miRNA Sequencing And Assay Market Size Report, 2024-2033
The global miRNA sequencing and assay market size was exhibited at USD 305.50 million in 2023 and is projected to hit around USD 1,112.84 million by 2033, growing at a CAGR of 13.8% during the forecast period 2024 to 2033.
The microRNA (miRNA) sequencing and assay market represents a pivotal segment in modern molecular biology and precision medicine. MicroRNAs are small, non-coding RNA molecules that play vital roles in post-transcriptional gene regulation. Their dysregulation is linked to numerous diseases, including cancers, autoimmune disorders, and neurological conditions, making them invaluable as diagnostic biomarkers and therapeutic targets.
miRNA sequencing and assay technologies have revolutionized biomedical research by enabling the high-throughput, quantitative, and qualitative analysis of these regulatory molecules. Next-generation sequencing (NGS) has further enhanced the resolution and scalability of miRNA detection, enabling the discovery of novel miRNAs and providing insights into complex gene regulatory networks.
The market encompasses a wide array of products and services, including library preparation kits, sequencing reagents, instruments, and data analysis platforms, as well as sequencing and analysis services provided by specialized vendors. With applications spanning oncology, neuroscience, autoimmune disorders, and rare diseases, miRNA sequencing is increasingly integrated into translational research, diagnostics, and drug development pipelines.
As the scientific community deepens its understanding of non-coding RNAs, miRNA sequencing is becoming a key tool in systems biology, epigenetics, and clinical decision-making. Fueled by technological advancements, falling sequencing costs, and the push for personalized medicine, the global miRNA sequencing and assay market is poised for robust and sustained growth.
Integration of Artificial Intelligence and Bioinformatics
AI-driven platforms are being used to interpret miRNA datasets, predict interactions, and uncover disease-specific regulatory patterns.
Expansion into Liquid Biopsy Applications
miRNAs found in circulating blood and biofluids are being explored for non-invasive cancer and disease diagnostics.
Commercialization of Point-of-Care miRNA Assays
Miniaturized, rapid miRNA detection kits are being developed for clinical applications, including infection detection and cancer risk assessment.
Rise of Multi-Omics Approaches
miRNA sequencing is increasingly combined with mRNA, DNA methylation, and proteomics data to deliver integrated biomarker panels.
Advancements in Single-Molecule and Long-Read Sequencing
Techniques such as nanopore and SMRT sequencing are improving miRNA detection accuracy and quantification in challenging biological matrices.
| Report Coverage | Details |
| Market Size in 2024 | USD 347.66 Million |
| Market Size by 2033 | USD 1,112.84 Million |
| Growth Rate From 2024 to 2033 | CAGR of 13.8% |
| Base Year | 2023 |
| Forecast Period | 2024-2033 |
| Segments Covered | Product & Service, Technology, Workflow, Application, End-use, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional Scope | North America; Europe; Asia Pacific; Central and South America; the Middle East and Africa |
| Key Companies Profiled | Thermo Fisher Scientific, Inc.; Illumina, Inc.; QIAGEN; PerkinElmer, Inc.; Abcam plc; New England Biolabs; Takara Bio Inc.; Lexogen GmbH; Norgen Biotek Corp.; Maravai LifeSciences; HTG Molecular Diagnostics, Inc.; Meridian Bioscience, Inc.; System Biosciences, LLC |
One of the strongest drivers of the miRNA sequencing and assay market is the surging demand for non-invasive and highly specific cancer biomarkers. miRNAs are remarkably stable in blood, saliva, urine, and other body fluids, making them ideal candidates for liquid biopsy-based diagnostics.
Cancer types such as breast, lung, prostate, and colorectal have distinct miRNA expression signatures that correlate with tumor grade, progression, and therapeutic response. Researchers and diagnostic companies are leveraging miRNA sequencing to discover and validate biomarkers for early detection, prognosis, and treatment stratification.
For example, a set of circulating miRNAs has been shown to differentiate between benign and malignant breast tumors with high sensitivity. These capabilities make miRNA assays invaluable in screening populations, monitoring minimal residual disease, and guiding immunotherapy decisions catalyzing market demand across clinical and translational research sectors.
