miRNA Sequencing and Assay Market By Product Type (Product (Library Preparation Kits, Sequencing Consumables, Instruments) and Service), By Technology (Sequencing by Synthesis, Single Molecule Real-time Sequencing, Sequencing by Oligonucleotide Ligation and Detection, Sanger Sequencing, and Nanopore Sequencing), By Application (Cancer, Schizophrenia, Polyglutamine Diseases, Autoimmune Disease, and Others), By Workflow (Sequencing, Library Preparation, Data Analysis & Storage), By End-user (Research and Academic Institutes, Pharmaceutical & Biotechnology Industry, and Others), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2025-2034

Report Overview

The miRNA Sequencing and Assay Market Size is expected to be worth around US$ 1.4 billion by 2034 from US$ 0.4 billion in 2024, growing at a CAGR of 13.4% during the forecast period 2025 to 2034.

Increasing interest in personalized medicine and advancements in genomic research are driving the growth of the miRNA sequencing and assay market. miRNA (microRNA) plays a pivotal role in regulating gene expression and is increasingly recognized for its potential in disease diagnosis, prognosis, and treatment monitoring. The growing applications of miRNA assays span across oncology, cardiovascular, metabolic diseases, and infectious conditions, fueling demand for efficient sequencing technologies and high-quality assays.

In October 2021, MiRXES Pte Ltd. broadened its portfolio by introducing new PCR-based diagnostic tests for early-stage detection of cardiovascular, metabolic, infectious, and cancerous conditions. This move highlights the growing focus on developing assays that provide sensitive, non-invasive, and rapid detection of diseases. With increasing research into biomarker discovery, miRNA sequencing is becoming integral to the early detection of various cancers, such as breast, liver, colorectal, and ovarian cancers.

Furthermore, the market is experiencing opportunities due to advancements in sequencing technologies and the growing emphasis on precision medicine. With expanding applications and technological innovations, the miRNA sequencing and assay market continues to evolve, offering significant potential for early disease detection and personalized therapeutic strategies.

Key Takeaways

• In 2024, the market for miRNA sequencing and assay generated a revenue of US$ 0.4 billion, with a CAGR of 13.4%, and is expected to reach US$ 1.4 billion by the year 2033.
• The product type segment is divided into product and service, with service taking the lead in 2024with a market share of 58.4%.
• Considering technology, the market is divided into sequencing by synthesis, single molecule real-time sequencing, sequencing by oligonucleotide ligation and detection, sanger sequencing, and nanopore sequencing. Among these, sequencing by synthesis held a significant share of 45.3%.
• Furthermore, concerning the application segment, the market is segregated into cancer, schizophrenia, polyglutamine diseases, autoimmune disease, and others. The polyglutamine diseases sector stands out as the dominant player, holding the largest revenue share of 46.2% in the miRNA sequencing and assay market.
• The workflow segment is segregated into sequencing, library preparation, data analysis & storage, with the sequencing segment leading the market, holding a revenue share of 49.1%.
• Considering end-user, the market is divided into research and academic institutes, pharmaceutical & biotechnology industry, and oth. Among these, research and academic institutes held a significant share of 54.7%.
• North America led the market by securing a market share of 40.7% in 2024.

Product Type Analysis

The service segment led in 2024, claiming a market share of 58.4% as researchers and healthcare providers increasingly seek comprehensive solutions for miRNA analysis. Services such as data analysis, assay development, and technical support are anticipated to see a surge due to the growing demand for personalized medicine and miRNA-based diagnostics.

These services play a crucial role in the interpretation and application of complex sequencing data, enabling clients to gain deeper insights into gene expression, disease biomarkers, and therapeutic targets. As research funding for molecular diagnostics continues to rise and miRNA applications expand, the service segment will likely experience significant growth, complementing the development of sequencing products.

Technology Analysis

The sequencing by synthesis held a significant share of 45.3% as it continues to offer high-throughput and accurate sequencing solutions. Sequencing by synthesis is expected to remain a preferred method due to its ability to produce large volumes of data with high accuracy and relatively lower error rates.

As the need for comprehensive miRNA analysis increases in drug discovery, cancer research, and genetic studies, this technology will likely be in high demand. Its adaptability to various platforms and its growing application in clinical diagnostics are expected to further drive the expansion of this segment in the market.

Application Analysis

The polyglutamine diseases segment had a tremendous growth rate, with a revenue share of 46.2% as researchers explore miRNA involvement in these diseases, such as Huntington’s disease. miRNA biomarkers are expected to be integral to understanding the molecular mechanisms underlying polyglutamine diseases.

Advances in sequencing technologies that enable deeper and more precise miRNA profiling are likely to drive the growth of this segment. With an increasing focus on targeted therapies and personalized medicine for neurodegenerative disorders, the potential for miRNA assays in early diagnosis and treatment monitoring is projected to enhance the segment’s growth prospects.

Workflow Analysis

The sequencing segment grew at a substantial rate, generating a revenue portion of 49.1% as advancements in sequencing technology continue to improve accuracy, speed, and cost-effectiveness. The increasing demand for high-quality miRNA data in biomarker discovery, disease understanding, and therapeutic development is expected to boost this segment.

Sequencing workflows that incorporate library preparation, sequencing, and data analysis are projected to grow due to their integration into more comprehensive research and clinical diagnostic applications. The expansion of sequencing capabilities to handle more complex and varied samples will likely fuel the segment’s growth, making it a crucial part of the miRNA analysis process.

End-User Analysis

The research and academic institutes held a significant share of 54.7% as academic research into miRNA biomarkers intensifies. With a growing focus on miRNA in disease mechanisms, gene regulation, and therapeutic targets, research institutions are anticipated to be major consumers of sequencing products and services.

Increased government funding for genomic research and collaborations with pharmaceutical companies are projected to drive the growth of this segment. As academic and research institutes continue to explore miRNA’s role in various diseases, including cancer and neurodegenerative disorders, their demand for advanced sequencing technologies and assays is likely to rise, further boosting this segment.

Key Market Segments

By Product Type

• Product
  • Library Preparation Kits
  • Sequencing Consumables
  • Instruments
• Service

By Technology

• Sequencing by Synthesis
• Single Molecule Real-time Sequencing
• Sequencing by Oligonucleotide Ligation and Detection
• Sanger Sequencing
• Nanopore Sequencing

By Application

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

By Workflow

• Sequencing
• Library Preparation
• Data Analysis & Storage

By End-user

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

Drivers

Increasing Applications in Cancer Diagnostics and Therapeutics is Driving the Market

The burgeoning applications of microRNAs (miRNAs) in the diagnosis and treatment of various cancers are a significant driver for the miRNA sequencing and assay market. miRNAs, small non-coding RNA molecules, play crucial roles in gene regulation and are often dysregulated in cancer. Their unique expression profiles in different cancer types offer promising biomarkers for early detection, prognosis, and prediction of treatment response.

For instance, the National Institutes of Health (NIH) highlighted in a January 2024 publication that specific miRNA signatures have shown significant potential in distinguishing between cancerous and non-cancerous lung tissue samples with high accuracy. This underscores the increasing clinical relevance of miRNA analysis in improving diagnostic precision.

Furthermore, research published in Nature Medicine in March 2023 detailed the promising results of a Phase I clinical trial using an miRNA-based therapeutic to target liver cancer, demonstrating the potential of miRNAs beyond diagnostics and into direct treatment modalities. The ongoing advancements and encouraging clinical findings in this area are significantly propelling the demand for technologies that can effectively profile and quantify miRNAs.

Restraints

High Cost and Technical Complexity are Restraining the Market

Despite the immense potential, the high cost and technical complexity associated with miRNA sequencing and assay technologies pose significant restraints on the market’s widespread adoption. Next-generation sequencing (NGS), a primary technique for comprehensive miRNA profiling, requires substantial capital investment for equipment and specialized personnel for data analysis.

According to a 2022 report by the National Human Genome Research Institute (NHGRI), the cost per genome for whole-genome sequencing has decreased significantly over the years, but specialized small RNA sequencing for miRNA analysis still involves specific library preparation and analysis costs that can be prohibitive for smaller labs.

Moreover, a study published in PLOS One in June 2023 emphasized the challenges in standardizing miRNA quantification across different platforms and laboratories, highlighting the technical complexities that need to be addressed for broader clinical translation. These financial and technical hurdles continue to limit the accessibility and widespread use of these powerful analytical tools.

Opportunities

Advancements in High-Throughput Sequencing Technologies are Creating Growth Opportunities

Continuous advancements in high-throughput sequencing (HTS) technologies are creating significant growth opportunities in the miRNA sequencing and assay market. Innovations in sequencing platforms are leading to increased throughput, higher accuracy, and reduced costs per sample, making comprehensive miRNA profiling more accessible. For example, Illumina’s NovaSeq 6000 platform, as detailed in their product specifications updated in 2023, offers significantly higher sample throughput compared to previous generations, driving down the cost per sample for RNA sequencing, including small RNA sequencing for miRNAs.

Furthermore, companies like QIAGEN are continuously developing more streamlined library preparation kits for small RNA sequencing, as outlined in their updated product manuals in 2024, which simplifies the experimental workflow and reduces the technical expertise required. These technological improvements are making miRNA sequencing more feasible for a wider range of researchers and clinical laboratories.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors introduce a layer of complexity to the trajectory of the miRNA sequencing and assay market. Economic downturns can lead to budget constraints in research institutions and healthcare systems, potentially slowing down investments in advanced technologies like miRNA analysis. Trade tensions and geopolitical instability can disrupt the supply chains of essential reagents and equipment required for sequencing and assay workflows, leading to increased costs and delays.

Conversely, government initiatives promoting research and development in life sciences and diagnostics, often seen as strategic sectors, can provide a buffer against economic headwinds and geopolitical uncertainties. For example, the European Union’s Horizon Europe program, with its increased funding for health research in its 2023-2024 work program, supports projects involving advanced diagnostics.

Furthermore, international collaborations in scientific research, which can be influenced by geopolitical relations, play a crucial role in advancing the understanding of miRNAs and developing new applications. A stable global economic and political landscape, fostering both public and private investment in scientific innovation, ultimately benefits the growth and accessibility of these vital diagnostic and research tools.

The current US tariffs on imported goods, including certain laboratory equipment and reagents, can have both positive and negative repercussions for the miRNA sequencing and assay market. On the negative side, tariffs may increase the cost of essential consumables and instruments sourced from overseas manufacturers, potentially raising the overall expenses for research laboratories and diagnostic facilities. This could particularly affect smaller institutions with limited budgets, potentially hindering their adoption of these technologies.

For example, the United States International Trade Commission (USITC) provides data on tariffs and trade restrictions, and ongoing tariffs on certain scientific instruments, as of April 2024, could translate to higher operational costs. However, these tariffs might also incentivize domestic production of sequencing platforms, reagents, and assay kits within the US. This could lead to the growth of local manufacturers and potentially create a more resilient domestic supply chain in the long term.

Moreover, increased government focus on bolstering domestic biotechnology and diagnostics industries, partly driven by trade considerations, could lead to greater investment in local innovation and manufacturing capabilities, as seen through initiatives like the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), which supports domestic biomanufacturing. While the immediate impact of tariffs might present financial challenges, it could also catalyze the development of a stronger domestic infrastructure for miRNA analysis technologies.

Latest Trends

Development of Point-of-Care miRNA Detection Assays is a Recent Trend

A prominent recent trend in the miRNA sequencing and assay market is the increasing focus on the development of point-of-care (POC) miRNA detection assays. Traditional miRNA analysis often requires centralized laboratory settings and specialized equipment, limiting its immediate clinical utility. The development of rapid, sensitive, and user-friendly POC assays aims to overcome these limitations by enabling miRNA detection at the patient’s bedside or in resource-limited environments.

For instance, researchers at the National Institute of Allergy and Infectious Diseases (NIAID) published a study in ACS Nano in August 2022 showcasing a novel microfluidic-based biosensor for the rapid detection of specific viral miRNAs, demonstrating the potential for POC diagnostics in infectious diseases. Similarly, advancements in electrochemical biosensors, as highlighted in a review in Biosensors and Bioelectronics in November 2023, are paving the way for cost-effective and portable miRNA detection devices. These developments indicate a strong push towards translating miRNA biomarkers into accessible clinical tools.

Regional Analysis

North America is leading the MiRNA Sequencing and Assay Market

North America held the highest revenue share of 40.7% in the global market in 2024. This dominance can be attributed to its advanced research infrastructure and substantial investments in genomics. The growing importance of microRNAs (miRNAs) as disease biomarkers, especially in oncology, has increased demand for sequencing and assay technologies. Research institutions across the region are actively adopting miRNA-based diagnostics. This rising adoption is closely linked to the availability of sophisticated technology and government support for molecular diagnostics.

The National Institutes of Health (NIH) plays a crucial role in supporting miRNA research. In both 2023 and 2024, the NIH awarded several grants focused on developing new methods to detect miRNAs for diagnostic use. These grants promote innovations in molecular biology and improve diagnostic accuracy. Such initiatives are helping build a strong foundation for miRNA testing across the U.S. The public sector’s continued commitment to biomarker research is fostering rapid adoption of advanced genomic technologies in North America.

Additionally, North America is home to several global biotechnology and pharmaceutical companies that actively explore miRNA applications. Firms like Illumina reported strong demand for their next-generation sequencing (NGS) platforms in 2023. These NGS systems are widely used by clinical labs and research institutions for miRNA profiling. The combined influence of academic research, industry investments, and advanced tools has driven regional market growth.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to grow with the fastest CAGR owing to the increasing healthcare expenditure, improving access to advanced diagnostics, and a growing focus on personalized medicine in the region. Countries like China and India are making significant investments in genomic research and infrastructure development, which is likely to drive the adoption of miRNA analysis technologies.

For example, the Chinese government’s “Healthy China 2030” initiative emphasizes the advancement of biotechnology and precision medicine, which is expected to increase the demand for miRNA sequencing and assay services. Additionally, the rising prevalence of chronic diseases and the growing awareness of the potential of miRNA-based diagnostics and therapeutics in the Asia Pacific region are projected to fuel market growth.

Collaborative research efforts and increasing funding for genomic studies in countries like Japan and South Korea, as highlighted in publications by the Japan Agency for Medical Research and Development (AMED) in 2022-2024, further support the anticipated strong growth of this market in the coming years.

Key Regions and Countries

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Russia
  • Netherland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • New Zealand
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of MEA

Key Players Analysis

Key players in the miRNA sequencing and assay market drive growth through technological innovation, strategic partnerships, and expanding global reach. They focus on developing advanced sequencing technologies and library preparation kits to enhance the accuracy and efficiency of miRNA profiling. Collaborations with academic institutions and research organizations facilitate the integration of new technologies and broaden market access.

Additionally, targeting emerging markets with increasing research activities and healthcare infrastructure presents significant growth opportunities.​ Thermo Fisher Scientific, headquartered in Waltham, Massachusetts, is a leading global provider of laboratory instruments, reagents, and consumables. The company offers a comprehensive range of miRNA sequencing and assay products, including library preparation kits and sequencing platforms, to support research in genomics and molecular biology.

Thermo Fisher Scientific operates in over 50 countries, serving customers in academia, healthcare, and industry sectors, and continues to expand its presence through strategic acquisitions and product innovations.

Top Key Players in the miRNA Sequencing and Assay Market

• Takara Bio Inc
• Sanofi
• QIAGEN
• PerkinElmer
• New England Biolabs
• Lexogen GmbH
• Allogene Therapeutics
• Abcam plc

Recent Developments

• In October 2024, Sanofi invested strategically in Resalis Therapeutics, aiming to accelerate the clinical development of RES-010. Resalis, focusing on miRNA-based therapeutics, is well-positioned in the growing RNA therapeutics market. The partnership strengthens its efforts to innovate treatments for metabolic disorders, backed by key industry support.
• In January 2022, Allogene Therapeutics and Antion Biosciences formed a collaboration to enhance multiplex gene silencing, advancing the development of future allogeneic CAR-T therapies. By incorporating Antion’s miRNA technology, the partnership aims to improve both the safety and effectiveness of CAR-T treatments.

Report Scope