IVD 품질관리 시장 규모, 점유율, 성장 분석 : 제품 및 서비스별, 기술별, 제조업체 유형별, 최종사용자별, 지역별 - 산업 예측(2025-2032년)
IVD Quality Control Market Size, Share, and Growth Analysis, By Product and Service, By Technology, By Manufacturer Type, By End User, By Region - Industry Forecast 2025-2032
상품코드:1677835
리서치사:SkyQuest Technology Consulting Pvt. Ltd.
발행일:2025년 03월
페이지 정보:영문 219 Pages
라이선스 & 가격 (부가세 별도)
한글목차
세계의 IVD 품질관리 시장 규모는 2023년에 11억 1,000만 달러로 평가되며, 2024년 11억 6,000만 달러에서 2032년에는 15억 9,000만 달러로 성장하며, 예측 기간(2025-2032년)의 CAGR은 4.1%로 성장할 전망입니다.
세계 체외진단(IVD) 품질관리 시장은 노인 인구 증가, 외부 품질 평가 프로그램에 대한 수요 증가, 선진국의 현장진단(POC) 기기 채택 등의 요인으로 인해 크게 성장하고 있습니다. 감염성 질환, HIV, 암 증가로 인해 효과적인 치료와 엄격한 품질 모니터링을 위한 혁신적인 진단 약품이 요구되고 있습니다. 예를 들어 2019년 현재 약 2,450만 명이 HIV 항레트로바이러스 치료를 받고 있으며, 신속한 진단 시스템의 필요성이 강조되고 있습니다. 그럼에도 불구하고 검사실 부담 증가, IVD 검사에 대한 불리한 상환 시나리오, 많은 신흥 시장에서 강제적인 인증 규정의 부재 등의 문제가 남아 있으며, 시장 발전을 저해할 수 있습니다.
목차
서론
조사의 목적
조사 범위
정의
조사 방법
정보 조달
2차와 1차 데이터 방법
시장 규모 예측
시장의 전제조건과 제한
개요
세계 시장 전망
공급과 수요 동향 분석
부문별 기회 분석
시장 역학과 전망
시장 개요
시장 규모
시장 역학
촉진요인과 기회
억제요인과 과제
Porter의 산업 분석
주요 시장 인사이트
주요 성공 요인
경쟁의 정도
주요 투자 기회
시장 에코시스템
시장의 매력 지수(2024년)
PESTEL 분석
거시경제 지표
밸류체인 분석
가격 분석
IVD 품질관리 시장 규모 : 제품·서비스별 & CAGR(2025-2032)
시장 개요
품질관리 제품
혈청/혈장 기반 컨트롤
전혈 기반 컨트롤
요검사
기타 컨트롤
데이터 관리 솔루션
검사 정보 관리 시스템(LIMS)
스탠드얼론 소프트웨어
품질 보증 서비스
IVD 품질관리 시장 규모 : 기술별 & CAGR(2025-2032)
시장 개요
면역화학
임상화학
전해질과 미네랄
신장 기능
간기능
단백질과 효소
심장 마커
기타
분자진단
핵산 증폭 검사
DNA 배열 해석
유전자 검사
기타
미생물학
혈액학
응고/지혈
기타 기술
IVD 품질관리 시장 규모 : 제조업체 유형별 & CAGR(2025-2032)
시장 개요
서드파티 컨트롤
독립 컨트롤
기기 고유 컨트롤
OEM(Original Equipment Manufacturer)에 의한 관리
IVD 품질관리 시장 규모 : 최종사용자별 & CAGR(2025-2032)
시장 개요
병원
임상 검사실
학술연구기관
기타 최종사용자
IVD 품질관리 시장 규모 : 지역별 & CAGR(2025-2032)
북미
미국
캐나다
유럽
독일
스페인
프랑스
영국
이탈리아
기타 유럽 지역
아시아태평양
중국
인도
일본
한국
기타 아시아태평양
라틴아메리카
브라질
기타 라틴아메리카 지역
중동 및 아프리카
GCC 국가
남아프리카공화국
기타 중동 및 아프리카
경쟁 정보
상위 5사의 비교
주요 기업의 시장 포지셔닝(2024년)
주요 시장 기업이 채택한 전략
최근 시장 동향
기업의 시장 점유율 분석(2024년)
주요 기업의 기업 개요
기업의 상세
제품 포트폴리오 분석
기업의 부문별 점유율 분석
매출의 전년대비 비교(2022-2024)
주요 기업 개요
Thermo Fisher Scientific(United States)
Danaher Corporation(United States)
Sysmex Corporation(Japan)
Tecan Group Ltd.(Switzerland)
Eurofins Scientific(France)
Intertek Group plc(United Kingdom)
Bio-Rad Laboratories(United States)
Roche Diagnostics(Switzerland)
Siemens Healthineers(Germany)
Abbott Laboratories(United States)
Becton, Dickinson and Company(United States)
Agilent Technologies(United States)
PerkinElmer(United States)
bioMerieux(France)
DiaSorin(Italy)
Ortho Clinical Diagnostics(United States)
Quidel Corporation(United States)
Hologic, Inc.(United States)
Qiagen N.V.(Netherlands)
결론과 제안
KSA
영문 목차
영문목차
Global IVD Quality Control Market size was valued at USD 1.11 billion in 2023 and is poised to grow from USD 1.16 billion in 2024 to USD 1.59 billion by 2032, growing at a CAGR of 4.1% during the forecast period (2025-2032).
The global in vitro diagnostics (IVD) quality control market is experiencing significant growth, driven by factors such as the rising elderly population, an uptick in demand for external quality assessment programs, and the adoption of point-of-care (POC) instruments in developed regions. The increase in infectious diseases, HIV, and cancers necessitates innovative diagnostics for effective treatment and stringent quality monitoring. For instance, as of 2019, approximately 24.5 million individuals were receiving antiretroviral therapy for HIV, highlighting the need for rapid diagnostic systems. Nevertheless, challenges remain, including added burdens on laboratories, unfavorable reimbursement scenarios for IVD tests, and a lack of mandatory accreditation regulations in many emerging markets, which may hinder market progression.
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 Segments Analysis
Global IVD Quality Control Market is segmented by Product and Service, Technology, Manufacturer Type, End User and region. Based on Product and Service, the market is segmented into Quality control products, Data Management Solutions and Quality Assurance Services. Based on Technology, the market is segmented into Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation/ Hemostasis and Other Technologies. Based on Manufacturer Type, the market is segmented into Third-party controls and Original Equipment Manufacturer controls. Based on End User, the market is segmented into Hospitals, Clinical Laboratories, Academic and Research Institutes and Other End users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Driver of the Global Ivd Quality Control Market
The rise in the prevalence of various diseases has led to an increase in laboratory testing, driving growth in the global IVD quality control market. With the surge in demand for diagnostic testing due to the COVID-19 pandemic that began in December 2019, both public and private laboratories have expanded significantly. Governments around the world have responded by establishing additional laboratories to enhance testing capacity and meet the growing need for accurate diagnostics. This increase in laboratory infrastructure and testing capabilities has been a key factor propelling the market forward, as the demand for reliable quality control in diagnostics continues to escalate.
Restraints in the Global Ivd Quality Control Market
The global IVD quality control market faces significant restraints due to the high costs associated with establishing quality control (QC) procedures in hospitals and clinical laboratories. Implementing effective QC requires both substantial investment and specialized expertise, which can be a barrier, especially for clinical laboratories that operate with low volume QC processes. Additionally, many hospitals and laboratories are constrained by tight budgets, which further hampers the implementation and adoption of these crucial QC procedures. Consequently, these financial and resource challenges can lead to slower growth and limited utilization of quality control systems in the IVD market.
Market Trends of the Global Ivd Quality Control Market
The Global IVD Quality Control market is experiencing significant growth, driven by the rising prevalence of chronic diseases and an increased focus on precision medicine. Medical device companies are investing in the development of innovative, technologically advanced diagnostic devices to enhance testing accuracy and efficiency. Concurrently, hospitals and laboratories are increasingly adopting point-of-care testing solutions, facilitating immediate access to real-time data for better clinical decision-making. This shift towards rapid diagnostics, combined with stringent regulatory standards for quality control, is propelling market expansion. As healthcare's demand for reliability and speed continues to rise, the IVD quality control sector is poised for robust growth.
Table of Contents
Introduction
Objectives of the Study
Scope of the Report
Definitions
Research Methodology
Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations
Executive Summary
Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis
Market Dynamics & Outlook
Market Overview
Market Size
Market Dynamics
Drivers & Opportunities
Restraints & Challenges
Porters Analysis
Competitive rivalry
Threat of substitute
Bargaining power of buyers
Threat of new entrants
Bargaining power of suppliers
Key Market Insights
Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2024
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis
Global IVD Quality Control Market Size by Product and Service & CAGR (2025-2032)
Market Overview
Quality control products
Serum/ Plasma based controls
Whole blood based controls
Urine based controls
Other controls
Data Management Solutions
Laboratory information management systems (LIMS)
Standalone software
Quality Assurance Services
Global IVD Quality Control Market Size by Technology & CAGR (2025-2032)
Market Overview
Immunochemistry
Clinical Chemistry
Electrolytes and minerals
Renal function
Liver function
Proteins and enzymes
Cardiac markers
Others
Molecular Diagnostics
Nucleic acid amplification tests
DNA sequencing
Genetic testing
Others
Microbiology
Hematology
Coagulation/ Hemostasis
Other Technologies
Global IVD Quality Control Market Size by Manufacturer Type & CAGR (2025-2032)
Market Overview
Third-party controls
Independent controls
Instrument specific controls
Original Equipment Manufacturer controls
Global IVD Quality Control Market Size by End User & CAGR (2025-2032)
Market Overview
Hospitals
Clinical Laboratories
Academic and Research Institutes
Other End users
Global IVD Quality Control Market Size & CAGR (2025-2032)
North America (Product and Service, Technology, Manufacturer Type, End User)
US
Canada
Europe (Product and Service, Technology, Manufacturer Type, End User)
Germany
Spain
France
UK
Italy
Rest of Europe
Asia Pacific (Product and Service, Technology, Manufacturer Type, End User)
China
India
Japan
South Korea
Rest of Asia-Pacific
Latin America (Product and Service, Technology, Manufacturer Type, End User)
Brazil
Rest of Latin America
Middle East & Africa (Product and Service, Technology, Manufacturer Type, End User)
