Cancer Diagnostics Market (By Product: Consumables, Instruments; By Type: IVD, LDT; By Application: Breast Cancer, Lung Cancer; By End-use; By Test Type) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The global cancer diagnostics market size was estimated at around USD 107.48 billion in 2023 and it is projected to hit around USD 195.77 billion by 2033, growing at a CAGR of 6.18% from 2024 to 2033. The cancer diagnostics market is witnessing robust growth owing to several factors including the rising prevalence of cancer globally, advancements in diagnostic technologies, and increasing awareness regarding early disease detection.

Key Pointers

• North America emerged as the dominant force in the market, commanding a notable revenue share of 41% in 2023.
• Asia Pacific market is poised to witness the fastest compound annual growth rate (CAGR) from 2024 to 2033.
• By Product, the consumables segment dominated the market with a share of 60% in 2023 and is poised to witness the most rapid growth throughout the forecast period.
• By Type, the in vitro diagnostics (IVD) segment held the largest revenue share of 53% in 2023.
• By Type, laboratory diagnostic tests (LDTs) are poised to exhibit the highest compound annual growth rate (CAGR) from 2024 to 2033.
• By Application, the breast cancer segment generated the maximum market share of 17% in 2023.
• By Application, lung cancer is anticipated to witness the fastest compound annual growth rate (CAGR) of 7.68% from 2024 to 2033.

Cancer Diagnostics Market Growth Factors

The cancer diagnostics market is propelled by several growth factors, including the escalating incidence of cancer worldwide, advancements in diagnostic technologies, and heightened awareness concerning early disease detection. Key players in the market are continually innovating and investing in research and development endeavors to introduce groundbreaking diagnostic solutions, thus enhancing precision and efficacy in cancer detection. Collaborations and partnerships between diagnostic companies and healthcare institutions are further augmenting market expansion and technological progression. Nonetheless, challenges such as the elevated costs associated with advanced diagnostic techniques, rigorous regulatory frameworks, and a shortage of skilled healthcare professionals remain significant hurdles to market growth.

U.S. Cancer Diagnostics Market Size 2024 to 2033

The U.S. cancer diagnostics market size was valued at USD 30.84 billion in 2023 and is expected to hit around USD 56.18 billion by 2033, at a CAGR of 6.18% from 2024 to 2033.

In 2023, North America emerged as the dominant force in the market, commanding a notable revenue share of 41%. The region's market dominance can be attributed to several factors, including the growing cancer burden in the United States and Canada. Additionally, there is a notable focus among medical device companies in the region on developing innovative diagnostic devices geared towards cancer detection, further propelling market growth. Product launches play a pivotal role in shaping market dynamics, exemplified by Nanostics Inc.'s announcement in July 2022 regarding the commencement of a clinical investigation for bladder cancer.

Conversely, the Asia Pacific market is poised to witness the fastest compound annual growth rate (CAGR) from 2024 to 2033, driven by various factors including increasing healthcare reforms. The region is experiencing a rise in cancer prevalence, particularly highlighted by a report published by PubMed Central in March 2022, which underscores the high incidence of cancer in China. With an estimated 4.8 million new cancer cases predicted in China by 2022, lung cancer emerges as the most prevalent type.

Cancer Diagnostics Market Trends:

• Liquid Biopsy Techniques: The emergence of liquid biopsy techniques, which involve the analysis of circulating tumor cells, cell-free DNA, and exosomes from blood samples, is revolutionizing cancer diagnostics by offering non-invasive and real-time monitoring of disease progression and treatment response.
• Advances in Genomic and Proteomic Profiling: Technological advancements in genomic and proteomic profiling technologies are enabling comprehensive molecular characterization of tumors, facilitating the identification of biomarkers for early detection, prognostication, and prediction of treatment response in cancer patients.
• Point-of-Care Diagnostics: The development of rapid and portable diagnostic devices for cancer detection at the point of care is facilitating early diagnosis and timely intervention, particularly in resource-limited settings, thus improving patient outcomes and reducing healthcare costs.
• Telemedicine and Remote Monitoring: The adoption of telemedicine platforms and remote monitoring technologies for cancer diagnostics is facilitating virtual consultations, remote imaging interpretation, and patient monitoring, thereby enhancing access to specialized care and improving patient outcomes, especially in rural and underserved areas.

