Global In Vitro Diagnostics (IVD) Quality Control Market to Reach USD 113.85 billion by 2030 growing at a CAGR of 6.00% During The Forecast Period 2023-2030

18 May 2023

Contrive Datum Insights

The Global In Vitro Diagnostics (IVD) Quality Control Market size was valued at USD 92.08 billion in 2021. The market is projected to grow from USD 71.43 Billion in 2022 to USD 113.85 Billion by 2030, exhibiting a CAGR of 6.0% during the forecast.

The increase in the number of accredited clinical laboratories across the globe acts as one of the major factors driving the growth of in vitro diagnostics (IVD) quality control market. The increase in the geriatric population and subsequent growth in the prevalence of chronic and infectious diseases accelerate the market growth. The market is also affected by the rise in the number of accredited clinical laboratories and the rise in the use of point-of-care (POC) instruments in developed areas.

Browse Market data Tables and Figures spread through Pages and in-depth TOC on " Global In Vitro Diagnostics (IVD) Quality Control Market Size, Share & Trends Estimation Report By Outlook, By Region, And Segment Forecasts, 2023 - 2030" View detailed Table of Content here- https://www.contrivedatuminsights.com/product-report/in-vitro-diagnostics-ivd-quality-control-market-9357

Segmentation Overview:

Deployment Outlook

Quality Control (QC) was the largest revenue-generating segment in 2021 and is anticipated to be the fastest-growing segment over the forecast period. IVDs fall under the category of medical devices and, hence, are regulated for quality by the FDA refers to the procedures monitoring work processes, detecting problems, and making corrections before delivery of products or services. Statistical QC is a major procedure for monitoring the analytical performance of clinical laboratory testing processes. Controls, such as calibrators and known concentration reagents and buffers are used for monitoring the precision and accuracy of instruments.

Organization Size Outlook:

The immunology application segment led the global market in 2021. Immunology includes the study of the molecular mechanism for understanding the function of the immune system. It majorly involves the mechanism of action of antigens, antibodies, and their interactions. Key applications of the immunochemistry include detection of infectious microorganisms, such as viruses, bacteria, and fungus, by detecting the presence of their toxins and coat antigens. A rise in the outbreaks of communicable and chronic diseases and the need for its early diagnosis are the key factors driving the demand for immunochemistry methods involving different types of Enzyme-Linked Immunosorbent Assay (ELISA).

Regional Analysis:

North America dominated the global market for in vitro diagnostic quality control in 2021 and is anticipated to maintain its dominance throughout the forecast period, owing to rising demand for technologically advanced multi-assay controls and stringent regulations governing the use of controls. On the basis of the assessment timeline, the APAC region is estimated to be a rapidly developing region, as it has immense market potential due to the increasing number of product manufacturing companies. Additionally, the Asia Pacific Federation of Clinical Biochemistry and Laboratory Medicine is expanding the use of IVD. Increasing awareness of the importance of early and accurate diagnosis drives product demand and, in turn, the IVD quality control market in the region. In addition, major regulatory authorities in the region, including the Ministry of Health, Labor, and Welfare (MHLW), the Pharmaceutical and Medical Device Evaluation Agency (PMDA), and the Ministry of Agriculture, Fisheries, and Food, will support the development of the market.

Scope of Report:

Market Dynamics:

Driver: Accelerating adoption of third-party quality assurance

On the market, IVD quality controls are produced by either IVD instrument manufacturers or independent manufacturers. Two categories of quality controls are available from independent manufacturers: instrument-specific controls and third-party controls. Third-party controls provide a number of benefits, including a decreased need for multiple instrument-specific controls, versatility, an extended shelf life, and utility in long-term QC monitoring.

Innovative multi-analyte, multi-instrument, third-party controls allow laboratories to assure the accuracy and dependability of multiple testing parameters with a single control, thereby reducing the time and expense of quality control procedures. In addition, numerous regulatory organizations, including the Clinical and Laboratory Standards Institute (CLSI), the National Association of Testing Authorities, Australia (NATA), the College of American Pathologists (CAP), the Quality Council of India (QCI), and the Clinical Laboratory Improvement Amendments (CLIA), recommend the use of third-party quality controls. This trend is anticipated to contribute to market expansion in the coming years.

Restraints: Unfavorable reimbursement scenario for IVD tests

In the majority of the world's nations, the reimbursement scenario for IVD tests is unfavorable. These include cancer tests and molecular tests, as well as targeted NGS analysis panels containing five to fifty genes. These developments are anticipated to have a negative impact on the molecular and genetic testing market in the United States, thereby impeding the expansion of the IVD quality control market.

According to MedPAC, reimbursement for medical diagnostics has decreased by 40% over the past four decades. In addition to budgetary considerations in hospitals and clinical laboratories, this is a significant barrier to the implementation of novel diagnostic techniques in clinical laboratories, as reimbursement for these tests is low.

Opportunities: The increasing demand for multi-analyte controls presents a market opportunity.

A new spectrum of multi-analyte and multi-instrument controls have been developed as a result of technological advances. These cutting-edge controls consolidate multiple instrument-specific controls into a single control, allowing clinical laboratories to save money and expedite QC procedures.

Multi-analyte controls on the market for immunoassay testing enable laboratories to conduct quality control tests for fifty or more parameters in the same serum, including cardiac and tumor markers, hormones, therapeutic pharmaceuticals, kidney functions, and vitamins. The rising demand for these controls is therefore anticipated to provide substantial growth opportunities for market participants in IVD quality control.

Challenge: Lack of regulations for clinical laboratory accreditation in a number of emerging nations present obstacles.

In many emerging nations around the world, clinical laboratory accreditations are not mandated by law. In India, for instance, accreditation of clinical laboratories is not required. A 'Shops and Establishment' license is required for establishing a new medical laboratory in the country. This license does not guarantee the laboratory's implementation of quality control procedures. This means the laboratory can operate without a quality control system.

In many nations, QC products are governed by private organizations and voluntary accreditation bodies. The Indian government has initiated a voluntary accreditation program through its registered entity, the National Accreditation Board for Testing and Calibration Laboratories (NABL), despite the absence of mandatory accreditation. Consequently, the absence of regulations mandating QC mechanisms for all diagnostic tests, as well as noncompliance with existing regulations, is a significant hindrance to the growth of the IVD quality control market.

Key Segments Covered:

Top Market Players:

Siemens Healthcare GmbH
Roche Diagnostics
Alere Inc.
Abbott Laboratories Inc.
Bio-Techne
Hologic Inc.
Others

By Type:

Quality Controls
Data Management
Quality Assurance Services
Other

By Application:

Clinical Chemistry
Hematology
Immunoassay
Molecular Diagnostics
Microbiology
Coagulation/Hemostasis
Others

By Industries

Government
Healthcare
Retail
Manufacturing
Others
BFSI
IT and telecom

By End-User:

Hospitals
Clinical/ Reference Laboratories
Research and Academic Institutes
Others

Regional Outlook (Revenue, USD Million, 2017 - 2030)

North America

US
Canada
Mexico
Rest of North America

Europe
- Germany
- France
- Italy
- Spain
- UK
- Nordic Countries
  - Denmark
  - Finland
  - Iceland
  - Sweden
  - Norway
- Benelux Union
  - Belgium
  - The Netherlands
  - Luxembourg
- Rest of Europe
Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Southeast Asia
  - Indonesia
  - Thailand
  - Malaysia
  - Singapore
  - Rest of Southeast Asia

Rest of Asia-Pacific

The Middle East & Africa

Saudi Arabia
UAE
Egypt
South Africa
Rest of the Middle East & Africa

Latin America

Brazil
Argentina
Rest of Latin America

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