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Fluid Biopsy Market

ID: MRFR/HC/40643-HCR
200 Pages
Garvit Vyas
October 2025

Fluid Biopsy Market Research Report: Size, Share, Trend Analysis By Applications (Cancer Diagnostics, Infectious Disease Monitoring, Transplant Rejection Monitoring, Personalized Medicine), By Sample Type (Blood, Urine, Saliva, Pleural Fluid), By Technology (Circulating Tumor Cell Isolation, Cell-Free DNA Analysis, Exosomes Isolation, RNA Sequencing), By End Use (Hospitals, Diagnostic Laboratories, Research Centers) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Growth Outlook & Industry Fo... read more

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Fluid Biopsy Market Summary

As per Market Research Future analysis, the Fluid Biopsy Market Size was estimated at 4.706 USD Billion in 2024. The Fluid Biopsy industry is projected to grow from 5.079 USD Billion in 2025 to 10.89 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 7.93% during the forecast period 2025 - 2035

Key Market Trends & Highlights

The Fluid Biopsy Market is poised for substantial growth driven by technological advancements and increasing demand for non-invasive diagnostics.

  • Technological advancements are enhancing the accuracy and efficiency of fluid biopsy procedures.
  • The demand for non-invasive diagnostics is growing, particularly in North America, which remains the largest market.
  • Personalized medicine is emerging as the fastest-growing segment, reflecting a shift towards tailored treatment approaches.
  • Key market drivers include the rising incidence of cancer and regulatory support, which are propelling the adoption of fluid biopsy technologies.

Market Size & Forecast

2024 Market Size 4.706 (USD Billion)
2035 Market Size 10.89 (USD Billion)
CAGR (2025 - 2035) 7.93%

Major Players

Guardant Health (US), GRAIL (US), Biocept (US), Freenome (US), Exact Sciences (US), Sysmex Corporation (JP), Roche Diagnostics (CH), Thermo Fisher Scientific (US), Qiagen (DE)

Fluid Biopsy Market Trends

The Fluid Biopsy Market is currently experiencing a transformative phase, driven by advancements in technology and an increasing emphasis on non-invasive diagnostic methods. This market encompasses a range of techniques that allow for the analysis of circulating tumor cells, cell-free DNA, and exosomes, providing critical insights into cancer progression and treatment response. As healthcare systems globally seek to enhance patient outcomes, the demand for fluid biopsy solutions appears to be on the rise. This trend is further supported by the growing awareness of personalized medicine, which necessitates precise and timely information regarding tumor dynamics. Moreover, the Fluid Biopsy Market is likely to benefit from ongoing research and development efforts aimed at improving the sensitivity and specificity of these diagnostic tools. Collaborations between academic institutions and industry players may foster innovation, leading to the introduction of novel assays and platforms. Additionally, regulatory bodies are increasingly recognizing the potential of fluid biopsies, which could facilitate faster approvals and wider adoption in clinical settings. As the landscape evolves, stakeholders must remain vigilant to emerging technologies and shifting regulatory frameworks that could shape the future of this market.

Technological Advancements

Recent innovations in sequencing technologies and bioinformatics are enhancing the capabilities of fluid biopsy tests. These advancements enable more accurate detection of genetic mutations and alterations, which are crucial for tailoring treatment strategies.

Growing Demand for Non-Invasive Diagnostics

There is a notable shift towards non-invasive diagnostic methods in oncology, as patients and healthcare providers seek alternatives to traditional tissue biopsies. Fluid biopsies offer a less invasive option, potentially improving patient comfort and compliance.

Increased Focus on Personalized Medicine

The Fluid Biopsy Market is increasingly aligned with the principles of personalized medicine. As healthcare moves towards individualized treatment plans, the ability to monitor tumor dynamics through fluid biopsies is becoming essential for optimizing therapeutic approaches.

Fluid Biopsy Market Drivers

Rising Incidence of Cancer

The Fluid Biopsy Market is significantly influenced by the rising incidence of cancer worldwide. As cancer rates continue to escalate, there is an urgent need for effective diagnostic tools that can facilitate early detection and ongoing monitoring. Liquid biopsies offer a promising solution, allowing for the identification of cancer biomarkers through minimally invasive procedures. Recent statistics indicate that cancer cases are expected to rise by nearly 50% by 2040, underscoring the critical demand for innovative diagnostic methods. This alarming trend is likely to drive investments and research in the Fluid Biopsy Market, as stakeholders seek to develop advanced solutions to combat the growing cancer burden.

Increased Focus on Personalized Medicine

The Fluid Biopsy Market is being propelled by an increased focus on personalized medicine, which emphasizes tailored treatment strategies based on individual patient profiles. Liquid biopsies play a crucial role in this paradigm by providing insights into the genetic makeup of tumors, enabling oncologists to select the most effective therapies for their patients. The ability to monitor treatment efficacy and detect resistance mutations in real-time further enhances the appeal of fluid biopsies in personalized treatment plans. As the market for personalized medicine expands, the Fluid Biopsy Market is expected to grow substantially, with projections indicating a potential market size increase of over 30% in the coming years.

Growing Demand for Non-Invasive Diagnostics

The Fluid Biopsy Market is witnessing a surge in demand for non-invasive diagnostic methods, which are perceived as safer and more patient-friendly compared to traditional tissue biopsies. Patients and healthcare providers alike are increasingly favoring procedures that minimize discomfort and risk. This shift is particularly evident in oncology, where liquid biopsies allow for the analysis of tumor-derived materials from blood samples. The convenience and reduced recovery time associated with non-invasive diagnostics are likely to contribute to a projected market growth rate of approximately 15% annually. As healthcare systems continue to prioritize patient-centric approaches, the Fluid Biopsy Market is poised to benefit significantly from this trend.

Regulatory Support and Reimbursement Policies

The Fluid Biopsy Market is benefiting from favorable regulatory support and evolving reimbursement policies that encourage the adoption of liquid biopsy technologies. Regulatory bodies are increasingly recognizing the clinical utility of liquid biopsies, leading to expedited approvals for innovative diagnostic tests. Additionally, many healthcare payers are beginning to cover liquid biopsy procedures, which enhances accessibility for patients and healthcare providers. This supportive environment is likely to stimulate market growth, as it reduces financial barriers and encourages the integration of fluid biopsies into standard clinical practice. As reimbursement frameworks continue to evolve, the Fluid Biopsy Market is expected to see a significant uptick in utilization and acceptance.

Technological Advancements in Fluid Biopsy Market

The Fluid Biopsy Market is experiencing rapid technological advancements that enhance the accuracy and efficiency of diagnostic procedures. Innovations in liquid biopsy technologies, such as next-generation sequencing and digital PCR, are enabling the detection of circulating tumor DNA and other biomarkers with unprecedented sensitivity. These advancements are not only improving early cancer detection rates but also facilitating real-time monitoring of treatment responses. According to recent estimates, the liquid biopsy segment is projected to grow at a compound annual growth rate of over 20% through the next few years. This growth is indicative of the increasing reliance on advanced technologies to provide precise and timely diagnostic information, thereby driving the Fluid Biopsy Market forward.

Market Segment Insights

By Application: Cancer Diagnostics (Largest) vs. Personalized Medicine (Fastest-Growing)

In the Fluid Biopsy Market, the application segment is witnessing a diverse distribution of shares across its primary categories: Cancer Diagnostics, Infectious Disease Monitoring, Transplant Rejection Monitoring, and Personalized Medicine. Among these, Cancer Diagnostics currently dominates the market, driven by the high prevalence of cancer and the increasing demand for non-invasive testing methods. Conversely, Personalized Medicine is emerging as a significant player, gaining traction due to the trend towards tailored therapies and individualized treatment plans.

Cancer Diagnostics (Dominant) vs. Personalized Medicine (Emerging)

Cancer Diagnostics is the dominant force in the Fluid Biopsy Market, leveraging advanced technologies for the early detection and monitoring of cancer through non-invasive sampling techniques. Its strong foundation in clinical practice and constant innovations bolster its market position. In contrast, Personalized Medicine, while still developing, is recognized for its transformative potential in healthcare. It emphasizes patient-centric approaches by customizing treatment based on genetic and molecular profiles, which resonates well with the growing paradigm shift towards tailored therapeutic interventions. This segment's rapid growth is fueled by advancements in genomic technologies and increasing investment in research, positioning it as a key component of future medical breakthroughs.

By Sample Type: Blood (Largest) vs. Urine (Fastest-Growing)

In the Fluid Biopsy Market, the sample type distribution showcases blood as the dominant choice, largely due to its rich biomolecular content, suitable for a variety of cancer diagnostics. Blood is widely used for detecting circulating tumor cells (CTCs) and cell-free DNA (cfDNA), which are critical in cancer management. Conversely, urine is emerging as a viable alternative, gaining traction due to its non-invasive collection process and the potential for detecting certain biomarkers without the need for more complex procedures. Market growth trends indicate that urine samples are experiencing a notable upward trajectory as advancements in technology enhance the reliability of urine-based diagnostics. Factors contributing to this growth include increased awareness of non-invasive testing's benefits, improved diagnostics techniques, and an expanding pipeline of products utilizing urine as a sample type. As research continues to deepen, the incorporation of urine samples in fluid biopsies is expected to accelerate markedly in the coming years.

Blood (Dominant) vs. Urine (Emerging)

Blood remains the dominant sample type in the Fluid Biopsy Market, providing comprehensive insights into a patient's health due to its extensive range of biomarkers. Its effectiveness in capturing circulating tumor cells and circulating free DNA positions it at the forefront of how cancer diagnostics evolve. However, urine is rapidly emerging, offering a less invasive alternative that appeals to both patients and healthcare providers. The advancements in analytical techniques and the ability to identify critical biomarkers in urine are driving its growth. Moreover, the patient-friendly nature of urine collection reduces barriers associated with blood draws, thereby potentially increasing patient participation in screening programs and clinical trials.

By Technology: Circulating Tumor Cell Isolation (Largest) vs. RNA Sequencing (Fastest-Growing)

In the Fluid Biopsy Market, Circulating Tumor Cell (CTC) Isolation currently holds the largest market share among the different technologies, favored for its capability to enable real-time monitoring of cancer progression and treatment response. Following CTC Isolation, Cell-Free DNA Analysis and Exosome Isolation are also notable in the market, but they are increasingly catching up as technologies advance and become integrated into clinical settings. The availability of sophisticated tools makes these technologies vital for clinicians aiming for precise cancer diagnostics. As for the growth outlook, RNA Sequencing is identified as the fastest-growing segment within the Fluid Biopsy Market, driven by its ability to provide detailed genomic insights into tumor biology. The rising demand for personalized medicine and targeted therapies is expected to propel growth in this segment. Additionally, advancements in sequencing technologies and decreased costs have made RNA Sequencing more accessible, thereby enhancing its adoption across clinical research and diagnostics, further contributing to the segment's rapid expansion.

Technology: CTC Isolation (Dominant) vs. RNA Sequencing (Emerging)

Circulating Tumor Cell (CTC) Isolation is recognized as the dominant technology in the Fluid Biopsy Market, known for its effectiveness in isolating and characterizing CTCs from blood samples, thereby enabling real-time insights into tumor dynamics. This technology provides a non-invasive means to evaluate cancer progression and response to therapies, making it an essential tool in oncology. On the other hand, RNA Sequencing, categorized as an emerging technology, is rapidly gaining traction due to its capability to analyze the expression profile of cancer genes. This segment focuses on the potential for developing targeted therapies based on the genetic makeup of tumors. Together, these technologies complement one another in enriching the understanding of cancer biology.

By End Use: Hospitals (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

In the Fluid Biopsy Market, the distribution of end-use segments reveals that hospitals command the most significant share, largely due to their extensive patient base and integrated healthcare services. They leverage fluid biopsy technologies for various clinical applications, enhancing patient care through early diagnosis and personalized treatment plans. Diagnostic laboratories, while smaller in share, are quickly gaining traction thanks to their specialized capabilities and growing partnerships with healthcare providers, allowing them to offer advanced biomarker testing services.

Hospitals (Dominant) vs. Diagnostic Laboratories (Emerging)

Hospitals are the dominant players in the Fluid Biopsy Market, equipped with state-of-the-art facilities and a wide array of resources to conduct fluid biopsies effectively. They play a critical role in utilizing these technologies for cancer detection and monitoring, thus ensuring improved patient outcomes. On the other hand, diagnostic laboratories represent an emerging segment, capitalizing on the rising demand for precise diagnostics and personalized medicine. With advancements in laboratory technology and the ability to provide faster turnaround times, diagnostic labs are becoming essential in the fluid biopsy landscape, appealing to a broader clientele including healthcare providers and patients.

Get more detailed insights about Fluid Biopsy Market

Regional Insights

The Global Fluid Biopsy Market reveals significant insights across different regional segments. In 2024, North America holds the majority share with a valuation of 2.02 USD Billion, reflecting its dominance and advanced healthcare infrastructure, which drives market growth in this region. Europe follows with a notable value of 1.06 USD Billion, benefitting from strong research and development initiatives in the healthcare sector.

The APAC region, valued at 0.83 USD Billion, showcases rapid growth due to increasing awareness and adoption of advanced diagnostic techniques.South America, with a valuation of 0.25 USD Billion, is gradually emerging, driven by improving healthcare access and technological advancements. 

Meanwhile, the Middle East and Africa (MEA) segment, valued at 0.20 USD Billion, remains in the early stages of market development but offers future growth opportunities as healthcare infrastructure continues to improve. Overall, the Regional segmentation indicates a diverse landscape, with North America leading, followed by Europe and APAC, which all contribute significantly to the Global Fluid Biopsy Market revenue through their unique growth drivers and opportunities.

Fluid Biopsy Market Regional Image

Key Players and Competitive Insights

The Global Fluid Biopsy Market is characterized by a rapidly evolving landscape driven by technological advancements and an increasing demand for non-invasive diagnostic methods. Fluid biopsy refers to the analysis of biological fluids, such as blood or urine, to detect cancer and other diseases through the evaluation of circulating tumor cells, cell-free DNA, and exosomes.

Competitive dynamics in this market are shaped by several factors, including the development of more precise and efficient technologies, regulatory approvals, strategic collaborations, and the entry of new players. The emphasis on early diagnosis and personalized medicine is propelling innovation, fostering an environment where companies must continuously enhance their offerings and maintain a competitive edge to capture the growing market share.

In the context of the Global Fluid Biopsy Market, SeaSpine has established a robust presence by harnessing its innovative capabilities and focus on differentiation through advanced technology solutions. The company has garnered recognition for its commitment to developing non-invasive diagnostic tools that are reliable and can enhance patient outcomes.

SeaSpine's strengths lie in its strong research and development foundation, enabling it to introduce unique fluid biopsy products that cater to the specific demands of clinicians and patients alike. Their focus on quality and regulatory compliance allows them to navigate complex market regulations effectively, positioning them favorably against competitors. Moreover, strategic partnerships and collaborations with key healthcare stakeholders have facilitated SeaSpine in augmenting its market reach and operational efficiency within this sector.

Exact Sciences has emerged as a notable player in the Global Fluid Biopsy Market, highlighting its strengths in innovation and product development tailored for cancer detection and monitoring. The company has forged a reputation for its commitment to research that drives significant advancements in liquid biopsy technologies, making them relevant in the clinical landscape. Exact Sciences' focus on non-invasive testing methodologies has resulted in reliable diagnostic tools that fulfill a critical need for early cancer detection, enhancing patient management strategies.

The company's ability to leverage advanced genomics and biomarker analytics positions it advantageously, as these are increasingly essential in today’s healthcare setting. Exact Sciences has effectively built strong relationships within the healthcare community, further enhancing its credibility and expanding its market presence through collaborations and strategic initiatives that align with industry needs.

Key Companies in the Fluid Biopsy Market market include

Industry Developments

  • Q2 2024: Biocept Announces Sale of CNSide™ Cerebrospinal Fluid Assay to Plus Therapeutics Biocept, Inc. announced the sale of its CNSide™ cerebrospinal fluid assay intellectual property and related assets to Plus Therapeutics, marking a significant transaction in the fluid biopsy sector focused on central nervous system cancers.
  • Q2 2024: Freenome Announces $254 Million Series D Financing to Advance Multiomics Liquid Biopsy Platform Freenome secured $254 million in Series D funding to accelerate the development and commercialization of its multiomics liquid biopsy platform for early cancer detection.
  • Q2 2024: Guardant Health Receives FDA Approval for Guardant360 CDx Liquid Biopsy Test as Companion Diagnostic for Tagrisso Guardant Health received FDA approval for its Guardant360 CDx liquid biopsy test to be used as a companion diagnostic for AstraZeneca’s Tagrisso in patients with non-small cell lung cancer.
  • Q1 2024: Grail, a unit of Illumina, launches new blood test for early cancer detection Grail, a subsidiary of Illumina, launched a new blood-based liquid biopsy test designed for early detection of multiple types of cancer, expanding its commercial portfolio.
  • Q1 2024: Natera Announces Partnership with Foundation Medicine to Advance Personalized Cancer Monitoring Natera and Foundation Medicine entered a partnership to integrate their liquid biopsy technologies, aiming to enhance personalized cancer monitoring and treatment selection.
  • Q2 2024: Lucence Receives CE Mark for LiquidHALLMARK Liquid Biopsy Test Lucence received the CE Mark for its LiquidHALLMARK liquid biopsy test, enabling its commercial launch in the European Union for cancer genomic profiling.
  • Q2 2024: Biocept Announces Appointment of Samuel Riccitelli as Interim President and CEO Biocept appointed Samuel Riccitelli as interim President and CEO, signaling a leadership change as the company continues to focus on its fluid biopsy business.
  • Q1 2024: Angle plc Announces FDA Clearance of Parsortix System for Metastatic Breast Cancer Angle plc received FDA clearance for its Parsortix system, a liquid biopsy platform for harvesting circulating tumor cells in metastatic breast cancer patients.
  • Q2 2024: Inivata and Geneseeq Announce Strategic Partnership to Expand Liquid Biopsy Offerings in Asia Inivata and Geneseeq formed a strategic partnership to jointly develop and commercialize liquid biopsy solutions for cancer detection and monitoring in Asian markets.
  • Q1 2024: Biocept Announces New Laboratory Facility Opening in San Diego Biocept opened a new laboratory facility in San Diego to expand its capacity for fluid and liquid biopsy testing services.
  • Q2 2024: Guardant Health Announces Partnership with Epic to Integrate Liquid Biopsy Results into EHR Guardant Health partnered with Epic to integrate its liquid biopsy test results directly into the Epic electronic health record system, streamlining clinical workflows.
  • Q1 2024: Caris Life Sciences Raises $400 Million in Growth Capital to Expand Liquid Biopsy Portfolio Caris Life Sciences raised $400 million in growth capital to accelerate the expansion of its liquid biopsy and molecular profiling offerings.

Future Outlook

Fluid Biopsy Market Future Outlook

The Fluid Biopsy Market is projected to grow at a 7.93% CAGR from 2024 to 2035, driven by technological advancements, increasing cancer prevalence, and demand for non-invasive diagnostics.

New opportunities lie in:

  • Development of portable fluid biopsy devices for point-of-care testing.
  • Partnerships with healthcare providers for integrated diagnostic solutions.
  • Expansion into emerging markets with tailored fluid biopsy services.

By 2035, the Fluid Biopsy Market is expected to achieve substantial growth, solidifying its role in modern diagnostics.

Market Segmentation

Fluid Biopsy Market End Use Outlook

  • Hospitals
  • Diagnostic Laboratories
  • Research Centers

Fluid Biopsy Market Technology Outlook

  • Circulating Tumor Cell Isolation
  • Cell-Free DNA Analysis
  • Exosomes Isolation
  • RNA Sequencing

Fluid Biopsy Market Application Outlook

  • Cancer Diagnostics
  • Infectious Disease Monitoring
  • Transplant Rejection Monitoring
  • Personalized Medicine

Fluid Biopsy Market Sample Type Outlook

  • Blood
  • Urine
  • Saliva
  • Pleural Fluid

Report Scope

MARKET SIZE 2024 4.706(USD Billion)
MARKET SIZE 2025 5.079(USD Billion)
MARKET SIZE 2035 10.89(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR) 7.93% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Billion
Key Companies Profiled Guardant Health (US), GRAIL (US), Biocept (US), Freenome (US), Exact Sciences (US), Sysmex Corporation (JP), Roche Diagnostics (CH), Thermo Fisher Scientific (US), Qiagen (DE)
Segments Covered Applications, Sample Type, Technology, End Use, Regional
Key Market Opportunities Advancements in non-invasive diagnostic technologies enhance growth potential in the Fluid Biopsy Market.
Key Market Dynamics Technological advancements and regulatory changes drive innovation and competition in the fluid biopsy market.
Countries Covered North America, Europe, APAC, South America, MEA

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FAQs

What is the projected market valuation of the Fluid Biopsy Market by 2035?

The Fluid Biopsy Market is projected to reach a valuation of 10.89 USD Billion by 2035.

What was the market valuation of the Fluid Biopsy Market in 2024?

In 2024, the Fluid Biopsy Market was valued at 4.706 USD Billion.

What is the expected CAGR for the Fluid Biopsy Market during the forecast period 2025 - 2035?

The expected CAGR for the Fluid Biopsy Market during the forecast period 2025 - 2035 is 7.93%.

Which application segment is expected to show significant growth in the Fluid Biopsy Market?

The Cancer Diagnostics segment is anticipated to grow from 1.882 USD Billion in 2024 to 4.25 USD Billion by 2035.

What are the key sample types analyzed in the Fluid Biopsy Market?

The key sample types include Blood, Urine, Saliva, and Pleural Fluid, with Blood expected to grow from 1.882 USD Billion to 3.75 USD Billion.

Which technology segment is projected to have the highest growth in the Fluid Biopsy Market?

Circulating Tumor Cell Isolation is projected to grow from 1.5 USD Billion in 2024 to 3.5 USD Billion by 2035.

What are the primary end-use sectors for Fluid Biopsy applications?

The primary end-use sectors include Hospitals, Diagnostic Laboratories, and Research Centers, with Hospitals expected to grow from 1.882 USD Billion to 4.25 USD Billion.

Who are the leading companies in the Fluid Biopsy Market?

Key players in the Fluid Biopsy Market include Guardant Health, GRAIL, Biocept, Freenome, Exact Sciences, Sysmex Corporation, Roche Diagnostics, Thermo Fisher Scientific, and Qiagen.

How does the Fluid Biopsy Market's growth compare across different sample types?

The growth across sample types varies, with Blood expected to reach 3.75 USD Billion and Urine projected to grow to 2.5 USD Billion by 2035.

What factors are driving the growth of the Fluid Biopsy Market?

The growth of the Fluid Biopsy Market is driven by advancements in technology, increasing demand for non-invasive diagnostic methods, and rising prevalence of cancer.

What will the market value of the Global Fluid Biopsy Market be in 2035?

By 2035, the Global Fluid Biopsy Market is projected to reach a value of 20.0 USD Billion.

What is the projected CAGR for the Global Fluid Biopsy Market from 2025 to 2035?

The projected CAGR for the Global Fluid Biopsy Market from 2025 to 2035 is 9.05%.

Which region is expected to have the largest market share in the Global Fluid Biopsy Market by 2035?

North America is expected to hold the largest market share in the Global Fluid Biopsy Market, valued at 8.45 USD Billion in 2035.

What is the market value of the Circulating Tumor Cells segment in 2024?

The Circulating Tumor Cells segment is valued at 3.5 USD Billion in 2024.

What are the key players in the Global Fluid Biopsy Market?

Key players in the market include Foundation Medicine, Veracyte, Biocept, and Guardant Health among others.

What is the expected market value for Circulating Tumor DNA in 2035?

The market value for Circulating Tumor DNA is expected to reach 7.0 USD Billion in 2035.

How much is the APAC region expected to contribute to the market by 2035?

The APAC region is anticipated to contribute 4.5 USD Billion to the Global Fluid Biopsy Market by 2035.

What opportunity does the Global Fluid Biopsy Market present for emerging players?

The Global Fluid Biopsy Market presents significant growth opportunities due to advancements in precision medicine and increased cancer prevalence.

What is the expected value of the Exosomes segment in 2024?

The Exosomes segment is expected to be valued at 1.41 USD Billion in 2024.

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