Cancer Diagnostics Market Challenges:

• High Cost of Advanced Diagnostic Technologies: The high initial investment and operating costs associated with advanced diagnostic technologies such as next-generation sequencing, molecular imaging, and liquid biopsy techniques pose a significant financial barrier to their widespread adoption, particularly in resource-constrained healthcare settings.
• Stringent Regulatory Frameworks: The complex and stringent regulatory requirements governing the development, approval, and commercialization of cancer diagnostic tests and devices, including rigorous clinical validation and compliance with quality standards, can delay market entry and increase development costs for companies operating in this space.
• Limited Access to Specialized Diagnostic Services: Disparities in access to specialized cancer diagnostic services, particularly in rural and underserved areas, hinder timely diagnosis and treatment initiation, leading to poorer outcomes for patients in these regions.
• Shortage of Skilled Healthcare Professionals: The shortage of trained pathologists, radiologists, laboratory technicians, and other healthcare professionals specializing in cancer diagnostics poses a significant challenge to the timely and accurate interpretation of diagnostic tests and imaging studies, potentially leading to diagnostic errors and treatment delays.

Product Insights

The consumables segment dominated the market with a share of 60% in 2023 and is poised to witness the most rapid growth throughout the forecast period. The development of advanced imaging diagnostic techniques and effective monoclonal antibody-based assays for detecting antigens and small chemicals produced by malignant cells holds significant promise for enhancing diagnostic capabilities. While monoclonal antibody (mAb) technology is still in its nascent stages, recent advancements in recombinant antigen synthesis and antibody creation techniques have substantially broadened its potential in diagnosis.

On the other hand, the instruments segment is expected to experience notable growth during the forecast period. Analytical instruments play a pivotal role in automating the diagnostic process and facilitating the convergence of samples and reagents. Kits and robots employed in pathology laboratories aid in the quantification and detection of infectious microorganisms, blood antigens, and viral load.

Type Insights

In 2023, the in vitro diagnostics (IVD) segment emerged as the dominant force, capturing a share of 53%, primarily fueled by the heightened adoption of IVD solutions amidst the COVID-19 pandemic. The surge in testing demand underscored the pivotal role of IVD in healthcare. The market is witnessing a shift towards automated IVD systems tailored for hospitals and laboratories, offering precise, efficient, and error-free diagnosis capabilities. Notably, in March 2019, BD obtained CE-IVD certification for its automated flow cytometry system, BD FACSDuet, empowering clinical laboratories to enhance efficacy and throughput compared to manual processes.

Meanwhile, laboratory diagnostic tests (LDTs) are poised to exhibit the highest compound annual growth rate (CAGR) from 2024 to 2033. These tests serve as critical tools for swiftly integrating new information and guiding personalized therapy decisions. By enabling treatments to pivot from a generalized approach to a more tailored one based on individual genetic profiles and disease characteristics, LDTs are revolutionizing patient care. Notably, LDTs are introduced to the market without independent regulatory assessment or FDA approval, as they are generated and utilized within the same facility.

Application Insights

In 2023, the breast cancer segment emerged as the leader in revenue, capturing a substantial share of 17%. This dominance is poised to continue, driven by increased research and development efforts aimed at advancing screening tools for breast cancer detection. Notably, a groundbreaking research study published in Scientific Reports in September 2019 introduced a novel screening test. This test combines the expression of MMP-1 (matrix metalloproteinase-1) and miR-21 in urinary exosomes, enabling the detection of 95% of breast cancers without metastasis development.

Conversely, lung cancer is anticipated to witness the fastest compound annual growth rate (CAGR) of 7.68% from 2024 to 2033, fueled by the availability of technologically advanced diagnostic products. Oncocyte's DetermaDx, a multigene assay facilitating gene expression measurement in circulating blood cells, stands out as a non-invasive alternative for identifying lung nodules, thereby minimizing the need for invasive biopsy procedures. The industry is experiencing a surge in research and development activities aimed at pioneering novel diagnostic tests.

End-use Insights

In 2023, the laboratories segment emerged as the dominant force in the market, commanding a significant share of 52%. This segment is poised for substantial growth over the forecast period, primarily driven by the increasing demand for testing services and the availability of resources to conduct these tests. Diagnostic laboratories are experiencing heightened reliance from hospitals for testing and evaluation purposes, thereby propelling accelerated growth. Several factors contribute to the segment's expansion, including heightened awareness about personalized medicine, advancements in technology, and a growing demand for cost-effective services. Additionally, government initiatives aimed at providing facilities such as compensation for diagnostic tests are further fueling growth. Regulatory authorities are also taking proactive steps to enhance clinical laboratory diagnostic services and streamline the diagnostic process.

Conversely, the others segment, encompassing home-based tests, is projected to exhibit the fastest compound annual growth rate (CAGR) of 7.18% from 2024 to 2033. This surge is attributed to the increased adoption of home-based and technologically advanced treatments, particularly amid the COVID-19 pandemic. Acknowledging the need for new models in the cancer community and among payers to mitigate unscheduled hospitalizations and emergency department visits, acute home-based treatment presents a promising alternative to traditional care settings. Key market players are focusing on developing home-based tests to enhance accessibility and acceptability, further driving demand within the segment.

Test Type Insights

Panel-based tests and BRCA1/2 genetic testing serve distinct yet complementary roles in assessing the inherited risk of breast and ovarian cancers. Panel-based tests offer broader coverage, detecting genetic mutations associated with a range of hereditary cancer syndromes beyond BRCA1/2, such as pheochromocytoma-paraganglioma and colon cancer. This expanded clinical value and yield make panel-based testing particularly valuable for individuals with diverse cancer risks. Moreover, patients with genetic abnormalities linked to hereditary cancer syndromes often exhibit an earlier onset of certain cancers, necessitating early detection measures. Consequently, the demand for panel tests is driven by the imperative to provide timely detection and intervention.

On the other hand, biopsy procedures are projected to witness the fastest compound annual growth rate (CAGR) from 2024 to 2033, owing to their numerous benefits, including early cancer detection and characterization. Biopsies not only facilitate the identification of cancer but also enable assessment of its aggressiveness and propensity for metastasis. This information is crucial in devising tailored treatment strategies based on the cancer's stage and behavior. Notably, product launches play a pivotal role in driving market growth.

Cancer Diagnostics Market Key Companies

• Abbott
• F. Hoffmann-La Roche Ltd.
• GE Healthcare
• QIAGEN
• BD
• Koninklijke Philips N.V. (Philips)
• Siemens Healthcare GmbH
• Hologic, Inc.
• Thermo Fisher Scientific, Inc.
• Illumina, Inc.

Cancer Diagnostics Market Segmentations:

By Product

• Instruments
  • Pathology-based Instruments
    • Slide Staining Systems
    • Tissue Processing Systems
    • Cell Processors
    • PCR Instruments
    • NGS Instruments
    • Microarrays
    • Other Pathology-based Instruments
  • Imaging Instruments
  • Others
• Consumables
  • Antibodies
  • Kits & reagents
  • Probes
  • Others
• Services

By Type

• IVD
  • By Type
    • Diagnosis
    • Early Detection
    • Therapy Selection
    • Monitoring
  • By Technology
    • Polymerase Chain Reaction (PCR)
    • In Situ Hybridization (ISH)
    • Immunohistochemistry (IHC)
    • Next-generation Sequencing (NGS)
    • Microarrays
    • Flow Cytometry
    • Immunoassays
    • Other IVD Testing Technologies
• LDT
• Imaging
  • Magnetic Resonance Imaging (MRI)
  • Computed Tomography (CT)
  • Positron Emission Tomography (PET)
  • Mammography
  • Ultrasound
  • Others

By Application

• Breast Cancer
• Colorectal Cancer
• Cervical Cancer
• Lung Cancer
• Prostate Cancer
• Skin Cancer
• Blood Cancer
• Kidney Cancer
• Liver Cancer
• Pancreatic Cancer
• Ovarian Cancer
• Others

By End-use

• Hospitals
• Laboratories
• Others

By Test Type

• Biopsy
  • Fine-needle Aspiration
  • Core Biopsy
  • Surgical Biopsy
  • Skin Biopsy /Punch Biopsy
  • Others
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)