首頁 > 市場調查報告書 > 醫療設備

體外診斷癌症癌症診斷

市場調查報告書

商品編碼

2126333

肺癌診斷市場：策略洞察與預測（2026-2035）

Lung Cancer Diagnostics Market - Strategic Insights and Forecasts (2026-2035)

出版日期: 2026年08月03日 | 出版商:

Knowledge Sourcing Intelligence | 英文 177 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

預計肺癌診斷市場規模將從 2026 年的 179 億美元成長到 2035 年的 308 億美元，複合年成長率為 6.2%。

肺癌診斷市場正經歷重大變革，其驅動力在於精準腫瘤學和全面分子特徵分析的模式轉移。這一市場演變的特點是，人們日益認知到治療方案的選擇不僅取決於組織病理學診斷，還取決於特定基因組突變的識別。先進影像技術、次世代定序、液態生物檢體技術和人工智慧的融合，使得診斷評估更加快速、準確且全面。醫療系統正擴大獲得多種診斷技術，這些技術能夠在單次檢測中識別多個治療標靶生物標記物，從而減少診斷延誤，並支持及時的治療性介入。隨著生物標記導向療法的普及，對全面基因組分析的需求也日益成長，因為治療合格越來越依賴有效的分子突變。國家癌症控制舉措正透過投資基因組醫學、檢查室現代化和標準化檢測指南，支持更廣泛地獲取先進的診斷技術。在這個市場中，人們正在大力投資開發伴隨診斷、液態生物檢體平台和人工智慧驅動的影像解決方案，肺癌診斷正日益被視為不僅僅是一種疾病檢測工具，而是影響治療結果的關鍵決定因素。

市場促進因素

精準腫瘤學領域的蓬勃發展是肺癌診斷市場的主要驅動力。精準腫瘤學正在重新定義現代肺癌的治療模式，因為治療方案的選擇不再僅僅依賴組織病理學診斷，而是取決於特定基因組突變的識別。隨著標靶治療在由多種生物標記定義的患者群體中不斷獲得監管部門的批准，臨床實踐中對治療前進行廣泛的分子檢測的需求日益成長。組織樣本的有限性仍然是臨床上的重要限制因素，促使檢查室採用多重定序技術，以從少量切片檢查檢體中提取盡可能多的基因組資訊。診斷設備製造商正透過與開發標靶治療的製藥公司合作，擴展其全面的基因組分析產品線，從而推動肺癌診斷應用的持續成長。液態生物檢體透過革新非侵入性癌症表徵方式，進一步加速了市場成長。雖然傳統的組織切片檢查仍然是診斷的標準方法，但操作流程的限制常常導致分子檢測的延遲，或隨著疾病的進展而無法獲得重複檢體。由於能夠透過微創血液採樣，利用循環腫瘤DNA (ctDNA) 進行基因組表徵，基於血漿的檢測方法在臨床上的應用日益廣泛。定序化學和生物資訊學的進步不斷提高分析靈敏度，增強了醫生對液態生物檢體在治療選擇和抗藥性監測中應用的信心。伴隨診斷監管範圍的擴大正在促進市場接受度和臨床整合。隨著法規核准越來越重視治療前生物標記的確認，伴隨診斷正在建立分子檢測和標靶治療之間的臨床路徑。由於使用明確生物標記的臨床試驗能夠改善患者選擇和治療效果，製藥公司正在將診斷開發更早整合到其臨床項目中。法規核准正在逐步批准伴隨診斷的適應症，增加了檢查室對檢驗的檢測平台的需求。人工智慧 (AI) 正在提高基於影像的檢測的準確性並簡化工作流程。醫學影像在肺癌檢測中仍然至關重要，因為篩檢項目高度依賴電腦斷層掃描 (CT) 來識別可疑的肺結節。隨著篩檢數量的增加，報告撰寫的挑戰也隨之而來，放射科正在將人工智慧融入影像判讀流程中。人工智慧演算法透過優先提取異常觀察來簡化工作流程，同時確保肺結節評估的一致性。

