查看購物車
  • Simplified Chinese
  • English
  • Japanese
  • Korean
封面
市場調查報告書
商品編碼
1844038

全球腫瘤生物標記診斷市場，2024-2030年

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個工作天內

價格
簡介目錄

基因組分析和人工智慧整合的進步推動了監管部門的核准、伴隨診斷夥伴關係和精準醫療，推動了行業的變革性成長

本研究服務提供全球腫瘤生物標記診斷市場的全面分析。該市場正因臨床需求、技術進步、策略聯盟/夥伴關係以及精準醫療計劃的整合而發生變革。本研究依技術（體學、免疫測量、生物資訊學和液態切片）對市場進行細分，並提供六年收益預測和主要市場參與企業的分析。本研究也提供北美、歐洲、亞太、中東/北非/南美和拉丁美洲的區域分析。

本報告探討了當前流行和新興的經營模式經營模式，分析了腫瘤生物標記的市場准入和償付趨勢，並提供了競爭力評估和收益佔有率分析。本報告還檢驗了市場促進因素和限制因素，並提供了關於發展趨勢、夥伴關係和投資環境的見解。本報告重點關注開發顛覆性NGS和液態切片技術的公司。

根據技術進步、經營模式和競爭動態，為市場參與者和其他相關人員確定該領域的成長機會，基準年為2024年，預測期為2025-2030年。

收益及預測

預計2023年基準年的收益將達到 232.8億美元，2024-2030年研究期間的年複合成長率為 13.9%，主要受腫瘤生物標記診斷市場成長的推動。

三大策略要務對全球腫瘤生物標記診斷產業的影響

顛覆性技術

  • 為什麼？
  • 腫瘤生物標記診斷市場對無需侵入性手術即可早期診斷癌症的檢測的需求日益成長。
  • 傳統的組織切片檢查耗時長，給患者帶來痛苦，並且往往無法提供有關腫瘤進展的重要資料，這就是為什麼全球液態切片液態切片，尤其是使用 ctDNA 的市場，即將成為遊戲規則的改變者。
  • 透過簡單的血液樣本，這些測試可以識別與癌症相關的突變，加快精準腫瘤診斷市場的診斷和監測。
  • 例如，Guardant Health 的Guardant360® CDx 是一項美國食品藥物管理局（FDA）核准的檢測（2020年），無需組織樣本，可在 7 天內提供全面結果。憑藉非侵入性監測、快速的周轉時間和廣泛的患者覆蓋率，這項技術代表著精準診斷和基於 NGS 的癌症生物標記市場的轉變。
  • Frost的觀點
  • Guardant360® 等檢測趨勢推動腫瘤生物標記診斷市場的發展，並重塑商業趨勢。類似 Guardant360® 的檢測從可選的附加功能發展成為標準腫瘤生物標記診斷的重要組成部分。
  • 這些測試的興起使得醫療保健專業人員能夠即時檢測基因變化並更快地做出治療決策，避免了多生物標記測試市場中昂貴的試驗。
  • 預計該技術將廣泛應用於癌症治療，改善患者的治療效果並減輕醫療保健系統的壓力。

產業融合

  • 為什麼：
  • 隨著人工智慧、數位病理學和生物標記發現的發展，腫瘤生物標記診斷市場見證產業融合，這將為癌症治療提供精確有效的方法。
  • 這些技術的融合將實現準確的腫瘤分析和關鍵突變的快速檢測，為全球液態切片市場帶來更有針對性的治療。
  • 例如，Guardant Health 等公司使用人工智慧和 ctDNA液態切片來識別突變並預測癌症將如何發展以及何時停止治療，而 Tempus 將機器學習和基因定序整合到精準腫瘤診斷市場中，為醫生提供相關見解並根據全面的資料分析制定治療計劃。
  • 這種融合帶來一種更全面、資料主導的癌症治療方法，突破了基於 NGS 的癌症生物標記市場中傳統診斷方法的界限。
  • Frost的觀點
  • 這種融合徹底改變了腫瘤生物標記的診斷和治療。借助即時基因定序和先進的人工智慧演算法，多分析物生物標記檢測市場實現更精準、更個人化的治療。
  • 這種融合將提高切片檢查效率，同時降低癌症死亡率，改善患者預後，並擴大治療機會。
  • 領先的生物標記公司相信個人化治療和臨床干預可以更快地推進，實現患者管理中更好、更快的決策。

