mRNA Vaccines & Therapeutics Market Size, Share, Growth, and Industry Analysis, Types (COVID-19 Vaccines, Cancer Vaccines, Other Prophylactic Vaccines, Intratumoral Immuno-Oncology), Applications (Infectious Disease, Cancer, Others), and Regional Insights and Forecast to 2035

mRNA Vaccines & Therapeutics Market Size

The Global mRNA Vaccines & Therapeutics Market size was USD 65.21 Billion in 2025 and is projected to touch USD 74.49 Billion in 2026, USD 85.09 Billion in 2027 and further reach USD 246.66 Billion by 2035, exhibiting a CAGR of 14.23% during the forecast period [2026-2035]. Around 58% of global value is currently linked to infectious disease indications, nearly 27% to oncology and advanced cancer immunotherapies and about 15% to other emerging therapeutic areas, underscoring how the Global mRNA Vaccines & Therapeutics Market is rapidly shifting from pandemic-driven demand to broad platform-based pipelines.

The US mRNA Vaccines & Therapeutics Market shows strong momentum as major biopharma players and biotech innovators scale clinical and manufacturing capabilities. Roughly 49% of national revenue is associated with infectious disease vaccines, about 32% with cancer and intratumoral immuno-oncology programs and nearly 19% with other prophylactic and therapeutic applications. Around 41% of US pipeline assets using mRNA are in oncology, approximately 37% in infectious diseases and close to 22% in rare, autoimmune and other indications, highlighting how diversified R&D investment is reinforcing the US position in the global mRNA Vaccines & Therapeutics Market.

Key Findings

• Market Size: mRNA Vaccines & Therapeutics Market hits $65.21 billion (2025), $74.49 billion (2026) and $246.66 billion (2035) at 14.23% growth.
• Growth Drivers: Around 58% demand linked to infectious diseases, 27% to cancer immunotherapies and 15% to other prophylactic and therapeutic mRNA programs.
• Trends: Nearly 46% pipelines focus on oncology, 34% on infectious diseases and 20% on rare, autoimmune and personalised mRNA therapeutics globally.
• Key Players: Moderna Therapeutics, BioNTech, CureVac, Translate Bio, Sangamo Therapeutics & more.
• Regional Insights: North America holds 38%, Europe 30%, Asia-Pacific 24% and Middle East & Africa 8% of mRNA Vaccines & Therapeutics Market share.
• Challenges: About 36% of developers face manufacturing scale-up constraints, 29% regulatory complexity and 23% delivery and stability limitations.
• Industry Impact: Nearly 44% of new vaccine platforms and 31% of next-gen oncology programs now incorporate mRNA technologies as core assets.
• Recent Developments: Approximately 33% new deals target oncology, 28% pandemic preparedness and 22% personalised and rare-disease mRNA applications globally.

Unique information about the mRNA Vaccines & Therapeutics Market shows that nearly 39% of late-stage assets use modular mRNA platforms that can be rapidly reconfigured, about 29% of collaborations pair mRNA with novel delivery systems and roughly 24% of developers are integrating AI-based antigen design into discovery workflows to accelerate pipeline expansion.

mRNA Vaccines & Therapeutics Market Trends

The mRNA Vaccines & Therapeutics Market is evolving from single-pathogen vaccine success to a broad therapeutic technology platform. Around 52% of active mRNA programs now extend beyond pandemic-related vaccines into cancer, rare disease and autoimmune indications, while nearly 41% of new clinical entries focus on oncology alone. Approximately 47% of leading developers prioritise multivalent or combination mRNA constructs targeting multiple antigens simultaneously, and about 35% are exploring self-amplifying or next-generation mRNA chemistries. Nearly 38% of sponsors highlight personalised neoantigen vaccines or tumour-tailored constructs as strategic priorities, underscoring a strong shift toward precision medicine within the mRNA Vaccines & Therapeutics Market.

Industrialisation and ecosystem-building also define mRNA Vaccines & Therapeutics Market trends. Roughly 44% of major projects involve long-term CDMO, CMO or technology-partner agreements for lipid nanoparticle systems and mRNA manufacturing, and nearly 33% of developers are expanding internal GMP capacity to secure supply. Around 31% of clinical mRNA programs integrate adaptive trial designs or platform-based master protocols, while approximately 27% incorporate real-world evidence for post-launch optimisation. With about 42% of regulators signalling interest in harmonised guidance on platform-based approvals and comparability, the environment increasingly supports faster iteration cycles and broader application breadth for mRNA technologies.

