| Study Period | 2024 - 2030 |
| Market Size (2025) | USD 0.63 Billion |
| Market Size (2030) | USD 1.11 Billion |
| CAGR (2025 - 2030) | 11.88 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Low |
Major Players
*Disclaimer: Major Players sorted in no particular order |
MicroRNA Biomarkers Market Analysis
The MicroRNA Biomarkers Market size is estimated at USD 0.63 billion in 2025, and is expected to reach USD 1.11 billion by 2030, at a CAGR of 11.88% during the forecast period (2025-2030).
Key drivers fueling the growth of the microRNA biomarkers market encompass the escalating prevalence of cancer and other chronic ailments, breakthroughs in next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies, and a surging demand for early disease diagnosis.
As chronic diseases like cancer and cardiovascular disorders become more prevalent, the demand for precise diagnostic tools, including miRNA biomarkers, is surging. This trend is expected to drive market growth in the coming years. For example, data from the Global Cancer Observatory (GCO) in February 2024 projects that global new cancer cases will hit 21.3 million by 2025 and 24.1 million by 2030. Additionally, an April 2023 report from the World Heart Federation highlighted that over 500 million people worldwide were affected by cardiovascular diseases in 2023. Given this significant burden of chronic diseases, the escalating demand for accurate diagnostic tools like miRNA biomarkers is evident, further fueling market growth.
Next-generation sequencing (NGS) and real-time polymerase chain reaction (qPCR) technologies have made it easier to detect miRNA biomarkers accurately and in large volumes, fueling market growth. For example, an August 2024 article in the Journal of Cells highlighted nanotechnology as a promising alternative to Northern blotting and RT-qPCR for miRNA detection. Nanomaterials, due to their unique properties, enable miRNA therapeutics to enter target cells more effectively, resist degradation in the bloodstream, and ensure targeted release in specific tissues or cells. Furthermore, in December 2023, TAmiRNA showcased its advanced transcriptomics technologies in Japan, focusing on developing microRNA biomarkers and characterizing exosome drugs. One of their innovations, the hepatomiR test, is tailored for assessing liver function in cancer patients. These technological strides are anticipated to boost the adoption of miRNA technologies for precise disease diagnosis, driving market growth during the forecast period.
Consequently, the increasing prevalence of chronic diseases, such as cancer and cardiovascular disorders, combined with technological advancements in next-generation sequencing (NGS) and PCR technologies, are pivotal drivers of market growth. Nonetheless, the steep costs associated with miRNA Profiling Technologies could hinder the expansion of the microRNA biomarkers market during the forecast period.
MicroRNA Biomarkers Market Trends
The Cancer Segment is Expected to Hold a Significant Market Share in the MicroRNA Biomarkers Over the Forecast Period
MicroRNAs (miRNAs) are emerging as pivotal biomarkers for cancer detection, prognosis, and treatment response. Their ability to modulate key pathways associated with cancer progression, combined with their stability in bodily fluids, makes them prime candidates for non-invasive diagnostics and tailored medical approaches. Consequently, the pronounced role of miRNA biomarkers in cancer diagnostics and therapeutics is set to propel the segment's growth.
Factors fueling this growth include the escalating incidence of cancer, technological and research advancements, a heightened demand for early diagnosis and personalized medicine, and intensified clinical research into the role of miRNA biomarkers in oncology.
Technological strides, especially in sequencing methods like next-generation sequencing (NGS), facilitate a comprehensive analysis of miRNA expression in tumor samples. This advancement bolsters the adoption of miRNA biomarkers for cancer diagnostics and prognostics, further fueling segment growth. For instance, a July 2024 article in the Oncogene Journal highlighted miRNAs as promising early diagnostic markers for cancers like non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). The article noted their proficiency in distinguishing between pancreatitis and pancreatic cancer. Moreover, it emphasized that platforms such as Nanostring's nCounter microRNA assay and next-generation RNA sequencing (RNAseq) have outperformed the traditional gold standard, RT-qPCR, in terms of sensitivity and specificity. These cutting-edge technologies offer heightened sensitivity, reduced limits of detection (LOD), and superior multiplexing capabilities, driving market growth.
Ongoing clinical research into miRNA biomarkers further bolsters segment growth. For example, in April 2024, researchers from the American Association for Cancer Research (AACR) unveiled an exosome-based signature. This signature, combining exosomal microRNAs and cell-free DNA, adeptly pinpointed early-stage pancreatic cancer patients. When used alongside the CA 19-9 biomarker, this experimental exosome-based liquid biopsy achieved a remarkable 97% identification rate for stage 1-2 pancreatic cancer. Such findings underscore the pivotal role of miRNA biomarkers in cancer detection, further fueling segment growth.
In summary, the convergence of technological advancements and intensified research into miRNA biomarkers in oncology is poised to drive the segment's growth in the coming years.
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North America is Anticipated to Hold the Largest Share in the MicroRNA Biomarkers Over the Forecast Period
Driven by a high burden of cancer and chronic diseases, technological advancements, a growing emphasis on precision medicine, and numerous product launches, the North America microRNA biomarkers market is poised to capture a substantial share during the forecast period.
As cancer cases rise in North America, the demand for microRNA biomarkers is set to surge, propelling regional market growth. For instance, in January 2024, the American Cancer Society projected over 2 million cancer cases in the U.S., up from 1.9 million in 2023. Furthermore, data from the Canadian Cancer Society in November 2023 highlighted that 239,000 Canadians were diagnosed with cancer in 2023, with an alarming statistic that about 45% of Canadians will face a cancer diagnosis in their lifetime. These figures underscore the escalating cancer burden in North America, signaling a rising demand for microRNA biomarkers.
Market players are also driving growth through innovative product developments. For example, in August 2024, Biotech Support Group in the U.S. unveiled a nanopore sensing platform capable of detecting various microRNAs, positioning it as a potential clinical diagnostic tool. Their Cleanascite technology efficiently enhances nanopore detection of microRNAs from saliva by removing lipid interferences. In another instance, in July 2023, DiamiR Biosciences initiated a clinical study for its CogniMir blood test, which evaluates Alzheimer's disease risk, aiming to collaborate with U.S. pharmaceutical research firms. Such strategic moves by market players further bolster the growth of microRNA biomarkers in North America.
In conclusion, the North American microRNA biomarkers market is set for growth, fueled by the rising cancer burden and proactive initiatives from key market players.
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MicroRNA Biomarkers Industry Overview
The microRNA biomarkers market is characterized by fragmentation and features a multitude of key players. These companies adopt diverse strategies and initiatives to bolster the global development and production of microRNA biomarker products and services. Notable players in this arena encompass Thermo Fisher Scientific, Inc., Illumina, Inc., QIAGEN N.V., Merck KGaA, and Bio-Rad Laboratories, Inc., among others.
MicroRNA Biomarkers Market Leaders
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Thermo Fisher Scientific, Inc.
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Illumina, Inc.
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QIAGEN N.V.
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Merck KGaA
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Bio-Rad Laboratories, Inc.
- *Disclaimer: Major Players sorted in no particular order
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MicroRNA Biomarkers Market News
- May 2024: Qiagen N.V. introduced its QIAseq multimodal DNA/RNA library kit, streamlining the preparation of DNA and RNA libraries for next-generation sequencing (NGS). This includes applications like whole genome sequencing (WGS) and whole transcriptome sequencing (WTS), enabling subsequent target enrichment via hybrid-capture from a single sample.
- February 2024: Researchers at Well Bioscience used the Cyto3D live-dead assay kit to confirm the link between specific miRNAs and cell viability. The identified microRNAs, miR-1-3p and miR-26a-1-3p, show promise as strong, non-invasive biomarkers for brain cancer.
MicroRNA Biomarkers Industry Segmentation
MicroRNA (miRNA) biomarkers, known for their specificity, stability, and regulatory roles in disease pathways, are emerging as powerful instruments in advanced molecular diagnostics and personalized medicine. Their unique expression patterns across a spectrum of diseases underscore their pivotal role as biomarkers for diagnosis, prognosis, and therapeutic monitoring.
The microRNA biomarkers market is segmented by technology, application, product and service, end-user and geography. By Technology, the market is segmented into next-generation sequencing (NGS), real-time PCR (qRT-PCR), microarray and other technology. By application, the market is segmented into cancer, cardiovascular diseases, neurological disorders, autoimmune diseases, infectious diseases and other diseases. By product and service , the market is segmented into kits and reagents, instruments, software and services. By end-user, the market is segmented into pharmaceutical and biotechnology companies, academic and research institutes and other end-user. By geography, the market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. For each segment, the market size is provided in terms of USD value.
| By Technology | Next-Generation Sequencing (NGS) | ||
| Real-Time PCR (qRT-PCR) | |||
| Microarray | |||
| Other Technology (In-Situ Hybridization, RNA Interference, Fluorescence-based assays, others) | |||
| By Application | Cancer | ||
| Cardiovascular Diseases | |||
| Neurological Disorders | |||
| Autoimmune Diseases | |||
| Infectious Diseases | |||
| Other Diseases (Kidney Diseases, Metabolic Disorders, Respiratory Diseases and others) | |||
| By Product and Service | Kits and Reagents | ||
| Instruments | |||
| Software | |||
| Services (miRNA Profiling services, Data Analysis, and Interpretation services, Custom Assay Development and others) | |||
| By End-User | Pharmaceutical and Biotechnology Companies | ||
| Academic and Research Institutes | |||
| Other End-User (Clinical Laboratories, Hospitals, Clinics, Contract Research Organizations and others) | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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MicroRNA Biomarkers Market Research FAQs
How big is the MicroRNA Biomarkers Market?
The MicroRNA Biomarkers Market size is expected to reach USD 0.63 billion in 2025 and grow at a CAGR of 11.88% to reach USD 1.11 billion by 2030.
What is the current MicroRNA Biomarkers Market size?
In 2025, the MicroRNA Biomarkers Market size is expected to reach USD 0.63 billion.
Who are the key players in MicroRNA Biomarkers Market?
Thermo Fisher Scientific, Inc., Illumina, Inc., QIAGEN N.V., Merck KGaA and Bio-Rad Laboratories, Inc. are the major companies operating in the MicroRNA Biomarkers Market.
Which is the fastest growing region in MicroRNA Biomarkers Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in MicroRNA Biomarkers Market?
In 2025, the North America accounts for the largest market share in MicroRNA Biomarkers Market.
What years does this MicroRNA Biomarkers Market cover, and what was the market size in 2024?
In 2024, the MicroRNA Biomarkers Market size was estimated at USD 0.56 billion. The report covers the MicroRNA Biomarkers Market historical market size for years: 2024. The report also forecasts the MicroRNA Biomarkers Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
MicroRNA Biomarkers Industry Report
Statistics for the 2025 MicroRNA Biomarkers market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. MicroRNA Biomarkers analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
