The global in vitro diagnostics quality control market size was valued at USD 1.30 Billion in 2022 and is likely to reach USD 2.09 Billion by 2031, expanding at a CAGR of 5.4% during 2023 – 2031. The growth of the market is attributed to the existence of regulatory bodies and growing number of recognized clinical laboratories around the world.
In vitro diagnostics tests are done on samples of blood or tissue that are taken from human body. In vitro diagnostics are used for detection of diseases or other health conditions and for monitoring over health of person to treat, cure, or prevent diseases. It is also used in precision medicine to recognize those patients who are anticipated to get benefits from particular treatment or therapy. Diagnostic laboratories are rapidly developing due to rising prevalence of chronic diseases such as cardiovascular diseases (CVDs), diabetes, and infectious diseases. Several public and private laboratories are going through laboratory authorization procedures to fulfill the industry standards, expand procedural volume, and attract more patients. Laboratories accredited by Clinical Laboratory Improvement Amendments (CLIA) accredited are entitled for reimbursement through Medicaid and Medicare services.
There are some regulatory bodies present to monitor quality control and quality checking of IVD devices and service. Some of the key service providers are Therapeutic Goods Administration (TGA) for Australia, Health Canada for Canada; European Medicines Agency (EMEA) for Europe, Medicines and Healthcare Products Regulatory Agency (MHRA) for the U.K., Ministry of Health, Labor & Welfare (MHLW) for Japan, Ministry of Health for South Africa, Central Drug Standard Control Organization (CDSCO) for India, Ministry of Health, Labor & Welfare (MHLW) for Brazil, and Food and Drug Administration (FDA) for the U.S.
Market Trends, Drivers, Restraints, and Opportunities
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Rising number of clinical laboratories is anticipated to fuel the market growth in the coming years.
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Increasing prevalence of obesity and chronic diseases and rising demand for third party quality assessments are key drivers of the in vitro diagnostics quality control market growth.
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Increasing adoption of advanced diagnostic devices specifically in hospitals is projected to fuel the market expansion over the forecast period.
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High cost of in vitro diagnostics is key factor responsible for hampering the market expansion.
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Lack of skilled technicians handling the in vitro diagnostics quality control testing devices is anticipated to impede the market growth.
Scope of the Report
The report on the global in vitro diagnostics quality control market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes
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Details
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Report Title
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In Vitro Diagnostics Quality Control Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2022
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Historic Data
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2016–2021
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Forecast Period
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2023–2031
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Segmentation
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Applications (Immunochemistry, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation, Microbiology, and Others), Types (Quality Control and Quality Assurance Services), and End-users (Laboratories, Home-care, and Hospitals)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast
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Key Players Covered in the Report
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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.
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Market Segment Insights
Immunochemistry segment to account for a key share
Based on applications, the global in vitro diagnostics quality control market is divided into immunochemistry, hematology, clinical chemistry, molecular diagnostics, coagulation, microbiology, and others. The immunology application segment dominated the global market in 2019 and is expected to account for a key market share during the forecast period. Immunology is a study of molecular mechanism to understand the functions of the immune system. It mainly includes the mechanism of action of antibodies, antigens, and their interactions. Detection of infectious microorganisms such as fungus, bacteria, and viruses by sensing the existence of their toxins and coat antigens is Strategic application of immunochemistry. Early diagnosis and growing outbreaks of chronic and communicable diseases are key factors for driving the demand of immunochemistry including various types of Enzyme-Linked Immunosorbent Assay (ELISA).
On the other hand, the molecular diagnostics segment is expected to expand at a substantial CAGR during the forecast period. Molecular diagnostics include a set of complex tests including major bacterial, viral, and parasitic infections. To overcome the traditional systems, advanced technologies are introduced such as Next-Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR). The key pathogens regularly diagnosed using multiplex PCR which are H. influenza, S. pneumonia (respiratory tract infections), G. Lombardia, Leishmaniaspp, N. gonorrhea, C. trachoma (genital infections), and HIV, HSV (meningitis and encephalitis).
Quality control segment is expected to grow at a rapid pace
On the basis of types, the market is bifurcated into quality control and quality assurance services. In 2019 the quality control segment held a high revenue share and it is projected to grow at a rapid pace during the forecast period. Quality control (QC) normally involves problems detection, monitoring work process, and doing correction in products or services before delivery. Statistical quality control is a process of monitoring analytical performance of clinical laboratory testing processes.
Quality control checks are performed at the time of installation of instrument, changing reagent lots, readings are not in range, and after servicing. There are many regulatory authorities such as American Association for Laboratory Accreditation (A2LA), Clinical Laboratory Improvement Amendments (CLIA) and European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) have increased demand of IVD quality control.
Hospitals segment to hold a large market share
Based on end-users, the global in vitro diagnostics quality control market is divided into laboratories, home-care, and hospitals. The hospitals segment is projected to hold a large market share in the coming years owing to increasing number of admissions of healthcare professionals and improving reliability on clinical diagnosis to decide treatment alternatives in hospitals. For diagnostic services, hospitals are preferred as they conduct regular monitoring of tests and install a variety of advanced instruments. Moreover, growing demand for fast diagnostic tests as well as the wide availability of a large number of IVD instruments and reagent kits are some key factors responsible for the segment growth.
The home-care segment is projected to grow at rapid pace during the forecast period. Home-care settings comprise of different devices such as Point-of-Care (POC) instruments, IVD devices and self-testing kits. Self-testing kits helps patients to reduce hospital visits and ease for everyday testing. Home-care products includes a range of devices and kits such as hemoglobin sensors, pregnancy detection kits/devices, hormone home tests, urine analyzers, and blood glucose monitoring devices for diabetes patients.
North America to account for a key share
On the basis of regions, the global in vitro diagnostics quality control market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America dominated the market share in 2019, representing a revenue share of more than 44.7% of the global market. The presence of key global players and early adoption of advanced technology in the healthcare and medical sector especially in the US are key driving factors for the regional market growth. Furthermore, growing medical devices convergence of regulatory systems is boosted by Global Harmonization Task Force (GHTF) regulatory authorities such as the US FDA, which is projected to enhance the market growth.
The market in Asia Pacific, on the other hand, is anticipated to grow at a fast pace during the forecast period owing to growing awareness of the IVD quality control and several government agencies’ initiatives that encourage the development of advanced healthcare facilities in the region. For instance, the use of IVDs is widely encouraged by several bodies such as the Asia Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB), which play key roles in the regional market growth.
Segments
Applications
- Immunochemistry
- Hematology
- Clinical Chemistry
- Molecular Diagnostics
- Coagulation
- Microbiology
- Others
Types
- Quality Control
- Quality Assurance Services
Products
- Hospitals
- Laboratories
- Home-care
Regions
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
- 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
- Thermo Fisher Scientific, Inc.
Competitive Landscape
Some of the key market players competing in the global in vitro diagnostics quality control market are 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.
Major market players are constantly focusing on application development and customized products as the market is increasingly competitive. Moreover, several companies are spending a huge amount on marketing and advertisement especially in developing countries for the expansion of their business operations and market share.
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