In Vitro Diagnostics Quality Control Market: Global Overview and Forecast (2024-2030)

In Vitro Diagnostics Quality Control Market size was valued at USD 1.86 Bn. in 2023 and the market is expected to grow at 5.5% from 2024 to 2030, reaching nearly USD 2.71 Bn.
Global In Vitro Diagnostics Quality Control Market Overview:
In Vitro Diagnostics (IVD) is a crucial and rapidly growing component of the global healthcare system, adding value to patients, medical professionals, and the industry while also improving population well-being. IVD quality controls are samples/materials that are used to verify the dependability of the IVD testing system in order to assure the correctness of test findings and to assess the influence of factors such as environmental conditions and operator performance on test results.

In Vitro Diagnostics Quality Control market's growth include an increase in the global incidence of infectious illnesses, HIV, and malignancies, which demand innovative diagnostic methods for effective treatment and quality controls to monitor their performance. According to the Joint United Nations Programme on HIV and AIDS (UNAIDS), 24.5 million HIV patients globally received antiretroviral medication in 2019. Likewise, greater government involvement in controlling infectious disease outbreaks, as well as an increase in demand for quality evaluation support and fast diagnosis systems, are anticipated to contribute to the global In Vitro Diagnostics Quality Control market's growth during the forecast period.

The existence of supportive regulatory authorities and a rising number of licensed clinical laboratories globally are expected to be significant drivers driving In Vitro Diagnostics Quality Control market growth during the forecast period. Diagnostic research labs are experiencing rapid evolution due to the increasing prevalence of chronic conditions, such as diabetes, Cardiovascular Diseases (CVDs), and infectious diseases. Many private and governmental laboratories are going through laboratory certification procedures in order to fulfill industry standards, increase procedural volume, and attract more patients. CLIA-accredited laboratories are eligible for Medicare and Medicaid payments.To know about the Research Methodology :- Request Free Sample Report
In Vitro Diagnostics Quality Control Market Dynamics:
Growing authorized clinical laboratories across the globe
The growing global burden of various diseases has resulted in an increase in the number of laboratory tests. To fulfill this need, the number of laboratories in the public and commercial sectors has increased rapidly. With the development of the COVID-19 pandemic in December 2019, the demand for diagnostic testing has grown. Many government agencies have established additional laboratories in response to the outbreak and to increase laboratory testing capacity.

In most countries, clinical laboratories must get regulatory body certification before performing diagnostic tests. However, certification to ISO 15189:2012 and other comparable standards is becoming essential in a number of countries. Authorities analyze a laboratory's quality system and competency based on specified requirements during the accreditation procedure. European nations such as Belgium, France, Hungary, Ireland, and Lithuania require certification for numerous laboratory tests, although Finland, the Netherlands, Sweden, Switzerland, and the United Kingdom have nearly completed clinical laboratory certification.
High costs of Quality Control (QC) systems and additional expenses
Installing a QC process in a clinical laboratory necessitates substantial expenditure. Laboratories must also keep committed employees on hand to administer the QC system. Also, regardless of the number of tests completed, QC procedures entail equal expenses. As a result, the expense of implementing QC processes is prohibitively expensive for clinical laboratories that perform limited quantities of diagnostic tests. This, along with economic restrictions in many hospitals and laboratories in both developed and emerging countries, is expected to result in a decrease in the adoption of In Vitro Diagnostics Quality Control market

In addition, the expense of data management solutions to handle QC data and QA services for independent diagnostic test assessment raises the total cost for end users. Small hospitals and laboratories may be unable to handle the higher expenditures even after deploying data management technologies.
Increasing need for multi-analyte controls
Technological developments have resulted in the creation of a new type of multi-analyte and multi-instrument controllers. These unique controls combine many instrument-specific controls into a single control, allowing clinical laboratories to save money and significantly reduce the time required for QC operations.

