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市場調查報告書
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1790199

美國藥品無菌測試市場規模、佔有率、趨勢分析報告：按類型、產品、測試、樣品、最終用途、細分市場預測，2025-2033

U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type, By Product, By Test, By Sample, By End-use, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10個工作天內

價格

美國藥品無菌檢測市場概況

美國藥品無菌測試市場規模預計在 2024 年為 6.7 億美元，預計到 2033 年將達到 17 億美元，2025 年至 2033 年的複合年成長率為 11.04%。市場受到研發活動活性化、藥品創新增加、對品質和無菌性的日益關注以及政府對醫療保健的投資增加的推動。

此外，生技藥品和個人化醫療需求的不斷成長，以及美國食品藥物管理局 (FDA) 和美國藥典 (USP) 的嚴格監管要求，預計將推動市場成長。此外，快速微生物學方法（例如 PCR 和 ATP 生物發光）的採用、自動化程度的提高以最大限度地減少錯誤，以及使用人工智慧主導的分析技術來改進數據解讀，都推動了外包和高效成本管理趨勢的日益成長。此外，隨著藥品生產的日益複雜以及對患者安全的日益重視，市場正在轉向更快、更可靠的檢測解決方案，以確保產品安全和合規性。

此外，全球藥品上市數量的不斷增加繼續成為藥品無菌檢測行業的主要驅動力。據美國FDA 稱，僅在 2024 年，藥品評估和研究中心 (CDER) 就核准了50 種新分子生技藥品(NME) 和生技藥品，由於個人化醫療、基因治療和新型生技藥品的進步，預計這一趨勢將在 2025 年加速。每種新推出的無菌藥品，包括注射劑、疫苗和先進治療程序 (ATMP)，都需要進行嚴格的無菌測試，以符合 FDA、EMA 和 WHO 等嚴格的法規結構。

藥物傳遞系統和生技藥品的創新正在增加無菌藥品的複雜性和多樣性，進一步推動無菌檢測的需求。研究表明，到2024年，無菌注射劑藥物的研發管線將年增15%以上，這反映了持續的研發投入以及針對尚未滿足的醫療需求的新型療法的市場進入。這種擴張需要提高無菌檢測能力，採用快速微生物檢測方法，並調整檢測通訊協定以確保安全性和有效性。

此外，隨著創新技術的採用，美國藥品無菌檢測領域正在快速發展。 ATP生物發光和PCR等新型快速微生物學方法正在加速污染檢測，縮短產品放行時間。自動化和機器人技術的日益普及，提高了測試準確性，減少了人為錯誤。此外，人工智慧正在輔助數據分析並提供預測性洞察，從而改善決策流程。這些進步與日益嚴格的FDA和USP要求一致，確保了複雜生技藥品和個人化療法的安全標準得到提升。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章美國藥品無菌測試市場變數、趨勢與範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 定價模式分析
  • 科技
  • 市場分析工具
    • 波特五力分析
    • PESTEL 與 SWOT 分析
    • COVID-19影響分析

第4章：美國藥品無菌測試市場類型、估價與趨勢分析

  • 美國藥品無菌測試市場（按類型）：細分儀表板
  • 美國藥品無菌測試市場（按類型）：波動分析
  • 按類型，2021-2033年
  • 內部
  • 外包

第5章：美國藥品無菌測試市場（按產品、估計和趨勢分析）

  • 美國藥品無菌檢測市場（按產品）：細分儀表板
  • 美國藥品無菌檢測市場（依產品）：變異分析
  • 按產品，2021-2033
  • 套件和試劑
  • 裝置
  • 服務

第6章：美國藥品無菌測試市場：依測試、估算與趨勢分析

  • 美國藥品無菌測試市場（按測試）：細分儀表板
  • 美國藥品無菌測試市場（按測試）：變異分析
  • 按考試，2021-2033
  • 無菌測試
    • 薄膜過濾
    • 直接接種
    • 產品快訊
  • 微生物附著量測試
  • 細菌內毒素檢測

第7章美國藥品無菌測試市場：按最終用途的估計和趨勢分析

  • 美國藥品無菌測試市場（依最終用途）：細分儀表板
  • 美國藥品無菌檢測市場（依最終用途）：差異分析
  • 按應用，2021-2033 年
  • 配藥藥房
  • 醫療設備公司
  • 製藥公司
  • 其他

第 8 章：美國藥品無菌測試市場：樣本、估算與趨勢分析

  • 美國藥品無菌測試市場（按樣本）：細分儀表板
  • 美國藥品無菌檢測市場（依樣本）：變異分析
  • 按樣本，2021-2033年
  • 製藥
  • 醫療設備
  • 生物製藥

第9章 競爭態勢

  • 市場參與企業分類
  • 2024 年公司市場佔有率/估值分析
  • 公司簡介
    • Pacific Biolabs
    • Steris Plc
    • Boston Analytical
    • Nelson Laboratories, LLC（Sotera Health）
    • Sartorius AG
    • SOLVIAS AG
    • SGS SA
    • Labcorp
    • Pace Analytical
    • Charles River Laboratories
    • Thermo Fisher Scientific, Inc.
    • Rapid Micro Biosystems
    • Almac Group

第10章 主要建議

Product Code: GVR-2-68038-403-1

U.S. Pharmaceutical Sterility Testing Market Summary

The U.S. pharmaceutical sterility testing market size was estimated at USD 0.67 billion in 2024 and is projected to reach USD 1.70 billion by 2033, growing at a CAGR of 11.04% from 2025 to 2033. The market is driven by increasing R&D activities, growing drug innovations, rising focus on quality & sterility, and rising government investments in healthcare.

Besides, rising demand for biologics, personalized medicines, and stringent regulatory requirements from the FDA and USP is expected to support the market growth. In addition, the adoption of rapid microbiological methods (such as PCR and ATP bioluminescence), increased automation to minimize errors, and the use of AI-driven analytics for improved data interpretation is contributing to growing trends toward outsourcing and managing costs effectively. Also, the market is shifting towards faster and more reliable testing solutions that ensure product safety and compliance, especially as the complexity of pharmaceutical manufacturing increases and there is an increased focus on patient safety.

Moreover, the rising number of drug launches globally continues to be a significant growth driver for the pharmaceutical sterility testing industry. According to the U.S. FDA, 50 new molecular entities (NMEs) and biologics were approved by Center for Drug Evaluation and Research (CDER) in 2024 alone, the trend is expected to accelerate in 2025 due to advancements in personalized medicine, gene therapies, and novel biologics. Each newly launched sterile drug, including injectables, vaccines, and advanced therapy medicinal products (ATMPs), requires stringent sterility testing to comply with rigorous regulatory frameworks such as those from the FDA, EMA, and WHO.

The growing complexity and diversity of sterile formulations, driven by innovations in drug delivery systems and biologics, further intensify sterility testing demands. As per the research study, the pipeline of sterile injectable drugs expanded by over 15% year-on-year in 2024, reflecting sustained R&D investment and market entry of novel therapies targeting unmet medical needs. This expansion requires enhanced sterility testing capacity, adoption of rapid microbiological methods, and tailored testing protocols to ensure safety and efficacy.

Furthermore, the U.S. pharmaceutical sterility testing sector is evolving rapidly due to the adoption of innovative technologies. Emerging rapid microbiological methods, such as ATP bioluminescence and PCR, are accelerating contamination detection and shortening product release times. The increased use of automation and robotics enhances testing accuracy while reducing manual errors. In addition, artificial intelligence aids in data analysis and provides predictive insights, improving decision-making processes. These advancements align with stricter FDA and USP requirements, ensuring enhanced safety standards for complex biologics and personalized therapies.

U.S. Pharmaceutical Sterility Testing Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. pharmaceutical sterility testing market report based on type, product, test, sample, and end-use.

  • Type Outlook (Revenue, USD Million, 2021 - 2033)
  • In-House
  • Outsourcing
  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Kits and Reagents
  • Instruments
  • Services
  • Test Outlook (Revenue, USD Million, 2021 - 2033)
  • Sterility Testing
    • Membrane Filtration
    • Direct Inoculation
    • Product Flush
  • Bioburden Testing
  • Bacterial Endotoxin Testing
  • Sample Outlook (Revenue, USD Million, 2021 - 2033)
  • Pharmaceuticals
  • Medical Devices
  • Biopharmaceuticals
  • End-use Outlook (Revenue, USD Million, 2021 - 2033)
  • Compounding Pharmacies
  • Medical Device Companies
  • Pharmaceutical Companies
  • Others

Table of Contents

Chapter 1. Research Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Market Definitions
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased Database
    • 1.4.2. GVR's Internal Database
    • 1.4.3. Secondary Sources
    • 1.4.4. Primary Research
  • 1.5. Information Or Data Analysis
    • 1.5.1. Data Analysis Models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity flow analysis (Model 1)
    • 1.7.2. Value chain based analysis (Model 2)
    • 1.7.3. Multivariate Analysis (Model 3)
  • 1.8. List Of Secondary Sources
  • 1.9. List Of Abbreviations
  • 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. U.S. Pharmaceutical Sterility 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. Supportive Government Investment in Healthcare Industry
      • 3.2.1.2. Increasing R&D Activities
      • 3.2.1.3. Increasing Number of Drug Launches
      • 3.2.1.4. Increasing Focus on Quality and Sterility
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Compliance Issues While Outsourcing
      • 3.2.2.2. Third Party Performance
  • 3.3. Pricing Model Analysis
  • 3.4. Technology Landscape
  • 3.5. Market Analysis Tools
    • 3.5.1. Porter's Five Force Analysis
    • 3.5.2. PESTEL by SWOT Analysis
    • 3.5.3. COVID-19 Impact Analysis

Chapter 4. U.S. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis

  • 4.1. U.S. Pharmaceutical Sterility Testing Market, By Type: Segment Dashboard
  • 4.2. U.S. Pharmaceutical Sterility Testing Market, By Type: Movement Analysis
  • 4.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Type, 2021-2033 (USD Million)
  • 4.4. In-House
    • 4.4.1. In-House Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Outsourcing
    • 4.5.1. Outsourcing Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Pharmaceutical Sterility Testing Market: Product Estimates & Trend Analysis

  • 5.1. U.S. Pharmaceutical Sterility Testing Market, By Product: Segment Dashboard
  • 5.2. U.S. Pharmaceutical Sterility Testing Market, By Product: Movement Analysis
  • 5.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Product, 2021-2033 (USD Million)
  • 5.4. Kits and Reagents
    • 5.4.1. Kits and Reagents Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Instruments
    • 5.5.1. Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Services
    • 5.6.1. Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Pharmaceutical Sterility Testing Market: Test Estimates & Trend Analysis

  • 6.1. U.S. Pharmaceutical Sterility Testing Market, By Test: Segment Dashboard
  • 6.2. U.S. Pharmaceutical Sterility Testing Market, By Test: Movement Analysis
  • 6.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Test, 2021-2033 (USD Million)
  • 6.4. Sterility Testing
    • 6.4.1. Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.2. Membrane Filtration
      • 6.4.2.1. Membrane Filtration Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.3. Direct Inoculation
      • 6.4.3.1. Direct Inoculation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.4. Product Flush
      • 6.4.4.1. Product Flush Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Bioburden Testing
    • 6.5.1. Bioburden Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Bacterial Endotoxin Testing
    • 6.6.1. Bacterial Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Pharmaceutical Sterility Testing Market: End-Use Estimates & Trend Analysis

  • 7.1. U.S. Pharmaceutical Sterility Testing Market, By End-Use: Segment Dashboard
  • 7.2. U.S. Pharmaceutical Sterility Testing Market, By End-Use: Movement Analysis
  • 7.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By End-Use, 2021-2033 (USD Million)
  • 7.4. Compounding Pharmacies
    • 7.4.1. Compounding Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5. Medical Device Companies
    • 7.5.1. Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6. Pharmaceutical Companies
    • 7.6.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7. Others
    • 7.7.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. U.S. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis

  • 8.1. U.S. Pharmaceutical Sterility Testing Market, By Sample: Segment Dashboard
  • 8.2. U.S. Pharmaceutical Sterility Testing Market, By Sample: Movement Analysis
  • 8.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Sample, 2021-2033 (USD Million)
  • 8.4. Pharmaceuticals
    • 8.4.1. Pharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 8.5. Medical Devices
    • 8.5.1. Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 8.6. Biopharmaceuticals
    • 8.6.1. Biopharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

  • 9.1. Market Participant Categorization
  • 9.2. Company Market Share/Assessment Analysis, 2024
  • 9.3. Company Profiles
    • 9.3.1. Pacific Biolabs
      • 9.3.1.1. Company overview
      • 9.3.1.2. Financial performance
      • 9.3.1.3. Service benchmarking
      • 9.3.1.4. Strategic initiatives
    • 9.3.2. Steris Plc
      • 9.3.2.1. Company overview
      • 9.3.2.2. Financial performance
      • 9.3.2.3. Service benchmarking
      • 9.3.2.4. Strategic initiatives
    • 9.3.3. Boston Analytical
      • 9.3.3.1. Company overview
      • 9.3.3.2. Financial performance
      • 9.3.3.3. Service benchmarking
      • 9.3.3.4. Strategic initiatives
    • 9.3.4. Nelson Laboratories, LLC (Sotera Health)
      • 9.3.4.1. Company overview
      • 9.3.4.2. Financial performance
      • 9.3.4.3. Service benchmarking
      • 9.3.4.4. Strategic initiatives
    • 9.3.5. Sartorius AG
      • 9.3.5.1. Company overview
      • 9.3.5.2. Financial performance
      • 9.3.5.3. Service benchmarking
      • 9.3.5.4. Strategic initiatives
    • 9.3.6. SOLVIAS AG
      • 9.3.6.1. Company overview
      • 9.3.6.2. Financial performance
      • 9.3.6.3. Service benchmarking
      • 9.3.6.4. Strategic initiatives
    • 9.3.7. SGS SA
      • 9.3.7.1. Company overview
      • 9.3.7.2. Financial performance
      • 9.3.7.3. Service benchmarking
      • 9.3.7.4. Strategic initiatives
    • 9.3.8. Labcorp
      • 9.3.8.1. Company overview
      • 9.3.8.2. Financial performance
      • 9.3.8.3. Service benchmarking
      • 9.3.8.4. Strategic initiatives
    • 9.3.9. Pace Analytical
      • 9.3.9.1. Company overview
      • 9.3.9.2. Financial performance
      • 9.3.9.3. Service benchmarking
      • 9.3.9.4. Strategic initiatives
    • 9.3.10. Charles River Laboratories
      • 9.3.10.1. Company overview
      • 9.3.10.2. Financial performance
      • 9.3.10.3. Service benchmarking
      • 9.3.10.4. Strategic initiatives
    • 9.3.11. Thermo Fisher Scientific, Inc.
      • 9.3.11.1. Company overview
      • 9.3.11.2. Financial performance
      • 9.3.11.3. Service benchmarking
      • 9.3.11.4. Strategic initiatives
    • 9.3.12. Rapid Micro Biosystems
      • 9.3.12.1. Company overview
      • 9.3.12.2. Financial performance
      • 9.3.12.3. Service benchmarking
      • 9.3.12.4. Strategic initiatives
    • 9.3.13. Almac Group
      • 9.3.13.1. Company overview
      • 9.3.13.2. Financial performance
      • 9.3.13.3. Service benchmarking
      • 9.3.13.4. Strategic initiatives

Chapter 10 Key Recommendations

List of Tables

  • Table 1. List of Tables
  • Table 2. List of Secondary Sources
  • Table 3. List of Abbreviations
  • Table 4. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Type, 2021 - 2033 (USD Million)
  • Table 5. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Product, 2021 - 2033 (USD Million)
  • Table 6. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Test, 2021 - 2033 (USD Million)
  • Table 7. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Sterility Testing, 2021 - 2033 (USD Million)
  • Table 8. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by End-Use, 2021 - 2033 (USD Million)
  • Table 9. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Sample, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 U.S. Pharmaceutical Sterility Testing Market Dynamics
  • Fig. 17 Porter's five forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. Pharmaceutical Sterility Testing Market: Type outlook and key takeaways
  • Fig. 20 U.S. Pharmaceutical Sterility Testing Market: Type movement analysis
  • Fig. 21 In-House Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Outsourcing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 U.S. Pharmaceutical Sterility Testing Market: Product outlook and key takeaways
  • Fig. 24 U.S. Pharmaceutical Sterility Testing Market: Product movement analysis
  • Fig. 25 Kits and Reagents Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 U.S. Pharmaceutical Sterility Testing Market: Test outlook and key takeaways
  • Fig. 29 U.S. Pharmaceutical Sterility Testing Market: Test movement analysis
  • Fig. 30 Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Membrane Filtration Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Direct Inoculation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 Product Flush Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Bioburden Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Bacterial Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 U.S. Pharmaceutical Sterility Testing Market: End-Use outlook and key takeaways
  • Fig. 37 U.S. Pharmaceutical Sterility Testing Market: End-Use movement analysis
  • Fig. 38 Compounding Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 U.S. Pharmaceutical Sterility Testing Market: Sample outlook and key takeaways
  • Fig. 43 U.S. Pharmaceutical Sterility Testing Market: Sample movement analysis
  • Fig. 44 Pharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Biopharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Key company categorization
  • Fig. 48 Service heat map analysis
  • Fig. 49 Strategic framework