市場限制因素

全面基因組分析和次世代定序的高成本持續限制資源匱乏的醫療系統對其應用。先進技術所需的大量資金投入，對預算有限的醫療機構而言是一大障礙。不同地區對先進分子診斷的報銷政策差異，阻礙了檢測的普及，並延緩了精準腫瘤學計畫的實施。不同地區的保險覆蓋政策差異，給診斷服務提供者帶來了不確定性，並限制了患者的就醫途徑。在一些新興醫療市場，專業分子病理學專家和經認證的基因組檢測機構數量有限，限制了檢測能力。缺乏訓練有素的人員，阻礙了全面基因組分析服務的擴充性。不同司法管轄區監管環境的複雜性，給尋求將新型診斷解決方案商業化的製造商帶來了合規負擔。為了跟上不斷變化的監管環境，製造商需要不斷調整自身，這增加了營運成本，並延長了產品上市時間。

依產品類型
- 裝置
- 試劑和試劑盒
- 軟體和服務
透過生物標記
- 分子和遺傳生物標記
- 蛋白質生物標記
- 新興生物標記
依樣本類型
- 組織切片檢查
- 液態生物檢體
- 其他檢體類型
按癌症類型
- 非小細胞肺癌（NSCLC）
- 小細胞肺癌（SCLC）
按測試類型
- 影像檢查
- 分子診斷
- 基於組織的診斷
- 其他
最終用戶
- 醫院
- 診斷檢查室
- 癌症中心
- 其他

第10章：全球肺癌診斷市場：區域分析

北美洲
歐洲
亞太地區
南美洲
中東和非洲

第11章全球肺癌診斷市場：國別分析

美國
加拿大
德國
英國
法國
義大利
西班牙
荷蘭
日本
中國
印度
韓國
澳洲
巴西
墨西哥
沙烏地阿拉伯
南非

第12章競爭格局

市佔率分析
策略趨勢
併購、合作與聯盟
新產品發布

第13章：公司簡介

Roche Holding AG
Thermo Fisher Scientific Inc.
Illumina, Inc.
QIAGEN NV
Agilent Technologies, Inc.
Abbott Laboratories
Koninklijke Philips NV
Bio-Rad Laboratories, Inc.
Guardant Health, Inc.
Exact Sciences Corporation

第14章全球肺癌診斷市場：商業預測分析

第15章：投資與資金籌措分析

創業投資趨勢
政府資金
研發投資

第16章：未來展望

主要成長機遇
未來產業趨勢

簡介目錄

Product Code: KSI-009045

The Lung Cancer Diagnostics Market is expected to grow at a CAGR of 6.2% from a market value of USD 17.9 billion in 2026 to USD 30.8 billion in 2035.

The lung cancer diagnostics market is undergoing significant transformation driven by the paradigm shift toward precision oncology and comprehensive molecular characterization. The market's evolution is characterized by the growing recognition that therapeutic selection depends on identifying specific genomic alterations rather than relying exclusively on histopathological diagnosis. The convergence of advanced imaging modalities, next-generation sequencing, liquid biopsy technologies, and artificial intelligence is enabling faster, more accurate, and increasingly comprehensive diagnostic evaluation. Healthcare systems are expanding access to multiplex diagnostic technologies that identify multiple actionable biomarkers in a single assay, reducing diagnostic delays and supporting timely therapeutic intervention. The growing availability of biomarker-directed therapies is increasing demand for comprehensive genomic profiling because treatment eligibility increasingly depends on actionable molecular alterations. National cancer control initiatives are supporting broader access to advanced diagnostics through investments in genomic medicine, laboratory modernization, and standardized testing guidelines. The market is witnessing significant investment in companion diagnostic development, liquid biopsy platforms, and AI-enabled imaging solutions, positioning lung cancer diagnostics as a critical determinant of treatment outcomes rather than solely a disease detection tool.

