RNA Therapy Clinical Trials

Global RNA Therapy Clinical Trials Market to Reach US$3.6 Billion by 2030

The global market for RNA Therapy Clinical Trials estimated at US$3.0 Billion in the year 2024, is expected to reach US$3.6 Billion by 2030, growing at a CAGR of 3.2% over the analysis period 2024-2030. RNA interference, one of the segments analyzed in the report, is expected to record a 2.6% CAGR and reach US$1.7 Billion by the end of the analysis period. Growth in the Antisense therapy segment is estimated at 4.2% CAGR over the analysis period.

The U.S. Market is Estimated at US$783.4 Million While China is Forecast to Grow at 3.2% CAGR

The RNA Therapy Clinical Trials market in the U.S. is estimated at US$783.4 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$583.7 Million by the year 2030 trailing a CAGR of 3.2% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 2.9% and 2.9% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 2.7% CAGR.

Global RNA Therapy Clinical Trials Market - Key Trends & Drivers Summarized

Why Are RNA-Based Therapies Gaining Traction In Clinical Research?

RNA-based therapies are rapidly gaining prominence in the clinical trial landscape, driven by their potential to revolutionize treatment paradigms across multiple disease areas. Unlike traditional small-molecule drugs, RNA therapies offer highly specific mechanisms of action, enabling precise gene regulation, protein replacement, and immune modulation. The success of mRNA vaccines during the COVID-19 pandemic has demonstrated the immense potential of RNA-based platforms in developing rapid, scalable, and highly effective therapeutics. Beyond vaccines, RNA interference (RNAi), antisense oligonucleotides (ASOs), and messenger RNA (mRNA)-based drugs are being explored for conditions ranging from rare genetic disorders to cancer and neurodegenerative diseases. Additionally, the flexibility of RNA therapy design allows for rapid modifications and personalized treatment approaches, making them particularly attractive in precision medicine. These factors have propelled a surge in clinical trials evaluating RNA-based drugs, with pharmaceutical companies and research institutions intensifying their efforts to bring RNA therapeutics to market.

How Are Advances In RNA Delivery Systems Enhancing Clinical Trial Success?

One of the most significant challenges in RNA therapy development has been efficient and targeted delivery. Recent advancements in lipid nanoparticles (LNPs), polymer-based carriers, and extracellular vesicle-mediated delivery are overcoming previous barriers to RNA drug stability, bioavailability, and cellular uptake. LNP technology, in particular, played a critical role in the success of COVID-19 mRNA vaccines and is now being optimized for broader applications, including oncology and rare disease therapies. Additionally, conjugation strategies, such as GalNAc (N-acetylgalactosamine)-conjugated siRNAs, are improving liver-targeted RNA drug delivery, expanding their potential therapeutic scope. These innovations are enhancing clinical trial outcomes, reducing toxicity, and improving patient responses to RNA-based treatments. The continuous refinement of delivery platforms is a key enabler of RNA therapy clinical trials, accelerating the development timeline for next-generation RNA-based therapeutics.

What Are The Key Regulatory & Investment Trends Influencing RNA Clinical Trials?

The regulatory landscape for RNA-based therapeutics is evolving, with agencies such as the FDA and EMA providing accelerated approval pathways for promising RNA drugs. Breakthrough therapy designations and orphan drug status are increasingly being granted to RNA-based treatments, particularly in the fields of rare diseases and oncology. Meanwhile, the influx of venture capital funding and public-private partnerships is driving clinical trial expansion, with major biotech firms collaborating with academic research centers to fast-track RNA drug development. Additionally, advancements in biomarker-driven clinical trial designs are enabling more efficient patient stratification, enhancing trial success rates. As regulatory agencies adapt to the growing wave of RNA therapies, the industry is witnessing a surge in new trial initiations across multiple indications, further fueling market growth.

What Is Driving The Rapid Growth Of The RNA Therapy Clinical Trials Market?

The growth in the RNA therapy clinical trials market is driven by several factors, including the success of RNA-based vaccines, increasing investment in RNA drug development, and advancements in RNA delivery technologies. The rising prevalence of genetic disorders, neurodegenerative diseases, and cancer is accelerating the demand for innovative RNA-based interventions. The expansion of AI-powered clinical trial platforms, coupled with improvements in RNA synthesis and modification techniques, is further streamlining the drug development process. The push toward personalized medicine is also driving interest in RNA therapies, as their modular design enables rapid adaptation for individualized treatment approaches. Additionally, favorable regulatory policies and the growing acceptance of RNA-based therapies among healthcare providers and patients are creating a robust clinical trial ecosystem. As research continues to validate the therapeutic potential of RNA drugs, the market is set for continued expansion, backed by strong scientific innovation, regulatory support, and increasing industry collaboration.

SCOPE OF STUDY:

The report analyzes the RNA Therapy Clinical Trials market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Modality (RNA interference, Antisense therapy, Messenger RNA, Others); Clinical Trials Phase (Phase I, Phase II, Phase III, Phase IV); Therapeutic Areas (Rare Diseases, Anti-infective, Anticancer, Neurological, Alimentary / Metabolic, Musculoskeletal, Cardiovascular Respiratory, Sensory, Others)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 37 Featured) -

• Abivax
• Alnylam Pharmaceuticals
• Arcturus Therapeutics
• Aro Biotherapeutics
• Arrowhead Pharmaceuticals
• AstraZeneca
• Avidity Biosciences
• Biogen Inc.
• BioNTech SE
• Capricor Therapeutics
• Cartesian Therapeutics
• CureVac AG
• Dicerna Pharmaceuticals
• eTheRNA immunotherapies
• Ethris GmbH
• GSK (GlaxoSmithKline)
• Ionis Pharmaceuticals
• Lexeo Therapeutics
• Moderna Inc.
• Nutcracker Therapeutics

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

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