El mercado de controles de calidad molecular comprende un espectro de productos diseñados para mantener la precisión y confiabilidad de las pruebas de diagnóstico molecular mediante el suministro de materiales estandarizados para el control de calidad y las pruebas de competencia. Estos controles se emplean para supervisar la eficacia de los ensayos moleculares, que abarcan técnicas como la reacción en cadena de la polimerasa (PCR), la secuenciación de próxima generación (NGS) y otras metodologías basadas en ácidos nucleicos , en diversos entornos de laboratorio , incluidos el diagnóstico clínico, la investigación y el desarrollo farmacéutico. Los controles de calidad molecular sirven para detectar y rectificar discrepancias, validar el rendimiento de los ensayos, cumplir con los mandatos regulatorios y, en última instancia, garantizar la difusión de resultados de pruebas precisos y replicables, aumentando así los estándares de atención al paciente y fomentando la confianza en los protocolos de pruebas de diagnóstico.
La genómica ha surgido como una faceta fundamental en el advenimiento de la medicina personalizada , ofreciendo estrategias terapéuticas y preventivas adaptadas a las condiciones individuales para obtener resultados optimizados. Este paradigma médico es muy prometedor para abordar enfermedades que hasta ahora han mostrado una respuesta limitada a los tratamientos o remedios convencionales. Según el informe de Medicina Personalizada publicado por la Coalición de Medicina Personalizada, en 2022, el Centro de Evaluación e Investigación de Medicamentos (CDER) de la FDA aprobó 37 nuevas entidades moleculares (NME), con dos NME designadas como productos terapéuticos y el resto clasificadas como agentes de diagnóstico. De las 35 nuevas entidades moleculares terapéuticas aprobadas por la FDA de EE. UU., 12 fueron intervenciones de medicina personalizada, junto con cinco nuevas terapias basadas en células.
| ATRIBUTO | DETALLES |
| Periodo de estudio | 2020-2029 |
| Año base | 2021 |
| Año estimado | 2022 |
| Año pronosticado | 2022-2029 |
| Periodo histórico | 2018-2020 |
| Unidad | Valor (millones de USD) |
| Segmentación | Por producto, por aplicación, por tipo de analito, por industria de uso final, por región |
| Por producto |
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| Por aplicación |
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| Por tipo de analito |
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| Por industria de uso final |
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En los últimos seis años, el coste de la secuenciación del genoma ha experimentado un descenso vertiginoso, que se estima en una reducción de aproximadamente un millón de veces. El Proyecto Genoma Humano, un esfuerzo colaborativo en el que han participado miles de investigadores durante 13 años, ha supuesto un gasto total de 2.700 millones de dólares, como documentó WIRED en septiembre de 2022. Una entrada de blog publicada en Sequencing in 2022 destaca el creciente interés por la secuenciación del ADN, lo que ha llevado a numerosas empresas de bioinformática a centrarse en desarrollar nuevas tecnologías, plataformas de secuenciación y consumibles con el objetivo de democratizar las pruebas genéticas ofreciéndolas a precios más accesibles.
The Molecular quality controls market size had crossed USD 154.43 Billion in 2020 and is expected to grow till USD 278.21 billion by 2029.
The Largest Regional market for Molecular quality controls market is APAC having a market share of 39%.
The global Molecular quality controls market registered a CAGR of 6.90% from 2022 to 2029.
Key players profiled in the report include F. Hoffmann-La Roche Ltd., Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Inc., Randox Laboratories Ltd., LGC Limited, Abbott Laboratories, Fortress Diagnostics, SERO AS, Anchor Molecular, Ortho-Clinical Diagnostics, Inc. , Quidel Corporation , Sun Diagnostics, LLC , Seegene Inc. , ZeptoMetrix, LLC, Qnostics ,Bio-Techne Corporation, Microbiologics, Inc., Microbix Biosystems Inc., SpeeDx Pty. Ltd., Maine Molecular Quality Controls, Inc., and Grifols, S.A.
The Molecular Quality Controls market is segmented by Product and service, Application, technology and end user.
On the basis of Product, the global Molecular Quality Control market is segmented into Independent, Instrument Specific (PCR, DNA Sequencing). The independent control segment held the greatest proportion of the global molecular quality control market. The expansion of the molecular quality control products market is being driven by an increase in the number of certified laboratories and regulatory mandates for the adoption of quality controls to ensure the accuracy of diagnostic test findings.
On the basis of Application, the global Molecular Quality Control market is segmented into Infectious Diseases Diagnostic, Oncology testing, genetic testing, others. The infectious disease diagnostics sector held the greatest proportion of the molecular quality controls market. The development of advanced assays for infectious diseases, a significant increase in the prevalence of infectious diseases, and rising awareness about the effective use of molecular diagnostic technologies to control the occurrence and spread of infectious diseases are all factors contributing to this segment's size.
On the basis of Analyte type, the global Molecular Quality Control market is segmented into Single-analyte Controls, Multi-analyte Controls. Due to the widespread use of single plex assays in hospitals and the benefits associated with single-analyte controls, such as straightforward analysis and interpretation and little risk of cross-reactivity, single-analyte controls dominated the molecular quality controls market in 2020.
On the basis of End use industry, the global Molecular Quality Control market is segmented into Diagnostic Laboratories, Hospitals, IVD Manufacturers & CROs, Academic and Research Institutes, Others.
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The Key Players in Molecular Quality Controls market are F. Hoffmann-La Roche Ltd., Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Inc., Randox Laboratories Ltd. , LGC Limited , Abbott Laboratories , Fortress Diagnostics , SERO AS , Anchor Molecular, Ortho-Clinical Diagnostics, Inc. , Quidel Corporation , Sun Diagnostics, LLC , Seegene Inc. , ZeptoMetrix, LLC, Qnostics , Bio-Techne Corporation , Microbiologics, Inc., Microbix Biosystems Inc., SpeeDx Pty. Ltd., Maine Molecular Quality Controls, Inc., and Grifols, S.A..
In February 2020, The EDX RP Positive Run Control from Bio-Rad Laboratories (US) is the first multi-analyte control to target 22 analytes in a single vial, saving laboratories time and space on their equipment. AcroMetrix Coronavirus 2019 (COVID-19) RNA Control was also introduced by Thermo Fisher Scientific (US).
Geographically, Molecular Quality Controls market is segmented into North America, Europe, Asia Pacific, and Rest of the world.
North America was the largest regional market for molecular quality controls due to the sophisticated healthcare systems in the United States and Canada, the existence of several major molecular quality control product manufacturers in the region, and easy access to technologically advanced goods.
The market in Asia Pacific, on the other hand, is expected to develop at the fastest rate over the projected period. The presence of rising economies like as China and India, as well as the strong need for high-quality and accurate diagnostic tests from the region's vast patient population, are driving the Asia Pacific molecular quality controls market forward.
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