無菌検査の市場規模、シェア、成長分析、製品・サービス別、検査タイプ別、用途別、地域別 - 産業予測、2024年～2031年

無菌検査の世界市場規模は、2022年に約11億米ドルと評価され、予測期間（2024-2031年）のCAGRは10.5%で、2023年の12億米ドルから上昇し、2031年には27億米ドルに達すると予測されています。

世界の無菌検査市場は、生物製剤、細胞・遺伝子治療、ワクチンの需要増に牽引され、大きな成長を遂げています。製薬およびバイオテクノロジー分野が拡大を続ける中、無菌検査は製品の安全性と有効性を確保するための重要な品質管理手段となりつつあります。慢性疾患、特にがんや自己免疫疾患の増加により、バイオ医薬品の開発が増加しており、製造過程で無菌検査が必要とされています。さらに、FDAやEMAなどの規制当局による医薬品の安全性への関心の高まりは、特に注射剤において、より厳しい無菌検査基準の採用を企業に促しています。無菌検査手順の自動化などの技術的進歩は、業務の合理化、人的ミスの削減、試験プロセスのスピードアップに役立っており、メーカーにとってはより効率的なものとなっています。北米は、確立された医薬品インフラ、強固な研究開発活動、有利な規制の枠組みにより、市場を独占しています。しかし、アジア太平洋地域は、ヘルスケアへの政府投資の増加、バイオファーマ企業の拡大、医療費の増加に後押しされ、高成長地域として浮上しています。また、コスト削減と納期短縮のため、検査工程を専門企業にアウトソーシングする企業が増えており、検査受託機関（CTO）も人気を集めています。Merck KGaA、Charles River Laboratories、Thermo Fisher Scientificなど市場の主要企業は、競争力を維持するために研究開発に投資し、新製品を発売しており、市場の成長をさらに促進しています。

目次

イントロダクション

• 調査の目的
• 定義
• 市場範囲

調査手法

• 情報調達
• 二次データソースと一次データソース
• 市場規模予測
• 市場の想定と制限

エグゼクティブサマリー

• 市場概要見通し
• 供給需要動向分析
• セグメント別機会分析

市場力学と見通し

• 市場力学
  • 促進要因
  • 機会
  • 抑制要因
  • 課題
• ポーターの分析

主な市場の考察

• 主な成功要因
• 競合の程度
• 主な投資機会
• 市場のエコシステム
• サプライチェーン分析
• 特許分析
• 顧客と購買基準の分析
• 貿易分析
• 規制分析

無菌検査市場：製品・サービス別

• 市場概要
• キットと試薬
• サービス
• 機器

無菌検査市場：テストタイプ別

• 市場概要
• 膜ろ過
• 直接接種
• その他のテストタイプ

無菌検査市場：用途別

• 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：エンドユーザー別

• 市場概要
• 製薬会社
• バイオテクノロジー企業
• その他のエンドユーザー

無菌検査市場規模：地域別

• 市場概要
• 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（MEA）
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ地域

競合情勢

• 上位5社の比較
• 主要企業の市場ポジショニング（2023年）
• 主な市場企業が採用した戦略
• 市場における最近の活動
• 主要企業の市場シェア（2023年）

主要企業プロファイル

• Merck Kgaa
• Charles River Laboratories
• Biomerieux Sa
• Sartorius Ag
• Wuxi Apptec
• Samsung Biologics
• Genscript
• Pacific Biolabs
• Nelson Laboratories, Llc
• Pace Analytical
• Tentamus
• Singota Solutions
• Lexamed
• Astell Scientific Ltd
• Himedia Laboratories
• Pall Corporation（Part Of Danaher Corporation）
• Boston Analytical
• Solvias Ag
• Bd

Global Sterility Testing Market size was valued at around 1.1 billion in 2022 and is expected to rise from USD 1.2 billion in 2023 to reach a value of USD 2.7 billion by 2031, at a CAGR of 10.5% over the forecast period (2024-2031).

The global sterility testing market is experiencing significant growth, driven by the increasing demand for biologics, cell and gene therapies, and vaccines. As the pharmaceutical and biotechnology sectors continue to expand, sterility testing is becoming a crucial quality control measure to ensure the safety and efficacy of products. The rise in chronic diseases, particularly cancer and autoimmune disorders, is leading to the increased development of biopharmaceutical products, which necessitate sterility testing during the manufacturing process. Furthermore, the growing focus on drug safety by regulatory authorities such as the FDA and EMA is pushing companies to adopt more stringent sterility testing standards, especially for injectable products. Technological advancements, such as automation in sterility testing procedures, are helping to streamline operations, reduce human errors, and speed up the testing process, making it more efficient for manufacturers. North America dominates the market due to its established pharmaceutical infrastructure, robust R&D activities, and favorable regulatory frameworks. However, Asia-Pacific is emerging as a high-growth region, fueled by increasing government investments in healthcare, expansion of biopharma companies, and rising healthcare expenditures. Contract testing organizations (CTOs) are also gaining traction as more companies outsource their sterility testing processes to specialized firms to reduce costs and improve turnaround times. Key players in the market, including Merck KGaA, Charles River Laboratories, and Thermo Fisher Scientific, are investing in R&D and launching new products to stay competitive, further propelling market growth.

