The U.S. pharmaceutical sterility testing market size is anticipated to reach USD 1.18 billion by 2030. 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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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.
U.S. Pharmaceutical Sterility Testing Market Report Highlights
- Outsourcing emerged as the largest segment in 2021 with a share of 45.2%, as pharmaceutical and biopharmaceutical companies are trying to reduce expenses and hence outsourcing non-core functions such as sterility testing
- The sterility testing segment, by test type is expected to witness the fastest CAGR of 11.3% across the forecast as these tests are recommended by regulatory authorities such as the USFDA
- Based on product type, the kits and reagents segment held the largest share of 59.7% in 2021, due to the high consumption of these products in sterility testing
- The biopharmaceuticals segment by the sample is expected to grow at the fastest rate of 11.2% CAGR across the forecast owing to the growing demand for biologics such as vaccines, and monoclonal antibodies in the country for treating chronic and infectious diseases
- Based on end-use, the pharmaceutical companies accounted for the largest share of 42.9% in 2021, owing to the growing number of drug recalls due to lack of sterility, thus supporting segment growth
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Table of Contents
Chapter 1 Methodology And Scope
Chapter 2 Executive Summary
Chapter 3 U.S. Pharmaceutical Sterility Testing Market Variables, Trends & Scope
Chapter 4 U.S. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis
Chapter 5 U.S. Pharmaceutical Sterility Testing Market: Product Type Estimates & Trend Analysis
Chapter 6 U.S. Pharmaceutical Sterility Testing Market: Test Type Estimates & Trend Analysis
Chapter 7 U.S. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis
Chapter 8 U.S. Pharmaceutical Sterility Testing Market: End-Use Estimates & Trend Analysis
Chapter 9 Competitive Analysis
Chapter 10 Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Sgs Sa
- Laboratory Corporation of America Holdings
- Boston Analytical
- Charles River Laboratories
- Pacific Biolabs
- Steris
- Pace Analytical
- Nelson Laboratories, LLC
- Infinity Laboratories
- Thermo Fisher Scientific, Inc.
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 100 |
| Published | November 2022 |
| Forecast Period | 2022 - 2030 |
| Estimated Market Value ( USD | $ 515.7 Million |
| Forecasted Market Value ( USD | $ 1180 Million |
| Compound Annual Growth Rate | 10.9% |
| Regions Covered | United States |
| No. of Companies Mentioned | 10 |
