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市场调查报告书
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1813823

美国mRNA 治疗合约开发和受託製造厂商市场规模、份额和趋势分析报告:适应症、应用、最终用途和细分预测,2025-2033 年

U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Size, Share & Trends Analysis Report By Indication (Infectious Diseases, Metabolic & Genetic Diseases), By Application, By End Use, And Segment Forecasts, 2025 - 2033

出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10个工作天内

价格

美国mRNA疗法合约开发与受託製造厂商市场摘要

美国mRNA 治疗合约开发和製造组织市场预计在 2024 年价值 14.3 亿美元,预计到 2033 年将达到 48.5 亿美元,2025 年至 2033 年的复合年增长率为 14.57%。

大量生物技术公司和研究机构以及完善的法规环境推动市场的发展。

此外,mRNA 在疫苗、癌症治疗和罕见遗传疾病领域的应用日益广泛,预计将推动市场成长。随着多家生物技术公司参与 mRNA 疗法的开发,这些公司越来越多地将质体DNA 生产、试管内转录 (IVT)、脂质奈米颗粒 (LNP) 製剂以及无菌灌装/封口等服务外包给受託製造厂商(CDM),以提高成本效益并缩短产品上市时间。此外,自动化、基于人工智慧的品管和先进的 LNP 系统等新技术的整合正在提高生产能力,从而在不久的将来提升市场的成长潜力。

大型製药、生物技术和生命科学公司的强大影响力推动市场需求。在深厚的科学专业知识、先进的基础设施和强大的资金筹措系统的支持下,该国仍然是药物发现和创新的中心。人们对临床试验的兴趣日益浓厚,特别是对肿瘤学、感染疾病和罕见遗传病领域的 mRNA 疗法的兴趣,这推动了对灵活且可扩展的受託製造厂商)服务的需求。此外,活体生物治疗药物和下一代生技药品的不断创新预计将推动市场成长。这些进步在针对以前无法治疗或罕见的疾病时尤其重要,它们为具有 mRNA 合成、脂质奈米颗粒 (LNP) 製剂和无菌填充/封口能力的受託製造厂商创造了重要的外包机会。此外,由美国FDA 等机构主导的既定法律规范有助于加快开发时间表,并促进突破性疗法的核准和核准利益。

此外,美国食品药物管理局 (FDA) 等完善的监管框架有助于加快研发进度,透过突破性疗法和快速通道认证核准,并提供清晰的 GMP 合规途径。因此,预计支持性监管政策和政府资金将在预计期间推动市场发展。

美国mRNA治疗合约开发与製造组织市场的细分

该报告预测了 2021 年至 2033 年国家层级的收益成长,并对每个细分市场的最新行业趋势进行了分析。关于研究 Grand View Research 根据适应症、应用和最终用途对美国mRNA 治疗合约开发和製造组织市场报告进行了细分。

  • 预测展望(销售额,2021-2033)
  • 感染疾病
  • 代谢和遗传疾病。
  • 心脑血管疾病。
  • 应用展望(销售额,2021-2033)
  • 病毒疫苗
  • 蛋白质替代疗法
  • 癌症免疫治疗
  • 最终用途展望(收益,2021-2033)
  • 生技公司
  • 製药公司
  • 政府及学术研究机构

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国mRNA 治疗合约开发与受託製造厂商市场变数、趋势与范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 经营模式分析
  • 定价模式分析
  • 技术格局
  • 产品平臺分析
  • 市场分析工具
    • 波特五力分析
    • PESTEL 与 SWOT 分析
    • COVID-19影响分析

第四章美国mRNA治疗合约开发与受託製造厂商市场:适应症与趋势分析

  • 美国mRNA 治疗合约开发和受託製造厂商市场(按适应症):细分仪表板
  • 美国mRNA治疗合约开发与受託製造厂商市场(按适应症):波动分析
  • 依症状,2021-2033 年
  • 感染疾病
  • 代谢和遗传疾病
  • 心臟和脑血管疾病

第五章美国mRNA治疗合约开发与受託製造厂商市场:应用评估与趋势分析

  • 美国mRNA 治疗合约开发和製造组织市场(按应用):细分仪表板
  • 美国mRNA 治疗合约开发和製造组织市场(按应用:波动分析)
  • 按应用,2021-2033
  • 病毒疫苗
  • 蛋白质替代疗法
  • 癌症免疫治疗

第六章美国mRNA 治疗合约开发和受託製造厂商市场:最终用途估计和趋势分析

  • 美国mRNA 治疗合约开发和製造组织市场(按最终用途):细分仪表板
  • 美国mRNA 治疗合约开发和製造组织市场(按最终用途):波动分析
  • 按应用,2021-2033
  • 生技公司
  • 製药公司
  • 政府及学术研究机构

第七章 竞争态势

  • 市场参与企业分类
    • 市场领导
    • 新兴企业
  • 2024年公司市占率/估值分析
  • 公司简介
    • Danaher(Aldevron)
    • Biomay AG
    • Bio-Synthesis, Inc.
    • eTheRNA
    • Kaneka Eurogentec SA
    • TriLink BioTechnologies
    • ApexBio Technology
    • BioNTech SE
    • Lonza
    • Recipharm AB
    • Catalent, Inc.
    • Samsung Biologics
Product Code: GVR-4-68040-698-6

U.S. mRNA Therapeutics CDMO Market Summary

The U.S. mRNA therapeutics contract development & manufacturing organization market size was estimated at USD 1.43 billion in 2024 and is projected to reach USD 4.85 billion by 2033, growing at a CAGR of 14.57% from 2025 to 2033. The market is driven by strong presence of biotech companies, research institutions, and a supportive regulatory environment.

Moreover, expanding usage of mRNA in vaccines, cancer treatments, and rare genetic diseases is expected to boost the market growth. As several biotech companies are involved in the development of mRNA-based therapeutics, these companies are increasingly turning to CDMOs for services such as plasmid DNA production, in vitro transcription (IVT), lipid nanoparticle (LNP) formulation, and aseptic fill/finish for cost-effectiveness and reduced time to market. In addition, integration of novel technologies such as automation, AI-based quality control, and advanced LNP systems boosts production capabilities, thereby driving the market growth potential in the near future.

The strong presence of leading pharmaceutical, biotechnology, and life sciences companies drives the demand in the market. The country remains a central drug discovery and innovation hub, supported by deep scientific expertise, advanced infrastructure, and robust funding ecosystems. The growing interest in clinical trials, particularly for mRNA-based therapeutics across oncology, infectious diseases, and rare genetic conditions, is propelling the demand for flexible and scalable CDMO services. Besides, increasing innovation of live biotherapeutics and next-generation biologics is expected to drive the market growth. These advancements are especially relevant in targeting previously untreatable or rare diseases, creating substantial outsourcing opportunities for CDMOs equipped with mRNA synthesis, lipid nanoparticle (LNP) formulation, and aseptic fill/finish capabilities. Furthermore, the well-established regulatory framework led by agencies such as the U.S. FDA facilitates accelerated development timelines, a

pprovals through breakthrough therapy and fast-track designations, and a clear path for GMP compliance. Thus, supportive regulatory policies and government funding are anticipated to drive the market over the estimated time period.

U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. mRNA therapeutics contract development & manufacturing organization market report based on indication, application, and end use.

  • Indication Outlook (Revenue, USD Million, 2021 - 2033)
  • Infectious Diseases
  • Metabolic & Genetic Diseases
  • Cardiovascular & Cerebrovascular Diseases
  • Application Outlook (Revenue, USD Million, 2021 - 2033)
  • Viral Vaccines
  • Protein Replacement Therapies
  • Cancer Immunotherapies
  • End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Biotech Companies
  • Pharmaceutical Companies
  • Government & Academic Research Institutes

