European RNA Therapy Clinical Trials Market Outlook 2025-2035: Innovation, Growth, and Demand Trends

The global RNA therapy clinical trials market is projected to expand significantly over the next decade, driven by rising interest in genetic medicine, increasing investment in RNA-based platforms, and growing demand for personalized therapies. From an estimated USD 2.70 billion in 2025, the market is forecast to reach approximately USD 3.75 billion by 2035, reflecting a compound annual growth rate (CAGR) of about 3.3%.

Key Market Highlights

2025 Market Size: USD 2.70 billion

2035 Forecast Value: USD 3.75 billion

Projected CAGR (2025-2035): ~3.3%

Leading Modality: Messenger RNA (mRNA) (~34.8% share)

Top Therapeutic Focus: Rare diseases

High-Growth Regions: Asia Pacific, Europe, North America

Major Service Providers: IQVIA; ICON Plc; Laboratory Corporation of America; Charles River Laboratories; PAREXEL; Syneos Health; Medpace; PPD; Novotech; Veristat

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Major Growth Drivers:

Surging Adoption of RNA-Based Therapeutics

Biotech and pharmaceutical companies are increasingly focusing on RNA platforms-such as mRNA, siRNA, and antisense molecules-because of their ability to target previously "undruggable" genes, enable rapid development, and customize therapies for individual patients. These platforms are becoming central to next-generation drug development.

Expansion of Clinical Capabilities for Rare Diseases

Rare and genetic disorders are driving the demand for RNA therapy trials. Given the specificity of RNA-based agents, they are well-suited for treating rare conditions, prompting sponsors to design specialized trials for small patient populations and novel indications.

Increasing Investment in Precision Medicine

Pharmaceutical sponsors are investing more in precision medicine. RNA therapies offer a highly modular and flexible approach to treatment, and companies are seeking clinical trial partners with expertise in RNA delivery, regulatory strategy, and patient recruitment.

Regulatory Momentum & Delivery Innovation

Regulatory agencies are adapting to the rise of RNA therapies, and delivery technologies such as lipid nanoparticles, polymeric carriers, and advanced conjugates are reducing barriers to clinical translation. These improvements are making RNA trials safer and more effective.

Growing CRO Specialization

Contract research organizations (CROs) have begun to specialize in RNA-focused clinical services. Their expertise in trial design, manufacturing support, and regulatory navigation is becoming increasingly critical for sponsors developing RNA therapeutics.

Market Segmentation
By Modality

Messenger RNA (mRNA): Dominant modality due to applications in gene expression, vaccines, and therapeutics.

siRNA / RNA Interference: Widely used for disease suppression and gene silencing.

Antisense Oligonucleotides (ASOs): Gaining traction for precision and targeted gene modulation.

Other RNA Types: Include microRNA-based therapies and RNA editing modalities.

By Therapeutic Area

Rare Diseases: The largest area, driven by genetic disorder treatments.

Oncology: RNA therapies targeting cancer are rising rapidly.

Infectious Diseases: Vaccines and antiviral RNA drugs remain key targets.

Neurological Diseases: Growing pipeline for neurodegenerative and rare neurological conditions.

By Trial Phase

Phase I: Early safety and dose-finding trials.

Phase II (largest share): Demonstrating efficacy and optimizing dose in selected patient populations.

Phase III: Large-scale trials aimed at regulatory approval.

Phase IV / Post-Marketing: Long-term safety and real-world data collection.

By Region

North America: Leading region, supported by mature biotech infrastructure and significant R&D investment.

Europe: Strong trial activity, especially in rare diseases and oncology, backed by regulatory harmonization.

Asia Pacific: Rapid growth, driven by increasing biotech capacity, lower trial costs, and expanding regulatory experience.

Challenges & Risks

High Development Complexity: RNA therapies require specialized delivery systems and manufacturing processes, increasing cost and time.

Regulatory Uncertainty: As novel modalities, RNA therapies still face evolving regulations, especially for first-in-class drugs.

Patient Recruitment Issues: Recruiting patients for rare diseases can be challenging and slow for clinical trials.

Safety & Immunogenicity: RNA drugs may trigger immune responses or off-target effects, making trial design more complex.

Competitive Landscape

Key players in the RNA clinical trial services market are focusing on:

Expanding capabilities for RNA delivery, manufacturing, and clinical execution

Forming strategic partnerships with biotech firms developing RNA therapeutic candidates

Developing fully integrated platforms to support phase I through phase III development

Investing in regulatory expertise and data infrastructure to support complex RNA trials

Building global trial networks, especially in regions with favorable regulatory and cost environments

Strategic Recommendations

Develop RNA-Optimized Trial Platforms: CROs should invest in RNA-specific infrastructure, from LNP management to mRNA-specific analytical methods.

Build Rare Disease Capabilities: Develop deep expertise in designing and enrolling patients for rare-disease RNA trials.

Form Long-Term Partnerships: Collaborate with biotech firms early to co-develop novel RNA therapies and share regulatory knowledge.

Enhance Regulatory Strategy: Invest in regulatory teams that specialize in RNA modalities to help sponsors navigate complex approval pathways.

Expand Regionally: Focus on establishing trial operations in Asia Pacific and Europe to tap into growing RNA therapy development globally.

Market Outlook

By 2035, the RNA therapy clinical trials market is expected to reach USD 3.75 billion, marking a significant step forward in the evolution of genetic medicine. Driven by mRNA innovation, rare-disease targeting, and advanced clinical capabilities, RNA therapies are becoming central to modern drug development.

Contract research organizations, biotech companies, and pharmaceutical sponsors that align their strategy with RNA specializations will be best positioned to capitalize on this transformative opportunity-delivering precision therapeutics that address unmet medical needs and shape the future of medicine.

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Related Reports:

RNA Editing for Neurodegenerative Diseases Market: https://www.factmr.com/report/rna-editing-for-neurodegenerative-diseases-market

RNA Editing Therapies Market: https://www.factmr.com/report/rna-editing-therapies-market

RNA Transcriptome Profiling Test Market: https://www.factmr.com/report/3113/rna-transcriptome-profiling-test-market

RNA-based Therapeutics and Vaccine Market: https://www.factmr.com/report/rna-based-therapeutics-and-vaccine-market

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