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市场调查报告书
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1844038

2024-2030年全球肿瘤生物标记诊断市场

Oncology Biomarker Diagnostics, Global, 2024-2030
出版日期: | 出版商: Frost & Sullivan | 英文 68 Pages | 商品交期: 最快1-2个工作天内

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简介目录

基因组分析和人工智慧整合的进步推动了监管部门的核准、伴随诊断伙伴关係和精准医疗，从而推动了行业的变革性成长

本研究服务提供全球肿瘤生物标记诊断市场的全面分析。该市场正因临床需求、技术进步、策略联盟/伙伴关係以及精准医疗计划的整合而发生变革。本研究按技术（体学、免疫测量、生物资讯学和液态切片）对市场进行细分，并提供六年收益预测和主要市场参与企业的分析。本研究也提供北美、欧洲、亚太、中东/北非/南美和拉丁美洲的区域分析。

本报告探讨了当前流行和新兴的经营模式经营模式，分析了肿瘤生物标记的市场准入和报销趋势，并提供了竞争力评估和收益份额分析。该报告还检验了市场驱动因素和限制因素，并提供了关于发展趋势、伙伴关係和投资环境的见解。本报告重点关注开发颠覆性NGS和液态切片技术的公司。

它根据技术进步、经营模式和竞争动态，为市场参与者和其他相关人员确定该领域的成长机会，基准年为 2024 年，预测期为 2025-2030 年。

收益及预测

预计 2023 年基准年的收益将达到 232.8 亿美元，2024-2030 年研究期间的复合年增长率为 13.9%，主要受肿瘤生物标记诊断市场成长的推动。

三大策略要务对全球肿瘤生物标记诊断产业的影响

颠覆性技术

  • 为什么？
  • 肿瘤生物标记诊断市场对无需侵入性手术即可早期诊断癌症的检测的需求日益增长。
  • 传统的组织切片检查耗时长，给患者带来痛苦，并且往往无法提供有关肿瘤进展的重要数据，这就是为什么全球液态切片液态切片，尤其是使用 ctDNA 的市场，即将成为游戏规则的改变者。
  • 透过简单的血液样本，这些测试可以识别与癌症相关的突变，从而加快精准肿瘤诊断市场的诊断和监测。
  • 例如，Guardant Health 的 Guardant360® CDx 是一项美国食品药物管理局(FDA)核准的检测（2020 年），无需组织样本，可在 7 天内提供全面结果。凭藉非侵入性监测、快速的周转时间和广泛的患者覆盖率，这项技术代表着精准诊断和基于 NGS 的癌症生物标记市场的转变。
  • 弗罗斯特的观点
  • Guardant360® 等检测趋势正在推动肿瘤生物标记诊断市场的发展，并重塑商业趋势。类似 Guardant360® 的检测正在从可选的附加功能发展成为标准肿瘤生物标记诊断的重要组成部分。
  • 这些测试的兴起使得医疗保健专业人员能够即时检测基因变化并更快地做出治疗决策，避免了多生物标记测试市场中昂贵的试验。
  • 预计该技术将广泛应用于癌症治疗，改善患者的治疗效果并减轻医疗保健系统的压力。

产业融合

  • 为什么：
  • 随着人工智慧、数位病理学和生物标记发现的发展，肿瘤生物标记诊断市场正在见证产业融合，这将为癌症治疗提供精确有效的方法。
  • 这些技术的融合将实现准确的肿瘤分析和关键突变的快速检测，从而为全球液态切片市场带来更有针对性的治疗。
  • 例如，Guardant Health 等公司正在使用人工智慧和 ctDNA液态切片来识别突变并预测癌症将如何发展以及何时停止治疗，而 Tempus 正在将机器学习和基因定序整合到精准肿瘤诊断市场中，为医生提供相关见解并根据全面的数据分析制定治疗计划。
  • 这种融合正在带来一种更全面、数据主导的癌症治疗方法，突破了基于 NGS 的癌症生物标记市场中传统诊断方法的界限。
  • 弗罗斯特的观点
  • 这种融合彻底改变了肿瘤生物标记的诊断和治疗。借助即时基因定序和先进的人工智慧演算法，多分析物生物标记检测市场正在实现更精准、更个人化的治疗。
  • 这种融合将提高切片检查效率，同时降低癌症死亡率，改善患者预后，并扩大治疗机会。
  • 领先的生物标记公司相信个人化治疗和临床干预可以更快地推进，从而实现患者管理中更好、更快的决策。

竞争激烈程度

  • 为什么：
  • 为了满足肿瘤生物标记诊断市场对个人化治疗和高精度的需求，成熟公司和新兴企业的竞争日益激烈，推动 NGS 技术和液态切片的进步。
  • Guardant Health 和 Foundation Medicine 正在不断突破液态切片和下一代定序 (NGS) 技术的发展界限。 Guardant360 是一项经 FDA核准的液态切片检测，因其能够提供晚期固体癌的全面基因组图谱而已广泛应用。 FoundationOne CDx 下一代定序 (NGS) 检测正成为识别肿瘤突变以及与罗氏等公司建立策略伙伴关係的重要工具。
  • Grail 和 Clarify Life Sciences 等新参与企业正在全球液态切片市场推出用于个人化治疗和早期癌症检测的创新基因组解决方案。
  • 弗罗斯特的观点
  • 成熟公司和新兴企业都在争取精准肿瘤诊断市场的主导地位，竞争非常激烈。
  • 该产业的最新发展，例如赛默飞世尔科技收购 OncoLabs 和 ASG 的 NGS 平台，将扩大创新解决方案的取得管道，从而形成更有活力、更合规的市场。
  • 随着其他公司透过策略联盟获得 FDA核准，对现实世界疗效的需求预计会成长，从而有可能使产品与竞争对手的产品区分开来。

分析范围

肿瘤生物标记是存在于组织或血液中的物质，用于检测癌症的存在、进展和治疗反应。它们对于早期发现、诊断、监测、治疗方法选择和预后至关重要。许多癌症生物标记与促进癌症生长并影响治疗效果的基因变异有关。本研究聚焦于全球肿瘤生物标记诊断市场，并对2024年至2030年六年间精准肿瘤诊断市场的收益进行了详细的预测。

本研究重点关注全球肿瘤生物标记诊断市场，并提供了从 2024 年到 2030 年六年的详细收益预测。它分析了体学技术（基因组学、转录组学、蛋白质组学、代谢体学）、免疫测量（IHC、ELISA、CLIA）、生物资讯学（计算生物学、基于 AI 的生物标记发现）和液态切片（循环肿瘤 DNA [ctDNA]、CTC、外泌体），以了解基于 NGS 的癌症生物标记市场的趋势。

它还提供北美、欧洲、亚太、拉丁美洲和 MENASA（中东、北非和南亚）的区域分析。

本研究不包括基于影像的肿瘤生物标记诊断，例如 PET、CT 和 MRI，也不包括尚未获得监管部门核准的实验室开发测试 (LDT)。鑑于其在数据解释和多组体学整合中的重要性，生物资讯学工具和人工智慧主导的平台被纳入多生物标记测试市场。

供应商格局包括在肿瘤生物标记诊断市场中提供用于肿瘤生物标记诊断的软体平台、耗材、检测试剂套件、试剂和工具的公司。该研究对癌症生物标记在各种分子和非分子检测环境中的使用进行了全球和区域分析，包括医院/诊断实验室、生物製药公司和 CRO、研究和学术机构以及其他机构（私人诊所、专科诊所、支持生物标誌物整合的健康 IT 和 AI/ML 公司以及健康科技平台）。

驱动程式

  • 随着个人化医疗的日益普及（例如，KEYNOTE-189 试验利用 PD-L1 检测对非小细胞肺癌患者进行Pembrolizumab治疗），癌症治疗途径中对基于生物标誌物的诊断的需求正在迅速增长。
  • 伴随诊断的支付方支持和报销力度不断加大，使患者更容易获得先进的生物标记检测。例如，2024年，CMS扩大了FoundationOne伴随诊断在结直肠癌和非小细胞肺癌（NSCLC）中的覆盖范围，这将对全球液态切片市场至关重要。
  • 生物标记相关疗法的简审类和加速监管核准正在简化精准肿瘤诊断市场中诊断技术与治疗的整合。例如，Grail 的 Galleri 检测就获得了 FDA 突破性疗法认定。
  • 随着液态切片和多体学技术的发展，诊断能力正在超越基于组织的测试，这些技术正在成为基于 NGS 的癌症生物标记市场的一部分，例如 Guardant Health 于 2024 年推出的用于早期检测 CRC 的 Shield 测试。
  • 扩大与製药公司的合作，共同开发伴随诊断产品，有助于加快产品上市速度，并带来更可靠的收益来源。例如，Astra Zeneca的Tagrisso和赛默飞世尔的Oncomine Dx已在肿瘤生物标记诊断市场展开合作。
  • 随着患者和肿瘤科医师（尤其是在新兴市场）对生物标记检测的认知度和教育程度不断提高，生物标记检测的应用正在稳步增长。罗氏在东南亚推出的2023-2024年认知倡议就是全球液态切片市场的一个例子。

成长抑制因素

  • 冗长的核准流程和复杂的法规可能会延迟进入肿瘤生物标记诊断市场。
  • 经济压力和限制性报销规定限制了患者的治疗机会，尤其是在新兴经济体，影响了全球液态切片市场。
  • 缺乏标准化和技术碎片化导致生物标记诊断与临床工作流程的整合不一致，影响了精准肿瘤诊断市场。
  • 中小企业面临着高昂的研发成本和生物标记检验技术挑战的压力，这可能会阻碍基于 NGS 的癌症生物标记市场的创新。
  • 大规模数据共用和分析受到与遗传和生物标记数据相关的道德和数据隐私问题的限制，从而影响了多分析物生物标记测试市场。
  • 生物资讯学和分子诊断领域合格人才的短缺阻碍了肿瘤生物标记诊断市场的采用并降低了其效率。

竞争环境

参赛者数

  • 约200家公司

竞争因素

  • 临床准确性、监管部门核准、週转时间、测试敏感性/特异性、成本效益、付款人覆盖范围以及与肿瘤生物标记诊断市场的製药公司/诊所的合作。

主要最终用户行业分类

  • 全球液态切片市场中的医院、诊断实验室、学术研究中心、肿瘤诊所和生物製药公司

主要竞争对手

  • 罗氏诊断、赛默飞世尔科技、Exact Sciences、Illumina Inc.、安捷伦科技、Guardant Health

前五大竞争对手的销售份额（2024 年）

  • 估计46.9

其他值得关注的竞争对手

  • Myriad Genetics Inc.、Hologic Inc.、Bio-Rad Laboratories、Natera、QIAGEN、Caris Life Sciences、NeoGenomics

流通结构

  • 与精准肿瘤诊断市场中的 EHR 和 LIS 系统整合。

值得关注的收购与合併

  • 2025年，罗氏控股公司收购了临床阶段细胞和基因治疗（CGT）开发商Poseida Therapeutics。此次15亿美元的收购是罗氏扩大在CAR-T细胞治疗领域影响力的策略性倡议。

主要技术竞争对手

  • Omics
  • Roche
  • Thermo Fisher Scientific Inc.
  • Illumina, Inc.
  • QIAGEN NV
  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Bio-Rad Laboratories, Inc.
  • Myriad Genetics, Inc.
  • Siemens Healthineers
  • Exact Sciences
  • Caris Life Sciences
  • Freenoem Holdings Inc.
  • Guardant Health
  • NanoString Technologies
  • Personalis Inc.
  • 10x Genomics
  • Adaptive Biotechnologies
  • BD Biosciences
  • BGI Genomics
  • Biodesix, Inc.
  • Bruker Corporation
  • Epigenomics AG
  • Bioinformatics
  • Roche
  • Thermo Fisher Scientific Inc.
  • Illumina, Inc.
  • QIAGEN NV
  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Bio-Rad Laboratories, Inc.
  • Myriad Genetics, Inc.
  • Siemens Healthineers
  • Exact Sciences
  • Hologic Inc.
  • Freenoem Holdings Inc.
  • Guardant Health
  • NanoString Technologies
  • Personalis Inc.
  • Aiforia Technologies
  • Almac Diagnostics
  • Berkeley Lights, Inc.
  • C2i Genomics
  • Deep Genomics
  • Deep Lens
  • Flagship Biosciences
  • Liquid Biopsy
  • Grail
  • Exact Sciences
  • Biocpet Inc.
  • DiaCarta
  • Invitae
  • Lucene Health Inc.
  • MDX Health
  • Medgemone
  • Novigenix
  • OncoDNA
  • ScreenCell
  • Luigile All Inc.
  • Bio-Techne
  • NeoGenomics Laboratories
  • ArcherDX
  • Olink Proteomics
  • Guardant Health
  • Freenoem Holdings
  • Tempus
  • C2i Genomics
  • Caris Life Sciences
  • Immunoassays
  • Roche
  • Thermo Fisher Scientific Inc.
  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Bio-Rad Laboratories, Inc.
  • Siemens Healthineers
  • Exact Sciences
  • Hologic Inc.
  • DiaSorin
  • Beckman Coulter
  • Ortho Clinical Diagnostics
  • Grifols
  • QIAGEN

目录

调查范围

  • 分析范围

成长环境：全球肿瘤生物标记诊断产业的转型

  • 为何成长变得越来越困难？
  • The Strategic Imperative 8
  • 三大策略要务对全球肿瘤生物标记诊断产业的影响

全球肿瘤生物标记诊断生态系统

  • 介绍
  • 肿瘤生物标记诊断工作流程
  • 竞争环境
  • 主要技术竞争对手

肿瘤生物标记诊断产业的成长要素

  • 成长指标
  • 驱动程式
  • 驱动因素分析
  • 成长抑制因素
  • 成长阻碍因素分析
  • 产业问题分析
  • 预测考虑因素
  • 收益预测
  • 收益预测分析
  • 按技术类型分類的收益预测
  • 癌症诊断领域的主要商业机会及其对商业动态的影响
  • 按技术类型分類的收益预测分析
  • 各地区收益预测
  • 各地区收益预测分析
  • 按癌症类型分析收益
  • 按癌症类型进行的收益预测分析
  • 按应用分類的收益预测
  • 按应用进行的收益分析
  • 按最终用户销售
  • 按最终用户进行的收益分析
  • 美国价格趋势及预测分析
  • 区域价格差异与报销效应
  • 监管和报销状况
  • FDA核准的癌症治疗方法
  • 销售份额
  • 收益份额分析
  • 竞争格局
  • 值得关注的活动

成长引擎：体学技术

  • 成长指标
  • 收益预测
  • 收益预测分析

生长发生器：免疫测量

  • 成长指标
  • 收益预测
  • 收益预测分析

成长动力：生物资讯学

  • 成长指标
  • 收益预测
  • 收益预测分析

生长发生器：液态切片

  • 成长指标
  • 收益预测
  • 收益预测分析

成长动力：北美

  • 成长指标
  • 收益预测
  • 收益预测分析

成长引擎：欧洲

  • 成长指标
  • 收益预测
  • 收益预测分析

成长动力：亚太地区

  • 成长指标
  • 收益预测
  • 收益预测分析

成长引擎：拉丁美洲

  • 成长指标
  • 收益预测
  • 收益预测分析

成长引擎：拉丁美洲

  • 成长指标
  • 收益预测
  • 收益预测分析

成长机会宇宙

  • 成长机会 1：下一代预测性生物标记物，用于个人化癌症免疫治疗
  • 成长机会2：全面的肿瘤基因组分析，以增强生物标记的发现与治疗优化
  • 成长机会3：伴随诊断作为标靶治疗的解决方案
  • 成长机会四：液态切片和主导诊断在新兴市场的扩张

后续步骤Next steps

  • 成长机会的益处和影响
  • 后续步骤Next steps
  • 图表目录
  • 免责声明
简介目录
Product Code: PFVA-55

Regulatory Approvals, Companion Diagnostic Partnerships, and Precision Medicine are Driving Transformational Growth in the Industry, Fueled by Advances in Genomic Profiling and AI Integration

This research service offers a comprehensive analysis of the global oncology biomarker diagnostics market, which has transformed with the convergence of clinical demand, advances in technology, and strategic collaborations/partnerships coupled with precision medicine initiatives. It categorizes the market by technology (omics, immunoassays, bioinformatics, and liquid biopsy), providing a 6-year revenue forecast and an analysis of key industry participants. Regional analyses are provided for North America; Europe; Asia-Pacific; the Middle East, North Africa, and South Asia; and Latin America.

The report discusses prevalent and emerging business models, analyzes trends in market access and reimbursement for oncology biomarkers, and offers competitive assessments and revenue share analyses. It examines market drivers and restraints, offering insights into development trends, partnerships, and the investment landscape. The report highlights companies developing disruptive NGS and liquid biopsy technology.

Based on technological advancements, business models, and competitive dynamics, the report identifies growth opportunities in this space for market players and other stakeholders. The base year is 2024, and the forecast period is 2025 to 2030.

Revenue Forecast

The revenue estimate for the base year 2023 is $23.28 billion, with a CAGR of 13.9% for the study period from 2024 to 2030, mainly driven by growth in the oncology biomarker diagnostics market.

The Impact of the Top 3 Strategic Imperatives on the Global Oncology Biomarker Diagnostics Industry

Disruptive Technologies

  • Why:
  • The demand for tests that can diagnose cancer early without invasive procedures is growing in the oncology biomarker diagnostics market.
  • Traditional tissue biopsies are time-consuming, painful for patients, and frequently fail to capture essential data regarding the progression of a tumor. Therefore, the global liquid biopsy market, particularly those that use ctDNA, is seen as a game changer.
  • With a simple blood sample, these tests can identify mutations linked to cancer in the precision oncology diagnostics market and speed up simplified diagnosis and monitoring.
  • For instance, Guardant Health's Guardant360(R) CDx, a US Food and Drug Administration (FDA)-approved test (2020), provides comprehensive results in 7 days without requiring tissue sample. With its non-invasive monitoring, quick turnaround, and wider patient eligibility, this signifies a move toward precision diagnostics and the NGS-based cancer biomarker market.
  • Frost Perspective:
  • Tests such as Guardant360(R) are gaining traction and remapping business trends in the oncology biomarker diagnostics market. They are evolving from optional add-ons to an essential part of standard oncology biomarker diagnostics.
  • With the rise of these tests, healthcare professionals can detect gene alterations in real time and make guided treatment decisions faster, avoiding costly trial and error in the multi-analyte biomarker testing market.
  • This technology is expected to become widely adopted across the oncology practice, which could improve patient outcomes and ease pressure on healthcare systems.

Industry Convergence

  • Why:
  • Industry convergence is observed with developments in AI, digital pathology, and biomarker discovery that combine to provide a precise and efficient approach to cancer care in the oncology biomarker diagnostics market.
  • The convergence of these technologies allows precise tumor profiling and faster detection of key mutations, which results in more targeted therapies in the global liquid biopsy market.
  • For instance, AI and ctDNA liquid biopsy are being used by companies such as Guardant Health to identify mutations and forecast how cancers might evolve and rest treatment. Tempus is integrating ML and genetic sequencing to offer physicians relevant insights and tailor treatment plans based on comprehensive data analysis in the precision oncology diagnostics market.
  • The convergence leads to a more comprehensive, data-driven approach to cancer, which is pushing the limits of traditional diagnostics in the NGS-based cancer biomarker market.
  • Frost Perspective:
  • This convergence revolutionized oncology biomarker diagnostics and treatment. With the help of real-time genetic sequencing and advanced AI algorithms, more precise and personalized treatments are made in the multi-analyte biomarker testing market.
  • This convergence will reduce cancer death rates, improve patient outcomes, and expand access to care while increasing the efficiency of biopsies.
  • Leading biomarker companies believe it is possible to move towards personalized therapy and clinical intervention more swiftly, which can lead to better and faster decisions in patient management.

Competitive Intensity

  • Why:
  • Competition is increasing, fueled by leading and emerging players addressing the demand for personalized care and precision in the oncology biomarker diagnostics market and driving advancements in NGS technology and liquid biopsy.
  • Guardant Health and Foundation Medicine are pushing the boundaries of liquid biopsy and NGS technology. Guardant360, an FDA-approved liquid biopsy test, is becoming a widely adopted test for offering a comprehensive genomic profile for advanced solid tumors. The FoundationOne CDx NGS test is becoming an essential tool to identify mutations in tumors and develop strategic partnerships with companies such as Roche.
  • New players, such as Grail and Clarify Life Sciences, are launching innovative genomic solutions for personalized treatment and early detection of cancer in the global liquid biopsy market.
  • Frost Perspective:
  • With the presence of both leading and emerging players, the industry is witnessing fierce competition for market dominance in the precision oncology diagnostics market.
  • Developments in this industry, such as Thermo Fisher's recent acquisition of OncoLabs, ASG's NGS platform expands access to innovative solutions, resulting in a more viable, regulatory-compliant market.
  • As others can obtain FDA approval from strategic partnerships, there is a rising demand for real-world clinical efficacy will be expected, and the potential to differentiate products in the competitive arena will result from this intense rivalry.

Scope of Analysis

Oncology biomarkers are substances found in tissues or blood that detect the presence of cancer, its progression, or how well it will respond to treatment. They are essential for early detection, diagnosis, monitoring, therapy selection, and prognosis. Many oncology biomarkers are linked to alterations in genes that promote cancer growth and affect how well a treatment works. This study focuses on the global oncology biomarker diagnostics market, offering a detailed 6-year revenue forecast from 2024 to 2030 in the precision oncology diagnostics market.

This study focuses on the global oncology biomarker diagnostics market, offering a detailed 6-year revenue forecast from 2024 to 2030. It analyzes omics technologies (genomics, transcriptomics, proteomics, and metabolomics), immunoassays (IHC, ELISA, and CLIAs), bioinformatics (computational biology and AI-driven biomarker discovery) and liquid biopsy (circulating tumor DNA [ctDNA], CTCs, and exosomes) to understand trends in the NGS-based cancer biomarker market.

Regional analyses are provided for North America, Europe, Asia-Pacific, Latin America, and MENASA (the Middle East, North Africa, and South Asia).

Imaging-based oncology biomarker diagnostics, such as PET, CT, and MRI, are not included in this study, nor are laboratory-developed tests (LDTs) that have not received regulatory approval. Considering their significance in data interpretation and multi-omics integration, bioinformatics tools and AI-driven platforms are included in the multi-analyte biomarker testing market.

The vendor landscape consists of companies that provide software platforms, consumables, assay kits, reagents, and tools for the diagnosis of cancer biomarkers within the oncology biomarker diagnostics market. The study offers global and regional analyses of the use of oncology biomarkers in a variety of molecular and non-molecular testing settings, including hospital/diagnostics labs, biopharmaceutical companies and CROs, research and academic institutions, and others (private practices, specialty clinics, health IT and AI/ML companies supporting biomarker integration, and healthtech platforms).

