mRNA Therapy Market Projected to Reach USD 70 Billion by 2035 Amid Expanding Applications

The mRNA therapy market is rapidly expanding beyond vaccines into oncology, rare diseases, and infectious disease treatments, with the market valued at USD 11.6 billion in 2024 and projected to reach USD 13.6 billion in 2025. Long-term projections estimate the market will achieve USD 70.0 billion by 2035, representing a CAGR of 17.8% from 2025 to 2035.

The market expansion is driven by rising research funding, growing chronic disease prevalence, and expanding therapeutic applications. Global digital health funding reached USD 28.8 billion in 2025, with the United States leading the sector, followed by Europe's fast-growing funding rates and rising investment in Asia Pacific and the Middle East.

The genital herpes treatment market represents a significant application area for mRNA technology, with its valuation projected to accelerate from USD 2,448.9 million in 2026 to USD 3,957.6 million by 2036, representing a CAGR of 4.9% over the ten-year forecast period. The market's evolution is underpinned by a critical transition from legacy nucleoside analogues toward a sophisticated pipeline of mRNA-based therapeutic vaccines and novel helicase-primase inhibitors.

The World Health Organization estimated in 2024 that approximately 491 million people aged 15 to 49 worldwide are living with HSV-2 infection. This massive scale of unmet therapeutic need is compelling manufacturers to move beyond symptom management toward viral load reduction and potential functional cures.

Moderna has achieved significant milestones, completing the enrollment of 300 participants in its Phase 1/2 clinical trial for mRNA-1608. This therapeutic vaccine candidate aims to leverage mRNA technology to reduce viral shedding and lesion frequency, representing a major technological leap for the genital herpes treatment market.

The competitive landscape is led by pharmaceutical leaders and biotechnology innovators accelerating clinical development. Key market manufacturers include Pfizer, BioNTech, Moderna, CureVac, Arcturus Therapeutics, eTheRNA, Helixmith, Chimeron Bio, Sutro Biopharma, Sibionics, Translate Bio, Innate Pharma, Genovate, and Ginkgo Bioworks. These companies focus on advanced delivery systems, lipid nanoparticle technologies, and scalable manufacturing processes to expand market share.

Market segmentation includes application areas such as infectious diseases, oncology, rare genetic disorders, and cardiovascular diseases. Type segmentation includes prophylactic vaccines, therapeutic vaccines, and protein replacement therapies, with therapeutic applications gaining increasing market share. Delivery methods include lipid nanoparticles, polymer-based carriers, and electroporation systems.

From a regional perspective, North America dominates the mRNA therapy market due to strong biotechnology ecosystems, high R&D investments, and rapid regulatory approvals. The United States maintains a dominant position in the genital herpes treatment landscape, supported by the world's largest pharmaceutical R&D expenditure and a concentration of pipeline assets. The U.S. market is further bolstered by extensive STI screening programs and a growing consumer preference for suppressive therapy.

Europe follows with steady growth supported by collaborative research programs and pharmaceutical innovation. In the genital herpes treatment market, the region is led by Germany, France, and the UK, where robust healthcare policies and well-developed sexual health clinics facilitate the use of suppressive regimens. The region is also seeing increased collaboration between biotech firms and research institutions for HSV vaccine trials.

The Asia-Pacific region is expected to witness substantial market growth driven by expanding healthcare infrastructure, rising vaccine demand, and increasing biotechnology investments in China, Japan, South Korea, and India. In the genital herpes treatment segment, this region is recognized as the fastest-growing, fueled by rising STI incidence rates, expanding pharmaceutical manufacturing capacity, and the integration of telemedicine networks for therapy consultation.

Increased research funding and government support are central drivers of market growth. Rising chronic diseases and expanding vaccine adoption continue to shape positive market trends. Regulatory advancements and accelerated approval pathways further strengthen the global outlook. However, manufacturing scalability, cold chain logistics, and regulatory compliance remain important considerations influencing commercialization strategies.