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市場調查報告書
商品編碼
1519455
2024-2032 年液體活體組織切片市場報告(按產品和服務、循環生物標記、癌症類型、最終用戶和地區)Liquid Biopsy Market Report by Product And Service, Circulating Biomarker, Cancer Type, End User, and Region 2024-2032 |
IMARC Group年全球液體切片市場規模達20億美元。癌症盛行率的不斷上升、對個人化醫療和治療的需求不斷成長以及自動化液體活體組織切片平台的發展是推動液體活體組織切片市場成長的一些關鍵因素。
主要市場促進因素:由於生活方式的改變,特別是在職業人士中,癌症盛行率不斷上升,再加上下一代定序的引入,正在推動市場成長。液體活體組織切片能夠檢測血液或尿液等體液中與癌症相關的生物標記物,例如循環腫瘤細胞 (CTC)、遊離 DNA (cfDNA) 和外泌體。早期檢測對於有效治療和改善患者治療效果至關重要,從而推動市場成長。
主要市場趨勢:技術進步、擴大臨床應用、向多分析方法的轉變、對早期檢測和篩檢的日益關注以及在臨床試驗中提高液體活體組織切片的採用是預計刺激市場成長的一些關鍵因素未來幾年。此外,定序技術、微流控和生物資訊學的不斷創新正在提高液體活體組織切片檢測的靈敏度、特異性和可擴展性,從而進一步增加液體活體組織切片市場的收入。
地理格局:根據報告,北美佔據最大的市場佔有率。癌症仍然是北美的一個主要健康問題,每年有很大一部分人口被診斷出患有各種類型的癌症。高發病率推動了對液體活體組織切片等創新診斷工具的需求,這些工具為癌症檢測和監測提供非侵入性且準確的方法。這進一步對液體活體組織切片市場需求產生正面影響。
競爭格局:液體切片市場的一些領先公司包括 ANGLE plc、Biocept Inc.、Bio-Rad Laboratories Inc、Epigenomics AG、Exact Sciences Corporation、F. Hoffmann-La Roche AG、Guardant Health Inc.、Illumina Inc.、MDxHealth SA 、Menarini Silicon Biosystems、QIAGEN NV 和Thermo Fisher Scientific Inc. 等。
挑戰與機會:檢測的標準化和驗證、臨床驗證和證據產生以及成本考量和報銷是市場目前面臨的一些關鍵挑戰。然而,液體活體組織切片可以與人工智慧 (AI) 和機器學習等數位健康技術相結合,以增強資料分析、解釋和臨床決策。這對製造商來說是重要的機會。
癌症盛行率上升
隨著全球癌症發生率的上升,人們越來越重視疾病的早期檢測和監測。例如,根據世界衛生組織的數據,到 2022 年,預計將有 2,000 萬新的癌症診斷和 970 萬人死亡。癌症診斷後五年預計存活人數為 5,350 萬人。大約五分之一的人一生中都會受到癌症的影響。預計到2050 年,癌症病例將增加超過3500 萬例,比2022 年預計的2000 萬例增加77%。 ) 和遊離DNA。這些生物標記可以為癌症的存在、進展和遺傳特徵提供有價值的見解,使臨床醫生能夠在早期階段診斷癌症並更有效地監測疾病進展。例如,在 2023 年美國癌症研究協會年會上,研究人員提交了一份關於液體活體組織切片多癌症早期檢測測試的報告,該測試使用創新平台分析 DNA 甲基化。傳統測試需要在定序前對 DNA 進行化學處理,而新方法無需任何化學或酶處理即可捕獲甲基化 cfDNA 分子。科學家進行了一項回顧性分析,以檢驗該平台在約4,000 人樣本中檢測12 種癌症類型的能力,其中包括最近診斷出的癌症患者、未接受過治療的癌症患者以及年齡和性別匹配的對照者。大約一半的癌症病例處於早期階段。此外,2020年,賓州大學的研究團隊在《臨床癌症研究》上發表了一篇論文,證明他們的液體切片在診斷早期胰臟癌方面的準確率高達92%。這些因素進一步對液體活體組織切片市場預測產生正面影響。
對非侵入性產前檢查 (NIPT) 的需求不斷成長
傳統的產前檢測方法,例如羊膜穿刺術和絨毛膜絨毛取樣(CVS),出現併發症(包括流產)的風險很小。 NIPT 涉及分析母親血液中循環的胎兒遊離 DNA (cffDNA),為產前篩檢提供了一種非侵入性替代方案。例如,根據國家醫學圖書館的數據,羊膜穿刺術可以在懷孕 15 週至出生期間的任何時間進行,在專家手中,單胎流產的可能性為 0.13%。據此,懷孕 15 週後進行羊膜穿刺術的風險估計為百分之一。此外,NIPT 在檢測常見胎兒染色體異常方面表現出很高的準確性,例如 21 三體(唐氏症)、18 三體症(愛德華茲症候群)和 13 三體(帕陶症候群)。此外,基於液體活體組織切片的 NIPT 檢測可以高靈敏度和特異性地檢測胎兒遺傳異常,為準父母提供有關嬰兒健康狀況的可靠資訊。例如,2023年11月,Novacyt子公司Yourgene Health與Laboriad合作在摩洛哥推出了第一個非侵入性產前檢測(NIPT)平台。除此之外,NIPT 最早可以在懷孕 9-10 週時進行,從而提供對胎兒遺傳健康狀況的早期了解。及早發現染色體異常可以讓準父母就懷孕做出明智的決定,並考慮進行額外的診斷測試或為有特殊需求的孩子的出生做好準備。此外,NIPT 最早可以在懷孕 9-10 週時進行,從而儘早了解胎兒遺傳健康狀況。及早發現染色體異常可以讓準父母就懷孕做出明智的決定,並考慮進行額外的診斷測試或為有特殊需求的孩子的出生做好準備。例如,根據克利夫蘭診所發表的一篇文章,NIPT 檢測最早可以從懷孕十週一直進行到分娩。這些因素進一步對液體切片市場近期的價格產生正面影響。
不斷增加的研發活動和臨床試驗
液體活體組織切片技術的不斷進步正在提高癌症篩檢、藥物試驗最佳化和治療選擇的頻率。各政府機構和公司正在專注於投資研發,以進行液體活體組織切片的臨床研究。例如,2023 年 6 月,Anzu Partners 領投了 Codetta Biosciences 的 1,500 萬美元 A 輪投資。 Genoa Ventures 和 VC23 LLC 也參與了此次融資。 Codetta 計劃利用這筆資金迅速擴大其在研發、工程、行銷和企業管理方面的團隊,並加快其用於液體活體組織切片的多組學 dsPCR 平台的開發。此外,臨床試驗可作為評估新型液體活體組織切片技術和平台性能的平台。對研發的投資有助於開發下一代定序 (NGS) 平台、數位 PCR 系統和其他創新技術,從而提高液體活體組織切片檢測的靈敏度、特異性和可擴展性。臨床試驗提供了在現實臨床環境中驗證這些進步的機會,為其商業化和廣泛採用鋪平了道路。例如,2024 年4 月,專注於解決基因治療製造差距的技術創新公司NewBiologix SA 推出了下一代定序(NGS) 和光學圖譜平台,這是一套新穎的技術,將為基因治療提供全面的基因組分析服務。這些因素進一步提高了液體活體組織切片的市場佔有率。
The global liquid biopsy market size reached US$ 2.0 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 6.5 Billion by 2032, exhibiting a growth rate (CAGR) of 13.5% during 2024-2032. The increasing prevalence of cancer, the rising demand for personalized medicine and treatments, and the development of automated liquid biopsy platforms, represent some of the key factors driving the liquid biopsy market growth.
Major Market Drivers: The rising prevalence of cancer owing to changing lifestyle patterns, especially among working professionals, along with the introduction of next-generation sequencing is propelling the market growth. Liquid biopsies enable the detection of cancer-related biomarkers, such as circulating tumor cells (CTCs), cell-free DNA (cfDNA), and exosomes, in bodily fluids like blood or urine. Early detection is crucial for effective treatment and improved patient outcomes, thereby driving the market growth.
Key Market Trends: Technological advancements, expanding clinical applications, a shift towards multi-analyte approaches, rising focus on early detection and screening, and elevating adoption of liquid biopsies in clinical trials are some of the key factors that are expected to stimulate the market growth in the coming years. Moreover, continuous innovation in sequencing technologies, microfluidics, and bioinformatics is enhancing the sensitivity, specificity, and scalability of liquid biopsy assays, thereby further bolstering the liquid biopsy market revenue.
Geographical Landscape: According to the report, North America accounted for the largest market share. Cancer remains a major health concern in North America, with a significant portion of the population being diagnosed with various types of cancer each year. The high incidence rates drive the demand for innovative diagnostic tools like liquid biopsies that offer non-invasive and accurate methods for cancer detection and monitoring. This is further positively impacting the liquid biopsy market demand.
Competitive Landscape: Some of the leading liquid biopsy market companies are ANGLE plc, Biocept Inc., Bio-Rad Laboratories Inc, Epigenomics AG, Exact Sciences Corporation, F. Hoffmann-La Roche AG, Guardant Health Inc., Illumina Inc., MDxHealth SA, Menarini Silicon Biosystems, QIAGEN N.V., and Thermo Fisher Scientific Inc., among many others.
Challenges and Opportunities: Standardization and validation of assays, clinical validation and evidence generation, and cost consideration and reimbursement are some of the key challenges that the market is currently facing. However, liquid biopsies can be integrated with digital health technologies, such as artificial intelligence (AI) and machine learning, to enhance data analysis, interpretation, and clinical decision-making. This represents key opportunities for the manufacturers.
Rising Prevalence of Cancer
With cancer rates on the rise globally, there's a growing emphasis on early detection and monitoring of the disease. For instance, according to WHO, in 2022, there were expected to be 20 million new cancer diagnoses and 9.7 million fatalities. The expected number of people who survived five years after a cancer diagnosis was 53.5 million. Cancer affects around one in every five persons in their lifetime. Over 35 million more cancer cases are expected in 2050, up 77% over the estimated 20 million in 2022. Liquid biopsies offer a non-invasive method to detect circulating tumor biomarkers, such as circulating tumor cells (CTCs) and cell-free DNA (cfDNA), in bodily fluids like blood or urine. These biomarkers can provide valuable insights into the presence, progression, and genetic profile of cancer, enabling clinicians to diagnose cancer at earlier stages and monitor disease progression more effectively. For instance, at the 2023 American Association of Cancer Research Annual Meeting, researchers presented a report on a liquid biopsy multicancer early detection test that analyzes DNA methylation using an innovative platform. While conventional tests need chemical treatment of DNA before sequencing, the novel approach captures methylated cfDNA molecules without any chemical or enzymatic treatment. The scientists conducted a retrospective analysis to examine the ability of the platform to detect 12 cancer types in a sample of around 4,000 people, including recently diagnosed, treatment-naive cancer patients, and age- and gender-matched controls. Approximately half of the cancer cases were in the early stages. In addition, in 2020, a team of researchers from the University of Pennsylvania released a paper in Clinical Cancer Research demonstrating that their liquid biopsy was 92% accurate in diagnosing early pancreatic cancer. These factors are further positively impacting the liquid biopsy market forecast.
Rising Demand for Non-Invasive Pre-Natal Tests (NIPT)
Traditional prenatal testing methods, such as amniocentesis and chorionic villus sampling (CVS), carry a small risk of complications, including miscarriage. NIPT, which involves analyzing cell-free fetal DNA (cffDNA) circulating in the mother's blood, offers a non-invasive alternative for prenatal screening. For instance, according to the National Library of Medicine, amniocentesis can be performed anywhere from 15 weeks of gestation to birth, with a 0.13% chance of loss in singletons in expert hands. In line with this, the risk of getting amniocentesis after 15 weeks of pregnancy is estimated to be 1 in 100. This non-invasive approach is preferred by many expectant parents due to its safety and reduced risk of procedure-related complications. Moreover, NIPT has demonstrated high accuracy in detecting common fetal chromosomal abnormalities, such as trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome). Also, liquid biopsy based NIPT assays can detect fetal genetic abnormalities with high sensitivity and specificity, providing expectant parents with reliable information about their baby's health status. For instance, in November 2023, Yourgene Health, a subsidiary of Novacyt collaborated with Laboriad to introduce the first non-invasive prenatal testing (NIPT) platform in Morocco. Besides this, NIPT can be performed as early as 9-10 weeks into pregnancy, providing early insights into fetal genetic health. Early detection of chromosomal abnormalities allows expectant parents to make informed decisions about their pregnancy and consider additional diagnostic testing or preparation for the birth of a child with special needs. Furthermore, NIPT can be performed as early as 9-10 weeks into pregnancy, providing early insights into fetal genetic health. Early detection of chromosomal abnormalities allows expectant parents to make informed decisions about their pregnancy and consider additional diagnostic testing or preparation for the birth of a child with special needs. For instance, according to an article published by Cleveland Clinic, NIPT testing can be performed from as early as ten weeks of pregnancy until delivery. These factors are further positively influencing the liquid biopsy market's recent prices.