Despite promising potential, the miRNA sequencing market faces a major restraint in the lack of standardized data analysis and interpretation frameworks. miRNAs are small in size and highly conserved, often leading to ambiguous alignments during sequencing. Furthermore, their expression is context-dependent and influenced by numerous environmental, genetic, and cellular factors.
Data generated from miRNA sequencing is voluminous, requiring advanced bioinformatics tools for quality filtering, normalization, differential expression analysis, and pathway enrichment. Currently, researchers often rely on custom-built scripts or fragmented software solutions, which may introduce variability and hinder reproducibility.
The absence of universal guidelines for miRNA sequencing workflows particularly in clinical environments limits the translation of discoveries into validated, regulatory-compliant diagnostic assays. This gap between bench and bedside represents a bottleneck for wider market adoption, particularly in the diagnostic segment.
The miRNA sequencing and assay market is uniquely positioned to benefit from the global shift toward precision medicine and companion diagnostics. As oncology and rare disease treatments become increasingly individualized, there is a critical need for molecular profiling tools that provide real-time insights into patient-specific biology.
miRNAs regulate gene networks associated with drug response, resistance mechanisms, and disease relapse. Their expression profiles can indicate whether a patient will benefit from certain chemotherapies, targeted therapies, or immune checkpoint inhibitors. This has catalyzed interest in developing miRNA-based companion diagnostics to guide therapeutic decisions.
Furthermore, miRNA profiles can serve as predictive markers in clinical trials, allowing for patient stratification and enhanced drug efficacy assessments. Pharmaceutical companies and CROs are exploring miRNA panels as surrogate endpoints in oncology, neurology, and inflammatory disease trials, making this a key area for strategic growth.
Products account for the largest share of the market, with library preparation kits and sequencing consumables leading the category. These kits are essential for converting RNA samples into sequence-ready libraries. Advances in automation, low-input protocols, and compatibility with degraded or FFPE samples have widened their utility in both basic and clinical research.
Sequencing consumables, including flow cells, reagents, and adapters, are consumed in high volumes, especially in high-throughput environments such as genomics core facilities and pharmaceutical R&D labs. The increasing number of miRNA-focused research projects ensures sustained demand for consumables across global institutions.
The services segment is the fastest growing due to rising demand for outsourcing miRNA sequencing and analysis. Many research groups, hospitals, and biotechs lack in-house NGS capabilities or bioinformatics infrastructure and prefer to rely on specialized providers for end-to-end sequencing and interpretation.
Companies offering comprehensive miRNA profiling including sample prep, NGS, and pathway analysis are expanding their service portfolios to cover applications in disease modeling, diagnostics, and therapeutic monitoring. The rise of subscription-based and cloud-integrated sequencing services also contributes to the segment’s rapid growth.
Cancer is the dominant application segment, as miRNAs are deeply involved in tumor initiation, progression, metastasis, and drug resistance. They serve as both oncogenes and tumor suppressors, making their profiling essential in early detection and therapeutic development.
Numerous studies have identified cancer-specific miRNA signatures in breast, lung, liver, colorectal, and prostate cancers. Clinical applications now include prognosis, recurrence monitoring, and prediction of therapeutic response, reinforcing cancer as the anchor segment for miRNA assays.
Autoimmune diseases are the fastest growing segment due to increasing evidence linking miRNA dysregulation with immune cell function and inflammatory signaling. Conditions such as rheumatoid arthritis, lupus, and multiple sclerosis exhibit distinct miRNA expression patterns that can guide diagnosis and treatment selection.
As biologics and immune-modulating therapies become more common, miRNA sequencing is used to assess treatment response, disease activity, and patient stratification. The need for non-invasive monitoring tools in chronic immune conditions is expected to drive adoption rapidly.
Library preparation dominates the workflow segment as it is the foundational step for miRNA sequencing. Efficient, bias-free preparation is critical for ensuring accurate quantification and isoform representation. Innovations such as multiplexed adapters, barcoded indices, and enzyme optimization have improved throughput and reproducibility.
Manufacturers offer ready-to-use library prep kits tailored for clinical samples, small inputs, and degraded RNA, reinforcing the demand for this segment. Labs focused on high-quality data generation consistently invest in proprietary and third-party preparation technologies.
Data analysis and storage represent the fastest growing workflow segment due to the complexity of miRNA datasets and the need for long-term data archiving. With growing interest in large-scale miRNA projects, bioinformatics platforms offering alignment, expression profiling, and target prediction are in high demand.
AI-enhanced tools capable of contextualizing miRNA data with transcriptomics, proteomics, and epigenetic data are transforming data analysis into a high-value component of the workflow. Secure, compliant storage systems that enable remote access and collaborative analysis also contribute to growth in this area.
Sequencing by Synthesis (SBS) remains the dominant technology in miRNA sequencing due to its high throughput, accuracy, and cost-efficiency. It is well-suited for detecting miRNAs and their isoforms, identifying novel sequences, and performing quantitative expression analysis across samples.
SBS platforms have evolved to accommodate low-input RNA and degraded tissue samples, expanding their role in clinical and FFPE-based studies. Widespread adoption of SBS in academic research and pharmaceutical pipelines has anchored this technology at the center of the market.
Nanopore sequencing is gaining rapid traction as it enables real-time, long-read sequencing of small RNA molecules without the need for amplification or labeling. It is particularly useful for detecting post-transcriptional modifications and novel miRNA isoforms that are often missed by other technologies.
As nanopore devices become more compact, cost-effective, and user-friendly, their deployment is increasing in both field-based diagnostics and decentralized labs. The flexibility of direct RNA sequencing positions this technology as a disruptor in both academic and clinical applications.
Based on end use, the market is segmented into the pharmaceutical & biotechnology industry, research and academic institutes, and others. The research and academic institutes segment dominated the market and accounted for the largest revenue share of over 51% in 2023. miRNA sequencing techniques and products are widely used in several research and academic institutes' research studies. Therefore, many research studies are expected to drive the market for miRNA sequencing and assay products. For instance, in June 2020, researchers from the Indian Institute of Technology Madras discovered an over-expressed specific miRNA called 'miR-155' in tongue cancer.
The pharmaceutical and biotechnology industries segment is expected to grow significantly during the forecast period. These industries deal with extensive research to develop therapeutics for several diseases. Major factors that drive the segment include an increase in R&D funding, the high adoption rate of high throughput sequencing technologies with advanced features, and a rise in the number of comparative and evolutionary genomic studies in the research and development department. Biopharmaceutical companies are increasingly searching for new therapeutic molecules that can act as new drugs, further driving the market for microRNA. Several miRNA-based candidates are under clinical trials, such as anti-miR compounds and specific inhibitors for miRNAs, which can act as potential therapeutic solutions. Hence, RNA therapeutics is considered a trending investment area that will lead to the development of profitable drugs.
North America dominates the miRNA sequencing and assay market due to its high R&D expenditure, advanced healthcare infrastructure, and strong presence of genomics companies. The U.S. is home to major players in sequencing technology, reagent manufacturing, and bioinformatics.
Academic centers, pharma giants, and federal research agencies regularly invest in miRNA-based projects for oncology, aging, and mental health. Regulatory support for biomarker-driven diagnostics and rising adoption of NGS in hospitals also reinforce the region’s leadership.
Asia-Pacific is the fastest-growing region, with countries like China, India, Japan, and South Korea investing in biotechnology, genomics, and personalized medicine. Rapid industrialization, increasing clinical trials, and growing academic collaborations are catalyzing demand for miRNA technologies.
National genomics initiatives, such as China’s Precision Medicine Strategy and India’s Genome Sequencing Program, support infrastructure development for miRNA research. Competitive pricing and localized manufacturing are further enhancing accessibility.
February 2025 – A U.S.-based genomics firm launched a real-time, nanopore-based miRNA sequencing platform targeting the cancer diagnostics market.
March 2025 – A leading European biotech received CE-IVD approval for its miRNA-based liquid biopsy test designed for early colorectal cancer detection.
January 2025 – A Japanese pharmaceutical company partnered with a sequencing startup to co-develop a miRNA companion diagnostic for immune checkpoint therapy in lung cancer.
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the global miRNA sequencing and assay market.
Product & Service
Technology
Workflow
Application
End-use
By Region
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
(Upto 5 With No Cost)
Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers