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市場調査レポート
商品コード
1532131
分子診断の世界市場の評価:製品・サービス別、検査タイプ別、サンプルタイプ別、技術別、用途別、エンドユーザー別、地域別、機会、予測(2017年~2031年)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 |
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カスタマイズ可能
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分子診断の世界市場の評価:製品・サービス別、検査タイプ別、サンプルタイプ別、技術別、用途別、エンドユーザー別、地域別、機会、予測(2017年~2031年) |
出版日: 2024年08月13日
発行: Markets & Data
ページ情報: 英文 230 Pages
納期: 3~5営業日
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世界の分子診断の市場規模は、2023年の143億1,000万米ドルから2031年に308億3,000万米ドルに達すると予測され、2024年~2031年の予測期間にCAGRで10.07%の成長が見込まれます。
分子診断は、重要な情報を提供することで、患者や医療従事者が治療について十分な知識を持った判断を下し、良好な結果を導くのに役立ちます。分子診断技術は、高感度で迅速な検出方法を可能にするため、臨床現場で有用であることが示されており、がんやその他の慢性疾患を含むさまざまな感染性疾患のモニタリングが容易になります。疾病の増加、病原体の増加、さらには疾病に罹患しやすく継続的な診断が必要な老年人口の増加により、分子診断市場の拡大が見込まれています。遺伝学的検査、微生物、性病、腫瘍、血液スクリーニング、ウイルス、組織型、出生前診断など、分子診断の普及により数多くの医学疾患が効果的に特定されています。DNA、RNA、タンパク質の研究を利用した実験室ベースの分子診断は、ヒトの疾患の検出に使用される重要な器具です。分子診断キットや試薬は、目的の用途に応じて調整され、特定の細菌、ウイルス、寄生虫の配列に特異的なプローブを含んでいます。分子診断市場は、あらゆる種類の投薬や治療を開始する前に不可欠な、バイオマーカーに特化した検査キットの使用が増加していることから、拡大が見込まれています。例えばUSFDAは、2023年5月にHologic, Inc.のPanther Fusion SARS-CoV-2/Flu A/B/RSVアッセイの510(k)認可を与えました。このアッセイは、分子診断検査によってもっとも流行している4種類の呼吸器ウイルスを区別します。
慢性疾患の有病率の増加による市場成長
分子診断市場は、慢性疾患の罹患率の増加によって大きく拡大しています。高齢化、ライフスタイルの変化、環境要因などはいずれも、がん、糖尿病、心血管疾患などの慢性疾患の増加に寄与しています。これらの疾患を管理し、効果的に治療するには、先進の診断法が必要です。このような状況では、遺伝子、ゲノム、プロテオミクスデータを解析する先進技術を用いた分子診断が不可欠です。慢性疾患に関連する特定のバイオマーカーや遺伝子変化を同定することで、疾患のタイムリーで正確な発見が容易になります。各患者固有の分子プロファイルに従って治療レジメンをカスタマイズすることは、治療効果を高め、患者の転帰を向上させます。例えば、腫瘍に特有の変異を検出することで、分子診断は、薬剤を選択する際の試行錯誤の必要性を最小限にすることで、最適ながん治療法を決定する手助けをする可能性があります。このような診断により、疾患の進行や治療に対する身体の反応を追跡し続けることが容易になり、迅速な治療法の変更が可能になります。
慢性疾患の有病率が伸び続けていることから、疾病の原因や患者の健康状態についての包括的かつ個別化された知見を提供する分子診断に対するニーズは高まっています。このような動向は、分子診断産業における継続的な開発と技術革新を促進し、長期的な疾患治療の改善に寄与しています。例えば、International Diabetes Federationは2023年に、2型糖尿病の有病率が世界中で顕著に増加していると報告しています。同連盟の調査によると、2023年に世界で5億3,700万人の成人が糖尿病を患っており、前年より大幅に増加しています。高齢化、肥満率の増加、座りがちな生活習慣がこの動向の原因とされています。2型糖尿病患者の増加は、この長期的な疾患の影響を制御し軽減するための、よりよい予防策と医学的治療へのニーズを浮き彫りにしています。
技術開発が市場成長を促進
技術開発が分子診断市場の拡大において大きな役割を果たしています。この分野はハイスループットシーケンシング、リアルタイムPCR、次世代シーケンシング(NGS)技術の進歩により革命的な変化を遂げ、精度、スピード、包括的な診断能力が向上しました。これらの技術により、以前には考えられなかったような精度で遺伝物質を解析することが可能になり、疾患の早期発見や個別化治療に役立っています。
当レポートでは、世界の分子診断市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。
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.