In Vitro Diagnostics And IVD Quality Control Industry | Forecast 2030
The global In Vitro Diagnostics (IVD) and IVD quality control markets combine to account for USD 112.79 billion in revenue in 2021, which is expected to reach USD 114.73 billion by 2030, growing at a cumulative rate of 0.2% over the forecast period. The combination bundle is designed to provide a holistic view of these highly dynamic market spaces.
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In Vitro Diagnostics (IVD) Market insights
The global in vitro diagnostics (IVD) market size was estimated at USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. The growth can be attributed to increasing adoption of IVD owing to a rise in the incidence of infectious and chronic diseases. The development of automated IVD systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnoses is expected to fuel market growth. The rising number of IVD products being launched by key players is also fueling market growth. For instance, in November 2023, ARUP Laboratories received a CE mark from EU-IVDR for AAV5 DetectCDx, a companion diagnostic to select the eligibility of severe hemophilia A-affected patients for BioMarin’s new gene therapy, Roctavian.
Technological advancements in terms of accuracy, portability, and cost-effectiveness are expected to be one of the high-impact rendering drivers of this market. Introduction of novel and highly accurate clinical laboratory tests is boosting the adoption of novel IVD tests worldwide. In June 2023, Toray Industries, Inc. received marketing approval from Japan’s Ministry of Health, Labour and Welfare for its Toray APOA2-iTQ used to diagnose pancreatic cancer. Moreover, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory Traumatic Brain Injury (TBI) blood test in the U.S. Increasing approvals of IVD tests for life-threatening diseases are expected to create new opportunities in the untapped market.
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In Vitro Diagnostics Quality Control Market insights
The global in vitro diagnostics quality control market size was estimated at USD 1.16 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 2.12% from 2023 to 2030. An increasing number of accredited clinical laboratories worldwide and the presence of favorable regulatory bodies are expected to be the key factors driving the market growth. Due to the high prevalence rate of diseases, such as diabetes, cardiovascular diseases, and infectious diseases, diagnostic laboratories have gained demand. 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.
The regulatory bodies monitoring quality control and regular quality check of in vitro diagnostics (IVD) devices and service providers include FDA for U.S.; Medicines and Healthcare Products Regulatory Agency (MHRA) for the UK; 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.
In Vitro Diagnostics And IVD Quality Control Industry, By Product
- Instruments
- Reagents
- Services
In Vitro Diagnostics And IVD Quality Control Industry, By Technology
- Immunoassay
- Hematology
- Clinical Chemistry
- Molecular Diagnostics
- Coagulation
- Microbiology
- Others
In Vitro Diagnostics And IVD Quality Control Industry, By Application
- Infectious Disease
- Diabetes
- Oncology
- Cardiology
- Nephrology
- Autoimmune Disease
- Drug Testing
- Others
In Vitro Diagnostics And IVD Quality Control Industry, By End-use
- Hospitals
- Laboratories
- Home Care
- Others
In Vitro Diagnostics And IVD Quality Control Industry, By Test Location
- Point of Care
- Home Care
- Others
In Vitro Diagnostics And IVD Quality Control Industry, By IVD Quality Control Services
- Quality Controls
- Quality Assurance Services
- Data Management