Next Generation Cancer Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (Next-generation Sequencing, qPCR & Multiplexing, Lab-on- a- chip (LOAC) & Reverse Transcriptase-PCR (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 Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 16.02 Billion
CAGR (2026-2031)	8.33%
Fastest Growing Segment	Breast Cancer
Largest Market	North America
Market Size (2031)	USD 25.89 Billion

Market Overview

The Global Next Generation Cancer Diagnostics Market will grow from USD 16.02 Billion in 2025 to USD 25.89 Billion by 2031 at a 8.33% CAGR. Next-generation cancer diagnostics utilize advanced genomic and proteomic technologies such as high-throughput sequencing and liquid biopsies to identify specific biomarkers for oncology patient management. The primary growth driver is the escalating global burden of malignancies which necessitates early and accurate detection methods to facilitate personalized therapeutic strategies. Reinforcing this demand, according to the American Cancer Society, in 2024, approximately 2,001,140 new cancer cases were projected to occur in the United States. This rising incidence emphasizes the critical requirement for scalable diagnostic solutions that guide precision oncology and improve patient outcomes.

Despite the clear clinical utility, the market faces a significant challenge regarding the substantial capital investment required for establishing sequencing infrastructure and the high costs associated with test execution. These financial barriers limit widespread adoption in cost-sensitive regions and are often compounded by complex reimbursement policies that create uncertainty for healthcare providers attempting to integrate these novel diagnostic assays into standard care protocols.

Key Market Drivers

Technological Innovations in Next-Generation Sequencing and Liquid Biopsy are fundamentally reshaping the cancer diagnostics landscape by enabling high-throughput, non-invasive tumor profiling. These advancements, particularly in liquid biopsy, allow for the precise detection of circulating tumor DNA, offering a viable alternative to traditional tissue biopsies for patient monitoring and early detection. The commercial impact of these innovations is evident in the surging test volumes for leading industry players. For instance, according to Guardant Health, February 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company reported a 31% increase in full-year revenue to $739 million, driven significantly by a 20% growth in clinical oncology test volumes. Such adoption rates underscore the market’s rapid shift toward scalable, tech-driven diagnostic solutions. Reinforcing this sector's expansion, according to Exact Sciences, February 2025, in the 'Fourth Quarter and Full Year 2024 Results', the company generated total revenue of $2.76 billion for the full year 2024, highlighting the substantial market demand for advanced screening and diagnostic tools.

Declining Costs of Genomic Sequencing Enhancing Market Accessibility serves as a critical catalyst for democratizing these advanced diagnostic capabilities across broader patient populations. Historically high expenses associated with genomic profiling have restricted widespread clinical implementation, particularly in cost-sensitive regions. However, continuous improvements in sequencing chemistry and platform efficiency are drastically reducing the price per gigabyte of data generated. According to Front Line Genomics, March 2025, in the article 'The $100 Genome: Where's the Limit?', sequencing giant Illumina claimed it could achieve whole genome sequencing for as little as $200 using its latest platforms. This reduction in financial barriers is pivotal, as it enables healthcare providers to integrate comprehensive genomic profiling into routine standard-of-care protocols, thereby accelerating the global uptake of precision oncology.

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Key Market Challenges

The substantial capital investment required for establishing sequencing infrastructure and the high operational costs associated with test execution present a formidable barrier to the expansion of the Global Next Generation Cancer Diagnostics Market. These financial requirements restrict the adoption of advanced genomic technologies to well-funded medical centers, effectively excluding smaller healthcare facilities and cost-sensitive regions from the market. This economic exclusivity prevents the widespread implementation of scalable diagnostic solutions, thereby limiting the potential customer base and stalling overall market volume growth.

Furthermore, the high cost of these assays creates significant financial toxicity for patients and payers, complicating reimbursement and integration into standard care. This financial strain is evidenced by recent data highlighting the economic burden of cancer management. According to the American Society of Clinical Oncology, in 2024, an analysis presented at their annual meeting indicated that the median total healthcare spending for working-age adults with private insurance was $60,123 in the six months immediately following a cancer diagnosis. Such prohibitive costs deter healthcare systems from standardizing these expensive diagnostic tools, directly hampering the market's ability to meet the escalating global demand for precision oncology.

Key Market Trends

The Integration of Artificial Intelligence for Precision Analytics is fundamentally reshaping the Global Next Generation Cancer Diagnostics Market by enabling the interpretation of increasingly complex biological data. As diagnostic assays move beyond single-biomarker detection to multimodal profiling, artificial intelligence is becoming essential for correlating genomic alterations with clinical outcomes and identifying subtle predictive signatures that traditional analysis may miss. This technological convergence is rapidly driving commercial growth for companies bridging the gap between data science and oncology. According to Tempus AI, February 2025, in the 'Fourth Quarter and Full Year 2024 Results', the company reported full-year revenue of $693.4 million, representing a 30.4% increase year-over-year, a surge attributed largely to the scalable adoption of its AI-enabled precision medicine and data licensing solutions.