Rising R&D Activities and Clinical Trials
The rising technological advancements in liquid biopsies are escalating the frequency of cancer screening, drug trial optimization, and therapeutic selection. Various government agencies and companies are focusing on investment in research and development to conduct clinical studies on liquid biopsy. For instance, in June 2023, Anzu Partners led a US$15 Million Series A investment round for Codetta Biosciences. Genoa Ventures and VC23 LLC also contributed to the funding. With the funding, Codetta plans to rapidly expand its team in R&D, engineering, marketing, and business administration as well as quicken the development of its multi-omic dsPCR platform for liquid biopsy. Moreover, clinical trials serve as platforms for evaluating the performance of novel liquid biopsy technologies and platforms. Investment in research and development enables the development of next-generation sequencing (NGS) platforms, digital PCR systems, and other innovative technologies that enhance the sensitivity, specificity, and scalability of liquid biopsy assays. Clinical trials provide opportunities to validate these advancements in real-world clinical settings, paving the way for their commercialization and widespread adoption. For instance, in April 2024, NewBiologix SA, a technology innovation company focused on addressing gene therapy manufacturing gaps, launched its next-generation sequencing (NGS) and optical mapping platform, a novel suite of technologies that will provide comprehensive genomic analysis services to the biopharmaceutical industry. These factors are further contributing to the liquid biopsy market share.
MARC Group provides an analysis of the key trends in each sub-segment of the global liquid biopsy market report, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on product and service, circulating biomarker, cancer type, and end user.
Kits and Reagents
Platforms and Instruments
Services
Kits and reagents assist dominates the market
The report has provided a detailed breakup and analysis of the liquid biopsy market based on the product and service. This includes kits and reagents, platforms and instruments and services. According to the report, kits and reagents represented the largest segment.
According to the liquid biopsy market outlook, the growth of kits and reagents segment is driven by the surging demand for liquid biopsy tests, especially for cancer diagnostics. These kits are used to isolate cell-free DNA from plasma or serum samples. They often utilize methods like spin column-based purification, magnetic bead-based purification, or precipitation-based methods. Moreover, rising research and development activities by the key players for the development of advanced kits are proliferating the segment's growth. For instance, in September 2023, Pillar Biosciences, Inc., Decision Medicine company, launched oncoReveal Core LBx, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories with a solution for liquid biopsy-based pan-cancer tumor profiling.
Circulating Tumor Cells
Extracellular Vesicles
Circulating Tumor DNA
Others
Circulating tumor cells hold the largest share in the market
A detailed breakup and analysis of the liquid biopsy market based on the circulating biomarker has also been provided in the report. This includes circulating tumor cells, extracellular vesicles, circulating tumor DNA and others. According to the liquid biopsy market report, circulating tumor cells accounted for the largest market share.
According to the liquid biopsy market overview, the surging demand for Circulating Tumor Cells (CTC) is attributed to its wide range of applications in biomarkers such as gene expressions, protein expressions, and DNA mutations. Moreover, the clinical utility of CTC analysis in cancer diagnosis, prognosis, and treatment monitoring is increasingly recognized. As more clinical studies demonstrate the prognostic value of CTC enumeration, characterization, and genomic profiling in various cancer types, there is a growing demand for CTC-based tests in routine clinical practice. For instance, in September 2023, nRichDX introduced a novel RUO-labeled CTC enrichment kit that isolates Circulating Tumor Cells (CTCs) from up to 40mL of whole blood samples, assisting researchers in liquid biopsy assay research and development.
