mRNA Vaccines Industry (PDF) Update: Clinical Phases Trails, Regulatory Approvals & Big M&A Activity, Pipline Analysis 2025

DataM Intelligence has released an in-depth research report on "mRNA Vaccines Market Size 2025". This report delivers power-packed insights into key growth drivers, market segmentation, regional trends, CAGR forecasts, revenue performance of top players, and emerging opportunities. Gain a 360° market perspective with detailed analysis on value, volume, and future development trends your ultimate guide to spotting high-impact opportunities and staying ahead in this dynamic market.

➠ FAD Approvals

✦ In late August 2025, the FDA approved updated mRNA COVID-19 vaccines from Pfizer/BioNTech (COMIRNATY) and Moderna (Spikevax and mNEXSPIKE), targeting the LP.8.1 sublineage to better match current virus strains.

✦ COMIRNATY received approval for adults 65+ and individuals aged 5-64 years at increased risk for severe COVID-19; shipments started immediately.

✦ Moderna's Spikevax was fully approved for children aged 6 months to 64 years with high-risk conditions, and for all adults 65+, with mNEXSPIKE approved for those 12+ at high risk.

✦ The updated vaccines are now available nationwide in pharmacies, clinics, and hospitals, following expedited FDA review for the 2025-2026 respiratory season.

✦ These approvals came amidst growing demand for variant-adapted boosters and reflect regulatory efforts to streamline access for vulnerable populations

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Mergers and Acquisitions

June 2024: Moderna, Inc. and Merck presented initial results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, evaluating mRNA-4157 (V940) neoantigen therapy with KEYTRUDA in 157 patients with resected high-risk melanoma (stage III/IV).

List of Top Key Players:

Regulatory Designations

January 2025: Moderna, Inc. secured support from the U.S. HHS via the RRPV Consortium and BARDA funding to fast-track mRNA pandemic influenza vaccine development.

November 2024: Arcturus Therapeutics received FDA's "Study Can Proceed" clearance for its ARCT-2304 sa-mRNA vaccine targeting H5N1 pandemic influenza.

Sanofi, GSK plc, AstraZeneca, Merck & Co., Inc., F. Hoffmann-La Roche Ltd, RinuaGene

Forecast Growth Projection:

Global mRNA Vaccines Market Positioned for Strong Growth 2025-2032, Building on the steady momentum of 2024, the market is poised for remarkable expansion as leading players embrace innovative technologies and strategic advancements. This evolving landscape is unlocking lucrative opportunities for businesses to invest, scale, and stay ahead in an increasingly competitive and fast-moving market.

Market Research Process:

The mRNA Vaccines Market research report by DataM Intelligence combines extensive Primary and Secondary research to provide powerful, in-depth insights. It examines key market drivers such as regulatory frameworks, evolving market conditions, competitive dynamics, historical trends, and breakthrough technologies, while spotlighting emerging innovations and potential challenges. This all-inclusive analysis uncovers high-growth opportunities and highlights possible barriers, equipping businesses to tackle market volatility and capture new avenues for success.

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Key Industry Developments

Several major pharmaceutical companies formed alliances and joint ventures to accelerate the pipeline of mRNA vaccines for respiratory diseases, cancer, and rare infectious threats.

New mRNA vaccine candidates for influenza and RSV advanced to phase 3 clinical trials, with early data showing encouraging safety and immune response results.

The FDA granted Fast Track designation to select mRNA vaccines targeting cytomegalovirus (CMV) and personalized cancer immunotherapy, expediting the review and approval process.

Product launches included next-generation COVID-19 booster shots designed to address newly circulating variants, now available in both the US and EU.

Companies invested in scaling modular mRNA manufacturing platforms for pandemic preparedness and rapid-response vaccine development against emerging pathogens.

Media coverage highlighted the expansion of mRNA clinical trials in diverse global populations, as well as new delivery technologies (like lipid nanoparticle improvements) to boost vaccine efficacy and stability.

The last quarter shows continuous momentum in mRNA vaccine innovation-driven by clinical progress, regulatory green lights, global launches, and partnerships poised to broaden the use of mRNA technology beyond COVID-19.

Market Segments:

By Disease/Application: Infectious Diseases (COVID-19, Influenza, RSV, Zika, CMV), Cancer (solid tumors, personalized cancer vaccines), Rare/Orphan Diseases, Other Immunizations (such as HIV and malaria, still in development)

By Type: Prophylactic Vaccines (preventing infection, e.g., COVID-19, flu), Therapeutic Vaccines (treating conditions like cancer or chronic infections)

By Delivery System: Lipid Nanoparticle (LNP) Delivery (most common), Polymer-based Nano-carriers, Electroporation and other physical delivery methods

By End User: Hospitals & Clinics, Research Institutes, Pharmaceutical Companies, Government & Public Health Agencies

By Route of Administration: Intramuscular (most common, e.g., arm injections), Intradermal, Intranasal (pipeline and clinical trials)

Global Growth Regions:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Opens the report with a comprehensive market overview, highlighting key segments by region, product type, and application. It presents a clear snapshot of market size, growth potential by segment, and both short- and long-term outlook.

Chapter 2: Showcases the most impactful insights, uncovering the emerging trends and disruptive forces shaping the industry's future.

Chapter 3: Delivers an in-depth competitive landscape analysis of the mRNA Vaccines market, covering revenue shares, strategic moves, and the latest mergers & acquisitions.

Chapter 4: Features detailed profiles of leading players, including their revenue streams, profit margins, product portfolios, and key milestones.

Chapters 5 & 6: Present a granular breakdown of regional and country-level revenue performance, offering a precise view of market size, opportunities, and development prospects worldwide.

Chapter 7: Analyzes market segmentation by product type, revealing the growth potential of each category and spotlighting high-impact.

Chapter 8: Examines application-based market growth, identifying the fastest-expanding sectors and lucrative opportunities for expansion.

Chapter 9: Maps the entire industry supply chain, providing insights into upstream and downstream activities for a complete market perspective.

Chapter 10: Concludes with key findings and actionable takeaways, guiding stakeholders toward strategic decisions and future growth opportunities.

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