mRNA 백신 및 치료제 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

The mRNA vaccines and therapeutics market size for construct types remains dominated by conventional non-replicating formats. This lineage retained 65.10% share in 2025 because existing facilities, regulatory precedents, and validated analytical assays minimize scale-up friction. Demand continues in RSV and influenza boosters, preserving baseline revenue even as competitive pressure mounts. Self-amplifying mRNA is accelerating at 17.10% CAGR between 2026 and 2031 owing to its lower dose requirement and improved antigen persistence, which collectively lower per-patient treatment cost.

Key Highlights

• The mRNA vaccines and therapeutics market was valued at USD 63.89 billion in 2025 and estimated to grow from USD 74.43 billion in 2026 to reach USD 159.59 billion by 2031, at a CAGR of 16.5% during the forecast period (2026-2031). Scale-up capital is flowing into specialized manufacturing hubs, strategic public-private alliances are broadening clinical pipelines, and next-generation constructs are moving from academic labs to pivotal trials. Investor appetite remains resilient because real-world effectiveness data validate the platform across COVID-19, RSV, and several oncology settings . Closing regulatory gaps through the FDA Platform Designation Program and similar fast-track schemes in Japan and Singapore is shortening development timelines, while modular closed-system plants reduce both capex and batch-to-batch variability. At the same time, supply-chain innovations-particularly continuous lipid-nanoparticle production and improved cold-chain monitors-are lowering cost per dose and expanding access in emerging regions.

Global MRNA Vaccines And Therapeutics Market Trends and Insights

Pandemic-preparedness demand surge

Government preparedness funding sustains the mRNA vaccines and therapeutics market as health agencies look beyond COVID-19 to influenza, mpox, and tuberculosis. BARDA's USD 176 million award to Moderna for an H5 influenza candidate anchors a multiyear procurement roadmap . CEPI followed with a USD 145 million facility commitment that enables BioNTech to co-locate fill-finish capabilities for malaria antigens in Rwanda. These programs embed contingent purchasing clauses that trigger automatic scale-up during future outbreaks, de-risking commercial capacity investments. The Coalition for Epidemic Preparedness Innovations has also published a Chemistry-Manufacturing-Control Framework that standardizes analytical release testing, curbing the historically high attrition seen at the "valley of death" stage of vaccine development. Collectively, these efforts extend global demand visibility, unlocking lower cost of capital for mid-sized developers.

Rising chronic & infectious disease burden

Escalating incidence of melanoma, cervical cancer, and respiratory infections is broadening the addressable pool for mRNA therapeutics. In oncology, the mRNA-4157 plus pembrolizumab combination demonstrated a 49% reduction in melanoma recurrence across a three-year readout. Rare-disease pipelines are equally buoyant; positive safety data in propionic acidemia patients confirmed the platform's potential in metabolic disorders. Autoimmune prospects are maturing, evident in Cartesian Therapeutics entering Phase 3 trials for Descartes-08 in myasthenia gravis. These clinical milestones translate into payer willingness to reimburse high-value therapies, reinforcing revenue forecasts for the mRNA vaccines and therapeutics market.

Cold-chain & stringent regulatory compliance

Key Highlights

• Deep-freeze distribution still demands -20 °C to -80 °C storage for many formulations, stressing logistics in equatorial climates. Japanese developers are testing thermostable excipients that hold potency for 14 days at 8 °C, yet commercial rollout remains nascent. On the regulatory front, the FDA's updated CMC guidance mandates granular reporting on process analytics and critical-quality attributes, extending dossier preparation timelines. While the agency's Platform Designation label offers accelerated reviews, only a handful of applicants have secured it to date, limiting near-term relief .

Other drivers and restraints analyzed in the detailed report include:

1. Government & venture R&D funding escalation
2. Commercial proof-of-concept post-COVID-19
3. Elevated production cost & scale-up complexity

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Japan's approval of ARCT-154 created a regulatory template that other jurisdictions are now studying, reducing the perceived development risk for startups.

Second-generation circular RNA is gathering momentum despite limited commercial exposure. Sail Biomedicines synthesized 8,000-nucleotide constructs at bench scale, demonstrating technical feasibility for large therapeutic payloads. Industry observers expect circular modalities to supplant linear templates within a decade because they resist exonuclease degradation and therefore prolong protein expression windows. Parallel academic research at Nagoya University presents disease-cell-selective translation initiation, hinting at oncology applications with minimal off-target toxicity. Collectively, these innovations diversify the mRNA vaccines and therapeutics market and attract platform licensing deals from companies that lack internal RNA chemistry expertise.

Infectious diseases remained the primary revenue pillar, securing 49.85% of 2025 turnover as COVID-19 boosters, RSV shots, and pediatric combination vaccines filled public-sector procurement pipelines. Beyond respiratory viruses, norovirus and cytomegalovirus programs are progressing toward late-stage trials, reinforcing the volume outlook. Yet oncology is registering the fastest expansion at 17.20% CAGR, catalyzed by the milestone 49% reduction in melanoma recurrence achieved by mRNA-4157 plus pembrolizumab. FDA Breakthrough Therapy Designation for that regimen accelerated trial enrollment in lung and bladder cancers, broadening addressable patient pools.

The oncology wave is also geo-diversifying. Likang Life Sciences received FDA IND clearance for a personalized neoantigen vaccine manufactured at one-tenth the cost of comparable Western protocols. Chinese hospitals are piloting these regimens under private payment models, signaling payer flexibility when efficacy endpoints are compelling. Autoimmune research is following a similar trajectory; Cartesian Therapeutics' Descartes-08 reached Phase 3 in myasthenia gravis, and OSE Immunotherapeutics is advancing IL-35 tolerizing constructs for autoimmune hepatitis. Each success story builds confidence that the mRNA vaccines and therapeutics market can sustain growth outside its infectious-disease origins.

