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市場調查報告書
商品編碼
1722450
2025 年至 2033 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、最終用戶和地區分類)Liquid Biopsy Market Report by Product And Service, Circulating Biomarker, Cancer Type, End User, and Region 2025-2033 |
2024 年全球液體切片市場規模達 23 億美元。展望未來, IMARC Group預計到 2033 年市場規模將達到 72 億美元,2025-2033 年期間的成長率 (CAGR) 為 12.82%。癌症發病率的上升、個人化醫療和治療需求的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,尤其是在工作專業人士中,癌症盛行率的上升,以及下一代定序的引入,推動了市場的成長。液體切片檢查能夠檢測血液或尿液等體液中的癌症相關生物標記物,例如循環腫瘤細胞 (CTC)、遊離 DNA (cfDNA) 和外泌體。早期發現對於有效治療和改善患者預後至關重要,從而推動市場成長。
主要市場趨勢:技術進步、擴大臨床應用、向多分析物方法的轉變、對早期檢測和篩檢的關注度不斷提高以及在臨床試驗中提高液體活體組織切片的採用率是預計將在未來幾年刺激市場成長的一些關鍵因素。此外,定序技術、微流體技術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敏感性、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。癌症仍然是北美的主要健康問題,每年有相當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了非侵入性和準確的方法。這進一步對液體活體組織切片市場需求產生了積極影響。
競爭格局:一些領先的液體活體組織切片市場公司包括 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 Bioicons、QIAG)、Illumina Inc。
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。這對製造商來說意味著重要的機會。
癌症發生率上升
隨著全球癌症發生率的上升,人們越來越重視癌症的早期發現和監測。例如,根據世界衛生組織預測,2022年將有2,000萬例新癌症診斷病例和970萬例死亡病例。預計癌症確診後五年內存活的人數為 5,350 萬人。大約每五個人中就有一人一生中會罹患癌症。預計 2050 年癌症病例將增加 3,500 多萬例,比 2022 年預計的 2,000 萬例增加 77%。液體活體組織切片提供了一種非侵入性方法來檢測血液或尿液等體液中的循環腫瘤生物標記物,例如循環腫瘤細胞 (CTC) 和遊離 DNA (cfDNA)。這些生物標記可以為癌症的存在、進展和基因特徵提供有價值的見解,使臨床醫生能夠在早期診斷癌症並更有效地監測病情進展。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使用創新平台分析DNA甲基化的液體活體組織切片多癌症早期檢測測試的報告。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的 cfDNA 分子。科學家進行了回顧性分析,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,其中包括最近確診的、未接受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,賓州大學的研究小組在《臨床癌症研究》上發表論文,證明他們的液體切片對早期胰臟癌的診斷準確率為92%。這些因素進一步對液體活體組織切片市場預測產生了積極影響。
非侵入性產前檢測(NIPT)需求不斷成長
傳統的產前檢查方法,例如羊膜穿刺術和絨毛膜絨毛取樣(CVS),具有發生併發症(包括流產)的風險。 NIPT 涉及分析母親血液中循環的無細胞胎兒 DNA(cffDNA),為產前篩檢提供了一種非侵入性的替代方法。例如,根據美國國家醫學圖書館的資料,羊膜穿刺術可以在懷孕 15 週至分娩期間的任何時間進行,在專業人員手中,單胎流產的幾率為 0.13%。據此估計,懷孕 15 週後進行羊膜穿刺術的風險為 1/100。這種非侵入性方法因其安全性和降低手術相關併發症的風險而受到許多準父母的青睞。此外,NIPT 在檢測常見的胎兒染色體異常方面表現出很高的準確性,例如 21 三體症候群(唐氏症)、18 三體症(愛德華茲氏症候群)和 13 三體症(帕陶氏症候群)。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基因異常,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 的子公司 Yourgene Health 與 Laboriad 合作在摩洛哥推出了首個非侵入性產前檢測 (NIPT) 平台。除此之外,NIPT 最早可在懷孕 9-10 週時進行,可提前了解胎兒的基因健康狀況。早期發現染色體異常可以讓準父母對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 最早可在懷孕 9-10 週時進行,可提前了解胎兒的基因健康狀況。早期發現染色體異常可以讓準父母對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 測試最早可以在懷孕十週後進行,直到分娩。這些因素進一步對液體活體組織切片市場近期的價格產生了積極影響。
研發活動和臨床試驗不斷增加
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。各政府機構及企業均著重投入研發力量,進行液體切片的臨床研究。例如,2023 年 6 月,Anzu Partners 領投了 Codetta Biosciences 的 1,500 萬美元 A 輪融資。 Genoa Ventures 和 VC23 LLC 也參與了此次融資。利用這筆資金,Codetta 計劃迅速擴大其研發、工程、行銷和業務管理團隊,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。研發投入促進了次世代定序 (NGS) 平台、數位 PCR 系統和其他創新技術的開發,從而提高了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,為其商業化和廣泛應用鋪平了道路。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 推出了其下一代定序 (NGS) 和光學映射平台,這是一套新穎的技術,將為生物製藥行業提供全面的基因組分析服務。這些因素進一步促進了液體活體組織切片市場佔有率的成長。
The global liquid biopsy market size reached USD 2.3 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 7.2 Billion by 2033, exhibiting a growth rate (CAGR) of 12.82% during 2025-2033. 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 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.
Kits and reagents assist dominates the market
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 hold the largest share in the market
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 accounts for the majority of the market share
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 hold the largest share in the market
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 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.