米国の医薬品無菌試験市場：規模、シェア、動向分析レポート：タイプ別、試験タイプ別、最終用途別、サンプル別、セグメント別予測（2022年～2030年）

米国の医薬品無菌試験の市場規模は、2022年～2030年の予測期間中に10.9%のCAGRで拡大し、2030年までに11億8,000万米ドルに達すると予測されています。

ヘルスケア産業への政府の支援投資、研究開発活動の増加、国内での新しい治療薬に対する需要の高まりが、成長の主な要因となっています。

当レポートでは、米国の医薬品無菌試験市場について調査し、市場の現状とともに、タイプ別、試験タイプ別、最終用途別、サンプル別、セグメント別動向、および市場に参入する企業のプロファイルなどを提供しています。

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 米国の医薬品無菌試験市場の変数、動向、範囲

• 市場系列の見通し
• 浸透と成長の見通しのマッピング
• 市場力学
• 米国の医薬品無菌試験市場分析ツール
  • ポーターのファイブフォース分析
  • PESTLE分析
  • 主要取引と戦略的提携分析
  • COVID-19の影響と改革戦略

第4章 米国の医薬品無菌試験市場：タイプ別推定・動向分析

• 定義と範囲
• 米国の医薬品無菌試験市場シェア、2021年および2030年
  • 社内の医薬品無菌試験
  • アウトソーシングによる医薬品無菌試験

第5章 米国の医薬品無菌試験市場：製品タイプ別推定・動向分析

• 定義と範囲
• 米国の医薬品無菌試験市場シェア、2021年および2030年
  • キットと試薬
  • 装置
  • サービス

第6章 米国の医薬品無菌試験市場：試験タイプ別推定・動向分析

• 定義と範囲
• 米国の医薬品無菌試験市場シェア、2021年および2030年
  • 無菌試験
  • バイオバーデン試験
  • 細菌エンドトキシン試験

第7章 米国の医薬品無菌試験市場：サンプル別推定・動向分析

• 定義と範囲
• 米国の医薬品無菌試験市場シェア、2021年および2030年
  • 医薬品
  • 医療機器
  • バイオ医薬品

第8章 米国の医薬品無菌試験市場：最終用途別推定・動向分析

• 定義と範囲
• 米国の医薬品無菌試験市場シェア、2021年および2030年
  • 調剤薬局
  • 医療機器メーカー
  • 製薬会社
  • その他

第9章 競合分析

• 主要な市場参入企業による最近の開発と影響分析
• 企業/競合の分類（主要なイノベーター、マーケットリーダー、新興企業）
• 参加者の分類
  • イノベーター
    • STERIS
    • Boston Analytical
    • Charles River Laboratories
    • SGS SA
• ベンダー情勢
  • 主要なサービスプロバイダーのリスト
  • 市場の差別化要因
  • 米国の医薬品無菌試験市場シェア分析

第10章 競合情勢

• 企業プロファイル
  • SGS SA
  • Laboratory Corporation of America Holdings
  • Boston Analytical
  • Charles River Laboratories
  • Pacific Biolabs
  • STERIS
  • Pace Analytical
  • Nelson Laboratories, LLC
  • Infinity Laboratories
  • Thermo Fisher Scientific, Inc.

List of Tables

• Table 1 List of secondary sources
• Table 2 List of Abbreviations

List of Figures

• Fig. 1 Market research process
• Fig. 2 Information procurement
• Fig. 3 Primary research pattern
• Fig. 4 Market research approaches
• Fig. 5 Value-chain-based sizing & forecasting
• Fig. 6 QFD modeling for market share assessment
• Fig. 7 Market formulation & validation
• Fig. 8 Commodity flow analysis
• Fig. 9 Volume Price Analysis
• Fig. 10 U.S. pharmaceutical sterility testing market snapshot (2021)
• Fig. 11 U.S. pharmaceutical sterility testing market segmentation
• Fig. 12 Market driver relevance analysis (Current & future impact)
• Fig. 13 Market restraint relevance analysis (Current & future impact)
• Fig. 14 Penetration & growth prospect mapping
• Fig. 15 Porter's five forces analysis
• Fig. 16 SWOT analysis, by factor (political & legal, economic and technological)
• Fig. 17 U.S. pharmaceutical sterility testing market type outlook: Segment dashboard
• Fig. 18 U.S. pharmaceutical sterility testing market: Type movement analysis
• Fig. 19 In-house U.S. pharmaceutical sterility testing market 2018 - 2030 (USD Million)
• Fig. 20 Outsourcing U.S. pharmaceutical sterility testing market 2018 - 2030 (USD Million)
• Fig. 21 U.S. pharmaceutical sterility testing market product type outlook: Segment dashboard
• Fig. 22 U.S. pharmaceutical sterility testing market: Product type movement analysis
• Fig. 23 Kits and Reagents market 2018 - 2030 (USD Million)
• Fig. 24 Instruments market 2018 - 2030 (USD Million)
• Fig. 25 Service testing market 2018 - 2030 (USD Million)
• Fig. 26 U.S. pharmaceutical sterility testing market test type outlook: Segment dashboard
• Fig. 27 U.S. pharmaceutical sterility testing market: Test type movement analysis
• Fig. 28 Sterility testing market 2018 - 2030 (USD Million)
• Fig. 29 Membrane Filtration market 2018 - 2030 (USD Million)
• Fig. 30 Direct Inoculation market 2018 - 2030 (USD Million)
• Fig. 31 Bioburden testing market 2018 - 2030 (USD Million)
• Fig. 32 Bacterial endotoxin testing market 2018 - 2030 (USD Million)
• Fig. 33 Container closure integrity testing market 2018 - 2030 (USD Million)
• Fig. 34 Rapid micro test market 2018 - 2030 (USD Million)
• Fig. 35 ATP bioluminescence market 2018 - 2030 (USD Million)
• Fig. 36 Fluorescent labeling market 2018 - 2030 (USD Million)
• Fig. 37 Electrical resistance market 2018 - 2030 (USD Million)
• Fig. 38 Others market 2018 - 2030 (USD Million)
• Fig. 39 Antimicrobial effectiveness testing market 2018 - 2030 (USD Million)
• Fig. 40 U.S. pharmaceutical sterility testing market sample outlook: Segment dashboard
• Fig. 41 U.S. pharmaceutical sterility testing market: Sample movement analysis
• Fig. 42 Pharmaceuticals market 2018 - 2030 (USD Million)
• Fig. 43 Medical devices market 2018 - 2030 (USD Million)
• Fig. 44 Biopharmaceuticals market 2018 - 2030 (USD Million)
• Fig. 45 U.S. pharmaceutical sterility testing market: Sample movement analysis
• Fig. 46 U.S. pharmaceutical sterility testing market end-use outlook: Segment dashboard
• Fig. 47 U.S. pharmaceutical sterility testing market: End-use movement analysis
• Fig. 48 Compounding Pharmacies market 2018 - 2030 (USD Million)
• Fig. 49 Medical devices companies market 2018 - 2030 (USD Million)
• Fig. 50 Pharmaceutical companies market 2018 - 2030 (USD Million)
• Fig. 51 Others market 2018 - 2030 (USD Million)

U.S. Pharmaceutical Sterility Testing Market Growth & Trends:

The U.S. pharmaceutical sterility testing market size is anticipated to reach USD 1.18 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 10.9% from 2022 to 2030. Supportive government investment in the healthcare industry, increasing R&D activities, and growing demand for new therapeutics in the country are the key factors driving the growth. The majority of clinical trials worldwide are performed in the U.S. alone.

According to ClinicalTrials.gov, as of October 2022, over 31% of global clinical trials were registered in the U.S. alone. This is due to the significant number of initiatives taken by public organizations in the country to support R&D activities. The presence of technologically advanced infrastructure and an increase in R&D investment by pharmaceutical companies are also supporting clinical trials in the country. This is expected to improve the number of new medications and medical devices in the coming years in the U.S. and support the market in the post-pandemic period.

The government is keen on bringing down healthcare costs, which is anticipated to encourage the U.S. Food and Drug Administration (FDA) to promote the fast approval of generic pharmaceuticals. Faster approvals drive the need for newer sterility testing methods. This is anticipated to encourage market participants to spend more on sterility solutions and, in turn, expand the market. With an increasing demand for drugs, companies are launching new drugs with different routes of administration, dosage, and indication. These launches require thorough sterility testing and, thus, are anticipated to drive the industry's growth.

The majority of pharmaceutical companies, biopharmaceutical companies, CROs, and CMOs are headquartered in the U.S. Companies such as Catalent, Inc., Pfizer Inc., AbbVie, Merck; Co. Johnson & Johnson, and Abbott are located in the U.S. The high number of pharmaceutical companies, biopharmaceutical companies, CMOs, and CROs located in the U.S. contributes to the high demand for sterility testing of pharmaceuticals, thus supporting the market growth.

The country suffers from a high burden of cancer. Due to this, government-based research institutes in the U.S. are constantly trying to improve cancer research funding in the country. For instance, in May 2022, the American Institute of Cancer Research stated that it had funded more than USD 110 million in cancer research in 2022, and it intends to fund more in the coming years to reduce the burden of cancer. Such initiatives are expected to increase the number of new medications for cancer in the coming years, thus increasing the demand for sterility testing of cancer drugs in the post-pandemic period.

U.S. Pharmaceutical Sterility Testing Market Report Highlights:

• Outsourcing emerged as the largest segment in 2021 with a share of 45.2%, as pharmaceutical and biopharmaceutical companies are trying to reduce expenses and hence outsourcing non-core functions such as sterility testing

• The sterility testing segment, by test type is expected to witness the fastest CAGR of 11.3% across the forecast as these tests are recommended by regulatory authorities such as the USFDA

• Based on product type, the kits and reagents segment held the largest share of 59.7% in 2021, due to the high consumption of these products in sterility testing

• The biopharmaceuticals segment by the sample is expected to grow at the fastest rate of 11.2% CAGR across the forecast owing to the growing demand for biologics such as vaccines, and monoclonal antibodies in the country for treating chronic and infectious diseases

• Based on end-use, the pharmaceutical companies accounted for the largest share of 42.9% in 2021, owing to the growing number of drug recalls due to lack of sterility, thus supporting segment growth

Table of Contents

Chapter 1 Methodology And Scope

• 1.1.Market Segmentation & Scope
  • 1.1.1.Type
  • 1.1.2.Product Type
  • 1.1.3.Test Type
  • 1.1.4.Sample
  • 1.1.5.End-Use
  • 1.1.6.Regional Scope
  • 1.1.7.Estimates And Forecast Timeline
• 1.2.Research Methodology
• 1.3.Information Procurement
  • 1.3.1.Purchased Database
  • 1.3.2.GVR's Internal Database
  • 1.3.3.Secondary Sources
  • 1.3.4.Primary Research
  • 1.3.5.Details Of Primary Research
• 1.4.Information Or Data Analysis
  • 1.4.1.Data Analysis Models
• 1.5.Market Formulation & Validation
• 1.6.Model Details
  • 1.6.1.Commodity Flow Analysis (Model 1)
  • 1.6.1.1.Approach 1: Commodity Flow Approach
  • 1.6.2.Volume Price Analysis (Model 2)
  • 1.6.2.1.Approach 2: Volume Price Analysis
• 1.7.List Of Secondary Sources
• 1.8.List Of Primary Sources
• 1.9.Objectives
  • 1.9.1.Objective 1
  • 1.9.2.Objective 2

Chapter 2 Executive Summary

• 2.1.Market Outlook

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.Penetration & Growth Prospect Mapping
• 3.3.Market Dynamics
  • 3.3.1.Market Driver Analysis
    • 3.3.1.1.Supportive Government Investment In The Healthcare Industry
    • 3.3.1.2.Increasing R&D Activities
    • 3.3.1.3.Increasing Number Of Drug Launches
    • 3.3.1.4.Increasing Focus On Quality And Sterility
  • 3.3.2.Market Restraint Analysis
    • 3.3.2.1.Third-Party Performance
• 3.4.U.S. Pharmaceutical Sterility Testing Market Analysis Tools
  • 3.4.1.Porter's Five Forces Analysis
  • 3.4.2.PESTLE Analysis
  • 3.4.3.Major Deals & Strategic Alliances Analysis
    • 3.4.3.1.Mergers And Acquisition
    • 3.4.3.2.Expansions
    • 3.4.3.3.Agreements And Collaborations
    • 3.4.3.4.Product And Service Launches
  • 3.5.Covid-19 Impact And Reformation Strategy

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

• 4.1.Definitions And Scope
• 4.2.U.S. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  • 4.2.1.In-House Pharmaceutical Sterility Testing
    • 4.2.1.1.In-House Pharmaceutical Sterility Testing Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 4.2.2.Outsourcing Pharmaceutical Sterility Testing
    • 4.2.2.1.Outsourcing Pharmaceutical Sterility Testing Market Estimates And Forecast 2018 - 2030 (USD Million)

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

• 5.1.Definitions And Scope
• 5.2.U.S. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  • 5.2.1.Kits And Reagents
    • 5.2.1.1.Kits And Reagents Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 5.2.2.Instruments
    • 5.2.2.1.Instruments Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 5.2.3.Service
    • 5.2.3.1.Service Market Estimates And Forecast 2018 - 2030 (USD Million)

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

• 6.1.Definitions And Scope
• 6.2. U.S. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  • 6.2.1.Sterility Testing
    • 6.2.1.1.Sterility Testing Market Estimates And Forecast 2018 - 2030 (USD Million)
    • 6.2.1.2.Membrane Filtration
      • 6.2.1.2.1.Membrane Filtration Market Estimates And Forecast 2018 - 2030 (USD Million)
    • 6.2.1.3.Direct Inoculation
      • 6.2.1.3.1.Direct Inoculation Market Estimates And Forecast 2018 - 2030 (USD Million)
    • 6.2.1.4.Product Flush
      • 6.2.1.4.1.Product Flush Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 6.2.2.Bioburden Testing
    • 6.2.2.1.Bioburden Testing Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 6.2.3.Bacterial Endotoxin Testing
    • 6.2.3.1.Bacterial Endotoxin Testing Market Estimates And Forecast 2018 - 2030 (USD Million)

Chapter 7 U.S. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis

• 7.1.Definitions And Scope
• 7.2.U.S. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  • 7.2.1.Pharmaceuticals
    • 7.2.1.1.Pharmaceuticals Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 7.2.2.Medical Devices
    • 7.2.2.1.Medical Devices Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 7.2.3.Biopharmaceuticals
    • 7.2.3.1.Biopharmaceuticals Market Estimates And Forecast 2018 - 2030 (USD Million)

Chapter 8 U.S. Pharmaceutical Sterility Testing Market: End-Use Estimates & Trend Analysis

• 8.1.Definitions And Scope
• 8.2.U.S. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  • 8.2.1.Compounding Pharmacies
    • 8.2.1.1.Compounding Pharmacies Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 8.2.2.Medical Devices Companies
    • 8.2.2.1.Medical Devices Companies Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 8.2.3.Pharmaceutical Companies
    • 8.2.3.1.Pharmaceutical Companies Market Estimates And Forecast 2018 - 2030 (USD Million)
  • 8.2.4.Others
    • 8.2.4.1.Other Market Estimates And Forecast 2018 - 2030 (USD Million)

Chapter 9 Competitive Analysis

• 9.1.Recent Developments & Impact Analysis, By Key Market Participant
• 9.2.Company/Competition Categorization (Key Innovators, Market Leaders, Emerging Players)
• 9.3.Participant Categorization
  • 9.3.1.Innovators
    • 9.3.1.1.STERIS
    • 9.3.1.2.Boston Analytical
    • 9.3.1.3.Charles River Laboratories
    • 9.3.1.4.SGS SA
• 9.4.Vendor Landscape
  • 9.4.1.List Of Key Service Providers
  • 9.4.2.Market Differentiators
  • 9.4.3.U.S. Pharmaceutical Sterility Testing Market Share Analysis

Chapter 10 Competitive Landscape

• 10.1.Company Profiles
  • 10.1.1.SGS SA
    • 10.1.1.1.Company Overview
    • 10.1.1.2.Service Benchmarking
    • 10.1.1.3.Strategic Initiatives
  • 10.1.2.Laboratory Corporation of America Holdings
    • 10.1.2.1.Company Overview
    • 10.1.2.2.Financial Performance
    • 10.1.2.3.Service Benchmarking
    • 10.1.2.4.Strategic Initiatives
  • 10.1.3.Boston Analytical
    • 10.1.3.1.Company Overview
    • 10.1.3.2.Financial Performance
    • 10.1.3.3.Service Benchmarking
    • 10.1.3.4.Strategic Initiatives
  • 10.1.4. Charles River Laboratories
    • 10.1.4.1.Company Overview
    • 10.1.4.2.Financial Performance
    • 10.1.4.3.Service Benchmarking
    • 10.1.4.4.Strategic Initiatives
  • 10.1.5.Pacific Biolabs
    • 10.1.5.1.Company Overview
    • 10.1.5.2.Financial Performance
    • 10.1.5.3.Service Benchmarking
    • 10.1.5.4.Strategic Initiatives
  • 10.1.6.STERIS
    • 10.1.6.1.Company Overview
    • 10.1.6.2.Financial Performance
    • 10.1.6.3.Service Benchmarking
    • 10.1.6.4.Strategic Initiatives
  • 10.1.7. Pace Analytical
    • 10.1.7.1.Company Overview
    • 10.1.7.2.Financial Performance
    • 10.1.7.3.Service Benchmarking
    • 10.1.7.4.Strategic Initiatives
  • 10.1.8.Nelson Laboratories, LLC
    • 10.1.8.1.Company Overview
    • 10.1.8.2.Financial Performance
    • 10.1.8.3.Service Benchmarking
    • 10.1.8.4.Strategic Initiatives
  • 10.1.9.Infinity Laboratories
    • 10.1.9.1.Company Overview
    • 10.1.9.2.Financial Performance
    • 10.1.9.3.Service Benchmarking
    • 10.1.9.4.Strategic Initiatives
  • 10.1.10.Thermo Fisher Scientific, Inc.
    • 10.1.10.1.Company Overview
    • 10.1.10.2.Financial Performance
    • 10.1.10.3.Service Benchmarking
    • 10.1.10.4.Strategic Initiatives