医薬品迅速微生物検査の市場規模、シェア、動向分析レポート：製品別、手法別、用途別、地域別、セグメント予測、2025年～2030年

医薬品迅速微生物検査市場の成長と動向

Grand View Research, Inc.の最新レポートによると、世界の医薬品迅速微生物検査市場規模は2030年までに28億米ドルに達し、2025～2030年のCAGRは17.53％で成長すると予測されています。

同市場の成長は、生物製剤や先進治療に対する需要の増加、規制圧力の高まり、核酸ベースの検査などの技術進歩などの要因によるもので、医薬品の安全性に対する社会的関心の高まりが、迅速微生物検査を含む先進的品質管理対策の採用をメーカーに促しています。

製造の拡大には、微生物汚染に非常に敏感な生物製剤、バイオシミラー、細胞療法、ワクチンも含まれます。これらの製品は複雑で保存期間が短いため、迅速な微生物検査が不可欠です。製薬産業は、特にインド、中国、ブラジルなどの新興市場で急速な成長を遂げています。これらの地域では、ジェネリック医薬品、バイオシミラー医薬品、ワクチン、生物製剤の製造施設への投資が進んでいます。いくつかのバイオ医薬品メーカーはCMOに製造を委託しており、CMOは多様な顧客ニーズや規制要件を満たすために、先進的迅速微生物検査技術を採用していることが多いです。例えば、2024年1月、Rapid Micro Biosystems, Inc.は、Samsung Biologicsが微生物の品質管理プロセスを強化するために同社のGrowth Directプラットフォームを採用したと発表しました。このパートナーシップの狙いは、効率を改善し、堅牢なデータの完全性を確保し、Samsungの製造フレームワーク内でスケーラブルな品質管理業務を可能にすることです。

さらに、厳格な規制遵守は、製薬産業における迅速微生物検査の導入と成長の重要な推進力となっています。世界中の規制機関は、医薬品の安全性、有効性、品質を保証するために厳格な微生物品質管理基準を課しています。FDA（米国）、EMA（欧州）、WHOなどの機関は、無菌性、微生物限度、バイオバーデン検査について、薬局方ガイドライン（USP、EP、JPなど）の厳格な遵守を求めています。さらに、PATのような規制の枠組みでは、プロセス管理とコンプライアンスを確保するため、リアルタイムの微生物モニタリングが奨励されています。迅速微生物検査法は、連続製造システムとの統合性に優れています。したがって、市場の成長を促進しています。

医薬品迅速微生物検査市場レポートハイライト

• 製品別では、試薬・キットセグメントが2024年に最大の市場シェアを占めました。この大きなシェアは、バイオ医薬品の迅速微生物検査を実施するために試薬とキットを繰り返し使用することによるものです。
• 手法別では、2024年に成長ベースの検査セグメントが市場を独占しました。これらの方法は信頼性が高く、規制当局に受け入れられているため、広く使用されています。
• 用途別では、無菌検査セグメントが2024年の市場を独占しました。迅速微生物検査は、注射剤や移植剤などの無菌製品に生存微生物が存在しないことを保証します。
• 北米地域は2024年に38.16%の市場シェアを占めました。特にCOVID-19パンデミックの間、医薬品とワクチンの開発スケジュールが加速されたため、この地域では規制要件と市場需要を迅速に満たすために迅速微生物検査の需要が高まっている

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 医薬品迅速微生物検査市場の変数、動向、範囲

• 市場系統の展望
  • 親市場の展望
  • 関連/補助市場展望
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
• 産業分析ツール
  • ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19の影響分析

第4章 医薬品迅速微生物検査市場：製品別、推定・動向分析

• 製品セグメントダッシュボード
• 世界の医薬品迅速微生物検査市場の製品変動分析
• 世界の医薬品迅速微生物検査市場規模と動向分析、製品別、2018～2030年
• 機器
• 試薬・キット
• 付属品

第5章 医薬品迅速微生物検査市場：手法別、推定・動向分析

• 手法セグメントダッシュボード
• 世界の医薬品迅速微生物検査市場の手法変動分析
• 世界の医薬品迅速微生物検査市場規模と動向分析、手法別、2018～2030年
• 成長ベースの検査
• 核酸検査
• 細胞成分ベースの検査
• 生存可能性ベースの検査
• その他

第6章 医薬品迅速微生物検査市場：用途別、推定・動向分析

• 用途セグメントダッシュボード
• 世界の医薬品迅速微生物検査市場の用途変動分析
• 世界の医薬品迅速微生物検査市場規模と動向分析、用途別、2018～2030年
• 原料のテスト
• 微生物限界検査
• バイオバーデン評価
• 無菌検査
• その他

第7章 医薬品迅速微生物検査市場：地域別、推定・動向分析

• 地域別市場シェア分析、2024年と2030年
• 地域別市場ダッシュボード
• 市場規模と予測と動向分析、2018～2030年
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • スウェーデン
  • ノルウェー
• アジア太平洋
  • 日本
  • 中国
  • インド
  • オーストラリア
  • タイ
  • 韓国
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
• 中東・アフリカ
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • クウェート

第8章 競合情勢

• 参入企業
• 企業市況分析、2024年
• 参入企業概要
  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • BD
  • bioMerieux
  • Danaher
  • Sartorius AG
  • Abbott
  • QuidelOrtho Corporation
  • Charles River Laboratories
  • Rapid Micro Biosystems, Inc.

List of Tables

• Table 1 List of secondary sources
• Table 2 List of abbreviations
• Table 3 Global pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 4 Global pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 5 Global pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 6 Global pharmaceutical rapid microbiology testing market, by region, 2018 - 2030 (USD Million)
• Table 7 North America pharmaceutical rapid microbiology testing market, by country, 2018 - 2030 (USD Million)
• Table 8 North America pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 9 North America pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 10 North America pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 11 U.S. pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 12 U.S. pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 13 U.S. pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 14 Canada pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 15 Canada pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 16 Canada pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 17 Mexico pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 18 Mexico pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 19 Mexico pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 20 Europe pharmaceutical rapid microbiology testing market, by country, 2018 - 2030 (USD Million)
• Table 21 Europe pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 22 Europe pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 23 Europe pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 24 UK pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 25 UK pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 26 UK pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 27 Germany pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 28 Germany pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 29 Germany pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 30 France pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 31 France pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 32 France pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 33 Italy pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 34 Italy pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 35 Italy pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 36 Spain pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 37 Spain pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 38 Spain pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 39 Denmark pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 40 Denmark pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 41 Denmark pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 42 Sweden pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 43 Sweden pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 44 Sweden pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 45 Norway pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 46 Norway pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 47 Norway pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 48 Asia Pacific pharmaceutical rapid microbiology testing market, by country, 2018 - 2030 (USD Million)
• Table 49 Asia Pacific pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 50 Asia Pacific pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 51 Asia Pacific pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 52 Japan pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 53 Japan pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 54 Japan pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 55 China pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 56 China pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 57 China pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 58 India pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 59 India pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 60 India pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 61 Australia pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 62 Australia pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 63 Australia pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 64 Thailand pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 65 Thailand pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 66 Thailand pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 67 South Korea pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 68 South Korea pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 69 South Korea pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 70 Latin America pharmaceutical rapid microbiology testing market, by country, 2018 - 2030 (USD Million)
• Table 71 Latin America pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 72 Latin America pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 73 Latin America pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 74 Brazil pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 75 Brazil pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 76 Brazil pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 77 Argentina pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 78 Argentina pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 79 Argentina pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 80 Middle East & Africa pharmaceutical rapid microbiology testing market, by country, 2018 - 2030 (USD Million)
• Table 81 Middle East & Africa pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 82 Middle East & Africa pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 83 Middle East & Africa pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 84 South Africa pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 85 South Africa pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 86 South Africa pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 87 Saudi Arabia pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 88 Saudi Arabia pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 89 Saudi Arabia pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 90 UAE pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 91 UAE pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 92 UAE pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 93 Kuwait pharmaceutical rapid microbiology testing market, by product, 2018 - 2030 (USD Million)
• Table 94 Kuwait pharmaceutical rapid microbiology testing market, by technique, 2018 - 2030 (USD Million)
• Table 95 Kuwait pharmaceutical rapid microbiology testing market, by application, 2018 - 2030 (USD Million)
• Table 96 Participant's overview
• Table 97 Financial performance
• Table 98 Key companies undergoing expansions
• Table 99 Key companies undergoing acquisitions
• Table 100 Key companies undergoing collaborations
• Table 101 Key companies launching new services
• Table 102 Key companies undertaking other strategies

List of Figures

• Fig. 1 Pharmaceutical Rapid Microbiology Testing market segmentation
• Fig. 2 Market research process
• Fig. 3 Data triangulation techniques
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Market formulation & validation
• Fig. 7 Market outlook
• Fig. 8 Segment snapshot
• Fig. 9 Competitive landscape snapshot
• Fig. 10 Parent market outlook
• Fig. 11 Pharmaceutical rapid microbiology testing market driver analysis
• Fig. 12 Pharmaceutical rapid microbiology testing market restraint analysis
• Fig. 13 Pharmaceutical rapid microbiology testing market: Porter's analysis
• Fig. 14 Pharmaceutical rapid microbiology testing market: PESTEL analysis
• Fig. 15 Pharmaceutical rapid microbiology testing market: Product outlook and key takeaways
• Fig. 16 Pharmaceutical rapid microbiology testing market: Product market share analysis, 2024 - 2030
• Fig. 17 Global pharmaceutical rapid microbiology testing market for instruments, 2018 - 2030 (USD Million)
• Fig. 18 Global pharmaceutical rapid microbiology testing market for reagents & kits, 2018 - 2030 (USD Million)
• Fig. 19 Global pharmaceutical rapid microbiology testing market for accessories, 2018 - 2030 (USD Million)
• Fig. 20 Pharmaceutical rapid microbiology testing market: Technique outlook and key takeaways
• Fig. 21 Pharmaceutical rapid microbiology testing market: Technique market share analysis, 2024 - 2030
• Fig. 22 Global pharmaceutical rapid microbiology testing market for growth-based testing analysis, 2018 - 2030 (USD Million)
• Fig. 23 Global pharmaceutical rapid microbiology testing market for nucleic acid-based testing, 2018 - 2030 (USD Million)
• Fig. 24 Global pharmaceutical rapid microbiology testing market for cellular component-based testing, 2018 - 2030 (USD Million)
• Fig. 25 Global pharmaceutical rapid microbiology testing market for viability-based testing, 2018 - 2030 (USD Million)
• Fig. 26 Global pharmaceutical rapid microbiology testing market for other techniques, 2018 - 2030 (USD Million)
• Fig. 27 Pharmaceutical rapid microbiology testing market: Application outlook and key takeaways
• Fig. 28 Pharmaceutical rapid microbiology testing market: Application market share analysis, 2024 - 2030
• Fig. 29 Global pharmaceutical rapid microbiology testing market for raw material testing, 2018 - 2030 (USD Million)
• Fig. 30 Global pharmaceutical rapid microbiology testing market for microbial limit testing, 2018 - 2030 (USD Million)
• Fig. 31 Global pharmaceutical rapid microbiology testing market for bioburden assessment, 2018 - 2030 (USD Million)
• Fig. 32 Global pharmaceutical rapid microbiology testing market for sterility testing, 2018 - 2030 (USD Million)
• Fig. 33 Global pharmaceutical rapid microbiology testing market for other applications, 2018 - 2030 (USD Million)
• Fig. 34 Regional marketplace: Key takeaways
• Fig. 35 North America pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 36 U.S. pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 37 Canada pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 38 Mexico pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 39 Europe pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 40 UK pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 41 Germany pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 42 France pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 43 Italy pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 44 Spain pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 45 Denmark pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 46 Sweden pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 47 Norway pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 48 Asia-Pacific pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 49 Japan pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 50 China pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 51 India pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 52 Australia pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 53 Thailand pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 54 South Korea pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 55 Latin America pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 56 Brazil pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 57 Argentina pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 58 MEA pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 59 South Africa pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 60 Saudi Arabia pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 61 UAE pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 62 Kuwait pharmaceutical rapid microbiology testing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 63 Key company categorization
• Fig. 64 Company market positioning
• Fig. 65 Market participant categorization
• Fig. 66 Strategy framework

Pharmaceutical Rapid Microbiology Testing Market Growth & Trends:

The global pharmaceutical rapid microbiology testing market size is anticipated to reach USD 2.80 billion by 2030 and grow at a CAGR of 17.53% from 2025 to 2030, according to a new report by Grand View Research, Inc. The market's growth is attributed to factors such as the increasing demand for biologics and advanced therapies, growing regulatory pressure, and technological advancements such as nucleic acid-based testing, and growing public concern about the safety of pharmaceuticals has pushed manufacturers to adopt advanced quality control measures, including rapid microbiology testing

Expanding manufacturing includes biologics, biosimilars, cell therapies, and vaccines, which are highly sensitive to microbial contamination. Due to their complexity and shorter shelf lives, rapid microbiology testing is critical for these products. The pharmaceutical industry is experiencing rapid growth, especially in emerging markets such as India, China, and Brazil. These regions are investing in manufacturing facilities for generics, biosimilars, vaccines, and biologics. Several biopharmaceutical manufacturers outsource production to CMOs, which often employ advanced rapid microbiology testing technologies to meet diverse client needs and regulatory requirements. For instance, in January 2024, Rapid Micro Biosystems, Inc. announced that Samsung Biologics had selected its Growth Direct platform to enhance microbial quality control processes. This partnership aims to improve efficiency, ensure robust data integrity, and allow for scalable quality control operations within Samsung's manufacturing framework.

Moreover, stringent regulatory compliance is a key driver of the adoption and growth of rapid microbiology testing in the pharmaceutical industry. Regulatory agencies worldwide impose rigorous microbial quality control standards to ensure the safety, efficacy, and quality of pharmaceutical products. Agencies such as the FDA (United States), EMA (Europe), and WHO require strict adherence to pharmacopeial guidelines (e.g., USP, EP, JP) for sterility, microbial limits, and bioburden testing. In addition, regulatory frameworks such as PAT encourage real-time microbial monitoring to ensure process control and compliance. Rapid microbiology methods integrate well with continuous manufacturing systems. Hence, driving the market growth.

Pharmaceutical Rapid Microbiology Testing Market Report Highlights:

• Based on product, reagents and kits segment held the largest market share in 2024. The large share is due to the repetitive usage of reagents and kits for carrying out rapid microbiology tests for biopharmaceuticals.
• Based on technology, the growth-based testing segment dominated the market in 2024. These methods are widely used due to their reliability and acceptance by regulatory agencies.
• Based on application, the sterility testing segment dominated the market in 2024. Rapid microbiology testing ensures that sterile products, such as injectables and implantables, are free from viable microorganisms.
• The North American region dominated the market share of 38.16% in 2024. Accelerated drug and vaccine development timelines, especially during the COVID-19 pandemic, have driven demand for rapid microbiology testing to meet regulatory requirements and market demands faster in this region.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
  • 1.2.1. Product
  • 1.2.2. Technique
  • 1.2.3. Application
• 1.3. Information Analysis
• 1.4. Market Formulation & Data Visualization
• 1.5. Data Validation & Publishing
• 1.6. Information Procurement
  • 1.6.1. Primary Research
• 1.7. Information Or Data Analysis
• 1.8. Market Formulation & Validation
• 1.9. Market Model
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Pharmaceutical Rapid Microbiology Testing Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Technologies Advancements In Rapid Testing
    • 3.2.1.2. Increasing Focus On Quality Control And Rising Microbiology Testing Needs
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Expensive Equipment And Technology Hinder Market Adoption.
    • 3.2.2.2. Complex Regulations Slow Down The Approval And Implementation Process.
• 3.3. Industry Analysis Tools
  • 3.3.1. Porter's Five Forces Analysis
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Pharmaceutical Rapid Microbiology Testing Market: Product Estimates & Trend Analysis

• 4.1. Product Segment Dashboard
• 4.2. Global Pharmaceutical Rapid Microbiology Testing Market Product Movement Analysis
• 4.3. Global Pharmaceutical Rapid Microbiology Testing Market Size & Trend Analysis, by Product, 2018 to 2030 (USD Million)
• 4.4. Instruments
  • 4.4.1. Instruments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Reagents & Kits
  • 4.5.1. Reagents & Kits Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Accessories
  • 4.6.1. Accessories Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Pharmaceutical Rapid Microbiology Testing Market: Technique Estimates & Trend Analysis

• 5.1. Technique Segment Dashboard
• 5.2. Global Pharmaceutical Rapid Microbiology Testing Market Technique Movement Analysis
• 5.3. Global Pharmaceutical Rapid Microbiology Testing Market Size & Trend Analysis, by Technique, 2018 to 2030 (USD Million)
• 5.4. Growth-based Testing
  • 5.4.1. Growth-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Nucleic Acid-based Testing
  • 5.5.1. Nucleic Acid-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Cellular Component-based Testing
  • 5.6.1. Cellular Component-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.7. Viability-based Testing
  • 5.7.1. Viability-based Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.8. Other Techniques
  • 5.8.1. Other Techniques Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Pharmaceutical Rapid Microbiology Testing Market: Application Estimates & Trend Analysis

• 6.1. Application Segment Dashboard
• 6.2. Global Pharmaceutical Rapid Microbiology Testing Market Application Movement Analysis
• 6.3. Global Pharmaceutical Rapid Microbiology Testing Market Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
• 6.4. Raw Material Testing
  • 6.4.1. Raw Material Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Microbial Limit Testing
  • 6.5.1. Microbial Limit Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Bioburden Assessment
  • 6.6.1. Bioburden Assessment Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.7. Sterility Testing
  • 6.7.1. Stability Testing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.8. Other Applications
  • 6.8.1. Other Applications Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Pharmaceutical Rapid Microbiology Testing Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Share Analysis, 2024 & 2030
• 7.2. Regional Market Dashboard
• 7.3. Market Size & Forecasts and Trend Analysis, 2018 to 2030
• 7.4. North America
  • 7.4.1. North America Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. U.S. Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Canada Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Mexico Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. UK Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Germany Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. France Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Italy Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Spain Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Denmark Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Sweden Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Norway Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Japan Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. China Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. India Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Australia Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.6. Thailand
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Thailand Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.7. South Korea
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. South Korea Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Brazil Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Argentina Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.8. MEA
  • 7.8.1. MEA Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. South Africa Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Saudi Arabia Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. UAE Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Kuwait Pharmaceutical Rapid Microbiology Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Participant Categorization
• 8.2. Company Market Position Analysis, 2024
• 8.3. Participant's Overview
  • 8.3.1. Thermo Fisher Scientific Inc.
    • 8.3.1.1. Participant's Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Product Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Merck KGaA
    • 8.3.2.1. Participant's Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Product Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. BD
    • 8.3.3.1. Participant's Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Product Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. bioMerieux
    • 8.3.4.1. Participant's Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Product Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. Danaher
    • 8.3.5.1. Participant's Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Product Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Sartorius AG
    • 8.3.6.1. Participant's Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Product Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Abbott
    • 8.3.7.1. Participant's Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Product Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. QuidelOrtho Corporation
    • 8.3.8.1. Participant's Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Product Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Charles River Laboratories
    • 8.3.9.1. Participant's Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Product Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Rapid Micro Biosystems, Inc.
    • 8.3.10.1. Participant's Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Product Benchmarking
    • 8.3.10.4. Strategic Initiatives