医薬品無菌性試験市場規模、シェア、成長分析：タイプ別、試験製品別、試験タイプ別、サンプル別、最終用途別、地域別 - 産業予測 2025～2032年

医薬品無菌性試験の世界市場規模は2023年に22億米ドルと評価され、2024年の24億8,000万米ドルから2032年には63億5,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは12.5%で成長する見通しです。

世界の医薬品無菌性試験市場は、厳格な規制要件、高品質な医薬品に対する需要の高まり、医薬品の安全性と有効性への強い関心に後押しされ、力強い成長を遂げています。米国FDAやEMAなどの規制機関は、医薬品に有害な微生物汚染がないことを確認するために無菌試験を義務付けており、患者の健康を守っています。しかし、試験手順や医薬品製剤の複雑化に伴う高コストのため、市場は課題に直面しています。とはいえ、多くの企業が無菌試験のアウトソーシングのために試験受託機関を利用し、専門的な専門知識とリソースの恩恵を受けているため、チャンスは生まれつつあります。さらに、個別化医療や生物製剤に対する需要の高まりが、この不可欠な市場の成長をさらに後押しするものと思われます。

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

医薬品無菌性試験市場規模：タイプ別& CAGR（2025-2032）

• 市場概要
• 社内
• アウトソーシング

医薬品無菌性試験市場規模：試験製品別& CAGR（2025-2032）

• 市場概要
• キットと試薬
• 機器
• サービス

医薬品無菌性試験市場規模：試験タイプ別& CAGR（2025-2032）

• 市場概要
• 無菌試験
  • 膜ろ過
  • 直接接種
  • 製品フラッシュ
• バイオバーデン試験
• 細菌エンドトキシン検査
• 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

医薬品無菌性試験市場規模サンプル& CAGR（2025-2032）

• 市場概要
• 医薬品
• 医療機器
• バイオ医薬品

医薬品無菌性試験市場規模：最終用途別& CAGR（2025-2032）

• 市場概要
• 調剤薬局
• 医療機器企業
• 製薬会社
• その他

医薬品無菌性試験市場規模：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）

主要企業プロファイル

• Bolzoni Auramo（Italy）
• Kaup GmbH & Co. KG（Germany）
• Meyer GmbH（Germany）
• CAM attachments（Italy）
• Durwen GmbH（Germany）
• Long Reach Manufacturing（USA）
• Liftomatic Material Handling, Inc.（USA）
• Brudi Equipment, Inc.（USA）
• Hanmare Attachments（South Korea）
• Mecalac Attachments（France）
• Atlas Polar Company Limited（Canada）
• BESSE Attachments（France）
• Landoll Corporation（USA）
• Rightline Equipment（USA）
• Lift Technologies, Inc.（USA）
• WIFO Anema BV（Netherlands）
• Intermercato AB（Sweden）
• CGM Handling（Italy）

結論と提言

Global Pharmaceutical Sterility Testing Market size was valued at USD 2.2 billion in 2023 and is poised to grow from USD 2.48 billion in 2024 to USD 6.35 billion by 2032, growing at a CAGR of 12.5% during the forecast period (2025-2032).

The global pharmaceutical sterility testing market is experiencing robust growth, propelled by stringent regulatory requirements, heightened demand for high-quality pharmaceutical products, and a strong focus on drug safety and efficacy. Regulatory bodies like the US FDA and EMA mandate sterility testing to ensure that medications are free from harmful microbial contamination, thus safeguarding patient health. However, the market faces challenges due to the high costs associated with testing procedures and the increasing complexity of pharmaceutical formulations. Nevertheless, opportunities are emerging as many companies turn to contract testing organizations for outsourcing sterility testing, benefiting from specialized expertise and resources. Additionally, the rising demand for personalized medicine and biologics is poised to further drive growth in this essential market.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Pharmaceutical 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 Pharmaceutical Sterility Testing Market Segments Analysis

Global Pharmaceutical Sterility Testing Market is segmented by Type, Test Product, Testing Type, Sample, End Use and region. Based on Type, the market is segmented into In-House and Outsourcing. Based on Test Product, the market is segmented into Kits and Reagents, Instruments and Services. Based on Testing Type, the market is segmented into Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing and Rapid Microbial Method. Based on Sample, the market is segmented into Pharmaceuticals, Medical Devices and Biopharmaceuticals. Based on End Use, the market is segmented into Compounding Pharmacies, Medical Device Companies, Pharmaceutical Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Pharmaceutical Sterility Testing Market

The global pharmaceutical sterility testing market is being significantly propelled by the rising demand for biologics and biosimilar drugs, which have proven effective in managing severe health conditions, including cancer, neurological disorders, and various infectious diseases. As the need for these innovative therapies grows, so does the necessity for rigorous pharmaceutical sterility testing to guarantee the safety and efficacy of such products. The recent approval of multiple biosimilars, including Trastuzumab, Rituximab, and Adalimumab, has further enhanced the market growth, reflecting a broader industry trend towards ensuring high-quality and safe therapeutic options for patients worldwide.

Restraints in the Global Pharmaceutical Sterility Testing Market

The Global Pharmaceutical Sterility Testing market faces a notable restraint due to the high costs associated with sterility testing services, which can create significant challenges for a wide range of customers, particularly in emerging markets or resource-limited environments. Small and medium-sized pharmaceutical and medical device companies often struggle with the necessary infrastructure to perform reliable sterility testing in-house. As a result, these companies are more inclined to outsource such testing services to ensure compliance with FDA regulations, further highlighting the financial constraints that can hinder their ability to utilize essential sterility testing services effectively.

Market Trends of the Global Pharmaceutical Sterility Testing Market

The Global Pharmaceutical Sterility Testing market is experiencing a notable shift toward the adoption of rapid microbial detection technologies, driven by the industry's need for efficiency and compliance. These advanced technologies significantly reduce testing timelines, enabling faster results while ensuring the sterility of pharmaceutical products. As regulatory bodies emphasize stringent quality control measures, manufacturers are increasingly investing in rapid testing solutions to streamline operations and maintain competitiveness. This trend is projected to continue in the coming years, with the market expanding as companies prioritize innovation to enhance their sterility testing processes, thereby meeting the evolving demands of the pharmaceutical landscape.

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

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

• Market Overview
• In-House
• Outsourcing

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

• Market Overview
• Kits and Reagents
• Instruments
• Services

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

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

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

• Market Overview
• Pharmaceuticals
• Medical Devices
• Biopharmaceuticals

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

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

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

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

• Bolzoni Auramo (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Kaup GmbH & Co. KG (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Meyer GmbH (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• CAM attachments (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Durwen GmbH (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Long Reach Manufacturing (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Liftomatic Material Handling, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Brudi Equipment, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hanmare Attachments (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Mecalac Attachments (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Atlas Polar Company Limited (Canada)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BESSE Attachments (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Landoll Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Rightline Equipment (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lift Technologies, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WIFO Anema BV (Netherlands)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intermercato AB (Sweden)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• CGM Handling (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations