Pharmaceutical Sterility Testing Market Analysis Report 2024-2030: A $3.28 Billion Market by 2030, with Growing Number of Drug Launches Worldwide

Dublin, April 15, 2024 (GLOBE NEWSWIRE) -- The "Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (Outsourcing, In-house), By Product Type, By Test Type, By Sample, By End-use, By Region, And Segment Forecasts, 2024 - 2030" report has been added to's offering.

The global pharmaceutical sterility testing market size is anticipated to reach USD 3.28 billion by 2030 and is projected to grow at a CAGR of 11.02% from 2024 to 2030.

A growing number of drug launches worldwide, and rising government investments are anticipated to influence the global market positively. As pharmaceutical companies are introducing an array of new drugs to the market, there is a parallel surge in the demand for rigorous sterility testing protocols. Besides, stringent regulatory requirements for pharmaceuticals products further support market growth. Thus, an upsurge in novel drug launches provided unprecedented growth opportunities to the pharmaceutical sterility testing market.

In addition, increasing emphasis on R&D activities in the pharmaceutical industry profoundly impacts the pharmaceutical sterility testing market. As pharmaceutical companies are proactively involved in the discovery and development of innovative & advanced drug formulations, there is a growing need for robust sterility testing protocols to ensure the safety and efficacy of these products. R&D activities drive the development of new pharmaceuticals, biologics, and vaccines, necessitating comprehensive sterility testing methodologies to comply with regulatory requirements.

Furthermore, stringent regulations by regulatory bodies for pharmaceutical product approval prompt pharmaceutical companies to invest significantly in R&D to meet these evolving standards. As a result, the market experiences a surge in demand for state-of-the-art testing solutions to align with the regulatory landscape. For instance, in September 2023, Sartorius AG introduced a sterisart septum for sampling from a sterility testing unit. It is a closed system for testing based on the membrane filtration method that mitigates the risk of secondary contamination. Such service launches offered a competitive edge in the market.

Moreover, the pharmaceutical industry's commitment to addressing unmet medical needs and discovering innovative therapeutic avenues further amplifies the importance of robust sterility testing protocols. The need for accuracy & reliability in detecting any potential contaminants becomes paramount to ensure the safety and efficacy of these newly launched drugs.

Pharmaceutical Sterility Testing Market Report Highlights

  • Based on type, the outsourcing segment led the market with the largest revenue share of 59.25% in 2023. The segment growth is driven by increasing requirements for Outsourcing sterility testing as attractive alternative for several small- & medium-sized pharmaceutical and medical device companies, which may lack the infrastructure to conduct quality sterility testing
  • Based on product type, the kits and reagents segment held the market with the largest revenue share of 60.30% in 2023, attributing to a standardized and reliable techniques to determine the absence of live microorganisms in pharmaceutical products
  • Based on test type, the bioburden testing segment led the market with the largest revenue share of 41.71% in 2023. The segment is driven by strict quality control processes and the demand for testing to quantify microbial contamination of a product at different stages of production from initial manufacturing to final distribution
  • Based on sample, the pharmaceuticals segment led the market with the largest revenue share of 42.45% in 2023. The products are widely used dosage forms. The growing demand or these dosage forms globally is one of the major factors driving this segment
  • Based on end-use, the pharmaceutical companies dominated the market in 2023. These companies conduct sterility tests to ensure the safety of the products, especially oral dosage forms, as most of these products are ingested by patients
  • North America dominated the market with a revenue share of 49.45% in 2023. The presence of a large number of major market players in this region is expected to contribute to the market growth significantly. Stringent regulatory requirements for sterility testing of pharmaceuticals and medical devices in this region further supports market growth

Key Attributes:

Report AttributeDetails
No. of Pages267
Forecast Period2023 - 2030
Estimated Market Value (USD) in 2023$1.59 Billion
Forecasted Market Value (USD) by 2030$3.28 Billion
Compound Annual Growth Rate11.0%
Regions CoveredGlobal

Key Topics Covered:

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
2.4. Market Lineage Outlook
2.5. Pharmaceutical Sterility Testing Market Dynamics
2.5.1. Market Driver Impact Analysis Supportive Government Investment In The Healthcare Industry Increasing R&D Activities Increasing Number Of Drug Launches Increasing Focus On Quality And Sterility
2.5.2. Market Restraint Analysis Compliance Issues While Outsourcing Third Party Performance
2.6. Pharmaceutical Sterility Testing Market: Analysis Tools
2.7. Impact Of Covid-19 On Pharmaceutical Sterility Testing Market
2.8. Post Covid-19 Reformation Strategies In The Market

Chapter 3. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis
3.1. Definitions and Scope
3.2. Segment Dashboard
3.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
3.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Type, 2018 to 2030 (USD Million)
3.4.1. In-House
3.4.2. Outsourcing

Chapter 4. Pharmaceutical Sterility Testing Market: Product Type Estimates & Trend Analysis
4.1. Definitions and Scope
4.2. Segment Dashboard
4.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
4.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Product Type, 2018 to 2030 (USD Million)

Chapter 5. Pharmaceutical Sterility Testing Market: Test Type Estimates & Trend Analysis
5.1. Definitions and Scope
5.2. Segment Dashboard
5.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
5.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Product Type, 2018 to 2030 (USD Million)
5.4.1. Sterility Testing Membrane Filtration Direct Inoculation Product Flush
5.4.2. Bioburden Testing
5.4.3. Bacterial Endotoxin Testing

Chapter 6. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis
6.1. Definitions and Scope
6.2. Segment Dashboard
6.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
6.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by Sample, 2018 to 2030 (USD Million)
6.4.1. Pharmaceuticals
6.4.2. Medical Devices
6.4.3. Biopharmaceuticals

Chapter 7. Pharmaceutical Sterility Testing Market: End-use Estimates & Trend Analysis
7.1. Definitions and Scope
7.2. Segment Dashboard
7.3. Global Pharmaceutical Sterility Testing Market Movement Analysis
7.4. Global Pharmaceutical Sterility Testing Market Size & Trend Analysis, by End-use, 2018 to 2030 (USD Million)
7.4.1. Compounding Pharmacies
7.4.2. Medical Device Companies
7.4.3. Pharmaceutical Companies
7.4.4. Others

Chapter 8. Pharmaceutical Sterility Testing Market: Regional Estimates & Trend Analysis by Type, Product Type, Test Type, Sample, End-use

Chapter 9. Competitive Landscape
9.1. Company Categorization
9.2. Pharmaceutical Sterility Testing Market Share Analysis, 2023
9.3. Major Deals and Strategic Alliances Analysis
9.4. Vendor Landscape

  • Pacific Biolabs
  • Steris Plc
  • Boston Analytical
  • Nelson Laboratories
  • Sartorius AG
  • SGS SA
  • Labcorp
  • Pace Analytical
  • Charles River Laboratories
  • Thermo Fisher Scientific, Inc.
  • Rapid Micro Biosystems
  • Almac Group
  • Labor LS SE & Co. KG

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Pharmaceutical Sterility Testing Market