MiRNA Sequencing and Assay Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (Sequencing by Synthesis, Sequencing by Oligonucleotide Ligation and Detection (SOLiD), Nanopore Sequencing, Sanger Sequencing, Single Molecule Real-time (SMRT) Sequencing), By Application (Cancer, Polyglutamine Diseases, Autoimmune Disease, Schizophrenia, Others), By End-use (Pharmaceutical & Biotechnology Industry, Research and Academic Institutes, Others), By Workflow (Library Preparation, Sequencing, Data Analysis & Storage), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 24.26 Billion
CAGR (2026-2031)	6.58%
Fastest Growing Segment	Sequencing By Synthesis
Largest Market	North America
Market Size (2031)	USD 35.56 Billion

Market Overview

The Global MiRNA Sequencing and Assay Market will grow from USD 24.26 Billion in 2025 to USD 35.56 Billion by 2031 at a 6.58% CAGR. MiRNA sequencing and assays encompass genomic technologies designed to detect and quantify small non-coding RNA molecules responsible for regulating gene expression. The market trajectory is primarily supported by the rising prevalence of chronic conditions such as cancer which necessitates advanced biomarker discovery tools for early diagnosis and patient stratification. Furthermore, the expansion of precision medicine initiatives and increased funding for genomic research provide substantial momentum for sectoral growth.

Despite these favorable conditions, the sector faces hurdles regarding the standardization of analytical protocols which complicates data reproducibility across different platforms. This technical variability presents a significant challenge to widespread clinical adoption and regulatory approval. Underscoring the urgent demand for such diagnostic capabilities, according to the American Cancer Society, in 2024, approximately 2,001,140 new cancer cases were projected to occur in the United States.

Key Market Drivers

The expansion of the Global MiRNA Sequencing and Assay Market is largely propelled by the rising global prevalence of cancer and chronic diseases. As the burden of these conditions intensifies, there is a critical need for non-invasive biomarkers that facilitate early detection and patient monitoring. MiRNAs, due to their stability in biological fluids, are increasingly utilized in these diagnostic workflows to improve clinical outcomes. Highlighting this escalating demand, according to the World Health Organization's International Agency for Research on Cancer, February 2024, in the 'Global cancer burden growing' press release, the agency predicted that over 35 million new cancer cases will occur in 2050, representing a 77% increase from 2022 levels. This projected growth underscores the necessity for scalable sequencing solutions capable of handling high-volume diagnostic screening for complex pathologies.

Concurrently, a surge in public and private funding for genomic research is accelerating the development of liquid biopsy-based diagnostics. This influx of capital enables biotechnology firms to refine assay sensitivity and validate clinical utility, thereby reducing barriers to market entry. For instance, according to Freenome, February 2024, in the 'Freenome Raises $254 Million to Advance Early Cancer Detection' announcement, the company secured $254 million to extend the reach of its screening platform. Such financial injections directly support the R&D required to commercialize complex miRNA-based tests. Furthermore, technological scalability remains a pivotal component of this ecosystem; according to Illumina, in 2024, the company reported shipping 352 NovaSeq X instruments during the prior fiscal year, indicating a robust industrial capacity to support the increasing throughput demands of modern genomic assays.

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Key Market Challenges

The lack of standardized analytical protocols constitutes a significant barrier to the progression of the global miRNA sequencing and assay market. Because different laboratories utilize varying workflows, extraction methods, and sequencing platforms, the resulting data often lacks consistency. This technical variability makes it difficult to reproduce results, which is a fundamental requirement for clinical acceptance. Without a unified framework for analysis, stakeholders struggle to compare findings across different studies effectively, leading to substantial hesitation among healthcare providers regarding the adoption of these assays for routine patient care.

This fragmentation directly impacts regulatory outcomes and commercial viability. Regulatory bodies require robust evidence of analytical validity, and inconsistent data significantly delays the approval process for new diagnostic tools. This bottleneck restricts the availability of reliable tests needed to support modern therapeutic approaches. Underscoring the critical need for reliable diagnostics to support the industry, according to the Personalized Medicine Coalition, in 2024, it was reported that personalized medicines accounted for 35 percent of all new drug approvals in 2023. The inability to standardize testing for such therapies limits the revenue potential and hampers the overall expansion of the miRNA sequencing landscape.

Key Market Trends

The integration of artificial intelligence for miRNA biomarker discovery is fundamentally reshaping the market by enabling the rapid identification of complex disease signatures that evade traditional analytical methods. Advanced algorithms are now capable of processing vast multi-omics datasets to predict miRNA targets with high precision, thereby accelerating the development of diagnostic panels. This technological shift is actively supported by major computing firms providing the necessary infrastructure for genomic analysis. For instance, according to NVIDIA, March 2024, in the 'NVIDIA Healthcare Launches Generative AI Microservices to Advance Drug Discovery, MedTech and Digital Health' press release, the company introduced over two dozen new microservices designed to deploy generative AI models across healthcare enterprises. These tools allow researchers to efficiently analyze genomic data and significantly reduce the time required to validate potential miRNA candidates for clinical applications.

Concurrently, the increasing adoption of single-cell miRNA sequencing is driving market expansion by resolving cellular heterogeneity that bulk sequencing often obscures. This granular approach is particularly vital in oncology where understanding the specific miRNA profiles of distinct cell populations within a tumor microenvironment is essential for developing targeted therapies. Manufacturers are facilitating this shift by releasing cost-effective platforms that lower the financial barriers to entry for large-scale studies. Highlighting this trend, according to 10x Genomics, October 2024, in the '10x Genomics Reports Third Quarter 2024 Financial Results' announcement, the company confirmed the shipping of its GEM-X Flex and Universal Multiplex assays which enable researchers to run millions of cells for less than one cent per cell. Such innovations in assay economy are critical for transitioning single-cell profiling from niche academic research to broader clinical utility.

