The global pharmaceutical sterility testing market size was estimated at USD 1.59 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 11.02% from 2024 to 2030. Increasing government investments, R&D activities, a growing number of drug launches, and a rising focus on quality & sterility are expected to drive the market growth. The development of comprehensive sterility testing procedures is regulated with stringent policies and quality control standards.

In addition, several government initiatives play a pivotal role in shaping the healthcare landscape, and their financial support significantly influences the development & implementation of advanced sterility testing procedures within the pharmaceutical sector. Increasing government funding for enhanced R&D activities for novel therapeutics, especially vaccines, biologics, and sterile products, which need sterility testing to ensure safety & efficacy. This leads to the introduction of cutting-edge technologies and innovative solutions in the sterility testing market. For instance, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), total healthcare R&D expenditure in the European Union (EU) was around USD 48.5 billion in 2022 compared to USD 46.4 billion in 2021.

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Pharmaceutical Sterility Testing Market Segments Highlights:

• Based on type, the outsourcing segment led the market with the largest revenue share of 59.25% in 2023. The market is classified into in-house, and outsourcing.
• Outsourcing sterility testing is considered an attractive alternative for several small- & medium-sized pharmaceutical and medical device companies, which may lack the infrastructure to conduct quality sterility testing.
• The in-house pharmaceutical sterility testing segment is anticipated to grow at a lucrative CAGR during the forecast period. The segment growth is driven by increasing requirements for product safety and growing demand for testing services to assess the compatibility & validation of products with routine quality test & control.
• Based on product type, the kits & reagents segment held the market with the largest revenue share of 60.30% in 2023. The market is segregated into kits and reagents, instruments, and services.
• The service segment is anticipated to grow at a fastest CAGR of 10.80% during the forecast period.
• Based on test-type, the bioburden testing segment held a market with the largest revenue share of 41.71% in 2023. The market is segregated into sterility testing, bioburden testing, and bacterial endotoxin testing.
• Based on sample, the pharmaceuticals companies segment held the market with the largest revenue share of 42.45% in 2023. The market is segregated into pharmaceuticals, medical devices, and biopharmaceuticals.
• The biopharmaceuticals segment is expected to grow at a fastest CAGR of 12.52% over the forecast period. The biopharmaceutical sector, including biologics and biosimilars, has been expanding.
• Based on end-use, the pharmaceutical companies segment held a market with the largest revenue share of 42.45% in 2023. The market is segregated into compounding pharmacies, medical devices companies, pharmaceutical companies, and others.
• The compounding pharmacies are expected to grow at a fastest CAGR of 12.20% over the forecast period. Compounding pharmacies prepare customized dosages of sterile drugs, which are required to comply with the stringent requirements and standards of sterility.
• North America dominated the market with the revenue share of 49.45% in 2023.
• An increase in R&D activities and a rise in the number of drug approvals in the country are among the major factors supporting the market growth.
• The Europe pharmaceutical sterility testing market is expected to grow significant CAGR during the forecast period, due to a growing regulation.
• The pharmaceutical sterility testing market of Asia Pacific is expected to grow at the fastest CAGR over the forecast period, due to numerous developed countries investing in Asia Pacific countries and various amendments made by the regulatory agencies to facilitate local manufacturing & contract services.

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Pharmaceutical Sterility Testing Market Segmentation

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

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

• In-House
• Outsourcing

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

• Kits & Reagents
• Instruments
• Services

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

• Sterility Testing
  • Membrane Filtration
  • Direct Inoculation
  • Product Flush
• Bioburden Testing
• Bacterial Endotoxin Testing
• Rapid Microbial Method
  • ATP Bioluminescence
  • Fluorescent -Based
  • Solid-phase Cytometry
  • Others

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

• Pharmaceuticals
• Medical Devices
• Biopharmaceuticals

Pharmaceutical Sterility Testing End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Compounding Pharmacies
• Medical Device Companies
• Pharmaceutical Companies
• Others

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

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)

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