Simultaneously, the Expansion of Companion Diagnostics Co-development Partnerships is solidifying the link between diagnostic testing and targeted therapeutic selection. Pharmaceutical and diagnostic companies are increasingly entering strategic collaborations to develop assays concurrently with novel drugs, particularly for immuno-oncology and antibody-drug conjugates, ensuring that patient eligibility is determined with high specificity at the point of care. These partnerships are critical for mitigating drug development risks and accelerating regulatory approvals, thereby creating a resilient revenue stream for diagnostic leaders. According to Agilent Technologies, November 2024, in the 'Fourth-Quarter Fiscal Year 2024 Financial Results', the Diagnostics and Genomics Group generated annual revenue of $1.65 billion, underscoring the substantial market demand for its pathology and companion diagnostic portfolio despite broader industry headwinds.

Segmental Insights

The breast cancer segment identifies as the fastest-growing category within the Global Next Generation Cancer Diagnostics Market. This expansion is fundamentally driven by the rising global incidence of the disease and the growing reliance on genomic profiling for effective treatment planning. The increased adoption of Next-Generation Sequencing allows clinicians to detect critical genetic mutations, such as BRCA1 and BRCA2, enabling the delivery of personalized medicine. Furthermore, the continuous approval of companion diagnostics by regulatory bodies, including the US FDA, validates these methods and ensures broader market accessibility, thereby fueling the segment’s substantial development.

Regional Insights

North America leads the global next generation cancer diagnostics market, driven by established healthcare infrastructure and substantial investment in oncology research. The region benefits from the concentrated presence of major biotechnology companies that facilitate the wide adoption of genomic testing. Additionally, strategic funding from institutions such as the National Cancer Institute accelerates research and development activities. The U.S. Food and Drug Administration further fosters market stability by establishing clear guidelines for diagnostic product approvals. Consequently, high public awareness regarding early detection and favorable reimbursement policies solidify North America’s position as the primary revenue generator.

Recent Developments

• In September 2025, Illumina announced strategic partnerships with several global pharmaceutical companies to develop companion diagnostics focused on KRAS mutations, a critical driver in many cancers. These collaborations were established to create genomic profiling tests capable of identifying specific genetic alterations, enabling the matching of patients with targeted therapies regardless of tumor type. The initiative utilized the company's comprehensive genomic profiling assay to support the development of standardized and globally distributable tests. This effort highlighted the company's commitment to advancing precision oncology by providing clinicians with the necessary tools to identify actionable biomarkers and improve therapeutic outcomes for patients.
• In September 2024, Roche significantly expanded its digital pathology ecosystem by integrating over twenty artificial intelligence algorithms from eight new collaborators. This initiative allowed the company to incorporate diverse AI-driven tools into its enterprise software, facilitating advanced analysis for various cancer types such as prostate, breast, and colorectal cancer. The integration aimed to support pathologists and scientists in research and diagnosis by providing easier access to third-party innovation. By combining its tissue diagnostics leadership with these advanced computational tools, the company sought to improve the precision and efficiency of cancer diagnosis, ultimately aiding clinicians in delivering personalized patient care.
• In July 2024, Guardant Health achieved a significant regulatory milestone with the U.S. FDA approval of its Shield blood test for colorectal cancer screening. This approval marked the first time a blood test was authorized as a primary screening option for this disease, allowing it to be used similarly to other non-invasive methods recommended in guidelines. The test was cleared for adults aged 45 and older who are at average risk. The decision was supported by results from a major registrational study that validated the test's performance, aiming to overcome adherence barriers associated with traditional screening methods and enhance early cancer detection efforts.
• In March 2024, Thermo Fisher Scientific entered into a strategic collaboration with Bayer to develop next-generation sequencing-based companion diagnostic assays. The partnership aimed to leverage Thermo Fisher's advanced genomic testing platform to identify patients who would benefit from the pharmaceutical company's precision cancer therapies. By utilizing a fully integrated NGS system capable of delivering rapid results from tumor or liquid biopsy samples, the collaboration sought to support decentralized testing. This initiative was designed to enhance patient access to targeted oncology treatments through faster and more accessible diagnostic solutions, ensuring that appropriate therapies are matched to patients based on their genomic profiles.

Key Market Players

• GE HealthCare
• Janssen Pharmaceuticals, Inc.
• Illumina, Inc.
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Koninklijke Philips N.V.
• QIAGEN
• Agilent Technologies, Inc.
• Abbott Laboratories Inc.
• Thermo Fisher Scientific Inc

By Technology	By Application	By Cancer Type	By Region
Next-generation Sequencing qPCR & Multiplexing Lab-on- a- chip (LOAC) & Reverse Transcriptase-PCR (RT-PCR) Protein Microarrays DNA Microarrays	Biomarker Development CTC Analysis Proteomic Analysis Epigenetic Analysis Genetic Analysis	Lung Cancer Breast Cancer Colorectal Cancer Cervical Cancer Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Next Generation Cancer Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Next Generation Cancer Diagnostics Market, By Technology:

• Next-generation Sequencing
• qPCR & Multiplexing
• Lab-on- a- chip (LOAC) & Reverse Transcriptase-PCR (RT-PCR)
• Protein Microarrays
• DNA Microarrays

• Next Generation Cancer Diagnostics Market, By Application:

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

• Next Generation Cancer Diagnostics Market, By Cancer Type:

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

• Next Generation Cancer Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE