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세계의 바이오버든 검사 시장은 2025년에는 14억 달러로 추정되고, 2032년에는 26억 3,000만 달러에 이를 것으로 예측되며, 2025-2032년 연평균 복합 성장률(CAGR) 9.4%를 나타낼 것으로 예측됩니다.

그림. 바이오버든 검사 지역별 시장 점유율(%)(2025년)

바이오버든 검사란 제품, 원료 또는 표면에 존재하는 미생물의 검출과 정량화를 의미합니다. 바이오버든 검사는 제조에 사용되는 재료나 기기가 적절한 위생 기준을 충족하는지 확인함으로써 의약품 및 헬스케어 제품의 품질 감시에 도움이 됩니다. 무균성을 유지하고 무균장치, 기기, 완제품의 오염을 방지하는 데 중요한 역할을 하고 있습니다. 바이오버든 검사 시장은 의료기기 검사를 의무화하는 엄격한 규제, 수탁제조 조직의 침투 고조, 의약품 제조 아웃소싱 증가로 확대되고 있습니다. 의료기기 및 의약품은 환자와 직접 접촉하는 것이기 때문에 무균 상태를 유지하고 미생물 번식을 막는 것이 중요합니다. 바이오버든 검사는 멸균 프로세스를 검증하고 제조 또는 출하 중에 혼입되었을 가능성이 있는 오염 물질을 검출하기 위한 품질 관리 수단을 제공합니다. 이러한 검사 결과는 적절한 보존 기간을 결정하고, 향후 제품 배치에 어떠한 문제가 발생했을 경우의 조사에 도움이 됩니다.

시장 역학 :

세계의 바이오버든 검사 시장은 의약품 및 의료기기 제조에 있어서 바이오버든 검사에 대한 엄격한 규제 의무화에 의해 견인되고 있습니다. 규제기관입니다. 식품의약국(FDA)이나 유럽의약품청(EMA) 같은 규제기관입니다. FDA와 유럽의약품청 EMA 등 규제기관은 비무균 제품의 안전성과 유효성을 확보하기 위해 다양한 단계에서 바이오버든 검사를 의무화하고 있습니다. 제약업계와 의료기기 업계의 성장도 바이오버든 검사의 수요를 뒷받침하고 있습니다. 그러나 바이오버든 검사 장비와 서비스에 관련된 고비용이 이 시장의 성장을 제한하고 있습니다. 신속한 자동 바이오버든 검사 솔루션의 출현은 보다 신속한 결과 및 높은 처리량을 가능하게 하기 때문에 유리한 기회를 제시합니다. 제조 중 바이오버든 검사를 위한 연속 모니터링 시스템의 채택은 향후 몇 년간 기회를 더 제공합니다.

본 조사의 주요 특징

• 본 보고서는 세계의 바이오버든 검사 시장을 상세하게 분석하여 2024년을 기준 연도로 한 예측 기간(2025-2032년) 시장 규모 및 복합연간 성장률(CAGR%)을 제공합니다.
• 또, 다양한 부문에 걸친 잠재적인 수익 기회를 밝혀, 이 시장의 매력적인 투자 제안 매트릭스에 대해서 해설했습니다.
• 또한 시장 성장 촉진요인, 억제요인, 기회, 신제품 출시 및 승인, 시장 동향, 지역별 전망, 주요 기업이 채용하는 경쟁 전략 등에 관한 중요한 인사이트도 제공합니다.
• 기업 하이라이트, 제품 포트폴리오, 주요 하이라이트, 재무 실적, 전략 등의 파라미터에 근거해, 세계 바이오 바덴 테스트 시장의 주요 기업을 프로파일 하고 있습니다.
• 본 보고서의 인사이트를 통해 마케팅 담당자나 기업의 경영진이, 장래의 제품 발매, 유형 업그레이드, 시장 확대, 마케팅 전술에 관한 정보에 근거한 의사 결정을 실시하는 것을 가능하게 합니다.
• 이 조사 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 참가자, 재무 분석가 등이 업계의 다양한 이해 관계자를 대상으로 합니다.