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 Segmental Analysis

Global Sterility Testing Market is segmented by Product & Services, Test Type, Application, End User, and region. Based on Product & Services, the market is segmented into Kits & Reagents, Services, Instruments. Based on Test type, the market is segmented into Membrane Filtration, Direct Inoculation, Other Tests. Based on Application, the market is segmented into Pharmaceuticals and Biologicals, Medical Devices, Other Applications. Based on End User, the market is segmented into Pharmaceutical Companies, Biotechnology Companies, and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Drivers of the Global Sterility Testing Market

One of the key drivers of the sterility testing market is the increasing demand for biologics and vaccines, driven by advancements in medical science and the ongoing threat of infectious diseases. Biologics, which include a wide range of products such as monoclonal antibodies, growth factors, and gene therapies, are highly sensitive to contamination due to their complex structure and manufacturing process. Vaccines, particularly during global pandemics like COVID-19, have underscored the importance of stringent sterility testing to ensure safety and efficacy. With the rise of personalized medicine and precision therapies, there is a growing emphasis on developing biologics tailored to specific patient populations, further boosting the need for robust sterility testing methods. This trend is expected to continue as new biopharmaceutical innovations emerge, supported by increasing investments in research and development. Manufacturers must comply with stringent regulatory guidelines that mandate thorough sterility testing, enhancing market growth.

Restraints in the Global Sterility Testing Market

Despite the positive market outlook, one of the major restraints in the sterility testing market is the high cost and time-intensive nature of these procedures. Sterility testing, especially for biologics and sterile injectable products, requires highly controlled environments, advanced equipment, and skilled personnel to ensure accurate results. The validation of testing methods, along with the need for multiple tests across different production batches, adds to the overall expense. Moreover, traditional sterility testing methods can take several days to yield results, which can slow down the production timeline, particularly in the case of urgent therapeutic products like vaccines. Small- and mid-sized pharmaceutical companies often find it challenging to balance the need for comprehensive sterility testing with cost constraints, potentially limiting their market participation. While automation and rapid microbial testing technologies offer solutions, the initial setup and operational costs of these technologies can be prohibitive for smaller market players.

Market Trends of the Global Sterility Testing Market

A notable trend in the global sterility testing market is the increasing adoption of rapid sterility testing technologies. Traditional sterility testing methods, such as membrane filtration and direct inoculation, are time-consuming, requiring up to 14 days to yield results. In contrast, rapid sterility testing methods, including ATP bioluminescence, nucleic acid amplification, and flow cytometry, can provide results in a matter of hours or days. These technologies not only speed up the quality control process but also enhance the sensitivity and accuracy of testing, reducing the risk of false negatives. As the pharmaceutical industry faces growing pressure to accelerate product development timelines, especially for critical therapies like vaccines, the demand for rapid testing solutions is rising. Moreover, regulatory bodies are beginning to recognize and approve these advanced methods, further encouraging their adoption. Companies that implement rapid sterility testing can streamline their production workflows, reduce storage costs associated with quarantine periods, and bring products to market faster, gaining a competitive edge.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

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

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factor
• Degree of Competition
• Top Investment Pockets
• Ecosystem of the Market
• Supply Chain Analysis
• Patent Analysis
• Customer & Buying Criteria Analysis
• Trade Analysis
• Regulatory Analysis

Sterility Testing Market, By Product & Service

• Market Overview
• Kits & Reagents
• Services
• Instruments

Sterility Testing Market, By Test Type

• Market Overview
• Membrane Filtration
• Direct Inoculation
• Other Test Types

Sterility Testing Market, By Application

• Market Overview
• Pharmaceutical & Biologics Manufacturing
• Medical Device Manufacturing
• Other Applications

Sterility Testing Market, By End User

• Market Overview
• Pharmaceutical Companies
• Biotechnology Companies
• Other End Users

Sterility Testing Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Merck Kgaa
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biomerieux Sa
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius Ag
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Wuxi Apptec
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Biologics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Genscript
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pacific Biolabs
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nelson Laboratories, Llc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tentamus
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Singota Solutions
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lexamed
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Astell Scientific Ltd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Himedia Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pall Corporation (Part Of Danaher Corporation)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Boston Analytical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Solvias Ag
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments