無菌測試市場規模：按產品類型、按應用、按地區、範圍和預測

無菌測試的市場規模與預測

2024 年無菌測試市場規模價值 14.3 億美元，預計到 2031 年將達到 33.6 億美元，2024 年至 2031 年的複合年增長率為 12.40%。無菌測試是指用來確定藥品、醫療器材和其他醫療相關物品中是否存在活體微生物的過程。此項測試對於確保產品在供人類使用之前的安全性和有效性至關重要。此外，無菌測試通常用於製藥業、生物技術領域和醫療器材製造，以符合監管要求並維持產品品質。

無菌檢測市場動態

影響無菌偵測市場的關鍵市場動態

主要市場驅動因子

增加製藥和生技產量

全球製藥和生物技術製造業的興起，尤其是無菌製劑的興起，是無菌測試產業發展的主要驅動力。根據國際製藥商協會聯合會（IFPMA）的報告，到2022年全球生物製藥市場規模將達到1.5兆美元。對無菌生物製劑和疫苗的需求不斷增加，推動了無菌測試的需求，以確保產品安全和法規遵循。

提高無菌藥物核准的監管要求

對無菌藥品生產和批准的嚴格監管要求促使公司利用無菌測試。美國食品藥物管理局 (FDA) 要求新的無菌藥品必須通過無菌測試，作為審批流程的一部分。 2021年，FDA批准了50種新型分子實體，其中許多需要進行大量的無菌測試，從而促進了市場的成長。

細胞和基因治療的需求不斷增加

細胞和基因療法等先進藥物的日益使用推動了無菌測試的需求。報告稱，預計2022年全球將進行2,500多項細胞和基因治療臨床試驗。這些治療藥物需要經過徹底的無菌測試才能滿足品質和安全法規的要求，這對無菌測試市場的成長有重大貢獻。

主要問題

無菌測試相關成本高：

與無菌測試設備、消耗品和熟練人力相關的成本被認為很高。這一因素可能會限制市場成長，尤其是在小型企業和新興市場。

傳統且耗時的方法：

傳統的無菌測試方法通常很耗時，會延遲產品的發佈。目前，人們正在透過開發快速無菌測試方法來應對這項課題，但採用這種方法仍然有限。

假陽性與偽陰性的風險：

無菌測試方法有時會產生假陽性或假陰性結果，對產品品質和安全有嚴重影響。克服這項課題對於提高無菌測試的可靠性至關重要。

主要趨勢

採用快速微生物檢測方法：

使用快速微生物學方法 (RMM) 進行無菌測試的趨勢日益增長。與傳統方法相比，這些方法的發展是為了提供更快的結果，同時保持或提高準確性。

無菌檢測外包增加：

許多製藥和生物技術公司將無菌測試外包給專門的合約測試組織。這一趨勢是由對專業知識、先進技術和成本效益的需求所驅動。

自動化與機器人整合：

自動化和機器人技術越來越多地被融入無菌測試過程中。這些技術有助於減少人為錯誤，提高吞吐量並提高無菌測試程序的整體效率。

無菌測試市場的區域分析

北美

根據經過驗證的市場研究，預計北美將在預測期內主導無菌測試市場。北美，尤其是美國，在生物製藥和疫苗生產方面處於領先地位，推動了對無菌測試的需求，以確保產品安全。根據美國藥品研究與製造商協會（PhRMA）統計，2021年美國生技公司將在研發上投入約1,023億美元，佔全球醫藥市場的40%以上。這種水準的生產和投資需要進行廣泛的無菌測試以滿足嚴格的監管標準。

美國食品藥物管理局 (FDA) 對無菌藥物和生物製劑實施嚴格的無菌測試指南。 2021 年，FDA 批准了 50 種新型分子實體，其中許多都需要在藥物審批過程中進行無菌測試。北美嚴格的監管環境確保無菌測試仍然是藥物開發的關鍵組成部分，從而極大地促進了該地區的市場成長。

此外，北美處於細胞和基因治療發展的前沿，這需要進行密集的無菌測試以確保產品安全。據再生醫學聯盟稱，截至 2021 年底，美國將有 92 種基因和細胞療法進入後期臨床試驗。隨著這些先進療法獲得批准並商業化，該地區對無菌測試的需求將持續上升，從而推動市場擴張。

歐洲

預計歐洲地區在預測期內將呈現最高的成長率。歐洲擁有蓬勃發展的製藥和生物製藥製造業，推動了對無菌測試的需求，以確保符合品質標準。根據歐洲製藥工業協會聯合會（EFPIA）的數據，2022年歐洲將佔全球醫藥銷售額的23.9%，重點是無菌藥物、生物製劑和疫苗。如此強大的生產能力正在為整個地區帶來對無菌測試的穩定需求。

歐洲藥品管理局（EMA）等歐洲監管機構對無菌測試實施了嚴格的指導方針，以確保藥品的安全性和有效性。 2021年，EMA批准了92種新藥，其中許多包括需要進行嚴格無菌測試的無菌生物製劑和疫苗。這些嚴格的監管要求正在推動歐洲在藥品製造中採用無菌測試。

此外，歐洲在細胞和基因療法等需要嚴格無菌測試的先進療法的研究和開發方面處於領先地位。報告稱，歐洲佔全球細胞和基因治療臨床試驗的23%。隨著這些治療方法通過臨床試驗並走向商業化，符合安全標準的無菌測試需求正在推動該地區的市場成長。

目錄

第 1 章 全球無菌測試市場簡介

市場概況
• 研究範圍
• 先決條件

第 2 章執行摘要

第 3 章：經過驗證的市場研究方法

• 資料探勘
• 驗證
• 主要來源
• 資料來源列表

第 4 章全球無菌測試市場展望

• 概述
• 市場動態
  • 驅動程式
  • 阻礙因素
  • 機會
• 波特五力模型
• 價值鏈分析

第 5 章全球無菌測試市場類型

• 概述
• 試劑盒和試劑
• 消耗品
• 生物醫學設備
• 服務

第6章 全球無菌檢測市場（依應用）

• 概述
• 製藥公司
• 醫院
• 病理學研究所
• 學術研究機構
• 其他

第 7 章 全球無菌測試市場（按地區）

• 概述
• 北美洲
  • 美國
  • 加拿大
  • 墨西哥
• 歐洲
  • 德國
  • 英國
  • 法國
  • 其他歐洲國家
  亞太地區
  • 中國
  • 日本
  • 印度
  • 其他亞太地區
• 世界其他地區
  • 拉丁美洲
  • 中東和非洲

第 8 章全球無菌測試市場的競爭格局

• 概述
• 各公司的市場排名
• 主要發展策略

第9章 公司簡介

• Danaher Corporation
• Pace Analytical Serv.
• Boston Analytical
• Toxicon Inc.
• Merck KGaA
• Thermo Fisher Scientific Inc.
• SGS SA
• Biomerieux SA
• Nelson Laboratories
• Charles River Laboratories International, Inc.

第 10 章附錄

• 相關報告

Sterility Testing Market Size And Forecast

Sterility Testing Market size was valued at USD 1.43 Billion in 2024 and is projected to reach USD 3.36 Billion by 2031 , growing at a CAGR of 12.40% from 2024 to 2031. Sterility testing is defined as a process used to determine the presence or absence of viable microorganisms in pharmaceutical products, medical devices, and other healthcare-related items. This testing is crucial for ensuring the safety and efficacy of products before they are released for human use. Furthermore, sterility testing is commonly employed in the pharmaceutical industry, biotechnology sector, and medical device manufacturing to comply with regulatory requirements and maintain product quality.

Sterility Testing Market Dynamics

The key market dynamics that are shaping the sterility testing market include:

Key Market Drivers

Increasing Pharmaceutical and Biotechnology Production

: The global rise in pharmaceutical and biotechnology manufacturing, particularly for sterile drug products, is a significant driver of the sterility testing industry. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) reports that the worldwide biopharmaceutical business was worth $1.5 trillion in 2022. The rising demand for sterile biologics and vaccines has increased the requirement for sterility testing to ensure product safety and regulatory compliance.

Growing Number of Regulatory Requirements for Sterile Drug Approval

: Stringent regulatory requirements for the production and approval of sterile medications are driving firms to use sterility testing. The United States Food and Drug Administration (FDA) requires that any new sterile drug product pass sterility testing as part of the clearance procedure. In 2021, the FDA authorized 50 novel molecular entities, many of which required significant sterility testing, resulting in market growth.

Rising Demand for Cell and Gene Therapies

: The growing use of sophisticated medicines like cell and gene therapy has increased the necessity for sterility testing. According to a Report, more than 2,500 clinical studies for cell and gene therapies will be conducted worldwide in 2022. These therapies must go through thorough sterility testing to meet quality and safety regulations, which contributes significantly to the sterility testing market's growth.

Key Challenges

High Costs Associated with Sterility Testing:

The costs associated with sterility testing equipment, consumables, and skilled personnel are being considered high. This factor is potentially limiting market growth, especially among smaller companies and in developing regions.

Time-Consuming Nature of Traditional Methods:

Traditional sterility testing methods are often time-consuming, which delays product release. This challenge is being addressed through the development of rapid sterility testing methods, but their adoption is still limited.

Risk of False Positives and Negatives:

Sterility testing methods sometimes produce false positive or false negative results, which have significant implications for product quality and safety. Overcoming this challenge is being seen as crucial for improving the reliability of sterility testing.

Key Trends

Adoption of Rapid Microbial Methods:

There is a growing trend towards the adoption of rapid microbial methods (RMM) for sterility testing. These methods are being developed to provide faster results while maintaining or improving accuracy compared to traditional methods.

Increasing Outsourcing of Sterility Testing:

Many pharmaceutical and biotechnology companies are outsourcing their sterility testing to specialized contract testing laboratories. This trend is being driven by the need for expertise, advanced technologies, and cost efficiencies.

Integration of Automation and Robotics:

Automation and robotics are increasingly being integrated into sterility testing processes. These technologies are helping to reduce human error, increase throughput, and improve the overall efficiency of sterility testing procedures.

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Sterility Testing Market Regional Analysis

The regional analysis of the sterility testing market is provided below:

North America

According to Verified Market Research, North America is estimated to dominate the sterility testing market over the forecast period. North America, particularly the U.S., is a leader in biopharmaceutical and vaccine production, driving the demand for sterility testing to ensure product safety. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), U.S. biopharmaceutical companies spent nearly $102.3 billion on research and development in 2021, accounting for over 40% of the global pharmaceutical market. This significant production and investment necessitate extensive sterility testing to meet stringent regulatory standards.

The U.S. Food and Drug Administration (FDA) enforces rigorous sterility testing guidelines for sterile pharmaceuticals and biologics. In 2021, the FDA approved 50 new molecular entities, many of which required sterility testing as part of the drug approval process. The strict regulatory landscape in North America ensures that sterility testing is a crucial component of pharmaceutical development, significantly boosting market growth in the region.

Furthermore, North America is at the forefront of cell and gene therapy development, which requires intensive sterility testing to ensure product safety. According to the Alliance for Regenerative Medicine, 92 gene and cell therapies were in late-stage clinical trials in the U.S. by the end of 2021. As these advanced therapies gain approval and commercialization, the demand for sterility testing in the region continues to rise, driving market expansion.

Europe

The Europe region is expected to exhibit the highest growth rate during the forecast period. Europe is home to thriving pharmaceutical and biopharmaceutical manufacturing sectors, driving the demand for sterility testing to ensure compliance with quality standards. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), Europe accounted for 23.9% of global pharmaceutical sales in 2022, with a focus on sterile drug products, biologics, and vaccines. This strong production capacity creates a consistent demand for sterility testing across the region.

European regulatory agencies, such as the European Medicines Agency (EMA), enforce strict guidelines for sterility testing to ensure the safety and efficacy of pharmaceuticals. In 2021, the EMA approved 92 new medicines, many of which included sterile biologics and vaccines that require rigorous sterility testing. These stringent regulatory requirements are driving the adoption of sterility testing across pharmaceutical manufacturing in Europe.

Furthermore, Europe is a leader in the research and development of advanced therapies such as cell and gene therapy, which necessitate thorough sterility testing. According to a Report, Europe accounted for 23% of global clinical trials for cell and gene therapies. As these therapies move through clinical trials and into commercialization, the demand for sterility testing to meet safety standards is driving market growth in the region.

Sterility Testing Market: Segmentation Analysis

The Global Sterility Testing Market is being segmented based on Product, Test Type, Application, and Geography.

Sterility Testing Market, By Product

• Kits & Reagents
• Instruments
• Services

Based on Product, the market is segmented into Kits & Reagents, Instruments, and Services. The kits & reagents segment is estimated to dominate the market over the forecast period. This dominance is attributed to the frequent and recurring use of these products in sterility testing procedures. The increasing demand for ready-to-use sterility testing kits and the growing emphasis on quality control in the pharmaceutical and biotechnology industries are further driving the growth of this segment.

Sterility Testing Market, By Test Type

• Membrane Filtration
• Direct Inoculation
• Others

Based on Test Type, the market is segmented into Membrane Filtration, Direct Inoculation, and Others. The membrane filtration segment is projected to hold the largest market share during the forecast period. This method is preferred due to its high sensitivity and ability to test large sample volumes. It is particularly suited for testing water-soluble products, which is contributing to its widespread adoption in the pharmaceutical industry.

Sterility Testing Market, By Application

• Pharmaceutical & Biological Manufacturing
• Medical Devices Manufacturing
• Others

Based on Application, the market is segmented into Pharmaceutical & Biological Manufacturing, Medical Devices Manufacturing, and Others. The pharmaceutical & biological manufacturing segment is estimated to dominate the market. This dominance is being attributed to the stringent regulatory requirements for ensuring the sterility of pharmaceutical and biological products, the increasing production of biologics and biosimilars, and the growing focus on quality assurance in drug manufacturing.

Sterility Testing Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World

Based on Geography, the sterility testing market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America is estimated to dominate the market during the forecast period. This dominance is attributed to the presence of a well-established pharmaceutical and biotechnology industry, stringent regulatory standards, and high adoption of advanced sterility testing technologies in the region.

Key Players

• The "Sterility Testing Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Charles River Laboratories, Merck KGaA, Thermo Fisher Scientific, bioMerieux SA, SGS SA, Sartorius AG, WuXi AppTec, Becton, Dickinson and Company, Nelson Laboratories, LLC, and Eurofins Scientific.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Sterility Testing Market Recent Developments
• In December 2023, Charles River Laboratories announced the expansion of its sterility testing capabilities in Europe with the opening of a new facility in Ireland, aimed at meeting the growing demand for these services in the region.
• In October 2023, Merck KGaA launched a new rapid sterility testing kit that promises to deliver results in half the time of traditional methods, addressing the industry's need for faster product release.
• In August 2023, Thermo Fisher Scientific introduced an automated sterility testing system that integrates robotics and advanced analytics, aimed at improving efficiency and reducing human error in sterility testing procedures.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL STERILITY TESTING MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL STERILITY TESTING MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL STERILITY TESTING MARKET, BY TYPE

• 5.1 Overview
• 5.2 Kits & Reagents
• 5.3 Consumables
• 5.4 Biomedical Instruments
• 5.5 Services.

6 GLOBAL STERILITY TESTING MARKET, BY APPLICATION

• 6.1 Overview
• 6.2 Pharmaceutical Companies
• 6.3 Hospitals
• 6.4 Pathological Laboratories
• 6.5 Academic Laboratories
• 6.6 Others

7 GLOBAL STERILITY TESTING MARKET, BY GEOGRAPHY

• 7.1 Overview
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
  • 7.2.3 Mexico
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 U.K.
  • 7.3.3 France
  • 7.3.4 Rest of Europe
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 Japan
  • 7.4.3 India
  • 7.4.4 Rest of Asia Pacific
• 7.5 Rest of the World
  • 7.5.1 Latin America
  • 7.5.2 Middle East and Africa

8 GLOBAL STERILITY TESTING MARKET COMPETITIVE LANDSCAPE

• 8.1 Overview
• 8.2 Company Market Ranking
• 8.3 Key Development Strategies

9 COMPANY PROFILES

• 9.1 Danaher Corporation
  • 9.1.1 Overview
  • 9.1.2 Financial Performance
  • 9.1.3 Product Outlook
  • 9.1.4 Key Developments
• 9.2 Pace Analytical Serv.
  • 9.2.1 Overview
  • 9.2.2 Financial Performance
  • 9.2.3 Product Outlook
  • 9.2.4 Key Developments
• 9.3 Boston Analytical
  • 9.3.1 Overview
  • 9.3.2 Financial Performance
  • 9.3.3 Product Outlook
  • 9.3.4 Key Developments
• 9.4 Toxicon Inc.
  • 9.4.1 Overview
  • 9.4.2 Financial Performance
  • 9.4.3 Product Outlook
  • 9.4.4 Key Developments
• 9.5 Merck KGaA
  • 9.5.1 Overview
  • 9.5.2 Financial Performance
  • 9.5.3 Product Outlook
  • 9.5.4 Key Developments
• 9.6 Thermo Fisher Scientific Inc.
  • 9.6.1 Overview
  • 9.6.2 Financial Performance
  • 9.6.3 Product Outlook
  • 9.6.4 Key Development
• 9.7 SGS SA
  • 9.7.1 Overview
  • 9.7.2 Financial Performance
  • 9.7.3 Product Outlook
  • 9.7.4 Key Developments
• 9.8 Biomerieux SA
  • 9.8.1 Overview
  • 9.8.2 Financial Performance
  • 9.8.3 Product Outlook
  • 9.8.4 Key Developments
• 9.9 Nelson Laboratories
  • 9.9.1 Overview
  • 9.9.2 Financial Performance
  • 9.9.3 Product Outlook
  • 9.9.4 Key Development
• 9.10 Charles River Laboratories International, Inc.
  • 9.10.1 Overview
  • 9.10.2 Financial Performance
  • 9.10.3 Product Outlook
  • 9.10.4 Key Development

10 Appendix

• 10.1.1 Related Reports