Global Pharmaceutical Sterility Testing Market Report to 2030: Increasing Number of Drug Launches and Focus on Quality & Sterility Drives Growth


Dublin, April 11, 2023 (GLOBE NEWSWIRE) -- The "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" report has been added to ResearchAndMarkets.com's offering.

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.

Companies Mentioned

  • 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.

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.

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 Report Highlights

  • 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

Key Attributes:

Report AttributeDetails
No. of Pages100
Forecast Period2022 - 2030
Estimated Market Value (USD) in 2022$1421 Million
Forecasted Market Value (USD) by 2030$3389.3 Million
Compound Annual Growth Rate11.5%
Regions CoveredGlobal

Key Topics Covered:

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Pharmaceutical Sterility Testing Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.2. Penetration & Growth Prospect Mapping
3.3. Market Dynamics
3.3.1. Market driver analysis
3.3.1.1. Supportive government investment in the healthcare industry
3.3.1.2. Increasing R&D activities
3.3.1.3. Increasing number of drug launches
3.3.1.4. Increasing focus on quality and sterility
3.3.2. Market restraint analysis
3.3.2.1. Third party performance
3.4. Pharmaceutical Sterility Testing Market Analysis Tools
3.5. COVID-19 Impact and Reformation Strategy

Chapter 4. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis
4.1. Definitions and Scope
4.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
4.2.1. In- house pharmaceutical sterility testing
4.2.1.1. In- house pharmaceutical sterility testing market estimates and forecast, 2018 to 2030 (USD Million)
4.2.2. Outsourcing pharmaceutical sterility testing
4.2.2.1. Outsourcing pharmaceutical sterility testing market estimates and forecast, 2018 to 2030 (USD Million)

Chapter 5. Pharmaceutical Sterility Testing Market: Product Type Estimates & Trend Analysis
5.1. Definitions and Scope
5.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
5.2.1. Kits and Reagents
5.2.1.1. Kits and Reagents market estimates and forecast, 2018 to 2030 (USD Million)
5.2.2. Instruments
5.2.2.1. Instruments market estimates and forecast, 2018 to 2030 (USD Million)
5.2.3. Service
5.2.3.1. Service market estimates and forecast, 2018 to 2030 (USD Million)

Chapter 6. Pharmaceutical Sterility Testing Market: Test Type Estimates & Trend Analysis
6.1. Definitions and Scope
6.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
6.2.1. Sterility testing
6.2.1.1. Sterility testing market estimates and forecast, 2018 to 2030 (USD Million)
6.2.1.2. Membrane Filtration
6.2.1.2.1. Membrane Filtration market estimates and forecast, 2018 to 2030 (USD Million)
6.2.1.3. Direct Inoculation
6.2.1.3.1. Direct Inoculation market estimates and forecast, 2018 to 2030 (USD Million)
6.2.2. Bioburden testing
6.2.2.1. Bioburden testing market estimates and forecast, 2018 to 2030 (USD Million)
6.2.3. Bacterial endotoxin testing
6.2.3.1. Bacterial endotoxin testing market estimates and forecast, 2018 to 2030 (USD Million)
6.2.4. Container closure integrity testing
6.2.4.1. Container closure integrity testing market estimates and forecast, 2018 to 2030 (USD Million)
6.2.5. Antimicrobial effectiveness testing
6.2.5.1. Antimicrobial effectiveness testing market estimates and forecast, 2018 to 2030 (USD Million)
6.2.6. Rapid Micro Test
6.2.6.1. Rapid Micro Test market estimates and forecast, 2018 to 2030 (USD Million)
6.2.6.2. ATP bioluminescence
6.2.6.2.1. ATP bioluminescence market estimates and forecast, 2018 to 2030 (USD Million)
6.2.6.3. Fluorescent labeling
6.2.6.3.1. Fluorescent labeling market estimates and forecast, 2018 to 2030 (USD Million)
6.2.6.4. Electrical resistance
6.2.6.4.1. Electrical resistance market estimates and forecast, 2018 to 2030 (USD Million)
6.2.7. Others
6.2.7.1. Others market estimates and forecast, 2018 to 2030 (USD Million)

Chapter 7. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis
7.1. Definitions and Scope
7.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
7.2.1. Pharmaceuticals
7.2.1.1. Pharmaceuticals market estimates and forecast, 2018 to 2030 (USD Million)
7.2.2. Medical devices
7.2.2.1. Medical devices market estimates and forecast, 2018 to 2030 (USD Million)
7.2.3. Biopharmaceuticals
7.2.3.1. Biopharmaceuticals market estimates and forecast, 2018 to 2030 (USD Million)

Chapter 8. Pharmaceutical Sterility Testing Market: End-Use Estimates & Trend Analysis
8.1. Definitions and Scope
8.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
8.2.1. Compounding Pharmacies
8.2.1.1. Compounding Pharmacies market estimates and forecast, 2018 to 2030 (USD Million)
8.2.2. Medical devices Companies
8.2.2.1. Medical devices Companies market estimates and forecast, 2018 to 2030 (USD Million)
8.2.3. Pharmaceutical Companies
8.2.3.1. Pharmaceutical Companies market estimates and forecast, 2018 to 2030 (USD Million)
8.2.4. Others
8.2.4.1. Other market estimates and forecast, 2018 to 2030 (USD Million)

Chapter 9. Pharmaceutical Sterility Testing Market: Regional Estimates & Trend Analysis

Chapter 10. Chapter 8 Competitive Analysis
10.1. Recent Developments & Impact Analysis, By Key Market Participant
10.2. Company/Competition Categorization (Key Innovators, Market Leaders, Emerging Players)
10.3. Participant Categorization
10.4. Vendor Landscape

Chapter 11. Competitive Landscape

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Global Pharmaceutical Sterility Testing Market

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