Number of pages: 100 | Report Format: PDF | Published date: March 22, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global in-vitro diagnostics standards and controls market was valued at US$ 1.10 billion in 2022 and is expected to register a revenue CAGR of 4.9% to reach US$ 3.57 billion by 2031.
In-vitro Diagnostics Standards and Controls Market Fundamentals
In-vitro diagnostic tests (IVDs) are performed on blood tissue samples to diagnose infectious diseases. Furthermore, they may monitor a patient’s health, cure illnesses, and help medical practitioners determine the best treatment process or therapy. IVDs are intended for collecting, preparing, and testing human body samples. These devices include reagents, equipment, software, sample-collecting devices and receptacles, calibrators, control materials, and accessories. These devices can be used individually or as part of a system (ISO 14971:2007 - H1 - General). The manufacturer designs them to investigate human body specimens to offer information for diagnostic, monitoring, or compatibility reasons (ISO 14971:2007). IVDs are applied to biological specimens or components derived from biological specimens. They specify qualitative or quantitative measuring techniques for a single biomarker or group of biomarkers.
IVQ quality controls are products used to assess these tests’ accuracy and quality. Molecular diagnostics, blood-based controls, immunochemistry, and clinical chemistry are key technologies utilized for IVD quality control. Quality control products, data management systems, and quality assurance services are the three primary categories of goods in in-vitro diagnostics quality control. Serum/plasma-based control products, whole blood-based control products, urine-based control products, and other control goods made by IVD instrument makers to cure, mitigate, or treat via in-vitro diagnostics quality control are examples of quality control products. Among the numerous manufacturer types are IVD instrument makers and third-party quality control manufacturers, which are used in various applications, such as clinical chemistry, hematology, immunoassay, molecular diagnostics, microbiology, coagulation, and hemostasis. It is used in multiple settings, including hospitals, clinical labs, research, and academic institutions.
Quality control offers confidence that the IVD will meet safety and performance criteria. IVDs must be appropriate for user needs and their intended therapeutic usage. As a result of the risk analysis process, quality control provides a risk mitigation method by proving the device’s or process’s performance (ISO 14971:2007 - A.2.4.2 Intended use and identification of features linked to the safety of the medical device). Quality control facilitates product or process monitoring and measurement by finding nonconformities or biases that necessitate corrective or preventative measures in the devices or changes to the QMS. Validated statistical quality control processes are important for keeping risk acceptable.
In-vitro Diagnostics Standards and Controls Market Dynamics
The increasing cases of infectious illnesses, such as HIV and cancer, drive the revenue growth of the in-vitro diagnostics quality control market. Infectious diseases are widespread and are caused by the spread of pathogens, such as viruses, bacteria, fungi, or parasites. The rising prevalence of infectious diseases, such as HIV and cancer, necessitates novel diagnostic testing goods and services for effective treatment. This drives demand for in-vitro diagnostics quality control, ensuring the accuracy, performance, and quality of test equipment and findings. For instance, according to a World Health Organization estimate, the number of HIV cases was expected to reach 37.7 million by 2020. Also, about 1.0 million people died from HIV in 2020, with 1.5 million developing HIV AIDS. Thus, the rising prevalence of infectious illnesses, such as HIV and cancer, is predicted to propel the in-vitro diagnostics quality control market throughout the forecast years.
The in-vitro diagnostics standards and controls market are being shaped by increased research and development conducted to develop, introduce, and optimize goods and processes. For instance, Microbiologic, a US-based biotechnology business, launched a novel SARS-CoV-2 quality control instrument for antigen point-of-care (POC) testing in August 2021. The immobilized SARS-CoV-2 Whole Virus Antigen Control is highly concentrated and retains fully intact genomic and viral proteins, making it suitable for both antigen testing and nucleic acid amplification experiments. SARS-CoV-2 Whole Virus Antigen Control from Microbiologic is the latest addition to the company’s extensive IVD quality controls and research use-only products developed to help in the current COVID-19 pandemic response.
In-vitro Diagnostics Standards and Controls Market Ecosystem
The global in-vitro diagnostics standards and controls market has been analyzed from five perspectives: products & services, application, manufacturer type, end user, and region.
In-vitro Diagnostics Standards and Controls Market by Product & Services
Based on products & services, the global in-vitro diagnostics standards and controls market has been segmented into quality control products, data management solutions, and quality assurance services.
The quality control products segment is expected to be the most profitable and fastest-growing segment throughout the projected period. IVDs are considered medical equipment and are thus subject to FDA quality control. In the United States, quality control refers to the methods for monitoring work processes, recognizing errors, and making repairs before delivering products or services. Statistical quality control is an important approach for assessing the analytical performance of clinical laboratory testing operations. Instrument precision and accuracy are monitored using controls, such as calibrators, known concentration reagents, and buffers.
Quality control in the laboratory aims to ensure that the findings presented to the patient are correct. These tests are often performed when an instrument is installed, after service, when reagent lots are changed, and when the instrument values are out of range. The European Communities Confederation of Clinical Chemistry and Laboratory Medicine is one of the organizations that oversee the quality of these IVDs (EC4). The demand for IVD quality control has increased due to the American Association for Laboratory Accreditation (A2LA) and Clinical Laboratory Improvement Amendments (CLIA).
In-vitro Diagnostics Standards and Controls Market by Application
Based on application, the global in-vitro diagnostics standards and controls market has been segmented into clinical chemistry, immunochemistry, hematology, molecular diagnostics, coagulation, microbiology, and others.
The molecular diagnostics segment is expected to show lucrative revenue growth during the forecast period. It is a collection of complicated tests to diagnose all major viral, bacterial, and parasite illnesses. The emergence of modern technologies, such as polymerase chain reaction (PCR) and next-generation sequencing (NGS), has assisted in overcoming the shortcomings of conventional methods. HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachoma (genital infections), G. Lombardia, C. parvum (diarrheal disorders), and Leishmaniaspp. are among the main pathogens commonly detected by multiplex PCR (Leishmaniasis).
The immunochemistry segment is likely to grow at a faster rate. Immunology studies molecular mechanisms to better understand how the immune system works. It is primarily concerned with the mechanisms of action of antigens, antibodies, and their interactions. Immunochemistry’s key applications include identifying infectious microbes, such as viruses, bacteria, and fungi, by detecting the presence of their toxins and coat antigens. The rise in infectious and chronic illness epidemics and the necessity for early detection are driving the need for immunochemistry approaches utilizing various types of enzyme-linked immunosorbent assays.
In-vitro Diagnostics Standards and Controls Market by Manufacturer Type
Based on manufacturer type, the global in-vitro diagnostics standards and controls market has been segmented into third-party control and original equipment manufacturer control.
The third-party control segment is expected to dominate the market during the forecast period. This segment’s rapid rise can be attributable to regulatory organizations encouraging certain measures. To get impartial quality inputs and findings, laboratories propose using third-party controls rather than those provided by instrument or reagent manufacturers.
In-vitro Diagnostics Standards and Controls Market by End User
Based on end user, the global in-vitro diagnostics standards and controls market has been segmented into home care, laboratory, hospitals, and others.
The hospital segment is likely to dominate the market during the forecast period due to increased admissions and reliance on clinical diagnosis by healthcare providers in choosing treatment options. A distinct department in hospitals provides diagnostic services. The tests and instruments in this section must be monitored regularly, which will help the market flourish. Also, third-party firms like Bio-Rad and Randox have partnered with hospitals to provide quality control reagents. Additional factors contributing to its domination include the increased need for rapid diagnostic tests in the critical care department and the availability of various IVD devices and reagent kits.
The home care segment is predicted to register growth at the fastest revenue CAGR throughout the projected period. Devices used in home care settings include self-testing kits, POC equipment used for near-patient bed testing, and IVD devices in assisted healthcare settings. Self-testing kits provide convenience for those who require routine testing and minimize hospital visits. Some tests used at home include blood glucose monitoring devices, pregnancy detection kits/devices, urine analyzers, hemoglobin sensors, and hormone home testing.
In-vitro Diagnostics Standards and Controls Market by Region
Based on region, the global in-vitro diagnostics standards and controls market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America is expected to dominate the market during the forecast period due to the presence of the US FDA, several recognized diagnostic laboratories, and robust quality control regulating systems. In collaboration with the GHTF, the US FDA oversees the market in North America, from manufacturing to pre- and post-marketing surveillance.
Asia Pacific is predicted to be the fastest-growing region throughout the projection period due to the expanding number of product manufacturing enterprises in the region. The rising prevalence of chronic, infectious, and genetic disorders worldwide drives market expansion. For instance, according to IDF statistics from 2022, about 74.1 million persons in India were diagnosed with diabetes in 2021. These statistics are expected to rise to 92.9 million by 2030 and 124.8 million by 2045, respectively. Thus, the increased prevalence of diabetes in the population is predicted to raise the need for in-vitro diagnostics for detecting blood glucose. This is expected to increase demand for effective in-vitro diagnostics and the necessity for stringent quality control in Asia Pacific.
According to the Canadian Cancer Society’s 2022 statistics, around 28,600 Canadian women are predicted to be diagnosed with breast cancer in 2022, accounting for 25% of all new cancer cases in women in 2022. The high prevalence of breast cancer in the population is predicted to boost the need for effective diagnostic tests, driving demand for IVD equipment and kits. As the need for diagnostic kits and devices grows, so does the requirement for quality control, which will likely drive market expansion throughout the forecast period.
In-vitro Diagnostics Standards and Controls Market Competitive Landscape
The rising number of product releases in the area will likely enhance the demand for strict and thorough quality control of diagnostic equipment to provide correct test findings, which is predicted to fuel regional market expansion. Bruker Corporation, for instance, announced plans to develop its market-leading MALDI Biotyper (MBT) platform and introduce novel multiplex PCR infectious disease tests based on its patented LiquidArray technology in April 2022. The FluoroType Mycobacteria PCT test employs advanced LiquidArray technology to differentiate 31 clinically relevant non-tuberculous mycobacteria and the Mycobacterium TB complex from cultures in a single test. In addition, ThermoFisher Scientific will debut the Applied Biosystem QuantSudio Absolute Q-Digital PCR System in October 2021, which is meant to offer highly accurate findings in genetic analysis.
The prominent market players in the global in-vitro diagnostics standards and controls market include:
In-vitro Diagnostics Standards and Controls Market Strategic Developments
North America is the key revenue growth region in the global in-vitro diagnostics standards and controls market.
The in-vitro diagnostics standards and controls industry is expected to reach US$ 1.69 billion by 2031.
The in-vitro diagnostics standards and controls market is expected to register a revenue CAGR of 4.9% during the forecast period.
Some prominent market players in the global in-vitro diagnostics standards and controls market include Siemens Healthcare GmbH, Bio-Rad Laboratories, Inc., and Becton, Dickinson, and Company.
The quality control segment leads the global in-vitro diagnostics standards and controls market.
*Insights on financial performance are subject to the availability of information in the public domain