In Vitro Diagnostics (IVD) Quality Control Market size is estimated to reach $1.2 Billion by 2025 and is poised to grow at a CAGR of 4.1% during the forecast period 2020-2025. In Vitro Diagnostics (IVD) Quality Control are samples/materials used to validate the reliability of IVD testing system to ensure accuracy of test results and evaluate the impact of factors such as environmental conditions and operator’s performance on test results. Continually evolving technology-oriented changes in the diagnostics field and growing need to ensure patient safety necessitate the implementation of quality assurance programs in various medical disciplines including radiology and Point-of-Care (PoC) devices. Rising number of certified clinical laboratories offering dependable IVD-based diagnostic services directly correlates with increased patient confidence, thus driving the market. In addition to quality assessments, amendments to the regulatory framework are made intermittently to enhance the existing standards with the main objective of safeguarding qualitative superiority of the diagnostic services.
Geographically, the North America accounted for the largest share of the market owing to extraordinary development and increased number of diagnostic centres.
High cost of In Vitro Diagnostics (IVD) control in hospitals and laboratories poses a significant challenge for the In Vitro Diagnostics quality control market
The third-party controls segment accounted for the largest market share in 2019 and is anticipated to grow with fastest CAGR. The large share of this segment is mainly attributed to the increasing demand for third-party quality controls owing to their unbiased test results.
Rise in demand for quality assessment support and immediate diagnosis systems are estimated to contribute to the expansion of the worldwide market during the forecast period 2020-2025.
By Technology- Segment Analysis
The global In Vitro Diagnostics (IVD) Quality Control market based on the technology has Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation & Hemostasis, and Other Technologies. The immunochemistry registers for the highest market share in 2019 and is set to continue for the forecast period (2020-2025) owing to its importance in identifying the molecular mechanism of various antigens, antibodies, and their interactions that affect the immune system. The molecular diagnostics segment is poised to witness the highest CAGR of 4.8% over the forecast period 2020-2025 owing to a rise in the adoption of advanced technologies such as Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS).
By End Use – Segment Analysis
The global In Vitro Diagnostics (IVD) Quality Control market based on end-use has Hospitals, Clinical Laboratories, Academic and Research Institutes, other end users. Hospitals segment registers for the highest market share in 2019 and is set to continue for the forecast period (2020-2025). The segment is set to emerge owing to the rising number of admissions and better reliability of healthcare professionals on clinical diagnosis for deciding treatment alternatives. Hospitals have a separate department for diagnostic services. The tests and instruments in this department need to be monitored regularly, which is poised to augment the market growth.
By Geography – Segment Analysis
Based on geographical analysis, the global In Vitro Diagnostics quality control market is segmented into North America, Asia-Pacific, Europe, and Rest of world. North America has accounted for largest market share of 48% in terms of revenue in 2019, and estimated to maintain its dominance over the forecast period 2020-2025, owing to the presence of the U.S. FDA and huge number of accredited diagnostic laboratories including strong QC regulation systems. The Asia pacific is estimated to be the fastest-growing region over the forecast period 2020-2025 as the region has a high potential for this market owing to increasing number of product manufacturing companies.
Drivers – In Vitro Diagnostics (IVD) Quality Control Market
Rise in clinical laboratories
The demand for In Vitro Diagnostics (IVD) quality control market is driving forward owing to the rising number of accredited clinical laboratories. Besides, increasing demand for third-party quality controls, and rising prevalence of chronic and infectious diseases are acting as drivers for supporting the growth of the In Vitro Diagnostics (IVD) quality control market.
Challenges – In Vitro Diagnostics (IVD) Quality Control Market
High cost of IVD quality control services
Factors such as high cost of the In Vitro Diagnostics (IVD) quality control services and unfavourable reimbursement policies are hampering the market growth. Owing to the additional costs involved in the quality control process, and budget constraints in hospitals and laboratories, it has become a challenge for the growth of the market in the forecast period (2020-2025).
In Vitro Diagnostics (IVD) Quality Control Market Industry outlook:
Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the In Vitro Diagnostics (IVD) Quality Control Market. Key companies of this market Abbott Laboratories, Bio-Rad Laboratories Inc, F. Hoffmann-La Roche AG, Quidel Corporation, bioMerieux Inc, Qnostics Ltd, Microbiologics Inc, SeraCare Life Sciences Inc, Thermo Fisher Scientific, ZeptoMetrix Corporation.
In October 2019, Thermo Fisher Scientific launched Acrometrix BCR-ABL Panel, a new external molecular quality control panel for the analytical validation of BCR-ABL test methods.
In February 2018, Qnostics (UK) and Randox Laboratories Ltd. (UK) entered into a partnership wherein Randox Laboratories to sell and distribute Qnostics’ molecular range of products, which strengthened Qnostics’ market penetration.