MicroRNA Biomarker Market By Product Type (Instruments, Kits & Reagents, Software), By Technology (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Microarray Technology, Northern Blotting, Isothermal Nucleic Acid Amplification Technology (INAAT), Others), By Biomarker Type (Circulating MicroRNAs, Tissue-Derived MicroRNAs, Extracellular Vesicle-Associated miRNAs), By Application (Cancer Diagnosis & Prognosis, Neurological Disorders, Cardiovascular Diseases, Autoimmune Disorders, Infectious Diseases, Other), By End-User (Hospitals & Diagnostic Laboratories, Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, Contract Research Organizations (CROs)), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The MicroRNA Biomarker Market accounted for USD 765.8 Million in 2024 and is expected to reach USD 2770.4 Million by 2035, growing at a CAGR of around 12.4% between 2025 and 2035. The MicroRNA Biomarker Market conducts development activities related to validated and commercialized microRNA (miRNA)-based biomarkers used for diagnostic testing, disease management, and therapeutic monitoring purposes.

Small non-coding RNA molecules known as microRNAs function as emerging critical indicators that regulate gene expression to provide diagnostic and prognostic information in oncology together with neurology, cardiovascular diseases, and infectious diseases. Market expansion benefits from the improvements in high-throughput sequencing, PCR detection, and bioinformatics technology. The fast-growing demand for precise healthcare testing tools alongside advanced medicine drives the development of miRNA-based test methods. The market features three main categories of key participants including biotechnology companies along with diagnostic businesses and research organizations. The market faces three main obstacles which stem from regulatory complications and standardization inconsistencies in addition to unreliable data output. The market demonstrates growing expansion because stakeholders increase their spending to develop biomarkers alongside personalized medical solutions.

Report Scope:

Market Dynamics

Increasing cancer, cardiovascular, and neurological cases boost demand for miRNA diagnostics

The microRNA biomarker market is experiencing significant growth because cancer, cardiovascular diseases, and neurological disorders are rising in numbers. The healthcare industry requires sophisticated biomarkers that are non-invasive because the movement toward personalized medicine is becoming more common. The miRNA biomarker market enjoys expanded growth because NGS and PCR technologies have improved the precision of miRNA detection through recent technological advancements.

According to the WHO, nearly ten million people died of cancer in the year 2020, underscoring an urgent need for improved identification of diagnostics using biomarkers. AHA confirms cardiovascular diseases as the chief cause of death worldwide while, with a matured marketplace, needs advanced biomarkers like miRNAs for early detection and therapeutic planning.

miRNA's role in precision medicine and targeted therapies drives research and adoption

Precision medicine together with targeted therapies rely on microRNA (miRNA) developments which end up driving the expansion of the miRNA biomarker market. Diagnostics based on microRNA technology are receiving augmented funding from pharmaceutical enterprises to improve drug performance while reducing treatment side effects. The combination of bioinformatics with artificial intelligence systems today quickens the discovery of biomarkers in miRNA studies. The detection capabilities of next-generation sequencing (NGS) and quantitative PCR (qPCR) have improved due to recent advancements which have led to better clinical applications.

Targeted therapies represent close to 50% of cancer treatments as per the National Cancer Institute (NCI) which emphasizes the growing medical need for biomarkers such as miRNA in precision oncology. Research collaborations along with commercial developments in miRNA biomarkers will escalate due to this ongoing trend.

Advanced techniques like NGS and microarrays are expensive, limiting widespread adoption

The miRNA biomarker market faces barriers due to advanced technologies such as next-generation sequencing (NGS) and microarrays because they have prohibitive costs. Advanced testing methods demand elaborate devices as well as laboratory reagents together with expert technicians which increase implementation costs in medical facilities and research centers. Limited budgets prevent small laboratories together with healthcare facilities operating in developing nations from implementing these technologies.

Both data analysis systems and bioinformatics tools impose substantial financial strains on the existing operations. The limited affordability stops big-scale studies from proceeding while it also delays the routine use of miRNA biomarkers in diagnosis. Although institutions methodically use traditional biomarker methods in their work they delay the shift toward miRNA-based approaches. Lowering technology prices achieved through innovation along with better access will push market expansion forward.

AI-driven tools can enhance biomarker discovery, improving diagnostic accuracy.

Current microRNA (miRNA) biomarker research benefits through the application of artificial intelligence (AI) technology. Computer tools equipped with AI capabilities provide accuracy in processing large datasets which help researchers spot hidden patterns not visible through conventional approaches. Biomarker discovery becomes more effective which results in better diagnostic accuracy and enhanced treatment approaches. Machine learning algorithms enhance miRNA diagnostic models by improving their clinical performance through efficient model optimization.

The application of artificial intelligence shortens drug detection times because of it. Forecasts molecular targets for therapy which facilitates customized medical treatment. Biomarker validation processes that utilize automated data processing systems decrease costs and shorten times thus making miRNA diagnostics available to more users. AI technology developments in the future will enable broader market acceptance of miRNA research through innovation.

Pharmaceutical companies explore miRNA biomarkers for therapy response, enhancing collaborations

The pharmaceutical industry uses microRNA (miRNA) biomarkers as they develop innovative market opportunities to enhance therapy response prediction abilities. An increasing number of collaborations exist between biotech companies’ pharmaceutical manufacturers and research facilities for the incorporation of miRNA diagnostic methods into medical trials and precision medicine initiatives. Partnerships between stakeholders help speed up biomarker testing and regulatory clearance process which in turn improves the speed of innovative therapy releases to the market.

The analysis of miRNA biomarkers becomes essential for pharmaceutical companies in their attempt to build better drug resistance research capabilities through therapeutic refinement. Research and investment in miRNA-based companion diagnostics will expand because of the increasing market need for personalized medicine diagnostics.

Industry Experts Opinion

“We can detect changes in miRNAs within hours to days of an infection, before the onset of symptoms and before antibodies or the pathogen itself can be directly detected.”

• Dr. Ryan Farr, acting team lead, host response, CSIRO, Australia’s National Science Agency.

Segment Analysis

Based on the Product Type, the MicroRNA Biomarker Market has been classified into Instruments, Kits & Reagents, and Software. Currently, the Kits & Reagents are the largest segment in the MicroRNA Biomarker Market segments because they serve as critical tools for miRNA extraction, quantification, and analysis requirements in research laboratories. High demand stems from extensive use of these products within research together with diagnostic and therapeutic development. Better liquid biopsy test adoption along with improved high-throughput sequencing requires efficient and reliable kits because of rising demand. Their market significance increases because of expanding uses in neurological disorder and cancer diagnostic applications. Academic and clinical research deeply relies on these kits because of their simple operation and accurate dependable results.

Based on the Technology, the MicroRNA Biomarker Market has been classified into Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Microarray Technology, Northern Blotting, Isothermal Nucleic Acid Amplification Technology (INAAT), and Others. Currently, the Polymerase Chain Reaction (PCR) is the largest segment in the MicroRNA Biomarker Market segments. Since it offers high sensitivity alongside specific performance and economical operation.

The analysis of miRNAs through PCR detection as well as quantitative real-time PCR (qRT-PCR) takes place commonly in both research laboratories and clinical settings. Technology stands indispensable for cancer diagnostic operations and biomarker development because it delivers precise analysis of rare miRNAs. The high speed of processing combined with straightforward workflow implementation makes the technique more desirable for widespread usage. PCR technology maintains its key position in the development of miRNA biomarkers because scientists require it to detect illnesses early and deliver targeted medical treatments.

Regional Analysis

Currently, In North America, there is a surge in the MicroRNA Biomarker Market because it benefits from technological developments in molecular diagnostics and rising cancer patient numbers along with increasing interest in personalized medicine approaches. Biomarker research receives substantial investment from both pharmaceutical and biotechnology sectors throughout the U.S. and Canada because of their well-developed industries. The federal agencies including FDA and Health Canada are simplifying the approval process for advanced microRNA-based diagnostic instruments.

Market growth continues to surge because of the rising use of liquid biopsy and non-invasive diagnostic technologies primarily for oncology and neurodegenerative disease applications. Scientific institutions and biotech firms together with healthcare providers actively participate in accelerated microRNA research data alongside commercial adoption initiatives. The joint use of artificial intelligence along with bioinformatics in biomarker exploration produces better and more efficient microRNA diagnostic solutions. The microRNA biomarker market keeps North America as its foundational market segment because of ongoing clinical trials and rising demand for precision medicine.

Asia Pacific MicroRNA Biomarker Market is on rapid growth because healthcare institutions are expanding their financial commitments and doctors are dealing with more cancers alongside scientific improvements in molecular diagnostic methods. China and India together with Japan possess the leading positions in biotechnology and precision medicine driven by national support from their governments. Biomarker discovery along with validation processes gain speed because of increasing research partnerships formed by academic institutions and pharmaceutical companies working together with diagnostic firms across the region.

The market experiences continued growth because of the development of liquid biopsy and non-invasive diagnostic technologies that primarily benefit oncology assessments and neurodegenerative disease diagnosis. The market experiences rising efficiency and accuracy in biomarker analysis because artificial intelligence and bioinformatics systems are being increasingly adopted for biomarker research. The market is expanding due to increased healthcare awareness alongside a rising number of elderly people and accessible cost-efficient diagnostic solutions. The Chinese and Indian regulatory authorities have started developing quicker approval systems for novel diagnostic technology.

Competitive Landscape

The microRNA (miRNA) biomarker market continues to grow rapidly because of dual factors involving rising chronic disease cases including cancer and cardiovascular disorders and improved genomic technologies. Eighteen companies lead the miRNA biomarker market including Thermo Fisher Scientific, Illumina, and QIAGEN along with Merck KGaA, Bio-Rad Laboratories, PerkinElmer, Takara Bio, Revvity Discovery, BioGenex, GeneCopoeia, Bruker Spatial Biology, Quantabio and SeqMatic, OriGene Technologies and Phalanx Biotech Group. The company focuses its efforts on miRNA-based innovation because it aims to respond to the expanding market need for personalized medicine outcomes and early disease detection. 

The miRNA biomarker industry is experiencing rapid progression through recent developments within this field. DiamiR Biosciences has created CogniMir which detects miRNA biomarkers in blood to evaluate Alzheimer's risk and plans to introduce it commercially. The miSignal Series from Craif depends on urinary miRNA to identify cancer at an early stage. Industrial leaders maintain their dedication to using miRNA technologies to create better diagnostics and therapeutic options through their current research developments.

MicroRNA Biomarker Market, Company Shares Analysis, 2024

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Recent Developments:

• In November 2023, to assist clients in the biopharma and food safety industries in increasing their use, QIAGEN unveiled new QIAcuity digital PCR kits and enhanced software.
• In October 2023, to broaden its life sciences portfolio, which supports drug discovery, Thermo Fisher Scientific intended to invest USD 3.1 Million to purchase Olink Holding AB.

Report Coverage:

By Product Type

• Instruments
• Kits & Reagents
• Softwares

By Technology

• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Microarray Technology
• Northern Blotting
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Others

By Biomarker Type

• Circulating MicroRNAs
• Tissue-Derived MicroRNAs
• Extracellular Vesicle-Associated miRNAs

By Application

• Cancer Diagnosis & Prognosis
• Neurological Disorders
• Cardiovascular Diseases
• Autoimmune Disorders
• Infectious Diseases
• Other

By End-User

• Hospitals & Diagnostic Laboratories
• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutes

• Contract Research Organizations (CROs)

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Thermo Fisher Scientific, Inc.
• Illumina, Inc.
• QIAGEN
• Merck KGaA
• Bio-Rad Laboratories, Inc.
• PerkinElmer
• Takara Bio Inc.
• Revvity Discovery Limited
• BioGenex
• GeneCopoeia, Inc.
• Bruker Spatial Biology, Inc.
• Quantabio
• SeqMatic LLC
• OriGene Technologies, Inc.
• Phalanx Biotech Group

Frequently Asked Questions (FAQs)