Lung Cancer
Breast Cancer
Colorectal Cancer
Prostate Cancer
Liver Cancer
Others
Lung cancer accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the liquid biopsy market based on the cancer type. This includes lung cancer, breast cancer, colorectal cancer, prostate cancer, liver cancer and others. According to the report, lung cancer represented the largest segment.
Liquid biopsy offers a non-invasive method for detecting and monitoring lung cancer compared to traditional tissue biopsies. Sampling blood for circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), or exosomes is less invasive and can be performed more frequently, allowing for real-time monitoring of disease progression and treatment response. Moreover, it enables the detection of lung cancer at early stages when tumors are smaller and more amenable to curative treatments. Additionally, it facilitates longitudinal monitoring of treatment response and disease recurrence, leading to timely adjustments in treatment strategies. For instance, in April 2024, researchers at The Royal Marsden and Guardant Health collaborated to develop a new liquid biopsy test that would assist thousands of lung cancer patients. Marsden360, a cutting-edge circulating tumor DNA (ctDNA) test, is expected to accelerate and personalize treatment for this patient population.
Hospitals and Laboratories
Academic and Research Centers
Others
Hospitals and laboratories hold the largest share in the market
A detailed breakup and analysis of the liquid biopsy market based on the end user has also been provided in the report. This includes hospitals and laboratories, academic and research centers and others. According to the report, hospitals and laboratories accounted for the largest market share.
The growing demand for liquid biopsies in hospitals is mainly driven by the surging adoption of liquid biopsy tests for cancer diagnosis. Additionally, as the clinical utility of liquid biopsy in cancer management becomes increasingly recognized, there is a growing demand from hospitals and laboratories for tests that utilize liquid biopsy techniques. Liquid biopsy offers non-invasive methods for detecting and monitoring cancer, providing valuable information for diagnosis, prognosis, treatment selection, and monitoring of treatment response. For instance, in May 2024, Syndicate Bio, a Nigeria-based biotechnology lab, collaborated with SophiaGenetics, a cloud-native software corporation specialized in data-driven medicine, to provide extensive genomic profiling and liquid biopsy services.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance in the market
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia and others); Latin America (Brazil, Mexico and others) and the Middle East and Africa. According to the report, North America was the largest market for liquid biopsy.
According to the liquid biopsy market statistics, some of the factors driving the North America liquid biopsy market included continual technological advancements, ongoing improvements in the healthcare industry, extensive research and development (R&D) activities conducted by key players, etc. Moreover, cancer remains a major health concern in North America, and the incidence rates continue to rise. Liquid biopsies offer a non-invasive method for detecting and monitoring cancer, which is particularly beneficial for early detection and personalized treatment strategies. Continuous advancements in technologies such as next-generation sequencing (NGS), digital PCR, and microfluidics have enhanced the sensitivity, accuracy, and reliability of liquid biopsy tests. These technological improvements have expanded the applications of liquid biopsies across various cancer types and stages. For instance, in April 2023, Quest Diagnostics, a diagnostic information services provider headquartered in U.S., acquired Haystack Oncology, an early-stage oncology company focused on minimal residual disease (MRD), the fastest-growing category of liquid biopsy testing to aid in the early, accurate detection of residual or recurring cancer and better inform therapy decisions.
ANGLE plc
Biocept Inc.
Bio-Rad Laboratories Inc
Epigenomics AG
Exact Sciences Corporation
F. Hoffmann-La Roche AG
Guardant Health Inc.
Illumina Inc.
MDxHealth SA
Menarini Silicon Biosystems
QIAGEN N.V.
Thermo Fisher Scientific Inc.
(Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.)
May 2024: VESICA HEALTH, INC., a leading multi-omics liquid biopsy company, launched its laboratory developed AssureMDx test to improve the management of hematuria patients and the early detection of bladder cancer.
April 2024: SOPHiA GENETICS, a cloud-native software firm in healthcare and a leader in data-driven medicine, announced that Nigeria-based Syndicate Bio signed on to adopt MSK-ACCESS powered by SOPHiA DDM.
April 2024: City of Hope, one of the largest cancer research and treatment organizations in the United States, collaborated with DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, to utilize DELFI's FirstLook Lung, a blood-based lung cancer liquid biopsy screening test, to improve screening rates in underserved communities in Los Angeles County.