無菌検査の市場規模：製品タイプ別、用途別、地域別、範囲および予測

無菌検査の市場規模と予測

無菌検査市場規模は、2024年に14億3,000万米ドルと評価され、2031年には33億6,000万米ドルに達すると予測され、2024年から2031年までのCAGRは12.40%で成長します。無菌検査は、医薬品、医療機器、その他のヘルスケア関連品目における生存微生物の有無を判定するために使用されるプロセスと定義されます。この検査は、人間が使用する前に製品の安全性と有効性を確保するために極めて重要です。さらに、無菌検査は製薬産業、バイオテクノロジー分野、医療機器製造において、規制要件を遵守し、製品の品質を維持するために一般的に採用されています。

無菌検査市場力学

無菌検査市場を形成している主な市場力学

主な市場促進要因

製薬およびバイオテクノロジー生産の増加

医薬品とバイオテクノロジー製造の世界の増加、特に無菌製剤の増加は、無菌検査産業の重要な促進要因です。国際製薬団体連合会（IFPMA）の報告によると、世界のバイオ医薬品ビジネスは2022年に1兆5,000億米ドル規模になります。無菌の生物製剤やワクチンに対する需要の高まりにより、製品の安全性と規制遵守を確保するための無菌検査の必要性が高まっています。

無菌医薬品承認のための規制要件の増加

無菌医薬品の製造と承認に関する厳しい規制要件が、企業に無菌検査の利用を促しています。米国食品医薬品局（FDA）は、新しい無菌医薬品が承認手続きの一環として無菌検査に合格することを義務付けています。2021年、FDAは50の新規分子体を認可したが、その多くが重要な無菌検査を必要としたため、市場成長がもたらされました。

細胞・遺伝子治療に対する需要の高まり

細胞治療や遺伝子治療のような高度な医薬品の使用が増加しているため、無菌検査の必要性が高まっています。報告書によると、2022年には世界中で2,500以上の細胞・遺伝子治療の臨床試験が実施される予定です。これらの治療法は、品質と安全性に関する規制を満たすために徹底的な無菌検査を受ける必要があり、これが無菌検査市場の成長に大きく寄与しています。

主な課題

無菌検査に伴う高コスト：

無菌検査機器、消耗品、熟練した人材に関連するコストは高いと考えられています。この要因は、特に中小企業や新興国市場において、市場の成長を制限する可能性があります。

時間を要する従来の方法：

従来の無菌検査法は時間がかかることが多く、製品リリースが遅れます。この課題は、迅速無菌検査法の開発によって解決されつつあるが、その採用はまだ限定的です。

偽陽性や偽陰性のリスク：

無菌検査法では時に偽陽性や偽陰性の結果が出ることがあり、これは製品の品質と安全性に重大な影響を及ぼします。この課題を克服することは、無菌検査の信頼性を向上させる上で極めて重要であると考えられています。

主要動向

迅速微生物法の採用：

無菌検査に迅速微生物法（RMM）を採用する傾向が高まっています。これらの方法は、従来の方法と比較して精度を維持または向上させながら、より迅速な結果を提供するために開発されています。

無菌検査のアウトソーシングの増加：

多くの製薬企業やバイオテクノロジー企業が、専門の試験受託機関に無菌検査をアウトソーシングしています。この動向は、専門知識、高度な技術、コスト効率の必要性によって推進されています。

自動化とロボット工学の統合：

無菌検査プロセスへの自動化とロボット工学の統合が進んでいます。これらの技術は、ヒューマンエラーの削減、スループットの向上、無菌検査手順の全体的な効率改善に役立っています。

無菌検査市場の地域分析

北米

Verified Market Researchによると、北米は予測期間中、無菌検査市場を独占すると予測されています。北米、特に米国は、バイオ医薬品とワクチン生産のリーダーであり、製品の安全性を確保するための無菌検査の需要を促進しています。米国研究製薬工業協会（PhRMA）によると、米国のバイオ医薬品企業は2021年に研究開発に約1,023億米ドルを投じており、世界の医薬品市場の40％以上を占めています。このような多額の生産と投資により、厳格な規制基準を満たすための広範な無菌検査が必要となります。

米国食品医薬品局（FDA）は、無菌医薬品と生物製剤に対して厳格な無菌検査ガイドラインを実施しています。2021年、FDAは50の新規分子体を承認したが、その多くは医薬品承認プロセスの一環として無菌検査を必要としました。北米の厳しい規制状況は、無菌検査が医薬品開発の重要な要素であることを保証し、同地域の市場成長を大幅に後押ししています。

さらに、北米は細胞・遺伝子治療開発の最前線にあり、製品の安全性を確保するために集中的な無菌検査が必要です。Alliance for Regenerative Medicineによると、米国では2021年末までに92の遺伝子・細胞治療が後期臨床試験段階にあります。これらの先進治療が承認され商業化されるにつれて、この地域における無菌検査の需要は高まり続け、市場拡大の原動力となっています。

欧州

欧州地域は予測期間中に最も高い成長率を示すと予想されます。欧州は、製薬およびバイオ医薬品の製造部門が盛んであり、品質基準への適合を確実にするための無菌検査に対する需要を促進しています。欧州製薬団体連合会（EFPIA）によると、2022年の世界の医薬品売上高の23.9%を欧州が占め、無菌医薬品、生物製剤、ワクチンに重点が置かれています。このような強力な生産能力は、この地域全体で無菌検査に対する安定した需要を生み出しています。

欧州医薬品庁（EMA）などの欧州の規制機関は、医薬品の安全性と有効性を確保するため、無菌検査に厳格なガイドラインを課しています。2021年、EMAは92の新薬を承認したが、その多くには厳格な無菌検査を必要とする無菌生物製剤やワクチンが含まれていました。こうした厳しい規制要件が、欧州の医薬品製造における無菌検査の採用を促進しています。

さらに、欧州は、徹底した無菌検査が必要な細胞治療や遺伝子治療などの先端療法の研究開発のリーダーでもあります。報告書によると、欧州は細胞・遺伝子治療の世界臨床試験の23％を占めています。これらの治療法が臨床試験を経て商業化へと進むにつれ、安全基準を満たすための無菌検査に対する需要が同地域の市場成長を牽引しています。

目次

第1章 世界の無菌検査市場のイントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 世界の無菌検査市場の展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 無菌検査の世界市場：タイプ別

• 概要
• キット・試薬
• 消耗品
• バイオメディカル機器
• サービス

第6章 無菌検査の世界市場：用途別

• 概要
• 製薬会社
• 病院
• 病理研究所
• 学術研究所
• その他

第7章 無菌検査の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第8章 世界の無菌検査市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な発展戦略

第9章 企業プロファイル

• 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 付録

• 関連レポート

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