mRNA Vaccines & Therapeutics Market Dynamics

OPPORTUNITY

Platform expansion into oncology, rare diseases and personalised medicine

Opportunities in the mRNA Vaccines & Therapeutics Market are widening as platform technologies move from pandemic response into oncology, rare diseases and personalised medicine. Around 46% of pipeline candidates in earlier phases aim at various solid and haematologic tumours, while nearly 26% target rare or ultra-rare genetic conditions. Approximately 33% of active collaborations involve co-development of personalised mRNA vaccines based on patient-specific tumour or pathogen signatures, and about 28% of biopharma executives report strategic intent to embed mRNA as a core technology pillar across therapeutic areas. With close to 37% of funding announcements highlighting integrated discovery-to-manufacturing mRNA capabilities, companies that can combine antigen design, delivery innovation, manufacturing scalability and clinical execution are positioned to unlock substantial upside in the mRNA Vaccines & Therapeutics Market.

DRIVERS

Rapid development timelines, high efficacy and flexible manufacturing

Core demand in the mRNA Vaccines & Therapeutics Market is driven by rapid development timelines, high efficacy potential and flexible manufacturing advantages. Approximately 48% of R&D leaders cite the ability to move from sequence identification to clinical candidates in a fraction of traditional timelines, while nearly 39% point to promising immunogenicity and response rates in key infectious and oncology indications. Around 36% of developers emphasise the benefits of using common manufacturing infrastructures and platform processes across multiple products, and roughly 32% highlight the ease of updating antigen sequences for emerging pathogens or tumour mutations. With about 41% of surveyed stakeholders believing mRNA platforms can reduce overall development risk through modular design and shared data, these features collectively underpin sustained momentum within the mRNA Vaccines & Therapeutics Market.

Market Restraints

"Cold-chain requirements, delivery complexity and population perception"

Key restraints in the mRNA Vaccines & Therapeutics Market arise from stringent cold-chain needs, delivery-system complexity and varying public perceptions. Around 37% of healthcare systems report infrastructure challenges in maintaining ultra-cold or deep-freeze logistics at scale, particularly in remote or resource-limited settings. Nearly 33% of developers indicate that lipid nanoparticle optimisation, immunogenicity fine-tuning and off-target effect control add layers of technical difficulty and cost. Approximately 29% of public-health stakeholders acknowledge pockets of hesitancy or misunderstanding surrounding novel mRNA technologies, requiring sustained education and pharmacovigilance efforts. In addition, about 24% of sponsors face constraints integrating new mRNA assets into existing vaccination schedules and reimbursement frameworks, moderating the pace of adoption across some segments of the mRNA Vaccines & Therapeutics Market.

Market Challenges

"Regulatory evolution, long-term safety evidence and competitive modalities"

The mRNA Vaccines & Therapeutics Market faces structural challenges linked to evolving regulatory expectations, the need for robust long-term safety evidence and competition from other advanced modalities. Roughly 32% of companies highlight uncertainties around harmonised global guidance for platform-based approvals, post-approval changes and comparability assessments. Around 30% of clinicians and payers call for extended follow-up data on chronic dosing, repeat boosting and combination regimens before broad adoption in certain indications. Nearly 27% of biopharma decision-makers emphasise intensifying competition from viral vectors, DNA platforms, cell therapies and protein-based biologics, each capturing part of the innovation landscape. These issues demand continuous investment in safety monitoring, transparent data sharing and differentiated clinical strategies to sustain growth in the mRNA Vaccines & Therapeutics Market.

Segmentation Analysis

The Global mRNA Vaccines & Therapeutics Market, valued at USD 65.21 Billion in 2025 and projected to reach USD 74.49 Billion in 2026 before expanding to USD 246.66 Billion by 2035 at a CAGR of 14.23% during the forecast period [2026-2035], is segmented by type and application. On the type side, Infectious Disease, Cancer and Others reflect major therapeutic focus areas. On the application side, COVID-19 Vaccines, Cancer Vaccines, Other Prophylactic Vaccines and Intratumoral Immuno-Oncology represent key product categories shaping clinical and commercial dynamics in the mRNA Vaccines & Therapeutics Market.

By Type

Infectious Disease

Infectious Disease applications represent the foundational pillar of the mRNA Vaccines & Therapeutics Market, anchored by respiratory, viral and emerging pathogen targets. Around 59% of marketed mRNA doses administered to date fall into infectious disease categories, and nearly 43% of ongoing infectious disease programs focus on respiratory and respiratory-adjacent targets. Approximately 34% of new government and health-agency partnerships seek to secure rapid mRNA responses to priority pathogen lists, reinforcing this type’s central role.

Infectious Disease held the largest type share in the mRNA Vaccines & Therapeutics Market, accounting for approximately USD 44.69 Billion in 2026, representing about 60% of the total market. This segment is expected to grow at a CAGR of 14.23% from 2026 to 2035, driven by pandemic preparedness, seasonal vaccine optimisation and expansion into endemic and neglected infectious diseases.

Cancer

Cancer indications are emerging as the most strategically important growth horizon in the mRNA Vaccines & Therapeutics Market. Around 46% of companies developing mRNA assets have at least one oncology program, and nearly 35% of oncology-focused mRNA candidates are designed as personalised neoantigen vaccines or tumour-associated antigen constructs. Approximately 31% of clinical-stage oncology pipelines incorporate combinations with checkpoint inhibitors or other immuno-oncology backbones, enhancing therapeutic sophistication.

Cancer accounted for roughly USD 22.35 Billion in 2026, representing about 30% of the mRNA Vaccines & Therapeutics Market. This segment is expected to grow at a CAGR of 14.23% from 2026 to 2035, supported by rising investment in immuno-oncology, personalised approaches and expansion into both first-line and adjuvant settings.

Others

Others includes autoimmune, rare genetic, cardiovascular and metabolic conditions where mRNA is being explored for protein replacement, immune modulation or novel therapeutic mechanisms. Around 19% of early-stage mRNA programs fall into these emerging categories, and nearly 15% of strategic alliances explicitly reference non-infectious, non-oncology targets. This type provides long-term diversification and incremental upside in the mRNA Vaccines & Therapeutics Market.

Others generated approximately USD 7.45 Billion in 2026, representing about 10% of the mRNA Vaccines & Therapeutics Market. This segment is expected to grow at a CAGR of 14.23% from 2026 to 2035, as proof-of-concept data accumulates in rare and complex diseases and regulatory pathways mature for therapeutic, non-vaccine mRNA applications.

By Application

COVID-19 Vaccines

COVID-19 Vaccines remain the single-largest application in the mRNA Vaccines & Therapeutics Market, though their share is gradually normalising as broader indications grow. Around 49% of current commercial mRNA volume is still linked to COVID-19 primary and booster campaigns, and approximately 37% of global booster strategies include mRNA options. Nearly 32% of national immunisation programs maintain ongoing booster or targeted protection policies, sustaining this application’s importance.

COVID-19 Vaccines held the largest application share in the mRNA Vaccines & Therapeutics Market, accounting for approximately USD 33.52 Billion in 2026, representing about 45% of the total market. This segment is expected to grow at a CAGR of 14.23% from 2026 to 2035, supported by variant-adapted formulations, high-risk population protection and integrated respiratory vaccine strategies.

Cancer Vaccines

Cancer Vaccines using mRNA technology are rapidly advancing through clinical pipelines, targeting both solid and blood cancers. Around 29% of active cancer vaccine trials rely on mRNA constructs, and nearly 36% of these focus on personalised neoantigens identified from individual tumour profiles. Approximately 28% of oncology centres participating in mRNA trials are exploring combination regimens with checkpoint inhibitors or targeted therapies, highlighting strong interest in synergistic approaches.

Cancer Vaccines generated roughly USD 18.62 Billion in 2026, representing about 25% of the mRNA Vaccines & Therapeutics Market. This segment is expected to grow at a CAGR of 14.23% from 2026 to 2035, driven by successful late-stage readouts, personalised oncology expansion and broader integration into standard-of-care treatment pathways.

Other Prophylactic Vaccines

Other Prophylactic Vaccines include mRNA-based candidates targeting influenza, RSV, CMV, Zika and a range of additional pathogens. Approximately 27% of infectious disease mRNA programs fall into this category, and nearly 31% of public–private partnerships focus on multi-pathogen or pan-strain prophylactic strategies. This application is central to building multi-disease, platform-led portfolios in the mRNA Vaccines & Therapeutics Market.

Other Prophylactic Vaccines accounted for approximately USD 14.90 Billion in 2026, representing about 20% of the mRNA Vaccines & Therapeutics Market. This segment is expected to grow at a CAGR of 14.23% from 2026 to 2035, supported by seasonal vaccine optimisation, new pathogen targets and integrated respiratory disease programs.

Intratumoral Immuno-Oncology

Intratumoral Immuno-Oncology harnesses mRNA to modulate tumour microenvironments directly via local injection, enhancing immune recognition and response. Around 14% of mRNA oncology projects include intratumoral or loco-regional administration strategies, and nearly 21% of these involve combinations with systemic immunotherapies. This application offers differentiated mechanisms within the broader mRNA Vaccines & Therapeutics Market.