Market Drivers

Expanding precision oncology represents the primary driver for the lung cancer diagnostics market. Precision oncology defines modern lung cancer management because therapeutic selection depends on identifying specific genomic alterations rather than relying exclusively on histopathological diagnosis. Clinical practice is increasingly requiring broad molecular testing before treatment initiation as targeted therapies continue receiving regulatory approvals across multiple biomarker-defined populations. Limited tissue availability remains a major clinical constraint, encouraging laboratories to adopt multiplex sequencing technologies that maximize genomic information from small biopsy specimens. Diagnostic manufacturers are expanding comprehensive genomic profiling portfolios through collaborations with pharmaceutical companies developing targeted therapies, resulting in sustained growth in lung cancer diagnostic utilization. Liquid biopsy is further accelerating market growth by transforming non-invasive cancer characterization. Traditional tissue biopsy remains the diagnostic standard, yet procedural limitations frequently delay molecular testing or prevent repeat sampling during disease progression. Plasma-based testing is expanding clinical adoption because circulating tumor DNA enables genomic characterization through minimally invasive blood collection. Analytical sensitivity continues improving through advances in sequencing chemistry and bioinformatics, increasing physician confidence in liquid biopsy applications for therapy selection and resistance monitoring. Regulatory expansion of companion diagnostics is strengthening market adoption and clinical integration. Companion diagnostics establish the clinical pathway between molecular testing and targeted treatment because regulatory approvals increasingly specify biomarker confirmation before therapy administration. Drug developers are integrating diagnostic development earlier within clinical programs as biomarker-defined trials improve patient selection and therapeutic outcomes. Regulatory agencies continue approving additional companion diagnostic indications, increasing laboratory demand for validated testing platforms. Artificial intelligence is improving imaging-based detection and workflow efficiency. Medical imaging remains fundamental for lung cancer detection because screening programs rely heavily on computed tomography to identify suspicious pulmonary nodules. Radiology departments are incorporating artificial intelligence into image interpretation workflows as increasing screening volumes create reporting challenges. AI-assisted algorithms improve workflow efficiency by prioritizing abnormal findings while supporting consistency in pulmonary nodule assessment.

Market Restraints

High costs associated with comprehensive genomic profiling and next-generation sequencing continue limiting adoption across resource-constrained healthcare systems. The significant financial investment required for advanced technologies creates barriers for facilities with limited budgets. Variability in reimbursement policies for advanced molecular diagnostics reduces testing accessibility and delays implementation of precision oncology programs. Inconsistent coverage policies across regions create uncertainty for diagnostic providers and limit patient access. Limited availability of specialized molecular pathology expertise and accredited genomic laboratories restricts testing capacity in several emerging healthcare markets. The shortage of trained personnel reduces the scalability of comprehensive genomic profiling services. Regulatory complexities across different jurisdictions create compliance burdens for manufacturers seeking to commercialize new diagnostic solutions. The evolving regulatory landscape requires continuous adaptation, increasing operational costs and time-to-market.

Technology and Segment Insights

The technology landscape is characterized by the growing importance of integrated precision oncology platforms. Demand is shifting from sequential single-gene testing toward comprehensive genomic profiling because targeted therapies continue expanding across biomarker-defined populations. NGS is improving diagnostic efficiency through simultaneous multi-gene analysis, reducing sequential biomarker testing. Liquid biopsy technologies are expanding clinical utilization because they provide a minimally invasive genomic assessment when tissue availability limits conventional testing. Imaging technologies, including low-dose CT and AI-assisted interpretation, remain fundamental for early detection and screening. The segment analysis reveals that molecular diagnostics constitute the fastest-evolving testing segment because precision oncology depends on identifying actionable genomic alterations before treatment selection. Healthcare providers are increasingly replacing sequential single-gene assays with comprehensive genomic profiling that evaluates multiple biomarkers simultaneously. Non-Small Cell Lung Cancer represents the largest diagnostic segment because it encompasses numerous molecularly distinct disease subtypes that require individualized therapeutic selection. Clinical practice is increasingly incorporating comprehensive genomic profiling before treatment initiation as targeted therapies continue expanding across biomarker-defined populations. Molecular and genetic biomarkers, including EGFR, ALK, ROS1, BRAF, KRAS, MET, RET, and NTRK, are essential for therapy selection. Protein biomarkers, including PD-L1, guide immunotherapy decisions. Tissue biopsy remains the diagnostic standard, yet liquid biopsy is expanding for minimally invasive testing when tissue is limited. Hospitals account for a substantial share of diagnostic utilization because multidisciplinary oncology teams coordinate imaging, pathology, molecular testing, surgery, and systemic treatment within integrated clinical pathways. Diagnostic laboratories and cancer centers are expanding specialized testing services. The integration of AI is becoming increasingly important across imaging and pathology workflows, with AI-assisted algorithms supporting lesion detection, biomarker quantification, and workflow prioritization.

