Towards Healthcare
Next Generation Cancer Diagnostics Market to Reach USD 41.64 Bn by 2035

Next Generation Cancer Diagnostics Market Growth Outlook 2035

Based on market forecasts, the global next generation cancer diagnostics market, projected at USD 19.20 billion in 2025, is expected to reach USD 41.64 billion by 2035, growing at a CAGR of 8.05% over the forecast period. The market is driven by the rising cancer prevalence worldwide and ongoing advancements in diagnostic technologies. North America leads the global market due to the strong presence of major players.

Category: Medical Imaging Insight Code: 6473 Format: PDF / PPT / Excel
next-arrow
Revenue, 2025
19.20 Billion
next-arrow
Forecast, 2035
41.64 Billion
next-arrow
CAGR, 2026 – 2035
8.05%
next-arrow
Report Coverage
Global

The global next generation cancer diagnostics market size is estimated at USD 19.20 billion in 2025, grew to USD 20.75 billion in 2026, and is projected to reach around USD 41.64 billion by 2035. The market is expected to expand at a CAGR of 8.05% between 2026 and 2035.

Next Generation Cancer Diagnostics Market Trends and Growth (2026)

Key Takeaways

  • Next generation cancer diagnostics market to crossed USD 20.75 billion by 2026.
  • Market projected at USD 41.64 billion by 2035.
  • CAGR of 8.05% expected in between 2026 to 2035.
  • North America held the largest share of the market in 2024.
  • Asia-Pacific is expected to witness the fastest growth during the predicted timeframe.
  • By technology, the next generation sequencing segment dominated the market with the largest share in 2024.
  • By technology, the qPCR & multiplexing segment is expected to grow at the highest CAGR in the market over the studied years.
  • By application, the biomarker development segment held the largest revenue share in the market in 2024.
  • By application, the genetic analysis segment is expected to grow at the fastest rate over the forecast period.
  • By cancer type, the lung cancer segment held a dominant share in the next generation cancer diagnostics market in 2024.
  • By cancer type, the breast cancer segment is expected to witness the fastest growth in the market over the forecast period.
  • By function, the therapeutic monitoring segment contributed the biggest revenue share in the market in 2024.
  • By function, the prognostics segment is expected to grow at the fastest CAGR in the market during the forecast period.

Key Indicators and Highlights

Key Elements Scope
Market Size in 2026 USD 20.75 Billion
Projected Market Size in 2035 USD 41.64 Billion
CAGR (2026 - 2035) 8.05%
Leading Region North America
Market Segmentation By Technology, By Application, By Cancer Type, By Function, By Region
Top Key Players F. Hoffmann La Roche Ltd. (Roche Diagnostics), QIAGEN N.V., Agilent Technologies, Inc., Abbott Laboratories, GE Healthcare, Koninklijke Philips N.V. (Philips), PerkinElmer, Inc., Myriad Genetics, Inc., Hologic, Inc, Novartis AG

The next generation cancer diagnostics market is experiencing strong growth driven by advances in genomics, liquid biopsy, and AI-based diagnostic tools. North America leads the market because of its advanced healthcare infrastructure, high awareness, and prominent diagnostic companies. The rising incidence of cancer, increasing demand for personalized medicine, and government support for precision oncology research further promote adoption. Additionally, ongoing innovations and collaborations across the biotech and healthcare sectors continue to enhance diagnostic accuracy and early cancer detection.

The next generation cancer diagnostics market is driven by a strong focus on the early detection of cancer at its molecular roots before it advances. Next-generation cancer diagnostics is an innovative approach that combines cutting-edge technologies such as genomic sequencing, liquid biopsy, digital pathology, and AI-powered analytics to provide deeper insights into tumor behavior. By integrating molecular profiling with big data, next-generation diagnostics enables clinicians to customize treatment plans for each patient’s genetic profile. This approach represents a transformative shift from reactive cancer management to proactive, data-driven, and patient-specific diagnosis and treatment planning.

Market Outlook

  • Industry Growth Overview: The next generation cancer diagnostics market is witnessing strong growth, fueled by advancements in genomics, AI-driven analytics, and liquid biopsy technologies. Rising cancer prevalence, increasing demand for early detection, and the shift toward personalized treatment strategies are driving widespread adoption across healthcare and research sectors worldwide.
  • Global Expansion: There is significant potential for market expansion around the world, especially in emerging regions. This is mainly due to the rising cancer cases, along with rapid urbanization, technological innovations, and growing healthcare investments. Increasing adoption of precision diagnostics, supportive government initiatives, and cross-border collaborations are accelerating market penetration across emerging and developed regions worldwide.
  • Major Investors: Leading venture capital and private equity firms are actively supporting companies in next-generation cancer diagnostics. For example, Illumina Ventures focuses on genomics and liquid-biopsy startups. Frazier Healthcare Partners invests in diagnostics and life-science growth companies. Institutional investors and strategic diagnostics divisions also allocate capital to accelerate early cancer detection platforms.
  • Startup Ecosystem: The startup ecosystem within the market is lively and changing. Early-stage companies are creating new solutions at the intersection of genomics, liquid biopsy, AI, and digital diagnostics. They benefit from strong venture capital support, academic spin-outs, and international collaborations to launch scalable, earlier, and more accessible cancer tests to the market.

AI integration is transforming the next generation cancer diagnostics market by improving accuracy, speed, and personalization in cancer detection and treatment planning. Machine learning algorithms analyze large amounts of genomic, imaging, and clinical data to spot subtle cancer patterns often missed by traditional diagnostics. AI-powered tools help pathologists automate image analysis, enhance diagnostic accuracy, and reduce human errors. Predictive analytics also support early detection and risk assessment, enabling timely interventions. Additionally, AI aids in developing personalized treatment plans by linking genetic mutations with targeted therapies. Combining with big data platforms speeds up biomarker discovery and clinical decision-making. Overall, AI enables healthcare professionals to provide faster, more reliable, and patient-specific cancer care, greatly improving outcomes and operational efficiency in oncology diagnostics.

Segment Outlook

Which Technology Dominates the Next Generation Cancer Diagnostics Market?

The next generation sequencing segment dominated the market while holding the largest share in 2024. This is primarily due to its high accuracy, scalability, and ability to analyze multiple genetic alterations simultaneously. Its efficiency in identifying mutations, guiding personalized therapies, and enabling comprehensive tumor profiling makes it a preferred technology in precision oncology and clinical diagnostics. Additionally, NGS supports liquid biopsy and targeted therapy approaches, further strengthening its dominance in the next-generation cancer diagnostics landscape.

The qPCR & multiplexing segment is expected to grow at the fastest CAGR in the upcoming period due to its ability to detect multiple cancer biomarkers simultaneously with high sensitivity and specificity. It offers rapid results, cost efficiency, and scalability, making it ideal for clinical applications and large-scale cancer screening programs. The technology is widely adopted in clinical laboratories and research settings because it supports both tissue and liquid biopsy applications, enabling personalized treatment decisions.

The protein microarrays segment is expected to expand at a notable rate over the forecast period, as these arrays enable high-throughput, simultaneous analysis of thousands of proteins, require minimal sample volume, and deliver exceptional sensitivity for biomarker detection. These capabilities support early cancer detection, personalized treatment strategies, and streamlined clinical workflows.

Why Did the Lung Cancer Segment Dominate the Next Generation Cancer Diagnostics Market?

The lung cancer segment led the market in 2024 because lung cancer has a high worldwide incidence and death rate, fueling strong demand for early detection. Advanced diagnostics, including liquid biopsies and genomic profiling, enable identification of actionable mutations and biomarkers, supporting targeted therapies and personalized treatment plans. Additionally, the increasing awareness of lung cancer screening programs and the integration of precision medicine in oncology further boost the adoption of next-generation diagnostic tools in this segment.

The breast cancer segment is projected to grow at the highest CAGR in the near future due to rising global incidence, increased awareness and screening efforts, and the quick adoption of advanced molecular testing technologies. These factors collectively drive greater demand and the deployment of next-generation diagnostics in breast oncology. Next-generation diagnostics, including genomic profiling, liquid biopsies, and advanced imaging technologies, enable precise identification of tumor subtypes and actionable genetic mutations, facilitating personalized treatment strategies.

The cervical cancer segment is expected to grow at a significant rate in the market due to increasing global incidence of cervical malignancies, widespread HPV screening initiatives, and greater public and governmental focus on women’s health. Technological advances in molecular and digital testing enhance early detection and diagnostic precision, supporting segmental growth.

What Made Therapeutic Monitoring the Dominant Segment in the Next Generation Cancer Diagnostics Market?

The therapeutic monitoring segment led the market in 2024 because it provides real-time evaluation of treatment effectiveness and tumor response, especially with targeted and immunotherapy treatments. Advanced diagnostics such as liquid biopsy, genomic profiling, and AI-driven analytics allow clinicians to track tumor progression, detect minimal residual disease, and adjust therapies promptly, improving patient outcomes. Increasing adoption of personalized medicine and targeted therapies has further amplified the demand for precise therapeutic monitoring.

The prognostics segment is expected to grow at the fastest rate in the market over the projection period because it enables clinicians to predict tumor behavior, recurrence risk, and survival outcomes. With increasing demand for precision medicine and treatment stratification, prognostic tools help tailor therapies and improve patient-centric care and long-term management. The increasing emphasis on precision medicine and outcome-driven care further bolsters segmental growth.

The companion diagnostics segment is likely to grow at a notable rate in the coming years because it plays a pivotal role in enabling personalized cancer therapy. By identifying specific biomarkers and genetic mutations, these diagnostics guide clinicians in selecting the most effective targeted treatments for individual patients. The integration of companion diagnostics with targeted therapies improves treatment efficacy, minimizes adverse effects, and enhances overall patient outcomes.

 

Why Did the Biomarker Development Segment Led the Next Generation Cancer Diagnostics Market?

The biomarker development segment dominated the market with the largest share in 2024 due to its critical role in identifying molecular targets for early detection and personalized treatment. Advancements in genomics, proteomics, and bioinformatics have enhanced biomarker discovery, enabling precise cancer profiling, improving diagnostic accuracy, and advancing prognosis assessment and therapy selection across oncology applications.

The genetic analysis segment is expected to grow at the fastest rate during the forecast period because it allows for comprehensive detection of cancer-causing mutations, hereditary risks, and tumor-specific genomic profiles, which are essential for early detection and personalized treatment. Clinicians and researchers increasingly rely on genetic insights to tailor therapies, predict treatment response, and monitor disease progression. The growing emphasis on precision medicine and targeted oncology therapies further drives the adoption and prominence of genetic analysis in cancer diagnostics.

The proteomic analysis segment is expected to grow significantly in the coming years because it allows high-throughput detection of protein biomarkers, uncovers tumor-specific protein expression and post-translational modifications, and supports personalized and early diagnostics by integrating multi-omics data and advanced bioinformatics for better patient stratification. Proteomic analysis also helps monitor therapeutic efficacy and resistance mechanisms, providing actionable insights for clinical decision-making.

Exclusive Analysis

The next generation cancer diagnostics market is poised for substantial expansion, underpinned by the convergence of molecular genomics, high-throughput sequencing technologies, and AI-driven bioinformatics platforms. The global rise in cancer prevalence, coupled with an urgent need for early-stage detection and personalized therapeutic regimens, has catalyzed investment in precision oncology. Market incumbents and emerging players alike are leveraging technological innovation in liquid biopsies, multiplexed qPCR assays, and NGS-based profiling to create scalable, clinically actionable solutions that can transform diagnostic workflows and patient stratification models.

From an investment and opportunity standpoint, the market offers pronounced upside potential in the companion diagnostics and prognostic segments, where linking biomarkers to targeted therapies can significantly de-risk clinical outcomes. Integration of predictive analytics and real-world evidence datasets into diagnostic pipelines enables pharmaceutical partners and healthcare providers to optimize treatment protocols, reduce downstream costs, and unlock value in underserved oncology indications. Moreover, the convergence of genomics and proteomics, supported by regulatory alignment toward precision medicine frameworks, offers fertile ground for cross-sector partnerships and platform-driven commercialization strategies.

Geographically, North America remains the epicenter of innovation and capital deployment, yet Europe and select APAC markets are emerging as fertile growth corridors driven by expanding healthcare infrastructure, greater reimbursement coverage, and rising adoption of minimally invasive diagnostics. The market trajectory is further reinforced by policy-level emphasis on population-level screening programs and digital health integration, suggesting a sustainable growth horizon for players capable of combining technological sophistication with scalable delivery models. Strategic early-mover advantages in these geographies will likely determine long-term market dominance, particularly for companies integrating AI-guided interpretation, high-sensitivity assays, and real-time clinical decision support capabilities.

Regional Analysis

Next Generation Cancer Diagnostics Market Share, By Region, 2025 (%)

  • North America led the market by capturing the largest share in 2024.
  • Asia Pacific is expected to experience the fastest growth in the market throughout the forecast period.
  • The Middle East & Africa (MEA) presents substantial growth opportunities for the expansion of the market.
  • Europe is witnessing an opportunistic rise in the market driven by strong government support for precision medicine and early cancer detection initiatives.
  • The growth of the market is supported by rising cancer prevalence, increasing awareness of early detection, and improving access to advanced healthcare technologies.

North America led the next generation cancer diagnostics market by capturing the largest share in 2024. This is due to advanced healthcare infrastructure, significant investment in R&D, especially in precision oncology, and early adoption of cutting-edge diagnostic technologies. High awareness of early cancer detection, significant government funding, and robust research and development initiatives further drive market growth. Additionally, supportive regulatory frameworks, widespread screening programs, and the strong presence of biotech firms further reinforce its leadership position.

U.S. Leads the Way in Next-Gen Cancer Diagnostics

The U.S. is a major contributor to the North American next generation cancer diagnostics market because it has one of the highest cancer burdens worldwide, with about 2,041,910 new cases expected in 2025 alone. This increasing prevalence is boosting demand for advanced diagnostic technologies. Furthermore, the U.S. benefits from a robust healthcare infrastructure, leading diagnostic technology companies based domestically, and supportive regulatory and reimbursement policies, all of which help accelerate the adoption of next-generation diagnostics.

Asia Pacific is expected to experience the fastest growth in the market throughout the forecast period, driven by expanding healthcare infrastructure, rising awareness of cancer, and increased investment in precision medicine. In particular, in India, cancer incidence is expected to rise from about 1.46 million in 2022 to roughly 1.57 million by 2025, driving demand for advanced diagnostics. The increasing cancer burden, combined with governmental focus on early detection and greater access to technology, is accelerating the adoption of next-generation diagnostic solutions across the region.

China’s Dominance in the Asia-Pacific Next Generation Cancer Diagnostics Market

China leads the market in Asia-Pacific because of its huge cancer burden. in 2024, the country reported an estimated 4.9 million new cases and 2.59 million deaths. Its large population, rising rates of lung and digestive system cancers, extensive government screening programs, and strong investment in diagnostic infrastructure position China as the dominant player in the region. Government initiatives such as Healthy China 2030, rapid development of healthcare infrastructure, and innovations from companies such as BGI Genomics further strengthen the country’s position. Rising healthcare spending, AI adoption, widespread cancer screening, and supportive NMPA regulations further reinforce its leadership in precision oncology diagnostics.

The Middle East & Africa (MEA) presents substantial growth opportunities for the expansion of the next generation cancer diagnostics market, driven by increasing cancer rates, expanding healthcare infrastructure, and rising investments in precision diagnostics. Public-private screening programs, adoption of molecular testing technologies, and collaborations with international diagnostic companies all support market growth across MEA.

UAE Next Generation Cancer Diagnostics Market Trends

The UAE's next generation cancer diagnostics market is rapidly advancing as healthcare infrastructure broadens and the adoption of precision medicine increases. Higher cancer rates and national screening programs drive demand for molecular diagnostics like NGS and liquid biopsy. Government investments, strategic partnerships with global companies, and AI-powered imaging deployments boost market growth and innovation in oncology testing.

Europe is witnessing an opportunistic rise in the market driven by strong government support for precision medicine and early cancer detection initiatives. The region’s emphasis on genomic research, favorable reimbursement policies, and collaborations between research institutions and biotech companies are accelerating innovation. Additionally, the growing adoption of liquid biopsies and AI-integrated diagnostic tools across major countries like Germany, the U.K., and France is enhancing Europe’s position as a key player in next-generation oncology diagnostics.

Germany Leads Europe in Next-Generation Cancer Diagnostics Innovation

Germany is a major contributor to the market in Europe due to its strong healthcare infrastructure, advanced research capabilities, and emphasis on precision medicine. The country’s extensive investment in genomic research, biotechnology, and digital health integration supports the rapid adoption of next-generation sequencing and molecular diagnostic technologies. Additionally, collaborations between academic institutions, healthcare providers, and diagnostic companies position Germany as a leader in innovation and implementation within Europe’s cancer diagnostics landscape.

The growth of the market is supported by rising cancer prevalence, increasing awareness of early detection, and improving access to advanced healthcare technologies. Government initiatives promoting cancer screening programs and the expansion of diagnostic infrastructure are also driving market adoption. Additionally, partnerships between local healthcare providers and global biotech companies are accelerating the availability of innovative diagnostic tools across countries like Brazil and Argentina.

Brazil Strengthens Cancer Care with Next-Generation Diagnostic Technologies

Brazil is the major contributor to the South American next generation cancer diagnostics market due to its expanding healthcare infrastructure, large patient population, and growing investments in cancer research. The country has been actively integrating advanced diagnostic technologies such as genomic sequencing and liquid biopsies into its oncology care framework. Furthermore, government-led cancer awareness initiatives and collaborations with international biotech firms have strengthened Brazil’s position as the regional hub for next-generation cancer diagnostics.

Other Major Companies and Their Offerings:

Next Generation Cancer Diagnostics Market Companies

Vendor Key Offerings/Contribution
F. Hoffmann La Roche Ltd. (Roche Diagnostics) Focuses on personalized healthcare solutions: biomarker-based testing, companion diagnostics, liquid-biopsy platforms, and partnerships in immuno-oncology diagnostics.
QIAGEN N.V. Specializes in sample preparation, molecular assays, and NGS-based panels geared toward precision oncology and target biomarker detection.
Agilent Technologies, Inc. Delivers laboratory instrumentation, reagents, and NGS target-enrichment kits optimized for high-throughput cancer diagnostics workflows.
Abbott Laboratories Provides diagnostic platforms for oncology, including both point-of-care and laboratory systems aimed at cancer biomarker testing and early detection.
GE Healthcare Leverages imaging and diagnostic equipment and is integrating next-generation cancer detection technologies (e.g., liquid biopsy, imaging analytics) into healthcare workflows.
Koninklijke Philips N.V. (Philips) Integrates diagnostic imaging, digital pathology, and AI-based analytics to support early cancer detection and personalized oncology care.
PerkinElmer, Inc. Offers molecular diagnostic reagents, instruments, and NGS workflows for biomarker discovery, tumor profiling, and oncology testing.
Myriad Genetics, Inc. Provides genetic and genomic testing solutions for hereditary cancer risk assessment, tumor profiling, and personalized therapy selection.
Hologic, Inc. Specializes in women’s health diagnostics, including advanced molecular assays for breast and cervical cancer screening and precision oncology applications.
Novartis AG Develops companion diagnostics in collaboration with diagnostic firms to support targeted cancer therapies and personalized medicine initiatives.

