MicroRNA market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product & Service (Products, Consumables, Services), By Application (Cancer, Infectious Diseases, Immunological Disorder, Cardiovascular Disease, Neurological Disease, Others), By End User (Biotechnology & Pharmaceutical Companies, Academic & Government Research Institutes, Other end users), By Region, and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.72 Billion
CAGR (2026-2031)	11.13%
Fastest Growing Segment	Services
Largest Market	North America
Market Size (2031)	USD 3.24 Billion

Market Overview

The Global MicroRNA market will grow from USD 1.72 Billion in 2025 to USD 3.24 Billion by 2031 at a 11.13% CAGR. MicroRNAs function as small non-coding RNA molecules that play a critical role in regulating gene expression by targeting messenger RNA for degradation or translational repression. The global market for these molecules is primarily driven by the escalating prevalence of chronic diseases and the substantial demand for precision biomarkers in early diagnosis. This trajectory is further supported by the integration of genomic technologies into clinical workflows which enables more accurate disease profiling. To illustrate the urgency propelling this sector, according to the American Cancer Society, in 2024, a total of 2,001,140 new cancer cases were projected to occur in the United States. This high incidence rate underscores the necessity for the advanced diagnostic capabilities that microRNA analysis provides.

A significant challenge impeding market expansion involves the lack of standardization in sample preparation and detection protocols. The inherent instability of RNA combined with technical variability across different assay platforms leads to issues with data reproducibility which complicates the regulatory validation required for widespread clinical adoption.

Key Market Drivers

The rising global prevalence of cancer and chronic diseases serves as a primary catalyst for the Global MicroRNA market, necessitating advanced diagnostic tools for early detection and disease management. MicroRNAs are increasingly recognized for their stability in biofluids and their specific expression patterns in pathological conditions, making them ideal candidates for liquid biopsy applications. This demand is intensified by the growing burden of malignancies; for instance, according to the World Health Organization, in February 2024, lung cancer remained the most commonly occurring cancer worldwide with approximately 2.5 million new cases. Such high incidence rates drive the urgent adoption of microRNA profiling to unravel complex disease mechanisms and facilitate timely therapeutic interventions.

Concurrently, strategic partnerships and accelerating clinical development are fundamentally reshaping the market landscape by validating microRNA-based therapeutic modalities. Pharmaceutical entities are actively investing in high-potential assets to expand their cardiovascular and metabolic portfolios through acquisitions and collaborative agreements. A notable example of this trend occurred when, according to Novo Nordisk, in March 2024, the company agreed to acquire Cardior Pharmaceuticals for up to 1.025 billion Euros to obtain its lead RNA-targeting compound for heart failure. This influx of capital and industrial expertise is paralleled by significant clinical milestones, as demonstrated when, according to Regulus Therapeutics, in March 2024, positive topline data from the second cohort of patients in its Phase 1b trial for RGLS8429 showed clear improvements in key biomarkers for kidney disease. These developments collectively underscore the market's progression from experimental research to commercially viable therapeutic solutions.

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Key Market Challenges

The primary obstacle restricting the Global MicroRNA market is the critical lack of standardization in sample preparation and detection protocols. Because RNA is inherently unstable, even minor deviations in handling or isolation techniques can result in significant data discrepancies between laboratories. This technical inconsistency creates a reliability gap, as biomarker profiles identified in one study often fail to replicate in another. Consequently, this inability to produce reproducible data complicates the validation process required by regulatory bodies, thereby delaying the approval and commercialization of new microRNA-based diagnostic tools.

The impact of this variability is substantial within the clinical workflow. When assays lack uniformity, they cannot be reliably scaled for widespread medical use, which directly suppresses market confidence and adoption rates. This issue is quantitatively highlighted by industry analysis regarding laboratory precision. According to the Association for Diagnostics & Laboratory Medicine, in 2024, preanalytical errors accounted for approximately 43% to 75% of all laboratory errors. Such high error rates in the foundational stages of testing underscore why regulatory agencies remain hesitant to approve microRNA diagnostics, ultimately stalling the sector’s revenue growth.

Key Market Trends

The integration of Artificial Intelligence for MicroRNA pattern analysis is fundamentally shifting the sector by resolving complex structural prediction challenges that previously hindered biomarker discovery. Advanced deep learning models are now capable of modeling the intricate three-dimensional interactions between RNA molecules and cellular targets with high precision, thereby accelerating the identification of viable therapeutic candidates. A major advancement in this domain was established when, according to Google DeepMind, in May 2024, the company released AlphaFold 3, which predicts the interactions of proteins with DNA and RNA with at least a 50% improvement in accuracy compared to existing methods. This leap in computational capability allows researchers to map microRNA regulatory networks more effectively, significantly reducing the time required for early-stage target validation.

