In-Vitro Diagnostics (IVD) Quality Control Market Expected to A...

In-Vitro Diagnostics (IVD) Quality Control Market Expected to A CAGR of 19.30%by 2028 Profiling Companies and Growth Strategies

Posted 2024-01-12 06:25:52

Market Overview: The global market size for In Vitro Diagnostics quality control reached USD 84.7 billion in 2020, with an anticipated Compound Annual Growth Rate (CAGR) of 19.30% over the forecast period. The sustained expansion is attributed to factors such as the increasing incidence of chronic diseases like diabetes and cancer, a rise in cardiovascular diseases, a growing demand for advanced diagnostic systems, and an escalating need for third-party quality controls in In Vitro Diagnostics (IVD).

In Vitro Diagnostics Quality Control: The evaluation of the overall performance of IVD tests for detecting Healthcare-associated Infections (HAIs), including pneumonia and urinary tract infections, is known as In Vitro Diagnostics quality control. These products play a crucial role in identifying defects and upholding the quality of IVD tests. Commonly used control panels include Blood Culture (BCID) and Human Papillomavirus (HPV), ensuring the safety and efficiency of IVD testing systems in clinical, research, and blood diagnostic centers. Compliance with ISO 9001 standards and regulations is maintained through government inspections, independent audits, and post-market surveillance by globally recognized regulatory bodies like the U.S. FDA, MHRA, CDSCO, MHLW, and EMEA.

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Market Dynamics: The market's growth is propelled by the advantages associated with in vitro diagnostics quality control, such as sensitive and long-term monitoring of IVD test system performance, multi-level quality control analysis, and identification of critical analytical system issues. However, a lack of technical expertise in quality control and assessment poses a significant restraint to market growth.

Application Outlook: Segmentation by application includes immunochemistry, clinical chemistry, molecular diagnostics, hematology, coagulation & hemostasis, microbiology, and others. Immunochemistry, dominating the market in 2020, is expected to exhibit the highest revenue growth, driven by its increasing significance, enhanced detection capabilities, and rising demand for rapid diagnostic methods.

Regional Analysis: The global market is divided into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America leads in revenue and is anticipated to experience the fastest growth due to the rapid spread of infectious diseases, a growing patient pool, an increasing number of accredited laboratories, and heightened awareness about early disease diagnosis.

Companies Profiled: Key players in the global in vitro diagnostics quality control market include Abbott Laboratories Inc., Bio-Rad Laboratories Inc., Thermo Fisher Scientific Inc., Siemens Healthineers, Randox Laboratories Ltd., Technopath Clinical Diagnostics, Fortress Diagnostics, Roche Diagnostics, Bio-Techne Corporation, Danaher Corporation, SeraCare Life Sciences Inc., Ortho-Clinical Diagnostics, Inc., Sysmex Corporation, and Helena Laboratories. These companies engage in strategic initiatives like mergers, acquisitions, collaborations, and joint ventures to strengthen their market positions.

Key Developments:

In March 2021, Bio-Rad Laboratories, Inc. expanded its partnership with Roche, introducing new InteliQ products to streamline lab workflows and enhance analytical performance.
In May 2020, Technopath Clinical Diagnostics launched Multichem ID-COVID-19 quality control solutions, serving as an advanced diagnostic method for COVID-19 antibody testing.
In November 2020, diagnostics company Devyser received MDSAP certification, reinforcing its commitment to IVD quality assurance standards.

Market Segmentation: The report segments the market based on product & service type, manufacturer, application, end-user, and region, providing comprehensive coverage of revenue forecasts, company rankings, competitive landscape, growth factors, and trends. The market is further categorized by product type, manufacturer type, application, and end-user, with a regional scope covering North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

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