Corporate Information

Headquarters: San Diego, California, U.S.  |  Year Founded: 1998

Business Overview

Illumina is a global leader in genomics and life sciences, offering integrated systems and consumables for DNA sequencing, genotyping, and molecular diagnostics. In cancer diagnostics, the company’s platforms support tumor genomic profiling, companion diagnostic development, and liquid biopsy workflows, all advancing precision oncology strategies.

Business Segments / Divisions

  • Sequencing & Genomics Platforms – Instruments (e.g., NovaSeq, NextSeq) and consumables for high-throughput sequencing.
  • Molecular Diagnostics Solutions – Kits and workflows for clinical and oncology applications (tumor profiling, companion diagnostics)
  • Services & Biodata Analytics – Supporting interpretation of genomic data, bioinformatics pipelines, and collaborations with pharmaceutical/biotech for diagnostics development.

Geographic Presence

Illumina serves customers globally across major regions: the Americas, Europe/Middle East/Africa (EMEA), China, and Asia-Pacific. The company has a major installed base of sequencers worldwide, providing a broad footprint across clinical and research markets.

Key Offerings

  • Highly scalable NGS platforms and consumables, which enable deep genomic profiling of tumors and cancer-associated biomarkers.
  • Companion diagnostic kits (for example, TruSight™ Oncology Comprehensive) that claim pan-cancer DNA and RNA profiling in a clinical IVD format for oncology use.
  • End-to-end solutions that support oncology labs in shifting from single-gene tests to multi-analyte and comprehensive tumor profiling workflows.

SWOT Analysis

Strengths

  • Dominant market position in NGS technology with a large installed base and strong brand recognition.
  • Extensive IP portfolio and ecosystem partnerships, supporting continued innovation and entry into clinical oncology diagnostics.
  • Diversified product portfolio spanning research and clinical markets, enabling cross-market leverage.

Weaknesses

  • High pricing of instruments and consumables, which may limit uptake in cost-sensitive markets or among smaller labs.
  • Dependence on research grant funding and academic market growth, which can be volatile.
  • Exposure to regulatory and legal risk, including previous antitrust issues (e.g., with associated company GRAIL).

Opportunities

  • Significant growth potential in clinical sequencing applications (especially oncology) and expanding into emerging markets (e.g., Latin America, Asia-Pacific).
  • Expansion into multi-omics (proteomics, transcriptomics), digital solutions/analytics, and companion diagnostics partnerships with pharma to drive personalized cancer care.

Threats

  • Increasing competition from emerging sequencing platforms and alternative technologies that may reduce pricing power.
  • Geopolitical, regulatory, and trade risks (for example, the China import ban) which may impact global operations and growth.
  • Macroeconomic pressures and potential reductions in research funding or capital spending that could dampen demand.

Recent News

  • In September 2025, Illumina Inc. partnered with multiple global pharmaceutical companies to develop companion diagnostics (CDx) using the TruSight™ Oncology (TSO) comprehensive genomic profiling test. The expansion of tumor-agnostic CDx claims advanced patient access to precision oncology, with new partnerships focusing on KRAS alterations linked to uncontrolled cancer cell growth.
  • In May 2025, Illumina Inc. announced an expanded clinical oncology portfolio to advance precision oncology and improve the standard of care. The broad range of offerings aimed to accelerate patient access to precision oncology, with tumor profiling and in vitro diagnostic (IVD) solutions showcased at the ASCO Annual Meeting in Chicago.

 

Corporate Information

Headquarters: Waltham, Massachusetts, U.S. | Year Founded: 1956

Business Overview

Thermo Fisher Scientific is a global leader in life sciences tools, clinical diagnostics, laboratory equipment, consumables, and services, helping researchers and clinicians accelerate discovery, diagnostics, and manufacturing of therapies. In the cancer diagnostics space, Thermo Fisher supports precision oncology through next-generation sequencing (NGS) workflows, companion diagnostics, and other molecular oncology solutions that help identify and monitor tumor biomarkers.

Business Segments / Divisions

Thermo Fisher’s broad operations is grouped into several major segments relevant to cancer diagnostics:

  • Specialty Diagnostics: Includes clinical diagnostics reagents, kits, and instruments for molecular diagnostics, immunodiagnostics, transplant diagnostics, and oncology biomarkers.
  • Life Sciences Solutions / Research & Laboratory Products: Provides instruments, consumables, and workflows for research labs, molecular biology, genomics, and diagnostics development.
  • Analytical Instruments / Services: Encompasses analytical equipment, software and laboratory services which support diagnostics labs and biopharmaceutical applications.

Geographic Presence

Thermo Fisher operates globally, serving customers across the Americas, Europe, the Middle East & Africa (EMEA), Asia Pacific, and Latin America through numerous offices, manufacturing sites, distribution centers, and R&D facilities. Its global reach enables the deployment of diagnostic and sequencing technologies across diverse markets, aiding the adoption of precision oncology worldwide.

Key Offerings

  • The Oncomine™ Solutions portfolio – end-to-end NGS workflows for clinical oncology research and diagnostics labs, facilitating tumor profiling, biomarker detection, and companion diagnostics development.
  • Ion Torrent™ Genexus System – a fully integrated, automated NGS platform designed to deliver specimenstoreport results rapidly (in as little as 24 hours), supporting solid tumor and liquid biopsy workflows.
  • A broad molecular oncology portfolio including solutions for MSI analysis, CNV detection, digital PCR liquid biopsy assays, and other targeted NGS panels for solid and hematologic tumors.
  • Strategic partnerships with pharmaceutical companies (e.g., AstraZeneca, Bayer) to co-develop NGS-based companion diagnostics (CDx) that link molecular tests to targeted cancer therapies.

SWOT Analysis

Strengths

  • Strong reputation and market presence as a major global supplier of diagnostics, genomics, and laboratory solutions.
  • Advanced NGS and molecular oncology offerings that align with the precision medicine trend.
  • Global footprint with broad access to markets, enabling partnerships, scale, and distribution of diagnostic technologies.

Weaknesses

  • High complexity and cost of cutting-edge diagnostics platforms may limit adoption in lower-income or cost-sensitive regions.
  • Diagnostics markets often face regulatory scrutiny and long validation timelines, which may slow product rollout.
  • As a large, diversified company, parts of the business may face slower growth compared to nimble pureplay diagnostics companies.

Opportunities

  • Growing global cancer incidence and increased adoption of early detection, precision oncology, and liquid biopsy diagnostics create strong demand.
  • Expansion into emerging markets (e.g., Latin America, AsiaPacific) where advanced genomic diagnostics are becoming accessible.
  • Development of integrated digital diagnostics, AI analytics, and rapid turnaround workflows to support personalized care.

Threats

  • Competitive pressure from other NGS and diagnostic platform providers (e.g., Illumina, Roche, Qiagen) that may erode pricing or market share.
  • Regulatory, reimbursement, and reimbursementpolicy barriers in diagnostics (especially in newer markets) could hinder adoption.
  • Macroeconomic constraints or funding cuts in healthcare/diagnostics may reduce the growth rate of high-end diagnostic spend.

Recent News

In August 2025, Thermo Fisher Scientific received FDA approval for its Oncomine Dx Target Test as a companion diagnostic for HERNEXEOS® (zongertinib), enabling clinicians to identify NSCLC patients with HER2/ERBB2 TKD mutations.

Value Chain Analysis

Research and Development (R&D)

  • In this stage, researchers identify cancer biomarkers, design molecular assays such as NGS panels or liquid biopsies, and optimize test performance for accuracy and reproducibility.
  • Organizations involved: Academic research institutes, biotech companies, diagnostic manufacturers, bioinformatics firms, and contract research organizations (CROs).