제1장 조사의 목적 및 전제조건

• 조사 목적
• 전제조건
• 약어

제2장 시장 개요

• 보고서 설명
• 시장 정의 및 범위
• 주요 요약
• 일관된 기회 지도(COM)

제3장 시장 역학, 규제 및 동향 분석

• 시장 역학
• 영향 분석
• 주요 하이라이트
• 규제 시나리오
• 제품 출시 및 승인
• PEST 분석
• Porter's Five Forces 분석
• 합병 및 인수 시나리오

제4장 바이오버든 검사 시장 : 코로나바이러스(COVID-19) 팬데믹의 영향

• COVID-19 역학
• 공급측 및 수요측 분석
• 바이오버든 검사 시장에 미치는 영향

제5장 바이오버든 검사 시장 : 제품별(2020-2032년)

• 소모품
• 기기

제6장 바이오버든 검사 시장 : 시험 유형별(2020-2032년)

• 호기성 균수 검사
• 혐기성 균수 시험
• 진균 및 곰팡이 검사
• 포자수 검사

제7장 바이오버든 검사 시장 : 용도별(2020-2032년)

• 원재료 검사
• 의료기기 검사
• 공정내 재료 검사
• 멸균 밸리데이션 검사
• 기기 세정 밸리데이션

제8장 바이오버든 검사 시장 : 최종 사용자별(2020-2032년)

• 제약 및 바이오테크놀러지 기업
• 의료기기 제조업체
• 계약 제조 조직
• 음식 및 농산물 제조업체
• 미생물 검사 연구소

제9장 바이오버든 검사 시장 : 지역별(2020-2032년)

• 지역별
• 북미
• 유럽
• 아시아태평양
• 중동 및 아프리카
• 라틴아메리카

제10장 바이오버든 검사 시장 : 기업 프로파일

• Charles River Laboratories International, Inc.
  • 기업 개요
  • 제품 및 서비스 포트폴리오
  • 재무실적
  • 최근 동향 및 업데이트
  • 전략 개요
• SGS SA
• Merck KGaA
• Becton
• Dickinson and Company
• Wuxi Apptec
• North American Science Associates Inc.
• Nelson Laboratories, LLC
• Biomerieux SA
• Thermo Fisher Scientific
• Pacific Biolabs

제11장 참고문헌 및 조사방법

• 참고문헌
• 조사 방법

영문목차

Global Bioburden Testing Market is estimated to be valued at USD 1.4 Bn in 2025 and is expected to reach USD 2.63 Bn by 2032, growing at a compound annual growth rate (CAGR) of 9.4% from 2025 to 2032.

Figure. Bioburden Testing Market Share (%), By Region 2025

Bioburden testing refers to the detection and quantification of microorganisms present in or on a product, raw material, or surface. Bioburden testing helps monitor the quality of pharmaceutical and healthcare products by ensuring materials and equipment used in production meet appropriate hygienic standards. It plays a key role in maintaining sterility and preventing contamination of sterile devices, equipment, and finished products. The bioburden testing market is growing due to stringent regulations mandating testing of medical devices, rising penetration of contract manufacturing organizations, and increasing outsourcing of pharmaceutical manufacturing. As medical devices and pharmaceuticals are intended to interact directly with patients, maintaining sterility and preventing microbial growth are critical. Bioburden testing provides quality control measures to validate sterilization processes and detect any contaminants that may have been introduced during manufacturing or shipping. The results of these tests help determine appropriate shelf life and assist in investigations should any issues arise with a product batch in the future.

Market Dynamics:

The global bioburden testing market is driven by stringent regulatory mandates for the testing of bioburden in pharmaceutical and medical device manufacturing. Regulatory agencies like the Food and Drug Administration. FDA and European Medicines Agency EMA require bioburden testing at various stages to ensure the safety and efficacy of non-sterile products. The growth in pharmaceutical and medical device industries has also fueled the demand for bioburden testing. However, the high costs associated with bioburden testing equipment and services limit the growth of this market. The emergence of rapid automated bioburden testing solutions presents lucrative opportunities, as they enable faster results and higher throughput. The adoption of continuous monitoring systems for bioburden testing during manufacturing further offers opportunities in the coming years.

Key features of the study:

• This report provides in-depth analysis of the global bioburden testing market, and provides market size (US$ Billion) and compound annual growth rate (CAGR%) for the forecast period (2025-2032), considering 2024 as the base year
• It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
• This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
• It profiles key players in the global bioburden testing market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies
• Key companies covered as a part of this study include Charles River Laboratories, Merck KGaA, SGS, WuXi AppTec, and Becton, Dickinson and Company ,North American Science Associates Inc. , Nelson Laboratories LLC , Biomerieux SA ,Thermo Fisher ScientifiC and Pacific Biolabs.
• Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
• The global bioburden testing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.

Detailed Segmentation:

• Bioburden Testing Market ,By Product
  • Consumables
  • Culture Media
  • Reagents and Kits
  • Instruments
  • Automated Microbial Identification Systems
  • PCR Instruments
• Bioburden Testing Market,By Test Type
  • Aerobic Count Testing
  • Anaerobic Count Testing
  • Fungi/Mold Count Testing
  • Spore Count Testing
• Bioburden Testing Market, By Application
  • Raw Material Testing
  • Medical Device Testing
  • In-Process Material Testing
  • Sterilization Validation Testing
  • Equipment Cleaning Validation
• Bioburden Testing Market, By End Use
  • Pharmaceutical & Biotechnology Companies
  • Medical Device Manufacturers
  • Contract Manufacturing Organizations
  • Manufacturers of Food & Beverage and Agricultural Products
  • Microbial Testing Laboratories
• Bioburden Testing Market, By Region
  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East and Africa
• Company Profiles
  • Charles River Laboratories International Inc.
  • SGS SA
  • Merck KGaA
  • Becton
  • Dickinson and Company
  • Wuxi Apptec
  • North American Science Associates Inc.
  • Nelson Laboratories LLC
  • Biomerieux SA,
  • Thermo Fisher Scientific
  • Pacific Biolabs.

Table of Content:

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Overview

• Report Description
• Market Definition and Scope
• Executive Summary
  • Bioburden Testing Market, By Product
  • Bioburden Testing Market, By Test Type
  • Bioburden Testing Market, By Application
  • Bioburden Testing Market, By End Use
  • Bioburden Testing Market, By Region
• Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Drivers
  • Restraints
  • Oppertunities
• Impact Analysis
• Key Highlights
• Regulatory Scenario
• Product Launches/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario

4. Bioburden Testing Market Impact of Coronavirus (COVID-19) Pandemic

• COVID-19 Epidemiology
• Supply Side and Demand Side Analysis
• Impact Bioburden Testing Market

5. Bioburden Testing Market, By Product, 2020 - 2032 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2020 - 2032, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Consumables, 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Instruments, 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)

6. Bioburden Testing Market, By Test Type, 2020 - 2032 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2020 - 2032, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Aerobic Count Testing 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Anaerobic Count Testing 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Fungi/Mold Count Testing 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Spore Count Testing 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)

7. Bioburden Testing Market, By Application, 2020 - 2032 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2020 - 2032, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Raw Material Testing , 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Medical Device Testing, 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• In-process Material Testing , 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Sterilization Validation Testing, 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecas and Y-o-Y Growth t, 2020 - 2032, ( US$ Billion)
• Equipment Cleaning Validation, 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)

8. Bioburden Testing Market, By End Use, 2020 - 2032 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2020 - 2032, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Pharmaceutical & Biotechnology Companies , 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast, 2020 - 2032, ( US$ Billion)
• Medical Device Manufacturers , 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth 2020 - 2032, ( US$ Billion)
• Contract Manufacturing Organizations , 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Manufacturers Of Food & Beverage And Agricultural Products , 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• Microbial Testing Laboratories, 2020 - 2032( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)

9. Bioburden Testing Market, By Region, 2020 - 2032 ( US$ Billion)

• Introduction
  • Market Share Analysis, 2020 - 2032, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• By Region
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
• North America
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Country, 2020 - 2032, ( US$ Billion)
    • U.S.
    • Canada
• Europe
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecas and Y-o-Y Growth t, By Country, 2020 - 2032, ( US$ Billion)
    • U.K
    • German
    • Italy
    • France
    • Spain
    • Russia
    • Rest Of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Country, 2020 - 2032, ( US$ Billion)
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Asean
    • Rest Of Asia Pacific
• Middle East & Africa
  • Introduction
  • Market Size and Forecast, By Product and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast, By Application and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast, By End Use and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast, By Country and Y-o-Y Growth, 2020 - 2032, ( US$ Billion)
    • GCC
    • Israel
    • Rest Of Middle East
• Latin America
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2020 - 2032, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Country, 2020 - 2032, ( US$ Billion)
    • Brazil
    • Mexico
    • Argentina

10. Company Profiles - Bioburden Testing Market

• Charles River Laboratories International, Inc.*
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• SGS SA
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Merck KGaA
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Becton
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Dickinson and Company
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Wuxi Apptec
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• North American Science Associates Inc.
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Nelson Laboratories, LLC
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Biomerieux SA
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Thermo Fisher Scientific
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• Pacific Biolabs
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview

11. References and Research Methodology

• References
• Research Methodology
• About us and Sales Contact