市场调查报告书
商品编码
1532131
全球分子诊断市场评估:依产品和服务、依测试类型、依样本类型、依技术、依应用、依最终用户、依地区、机会、预测(2017-2031)Molecular Diagnostics Market Assessment, By Product and Service, By Test Type, By Sample Type, By Technology, By Application, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球分子诊断市场规模预计将从2023年的 143.1亿美元增至2031年的 308.3亿美元,预计在2024-2031年预测期内年复合成长率为 10.07%。
分子诊断提供重要讯息,帮助患者和医疗保健专业人员做出明智的治疗决策并改善结果。分子诊断技术已证明在临床实践中非常有用,因为它们可以提供灵敏且快速的检测方法,有助于监测各种传染病,包括癌症和其他慢性疾病。由于疾病、病原体数量的增加以及更容易感染疾病并需要持续诊断的人口老化,分子诊断市场预计将扩大。随着分子诊断的广泛使用,许多医学疾病已被有效识别,包括基因检测、微生物学、性传染病、肿瘤、血液筛检、病毒、组织学和产前诊断。以实验室为基础的分子诊断利用 DNA、RNA 和蛋白质的研究,是检测人类疾病的重要工具。分子诊断试剂盒和试剂根据其预期用途量身定制,并包含针对特定细菌、病毒或寄生虫序列的探针。由于生物标记特异性检测试剂盒的使用不断增加,分子诊断市场预计将扩大,这在开始任何药物或治疗之前都是不可或缺的。例如,美国 FDA 于2023年 5月批准了 Hologic, Inc. 的 Panther Fusion SARS-CoV-2/Flu A/B/RSV 检测的 510(k)许可。该检测使用分子诊断测试来区分四种最普遍的呼吸道病毒。
慢性病盛行率增加导致市场成长
由于慢性病盛行率不断上升,分子诊断市场显着扩大。人口老化、生活方式的改变和环境因素都会导致癌症、糖尿病和心血管疾病等慢性疾病的增加。需要先进的诊断方法来管理和有效治疗这些疾病。在这种情况下,使用先进技术来分析遗传、基因组和蛋白质组资料的分子诊断非常重要。识别与慢性病相关的特定生物标记和遗传变化有助于及时、准确地检测疾病。根据每位患者独特的分子特征客製化治疗方案可提高治疗效果并改善患者的治疗结果。例如,透过检测肿瘤特异性突变,分子诊断有可能透过最大限度地减少选择药物时的反覆试验来帮助确定最佳的癌症治疗方法。此类诊断可以更轻鬆地追踪疾病进展和身体对治疗的反应,可以快速改变治疗方法。
随着慢性病盛行率的持续成长,对分子诊断的需求日益成长,以提供全面、个人化的疾病病因和患者健康状况洞察。这些趋势推动分子诊断产业的持续发展和创新,有助于改善长期疾病治疗。例如,国际糖尿病联盟在2023年报告指出,全球 2 型糖尿病的盛行率显着增加。根据该联合会的研究,到2023年,全球将有5.37亿成年人患有糖尿病,比前一年大幅增加。人口老化、肥胖率上升和久坐的生活方式是造成这一趋势的原因。越来越多的第2 型糖尿病患者凸显出需要更好的预防措施和医疗方法来控制和减少这种长期疾病的影响。
科技发展推动市场成长
技术发展在扩大分子诊断市场方面发挥重要作用。高通量定序、即时 PCR 和新一代定序(NGS)技术的进步彻底改变了这一领域,提高了准确性、速度和全面的诊断能力。这些技术使得以以前难以想像的精度分析遗传物质成为可能,有助于疾病的早期检测和个人化治疗。
本报告研究和分析了全球分子诊断市场,提供市场规模和预测、市场动态以及主要参与者的现状和前景。
Global molecular diagnostics market is projected to witness a CAGR of 10.07% during the forecast period 2024-2031, growing from USD 14.31 billion in 2023 to USD 30.83 billion in 2031.