Multi-analyte controls, which may be utilized with numerous reagents and devices, are important in screening and diagnostic operations. Several multi-analyte controls are currently available on the market, including Liquichek Tumor Marker Control (Bio-Rad Laboratories), Acusera Infectious Disease (Serology) Controls (Randox Laboratories), AcroMetrix Multi-Analyte Controls—Transplant (Thermo Fisher Scientific), and ACCURUN 1 Series 4400 Multi-Analyte Positive Control (Accura) (SeraCare Life Sciences). Previously, laboratories had to keep more than thirty unique controls in order to execute QC operations; however, with the advancement of multi-analyte controls, clinical laboratories can now provide reliable and exact test findings with only one or two multi-analytes.

Multi-analyte controls on the market for immunoassay testing assist laboratories in performing QC tests for fifty or more parameters in the same blood, including cardiac and tumor indicators, hormones, therapeutic medicines, renal functions, and vitamins. Additionally, these controls do not need to be updated with reagent batches, allowing for long-term QC monitoring. The growing popularity of these controls is thus expected to continue providing considerable growth opportunities for IVD quality control market players.
Increasingly complicated regulatory procedure
IVD organizations have experienced challenges in recent years as a result of an increasingly complicated regulatory procedure. For more than two decades, the FDA has stressed its regulatory jurisdiction over LDTs and associated goods while exercising enforcement discretion over such tests. However, in recent years, the FDA has stated that further regulation of LDTs and related devices is required, and the agency intends to produce a guideline paper on the subject. The Quality System Rule (QSR), 21 CFR Part 820, and the labeling regulation, 21 CFR 809.10, apply to both tested and unassayed QC items.

The FDA's standards, notably for 510(k) notifications, have grown in recent years, necessitating more data and information than previously. This move, which results in unexpected premarket submission requirements, is particularly detrimental to IVD producers that require 510(k) approval.
In Vitro Diagnostics Quality Control Market Segment Analysis:
By Technology, the Immunochemistry segment dominated the market with the largest market share in 2023 and is expected to maintain its dominance at the end of the forecast period. Immunochemistry diagnostics are expected to hold the largest market share in the IVD quality controls market because of their value in determining the molecular mechanism of various antigens, antibodies, and their interactions that affect the immune system.

The rapid growth for the segment is due to an increase in the prevalence of various autoimmune disorders, infections, and communicable and chronic diseases among all age groups in recent years, necessitating earlier diagnosis with greater accuracy and precision for better treatment, which is driving the global market growth.

Immunochemistry incorporates techniques from anatomy, immunology, and biochemistry. Protein-based tests are commonly used to identify antigen-antibody responses. In 2020, this IVDs segment earned a revenue of EUR 1.18 billion. It is divided into several subcategories, including the diagnosis of anemia, therapeutic medication monitoring, and the detection of drug misuse. The identification of hormone levels in endocrinology pertains to thyroid function, fertility levels, and pregnancy. Allergies and autoimmune illnesses can also be detected with testing. Tumor marker assays enable the identification of cancer subtypes and mutations.

The molecular diagnostics segment is expected to grow at the fastest rate during the forecast period, owing to an increased usage of innovative tools such as Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS). However, with a rising global prevalence of disease, greater research on cancer biomarkers, enhanced diagnosis infrastructure, and other applications in detecting multiplex PCR, HIV, respiratory tract infections, and genital infections, the global market revenue is expected to grow during the forecast period.

Molecular diagnostics has emerged as one of the IVD industry's largest and fastest-growing segments. This progress is being driven by the emergence of advanced instruments like real-time polymerase chain reaction (PCR) and next-generation sequencing (NGS), which allow for the amplification and decoding of genetic and epigenetic information.

The quantitative real-time polymerase chain reaction (qPCR) is a technique for amplification of genetic information contained in RNA and DNA. This approach is presently utilized in diagnostics to detect pathogen nucleic acids like viruses and bacteria, cancer mutations, and other genetic abnormalities. In particular, the diagnosis of infectious disorders has improved. Without sequencing, quantitative real-time polymerase chain reaction enables the quantification and genotyping of viruses such as the hepatitis B virus using a distinctive melting curve. Pathogens that are newly developing, such as novel strains of the influenza virus, can also be detected rapidly.

