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市場調查報告書
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1813823

美國mRNA 治療合約開發和受託製造廠商市場規模、佔有率和趨勢分析報告：適應症、應用、最終用途和細分預測，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個工作天內

價格

美國mRNA療法合約開發與受託製造廠商市場摘要

美國mRNA 治療合約開發和製造組織市場預計在 2024 年價值 14.3 億美元，預計到 2033 年將達到 48.5 億美元，2025 年至 2033 年的複合年成長率為 14.57%。

大量生物技術公司和研究機構以及完善的法規環境推動市場的發展。

此外，mRNA 在疫苗、癌症治療和罕見遺傳疾病領域的應用日益廣泛，預計將推動市場成長。隨著多家生物技術公司參與 mRNA 療法的開發，這些公司擴大將質體DNA 生產、試管內轉錄 (IVT)、脂質奈米顆粒 (LNP) 製劑以及無菌灌裝/封口等服務外包給受託製造廠商(CDM)，以提高成本效益並縮短產品上市時間。此外，自動化、基於人工智慧的品管和先進的 LNP 系統等新技術的整合正在提高生產能力，從而在不久的將來提升市場的成長潛力。

大型製藥、生物技術和生命科學公司的強大影響力推動市場需求。在深厚的科學專業知識、先進的基礎設施和強大的資金籌措系統的支持下，該國仍然是藥物發現和創新的中心。人們對臨床試驗的興趣日益濃厚，特別是對腫瘤學、感染疾病和罕見遺傳病領域的 mRNA 療法的興趣，這推動了對靈活且可擴展的受託製造廠商)服務的需求。此外，活體生物治療藥物和下一代生技藥品的不斷創新預計將推動市場成長。這些進步在針對以前無法治療或罕見的疾病時尤其重要，它們為具有 mRNA 合成、脂質奈米顆粒 (LNP) 製劑和無菌填充/封口能力的受託製造廠商創造了重要的外包機會。此外，由美國FDA 等機構主導的既定法律規範有助於加快開發時間表，並促進突破性療法的核准和核准利益。

此外，美國食品藥物管理局 (FDA) 等完善的監管框架有助於加快研發進度，透過突破性療法和快速通道認證核准，並提供清晰的 GMP 合規途徑。因此，預計支持性監管政策和政府資金將在預計期間推動市場發展。

美國mRNA治療合約開發與製造組織市場的細分

該報告預測了 2021 年至 2033 年國家層級的收益成長，並對每個細分市場的最新行業趨勢進行了分析。關於研究 Grand View Research 根據適應症、應用和最終用途對美國mRNA 治療合約開發和製造組織市場報告進行了細分。

  • 預測展望（銷售額，2021-2033）
  • 感染疾病
  • 代謝和遺傳疾病。
  • 心腦血管疾病。
  • 應用展望（銷售額，2021-2033）
  • 病毒疫苗
  • 蛋白質替代療法
  • 癌症免疫治療
  • 最終用途展望（收益，2021-2033）
  • 生技公司
  • 製藥公司
  • 政府及學術研究機構

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國mRNA 治療合約開發與受託製造廠商市場變數、趨勢與範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 經營模式分析
  • 定價模式分析
  • 技術格局
  • 產品平臺分析
  • 市場分析工具
    • 波特五力分析
    • PESTEL 與 SWOT 分析
    • COVID-19影響分析

第4章美國mRNA治療合約開發與受託製造廠商市場：適應症與趨勢分析

  • 美國mRNA 治療合約開發和受託製造廠商市場（按適應症）：細分儀表板
  • 美國mRNA治療合約開發與受託製造廠商市場（按適應症）：波動分析
  • 依症狀，2021-2033 年
  • 感染疾病
  • 代謝和遺傳疾病
  • 心臟和腦血管疾病

第5章美國mRNA治療合約開發與受託製造廠商市場：應用評估與趨勢分析

  • 美國mRNA 治療合約開發和製造組織市場（按應用）：細分儀表板
  • 美國mRNA 治療合約開發和製造組織市場（按應用：波動分析）
  • 按應用，2021-2033
  • 病毒疫苗
  • 蛋白質替代療法
  • 癌症免疫治療

第6章美國mRNA 治療合約開發和受託製造廠商市場：最終用途估計和趨勢分析

  • 美國mRNA 治療合約開發和製造組織市場（按最終用途）：細分儀表板
  • 美國mRNA 治療合約開發和製造組織市場（按最終用途）：波動分析
  • 按應用，2021-2033
  • 生技公司
  • 製藥公司
  • 政府及學術研究機構

第7章 競爭態勢

  • 市場參與企業分類
    • 市場領導
    • 新興企業
  • 2024年公司市佔率/估值分析
  • 公司簡介
    • 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)