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세계의 IVD 품질관리 시장 규모, 점유율, 성장 분석 : 제품 및 서비스별, 용도별, 제조업체 유형별 - 산업 예측(2024-2031년)

Global IVD Quality Control Market Size, Share, Growth Analysis, By Product and Service, By Application, By Manufacturer type - Industry Forecast 2024-2031

발행일: | 리서치사: SkyQuest | 페이지 정보: 영문 219 Pages | 배송안내 : 3-5일 (영업일 기준)

    
    
    


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세계의 IVD 품질관리 시장 규모는 2022년에 11억 달러에 달하며, 2023년 11억 1,000만 달러에서 2031년까지는 15억 달러로 성장하며, 예측 기간(2024-2031년)의 CAGR은 4.10%로 성장할 전망입니다.

세계 IVD 품질관리 시장은 임상 실험실의 중요한 역할, 노인 인구 증가, 외부 품질 평가 구상에 대한 수요 증가, 선진국의 현장 진료 기기 보급 확대, 제3자 품질관리 조치의 급증 등의 요인으로 인해 큰 폭의 성장을 보이고 있습니다. 또한 감염성 질환, HIV, 암 발병률 증가로 인해 첨단 진단과 엄격한 품질 모니터링이 필요해지면서 시장 확대가 더욱 가속화되고 있습니다. 예를 들어 유엔 HIV/에이즈 합동 계획의 데이터에 따르면 2019년 약 2,450만 명의 HIV 환자가 항레트로바이러스 치료를 받고 있으며, 이는 신속한 진단 솔루션과 견고한 품질 보증 메커니즘의 필요성을 강조하고 있습니다. 그러나 품질관리를 위한 검사 시설의 부담 증가, IVD 검사에 대한 불리한 상환 조건, 많은 신흥 경제국에서 임상 검사 시설 인증을 위한 의무적인 규제 프레임워크의 부재 등 여전히 과제가 남아있습니다.

목차

주요 요약

  • 시장 개요
  • Wheel of Fortune

조사 방법

  • 정보 조달
  • 2차·1차 정보원
  • 시장 규모 추정
  • 시장의 전제조건과 제한

모시장 분석

  • 시장 개요
  • 시장 규모
  • 시장 역학
    • 촉진요인
    • 기회
    • 억제요인
    • 과제

주요 시장 인사이트

  • 기술 분석
  • 가격 분석
  • 공급망 분석
  • 밸류체인 분석
  • 시장의 에코시스템
  • IP 분석
  • 무역 분석
  • 스타트업 분석
  • 원재료 분석
  • 혁신 매트릭스
  • 파이프라인 제품 분석
  • 거시경제 지표
  • 주요 투자 분석
  • 주요 성공요인
  • 경쟁의 정도

시장 역학과 전망

  • 시장 역학
    • 촉진요인
    • 기회
    • 억제요인
    • 과제
  • 규제 상황
  • Porter의 산업 분석
  • 향후 혼란에 관한 특별 인사이트

세계의 IVD 품질관리 시장 : 제품·서비스별

  • 시장 개요
  • 품질관리 제품
  • 데이터 관리 솔루션
  • 품질 보증 서비스

세계의 IVD 품질관리 시장 : 용도별

  • 시장 개요
  • 임상화학
  • 면역화학/면역측정
  • 혈액학
  • 분자진단
  • 응고와 지혈
  • 미생물학
  • 기타

세계의 IVD 품질관리 시장 : 제조업체 유형별

  • 시장 개요
  • 서드파티 제어 제조업체
  • OEM 제조업체

세계의 IVD 품질관리 시장 규모 : 지역별

  • 시장 개요
  • 북미
    • 미국
    • 캐나다
  • 유럽
    • 독일
    • 스페인
    • 프랑스
    • 영국
    • 기타 유럽 지역
  • 아시아태평양
    • 중국
    • 인도
    • 일본
    • 한국
    • 기타 아시아태평양
  • 라틴아메리카
    • 브라질
    • 기타 라틴아메리카 지역
  • 중동 및 아프리카(MEA)
    • GCC 국가
    • 남아프리카공화국
    • 기타 중동 및 아프리카

경쟁 구도

  • 상위 5사의 비교
  • 주요 기업의 시장 포지셔닝(2023년)
  • 주요 시장 기업이 채택한 전략
  • 주요 성공 전략
  • 시장에서의 최근 활동
  • 주요 기업의 시장 점유율(2023년)

주요 기업 개요

  • Bio-Rad Laboratories
  • Abbott Laboratories
  • Siemens Healthineers
  • Thermo Fisher Scientific
  • Roche Diagnostics
  • Randox Laboratories
  • Bio-Techne Corporation
  • Ortho Clinical Diagnostics
  • Streck
  • Sysmex Corporation
  • Technopath Clinical Diagnostics
  • Helena Biosciences
  • SeraCare Life Sciences
  • Quidel Corporation
  • ZeptoMetrix Corporation
  • Merck KGaA
  • Seracare Life Sciences
  • Fortress Diagnostics
  • Maine Molecular Quality Controls
  • LGC Group
KSA 24.05.16

Global IVD Quality Control Market size was valued at USD 1.10 billion in 2022 and is poised to grow from USD 1.11 billion in 2023 to USD 1.5 billion by 2031, growing at a CAGR of 4.10% during the forecast period (2024-2031).

The global IVD quality control market is experiencing substantial growth, driven by factors such as the pivotal role played by clinical laboratories, the expanding geriatric demographic, heightened demand for external quality assessment initiatives, increased uptake of point-of-care instruments in developed regions, and the surge in third-party quality control measures. Furthermore, the escalating incidence of infectious diseases, HIV, and cancers necessitating advanced diagnostics and rigorous quality monitoring further bolster market expansion. For instance, data from the Joint United Nations Program on HIV and AIDS reveal that in 2019, approximately 24.5 million HIV patients received antiretroviral therapy, emphasizing the need for swift diagnostic solutions and robust quality assurance mechanisms. However, challenges persist, including the added burdens placed on laboratories for quality control, unfavorable reimbursement conditions for IVD tests, and the absence of mandatory regulatory frameworks for clinical laboratory accreditation in numerous emerging economies.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global IVD Quality Control Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global IVD Quality Control Market Segmental Analysis

Global In Vitro Diagnostics (IVD) Quality Control market is segmented into product and service, application, manufacturer type, end user, and region. Based on product and service, the IVD Quality Control Market is segmented into quality control products, data management solutions, and quality assurance services. In terms of application, the global market is classified into clinical chemistry, immunochemistry/immunoassay, hematology, molecular diagnostics, coagulation and hemostasis, microbiology, and others. With respect to categorization by manufacturer type, the global IVD Quality Control Market is divided into third-party control manufacturers, and original equipment manufacturers. Based on end users, the global IVD Quality Control Market is segmented into hospitals, home care settings, clinical laboratories, and academic and research institutes.

Drivers of the Global IVD Quality Control Market

The surge in the prevalence of diverse diseases has led to a rise in the demand for laboratory tests, prompting an expansion in both public and commercial laboratory facilities. The swift spread of COVID-19 since December 2019 further intensified the need for diagnostic testing, prompting governmental bodies to establish supplementary laboratories to bolster testing capacity, consequently fueling market growth.

Restraints in the Global IVD Quality Control Market

Establishing quality control (QC) procedures in hospital settings requires both financial investment and specialized knowledge. Clinical laboratories dealing with low volume QC procedures often find the adoption of such protocols financially burdensome. This challenge is compounded by budgetary limitations in many healthcare facilities and labs, leading to a reduced uptake of QC procedures.

Market Trends of the Global IVD Quality Control Market

As diseases become more widespread, medical device companies are increasingly prioritizing the advancement of technologically sophisticated diagnostic tools. Hospitals and laboratories are increasingly favoring point-of-care testing devices to obtain precise real-time data, leading to a surge in demand for such devices and driving market growth.

Table of Contents

Executive Summary

  • Market Overview
  • Wheel of Fortune

Research Methodology

  • Information Procurement
  • Secondary & Primary Data Sources
  • Market Size Estimation
  • Market Assumptions & Limitations

Parent Market Analysis

  • Market Overview
  • Market Size
  • Market Dynamics
    • Drivers
    • Opportunities
    • Restraints
    • Challenges

Key Market Insights

  • Technology Analysis
  • Pricing Analysis
  • Supply Chain Analysis
  • Value Chain Analysis
  • Ecosystem of the Market
  • IP Analysis
  • Trade Analysis
  • Startup Analysis
  • Raw Material Analysis
  • Innovation Matrix
  • Pipeline Product Analysis
  • Macroeconomic Indicators
  • Top Investment Analysis
  • Key Success Factor
  • Degree of Competition

Market Dynamics & Outlook

  • Market Dynamics
    • Drivers
    • Opportunities
    • Restraints
    • Challenges
  • Regulatory Landscape
  • Porters Analysis
    • Competitive rivalry
    • Threat of Substitute Products
    • Bargaining Power of Buyers
    • Threat of New Entrants
    • Bargaining Power of Suppliers
  • Skyquest Special Insights on Future Disruptions
    • Political Impact
    • Economic Impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Global IVD Quality Control Market by Product and Service

  • Market Overview
  • Quality control products
  • data management solutions
  • and quality assurance services.

Global IVD Quality Control Market by Application

  • Market Overview
  • Clinical Chemistry
  • immunochemistry/immunoassay
  • hematology
  • molecular diagnostics
  • coagulation and hemostasis
  • microbiology
  • and others

Global IVD Quality Control Market by Manufacturer type

  • Market Overview
  • Third-party control manufacturers
  • and original equipment manufacturers

Global IVD Quality Control Market Size by Region

  • Market Overview
  • North America
    • USA
    • Canada
  • Europe
    • Germany
    • Spain
    • France
    • UK
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of Asia-Pacific
  • Latin America
    • Brazil
    • Rest of Latin America
  • Middle East & Africa (MEA)
    • GCC Countries
    • South Africa
    • Rest of MEA

Competitive Landscape

  • Top 5 Player Comparison
  • Market Positioning of Key Players, 2023
  • Strategies Adopted by Key Market Players
  • Top Winning Strategies
    • By Development
    • By Company
    • By Year
  • Recent Activities in the Market
  • Key Companies Market Share (%), 2023

Key Company Profiles

  • Bio-Rad Laboratories
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Abbott Laboratories
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Siemens Healthineers
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Thermo Fisher Scientific
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Roche Diagnostics
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Randox Laboratories
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Bio-Techne Corporation
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Ortho Clinical Diagnostics
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Streck
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Sysmex Corporation
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Technopath Clinical Diagnostics
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Helena Biosciences
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • SeraCare Life Sciences
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Quidel Corporation
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • ZeptoMetrix Corporation
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Merck KGaA
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Seracare Life Sciences
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Fortress Diagnostics
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • Maine Molecular Quality Controls
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
  • LGC Group
    • Company Overview
    • Business Segment Overview
    • Financial Updates
    • Key Developments
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