Clinical Trial and Approval

  • Clinical validation studies are conducted to assess diagnostic accuracy and clinical relevance, followed by regulatory submissions for safety and efficacy approval.
  • Organizations involved: Clinical research organizations, hospital networks, regulatory bodies such as the FDA and EMA, notified bodies, and health technology assessment agencies.

Patient Support and Service

  • This stage focuses on sample collection, testing, result reporting, and clinical interpretation to guide personalized treatment decisions and patient care.
  • Organizations involved: Diagnostic laboratories, oncology hospitals, digital health platforms, molecular tumor boards, and patient support or advocacy organizations.

Recent Developments

  • In March 2025, Noul Co., Ltd. launched its miLab CER platform, an AI-powered, fully automated diagnostic device for cervical cancer screening. It conducts staining, imaging, and AI-based analysis on-site within 15 minutes, removing the need for cloud processing.
  • In January 2025, the Punjab, India, Government deployed AI-enabled cancer screening devices such as Thermalytix for breast cancer and Smart Scope for cervical cancer across eight districts, enhancing accessibility to early diagnostics in public hospitals.
  • In February 2025, Roche Diagnostics received FDA Breakthrough Device Designation for its VENTANA TROP2 RxDx assay, which incorporates AI-based digital pathology algorithms to enhance accuracy in companion diagnostics for targeted cancer therapies.

Segments Covered in the Report

By Technology

  • Next Generation Sequencing
  • qPCR & Multiplexing
  • LOAC & RT-PCR
  • Protein Microarrays
  • DNA Microarrays

By Application

  • Biomarker Development
  • CTC Analysis
  • Proteomic Analysis
  • Epigenetic Analysis
  • Genetic Analysis

By Cancer Type

  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Cervical Cancer
  • Others

By Function

  • Therapeutic Monitoring
  • Companion Diagnostics
  • Prognostics
  • Cancer Screening
  • Risk Analysis

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
    • Rest of North America
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Europe
    • Western Europe
      • Germany
      • Italy
      • France
      • Netherlands
      • Spain
      • Portugal
      • Belgium
      • Ireland
      • UK
      • Iceland
      • Switzerland
      • Poland
      • Rest of Western Europe
  • Eastern Europe
    • Austria
    • Russia & Belarus
    • Türkiye
    • Albania
    • Rest of Eastern Europe
  • Asia Pacific
    • China
    • Taiwan
    • India
    • Japan
    • Australia and New Zealand
    • ASEAN Countries (Singapore, Malaysia)
    • South Korea
    • Rest of APAC
  • MEA
    • GCC Countries
    • Saudi Arabia
    • United Arab Emirates (UAE)
    • Qatar
    • Kuwait
    • Oman
    • Bahrain
  • South Africa
  • Egypt
  • Rest of MEA
FAQ's

The next generation cancer diagnostics market stands at USD 20.75 billion in 2026 and is expected to reach USD 41.64 billion by 2035, growing at a CAGR of 8.05% from 2026 to 2035.

North America is leading the next generation cancer diagnostics market due to the growing prevalence of cancer, presence of major key players, and increasing number of diagnostics clinics in the region.

The next sgeneration cancer diagnostics market comprises 5 segments by technology, by application, by cancer type, by function, and by region.

American Association for Cancer Research (AACR), Indian Cancer Society, Food and Drug Administration, IARC – International Agency for Research on Cancer, clinicaltrials.gov, WHO, Association for Diagnostics & Laboratory Medicine (ADLM)

AI improves data interpretation, image analysis, and genomic sequencing accuracy.

Tags

Meet the Team

Shivani Zoting is a dedicated research analyst specializing in the healthcare industry. With a strong academic foundation, a B.Sc. in Biotechnology and an MBA in Pharmabiotechnology, she brings a unique blend of scientific understanding and strategy.

Learn more about Shivani Zoting

Aditi Shivarkar is a seasoned professional with over 14 years of experience in healthcare market research. As a content reviewer, Aditi ensures the quality and accuracy of all market insights and data presented by the research team.

Learn more about Aditi Shivarkar

Related Reports