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The global pharmaceutical sterility testing market size is expected to reach USD 3,389.3 million by 2030, registering a CAGR of 11.5% during the forecast period, according to a new report by Grand View Research, Inc. Actively growing investment in pharmaceutical R&D, increasing demand for the new therapies, and a rise in the number of drug and medical device approvals in recent years are some of the major factors driving the market’s growth.

Key industry Insights & Findings from the report:

  • Outsourcing segment emerged as the largest segment in 2021, as pharmaceutical and medical device companies are trying to focus on their core competencies such as research and marketing, owing to which they outsource sterility testing service.
  • The bacterial endotoxin testing segment is expected to account for the largest share with 39.4% in 2021. The growing demand for implants and sterile medicines is supporting the growth of the segment market.
  • The biologics and therapeutics segment by the sample is expected to grow at the fastest rate of 11.7% CAGR throughout the forecast period as we anticipate rising clinical trials for the biologics and biosimilar, globally, for the treatment of cancer, autoimmune diseases, infectious diseases, and others.
  • Based on end use, the pharmaceutical companies accounted for the largest share of 42.9% in 2021; owing to the current high spending on medicines, globally.
  • In Asia Pacific, the market is expected to encounter the highest CAGR during the forecast period, owing to the significant number of initiatives taken by the public organization in the region to boost pharmaceutical manufacturing and R&D. This contributes to the demand for sterility testing of the pharmaceuticals in Asia Pacific.

Read 100-page full market research report for more Insights, “Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourcing), By Product Type, By Test Type, By End-use, By Sample, By Region, And Segment Forecasts, 2022 – 2030“, published by Grand View Research.

Pharmaceutical Sterility Testing Market Growth & Trends

During the initial period of COVID-19, the majority of the clinical research conducted was related to COVID-19 therapeutics with an aim to eradicate the issue at hand. However, this trend has witnessed a transition post-2021. For instance, Pharma R&D Review January 2022 stated that the majority of therapeutics pertaining to the oncology area was in the late-stage clinical pipeline, which indicates a rise in demand for the sterility testing of these anti-cancer drugs, thus supporting the market’s growth.

There is a growing focus to improve the quality and sterility of drugs. Stringent regulations regarding the quality and sterility of the products are improving the demand for sterility testing of pharmaceutical and medical devices. Moreover, in recent years, a significant number of recalls have been witnessed on the FDA and EMA websites due to the lack of drug sterility. For instance, in July 2021, Innoveix Pharmaceuticals, Inc. voluntarily recalled their injectable AOD-9604 3mg due to lack of sterility.

Recalls not only cause heavy losses but also affect the brand image of the company. Contracting organizations have seized this opportunity to help gain more clientele, which in turn has increased the revenue for sterility testing of the pharmaceuticals and medical devices in the market.

The governments are actively trying to improve R&D by providing tax deductions. For instance, the Indian government in January 2022, stated that it is providing a weighted average tax deduction upto 200% in R&DSuch initiatives are expected to improve the R&D activities on drugs and thus showcase the growing investment within the sector.

Global expenditure on medicines is also on the rise. According to the data provided in a report published by IQVIA, one can conclude that global spending on medicines is expected to increase in the next 4-5 years. The report states that global payments on medicine accounted for USD 955.0 billion in 2019 and will reach USD 1,115.0–1,145.0 billion by 2024. The rise in pharmaceutical spending is expected to increase the development of the medication, which in turn grows demand for pharmaceutical sterility testing in the post-pandemic period.

Pharmaceutical Sterility Testing Market Segmentation

Grand View Research has segmented the global pharmaceutical sterility testing market based on the type, product type, test type, sample, end-use, and region

Pharmaceutical Sterility Testing Market – Type Outlook (Revenue, USD Million, 2018 – 2030)

  • In-house
  • Outsourcing

Pharmaceutical Sterility Testing Market – Product Type Outlook (Revenue, USD Million, 2018 – 2030)

  • Kits and Reagents
  • Instruments
  • Service

Pharmaceutical Sterility Testing Market – Test Type Outlook (Revenue, USD Million, 2018 – 2030)

  • Sterility Testing
  • Membrane Filtration
  • Direct Inoculation
  • Bioburden Testing
  • Bacterial Endotoxin Testing
  • Container closure integrity testing
  • Antimicrobial effectiveness testing
  • Rapid micro test
  • ATP bioluminescence
  • Fluorescent labeling
  • Electrical resistance
  • Others

Pharmaceutical Sterility Testing Market – Sample Outlook (Revenue, USD Million, 2018 – 2030)

  • Pharmaceuticals
  • Medical Devices
  • Biopharmaceuticals

Pharmaceutical Sterility Testing Market – End-Use Outlook (Revenue, USD Million, 2018 – 2030)

  • Compounding Pharmacies
  • Medical Devices Companies
  • Pharmaceutical Companies
  • Others

Pharmaceutical Sterility Testing Market – Regional Outlook (Revenue, USD Million, 2018 – 2030)

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Italy
    • Spain
    • Netherlands
    • Belgium
    • Sweden
    • Switzerland
    • Russia
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Philippines
    • Malaysia
    • New Zealand
    • Singapore
    • Thailand
  • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Colombia
    • Chile
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • Egypt
    • Israel
    • UAE

List of Key Players in Pharmaceutical Sterility Testing Market

  • Pacific Bio labs
  • STERIS
  • Boston Analytical
  • Nelson Laboratories, LLC
  • Sartorius AG
  • SOLVIAS AG
  • SGS SA
  • Laboratory Corporation of America Holding
  • Pace Analytical
  • Charles River Laboratories
  • Thermo Fisher Scientific, Inc.
  • Rapid Micro Bio systems, Inc.
  • Thermo fisher Scientific Inc
  • Almac Group

Check out more related studies published by Grand View Research:

  • U.S. Pharmaceutical Sterility Testing Market – The U.S. pharmaceutical sterility testing market size is expected to reach USD 713.6 million by 2025, according to a new report by Grand View Research, Inc. It is anticipated to expand at a CAGR of 11.3% over the forecast period. Supportive government investment in healthcare industry, increasing R&D activities, and drug launches are the key factors driving market growth.
  • Central Lab Market – The global central lab market size is expected to reach USD 5.08 billion by 2030, according to a new report by Grand View Research, Inc. It is estimated to register a CAGR of 6.7% during the forecast period, driven by the increasing investment in R&D and increased focus of sponsors & investigators on reducing research costs. The outsourcing of central lab work is a significant factor driving the market growth.
  • Laboratory Proficiency Testing Market – The global laboratory proficiency testing market size is expected to reach USD 1.9 billion by 2027, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 7.3% from 2020 to 2027. The market is driven by the increasing focus on water tests, legalization of medical cannabis, a growing number of cannabis testing laboratories, and increasing outbreaks of foodborne illnesses.
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