競爭激烈程度

  • 為什麼：
  • 為了滿足腫瘤生物標記診斷市場對個人化治療和高精度的需求，成熟公司和新興企業的競爭日益激烈，推動 NGS 技術和液態切片的進步。
  • Guardant Health 和 Foundation Medicine 不斷突破液態切片和下一代定序（NGS）技術的發展界限。 Guardant360 是一項經 FDA核准的液態切片檢測，因其能夠提供晚期固體癌的全面基因組圖譜而已廣泛應用。 FoundationOne CDx 下一代定序（NGS）檢測正成為識別腫瘤突變以及與Roche等公司建立策略夥伴關係的重要工具。
  • Grail 和 Clarify Life Sciences 等新參與企業全球液態切片市場推出用於個人化治療和早期癌症檢測的創新基因組解決方案。
  • Frost的觀點
  • 成熟公司和新興企業都在爭取精準腫瘤診斷市場的主導地位，競爭非常激烈。
  • 該產業的最新發展，例如Thermo Fisher Scientific收購 OncoLabs 和 ASG 的NGS 平台，將擴大創新解決方案的取得管道，形成更有活力、更合規的市場。
  • 隨著其他公司透過策略聯盟獲得 FDA核准，對現實世界療效的需求預計會成長，有可能使產品與競爭對手的產品區分開來。

分析範圍

腫瘤生物標記是存在於組織或血液中的物質，用於檢測癌症的存在、進展和治療反應。它們對於早期發現、診斷、監測、治療方法選擇和預後非常重要。許多癌症生物標記與促進癌症生長並影響治療效果的基因變異有關。本研究聚焦於全球腫瘤生物標記診斷市場，並對2024年至2030年六年間精準腫瘤診斷市場的收益進行了詳細的預測。

本研究重點關注全球腫瘤生物標記診斷市場，並提供了從2024年到2030年六年的詳細收益預測。它分析了體學技術（基因組學、轉錄組學、蛋白質組學、代謝體學）、免疫測量（IHC、ELISA、CLIA）、生物資訊學（計算生物學、基於 AI 的生物標記發現）和液態切片（循環腫瘤 DNA [ctDNA]、CTC、外泌體），以了解基於 NGS 的癌症生物標記市場的趨勢。

提供北美、歐洲、亞太、拉丁美洲和 MENASA（中東、北非和南亞）的區域分析。

本研究不包括基於影像的腫瘤生物標記診斷，例如 PET、CT 和 MRI，也不包括尚未獲得監管部門核准的實驗室開發測試（LDT）。鑑於其在資料解釋和多組體學整合中的重要性，生物資訊學工具和人工智慧主導的平台被納入多生物標記測試市場。

供應商格局包括在腫瘤生物標記診斷市場中提供用於腫瘤生物標記診斷的軟體平台、耗材、檢測試劑套件、試劑和工具的公司。本研究對癌症生物標記在各種分子和非分子檢測環境中的使用進行了全球和區域分析，包括醫院/診斷實驗室、生物製藥公司和 CRO、研究和學術機構以及其他機構（私人診所、專科診所、支持生物標記整合的健康 IT 和 AI/ML 公司以及健康科技平台）。

促進因素

  • 隨著個人化醫療的日益普及（例如，KEYNOTE-189 試驗利用 PD-L1 檢測對非小細胞肺癌患者進行Pembrolizumab治療），癌症治療途徑中對基於生物標記的診斷的需求迅速成長。
  • 伴隨診斷的支付方支持和償付力度不斷加大，使患者更容易獲得先進的生物標記檢測。例如，2024年，CMS擴大了FoundationOne伴隨診斷在結直腸癌和非小細胞肺癌（NSCLC）中的覆蓋範圍，這將對全球液態切片市場非常重要。
  • 生物標記相關療法的簡審類和加速監管核准簡化精準腫瘤診斷市場中診斷技術與治療的整合。例如，Grail 的Galleri 檢測就獲得了 FDA 突破性療法認定。
  • 隨著液態切片和多體學技術的發展，診斷能力超越基於組織的測試，這些技術成為基於 NGS 的癌症生物標記市場的一部分，例如 Guardant Health 於2024年推出的用於早期檢測 CRC 的Shield 測試。
  • 擴大與製藥公司的合作，共同開發伴隨診斷產品，有助於加快產品上市速度，並帶來更可靠的收益來源。例如，Astra Zeneca的Tagrisso和賽默飛世爾的Oncomine Dx已在腫瘤生物標記診斷市場展開合作。
  • 隨著患者和腫瘤科醫師（尤其是在新興市場）對生物標記檢測的認知度和教育程度不斷提高，生物標記檢測的應用穩步成長。Roche在東南亞推出的2023-2024年認知舉措就是全球液態切片市場的一個例子。

