MiRNA Sequencing and Assays Market Intelligence: Growth Drivers, Competitive Strategy, and Trends

MiRNA Sequencing and Assays Market is projected to reach USD 2.96 billion in 2029 from USD 2.23 billion in 2024. This market is projected to grow at a CAGR of 5.8% over the forecast period. The primary drivers behind the expansion of this industry are the growing focus on mRNA-based vaccine development, expanding therapeutic applications of mRNA technology, advancements in mRNA synthesis technology, increased outsourcing for mRNA synthesis and modification, and collaborations among industry players. However, stability, storage, and manufacturing scalability present a challenge to this industry. This is further amplified by the slow patient adoption rate and the complexity of the development of mRNA-based therapy.

In many important respects, artificial intelligence (AI) is transforming the mRNA synthesis and manufacturing sector. First, by scanning large databases to find suitable mRNA sequences for therapeutic usage, artificial intelligence speeds up drug research and development greatly. Developed tools like the LinearDesign AI aim to maximize mRNA sequences, therefore producing vaccines with more antibody responses than conventional techniques. From raw material acquisition to final product packaging, artificial intelligence maximizes several manufacturing steps, thereby lowering costs and raising efficiency. AI-powered predictive maintenance reduces downtime and guarantees manufacturing equipment's seamless running.

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Key Market Players

Major vendors in the Microscope software market include Illumina (US), Thermo Fisher Scientific (US), QIAGEN (Germany), Takara Bio (Japan), and NEB (UK), among others.

Sequencing consumables are projected to hold the largest share of the miRNA sequencing and assay market during the forecast period.

Based on product, the miRNA sequencing & assays market is segmented into library preparation kits and sequencing consumables. Sequencing consumables dominated the market with a larger share in 2018. The large share of this segment can primarily be attributed to the growing demand for consumables and increasing adoption of small RNA sequencing.

The research and academic institutes end-user segment held the largest share of the market in 2018

Based on end users, the miRNA sequencing & assays market is segmented into academic and research institutes and contract research organizations. In 2018, academic and research institutes accounted for the largest share of the miRNA sequencing & assays market. The large share of this segment can be attributed to the availability of research grants and the increasing focus of market players on providing efficient miRNA sequencing products and services for research applications.

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DRIVER: Growing demand of personalized medicines

The growing demand for personalized medicines is significantly boosting the mRNA synthesis & manufacturing market. Personalized medicine, which tailors medical treatment to the individual characteristics of each patient, is leading to more effective and targeted therapies. For instance, personalized mRNA vaccines are being developed in cancer treatment to target specific mutations in a patient’s tumor. Companies such as BioNTech and Moderna are at the forefront of creating mRNA-based cancer vaccines that stimulate an immune response against the tumor. Similarly, mRNA therapies are being explored for rare genetic disorders, such as Translate Bio’s work on cystic fibrosis, aiming to correct the underlying genetic defect.

The success of mRNA vaccines for COVID-19 has paved the way for personalized vaccines for other infectious diseases. This adaptability allows for quick responses to new virus strains, providing a personalized approach to vaccination. Investment in mRNA technology has surged. For instance, in July 2024, the US government awarded USD 176.0 million to vaccine maker Moderna to develop an mRNA-based influenza shot. There has been a significant increase in clinical trials involving mRNA therapies. As of 2023, over 150 clinical trials were registered for mRNA-based therapies, covering a wide range of diseases, from cancer to infectious diseases.

RESTRAINT: High production cost

Demand for mRNA vaccines has increased, indicating a need for cost-effective solutions for mRNA synthesis and scale-up processes. Large-scale production/manufacturing of mRNA vaccines includes single or 2-step in vitro (IVT) reaction, after which multiple steps of purification are performed. In vitro transcription is quick, safe, and the most reliable approach for manufacturing mRNA therapeutics (drugs and vaccines). However, it incorporates expensive materials. Currently, the average selling price (ASP) range of consumables is highest in transcription compared to purification, analysis & characterization. This is attributed to the complex process of transcription, which mandates the use of diverse components, including nucleotides, enzymes, capping reagents, and vectors, among others.

Challenges associated with low titer and poor purification yield persist, leading to inefficient manufacturing and costs to the overall manufacturing or synthesis process. Consumables offered by each vendor have a slightly different efficacy. This requires additional optimization again and again if any of the components, particularly polymerases, are bought from a different supplier than the previous one. Thus, sustainable supply is essential from a reliable, single vendor to mitigate the challenges.

OPPORTUNITY: Advancements in drug delivery technologies

Several vectors have been developed to improve the efficiency of mRNA delivery. These include lipid nanoparticles (LNP), cationic nanoemulsions (CNE), and polymetric nanoparticles, among others. It is imperative to optimize the delivery systems as they largely improve mRNA transfection capabilities and activity. This is, in turn, crucial for the successful development and commercialization of mRNA therapeutics. The clinical potential of mRNA therapeutics has led to the development of advanced systems that safely deliver bioactive agents while avoiding side effects. LNPs have emerged as a potent drug delivery technology for mRNA and are being incorporated to improve mRNA delivery while avoiding extracellular degradation. LNP encapsulation is a critical aspect of mRNA vaccine manufacturing and has been proven to improve mRNA delivery.

In addition, CRISPR technology can target mutations specific to genomic sites. Ongoing research activities have led to the advent of intracellular mRNA delivery targeted to carry out gene editing through CRISPR/Cas9. Thus, companies are exploring different drug delivery systems, including tissue-targeted and cell-targeted delivery, to expand druggable targets. Combining drugs with selected nanoparticles and using targeted ligands to functionalize nanoparticles is another potential technology for delivering mRNA. The advent of such technologies is expected to open new opportunities for market expansion.

CHALLENGES: Stability, storage, and manufacturing scalability issues

The synthesis and production of mRNA presents major hurdles, notably in terms of stability, storage, and scalability. mRNA molecules are intrinsically unstable and susceptible to RNase decay. Thus, they must be handled and protected carefully throughout the manufacturing process. Chemical changes, such as adding modified nucleosides, are frequently necessary to improve protein stability and translation efficiency. mRNA vaccines require advanced cold storage conditions to ensure stability, which presents supply chain issues in areas with underdeveloped cold chain infrastructure.

The encapsulation of mRNA with lipid nanoparticles is crucial to ensure stability because LNPs protect the mRNA from degradation and promote its distribution into cells. However, ensuring the long-term stability of these formulations remains a difficulty. Scaling up mRNA production to satisfy global demand is especially challenging, as typical biopharmaceutical manufacturing facilities are sometimes unequipped to manage the specialized requirements of mRNA production. There is a scarcity of dedicated equipment and supplies intended exclusively for mRNA processing, resulting in inefficiencies and discrepancies in manufacturing. Guaranteeing consistent quality and regulatory compliance across large-scale production batches is challenging, necessitating thorough control and validation of each stage in the manufacturing process.

Recent Developments of mRNA Synthesis & Manufacturing Market

• In November 2024, Cytiva a subsidiary of Danaher Corporation (US) launched Poland’s first mRNA FlexFactory for developing mRNA therapies targeting cancer and COVID-19.
• In May 2024, GenScript launched self-amplifying RNA synthesis service for advanced therapeutic applications. These enhance the potency and efficacy of vaccines, immunotherapies, and gene therapies.
• In April 2024, New England Biolabs (US) company launched Monarch Mag Viral DNA/RNA Extraction Kit to enhance recovery of small amounts of viral nucleic acid.
• In April 2024, TriLink BioTechnologies, a Maravai LifeSciences company, entered into a license and supply agreement with Lonza to provide CleanCap mRNA capping technology for Lonza’s global mRNA development and manufacturing services.