keen on bringing down healthcare costs, which is anticipated to encourage the U.S. Food and Drug Administration (FDA) to promote the fast approval of generic pharmaceuticals. Faster approvals drive the need for newer sterility testing methods. This is anticipated to encourage market participants to spend more on sterility solutions and, in turn, expand the market. With an increasing demand for drugs, companies are launching new drugs with different routes of administration, dosage, and indication. These launches require thorough sterility testing and, thus, are anticipated to drive the industry’s growth.

The majority of pharmaceutical companies, biopharmaceutical companies, CROs, and CMOs are headquartered in the U.S. Companies such as Catalent, Inc., Pfizer Inc., AbbVie, Merck; Co. Johnson & Johnson, and Abbott are located in the U.S. The high number of pharmaceutical companies, biopharmaceutical companies, CMOs, and CROs located in the U.S. contributes to the high demand for sterility testing of pharmaceuticals, thus supporting the market growth.

The country suffers from a high burden of cancer. Due to this, government-based research institutes in the U.S. are constantly trying to improve cancer research funding in the country. For instance, in May 2022, the American Institute of Cancer Research stated that it had funded more than USD 110 million in cancer research in 2022, and it intends to fund more in the coming years to reduce the burden of cancer. Such initiatives are expected to increase the number of new medications for cancer in the coming years, thus increasing the demand for sterility testing of cancer drugs in the post-pandemic period.

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U.S. Pharmaceutical Sterility Testing Market Report Highlights

• In 2024, the outsourcing segment dominated the market, accounting for a revenue share of 58.25%. Besides, the in-house pharmaceutical sterility testing segment is anticipated to grow at a lucrative CAGR during the forecast period.

• On the basis of product segment, the kits & reagents segment dominated the market in 2024. The service segment is expected to grow at a CAGR of 10.89% during the forecast period.

• The bioburden testing segment held a market share of more than 41.52% in 2024. In addition, the sterility testing market is anticipated to witness growth at a rapid pace during the forecast period.

• Pharmaceuticals held the largest market share in 2024.The biopharmaceuticals segment is expected to grow at a fastest CAGR of 12.57% over the forecast period.

• In terms of end use, the market is segregated into compounding pharmacies, medical devices companies, pharmaceutical companies, and others. The compounding pharmacies are expected to grow at a CAGR of 12.76% over the forecast period.

U.S. Pharmaceutical Sterility Testing Market Segmentation

Grand View Research has segmented U.S. pharmaceutical sterility testing market report based on type, product, test, sample, and end-use:

U.S. Pharmaceutical Sterility Testing Type Outlook (Revenue, USD Million, 2021 - 2033)

• In-House

• Outsourcing

U.S. Pharmaceutical Sterility Testing Product Outlook (Revenue, USD Million, 2021 - 2033)

• Kits and Reagents

• Instruments

• Services

U.S. Pharmaceutical Sterility Testing Test Outlook (Revenue, USD Million, 2021 - 2033)

• Sterility Testing

  • Membrane Filtration

  • Direct Inoculation

  • Product Flush

• Bioburden Testing

• Bacterial Endotoxin Testing

U.S. Pharmaceutical Sterility Testing Sample Outlook (Revenue, USD Million, 2021 - 2033)

• Pharmaceuticals

• Medical Devices

• Biopharmaceuticals

U.S. Pharmaceutical Sterility Testing End-use Outlook (Revenue, USD Million, 2021 - 2033)

• Compounding Pharmacies

• Medical Device Companies

• Pharmaceutical Companies

• Others

List of Key Players of U.S. Pharmaceutical Sterility Testing Market

• Pacific Biolabs

• Steris Plc

• Boston Analytical

• Sotera Health Company (Nelson Labs)

• Sartorius Ag

• Solvias Ag

• SGS SA

• Labcorp

• Pace Analytical

• Charles River Laboratories

• Thermo Fisher Scientific, Inc.

• Rapid Micro Biosystems, Inc.

• Almac Group