In Vitro Diagnostics Quality Control Market To Reach $1.59 Billion By 2030

In Vitro Diagnostics Quality Control Market Growth & Trends

The global in vitro diagnostics quality control market size is expected to reach USD 1.59 billion by 2030, registering a CAGR of 3.2% from 2024 to 2030, according to a new report by Grand View Research, Inc. The continually evolving technology-oriented changes in the diagnostics field and the growing requirement to ensure patient safety necessitate the execution of quality assurance programs in several medical domains including point-of-care devices and radiology.The patients rely on self-testing in vitro diagnostics (IVD) devices for long-term disease management and hence it is important for such IVD devices to be checked for quality in terms of result reproducibility and validity to guarantee patient safety.

The rising number of certified clinical laboratories offering dependable IVD-based diagnostic services directly correlates with increased patient confidence, thus driving market growth. Some of the key pathogens routinely diagnosed using multiplex PCR, but not limited to, are HIV, HSV (meningitis and encephalitis), H. influenza, S. pneumonia (respiratory tract infections), N. gonorrhea, C. trachoma (genital infections), G. lambardia, C. parvum (diarrheal diseases), and Leishmaniaspp (Leishmaniasis).In addition to assessments, amendments to the regulatory framework are made intermittently to enhance the present standards with the main objective of safeguarding the qualitative superiority of the diagnostic services rendered to patients.

Quality control in the laboratory is focused on ensuring that the results delivered to the patient are accurate. Control checks are usually undertaken while installing an instrument, after servicing, changing reagent lots, and when the instrument readings are not in range.Home care settings include a variety of devices, such as point-of-care (PoC) instruments used for near-patient bed testing, self-testing kits, and IVD devices in assisted healthcare settings. Self-testing kits giveease of convenience for patients who require everyday testing and further reduce hospital visits.

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In Vitro Diagnostics Quality Control Market Report Highlights

• In 2023, the clinical chemistry segment held the largest share of the market. The increasing demand for preventive medicine and the rapid transformation of clinical laboratories into highly automated and efficient businesses are some of the factors responsible for its high market share

• The quality control segment dominated the market in 2023 and is estimated to grow at the highest CAGR over the forecast period. Quality control in the research laboratory is concentrated on certifying the results provided to the individuals are precise

• The hospital segment held the largest share in 2023 due to the presence of highly advanced technology-based devices, such as Next Generation Sequencing (NGS), mass spectrophotometry, and microarrays, and the rising applications of the optimized quality-control procedures

• Many pharmaceutical companies are implementing the new draft guidance enforced by the U.S. FDA for data integrity on current Good Manufacturing Practices (cGMP)

• It provides information in relation to establishing robust operating procedures and strong management systems, obtaining high-quality raw materials, investigating deviations, and maintaining reliable diagnostic laboratories 

In Vitro Diagnostics Quality Control Market Segmentation

Grand View Research has segmented the global in vitro diagnostics quality control market based on product, type, application, manufacturer type, end-use, & region:

In Vitro Diagnostics Quality Control Product Outlook (Revenue, USD Million, 2018 - 2030)

• Controls

• Total Protein

• Albumin

• Blood Urea Nitrogen

• Uric Acid

• Creatinine

• Sodium

• Potassium

• Chloride

• Calcium

• Magnesium

• Inorganic Phosphorus

• Aspartate Transaminase

• Creatine Kinase

• Gamma Glutamyl transferase

• Total Bilirubin

• Glucose

• Iron

• Alanine Transaminase

• Alkaline Phosphatase

• Alpha-Amylase

• Total Cholesterol

• Triglyceride

• Lactate Dehydrogenase

• Immunoglobulin G

• Immunoglobulin A

• Immunoglobulin M

• Complement 3

• Complement 4

• C-Reactive Protein

• Rheumatoid Factor

• Anti-Streptolysin -O

• Beta 2 Mi

• Cystatin-C

• Myoglobin

• Troponin T and I

• Others

• Calibrators

• Others

In Vitro Diagnostics Quality Control Type Outlook (Revenue, USD Million, 2018 - 2030)

• Quality Controls

• Plasma-based Control

• Serum-based Control

• Whole blood-based Control

• Others

• Quality Assurance Services

• Data Management Solutions

In Vitro Diagnostics Quality Control Application Outlook (Revenue, USD Million, 2018 - 2030)

• Immunochemistry

• Hematology

• Clinical Chemistry

• Alkaline Phosphatase (ALP)

• Alanine Transaminase (ALT)

• Aspartate Transaminase (AST)

• Creatine Kinase MB (CK-MB)

• Albumin

• Creatinine

• Glucose

• Triglycerides

• Amylase

• Others

• Molecular Diagnostics

• Coagulation

• Microbiology

• Others

In Vitro Diagnostics Quality Control Manufacturer Type Outlook (Revenue, USD Million, 2018 - 2030)

• Third-Party Controls

• Independent Controls

• Instrument Specific Controls

• OEM Controls

In Vitro Diagnostics Quality Control End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Hospitals

• Laboratories

• Home Care

• Others

In Vitro Diagnostics Quality Control Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • UK

  • Germany

  • Spain

  • France

  • Italy

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • South Korea

  • Australia

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List Of Key Players In Vitro Diagnostics Quality Control Market

• Siemens Healthineers AG

• Abbott

• Bio-Rad Laboratories

• Danaher

• F. Hoffmann-La Roche Ltd

• Sysmex Corporation

• QuidelOrtho Corporation

• Randox Laboratories Ltd

• Helena Laboratories Corporation

• Thermo Fisher Scientific Inc

• SeraCare Life Sciences Inc

• BD

• Merck KGaA

• QIAGEN

• Hologic, Inc.

• Bio-Techne

• Fortress Diagnostics

• Microbiologics

• Trina Bio Reactive AG

• ConeBioproducts

• Biorex Diagnostics