Growth Drivers

  • The demand for biomarker-based diagnostics in oncology care pathways is expanding rapidly due to the increasing adoption of personalized medicine (e.g., the KEYNOTE-189 trial utilizing PD-L1 testing for pembrolizumab in patients with non-small cell lung cancer).
  • Advanced biomarker testing is becoming more accessible to patients due to increased payer support and reimbursement for companion diagnostics. For instance, in 2024, CMS expanded coverage for FoundationOne CDx in colorectal and NSCLC, which is crucial for the global liquid biopsy market.
  • Fast-track designations and accelerated regulatory approvals for biomarker-linked therapies are simplifying the integration of diagnostics into treatment in the precision oncology diagnostics market. For instance, Grail's Galleri test was designated an FDA breakthrough.
  • Diagnostic capabilities are evolving beyond tissue-based testing due to developments in liquid biopsy and multi-omics technologies, which are becoming part of the NGS-based cancer biomarker market. For instance, the Shield test for CRC early detection from Guardant Health was launched in 2024.
  • Expanding pharmaceutical collaborations for companion diagnostics co-development contributes to early market entrance and reliable revenue streams. For instance, AstraZeneca's Tagrisso combined with Thermo Fisher's Oncomine Dx in the oncology biomarker diagnostics market.
  • The uptake of biomarker testing is steadily growing due to increased patient and oncologist education and awareness, particularly in emerging markets. Roche's 2023-2024 awareness initiatives in Southeast Asia are an example in the global liquid biopsy market.

Growth Restraints

  • Long approval processes and complicated regulations can delay entry into the oncology biomarker diagnostics market.
  • Economic pressures and limited reimbursement regulations limit patient access, especially in developing regions, which impacts the global liquid biopsy market.
  • The lack of standardization and fragmentation of technology have resulted in inconsistent integration of biomarker diagnostics with clinical workflows, affecting the precision oncology diagnostics market.
  • Midsize and smaller companies are strained by high R&D expenses and technological challenges in biomarker validation, which could impede innovation in the NGS-based cancer biomarker market.
  • Large-scale data sharing and analytics are constrained by ethical and data privacy issues related to genetic and biomarker data, impacting the multi-analyte biomarker testing market.
  • The lack of qualified workers in bioinformatics and molecular diagnostics hinders adoption and reduces efficiency across the oncology biomarker diagnostics market.

Competitive Environment

Number of Competitors

  • About 200

Competitive Factors

  • Clinical accuracy, regulatory approval, turnaround time, test sensitivity/specificity, cost-effectiveness, payer coverage, partnerships with pharma/clinics in the oncology biomarker diagnostics market.

Key End-User Industry Verticals

  • Hospitals, diagnostic laboratories, academic research centers, oncology clinics, biopharmaceutical companies within the global liquid biopsy market.

Leading Competitors

  • Roche Diagnostics, Thermo Fisher Scientific, Exact Sciences, Illumina Inc., Agilent Technologies, Guardant Health

Revenue Share of Top 5 Competitors (2024)

  • Estimated 46.9%

Other Notable Competitors

  • Myriad Genetics Inc., Hologic Inc., Bio-Rad Laboratories, Natera, QIAGEN, Caris Life Sciences, NeoGenomics

Distribution Structure

  • Direct-to-hospital/lab partnerships, diagnostic lab networks, collaborations with biopharma, integrated with EHR and LIS systems in the precision oncology diagnostics market.

Notable Acquisitions and Mergers

  • In 2025, Roche Holding AG acquired Poseida Therapeutics, a clinical-stage cell and gene therapy (CGT) developer. The finalization of a $1.5 billion deal will be a strategic move to expand its presence in CAR-T cell therapy.

