IVD Quality Control Market by Offering (Product [Serum, Blood, Urine-based], Data Management, Service), Technology (Biochemistry, Molecular, Immunoassay, Hematology), Application (Infectious Diseases, Oncology, Cardiology), and End User – Global Forecast

IVD Quality Control Market by Offering (Product [Serum, Blood, Urine-based], Data Management, Service), Technology (Biochemistry, Molecular, Immunoassay, Hematology), Application (Infectious Diseases, Oncology, Cardiology), and End User–Global Forecast to 2030

The IVD quality control market is expected to reach $2.19 billion by 2030, at a CAGR of 4.3% from 2023 to 2030.

After extensive primary and secondary research, the report provides an in-depth analysis of the IVD quality control market. The report also provides insights into the key drivers, restraints, challenges, and opportunities in the IVD quality control market. The growth of the IVD quality control market is driven by the rising prevalence of chronic diseases, coupled with the increasing geriatric population, growing demand for third-party quality controls, need for internal and external quality assessment reports, increasing number of clinical laboratories, growing demand for Point-of-Care (POC) and rapid diagnostics. However, stringent technical requirements and regulatory processes for quality controls restrain this market's growth.

The growing demand for multi-analyte and multi-instrument controls offers opportunities for market growth. However, the evolving regulatory landscape and lack of access to quality control/quality assurance materials are the major challenges to market growth.

Among the offering, in 2023, the quality control products segment is estimated to account for the largest share of the IVD quality control market. Increasing adoption of diagnostic products, demand for external quality assessment programs as these programs use quality controls in their programs, development of multi-analyte quality controls, new product launches, and increasing demand for independent controls contribute to the segments’ largest share.

Among the technologies, in 2023, the immunoassay/immunochemistry segment is estimated to account for the largest share of the IVD quality control market. The growing prevalence of chronic and infectious diseases and the increased adoption of immunoassay/immunochemistry tests, technological innovations in these tests, and the simultaneous development of quality control contributed to the segment's largest share.

Among the application, in 2023, the infectious diseases segment is estimated to account for the largest share of the IVD quality control market. The increasing prevalence of infectious diseases has led to the availability of a broad range of quality controls that are designed to monitor the assay precision of IVD tests for infectious diseases such as hepatitis, retrovirus, sexually transmitted diseases, congenital diseases, and other infectious diseases. According to the WHO, in 2020, there were an estimated 376 million new cases of sexually transmitted infections (STIs) worldwide, with chlamydia accounting for 129 million, gonorrhea for 82 million, syphilis for 7.1 million, and trichomoniasis for 156 million of the reported cases. The need for diagnosis of such infectious diseases also required quality controls for the quality assessment of tests, which further supported the largest share of the segment.

Among the end users, in 2023, the hospitals & clinics segment is estimated to account for the largest share of the IVD quality control market. The large segment share is majorly attributed to the large volume of diagnostics tests carried out in the hospitals, the rising prevalence of healthcare-associated infections (HAIs), increasing healthcare expenditure, and the rising number of hospitals and clinics across emerging markets.

An in-depth analysis of the geographical scenario of the IVD quality control market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, the Middle East & Africa) along with the coverage of major countries in each region. In 2023, North America is estimated to account for the largest share of the IVD quality control market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The high prevalence of chronic and infectious diseases, increasing awareness regarding early disease diagnosis, growing adoption of advanced diagnostic products, and increasing funding activities, coupled with novel developments in diagnostic technologies, are the factors supporting the largest share of this market.

The key players operating in the IVD quality control market are Seimens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), LGC Group (U.K.), Thermo Fisher Scientific Inc. (U.S.), SERO AS (Norway), Randox Laboratories Ltd. (U.K.), QuidelOrtho Corporation (U.S.), Streck LLC (U.S.), Microbiologics, Inc. (U.S.), and Bio-Techne Corporation (U.S.)

Scope of the Report:

IVD Quality Control Market Assessment - by Offering

Quality Control Products
Quality Control Products, by Type
Serum/Plasma-based Controls
Whole Blood-based Controls
Urine-based Controls
Other Controls
Quality Control Products, by Function
Independent Controls
Instrument-Specific Controls
Quality Assessment Services
Data Management Solutions

Notes: Other controls include saliva-based controls, cerebrospinal fluid-based, and protein controls.

IVD Quality Control Market Assessment - by Technology

Immunoassay/Immunochemistry
Biochemistry/Clinical Chemistry
Molecular Diagnostics
Hematology
Coagulation/Hemostasis
Microbiology
Other Technologies

Notes:Other technologies include histochemistry, urinalysis, and whole-blood glucose monitoring

IVD Quality Control Market Assessment - by Application

Infectious Diseases
Oncology
Cardiology
Autoimmune Disorders
Neurology
Other Applications

Notes:Other applications include pregnancy and fertility testing, drug abuse testing, diabetes, genetic disorders, and trace elements testing

IVD Quality Control Market Assessment - by End User

Hospitals & Clinics
Diagnostic Laboratories
Academic Institutes & Research Laboratories
Other End Users

Notes:Other end users include home care, nursing homes, ambulatory care centers, and transfusion laboratories.

IVD Quality Control Market Assessment - by Geography

North America
U.S.
Canada
Europe
Germany
France
U.K.
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Rest of Asia-Pacific
Latin America
Brazil
Mexico
Rest of Latin America
Middle East & Africa

IVD Quality Control Market - Global Opportunity Analysis and Industry Forecast (2023–2030) - Report Summary

Report Metrics	Details
Years Considered	2021 - 2030
Base Year	2022
Forecast Period	2023-2030
Page Count	267
Units Referenced	Value (USD Million)
Segments/Key Topics	Market by Offering, Technology, Application, and End User
Regions Covered	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Key Companies Mentioned	Siemens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), LGC Group (U.K.), Thermo Fisher Scientific Inc. (U.S.), SERO AS (Norway), Randox Laboratories Ltd. (U.K.), QuidelOrtho Corporation (U.S.), Streck LLC (U.S.), Microbiologics, Inc. (U.S.), and Bio-Techne Corporation (U.S.)

FAQs About the Report

What is the focus of the IVD quality control market study?

This study covers quality control products, quality assessment services, and data management solutions applied in hospitals & clinics, diagnostic laboratories, academic institutes & research laboratories, and other end users.

What is the revenue generated from the sales of IVD quality control products & services? At what rate is their demand expected to grow for the next 5-7 years?

The IVD quality control market is projected to reach $2.19 billion by 2030, at a CAGR of 4.3% during the forecast period.

Which offering is expected to hold the major share of the market in 2023?

Based on offering, in 2023, the quality control products segment is expected to account for the largest share of the IVD quality control market. Development of multi-analyte quality controls and new product launches contribute to the segment’s largest share.

Which technology segment is expected to hold the major share of the market in 2023?

Based on technology, in 2023, the immunoassay/immunochemistry segment is expected to account for the largest share of the IVD quality control market. The growing number of immunoassay/immunochemistry tests, as they provide rapid, convenient, and accurate results for the detection and quantitation of targets and continuous development of new biomarkers, contribute to the segment’s largest share.

Which application segment is expected to hold the major share of the market in 2023?

Based on application, in 2023, the infectious diseases segment is expected to account for the largest share of the IVD quality control market. The rising prevalence of infectious diseases and government initiatives to promote awareness and testing of these infectious diseases contribute to the segment’s largest share.

Which end user segment is expected to hold the major share of the market in 2023?

Based on end user, in 2023, the hospitals & clinics segment is expected to account for the largest share of the IVD quality control market. The expansion of hospitals, the increasing number of patients visiting the hospitals & clinics, and the collaborations between hospitals and government organizations for screening programs support the segment’s largest share.

What are the key factors supporting the growth of this market? Also, what are the major opportunities for existing market players and new entrants in the IVD quality control market?

The rising prevalence of chronic diseases, coupled with the increasing geriatric population, growing demand for third-party quality controls, need for internal and external quality assessment reports, increasing number of clinical laboratories, growing demand for Point-of-Care (POC) and rapid diagnostics are some of the factors driving the growth of this market. Additionally, the growing demand for multi-analyte and multi-instrument controls offers opportunities for market growth.

Who are the major players operating in the IVD quality control market?

Key companies operating in the IVD quality control market are Seimens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (U.S.), Danaher Corporation (U.S.), LGC Group (U.K.), Thermo Fisher Scientific Inc. (U.S.), SERO AS (Norway), Randox Laboratories Ltd. (U.K.), QuidelOrtho Corporation (U.S.), Streck LLC (U.S.), Microbiologics, Inc. (U.S.), and Bio-Techne Corporation (U.S.)