By End-User, the Hospitals segment held the largest revenue share in 2023 and is expected to grow at a CAGR of 4.9% during the forecast period. The growth is attributed to an increase in admissions and improved clinical diagnostic reliability among healthcare experts in determining treatment options. Diagnostic services are provided by distinct departments in hospitals. The tests and instruments in this section must be monitored regularly, which would help the market to grow.

Moreover, third-party organizations like Bio-Rad and Randox have formed partnerships with hospitals to provide QC reagents. Another reason contributing to its domination is the growing demand for rapid diagnostic tests in the critical care department, as well as the existence of a significant number of IVD devices and reagent kits.

In addition, the Home care segment is expected to be the fastest-growing end-use segment during the forecast period. Devices used in home care settings include self-testing kits, Point-of-Care (POC) equipment used for near-patient bed testing, and IVD devices in assisted healthcare settings. Self-testing kits provide convenience for patients who require routine testing and help to reduce hospital visits.

Diabetes patients can use blood glucose monitoring devices at home, as well as pregnancy detection kits/devices, urine analyzers, hemoglobin sensors, and hormone home testing. Because they are used by laypeople, these gadgets represent a great danger. These devices are subjected to pre- and post-marketing quality assurance and control to assure patient safety.
In Vitro Diagnostics Quality Control Market Regional Insights:
North American market held the largest market share in 2023 and is expected to dominate the In Vitro Diagnostics quality controls market, with the highest CAGR of about 5.1% during the forecast period. The region's market is expected to be driven by the region's high adoption rate of advanced infrastructure, a growing number of diagnostic facilities, and recognized clinical laboratories.

In North America, the United States dominated the market due to the increased incidence of chronic diseases in 2021. For example, according to a 2020 U.S. Department of Health and Human Services report, approximately 37,832 people in the United States were diagnosed with HIV in 2018, and 38,000 new HIV infections continue to occur in the United States and 6 dependent areas each year, resulting in the rapid spread of various infectious diseases such as meningitis and urinary tract infections, fueling the market and contributing its outstanding share of global market revenue during the forecast period.

One of the primary reasons driving the growth of the market is the prominent presence of prominent companies in the nation. Meanwhile, Global Harmonization Task Force (GHTF) regulatory agencies such as the United States Food and Drug Administration (FDA) are supporting the convergence of regulatory systems for medical devices, which is expected to enhance commerce while preserving public health through regulatory measures.

According to the American Clinical Laboratory Association (ACLA), more than 7.5 billion lab tests are done in the United States each year, and lab testing influences 80% of clinical decisions. According to the International Diabetes Federation (IDF), the number of tests done in the United States in 2013 was over 1.5 million, and 422 million individuals globally were affected by the condition in 2014. As a result, the use of IVD services is growing.

The Asia-Pacific market is expected to grow at a CAGR of 4.2% during the forecast period. The increasing occurrence of infectious illnesses, such as the COVID-19 epidemic, has boosted R&D spending, strengthening regional market trends. With the pressing need to solve current healthcare issues, the need for accurate in vitro diagnostics solutions is growing. Various measures are being undertaken by regional governments to stimulate indigenous development of better testing equipment.

In addition, Companies are collaborating with regional governments to provide quality service to an increasing patient population. For example, Thermo Fisher Scientific announced in August 2022 that it has partnered with India's National Forensic Sciences University (NFSU) to establish a first-of-its-kind diagnostic center in Gujarat. The pharmaceutical conglomerate would outfit the facility with real-time PCR devices, analyzers, and other forensic testing equipment.

The China market held the largest revenue share in 2023 and is expected to dominate the Asia-Pacific regional market with a CAGR of 4.1% during the forecast period. The growth is attributed to the increasing emphasis on delivering high-quality treatment to all citizens across the country. The growing proliferation of independent diagnostic facilities, hospitals, and academic institutes is to blame for the regional market's consistent rise. The country's government financing for healthcare infrastructure and the introduction of new diagnostic kits would drive market growth. Several nations, like India, Japan, and China, are witnessing an increase in demand for in vitro diagnostic tests as the senior population is growing and the frequency of infectious and chronic illnesses rises.
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In Vitro Diagnostics Quality Control Market


Report Coverage
Details


Base Year:
2023
Forecast Period:
2024-2030


Historical Data:
2018 to 2023
Market Size in 2023:
US $ 1.86 Bn.


Forecast Period 2024 to 2030 CAGR:
5.5%
Market Size in 2030:
US $ 2.71 Bn.


 Segments Covered:
by Product And Service
1. Quality Control Products
2. Data Management Solutions
3. Quality Assurance Services


by Technology
1. Immunochemistry
2. Clinical Chemistry
3. Molecular Diagnostics
4. Microbiology
5. Hematology
6. Coagulation/ Hemostasis
7. Other Technologies


by End User
1. Hospitals
2. Clinical Laboratories
3. Academic and Research Institutes
4. Home-care
5. Other End users


by Manufacturer Type
1. IVD Instrument Manufacturers
2. Third Party Quality Control Manufacturers
2.1. Independent third party quality controls
2.2. Instrument specific third party quality controls



In Vitro Diagnostics Quality Control Market, by Region
North America (United States, Canada and Mexico)
Europe (UK, France, Germany, Italy, Spain, Sweden, Austria and Rest of Europe)
Asia Pacific (China, South Korea, Japan, India, Australia, Indonesia, Malaysia, Vietnam, Taiwan, Bangladesh, Pakistan and Rest of APAC)
Middle East and Africa (South Africa, GCC, Egypt, Nigeria and Rest of ME&A)
South America (Brazil, Argentina Rest of South America)
In Vitro Diagnostics Quality Control Market Key Players
1. Bio-Rad Laboratories, Inc.
2. Randox Laboratories Ltd.
3. Thermo Fisher Scientific, Inc. 
4. LGC Limited
5. Abbott Laboratories
6. Roche Diagnostics
7. Siemens Healthineers
8. Danaher Corporation
9. Fortress Diagnostics
10. SERO AS
11. Sysmex Corporation
12. Ortho-Clinical Diagnostics
13. Helena Laboratories Corporation
14. Quidel Corporation
15. Sun Diagnostics, LLC.
16. Seegene Inc.
17. ZeptoMetrix Corporation
18. Qnostics
19. Bio-Techne Corporation
20. Microbiologics
21. Microbix Biosystems
22. Streck, Inc.
23. Alpha-Tec Systems
24. Maine Molecular Quality Controls, Inc.
25. Grifols, S.A.

FAQs:

1. Which is the potential market for the In Vitro Diagnostics (IVD) Quality Control in terms of the region?
Ans. North America is the potential market for In Vitro Diagnostics (IVD) Quality Control in terms of the region.

2. What are the opportunities for new market entrants?
Ans. The key opportunity in the market is the Increasing need for multi-analyte controls.

3. What is expected to drive the growth of the In Vitro Diagnostics Quality Control Market in the forecast period?
Ans. A major driver in the In Vitro Diagnostics Quality Control Market is the Growing authorized clinical laboratories across the globe.

4. What is the projected market size & growth rate of the In Vitro Diagnostics Quality Control Market?
Ans. In Vitro Diagnostics Quality Control Market size was valued at USD 1.86 Bn. in 2023 and the total In Vitro Diagnostics (IVD) Quality Control revenue is expected to grow at 5.5% from 2024 to 2030, reaching nearly USD 2.71 Bn.

5. What segments are covered in the In Vitro Diagnostics Quality Control Market report?
Ans. The segments covered are Product and Service, Technology, End User, Manufacturer Type and Region.