Competitive and Strategic Outlook

The competitive landscape features established diagnostic and life science companies alongside specialized liquid biopsy and precision oncology providers. Roche maintains a leading position through its integrated oncology diagnostics portfolio, including the VENTANA tissue diagnostics platform, cobas molecular diagnostics, and multiple FDA-approved companion diagnostics, continuing to expand its pharmaceutical-diagnostic co-development strategies. Thermo Fisher Scientific differentiates itself through the Oncomine portfolio, which supports comprehensive genomic profiling and multiple companion diagnostic applications, continuing to invest in NGS workflows, automation, and bioinformatics. Illumina remains a global leader in sequencing technology through its TruSight Oncology portfolio and high-throughput NGS platforms for comprehensive cancer genomic profiling, continuing to expand collaborations with pharmaceutical and clinical laboratories. QIAGEN focuses on companion diagnostics, PCR-based molecular testing, and NGS sample preparation solutions that support biomarker identification in lung cancer. Agilent provides pathology, immunohistochemistry, in situ hybridization, and genomic analysis solutions that support integrated lung cancer diagnostics. Guardant Health specializes in liquid biopsy and comprehensive genomic profiling through the Guardant360 platform, supporting therapy selection and genomic monitoring in advanced lung cancer. Companies are pursuing product portfolio expansion through innovation in NGS panels, liquid biopsy assays, AI-enabled imaging, and companion diagnostic technologies. Strategic collaborations between diagnostic manufacturers and pharmaceutical companies are increasing, driven by the need for companion diagnostic development alongside targeted therapies. Recent key developments include Optellum announcing it has surpassed 250 clinical sites and analyzed more than 3 million cases, helping one patient every 14 seconds with its AI-driven lung cancer risk stratification. NHS launched a single end-to-end lung cancer diagnostic pathway initiative combining Optellum's AI-driven risk stratification with robotic-assisted bronchoscopy. Roche received FDA Breakthrough Device Designation for its first AI-powered diagnostic for lung cancer, the VENTANA TROP2 RxDx Device. Geographic expansion remains a key strategic priority, with companies targeting rapidly growing Asia Pacific and emerging markets where healthcare infrastructure is expanding. Mergers and acquisitions are occurring as larger players seek to expand market presence and technology capabilities.

Short Conclusion

The lung cancer diagnostics market is positioned for sustained growth driven by the convergence of precision oncology, technological innovation, and expanding healthcare investment. The transition from conventional disease detection toward comprehensive precision oncology represents a fundamental shift in lung cancer management. While challenges related to high costs, reimbursement variability, and expertise shortages persist, strategic investments in technology, automation, and partnerships are creating durable competitive advantages for market leaders. The long-term market outlook remains positive, with lung cancer diagnostics evolving into a foundational component of precision oncology, supporting earlier detection, accurate molecular characterization, therapeutic selection, and longitudinal disease monitoring across global healthcare systems.

Key Benefits of this Report

Insightful Analysis: Detailed market insights across regions, customer segments, policies, socio-economic factors, consumer preferences, and industry verticals.
Competitive Landscape: Understand strategic moves by key players to identify optimal market entry approaches.
Market Drivers and Future Trends: Assess major growth forces and emerging developments shaping the market.
Actionable Recommendations: Support strategic decisions to unlock new revenue streams.
Caters to a Wide Audience: Suitable for startups, research institutions, consultants, SMEs, and large enterprises.

What Businesses Use Our Reports For

Industry and market insights, opportunity assessment, product demand forecasting, market entry strategy, geographical expansion, capital investment decisions, regulatory analysis, new product development, and competitive intelligence.

