의약품 무균 검사 시장 : 제품별, 검사별, 샘플별, 유형별, 최종사용자별, 세계 예측(2024-2032)

Pharmaceutical sterility testing market size is anticipated to observe 10.8% CAGR from 2024 to 2032, driven by stringent regulatory requirements, the increasing emphasis on quality control, and the rising demand for biopharmaceuticals as well as sterile pharmaceutical products.

Lately, sterility testing has grown fundamental to the pharmaceutical industry for ensuring that products are free from microbial contamination and safe to use. For instance, in October 2022, Tema Sinergie developed a new pharmaceutical isolator for sampling sterile powders (API) under aseptic conditions to meet the needs for aseptic sampling of large volumes of sterile pharmaceuticals and handling of large containers. Regulatory agencies worldwide, such as the FDA in the U.S. and the EMA in Europe are mandating rigorous infertility testing programs to ensure product safety and efficacy.

The growing complexity and diversity of pharmaceutical formulations, including biologics and personalized medicines, are necessitating specialized sterility testing methods to accurately detect even low levels of contaminants. The increasing adoption of new drug delivery systems, such as injectables and implants is also highlighting the need for reliable infertility testing solutions to provide resource integrity throughout the production process. Increasing healthcare costs especially in emerging markets are fueling the demand for generic drugs, adding to the market growth.

The industry is classified into product, test, type, sample, end-user and region.

Based on product, the pharmaceutical sterility testing market value from the services segment is slated to witness substantial growth rate during 2024-2032 favored by their ability for offering specialized expertise, regulatory compliance, and efficiency in testing operations. Pharmaceutical companies are increasingly relying on outsourced infertility testing services to create cutting-edge areas and specialized knowledge. Outsourcing sterility testing allows manufacturers to optimize costs, streamline operations, and focus content on core competencies, such as research, development, and manufacturing, leading to the segment growth.

Pharmaceutical sterility testing industry from the compounding pharmacies end-user segment will grow significantly through 2032, due to the critical need for stringent quality assurance in personalized medication preparations. These pharmacies produce customized medications based on the needs of individual patients, often requiring organic medications to ensure patient safety and efficacy. Sterility testing helps in ensuring the absence of microbial contaminants in these products while meeting the compliance with regulatory standards and reducing the risk of infection or adverse events for patients.

Europe pharmaceutical sterility testing industry is expected to expand at significant rate over 2024-2032 attributed to stringent regulatory standards, robust pharmaceutical manufacturing infrastructure, and the increasing investments in biopharmaceutical R&D activities. European countries follow strict regulations set by authorities, such as the European Medicines Agency (EMA), which mandate a rigorous infertility testing program to ensure that pharmaceutical products are safe and efficient. The high prevalence of chronic diseases and rising healthcare costs in Europe are contributing to the demand for generic medicines, further stimulating the regional market growth.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising prevalence of infectious diseases
    • 3.2.1.2 Increasing outsourcing of sterility testing services
    • 3.2.1.3 Stringent regulatory requirements for pharmaceutical companies
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Complexity of testing procedures
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Porter's analysis
• 3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Product, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Kits & reagents
• 5.3 Services
• 5.4 Instruments

Chapter 6 Market Estimates and Forecast, By Test, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Membrane filtration
• 6.3 Direct inoculation
• 6.4 Rapid microbial method
  • 6.4.1 ATP bioluminescence
  • 6.4.2 Fluorescent -based
  • 6.4.3 Solid-phase cytometry
  • 6.4.4 Other rapid microbial methods
• 6.5 Other tests

Chapter 7 Market Estimates and Forecast, By Type, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 In-house testing
• 7.3 Outsourced testing

Chapter 8 Market Estimates and Forecast, By Sample, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 Sterile drugs
• 8.3 Biologics and therapeutics

Chapter 9 Market Estimates and Forecast, By End-user, 2021 - 2032 ($ Mn)

• 9.1 Key trends
• 9.2 Pharmaceutical & biotechnology companies
• 9.3 CROs and contract testing laboratories
• 9.4 Compounding pharmacies
• 9.5 Other end-users

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 10.1 Key trends
• 10.2 North America
  • 10.2.1 U.S.
  • 10.2.2 Canada
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 France
  • 10.3.4 Spain
  • 10.3.5 Italy
  • 10.3.6 Netherlands
  • 10.3.7 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 China
  • 10.4.2 Japan
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 South Korea
  • 10.4.6 Rest of Asia Pacific
• 10.5 Latin America
  • 10.5.1 Brazil
  • 10.5.2 Mexico
  • 10.5.3 Rest of Latin America
• 10.6 Middle East and Africa
  • 10.6.1 South Africa
  • 10.6.2 Saudi Arabia
  • 10.6.3 UAE
  • 10.6.4 Rest of Middle East and Africa

Chapter 11 Company Profiles

• 11.1 Alcami Corporation
• 11.2 bioMerieux SA
• 11.3 BA Sciences
• 11.4 Charles River Laboratories
• 11.5 Nelson Laboratories, LLC
• 11.6 Merck KGaA
• 11.7 Pacific BioLabs Inc.
• 11.8 Rapid Micro Biosystems Inc.
• 11.9 SGS Societe Generale de Surveillance SA.
• 11.10 STERIS Corporation
• 11.11 Thermo Fisher Scientific Inc.