U.S. Circulating Tumor Cells Market (By Application: Clinical/Liquid Biopsy, Research; By Specimen: Bone Marrow, Blood; By Product; By Technology) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. circulating tumor cells market size was valued at USD 4.48 billion in 2023 and is anticipated to reach around USD 14.93 billion by 2033, growing at a CAGR of 12.79% from 2024 to 2033.

Key Pointers

• By Specimen, the blood segment held the largest revenue share of 48% in 2023.
• By Specimen, the body fluids predicted to grow at the remarkable CAGR of from 2024 to 2033.
• By Technology, the CTC enrichment methods segment dominated the market with a share of 67% in 2023.
• By Technology, the CTC analysis segment is forecasted to experience the highest compound annual growth rate (CAGR) from 2024 to 2033.
• By Application, the research segment commanded the largest market share at 75% in 2023.
• By Product, the kits & reagents segment led the market with a share of 45% in 2023.
• By Product, the devices or systems segment is forecasted to experience the highest compound annual growth rate (CAGR) from 2024 to 2033.

U.S. Circulating Tumor Cells Market Overview

The U.S. circulating tumor cells (CTCs) market represents a pivotal segment within the broader landscape of cancer diagnostics and monitoring. CTCs, as rare cancer cells shed from primary tumors into the bloodstream, hold significant promise as a non-invasive tool for early cancer detection, prognosis assessment, and treatment response monitoring. This overview delves into the key facets shaping the U.S. CTCs market, including market dynamics, technological advancements, regulatory landscape, competitive scenario, and future prospects.

U.S. Circulating Tumor Cells Market Growth Factors

The growth of the U.S. circulating tumor cells (CTCs) market is propelled by an increasing incidence of cancer and the pressing need for early detection and monitoring drive demand for CTC-based diagnostics. Technological advancements in CTC isolation and detection methods enhance the sensitivity and specificity of assays, making them more reliable for clinical use. Additionally, the shift towards personalized medicine and the rising adoption of liquid biopsy approaches further boost market growth. Regulatory support, including stringent validation requirements by the FDA, ensures the quality and reliability of CTC-based tests, instilling confidence among healthcare providers and patients. Moreover, strategic collaborations and partnerships within the industry foster innovation and market expansion, contributing to the overall growth trajectory of the U.S. CTCs market.

U.S. Circulating Tumor Cells Market Trends:

• Increasing Adoption of Liquid Biopsy: There is a growing trend towards the adoption of liquid biopsy approaches for cancer detection and monitoring, with CTC-based tests playing a pivotal role in this shift.
• Expansion of Clinical Applications: CTC-based assays are increasingly being utilized across various cancer types for prognostic assessment, treatment selection, and monitoring of therapeutic responses, reflecting a broader acceptance and integration into clinical practice.
• Personalized Medicine: With a rising emphasis on personalized medicine, CTC-based tests offer the potential to tailor treatment strategies based on individual patient profiles, driving the demand for molecular characterization of CTCs and biomarker analysis.
• Regulatory Developments: Regulatory frameworks governing CTC-based tests are evolving to ensure safety, efficacy, and quality standards, with stringent validation requirements by regulatory bodies like the FDA shaping market dynamics and product development strategies.

U.S. Circulating Tumor Cells Market Challenges:

• Technological Limitations: Despite advancements, current CTC isolation and detection methods still face challenges in terms of sensitivity, specificity, and reproducibility, impacting the reliability of CTC-based assays.
• Standardization Issues: Lack of standardized protocols for CTC isolation, enumeration, and molecular characterization hampers comparability of results across different assays and platforms, hindering widespread adoption and clinical utility.
• Regulatory Hurdles: Stringent regulatory requirements for validation studies and FDA approval processes add time, cost, and complexity to the development and commercialization of CTC-based tests, delaying market entry and innovation.
• Reimbursement Challenges: Uncertain reimbursement policies and coverage determinations by payers create barriers to market access and adoption of CTC-based assays, limiting their integration into routine clinical practice.

Specimen Insights

The blood segment dominated the market with a share of 48% in 2023. Detecting circulating tumor cells (CTCs) in blood samples is crucial for predicting prognosis and determining the response to systemic chemotherapy in cancer patients. Therefore, the identification of CTCs in blood samples holds significant importance in cancer research. Moreover, the use of untreated whole blood samples proves beneficial in enriching CTCs. Technological advancements aimed at addressing the challenges associated with detecting CTCs in blood samples are expected to drive further growth in this segment.

The segment focusing on other body fluids is projected to experience the highest compound annual growth rate (CAGR) from 2024 to 2033. Several leading companies offer blood collection tubes containing preservatives for stabilizing blood samples. Additionally, proprietary storage tubes like Cell-Free DNA tubes are available, enabling the stability of CTCs for at least four days at room temperature. EDTA, the most commonly used anticoagulant agent in these tubes, helps stabilize blood samples by preserving cell viability, thus allowing for genetic and proteomic-level studies and facilitating biomarker analysis.

Technology Insights

In 2023, the CTC enrichment methods segment dominated the market with a share of 67%. This was largely due to the wide array of available techniques aimed at enriching circulating tumor cells (CTCs) in cancer detection. Various methods include filtration, centrifugal force, magnetic beads-based enrichment, and leveraging physical properties like size, density, deformity, and electric charges for CTC detection. The positive or negative enrichment of CTCs based on biological properties is expected to notably drive market growth during the forecast period. Additionally, successful enrichment processes contribute to sensitivity, selectivity, and yield enhancement, ensuring the positive clinical translation of CTCs.

On the other hand, the CTC analysis segment is forecasted to experience the highest compound annual growth rate (CAGR) from 2024 to 2033. This segment holds promise in helping clinicians identify the underlying reasons for unresponsiveness among patients undergoing targeted therapy. CTC analysis serves as a minimally invasive method for repetitive analysis and is a validated technology for tumor study and clinical decision-making. Furthermore, technological advancements such as next-generation sequencing (NGS) and immunofluorescence are anticipated to significantly enhance CTC analyses, thereby further propelling the growth of this segment.

Application Insights

In 2023, the research segment commanded the largest market share at 75% and is projected to demonstrate the fastest compound annual growth rate (CAGR) throughout the forecast period. Circulating tumor cells (CTCs) play a pivotal role in cancer metastasis and serve as valuable material for liquid biopsy. The enumeration of CTCs stands as a reliable predictive and prognostic biomarker, offering enhanced capabilities in monitoring treatment efficacy, detecting early metastasis development, and assessing therapeutic responses more accurately compared to traditional imaging methods.

There's an increasing emphasis on characterizing and isolating CTCs, presenting promising avenues for predictive testing research. Given that repeated tissue biopsies can be costly, invasive, and impractical in some cases, the characterization of CTCs in liquid biopsy emerges as an appealing alternative to minimize invasiveness and expenses. Consequently, the genomic and molecular characterization of CTCs contributes significantly to treatment selection and the development of more personalized treatment approaches.

Product Insights

In 2023, the kits & reagents segment dominated the market with a share of 45%, largely due to the frequent purchases of these products and their widespread usage rates. Notably, the CellSearch Circulating Tumour Cell Kit is extensively utilized in the U.S., making it the most popular CTC kit in the country. Researchers favor this kit for its ease of use, with several cancer cell lines tested using it, resulting in the production of label-free viable cells for downstream analysis. Moreover, the accessibility of a diverse product portfolio, coupled with advancements in microfluidic technology, is anticipated to further drive market growth.

On the other hand, the devices or systems segment is forecasted to experience the highest compound annual growth rate (CAGR) from 2024 to 2033. This growth is attributed to various advances in microfluidics technology and the availability of a wide product portfolio. The introduction of fabricated glass microchips aimed at overcoming challenges and enhancing technical feasibility for mass production is expected to propel the growth of this segment in the coming years.

U.S. Circulating Tumor Cells Market Key Companies

• QIAGEN
• Bio-Techne Corporation
• Precision for Medicine
• AVIVA Biosciences
• BIOCEPT, Inc.
• BioCEP Ltd.
• Fluxion Biosciences, Inc.
• Greiner Bio-One International GmbH
• Ikonisys, Inc.
• Miltenyi Biotec
• IVDiagnostics, Inc.
• BioFluidica
• Canopus Bioscience Ltd.
• Biolidics Limited
• Creativ MicroTech, Inc.
• LungLife AI, Inc.
• Epic Sciences
• Rarecells Diagnostics
• ScreenCell
• Menarini Silicon Biosystems
• LineaRx, Inc. (Vitatex, Inc.)
• Sysmex Corporation
• STEMCELL Technologies, Inc.

Recent Developments

• In February 2024, BioXcel Therapeutics, Inc. received Fast Track Designation from the U.S. FDA for BXCL701. This investigational, oral innate immune activator is designed to induce inflammation in the tumor microenvironment.
• In August 2023, Cell Microsystems acquired Fluxion Biosciences, Inc. This acquisition complements Cell Microsystems' CellRaft technology-based platforms and applications, allowing for the development of innovative cell analysis solutions.
• In February 2022, Epic Sciences entered into a collaboration with Fulgent Genetics. This collaboration aims to integrate DefineMBC results into Fulgent's existing testing portfolio, enhancing accessibility for healthcare providers and metastatic breast cancer (MBC) patients.

U.S. Circulating Tumor Cells Market Segmentations:

By Technology

• CTC Detection & Enrichment Methods
  • Immunocapture (Label-based)
    • Positive Selection
    • Negative Selection
  • Size-based Separation (Label-free)
    • Membrane-based
    • Microfluidic-based
  • Density-based Separation (Label-free)
  • Combined Methods
• CTC Direct Detection Methods
  • SERS
  • Microscopy
  • Others
• CTC Analysis

By Application

• Clinical/ Liquid Biopsy
  • Risk Assessment
  • Screening and Monitoring
• Research
  • Cancer Stem Cell & Tumorogenesis Research
  • Drug/Therapy Development

By Product

• Kits & Reagents
• Blood Collection Tubes
• Devices or Systems

By Specimen

• Blood
• Bone Marrow
• Other Body Fluids