Table of Contents

Chapter 1. Research Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Indication
    • 1.2.2. Application
    • 1.2.3. End Use
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased Database
    • 1.4.2. GVR's Internal Database
    • 1.4.3. Secondary Sources
    • 1.4.4. Primary Research
  • 1.5. Information Or Data Analysis
    • 1.5.1. Data Analysis Models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity Flow Analysis
    • 1.7.2. Value-Chain-Based Sizing & Forecasting
    • 1.7.3. Multivariate Model Analysis
  • 1.8. List Of Secondary Sources
  • 1.9. List Of Abbreviations
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Related/Ancillary Market Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
      • 3.2.1.1. High growth in mRNA-based vaccine development
      • 3.2.1.2. Growing clinical trial activities for development of novel mRNA therapeutics
      • 3.2.1.3. Surge in government funding and strategic public-private partnerships
      • 3.2.1.4. Rapid Adoption of Personalized and Decentralized Therapies
      • 3.2.1.5. Growing preference for one-stop shop CDMOs
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Availability of low-cost substitute therapies
      • 3.2.2.2. High Technical Barriers and Capital Intensity
  • 3.3. Business Model Analysis
  • 3.4. Pricing Model Analysis
  • 3.5. Technology Landscape
  • 3.6. Product Pipeline Analysis
  • 3.7. Market Analysis Tools
    • 3.7.1. Porter's Five Force Analysis
    • 3.7.2. PESTEL by SWOT Analysis
    • 3.7.3. COVID-19 Impact Analysis

Chapter 4. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Indication Estimates & Trend Analysis

  • 4.1. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, By Indication: Segment Dashboard
  • 4.2. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, By Indication: Movement Analysis
  • 4.3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates & Forecasts, By Indication, 2021-2033 (USD Million)
  • 4.4. Infectious Diseases
    • 4.4.1. Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Metabolic & Genetic Diseases
    • 4.5.1. Metabolic & Genetic Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6. Cardiovascular & Cerebrovascular Diseases
    • 4.6.1. Cardiovascular & Cerebrovascular Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Application Estimates & Trend Analysis

  • 5.1. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, By Application: Segment Dashboard
  • 5.2. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, By Application: Movement Analysis
  • 5.3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates & Forecasts, By Application, 2021-2033 (USD Million)
  • 5.4. Viral Vaccines
    • 5.4.1. Viral Vaccines Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Protein Replacement Therapies
    • 5.5.1. Protein Replacement Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Cancer Immunotherapies
    • 5.6.1. Cancer Immunotherapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: End Use Estimates & Trend Analysis

  • 6.1. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, By End Use: Segment Dashboard
  • 6.2. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market, By End Use: Movement Analysis
  • 6.3. U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates & Forecasts, By End Use, 2021-2033 (USD Million)
  • 6.4. Biotech Companies
    • 6.4.1. Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Pharmaceutical Companies
    • 6.5.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Government & Academic Research Institutes
    • 6.6.1. Government & Academic Research Institutes Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

  • 7.1. Market Participant Categorization
    • 7.1.1. Market Leaders
    • 7.1.2. Emerging Players
  • 7.2. Company Market Share/Assessment Analysis, 2024
  • 7.3. Company Profiles
    • 7.3.1. Danaher (Aldevron)
      • 7.3.1.1. Company Overview
      • 7.3.1.2. Financial Performance
      • 7.3.1.3. Service Benchmarking
      • 7.3.1.4. Strategic Initiatives
    • 7.3.2. Biomay AG
      • 7.3.2.1. Company Overview
      • 7.3.2.2. Financial Performance
      • 7.3.2.3. Service Benchmarking
      • 7.3.2.4. Strategic Initiatives
    • 7.3.3. Bio-Synthesis, Inc.
      • 7.3.3.1. Company Overview
      • 7.3.3.2. Financial Performance
      • 7.3.3.3. Service Benchmarking
      • 7.3.3.4. Strategic Initiatives
    • 7.3.4. eTheRNA
      • 7.3.4.1. Company Overview
      • 7.3.4.2. Financial Performance
      • 7.3.4.3. Service Benchmarking
      • 7.3.4.4. Strategic Initiatives
    • 7.3.5. Kaneka Eurogentec S.A.
      • 7.3.5.1. Company Overview
      • 7.3.5.2. Financial Performance
      • 7.3.5.3. Service Benchmarking
      • 7.3.5.4. Strategic Initiatives
    • 7.3.6. TriLink BioTechnologies
      • 7.3.6.1. Company Overview
      • 7.3.6.2. Financial Performance
      • 7.3.6.3. Service Benchmarking
      • 7.3.6.4. Strategic Initiatives
    • 7.3.7. ApexBio Technology
      • 7.3.7.1. Company Overview
      • 7.3.7.2. Financial Performance
      • 7.3.7.3. Service Benchmarking
      • 7.3.7.4. Strategic Initiatives
    • 7.3.8. BioNTech SE
      • 7.3.8.1. Company Overview
      • 7.3.8.2. Financial Performance
      • 7.3.8.3. Service Benchmarking
      • 7.3.8.4. Strategic Initiatives
    • 7.3.9. Lonza
      • 7.3.9.1. Company Overview
      • 7.3.9.2. Financial Performance
      • 7.3.9.3. Service Benchmarking
      • 7.3.9.4. Strategic Initiatives
    • 7.3.10. Recipharm AB
      • 7.3.10.1. Company Overview
      • 7.3.10.2. Financial Performance
      • 7.3.10.3. Service Benchmarking
      • 7.3.10.4. Strategic Initiatives
    • 7.3.11. Catalent, Inc.
      • 7.3.11.1. Company Overview
      • 7.3.11.2. Financial Performance
      • 7.3.11.3. Service Benchmarking
      • 7.3.11.4. Strategic Initiatives
    • 7.3.12. Samsung Biologics
      • 7.3.12.1. Company Overview
      • 7.3.12.2. Financial Performance
      • 7.3.12.3. Service Benchmarking
      • 7.3.12.4. Strategic Initiatives

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates and Forecasts, by Indication, 2021 - 2033 (USD Million)
  • Table 4 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates and Forecasts, by Application, 2021 - 2033 (USD Million)
  • Table 5 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates and Forecasts, by End Use, 2021 - 2033 (USD Million)

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates and Forecasts, by Indication, 2021 - 2033 (USD Million)
  • Table 4 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Estimates and Forecasts, by Application, 2021 - 2033 (USD Million)
  • Table 5 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market EsList of Figures
  • Fig. 1 Market Research Process
  • Fig. 2 Information Procurement
  • Fig. 3 Primary Research Pattern
  • Fig. 4 Market Research Approaches
  • Fig. 5 Market Formulation & Validation
  • Fig. 6 Commodity Flow Analysis
  • Fig. 7 Value-chain-based Sizing & Forecasting
  • Fig. 8 QFD Model Sizing & Forecasting
  • Fig. 9 Bottom-up Approach
  • Fig. 10 Market Snapshot
  • Fig. 11 Segment Snapshot 1
  • Fig. 12 Segment Snapshot 2
  • Fig. 13 Competitive Landscape Snapshot
  • Fig. 14 Parent Market Outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary Market Outlook, 2024 (USD Billion)
  • Fig. 16 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market Dynamics
  • Fig. 17 Porter's Five Forces Analysis
  • Fig. 18 PESTEL Analysis
  • Fig. 19 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Indication Outlook and Key Takeaways
  • Fig. 20 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Indication Movement Analysis
  • Fig. 21 Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Metabolic & Genetic Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 Cardiovascular & Cerebrovascular Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Application Outlook and Key Takeaways
  • Fig. 25 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: Application Movement Analysis
  • Fig. 26 Viral Vaccines Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Protein Replacement Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Cancer Immunotherapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: End Use Outlook and Key Takeaways
  • Fig. 30 U.S. mRNA Therapeutics Contract Development & Manufacturing Organization Market: End Use Movement Analysis
  • Fig. 31 Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 Government & Academic Research Institutes Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Key Company Categorization
  • Fig. 35 Service Heat Map Analysis
  • Fig. 36 Strategic Frameworkimates and Forecasts, by End Use, 2021 - 2033 (USD Million)