市場調查報告書
商品編碼
1532131
全球分子診斷市場評估:依產品和服務、依測試類型、依樣本類型、依技術、依應用、依最終用戶、依地區、機會、預測(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 |
全球分子診斷市場規模預計將從2023年的 143.1億美元增至2031年的 308.3億美元,預計在2024-2031年預測期內年複合成長率為 10.07%。
分子診斷提供重要訊息,幫助患者和醫療保健專業人員做出明智的治療決策並改善結果。分子診斷技術已證明在臨床實踐中非常有用,因為它們可以提供靈敏且快速的檢測方法,有助於監測各種傳染病,包括癌症和其他慢性疾病。由於疾病、病原體數量的增加以及更容易感染疾病並需要持續診斷的人口老化,分子診斷市場預計將擴大。隨著分子診斷的廣泛使用,許多醫學疾病已被有效識別,包括基因檢測、微生物學、性傳染病、腫瘤、血液篩檢、病毒、組織學和產前診斷。以實驗室為基礎的分子診斷利用 DNA、RNA 和蛋白質的研究,是檢測人類疾病的重要工具。分子診斷試劑盒和試劑根據其預期用途量身定制,並包含針對特定細菌、病毒或寄生蟲序列的探針。由於生物標記特異性檢測試劑盒的使用不斷增加,分子診斷市場預計將擴大,這在開始任何藥物或治療之前都是不可或缺的。例如,美國 FDA 於2023年 5月批准了 Hologic, Inc. 的 Panther Fusion SARS-CoV-2/Flu A/B/RSV 檢測的 510(k)許可。該檢測使用分子診斷測試來區分四種最普遍的呼吸道病毒。
慢性病盛行率增加導致市場成長
由於慢性病盛行率不斷上升,分子診斷市場顯著擴大。人口老化、生活方式的改變和環境因素都會導致癌症、糖尿病和心血管疾病等慢性疾病的增加。需要先進的診斷方法來管理和有效治療這些疾病。在這種情況下,使用先進技術來分析遺傳、基因組和蛋白質組資料的分子診斷非常重要。識別與慢性病相關的特定生物標記和遺傳變化有助於及時、準確地檢測疾病。根據每位患者獨特的分子特徵客製化治療方案可提高治療效果並改善患者的治療結果。例如,透過檢測腫瘤特異性突變,分子診斷有可能透過最大限度地減少選擇藥物時的反覆試驗來幫助確定最佳的癌症治療方法。此類診斷可以更輕鬆地追蹤疾病進展和身體對治療的反應,可以快速改變治療方法。
隨著慢性病盛行率的持續成長,對分子診斷的需求日益成長,以提供全面、個人化的疾病病因和患者健康狀況洞察。這些趨勢推動分子診斷產業的持續發展和創新,有助於改善長期疾病治療。例如,國際糖尿病聯盟在2023年報告指出,全球 2 型糖尿病的盛行率顯著增加。根據該聯合會的研究,到2023年,全球將有5.37億成年人患有糖尿病,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這一趨勢的原因。越來越多的第2 型糖尿病患者凸顯出需要更好的預防措施和醫療方法來控制和減少這種長期疾病的影響。
科技發展推動市場成長
技術發展在擴大分子診斷市場方面發揮重要作用。高通量定序、即時 PCR 和新一代定序(NGS)技術的進步徹底改變了這一領域,提高了準確性、速度和全面的診斷能力。這些技術使得以以前難以想像的精度分析遺傳物質成為可能,有助於疾病的早期檢測和個人化治療。
本報告研究和分析了全球分子診斷市場,提供市場規模和預測、市場動態以及主要參與者的現狀和前景。
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.