Simultaneously, innovation in Lipid Nanoparticle and GalNAc delivery systems is addressing the critical bottleneck of delivering RNA payloads to extra-hepatic tissues. While earlier carriers were predominantly limited to liver accumulation, next-generation platforms are being engineered with selective organ targeting capabilities to reach organs such as the lungs and spleen. This technical evolution is actively supported by targeted investments; for instance, according to ReCode Therapeutics, in November 2024, the Cystic Fibrosis Foundation agreed to invest up to $15 million to support the company's development of tissue-specific lipid nanoparticles for gene correction in lung cells. Such advancements in delivery architecture are essential for expanding the clinical utility of microRNA therapeutics beyond metabolic disorders into respiratory and systemic conditions.

Segmental Insights

Based on recent market research, the Services segment is identified as the fastest-growing category within the Global MicroRNA market. This expansion is primarily driven by the increasing preference among biotechnology companies and academic institutions to outsource complex genomic analysis. conducting microRNA isolation, purification, and sequencing requires specialized technical expertise and substantial investment in high-throughput infrastructure. Consequently, organizations are partnering with Contract Research Organizations (CROs) to leverage their established proficiency and validated workflows. This strategic outsourcing model allows entities to ensure precise, regulatory-compliant data generation while eliminating the operational burden of maintaining internal sequencing facilities.

Regional Insights

North America holds a dominant position in the global microRNA market due to substantial investments in genomic research and a high concentration of established biotechnology companies. This leadership is supported by significant funding for life sciences from federal organizations such as the National Institutes of Health, which drives continuous innovation in disease diagnostics and therapeutics. Additionally, the region benefits from a well-structured regulatory environment under the US Food and Drug Administration that facilitates clinical trials and product approvals. These factors collectively create a favorable ecosystem for the rapid development and commercialization of microRNA technologies.

Recent Developments

• In October 2025, Mirxes received approval from Chinese regulatory authorities to launch its flagship stomach cancer screening test, GASTROClear, in the mainland China market. This non-invasive blood-based diagnostic test utilizes microRNA technology to detect gastric cancer biomarkers at early stages. The regulatory clearance represented a major commercial breakthrough, allowing the company to access a substantial patient population in a region known for high gastric cancer incidence. The approval underscored the growing acceptance and clinical utility of microRNA biomarkers in oncology diagnostics and expanded the company's commercial footprint significantly in the Asian market.
• In March 2025, Regulus Therapeutics announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. This investigational microRNA inhibitor was specifically designed to target miR-17 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The reported data indicated that the therapeutic was well-tolerated and demonstrated a mechanistic dose response, as evidenced by consistent changes in urinary biomarkers and kidney volume measurements. These positive results supported the company’s plan to progress the candidate into late-stage clinical development, marking a significant milestone in microRNA-targeted drug discovery for genetic kidney disorders.
• In October 2024, Resalis Therapeutics secured a strategic equity investment from Sanofi to accelerate the global development of its lead therapeutic program, RES-010. This drug candidate is an antisense oligonucleotide designed to target microRNA-22 (miR-22), which serves as a key regulator of lipid metabolism and energy expenditure in the body. The funding was intended to support the advancement of the drug through necessary clinical trials for metabolic disorders, including obesity and non-alcoholic fatty liver disease. This financial backing served to validate the company's approach to modulating microRNA pathways as a viable treatment strategy for complex metabolic conditions.
• In January 2024, TransCode Therapeutics announced a strategic collaboration with Debiopharm to advance the development of targeted nucleic acid therapeutics for cancer treatment. This partnership was established to evaluate the efficacy of combining TransCode’s proprietary delivery platform with Debiopharm’s specialized technologies. The joint effort aimed to overcome longstanding technical challenges associated with delivering RNA-based therapies effectively to tumor cells. The collaboration specifically focused on utilizing microRNA-targeted technology to address metastatic diseases, highlighting a significant step in the companies' shared commitment to expanding the clinical potential of RNA therapeutics within the global oncology sector.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Horizon Discovery Ltd.
• OriGene Technologies, Inc.
• QIAGEN
• GeneCopoeia, Inc.
• Merck KGaA
• Miltenyi Biotec
• Sistemic Scotland Limited
• SeqMatic LLC
• Biodynamics Laboratory Inc.

By Product & Service	By Application	By End User	By Region
Products Consumables Services	Cancer Infectious Diseases Immunological Disorder Cardiovascular Disease Neurological Disease Others	Biotechnology & Pharmaceutical Companies Academic & Government Research Institutes Other end users	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global MicroRNA market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• MicroRNA market , By Product & Service:

• Products
• Consumables
• Services

• MicroRNA market , By Application:

• Cancer
• Infectious Diseases
• Immunological Disorder
• Cardiovascular Disease
• Neurological Disease
• Others

• MicroRNA market , By End User:

• Biotechnology & Pharmaceutical Companies
• Academic & Government Research Institutes
• Other end users

• MicroRNA 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