Cell Free RNA Diagnostics Market Size Forecast to USD 204.5 Million by 2035 - Analysis by Transparency Market Research

Cell Free RNA Diagnostics Market to Hit USD 204.5 Million by 2035 at 14.5% CAGR Amid Growing Adoption of Liquid Biopsy and Precision Medicine – TMR

WILMINGTON, DE, UNITED STATES, February 23, 2026 /EINPresswire.com/ -- Cell Free RNA Diagnostics Market Outlook 2035

The global cell free RNA diagnostics market was valued at US$ 46.1 million in 2024 and is projected to reach US$ 204.5 million by 2035, expanding at a robust CAGR of 14.5% from 2025 to 2035. Market growth is driven by rising demand for non-invasive diagnostic methods, advancements in liquid biopsy technologies, and increasing prevalence of cancer and other chronic diseases.

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Market Overview

Cell free RNA (cfRNA) diagnostics involves the detection and analysis of RNA fragments circulating in blood plasma or other body fluids. These biomarkers provide valuable insights for early disease detection, prognosis, treatment monitoring, and personalized medicine applications.

The growing adoption of liquid biopsy techniques is enabling non-invasive testing for cancer, prenatal screening, and organ transplant monitoring. Technological advancements in next-generation sequencing (NGS), microfluidics, and bioinformatics are further enhancing sensitivity, specificity, and clinical utility of cfRNA-based diagnostics.

Increasing healthcare expenditure, rising awareness of early detection benefits, and regulatory approvals of cfRNA-based tests are fueling global market expansion.

Analysts’ Viewpoint on the Global Cell Free RNA Diagnostics Market

Analysts observe strong growth prospects due to the shift toward minimally invasive diagnostics and precision medicine. Rising investment in genomics research, integration of artificial intelligence for data analysis, and increasing clinical adoption are driving market momentum.

North America leads the market with high research activity, established healthcare infrastructure, and favorable reimbursement policies. Asia Pacific is expected to witness rapid growth due to increasing cancer prevalence, expanding diagnostic infrastructure, and growing adoption of advanced technologies.

Analysis of Key Players in the Cell Free RNA Diagnostics Market

The market is highly competitive, with companies focusing on innovation, strategic collaborations, and clinical validation studies. Key players are advancing platforms that improve sensitivity, reduce turnaround time, and expand applications across oncology, prenatal care, and transplant medicine.

Leading companies include:
• Agilent Technologies, Inc.
• AMS Biotechnology (Europe) Ltd.
• Bio-Rad Laboratories, Inc.
• BioVision, Inc.
• Canopy Biosciences, LLC
• F. Hoffmann-La Roche Ltd.
• Geneaid Biotech Ltd.
• Illumina, Inc.
• QIAGEN N.V.
• Lexogen GmbH
• LGC Biosearch Technologies
• Merck KGaA
• New England Biolabs, Inc.
• Norgen Biotek Corp.
• Omega Bio-Tek, Inc.
• PerkinElmer, Inc.
• Other Prominent Players

These companies are strengthening their position through R&D, strategic acquisitions, partnerships with hospitals and research institutions, and global expansion.

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Recent Key Developments in Cell Free RNA Diagnostics

• January 2025: Flomics Biotech reported a multi-cancer screening test combining cfRNA, NGS, and AI, achieving ~92% AUC and ~83% sensitivity at 90% specificity for five major cancers, and ~80% sensitivity for Stage I cancers.
• May 2025: A study published in Genome Biology introduced cfPeak, a method leveraging machine learning and statistical modeling to detect fragmented cfRNA signals with clinical applications.
• September 2024: Cornell University–led collaboration demonstrated that cfRNA analysis from blood, combined with machine-learning models, can enhance early detection of pediatric inflammatory conditions.

Key Player Strategies

🧬 Technological Innovation
Developing ultra-sensitive sequencing platforms and multiplex cfRNA assays.
🏥 Clinical Partnerships
Collaborations with hospitals, cancer centers, and research institutions to validate clinical utility.
🌍 Geographic Expansion
Targeting emerging markets in Asia Pacific and Latin America.
📈 Product Diversification
Offering comprehensive solutions including diagnostic kits, services, and software analytics.

Challenges

• High cost of advanced cfRNA tests
• Regulatory approval hurdles across multiple regions
• Limited awareness among healthcare providers
• Technical challenges in RNA isolation and stability

Opportunities

💉 Oncology Applications
Early detection, therapy monitoring, and relapse prediction for various cancers.
👶 Prenatal & Maternal Health
Non-invasive screening for fetal abnormalities and pregnancy monitoring.
🧠 Chronic & Rare Diseases
Expanding cfRNA applications beyond oncology for personalized medicine.
🌐 Integration with AI & Bioinformatics
Enhancing predictive accuracy and clinical decision-making.
🏥 Rising Adoption of Liquid Biopsies
Shift from invasive tissue biopsies to minimally invasive diagnostics.

Market Segmentation

➤ By Application
• Oncology
• Prenatal & Maternal Health
• Transplant Monitoring
• Others

➤ By Product Type
• Diagnostic Kits
• Services
• Analytical Software & Platforms

➤ By End User
• Hospitals & Clinics
• Diagnostic Laboratories
• Research Institutes

➤ By Region
• North America – Dominant due to advanced diagnostics infrastructure
• Europe – High adoption of liquid biopsy technologies
• Asia Pacific – Fastest-growing region with expanding healthcare investments
• Latin America
• Middle East & Africa

Why Invest in the Cell Free RNA Diagnostics Market Outlook 2035

✅ Long-term forecast till 2035 with detailed market analytics
✅ Competitive profiling of leading global manufacturers
✅ Insights on technological advancements and liquid biopsy trends
✅ Regional analysis to identify high-growth opportunities
✅ Evaluation of clinical adoption and emerging applications

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FAQs

1. What is the projected cell free RNA diagnostics market size by 2035?
The market is expected to reach US$ 204.5 million by 2035.

2. What is the CAGR from 2025–2035?
The market is projected to grow at a CAGR of 14.5%.

3. Which application dominates the market?
Oncology applications hold the largest share due to rising cancer prevalence.

4. Which region leads the market?
North America dominates due to advanced diagnostics infrastructure and favorable reimbursement.

5. What are key market trends?
Integration with AI, liquid biopsy adoption, multi-cancer detection panels, and expansion into emerging markets are shaping growth.

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