Segmental Insights

Sequencing By Synthesis represents the fastest-growing segment within the Global MiRNA Sequencing and Assay Market, primarily due to its high throughput capabilities and precision in detecting both known and novel biomarkers. This technology is increasingly utilized by research institutions and pharmaceutical companies because it allows for the comprehensive analysis of microRNA without relying on pre-designed probes. The segment growth is further accelerated by the cost-effectiveness of large-scale sequencing projects and the rising demand for reliable genomic data in precision medicine. Consequently, this method remains the preferred choice for detailed transcriptomic profiling.

Regional Insights

North America maintains a dominant position in the global miRNA sequencing and assay market, driven by robust infrastructure for genomic research and significant healthcare investments. The region benefits from substantial funding for biomarker studies from organizations like the National Institutes of Health, which accelerates the development of precision medicine tools. Additionally, the increasing prevalence of cancer and chronic disorders heightens the demand for early diagnostic solutions. Supportive policies from the US Food and Drug Administration further streamline product approvals, ensuring a steady expansion of the regional sector.

Recent Developments

• In February 2025, Bio-Rad Laboratories announced that it had submitted a binding offer to acquire Stilla Technologies, a France-based developer of high-multiplex digital PCR solutions. This proposed acquisition was designed to complement Bio-Rad’s existing droplet digital PCR portfolio by incorporating Stilla’s Crystal Digital PCR technology, which allows for advanced multiplexing and sensitivity. Digital PCR is a critical technology in the microRNA market, enabling the absolute quantification of nucleic acids without the need for standard curves. The move signaled a consolidation in the industry, aiming to provide a more comprehensive suite of advanced genomic analysis tools to researchers globally.
• In September 2024, Qiagen announced the launch of over 100 new validated assays for its QIAcuity digital PCR platform, significantly expanding its GeneGlobe content menu. These new offerings included specific assays for microRNAs, as well as targets related to cancer research and inherited genetic disorders. The launch aimed to provide researchers with precise, absolute quantification tools necessary for detecting low-abundance microRNA targets in complex biological samples. The Senior Vice President of Qiagen’s Life Sciences Business Area highlighted that this expansion addressed the urgent customer need for multiplexed and sensitive detection capabilities in both pharmaceutical development and academic research settings.
• In August 2024, DiamiR Biosciences announced that the European Patent Office had granted a new patent covering its proprietary methods for using microRNAs as diagnostic biomarkers. The patent, titled "Methods of using miRNAs from bodily fluids for detection and differentiation of neurodegenerative diseases," specifically addressed the diagnosis of amyotrophic lateral sclerosis (ALS). This intellectual property milestone validated the company’s approach to analyzing organ-enriched microRNA signatures in plasma for non-invasive disease monitoring. The Chief Scientific Officer of DiamiR stated that this approval strengthened their global portfolio, supporting the development of tests for early detection and progression monitoring of brain health conditions.
• In May 2024, Bruker Corporation completed the acquisition of substantially all assets of NanoString Technologies for approximately $392.6 million in cash. This strategic transaction integrated NanoString’s established nCounter, GeoMx, CosMx, and AtoMx product lines into Bruker’s Spatial Biology business. The nCounter analysis system is a prominent platform in the Global MiRNA Sequencing and Assay Market, widely recognized for its ability to profile hundreds of microRNAs simultaneously without amplification. The acquisition ensured the continued availability of these critical research tools, with the President and CEO of Bruker noting that the move would accelerate their leadership in the post-genomic era and spatial biology sectors.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Illumina, Inc.
• QIAGEN N.V.
• PerkinElmer, Inc.
• Abcam plc
• New England Biolabs, Inc.
• Takara Bio USA Inc.
• Lexogen GmbH
• Norgen Biotek Corp.
• Maravai LifeSciences Holdings, Inc

By Technology	By Application	By End-use	By Workflow	By Region
Sequencing by Synthesis Sequencing by Oligonucleotide Ligation and Detection (SOLiD) Nanopore Sequencing Sanger Sequencing Single Molecule Real-time (SMRT) Sequencing	Cancer Polyglutamine Diseases Autoimmune Disease Schizophrenia Others	Pharmaceutical & Biotechnology Industry Research and Academic Institutes Others	Library Preparation Sequencing Data Analysis & Storage	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global MiRNA Sequencing and Assay Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• MiRNA Sequencing and Assay Market, By Technology:

• Sequencing by Synthesis
• Sequencing by Oligonucleotide Ligation and Detection (SOLiD)
• Nanopore Sequencing
• Sanger Sequencing
• Single Molecule Real-time (SMRT) Sequencing

• MiRNA Sequencing and Assay Market, By Application:

• Cancer
• Polyglutamine Diseases
• Autoimmune Disease
• Schizophrenia
• Others

• MiRNA Sequencing and Assay Market, By End-use:

• Pharmaceutical & Biotechnology Industry
• Research and Academic Institutes
• Others

• MiRNA Sequencing and Assay Market, By Workflow:

• Library Preparation
• Sequencing
• Data Analysis & Storage

• MiRNA Sequencing and Assay Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE