In Vitro Diagnostics Quality Control Market Size, Share & Trends Analysis Report By Application, By Type (Quality Control, Quality Assurance Services), By End Use (Lab, Home-care, Hospital), And Segment Forecasts, 2019 - 2026

Industry Insights

The global In-Vitro Diagnostics quality control market size was valued at USD 905 million in 2018 and is anticipated to register a CAGR of 4.1% over the forecast period. An increasing number of accredited clinical laboratories worldwide and the presence of favorable regulatory bodies are expected to be the key factors boosting the market growth. Diagnostic laboratories are witnessing rapid development due to the high prevalence of diseases, such as diabetes, Cardiovascular Diseases (CVDs), and infectious diseases. Many private, as well as public laboratories, are undergoing laboratory accreditation procedures to meet industry standards, improve their procedural volume, and attract more patients. Laboratories accredited by CLIA are eligible for reimbursement through Medicare and Medicaid Services.

Regulatory bodies monitoring quality control and regular quality check of IVD devices and service providers include FDA for the U.S.; Medicines and Healthcare Products Regulatory Agency (MHRA) for the U.K.; Therapeutic Goods Administration (TGA) for Australia; Central Drug Standard Control Organization (CDSCO) for India; Health Canada for Canada; European Medicines Agency (EMEA) for Europe; Ministry of Health, Labor & Welfare (MHLW) for Japan; Ministry of Health, Labor & Welfare (MHLW) for Brazil; and Ministry of Health for South Africa.

The U.S. was the major region in the North America market in 2018 and will maintain dominance in the years to come. The strong presence of key companies in the country is one of the important factors supporting this growth. Moreover, Global Harmonization Task Force (GHTF) regulatory authorities like the U.S. FDA are encouraging convergence of regulatory systems for medical devices, which is anticipated to boost trade, while protecting public health through regulatory means.

The American Clinical Laboratory Association (ACLA) states that more than 7.5 billion lab tests are performed in the U.S. annually and 80% of clinical decisions are taken after lab testing. According to the International Diabetes Federation (IDF) in 2013, the number of tests performed was around 1.5 million in the U.S., and, in 2014, globally, 422 million people were suffering from the disease. Hence, increasing the usage of IVD services.

Application Insights

The immunology application segment led the global market in 2018. 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).

Molecular diagnostics is anticipated to be the fastest-growing segment at a CAGR of 5.2% over the forecast period. It is a set of complex tests for a medical diagnosis for all major viral, bacterial, and parasitic infections. The introduction of advanced technologies, such as Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS), has helped overcome the drawbacks of traditional systems. Some of the key pathogens routinely diagnosed using multiplex PCR, but not limited to, are HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachoma (genital infections), G. Lombardia, C. parvum (diarrheal diseases), and Leishmaniaspp (Leishmaniasis).

Type Insights

Quality Control (QC) was the largest revenue-generating segment in 2018 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. In U.S. QC 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.

Quality control in the laboratory is focused on ensuring that the results delivered to the patient are accurate. These checks are usually undertaken while installing an instrument, after servicing, changing reagent lots, and when the instrument readings are not in range. Authorities that regulate the quality of these IVDs include the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4). American Association for Laboratory Accreditation (A2LA) and Clinical Laboratory Improvement Amendments (CLIA) have enhanced the demand for IVD quality control.

End-Use Insights

Hospitals segment was the largest end-use segment in 2018 and is likely to retain the position in the future owing to a rising number of admissions and better reliability of healthcare professionals on clinical diagnosis for deciding treatment alternatives. Hospitals have a separate department for diagnostic services. The tests and instruments in this department need to be monitored regularly, which will augment the market growth. Moreover, third-party companies, such as Bio-Rad and Randox, entered into a collaboration with hospitals for providing reagents of QC. Other factors contributing toward its dominance include increasing demand for fast diagnostic tests in the critical care department and the presence of a large number of IVD instruments and reagent kits.

Home care is expected to be the fastest-growing end-use segment over the forecast period. Home care settings include a variety of devices, such as self-testing kits, Point-of-Care (POC) instruments used for near-patient bed testing, and IVD devices in assisted healthcare settings. Self-testing kits give ease of convenience for the patient who requires everyday testing and further reduces hospital visits. Home care products include blood glucose monitoring devices for diabetes patients, pregnancy detection kits/devices, urine analyzers, hemoglobin sensors, and hormone home tests. These devices pose a high risk due to their use by the layman. Pre- and post-marketing quality assurance and control are performed on these devices to ensure patient safety.

Regional Insights

North America was the largest regional market in 2018 and accounted for a revenue share of 47.62% owing to the presence of the U.S. FDA and many accredited diagnostic laboratories coupled with strong QC regulation systems. U.S. FDA along with GHTF regulates the North America region for the IVD QC market, from the production to pre- and post-marketing surveillance. The Asia Pacific is expected to be the fastest-growing region over the forecast period as the region has a high potential for this market due to the increasing number of product manufacturing companies.

Moreover, the Asia Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB) has been encouraging the use of IVDs. Thus, a rise in awareness for early and precise diagnosis fosters the product demand. Also, the presence of key regulatory authorities in the region, such as the Ministry of Health, Labor and Welfare (MHLW), Pharmaceuticals and Medical Devices Evaluation Agency (PMDA), and Ministry of Agriculture and Fisheries and Food, will support the market growth.

In Vitro Diagnostics Quality Control Market Share Insights

Some of the key companies in the global market include Siemens Healthcare GmbH; Roche Diagnostics; Alere, Inc.; Abbott Laboratories, Inc.; Bio-Techne; Hologic, Inc. (Gen-Probe); Qiagen N.V.; Bio-Rad Laboratories, Inc.; Quidel Corp.; Becton, Dickinson, and Company (BD); bioMerieux, Inc.; Sysmex Corp.; Sero AS; and Thermo Fisher Scientific, Inc. Customized products and application development are expected to be the key parameters for being competitive in this market. Companies also focus on M&A for expanding their businesses in developing regions to increase their market share.

Report Scope

Segments Covered in the Report

This report forecasts revenue and volume growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2026. For this study, Grand View Research has segmented the global In-Vitro Diagnostics quality control market report based on application, type, end-use, and region:

• Application Outlook (Revenue, USD Million, 2014 - 2026)

  • Immunochemistry

  • Hematology

  • Clinical Chemistry

  • Molecular Diagnostics

  • Coagulation

  • Microbiology

  • Others

• Type Outlook (Revenue, USD Million, 2014 - 2026)

  • Quality Control

    • Quality Controls, by Type

      • Plasma-based Control

      • Serum-based Control

      • Whole Blood-based Control

      • Others

    • Quality Controls, by Application

      • Immunochemistry

      • Hematology

      • Clinical Chemistry

      • Molecular Diagnostics

      • Coagulation

      • Microbiology

      • Others

  • Quality Assurance Services

  • Immunochemistry

  • Hematology

  • Clinical Chemistry

  • Molecular Diagnostics

  • Coagulation

  • Microbiology

  • Others

  • Data Management

    • Clinical Chemistry

    • Immunochemistry

    • Hematology

    • Molecular Diagnostics

    • Coagulation

    • Microbiology

    • Others

• End-Use Outlook (Revenue, USD Million, 2014 - 2026)

  • Hospitals

  • Laboratories

  • Home-care

  • Others

• Regional Outlook (Revenue, USD Million, 2014 - 2026)

  • North America

    • The U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • UAE

    • Saudi Arabia