Market Trends of In-Vitro Diagnostics Quality Control Industry
Molecular Diagnostics Segment is Expected to Register a Significant CAGR in the In-Vitro Diagnostics Quality Control Market Over the Forecast Period
Molecular diagnostic devices are used to analyze biological markers in the genome and proteome to detect pathogens or mutations. Based on the technology, molecular diagnostic devices can be segmented into chips and microarrays, mass spectroscopy, next-generation sequencing (NGS), polymerase chain reaction (PCR)-based methods, cytogenetics, and molecular imaging. Factors such as large outbreaks of bacterial and viral epidemics, increasing demand for point-of-care diagnostics, and rapidly evolving technology are driving the growth of the molecular diagnostics segment.
The advancement of precision medicine has provided specific strategies for targeted therapies and medicines for patients with cancer and Mendelian diseases, which prove to be better than traditional clinical practices, increasing the demand for next-generation sequencing, which is also expected to propel the segment growth. For instance, according to the data published by the CDC in January 2021, it is projected that more than 60 million people are likely to have their genomes sequenced by 2025 worldwide.
Furthermore, the increasing company focus on developing technologically advanced products in molecular diagnostics and rising new product launches contributes to market growth. For instance, in October 2021, ELITechGroup, an Italy-based company focused on manufacturing and distributing diagnostic solutions to laboratories, launched ELITe BeGenius, a new CE-IVD stand-alone 'Sample-to-Result' real-time (RT) PCR solution. The product makes molecular biology universally accessible with a compact footprint, ease of use, and total automation. The company also offers ELITe InGenius and ELITe BeGenius molecular diagnostics instruments to every lab.
Similarly, in June 2021, Thermo Fisher Scientific Inc. launched TaqPath, a new CE-IVD-marked fast PCR combo kit 2.0, to detect active SARS-CoV-2 infection. Such developments are expected to contribute to segment growth over the forecast period.
Therefore, owing to the abovementioned factors such as increasing company focus on developing technologically advanced products in molecular diagnostics and rising new product launches, the segment is anticipated to witness growth over the forecast period.
North America Dominates the In-Vito Diagnostics Quality Control Market and Expects to do Same in the Forecast Period.
North America is expected to witness significant growth in the in-vitro diagnostics quality control market over the forecast period. The factors attributing to the market growth are the rising incidences and prevalence of chronic and infectious diseases, genetic disorders, rising technological advancements, and a growing number of regional diagnostic labs.
In addition, the high healthcare expenditures in the region are creating opportunities and rising company focus on developing technologically advanced in-vitro diagnostic devices, which are expected to increase the market growth. For instance, according to the OECD data published in June 2022, United States healthcare spending in 2021 was 17.8% of the country's total GDP.
Furthermore, the growing burden of chronic, infectious diseases and genetic disorders is the key factor driving the demand for in-vitro diagnostic tests, propelling the need for effective diagnostic instruments and devices, thereby propelling the market growth. For instance, according to 2022 statistics published by IDF, about 2.9 million people were living with diabetes in Canada in 2021. In addition, as per the same source, this number is projected to reach 3.2 million and 3.4 million by 2030 and 2045, respectively.
Also, as per the 2022 statistics published by the Canadian Cancer Society, about 28,600 Canadian women are expected to be diagnosed with breast cancer in 2022, representing 25% of all new cancer cases in women in 2022. The high number of breast cancer cases among the population is expected to increase the demand for effective diagnostic tests, which is anticipated to propel the demand for in-vitro diagnostic devices and kits. Thus, with the rising demand for diagnostic kits and devices, the need for quality control also increases, which is expected to augment the market growth over the forecast period.
Moreover, the increasing product launches in the region are also expected to increase the need for strict and comprehensive quality control of diagnostic devices to provide accurate test results, which are anticipated to fuel the market growth in the region. For instance, in April 2022, Bruker Corporation announced further to advance its market-leading MALDI Biotyper (MBT) platform and launch new multiplex PCR infectious disease assays based on its proprietary LiquidArray technology. In a single test, the FluoroType Mycobacteria PCT test uses sophisticated Liquid Array technology to distinguish 31 clinically important non-tuberculous mycobacteria and the Mycobacterium tuberculosis complex from cultures. Also, in October 2021, ThermoFisher Scientific launched Applied Biosystem QuantSudio Absolute Q-Digital PCR System, designed to provide highly accurate results in genetic analysis. Digital PCR is already in use for monitoring cancer-driven mutations in liquid biopsy. This has helped the company to increase its product portfolio. Therefore, owing to the abovementioned factors, the segment is anticipated to witness growth over the forecast period.