Molecular diagnostics help patients and healthcare professionals make educated decisions about their treatment, which leads to positive results, by offering vital information. Molecular diagnostics techniques have shown to be useful in clinical settings since they allow sensitive and quick detection methods, which makes it easier to monitor a variety of infectious disorders, including cancer and other chronic illnesses. The market for molecular diagnostics is expected to rise due to the growing illness, rising numbers of pathogens and even rising geriatric population, which is more prone to disease and hence needs continuous diagnosis. Numerous medical diseases have been effectively identified by the widespread use of molecular diagnostics, including genetic testing, microbiology, STDs, oncology, blood screening, virology, tissue type, and prenatal diagnosis. Using the study of DNA, RNA, or proteins, laboratory-based molecular diagnostics are vital instruments used for the detection of human diseases. Molecular diagnostic kits and reagents are tailored according to the desired use and contain probes that are unique to certain bacterial, viral, or parasitic sequences. The market for molecular diagnostics is expected to rise due to the growing use of biomarker-specific testing kits, which are essential before starting any kind of medication or treatment. The USFDA, for instance, granted 510(k) clearance for Hologic, Inc.'s Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in May 2023. This assay distinguishes between the four most prevalent respiratory viruses by molecular diagnostic testing.
Market Growth Due to Rising Prevalence of Chronic Ailments
The market for molecular diagnostics is expanding significantly due to the increased incidence of chronic illnesses. Aging populations, changing lifestyles, and environmental factors are all contributing to the rise in chronic diseases such as cancer, diabetes, and cardiovascular ailments. For these illnesses to be managed and treated effectively, sophisticated diagnostic methods are required. In this setting, molecular diagnostics, which use advanced technology to analyze genetic, genomic, and proteomic data, are essential. Through the identification of particular biomarkers and genetic alterations linked to chronic disorders, they facilitate the timely and accurate detection of diseases. Customizing therapy regimens according to each patient's unique molecular profile increases treatment effectiveness and boosts patient outcomes. For instance, by detecting mutations unique to a tumor, molecular diagnostics might assist in determining the best cancer treatments by minimizing the need for trial-and-error when choosing medications. These diagnostics make it easier to continue tracking how the disease progresses and how the body responds to treatment, which enables prompt therapeutic modifications.
The need for molecular diagnostics that offer comprehensive and individualized insights into disease causes and patient health is growing as the prevalence of chronic diseases keeps rising. The pattern promotes ongoing development and innovation in the molecular diagnostics industry, aiding in the improved treatment of long-term medical disorders. For instance, the International Diabetes Federation reported in 2023 that there has been a notable global increase in prevalence of Type 2 diabetes. According to the federation's research, 537 million adults worldwide had diabetes in 2023, i.e., a significant increase over the previous year. Ageing populations, an increase in obesity rates, and sedentary lifestyles are blamed for the trend. The increasing number of people with Type 2 diabetes highlights the critical need for better preventative measures and medical therapies to control and lessen the effects of this long-term illness.
Technological Developments Fuel Market Growth
Technological developments have a major role in propelling the molecular diagnostics market's expansion. The area has seen a revolutionary change due to the advancement of high-throughput sequencing, real-time PCR, and next-generation sequencing (NGS) technologies, which offer enhanced precision, speed, and comprehensive diagnostic capabilities. These technologies make it possible to analyze genetic material with previously unheard-of precision, which helps with disease early detection and individualized therapy. High-throughput sequencing makes it possible to analyze multiple genetic variants which improves the efficiency of identifying mutations linked to disease. To diagnose infections and genetic abnormalities, real-time PCR improves the sensitivity and specificity of detecting particular genetic sequences. Deep genetic data insights are provided by NGS, which helps with focused therapy development and the identification of new biomarkers. Moreover, developments in data analytics and bioinformatics have enhanced the ability to comprehend intricate molecular data, enabling the extraction of useful insights from sizable datasets. Molecular diagnostics benefits from the integration of artificial intelligence (AI) and machine learning, which improves predictive analytics facilitates early diagnosis and personalized medication. The market for molecular diagnostics is growing due to these technical advancements since they provide more advanced instruments for accurate and effective illness detection and treatment. For instance, F. Hoffmann-La Roche Ltd. introduced the LightCycler PRO System in November 2023 to improve the usefulness of molecular PCR testing for applications such as in vitro diagnostics and translational research.