The MRNA Vaccines and Therapeutics Market is Segmented by MRNA Construct Type (Conventional Non-Replicating MRNA, and More), Therapeutic Area (Infectious Diseases, Oncology, and More), Delivery System (Polymer-Based Nanocarriers, Cationic Nano-Emulsions, and More), Distribution Channel (Public and Private), and Geography (North America, Europe, and More). The Market and Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America held 41.95% of global revenue in 2025, anchored by robust federal funding, dense contract-manufacturing networks, and a regulatory environment that first validated mRNA technology. BARDA's influenza contract and Blackstone's multibillion-dollar R&D support underscore institutional confidence. Ongoing investment in modular plants across Texas and Massachusetts keeps capacity flexible for both pandemic surges and therapeutic rollouts, sustaining the regional leadership position.

Asia-Pacific is expected to register a 17.35% CAGR from 2026 to 2031, the fastest across all regions. Regulatory agility is a key driver; Japan approved the first self-amplifying mRNA vaccine, and Singapore has issued guidance that treats circular RNA as an incremental modification rather than a brand-new modality, shortening review cycles. Governments are also funding domestic supply chains-Australia's RNA Blueprint forecasts an AUD 8 billion GDP contribution, and South Korea's GC Biopharma is co-developing autoimmune candidates with Immetas. Cost-innovation dynamics are particularly acute in China, where localized manufacturing is delivering individualized cancer vaccines at prices 99% below Western benchmarks, effectively expanding patient access and challenging incumbent pricing strategies across the mRNA vaccines and therapeutics market.

Europe maintains steady mid-teens growth, supported by strategic industrial policy. BioNTech committed GBP 1 billion for two UK R&D hubs specializing in genomics and regenerative medicine, a project subsidized by GBP 129 million in government grants. CEPI's USD 145 million facility in Rwanda, although located in Africa, employs European process technology and quality-management protocols, extending the continent's influence. Meanwhile, Latin America is leveraging PAHO's capacity-building program, which equips plants in Argentina and Brazil with modular cleanrooms and knowledge transfer packages provided by Canadian funding. These initiatives collectively diffuse manufacturing know-how and reduce single-region supply dependence, boosting resilience across the mRNA vaccines and therapeutics market.

1. Pfizer
2. Moderna
3. BioNTech
4. CureVac SE
5. Arcturus Therapeutics
6. GlaxoSmithKline
7. Sanofi
8. Daiichi Sankyo
9. AstraZeneca
10. CSL Seqirus
11. Chugai Pharmaceutical
12. Gennova Biopharmaceuticals
13. eTheRNA Immunotherapies
14. Orbital Therapeutics
15. SAB Biotherapeutics
16. Strand Therapeutics
17. GreenLight Biosciences
18. Providence Therapeutics
19. CanSino Biologics
20. Walvax Biotechnology

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Pandemic-Preparedness Demand Surge
  • 4.2.2 Rising Chronic & Infectious Disease Burden
  • 4.2.3 Government & Venture R&D Funding Escalation
  • 4.2.4 Commercial Proof-Of-Concept Post-COVID-19
  • 4.2.5 Modular Closed-System mRNA Manufacturing Roll-Out
  • 4.2.6 Advancements in Self-Amplifying/Circular mRNA
• 4.3 Market Restraints
  • 4.3.1 Cold-Chain & Stringent Regulatory Compliance
  • 4.3.2 Elevated Production Cost & Scale-Up Complexity
  • 4.3.3 LNP Excipient Supply Bottlenecks & Patent Thickets
  • 4.3.4 Vaccine-Hesitancy & Misinformation Headwinds
• 4.4 Regulatory Landscape
• 4.5 Porters Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By mRNA Construct Type
  • 5.1.1 Conventional non-replicating mRNA
  • 5.1.2 Self-amplifying mRNA
  • 5.1.3 Circular mRNA
  • 5.1.4 Others
• 5.2 By Therapeutic Area
  • 5.2.1 Infectious Diseases
  • 5.2.2 Oncology
  • 5.2.3 Autoimmune Disorders
  • 5.2.4 Others
• 5.3 By Delivery System
  • 5.3.1 Lipid Nanoparticles (LNP)
  • 5.3.2 Polymer-based Nanocarriers
  • 5.3.3 Cationic Nano-emulsions
  • 5.3.4 Viral Vectors
  • 5.3.5 Others
• 5.4 By Distribution Channel
  • 5.4.1 Public
  • 5.4.2 Private
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Pfizer Inc.
  • 6.3.2 Moderna Inc.
  • 6.3.3 BioNTech SE
  • 6.3.4 CureVac SE
  • 6.3.5 Arcturus Therapeutics
  • 6.3.6 GSK plc
  • 6.3.7 Sanofi
  • 6.3.8 Daiichi Sankyo
  • 6.3.9 AstraZeneca
  • 6.3.10 CSL Seqirus
  • 6.3.11 Chugai Pharmaceutical
  • 6.3.12 Gennova Biopharmaceuticals
  • 6.3.13 eTheRNA Immunotherapies
  • 6.3.14 Orbital Therapeutics
  • 6.3.15 SAB Biotherapeutics
  • 6.3.16 Strand Therapeutics
  • 6.3.17 GreenLight Biosciences
  • 6.3.18 Providence Therapeutics
  • 6.3.19 CanSino Biologics
  • 6.3.20 Walvax Biotechnology

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment