Pharmaceutical Sterility Testing Market Size Worth USD 1,285 Million by 2027 at a CAGR of 6.6% – Market Research Future (MRFR) Report


Pharmaceutical Sterility Testing Market Trends & Outlook By Product Type (Kits & Reagents, Instruments & Services), By Sample (Medical Devices, Sterile Drugs & Biologics), By Type (In-house & Outsourced), By End-User (Pharmacies preparation companies, pharmaceutical companies, medical device companies and others), by type of test (sterility test, bioburden test and bacterial endotoxin test) and by region (North America, Europe, Asia-Pacific and rest of the World), Competitive Market Size, Growth, Share and Forecast to 2027

/EIN News/ — New York, U.S., May 9, 2022 (GLOBE NEWSWIRE) — Pharmaceutical Sterility Testing Market Overview

According to a comprehensive research report by Market Research Future (MRFR),”Pharmaceutical Sterility Testing Market Information by sample, product type, type, test type, end user and region – Forecast to 2027”, the market is estimated to surpass USD 1,285.8 million by 2027, growing at a CAGR of 6.6%.

Market scope:

Inventing or verifying product-specific procedures and reliable sterility testing are key phases of drug discovery and development. Sterility testing is essential to confirm the absence of viable contaminating microorganisms in a product. Pharmaceutical sterility testing is an essential part of good manufacturing practice microbiology and is required for tissue samples, pharmaceutical preparations and medical equipment, all of which must be sterile due to their intended use. In addition, it is used in cell banks, raw materials and pharmaceutical finished products. This test is performed in an isolator or clean room using direct inoculation or membrane filtration methods.

Market Competitive Landscape:

The distinguished competitors in the pharmaceutical sterility testing market are

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

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Covered USP market:

Market factors:

Over the years, new drug approvals and drug introductions have increased. These new product launches are increasing the acceptance of pharmaceutical sterility testing, and the global market is expected to grow throughout the forecast period. Additionally, pharmaceutical sterility testing is performed at all levels of production in the pharmaceutical and biopharmaceutical industries to reduce the risk of product contamination. Technological developments in pharmaceutical sterility testing procedures have reduced procedure time and human contact, improving testing efficiency and accuracy and propelling the market.

Market constraints:

Sterility testing is the first step in determining the quality of pharmaceutical drugs. Nonetheless, in many countries, stringent regulatory laws, regulations, and time-consuming processes may hinder the growth of the Pharmaceutical Sterility Testing Market.

COVID 19 analysis

The global pharmaceutical sterility testing industry has emerged from the COVID-19 shutdown due to the race of pharmaceutical and biotech companies to develop a vaccine against COVID-19. Rapid tests are necessary to ensure that the vaccination is acceptable, effective and approved by regulatory bodies. Every vaccine and injection provided to patients must undergo end-product sterility testing to be considered safe. This will propel the pharmaceutical sterility testing industry, which is expected to grow rapidly during the pandemic period. Concerns about sterility and out-of-specification test reports are two major causes of drug recalls. The unrest has now hit two pharmaceutical companies at the same time. This isn’t the first time the FDA has become concerned about one of the companies’ production practices. Teligent Pharma, a specialist in injectable and topical products, and Edge Pharma, a contracted facility, issued separate recalls in December 2021 for superpotent test results and sterility concerns, respectively. Using drugs that are supposed to be sterile but are not can lead to localized infections and major systemic infections that can be fatal.

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Market segmentation

Per sample

The sterile drugs segment is estimated to capture a majority stake during the forecast period.

By product type

Pharmaceutical sterility testing companies are introducing new sterility testing services to complement their product line and improve their market position. Companies have created well-equipped departments to capitalize on the pharmaceutical sterility testing market. Medical device companies, by type, lack the infrastructure required to perform high-quality sterility testing. They prefer to outsource these services. Additionally, to save money, many companies outsource sterility testing, resulting in the growth of the segment.

By type of test

Bioburden testing will reach maximum stake during the forecast period.

Per end user

Pharmaceutical companies have launched an increasing number of drugs globally, and the growing number of pharmaceutical companies are driving the growth of the market.

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Regional outlook

Due to the presence of a large number of foreign and domestic competitors in the region and innovative technologies, the North American market accounted for the largest market share. Additionally, increasing R&D expenditures and modernization of healthcare infrastructure are expected to influence the expansion of the pharmaceutical sterility testing market throughout the forecast period. The European pharmaceutical sterility testing market is propelled by increased government initiatives and abundant research funds. Due to the expansion of biopharmaceutical product design and technological improvements in the region, the European market is full of sophisticated and well-equipped outsourced organizations for pharmaceutical sterility testing. Due to the increasing harmonization of regulatory standards, the pharmaceutical sterility testing industry is estimated to be the key regional market. Additionally, many developing economies in the region are taking initiatives to strengthen the pharmaceutical market and encourage global companies to locate in the region, fueling the expansion of the pharmaceutical sterility testing market in Asia-Pacific.

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Recently, Piramal Pharma Solutions, a CDMO, plans to scale up operations at its antibody-drug conjugates plant in Grangemouth, Scotland, and invest in new active pharmaceutical ingredient facilities at its plant in England. The additions and improvements represent a total investment of £55 million in drug research and manufacturing capabilities in the UK and new employment opportunities for operational and technical workers. The new structure has been built to support future development, with future steps including a new sterile fill/finish suite dedicated to ADCs and two super-scale manufacturing facilities capable of handling larger batch sizes. A new guest experience facility will also assist guests visiting the property while it is under development or manufacturing.

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