成長抑制因素

  • 冗長的核准流程和複雜的法規可能會延遲進入腫瘤生物標記診斷市場。
  • 經濟壓力和限制性償付規定限制了患者的治療機會，尤其是在新興經濟體，影響了全球液態切片市場。
  • 缺乏標準化和技術碎片化導致生物標記診斷與臨床工作流程的整合不一致，影響了精準腫瘤診斷市場。
  • 中小企業面臨著高昂的研發成本和生物標記檢驗技術挑戰的壓力，這可能會阻礙基於 NGS 的癌症生物標記市場的創新。
  • 大規模資料共用和分析受到與遺傳和生物標記資料相關的道德和資料隱私問題的限制，影響了多分析物生物標記測試市場。
  • 生物資訊學和分子診斷領域合格人才的短缺阻礙了腫瘤生物標記診斷市場的採用並降低了其效率。

競爭環境

參賽者數

  • 約200家公司

競爭因素

  • 臨床準確性、監管部門核准、週轉時間、測試敏感性/特異性、成本效益、付款人覆蓋範圍以及與腫瘤生物標記診斷市場的製藥公司/診所的合作。

主要最終用戶行業分類

  • 全球液態切片市場中的醫院、診斷實驗室、學術研究中心、腫瘤診所和生物製藥公司

主要競爭對手

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

前五大競爭對手的銷售佔有率（2024年）

  • 估計46.9

其他值得關注的競爭對手

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

流通結構

  • 與精準腫瘤診斷市場中的EHR 和 LIS 系統整合。

值得關注的收購與合併

  • 2025年，Roche Holding AG收購了臨床階段細胞和基因治療（CGT）開發商Poseida Therapeutics。此次15億美元的收購是Roche擴大在CAR-T細胞治療領域影響力的策略性舉措。

主要技術競爭對手

  • 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

目錄

調查範圍

  • 分析範圍

成長環境：全球腫瘤生物標記診斷產業的轉型

  • 為何成長變得越來越困難？
  • The Strategic Imperative 8
  • 三大策略要務對全球腫瘤生物標記診斷產業的影響

全球腫瘤生物標記診斷生態系統

  • 介紹
  • 腫瘤生物標記診斷工作流程
  • 競爭環境
  • 主要技術競爭對手

腫瘤生物標記診斷產業的成長要素

  • 成長指標
  • 促進因素
  • 促進因素分析
  • 成長抑制因素
  • 成長阻礙因素分析
  • 產業問題分析
  • 預測考慮因素
  • 收益預測
  • 收益預測分析
  • 依技術類型分類的收益預測
  • 癌症診斷領域的主要商業機會及其對商業動態的影響
  • 依技術類型分類的收益預測分析
  • 各地區收益預測
  • 各地區收益預測分析
  • 依癌症類型的分析收益
  • 依癌症類型的收益預測分析
  • 依應用的收益預測
  • 依應用的收益分析
  • 依最終用戶銷售
  • 依最終用戶進行的收益分析
  • 美國價格趨勢及預測分析
  • 區域價格差異與償付效應
  • 監管和償付狀況
  • FDA核准的癌症治療方法
  • 銷售佔有率
  • 收益佔有率分析
  • 競爭格局
  • 值得關注的活動

成長引擎：體學技術

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：免疫測量

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：生物資訊學

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：液態切片

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：北美

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：歐洲

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：亞太地區

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：拉丁美洲

  • 成長指標
  • 收益預測
  • 收益預測分析

成長引擎：拉丁美洲

  • 成長指標
  • 收益預測
  • 收益預測分析

成長機會宇宙

  • 成長機會1：下一代預測性生物標記物，用於個人化癌症免疫治療
  • 成長機會2：全面的腫瘤基因組分析，以增強生物標記的發現與治療最佳化
  • 成長機會3：伴隨診斷作為標靶治療的解決方案
  • 成長機會4：液態切片和主導診斷在新興市場的擴張

後續步驟

  • 成長機會的益處和影響
  • 後續步驟
  • 圖表目錄
  • 免責聲明
簡介目錄
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