Report Coverage

Historical data from 2021 to 2024, Base year 2025, and Forecast years from 2026 to 2035
Growth opportunities, challenges, supply chain outlook, regulatory framework, and trend analysis
Competitive positioning, strategies, and market share evaluation, and trade analysis
Revenue growth and forecast assessment across segments and regions
Company profiling including strategies, products, financials, and key developments

1. Executive Summary

1.1 Market Snapshot
1.2 Key Findings
1.3 Analyst Insights
1.4 Strategic Recommendations

2. Research Methodology

2.1 Research Design
2.2 Data Collection Methodology
2.3 Market Size Estimation
2.4 Forecasting Model
2.5 Assumptions & Limitations

3. Global Lung Cancer Diagnostics Market Overview, Size & Forecast

3.1 Market Definition & Scope
3.2 Lung Cancer Overview
3.3 Disease Classification
3.4 Disease Burden & Unmet Clinical Needs
3.5 Epidemiology and Prevalence Analysis
- 3.5.1 Disease Prevalence
- 3.5.2 Diagnosed Patient Population
3.6 Patient Journey Analysis
3.7 Diagnostic Pathway and Standard of Care
3.8 Industry Evolution
3.9 Key Market Trends
3.10 Historical Market Size Analysis (2021-2025)
3.11 Market Forecast (2026-2035)

4. Market Dynamics

4.1 Market Drivers
4.2 Market Restraints
4.3 Market Opportunities
4.4 Market Challenges

5. Industry Landscape

5.1 Industry Value Chain Analysis
5.2 Pricing Analysis
5.3 Reimbursement Landscape

6. Innovation Landscape

6.1 Emerging Diagnostic Technologies
6.2 Product Innovation
6.3 Clinical Trial Analysis
6.4 Pipeline Analysis
6.5 Artificial Intelligence Integration in Lung Cancer Diagnostics
6.6 Digital Pathology and Integrated Diagnostics

7. Regulatory Landscape

7.1 Regulatory Framework
7.2 Approval Pathways
7.3 Compliance Requirements

8. Global Lung Cancer Diagnostics Market Landscape Analysis

8.1 Analysis by Technology Platform
8.2 Analysis by Biomarker
8.3 Analysis by Sample Type
8.4 Analysis by Clinical Application
8.5 Analysis by Testing Methodology

9. Global Lung Cancer Diagnostics Market Segment Analysis (2021-2035)

9.1 By Product Type
- 9.1.1 Instruments
- 9.1.2 Reagents & Kits
- 9.1.3 Software & Services
9.2 By Biomarker
- 9.2.1 Molecular & Genetic Biomarkers
- 9.2.2 Protein Biomarkers
- 9.2.3 Emerging Biomarkers
9.3 By Sample Type
- 9.3.1 Tissue Biopsy
- 9.3.2 Liquid Biopsy
- 9.3.3 Other Sample Types
9.4 By Cancer Type
- 9.4.1 Non-Small Cell Lung Cancer (NSCLC)
- 9.4.2 Small Cell Lung Cancer (SCLC)
9.5 By Test Type
- 9.5.1 Imaging Tests
- 9.5.2 Molecular Diagnostics
- 9.5.3 Tissue-Based Diagnostics
- 9.5.4 Others
9.6 By End User
- 9.6.1 Hospitals
- 9.6.2 Diagnostic Laboratories
- 9.6.3 Cancer Centers
- 9.6.4 Others

10. Global Lung Cancer Diagnostics Market Geographical Analysis (2021-2035)

10.1 North America
10.2 Europe
10.3 Asia-Pacific
10.4 South America
10.5 Middle East & Africa

11. Global Lung Cancer Diagnostics Market Country Analysis (2021-2035)

11.1 United States
11.2 Canada
11.3 Germany
11.4 United Kingdom
11.5 France
11.6 Italy
11.7 Spain
11.8 Netherlands
11.9 Japan
11.10 China
11.11 India
11.12 South Korea
11.13 Australia
11.14 Brazil
11.15 Mexico
11.16 Saudi Arabia
11.17 South Africa

12. Competitive Landscape

12.1 Market Share Analysis
12.2 Strategic Developments
12.3 Mergers & Acquisitions, Partnerships & Collaborations
12.4 Product Launches

13. Company Profiles

13.1 Roche Holding AG
- 13.1.1 Company Overview
- 13.1.2 Financials
- 13.1.3 Product Portfolio
- 13.1.4 Recent Developments
13.2 Thermo Fisher Scientific Inc.
13.3 Illumina, Inc.
13.4 QIAGEN N.V.
13.5 Agilent Technologies, Inc.
13.6 Abbott Laboratories
13.7 Koninklijke Philips N.V.
13.8 Bio-Rad Laboratories, Inc.
13.9 Guardant Health, Inc.
13.10 Exact Sciences Corporation