IVD 품질관리 시장 : 제공 서비스별(제품, 데이터 관리, 서비스), 기술별(생화학, 분자, 면역측정, 혈액학), 용도별(감염증, 종양학, 심장병학), 최종사용자별 - 세계 예측(-2030년)

IVD Quality Control Market by Offering (Product [Serum, Blood, Urine-based], Data Management, Service), Technology (Biochemistry, Molecular, Immunoassay, Hematology), Application (Infectious Diseases, Oncology, Cardiology), and End User-Global Forecast to 2030

The IVD quality control market is expected to reach $2.19 billion by 2030, at a CAGR of 4.3% from 2023 to 2030.

After extensive primary and secondary research, the report provides an in-depth analysis of the IVD quality control market. The report also provides insights into the key drivers, restraints, challenges, and opportunities in the IVD quality control market. The growth of the IVD quality control market is driven by the rising prevalence of chronic diseases, coupled with the increasing geriatric population, growing demand for third-party quality controls, need for internal and external quality assessment reports, increasing number of clinical laboratories, growing demand for Point-of-Care (POC) and rapid diagnostics. However, stringent technical requirements and regulatory processes for quality controls restrain this market's growth.

The growing demand for multi-analyte and multi-instrument controls offers opportunities for market growth. However, the evolving regulatory landscape and lack of access to quality control/quality assurance materials are the major challenges to market growth.

Among the offering, in 2023, the quality control products segment is estimated to account for the largest share of the IVD quality control market. Increasing adoption of diagnostic products, demand for external quality assessment programs as these programs use quality controls in their programs, development of multi-analyte quality controls, new product launches, and increasing demand for independent controls contribute to the segments' largest share.

Among the technologies, in 2023, the immunoassay/immunochemistry segment is estimated to account for the largest share of the IVD quality control market. The growing prevalence of chronic and infectious diseases and the increased adoption of immunoassay/immunochemistry tests, technological innovations in these tests, and the simultaneous development of quality control contributed to the segment's largest share.

Among the application, in 2023, the infectious diseases segment is estimated to account for the largest share of the IVD quality control market. The increasing prevalence of infectious diseases has led to the availability of a broad range of quality controls that are designed to monitor the assay precision of IVD tests for infectious diseases such as hepatitis, retrovirus, sexually transmitted diseases, congenital diseases, and other infectious diseases. According to the WHO, in 2020, there were an estimated 376 million new cases of sexually transmitted infections (STIs) worldwide, with chlamydia accounting for 129 million, gonorrhea for 82 million, syphilis for 7.1 million, and trichomoniasis for 156 million of the reported cases. The need for diagnosis of such infectious diseases also required quality controls for the quality assessment of tests, which further supported the largest share of the segment.

Among the end users, in 2023, the hospitals & clinics segment is estimated to account for the largest share of the IVD quality control market. The large segment share is majorly attributed to the large volume of diagnostics tests carried out in the hospitals, the rising prevalence of healthcare-associated infections (HAIs), increasing healthcare expenditure, and the rising number of hospitals and clinics across emerging markets.

An in-depth analysis of the geographical scenario of the IVD quality control market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, the Middle East & Africa) along with the coverage of major countries in each region. In 2023, North America is estimated to account for the largest share of the IVD quality control market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The high prevalence of chronic and infectious diseases, increasing awareness regarding early disease diagnosis, growing adoption of advanced diagnostic products, and increasing funding activities, coupled with novel developments in diagnostic technologies, are the factors supporting the largest share of this market.

The key players operating in the IVD quality control market are Seimens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), LGC Group (U.K.), Thermo Fisher Scientific Inc. (U.S.), SERO AS (Norway), Randox Laboratories Ltd. (U.K.), QuidelOrtho Corporation (U.S.), Streck LLC (U.S.), Microbiologics, Inc. (U.S.), and Bio-Techne Corporation (U.S.)

Scope of the Report:

IVD Quality Control Market Assessment-by Offering

• Quality Control Products
  • Quality Control Products, by Type
• Serum/Plasma-based Controls
• Whole Blood-based Controls
• Urine-based Controls
• Other Controls
  • Quality Control Products, by Function
• Independent Controls
• Instrument-Specific Controls
• Quality Assessment Services
• Data Management Solutions

Notes: Other controls include saliva-based controls, cerebrospinal fluid-based, and protein controls.

IVD Quality Control Market Assessment-by Technology

• Immunoassay/Immunochemistry
• Biochemistry/Clinical Chemistry
• Molecular Diagnostics
• Hematology
• Coagulation/Hemostasis
• Microbiology
• Other Technologies

Notes: Other technologies include histochemistry, urinalysis, and whole-blood glucose monitoring

IVD Quality Control Market Assessment-by Application

• Infectious Diseases
• Oncology
• Cardiology
• Autoimmune Disorders
• Neurology
• Other Applications

Notes: Other applications include pregnancy and fertility testing, drug abuse testing, diabetes, genetic disorders, and trace elements testing

IVD Quality Control Market Assessment-by End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Academic Institutes & Research Laboratories
• Other End Users

Notes: Other end users include home care, nursing homes, ambulatory care centers, and transfusion laboratories.

IVD Quality Control Market Assessment-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• 1.1. Market Definition & Scope
• 1.2. Market Ecosystem
• 1.3. Currency & Limitations
• 1.4. Key Stakeholders

2. Research Methodology

• 2.1. Research Approach
• 2.2. Process of Data Collection and Validation
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
• 2.3. Market Sizing and Forecast
  • 2.3.1. Market Size Estimation Approach
  • 2.3.2. Growth Forecast Approach
• 2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

• 4.1. Overview
• 4.2. Factors Affecting Market Growth
  • 4.2.1. Impact Analysis of Market Dynamics
  • 4.2.2. Factor Analysis
• 4.3. Technology Trends
• 4.4. Regulatory Analysis
  • 4.4.1. Regulations for IVD Products
    • 4.4.1.1. North America
      • 4.4.1.1.1. U.S.
      • 4.4.1.1.2. Canada
    • 4.4.1.2. Europe
    • 4.4.1.3. Asia-Pacific
      • 4.4.1.3.1. China
      • 4.4.1.3.2. Japan
      • 4.4.1.3.3. India
    • 4.4.1.4. Latin America
    • 4.4.1.5. Middle East & Africa
  • 4.4.2. Regulations for Quality Management
    • 4.4.2.1. North America
      • 4.4.2.1.1. U.S.
      • 4.4.2.1.2. Canada
    • 4.4.2.2. Europe
      • 4.4.2.2.1. Germany
      • 4.4.2.2.2. France
      • 4.4.2.2.3. U.K.
      • 4.4.2.2.4. Italy
      • 4.4.2.2.5. Spain
      • 4.4.2.2.6. Rest of Europe (RoE)
    • 4.4.2.3. Asia-Pacific
      • 4.4.2.3.1. China
      • 4.4.2.3.2. Japan
      • 4.4.2.3.3. India
      • 4.4.2.3.4. Rest of Asia-Pacific (RoAPAC)
    • 4.4.2.4. Latin America
    • 4.4.2.5. Middle East & Africa
• 4.5. Pricing Analysis
• 4.6. Porter's Five Forces Analysis
  • 4.6.1. Bargaining Power of Buyers
  • 4.6.2. Bargaining Power of Suppliers
  • 4.6.3. Threat of Substitutes
  • 4.6.4. Threat of New Entrants
  • 4.6.5. Degree of Competition
• 4.7. Associated Market Analysis: In Vitro Diagnostics (IVD) Market

5. IVD Quality Control Market Assessment-by Offering

• 5.1. Overview
• 5.2. Quality Control Products
  • 5.2.1. Quality Control Products, by Type
    • 5.2.1.1. Serum/Plasma-based Controls
    • 5.2.1.2. Whole Blood-based Controls
    • 5.2.1.3. Urine-based Controls
    • 5.2.1.4. Other Controls
  • 5.2.2. Quality Control Products, by Function
    • 5.2.2.1. Independent Controls
    • 5.2.2.2. Instrument-specific Controls
• 5.3. Quality Assessment Services
• 5.4. Data Management Solutions

6. IVD Quality Control Market Assessment-by Technology

• 6.1. Overview
• 6.2. Immunoassay/Immunochemistry
• 6.3. Biochemistry/Clinical Chemistry
• 6.4. Molecular Diagnostics
• 6.5. Hematology
• 6.6. Coagulation/Hemostasis
• 6.7. Microbiology
• 6.8. Other Technologies

7. Global IVD Quality Control Market Assessment-by Application

• 7.1. Overview
• 7.2. Infectious Diseases
• 7.3. Oncology
• 7.4. Cardiology
• 7.5. Autoimmune Disorders
• 7.6. Neurology
• 7.7. Other Applications

8. IVD Quality Control Market Assessment-by End User

• 8.1. Overview
• 8.2. Hospitals & Clinics
• 8.3. Diagnostic Laboratories
• 8.4. Academic Institutes & Research Laboratories
• 8.5. Other End Users

9. IVD Quality Control Market Assessment-by Geography

• 9.1. Overview
• 9.2. North America
  • 9.2.1. U.S.
  • 9.2.2. Canada
• 9.3. Europe
  • 9.3.1. Germany
  • 9.3.2. France
  • 9.3.3. U.K.
  • 9.3.4. Italy
  • 9.3.5. Spain
  • 9.3.6. Rest of Europe
• 9.4. Asia-Pacific
  • 9.4.1. China
  • 9.4.2. Japan
  • 9.4.3. India
  • 9.4.4. Rest of Asia-Pacific
• 9.5. Latin America
  • 9.5.1. Brazil
  • 9.5.2. Mexico
  • 9.5.3. Rest of Latin America
• 9.6. Middle East & Africa

10. Competition Analysis

• 10.1. Introduction
• 10.2. Key Growth Strategies
• 10.3. Competitive Benchmarking
• 10.4. Competitive Dashboard
  • 10.4.1. Industry Leaders
  • 10.4.2. Market Differentiators
  • 10.4.3. Vanguards
  • 10.4.4. Emerging Companies

11. Company Profiles

• 11.1. Siemens Healthineers AG
  • 11.1.1. Company Overview
  • 11.1.2. Financial Overview
  • 11.1.3. Product Portfolio
  • 11.1.4. SWOT Analysis
• 11.2. Bio-Rad Laboratories, Inc.
  • 11.2.1. Company Overview
  • 11.2.2. Financial Overview
  • 11.2.3. Product Portfolio
  • 11.2.4. Strategic Developments
  • 11.2.5. SWOT Analysis
• 11.3. Danaher Corporation
  • 11.3.1. Company Overview
  • 11.3.2. Financial Overview
  • 11.3.3. Product Portfolio
  • 11.3.4. SWOT Analysis
• 11.4. LGC Group
  • 11.4.1. Company Overview
  • 11.4.2. Financial Overview
  • 11.4.3. Product Portfolio
  • 11.4.4. Strategic Developments
  • 11.4.5. SWOT Analysis
• 11.5. Thermo Fisher Scientific Inc.
  • 11.5.1. Business Overview
  • 11.5.2. Financial Overview
  • 11.5.3. Product Portfolio
  • 11.5.4. Strategic Developments
  • 11.5.5. SWOT Analysis
• 11.6. Randox Laboratories Ltd.
  • 11.6.1. Company Overview
  • 11.6.2. Product Portfolio
  • 11.6.3. Strategic Developments
  • 11.6.4. SWOT Analysis
• 11.7. SERO AS
  • 11.7.1. Company Overview
  • 11.7.2. Product Portfolio
  • 11.7.3. Strategic Developments
• 11.8. QuidelOrtho Corporation
  • 11.8.1. Business Overview
  • 11.8.2. Financial Overview
  • 11.8.3. Product Portfolio
  • 11.8.4. Strategic Developments
• 11.9. Streck LLC
  • 11.9.1. Company Overview
  • 11.9.2. Product Portfolio
  • 11.9.3. Strategic Developments
• 11.10. Microbiologics, Inc.
  • 11.10.1. Company Overview
  • 11.10.2. Product Portfolio
  • 11.10.3. Strategic Developments
• 11.11. Bio-Techne Corporation
  • 11.11.1. Company Overview
  • 11.11.2. Financial Overview
  • 11.11.3. Product Portfolio
  • 11.11.4. Strategic Developments

12. Appendix

• 12.1. Available Customization
• 12.2. Related Reports