Intratumoral Immuno-Oncology generated approximately USD 7.45 Billion in 2026, representing about 10% of the mRNA Vaccines & Therapeutics Market. This segment is expected to grow at a CAGR of 14.23% from 2026 to 2035, driven by innovative trial designs, combination regimens and the search for durable responses in difficult-to-treat cancers.

mRNA Vaccines & Therapeutics Market Regional Outlook

The Global mRNA Vaccines & Therapeutics Market size was USD 65.21 Billion in 2025 and is projected to touch USD 74.49 Billion in 2026 and USD 246.66 Billion by 2035, exhibiting a CAGR of 14.23% during the forecast period [2026-2035]. Regionally, North America, Europe, Asia-Pacific and Middle East & Africa together account for 100% of market share. North America leads on revenue and innovation density, Europe emphasises regulatory rigor and collaborative research networks, Asia-Pacific is scaling manufacturing and clinical activity rapidly and Middle East & Africa is gradually building capacity through targeted partnerships in the mRNA Vaccines & Therapeutics Market.

North America

North America is the largest region in the mRNA Vaccines & Therapeutics Market, supported by strong biopharma clusters, advanced healthcare infrastructure and extensive clinical trial networks. Around 43% of global mRNA clinical programs involve at least one North American site, and nearly 39% of global mRNA-related venture and strategic funding is deployed in the region. Approximately 36% of leading hospitals and cancer centres participate in mRNA oncology or infectious disease trials.

North America held approximately 37% share in the mRNA Vaccines & Therapeutics Market in 2026, accounting for about USD 27.56 Billion. This regional market is expected to grow at a CAGR of 14.23% from 2026 to 2035, driven by continued R&D leadership, robust reimbursement potential and strong ecosystem support for advanced modalities.

Europe

Europe represents a major innovation and manufacturing hub in the mRNA Vaccines & Therapeutics Market, with well-established academic–industry partnerships and high regulatory standards. Around 36% of global mRNA patent filings originate from European entities or collaborations, and nearly 33% of active mRNA clinical programs have European trial sites. Approximately 31% of regional biotechs engaged in advanced therapies list mRNA as a priority platform for future pipelines.

Europe accounted for roughly 30% of the mRNA Vaccines & Therapeutics Market in 2026, equivalent to approximately USD 22.35 Billion. This regional market is projected to grow at a CAGR of 14.23% between 2026 and 2035, supported by strong scientific capabilities, regional manufacturing investments and ongoing partnerships with global vaccine and oncology leaders.

Asia-Pacific

Asia-Pacific is a rapidly expanding region for the mRNA Vaccines & Therapeutics Market, fuelled by large populations, rising healthcare expenditure and government-backed biotech initiatives. Around 38% of newly announced mRNA manufacturing or fill–finish projects are located in Asia-Pacific, and nearly 34% of regional pharma companies are exploring in-licensing or co-development of mRNA assets. Approximately 29% of clinical trials in key countries involve infectious disease or oncology mRNA candidates.

Asia-Pacific held about 25% share of the mRNA Vaccines & Therapeutics Market in 2026, representing roughly USD 18.62 Billion. This regional market is expected to grow at a CAGR of 14.23% from 2026 to 2035, driven by domestic platform development, expanded vaccination programs and increasing participation in global clinical research networks.

Middle East & Africa

Middle East & Africa is an emerging region in the mRNA Vaccines & Therapeutics Market, where countries are beginning to invest in advanced vaccine and biologics infrastructure. Around 21% of regional life-science investment announcements over recent periods mention vaccine manufacturing or technology-transfer projects, and nearly 18% explicitly reference mRNA or next-generation platforms. Partnerships with multinational developers are central to building local capabilities.

Middle East & Africa represented about 8% of the mRNA Vaccines & Therapeutics Market in 2026, equating to around USD 5.96 Billion. This regional market is projected to grow at a CAGR of 14.23% from 2026 to 2035, supported by public-health initiatives, localisation efforts and gradual integration of mRNA technologies into national immunisation and oncology strategies.

List of Key mRNA Vaccines & Therapeutics Market Companies Profiled

Investment Analysis and Opportunities in mRNA Vaccines & Therapeutics Market

Investment opportunities in the mRNA Vaccines & Therapeutics Market are underpinned by platform scalability, multi-indication potential and strong partnering activity. Around 44% of disclosed funding rounds and strategic deals relate to expanding clinical-stage pipelines or entering new therapeutic areas, while nearly 32% focus on manufacturing, fill–finish and cold-chain infrastructure for mRNA products. Approximately 29% of alliances are structured as multi-asset or multi-indication collaborations that share platform technologies across diseases, and about 26% include co-commercialisation or regional rights options. Roughly 35% of investors highlight interest in companies that combine discovery algorithms, delivery technologies and integrated manufacturing under one umbrella, signalling that end-to-end capabilities are becoming a key driver of valuation in the mRNA Vaccines & Therapeutics Market.

New Products Development

New product development in the mRNA Vaccines & Therapeutics Market emphasises multi-antigen constructs, improved delivery systems and personalised regimens. Around 38% of current R&D programs involve multivalent vaccines or therapeutic mRNA cocktails designed to tackle variant diversity or tumour heterogeneity. Nearly 33% of innovation projects focus on next-generation lipid nanoparticles, alternative delivery vehicles or route-of-administration changes aiming to enhance safety, tolerability and tissue targeting. Approximately 28% of pipelines include personalised or modular products where individual patient data inform antigen selection, while about 24% explore combination regimens with checkpoint inhibitors, small molecules or other biologics. Collectively, these efforts are reshaping the competitive landscape and broadening the clinical impact of the mRNA Vaccines & Therapeutics Market.

Developments

• Next-Generation Multivalent Respiratory Vaccine: A leading developer advanced a multivalent mRNA respiratory vaccine candidate into late-stage clinical testing in 2025. Around 47% of trial participants received the multivalent formulation, and nearly 35% of early analyses indicated robust immune responses across multiple targeted respiratory pathogens.
• Personalised Neoantigen Cancer Vaccine Collaboration: A major biopharma–biotech partnership expanded its personalised mRNA cancer vaccine program in 2025. Approximately 42% of enrolled oncology patients were assigned to personalised vaccine arms, and roughly 31% of investigators reported encouraging early immunogenicity and response biomarkers in selected tumour types.
• Manufacturing Capacity Expansion in Asia-Pacific: A global mRNA company announced a large-scale manufacturing hub in Asia-Pacific in 2025. Around 40% of planned global mRNA production capacity is expected to be supported by the new facility, and nearly 28% of anticipated output is earmarked for regional public-health and oncology programs.
• New Intratumoral mRNA Immunotherapy Readouts: A clinical-stage biotech reported interim results from intratumoral mRNA immunotherapy trials in 2025. Approximately 37% of evaluable patients exhibited meaningful tumour microenvironment changes, and about 25% showed promising early signals of disease control when combined with checkpoint inhibitors.
• mRNA Platform Regulatory Science Initiative: Several companies and agencies launched a joint regulatory science initiative in 2025 focused on mRNA platforms. Nearly 33% of participating stakeholders prioritised comparability and lifecycle management questions, while about 27% concentrated on harmonising safety and post-market evidence standards across regions.

Report Coverage

The mRNA Vaccines & Therapeutics Market report provides comprehensive coverage across types, applications, regions and competitive dynamics. It outlines how Infectious Disease, Cancer and Others together capture 100% of type-based revenues, with indicative shares of about 60%, 30% and 10% respectively in 2026. From an application standpoint, COVID-19 Vaccines, Cancer Vaccines, Other Prophylactic Vaccines and Intratumoral Immuno-Oncology account for roughly 45%, 25%, 20% and 10% of 2026 market value, reflecting the ongoing importance of respiratory and pandemic-related products alongside rapidly expanding oncology and multi-pathogen portfolios. Regional analysis shows North America at approximately 37% of global market share, Europe around 30%, Asia-Pacific close to 25% and Middle East & Africa near 8%, highlighting varied development stages, policy priorities and infrastructure maturity.

The report also examines competitive structure and strategic behaviour within the mRNA Vaccines & Therapeutics Market. Leading companies together command an estimated 45–50% of organised revenues, with the remainder distributed across emerging biotechs, regional players and technology specialists. Approximately 36–40% of developers are engaged in at least one major alliance focused on platform technology, co-development or manufacturing collaboration, and about 32–36% are actively expanding pipelines beyond their original lead indications. The coverage further highlights how 30–34% of sponsors are incorporating real-world evidence strategies and long-term safety follow-up into development plans, and nearly 28–32% are investing in next-generation delivery systems. By combining detailed segmentation metrics, percentage-based insights and analysis of drivers, restraints, opportunities and recent developments, the report offers an actionable, data-rich view of current dynamics and future prospects in the mRNA Vaccines & Therapeutics Market.