無菌検査の市場規模、シェア、成長分析、製品別、検査別、タイプ別、用途別、エンドユーザー別、地域別 - 産業予測 2025～2032年

無菌検査の世界市場規模は、2023年に18億米ドルと評価され、2024年の20億米ドルから2032年には46億8,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは11.2％で成長する見通しです。

世界のバイオ医薬品および製薬セクターは急速な成長を遂げており、無菌検査ソリューションおよびサービスに対する需要の増加を牽引しています。当局からの厳しい規制要件は、無菌検査企業に長期的なビジネスチャンスをもたらすでしょう。さらに、ヘルスケアにおけるアウトソーシングの動向は、この市場に大きな収益ポテンシャルをもたらすと期待されています。また、飲食品業界では品質保証の強化が重視されており、無菌検査のニーズが高まることが予想されます。無菌検査技術の革新は、迅速な検査ソリューションへの嗜好の高まりと相まって、予測期間中およびそれ以降も市場企業の利益をさらに高めるでしょう。しかし、複雑な手順、熟練者の不足、一貫性のない規制の枠組みといった課題が、近い将来の需要拡大を阻害する可能性があります。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次と一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• 規制分析

無菌検査市場規模：製品別& CAGR（2025-2032）

• 市場概要
• キットと試薬
• サービス
• 機器

無菌検査市場規模：検査別& CAGR（2025-2032）

• 市場概要
• 膜ろ過
• 直接接種
• 迅速微生物法
  • ATP生物発光
  • 蛍光ベース
  • 固相サイトメトリー
  • その他の迅速な微生物検査法
• その他の検査

無菌検査市場規模：タイプ別& CAGR（2025-2032）

• 市場概要
• 社内
• アウトソーシング

無菌検査市場規模：用途別& CAGR（2025-2032）

• 市場概要
• 医薬品および生物製剤製造
• 医療機器製造
• その他の用途

無菌検査市場規模：エンドユーザー別& CAGR（2025-2032）

• 市場概要
• 製薬・バイオテクノロジー企業
• 医療機器企業
• CROと契約検査機関
• その他のエンドユーザー

無菌検査市場規模：地域別& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 最近の市場動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業のセグメント別シェア分析
  • 収益の前年比比較（2022-2024年）

主要企業プロファイル

• Charles River Laboratories（USA）
• Merck KGaA（Germany）
• bioMerieux SA（France）
• SGS SA（Switzerland）
• Thermo Fisher Scientific Inc.（USA）
• Sartorius AG（Germany）
• WuXi AppTec（China）
• Nelson Laboratories, LLC（USA）
• Pacific BioLabs（USA）
• Eurofins Scientific（Luxembourg）
• Alcami Corporation（USA）
• Steris plc（Ireland）
• Pace Analytical（USA）
• Rapid Micro Biosystems, Inc.（USA）
• Tentamus（Germany）
• Singota Solutions（USA）
• Neopharm Labs Inc.（Canada）
• LexaMed（USA）
• Astell Scientific Ltd.（UK）
• Pall Corporation（USA）

結論と提言

Global Sterility Testing Market size was valued at USD 1.8 billion in 2023 and is poised to grow from USD 2.0 billion in 2024 to USD 4.68 billion by 2032, growing at a CAGR of 11.2% during the forecast perod (2025-2032).

The global biopharmaceutical and pharmaceutical sectors are experiencing rapid growth, driving increased demand for sterility testing solutions and services. Stringent regulatory requirements from authorities will create long-term opportunities for sterility testing companies. Furthermore, the trend of outsourcing in healthcare is expected to generate significant revenue potential in this market. The emphasis on enhancing quality assurance in the food and beverage industry is also anticipated to boost the need for sterility testing moving forward. Innovations in sterility testing technologies, coupled with a rising preference for rapid testing solutions, will further benefit market players during the forecast period and beyond. However, challenges such as complex procedures, a lack of skilled personnel, and inconsistent regulatory frameworks may impede demand growth in the near future.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Sterility Testing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Sterility Testing Market Segments Analysis

Global Sterility Testing Market is segmented by Product, Test, Type, Application, End-user and region. Based on Product, the market is segmented into Kits & reagents, Services and Instruments. Based on Test, the market is segmented into Membrane filtration, Direct inoculation, Rapid microbial method and Other tests. Based on Type, the market is segmented into In-house and Outsourced. Based on Application, the market is segmented into Pharmaceutical and biological manufacturing, Medical devices manufacturing and Other applications. Based on End-user, the market is segmented into Pharmaceutical & biotechnology companies, Medical device companies, CROs and contract testing laboratories and Other end-users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Sterility Testing Market

The growing focus on ensuring that healthcare products remain uncontaminated is driving governments and regulatory organizations, including the U.S. FDA and the European Medicines Agency (EMA), to enforce stringent regulations regarding sterility testing. This heightened emphasis on compliance necessitates the widespread adoption of sterility testing protocols globally, as healthcare providers and manufacturers strive to meet these requirements. Consequently, the demand for effective sterility testing solutions is increasing, fostering a robust growth environment for the global sterility testing market. Adhering to these regulations not only safeguards public health but also enhances the overall quality and safety of healthcare products.

Restraints in the Global Sterility Testing Market

The global sterility testing market faces significant challenges due to a shortage of skilled professionals who possess the necessary expertise in handling advanced techniques and equipment. This deficit is likely to hinder the widespread adoption of sterility testing practices in the foreseeable future. Particularly, this issue will be more pronounced in developing and underdeveloped countries, where access to properly trained personnel is already limited. As a result, the lack of adequately trained individuals may create barriers to effective implementation and adherence to sterility testing protocols, potentially stalling growth and innovation within the market and impacting overall industry standards.

Market Trends of the Global Sterility Testing Market

The Global Sterility Testing market is witnessing a robust trend towards automation, as companies increasingly prioritize the development of automated solutions to enhance the testing workflow's accuracy and efficiency. Integrating advanced technologies such as artificial intelligence and machine learning not only streamlines processes but also significantly reduces human error, thereby improving overall reliability. This shift is becoming a key differentiator for companies striving to maintain competitiveness in the evolving industry landscape. As demand for faster and more accurate sterility testing grows, automation is likely to play a pivotal role in shaping the future of the Global Sterility Testing market.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Regulatory Analysis

Global Sterility Testing Market Size by Product & CAGR (2025-2032)

• Market Overview
• Kits & reagents
• Services
• Instruments

Global Sterility Testing Market Size by Test & CAGR (2025-2032)

• Market Overview
• Membrane filtration
• Direct inoculation
• Rapid microbial method
  • ATP bioluminescence
  • Fluorescent -based
  • Solid-phase cytometry
  • Other rapid microbial methods
• Other tests

Global Sterility Testing Market Size by Type & CAGR (2025-2032)

• Market Overview
• In-house
• Outsourced

Global Sterility Testing Market Size by Application & CAGR (2025-2032)

• Market Overview
• Pharmaceutical and biological manufacturing
• Medical devices manufacturing
• Other applications

Global Sterility Testing Market Size by End-user & CAGR (2025-2032)

• Market Overview
• Pharmaceutical & biotechnology companies
• Medical device companies
• CROs and contract testing laboratories
• Other end-users

Global Sterility Testing Market Size & CAGR (2025-2032)

• North America (Product, Test, Type, Application, End-user)
  • US
  • Canada
• Europe (Product, Test, Type, Application, End-user)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product, Test, Type, Application, End-user)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product, Test, Type, Application, End-user)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product, Test, Type, Application, End-user)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Charles River Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• bioMerieux SA (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SGS SA (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius AG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nelson Laboratories, LLC (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pacific BioLabs (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific (Luxembourg)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Alcami Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Steris plc (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Rapid Micro Biosystems, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tentamus (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Singota Solutions (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Neopharm Labs Inc. (Canada)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• LexaMed (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Astell Scientific Ltd. (UK)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pall Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations