In Vitro Diagnostics (IVD) Quality Controls Market by Application (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology) Source (Serum, Blood, Plasma Based Controls) Type (Instrument Specific & Third Party Controls) - Forecast to 2021 - 2026

Report Code: HCR 0553 Report Format: PDF + Excel

In Vitro Diagnostics (IVD) Quality Controls Market Overview

The In-Vitro Diagnostics (IVD) Quality Controls market size is estimated to reach $1,432 million by 2026, growing at a CAGR of 5.6% during the forecast period 2021-2026. In-vitro diagnostic tests are conducted on collected blood tissue samples in order to detect various communicable and non-communicable diseases. Moreover, they can also be used to monitor a patient’s health, cure diseases, and also enable medical professionals to identify the most effective treatment procedure or therapy for the patient. IVQ Quality Controls are products used to evaluate the quality and accuracy of these tests. Key technologies used for IVD quality controls include molecular diagnostics, blood-based controls, immunochemistry, and clinical chemistry. The rapid growth of the global geriatric population is anticipated to drive the market for IVD testing and quality control products. However, the lack of stringent regulations regarding quality controls in low and middle-income countries acts as a major challenge for the In Vitro Diagnostics (IVD) Quality Controls Industry.

Report Coverage

The report: “In Vitro Diagnostics (IVD) Quality Controls Market Forecast (2021-2026)”, by Industry ARC, covers an in-depth analysis of the following segments of the In Vitro Diagnostics (IVD) Quality Controls Market.

By Product and Service Type: Quality Control Products, Data Management Solutions, and Quality Assurance Services.
By Technology: Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation & Hemostasis, and Others.
By Manufacturer: Third-Party Controls and Original Equipment Manufacturer Controls.
By End User: Hospitals, Clinical Laboratories, Academic and Research Institutes, and Others.
By Geography: North America (U.S., Canada, and Mexico), Europe (Germany, UK, France, Italy, Spain, Russia, and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea, Australia & New Zealand, and Rest of Asia-Pacific), South America (Brazil, Argentina, and Rest of South America) and Rest of World (the Middle East and Africa). 

Key Takeaways

  • Geographically, the North American In Vitro Diagnostics (IVD) Quality Controls market accounted for the largest share in 2020 owing to the presence of well-developed healthcare infrastructure and increasing lifestyle diseases in the region.
  • The growing number of certified clinical laboratories providing IVD diagnostics is driving the market during the forecast period. However, the high cost of IVD quality control products is predicted to hamper growth, especially in developing regions.
  • Detailed analysis on the Strength, Weaknesses, and Opportunities of the prominent players operating in the market will be provided in the In Vitro Diagnostics (IVD) Quality Controls Report.

In Vitro Diagnostics (IVD) Quality Controls Market Share, By Geography, 2020(%) 

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In Vitro Diagnostics (IVD) Quality Controls Market Segment Analysis - By Technology

Based on Technology, the In Vitro Diagnostics (IVD) Quality Controls Market is segmented into Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation & Hemostasis, and other technologies. The Immunochemistry segment is anticipated to have the largest share of the market in 2020 and is poised to dominate the market during the forecast period 2021-2026 owing to the surge in cases of cancer. Immunochemistry involves the use of antibodies to identify certain antigen markers in tissue or blood sample. It helps predict the prognosis of tumors, diagnose tumors with unknown origin and also predict the patient response towards therapeutic procedures. The molecular diagnostics segment is projected to grow the fastest at a CAGR of 6.3% owing to the global rise in the Covid-19 Pandemic and the resulting demand for Polymerase Chain Reaction (PCR) tests for diagnosis.

In Vitro Diagnostics (IVD) Quality Controls Market Segment Analysis - By End User

The In-Vitro Diagnostics (IVD) Quality Controls Market based on End User can be further segmented into Hospitals, Clinical Laboratories, Academic and Research Institutes, and Others. The Hospitals segment accounted for the largest share of the market in 2020. The growth of the segment can be attributed to the rise in the number of admissions and consultation visits, the presence of more experienced healthcare professionals, and higher convenience for the patient. Hospitals provide services such as consulting, diagnostic testing, treatment, surgery, and therapy in a single location. The clinical laboratories segment is also anticipated to witness significant growth during the forecast period at a CAGR of 6.4% owing to the absence of a separate department for diagnosis in many hospitals in low and middle-income countries. Therefore, patients in the region may have to undergo IVD in these centers before the results can be shared with the medical professionals in the hospital.

In Vitro Diagnostics (IVD) Quality Controls Market Segment Analysis - By Geography

The In-Vitro Diagnostics (IVD) Quality Controls Market based on Geography can be segmented into North America, Europe, Asia-Pacific, South America, and the Rest of the World. The North American segment is projected to dominate the In Vitro Diagnostics (IVD) Quality Controls Market during the forecast period 2021-2026 with a market share of 36% owing to the presence of highly developed healthcare infrastructure, growing geriatric population, rising cases of cancer, and high patient awareness regarding the importance of early diagnosis and treatment. Moreover, the growth in the private and public expenditure on R&D is leading to the introduction of more innovative technologies in the region, thereby promoting growth. The Asia Pacific region is predicted to register the fastest growth owing to the increase in communicable and non-communicable diseases and growth in public healthcare funding in major emerging economies like China and India.

In Vitro Diagnostics (IVD) Quality Controls Market Drivers

Increase in Geriatric Population is Projected to Drive Market Growth

There were around 727 million persons over the age of 65 in 2020 and constituted 9.3% of the overall population. The geriatric population is predicted to reach 16% by 2050. This is anticipated to drive the market during the forecast period as the geriatric population is more prone to be diagnosed with diseases such as cancer. For instance, the median age of diagnosis is 62 years for breast cancer, 67 years for colorectal cancer, 71 years for lung cancer, and 66 years for prostate cancer. This is increasing the demand for IVD diagnostics quality controls to ensure the accuracy and reliability of the diagnosis being conducted to detect the disease.

The rise in Covid-19 infections is Anticipated to Boost Product Demand

The covid-19 pandemic has resulted in at least 219 million infections and more than 4.55 million deaths worldwide. The emergence of new variants such as the delta variant has posed a significant challenge for vaccinations and treatment. This is boosting the demand for IVD diagnostics such as PCR for accurately determining if an individual is infected. This is driving the market for IVD diagnostics quality control as high accuracy is demanded from the testing kits. False positives or false negatives may result in the patient not getting adequate treatment or cause them to unknowingly spread the virus to other individuals. 

In Vitro Diagnostics (IVD) Quality Controls Market Challenges

The High Cost of IVD Quality Control Equipment is Anticipated to Hamper Market Growth

The high cost of IVD quality control devices is hampering growth, especially in developing economies. The covid-19 pandemic has already caused a massive burden for the healthcare sector in these regions. It is estimated that developing regions require around $52 billion every 4 weeks to combat the pandemic. The World Bank projects that global economic growth will decrease by almost 8% with poorer countries being affected the most, and the United Nations projects that the pandemic will cost the global economy around 2 trillion dollars in 2020. This significantly decreases the purchasing power of healthcare facilities in the region to buy expensive IVD quality control equipment.

Absence of Stringent Regulations in Developing Regions is Projected to Limit Growth Opportunities

The absence of stringent regulations regarding diagnostic device quality and accuracy significantly decreases the demand for the IVD quality controls market in developing regions. Setting up a quality control system is expensive and the laboratory is also required to have dedicated personnel for the system. However, since the regulations are not stringent, most of the laboratories choose to avoid them altogether to save costs. For instance, in India, the National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to testing and calibration of clinical laboratories in the country. However, only around 202 labs across the country were NABL accredited for Covid-19 testing, of which only 15 were government laboratories.

In Vitro Diagnostics (IVD) Quality Controls Market Industry Outlook:

Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the In Vitro Diagnostics (IVD) Quality Controls Market. The top 10 companies of the industry include:

  1. Abbott Laboratories
  2. Bio-Rad Laboratories Inc
  3. F. Hoffmann-La Roche AG
  4. Quidel Corporation
  5. bioMerieux Inc
  6. Qnostics Ltd
  7. Microbiologics Inc
  8. SeraCare Life Sciences Inc
  9. Thermo Fisher Scientific
  10. ZeptoMetrix Corporation.

Partnerships/Product Launches:

  • In June 2021, Abbott announced that it has received CE Mark for its Panbio COVID-19 Antigen Self-Test. The test kit will be for sale directly to consumers for use in the detection of the SARS-CoV-2 virus in adults and children with or without symptoms. This is aimed to improve rapid testing for the virus in school, office, and home environments.
  • In October 2019, Thermo Fisher Scientific announced the launch of the Thermo Scientific Acrometrix BCR-ABL molecular quality control panel. This panel is intended for use as an external control panel for analytical validation of BCR-ABL test methods. The Acrometrix BCR-ABL Panel is the first full-process molecular control for challenging validated BCR-ABL assay performance.

Relevant Links:

Report Code: HCR 0549

Report Code: HCR 25557

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1. In Vitro Diagnostics (IVD) Quality Controls Market - Overview
    1.1 Definitions and Scope
2. In Vitro Diagnostics (IVD) Quality Controls Market - Executive Summary
    2.1 Market Revenue and Key Trends by Company
    2.2 Key trends by Product and Service Type
    2.3 Key trends by End User
    2.4 Key trends by Geography
3. In Vitro Diagnostics (IVD) Quality Controls Market – Comparative Analysis
    3.1 Company Benchmarking – Key Companies
    3.2 Financial Analysis – Key Companies
    3.3 Market Value Split by Key Companies
    3.4 Patent Analysis
    3.5 Pricing Analysis – Average Selling Price
4. In Vitro Diagnostics (IVD) Quality Controls Market - Startup Companies Scenario Premium
    4.1 Key Startup Company Analysis by
        4.1.1 Investment
        4.1.2 Revenue
        4.1.3 Venture Capital and Funding Scenario
5. In Vitro Diagnostics (IVD) Quality Controls Market – Industry Market Entry Scenario Premium Premium
    5.1 Regulatory Framework Overview
    5.2 New Business and Ease of Doing business index
    5.3 Case Studies of Successful Ventures
6. In Vitro Diagnostics (IVD) Quality Controls Market - Forces
    6.1 Market Drivers
    6.2 Market Constraints/Challenges
    6.3 Porters five force model
        6.3.1 Bargaining power of suppliers
        6.3.2 Bargaining powers of customers
        6.3.3 Threat of new entrants
        6.3.4 Rivalry among existing players
        6.3.5 Threat of substitutes
7. In Vitro Diagnostics (IVD) Quality Controls Market – Strategic Analysis
    7.1 Value Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle
8. In Vitro Diagnostics (IVD) Quality Controls Market – By Product and Service Type (Market Size –$Million/$Billion)
    8.1 Quality Control Products
        8.1.1 Serum/Plasma-Based Control
        8.1.2 Whole Blood-Based Controls
        8.1.3 Urine-Based Controls
        8.1.4 Other Controls
    8.2 Data Management Solutions
    8.3 Quality Assurance Services
9. In Vitro Diagnostics (IVD) Quality Controls Market – By Technology (Market Size –$Million/$Billion)
    9.1 Immunochemistry
    9.2 Clinical Chemistry
    9.3 Molecular Diagnostics
    9.4 Microbiology
    9.5 Hematology
    9.6 Coagulation & Hemostasis
    9.7 Others.
10. In Vitro Diagnostics (IVD) Quality Controls Market – By Manufacturer (Market Size –$Million/$Billion)
    10.1 Third-Party Controls
        10.1.1 Independent Controls
        10.1.2 Instrument-Specific Controls
    10.2 Original Equipment Manufacturer Controls
11. In Vitro Diagnostics (IVD) Quality Controls Market - By End User (Market Size –$Million/$Billion)
    11.1 Hospitals
    11.2 Clinical Laboratories
    11.3 Academic and Research Institutes
    11.4 Others.
12. In Vitro Diagnostics (IVD) Quality Controls Market - By Geography (Market Size –$Million/$Billion)
    12.1 North America
        12.1.1 U.S.
        12.1.2 Mexico
        12.1.3 Canada
    12.2 Europe
        12.2.1 U.K.
        12.2.2 France
        12.2.3 Germany
        12.2.4 Italy
        12.2.5 Spain
        12.2.6 Russia
        12.2.7 Rest of Europe
    12.3 Asia Pacific
        12.3.1 China
        12.3.2 India
        12.3.3 Japan
        12.3.4 South Korea
        12.3.5 Australia & New Zealand
        12.3.6 Rest of Asia Pacific
    12.4 South America
        12.4.1 Brazil
        12.4.2 Argentina
        12.4.3 Rest of South America
    12.5 Rest of the World
        12.5.1 Middle East
        12.5.2 Africa
13. In Vitro Diagnostics (IVD) Quality Controls Market - Entropy
14. In Vitro Diagnostics (IVD) Quality Controls Market – Industry/Segment Competition Landscape Premium
    14.1 Market Share Analysis
        14.1.1 Global Market Share cc– Key Companies
        14.1.2 Market Share by Region – Key companies
        14.1.3 Market Share by Countries – Key Companies
        14.1.4 Competition Matrix
        14.1.5 Best Practices for Companies
15. In Vitro Diagnostics (IVD) Quality Controls Market – Key Company List by Country Premium Premium
16. In Vitro Diagnostics (IVD) Quality Controls Market Company Analysis
    16.1 Company 1
    16.2 Company 2
    16.3 Company 3
    16.4 Company 4
    16.5 Company 5
    16.6 Company 6
    16.7 Company 7
    16.8 Company 8
    16.9 Company 9
    16.10 Company 10
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