Key Competitors by Technology

  • Omics
  • Roche
  • Thermo Fisher Scientific Inc.
  • Illumina, Inc.
  • QIAGEN N.V.
  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Bio-Rad Laboratories, Inc.
  • Myriad Genetics, Inc.
  • Siemens Healthineers
  • Exact Sciences
  • Caris Life Sciences
  • Freenoem Holdings Inc.
  • Guardant Health
  • NanoString Technologies
  • Personalis Inc.
  • 10x Genomics
  • Adaptive Biotechnologies
  • BD Biosciences
  • BGI Genomics
  • Biodesix, Inc.
  • Bruker Corporation
  • Epigenomics AG
  • Bioinformatics
  • Roche
  • Thermo Fisher Scientific Inc.
  • Illumina, Inc.
  • QIAGEN N.V.
  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Bio-Rad Laboratories, Inc.
  • Myriad Genetics, Inc.
  • Siemens Healthineers
  • Exact Sciences
  • Hologic Inc.
  • Freenoem Holdings Inc.
  • Guardant Health
  • NanoString Technologies
  • Personalis Inc.
  • Aiforia Technologies
  • Almac Diagnostics
  • Berkeley Lights, Inc.
  • C2i Genomics
  • Deep Genomics
  • Deep Lens
  • Flagship Biosciences
  • Liquid Biopsy
  • Grail
  • Exact Sciences
  • Biocpet Inc.
  • DiaCarta
  • Invitae
  • Lucene Health Inc.
  • MDX Health
  • Medgemone
  • Novigenix
  • OncoDNA
  • ScreenCell
  • Luigile All Inc.
  • Bio-Techne
  • NeoGenomics Laboratories
  • ArcherDX
  • Olink Proteomics
  • Guardant Health
  • Freenoem Holdings
  • Tempus
  • C2i Genomics
  • Caris Life Sciences
  • Immunoassays
  • Roche
  • Thermo Fisher Scientific Inc.
  • Agilent Technologies, Inc.
  • Abbott Laboratories
  • Bio-Rad Laboratories, Inc.
  • Siemens Healthineers
  • Exact Sciences
  • Hologic Inc.
  • DiaSorin
  • Beckman Coulter
  • Ortho Clinical Diagnostics
  • Grifols
  • QIAGEN

Table of Contents

Research Scope

  • Scope of Analysis

Growth Environment: Transformation in Global Oncology Biomarker Diagnostics Industry

  • Why is it Increasingly Difficult to Grow?
  • The Strategic Imperative 8
  • The Impact of the Top 3 Strategic Imperatives on the Global Oncology Biomarker Diagnostics Industry

Ecosystem in the Global Oncology Biomarker Diagnostics Industry

  • Introduction
  • Workflow of Oncology Biomarker Diagnostics
  • Competitive Environment
  • Key Competitors by Technology

Growth Generator in the Oncology Biomarker Diagnostics Industry

  • Growth Metrics
  • Growth Drivers
  • Growth Driver Analysis
  • Growth Restraints
  • Growth Restraint Analysis
  • Industry Challenges Analysis
  • Forecast Considerations
  • Revenue Forecast
  • Revenue Forecast Analysis
  • Revenue Forecast by Technology Type
  • Key Oncology Diagnostics Opportunities and the Impact on Business Dynamics
  • Revenue Forecast Analysis by Technology Type
  • Revenue Forecast by Region
  • Revenue Forecast Analysis by Region
  • Revenue Analysis by Cancer Type
  • Revenue Forecast Analysis by Cancer Type
  • Revenue Forecast by Application
  • Revenue Forecast Analysis by Application
  • Revenue by End User
  • Revenue Analysis by End User
  • US Pricing Trends and Forecast Analysis
  • Regional Pricing Disparities and Reimbursement Effects
  • Regulatory and Reimbursement Landscape
  • FDA-Approved Therapy by Cancer Type
  • Revenue Share
  • Revenue Share Analysis
  • Competitive Landscape
  • Notable Activities

Growth Generator: Omics Technologies

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: Immunoassays

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: Bioinformatics

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: Liquid Biopsy

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: North America

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: Europe

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: Asia-Pacific

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: MENASA

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Generator: Latin America

  • Growth Metrics
  • Revenue Forecast
  • Revenue Forecast Analysis

Growth Opportunity Universe

  • Growth Opportunity 1: Next-Gen Predictive Biomarkers to Personalize Immunotherapy in Cancer Care
  • Growth Opportunity 2: Comprehensive Tumor Genomic Profiling for Enhanced Biomarker Discovery and Therapy Optimization
  • Growth Opportunity 3: Companion Diagnostics as a Solution for Targeted Therapies
  • Growth Opportunity 4: Expanding Liquid Biopsy and AI-Driven Diagnostics in Emerging Markets

Next Steps

  • Benefits and Impacts of Growth Opportunities
  • Next Steps
  • List of Exhibits
  • Legal Disclaimer