Instruments to Dominate the Global Molecular Diagnostics Market Share
Due to the high cost of equipment and the requirement for regular replacement or updates, the instruments category holds the highest revenue share of the market based on products and services. The rising incidence of chronic illnesses including cancer, genetic abnormalities, and infectious diseases, which need more sophisticated diagnostic techniques, expected to drive the demand for molecular diagnostic tools. This expansion can be linked to the growing need for personalized medicine and companion diagnostics, which need specifically designed instruments for particular uses. New and affordable diagnostic assays are anticipated to drive growth in the reagent and kit market. As more people are using electronic health record (EHR) and laboratory information management system (LIMS) systems, the software market is predicted to grow significantly over the course of the forecast period. More accurate and efficient patient diagnosis and treatment are expected to be made possible by the integration of molecular diagnostic software with electronic medical records.
Furthermore, it is anticipated that the advancement of machine learning and artificial intelligence (AI) technologies would support the growth of molecular diagnostic software by enabling the automated analysis of big datasets. For instance, Thermo Fisher Scientific, Inc. announced the release of a new digital PCR research tool called QuantStudio, Applied Biosystems, Absolute Q AutoRun dPCR (digital polymerase chain reaction) Suite in February 2023. Additionally, in May 2023, Sansure Biotech Inc. showcased its extensive line of IVD devices at EuroMedLab Rome 2023, which included the iconic III portable molecular workstations.
North America Dominates the Global Molecular Diagnostics Market Share
With the highest market share, North America led the largest proportion of the market. This is ascribed to the increasing prevalence of both infectious and chronic illnesses, which in turn motivates businesses to launch cutting-edge molecular diagnostic tests and propel market expansion. The growth is due to the robust healthcare infrastructure present in the region. Highly advanced diagnostic centers and laboratories in the region aid scientific development and growth, leading to a highly competitive market. For instance, QIAGEN N.V.'s therascreen PDGFRA RGQ PCR kit was approved by the USFDA in August 2023. This tool helps doctors detect individuals who have gastrointestinal stromal tumors (GIST). Additionally, the VIASURE Monkeypox viral Real-Time PCR Reagents, created by Becton, Dickinson and Company and CerTest Biotec, S.L. for Mpox viral identification, was authorized by the USFDA in January 2023. Furthermore, a strong healthcare system, excellent living standards, and consumer knowledge of early diagnosis serve as important growth-promoting factors.
Future Market Scenario (2024 - 2031F)
The main factors contributing to the anticipated growth of the molecular diagnostics market are the rising numbers of pathogens, the increasing prevalence of diseases, and, thus, the rising requirement to conduct diagnostic tests. However, the growing need to have precision medicine to maintain a healthy population is going to fuel market growth in the future. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. Policies by welfare bodies and the government are greatly fueling the market expansion. For instance, the USFDA gave the COVID-19 and Flu Home Test, the first and only Emergency Use Authorization (EUA) for OTC usage at home and other non-laboratory locations.
Key Players Landscape and Outlook
Several companies are expanding their businesses by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launch of newly developed molecular diagnostics to help researchers and strengthen their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve the same.
For example, in October 2023, QIAGEN N.V. and Myriad Genetics, Inc. collaborated to create companion diagnostic tests for cancer based on PCR, dPCR, and NGS technology.
Additionally, Oxford Nanopore and bioMerieux SA established a strategic alliance in April 2023 to use nanopore technology to provide innovative cures for infectious diseases.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.