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市场调查报告书
商品编码
1790424

美国细胞和基因治疗受託研究机构市场规模、份额和趋势分析报告：按类型、服务、适应症、模式和细分市场预测，2025 年至 2033 年

U.S. Cell & Gene Therapy Contract Research Organizations Market Size, Share & Trends Analysis Report By Type (Drug Discovery, Preclinical, Clinical), By Service, By Indication, By Modality, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10个工作天内

价格

市场规模与趋势：

预计 2024 年美国细胞和基因治疗受託研究机构市场价值为 20.9 亿美元，到 2033 年将达到 48.6 亿美元，2025 年至 2033 年的复合年增长率为 9.91%。

市场成长归因于细胞和基因治疗日益复杂、CGT 临床试验量不断增加、生物技术公司外包不断增加以及监管日益复杂等因素。

市场驱动力源自于科学创新、监管变革和申办者需求的不断增长，而这些需求又推动着合作的不断增加。越来越多的先进治疗方法，包括自体细胞疗法、基因编辑干预和基于体内病毒载体的疗法，已进入临床实验和临床阶段，通常需要高度协调的临床前和临床开发项目。大多数中小型生物技术公司缺乏内部基础设施来满足此类疗法（尤其是针对罕见和极罕见疾病的疗法）复杂的临床、监管和生物分析需求。这种缺口推动了对拥有转化生物学、符合GMP标准的样本管理和免疫抗原性测试等专业技能的合约研究组织（CRO）的需求。

此外，策略性外包模式的兴起，即申办方与合约研究组织 (CRO) 建立一体化伙伴关係关係，以降低固定营运成本并提高扩充性，也推动了市场成长。 CAR-T 和基于腺相关病毒 (AAV) 的治疗方法等物流和患者个体化程度较高的疗法，需要临床试验赞助者、临床机构和监管机构之间的密切协调，这促使临床试验赞助者选择既具备科学深度又具备业务灵活性的 CRO。产学合作的不断扩大、政府支持罕见疾病临床试验的倡议，以及创业投资流入细胞和基因疗法新兴企业企业的不断增加，进一步推动了对 CRO 的需求。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国细胞和基因治疗受託研究机构市场：变数、趋势和范围

  • 市场体系展望
  • 美国细胞与基因治疗受託研究机构市场动态
  • 技术格局
  • 定价模式分析
  • 美国细胞与基因治疗受託研究机构市场：分析工具

第四章：美国细胞和基因治疗受託研究机构市场：按类型估计和趋势分析

  • 细分仪表板
  • 美国细胞与基因治疗受託研究机构市场类型波动
  • 美国细胞与基因治疗受託研究机构)市场规模及趋势分析（按类型），2021 年至 2033 年
  • 药物研发
    • 目标检验
    • 线索识别
    • 先导药物最适化
  • 临床前
  • 临床
    • 第一阶段
    • 第二阶段
    • 第三阶段
    • 第四阶段

第五章美国细胞和基因治疗受託研究机构市场：按服务分類的估计和趋势分析

  • 细分仪表板
  • 美国细胞和基因治疗受託研究机构市场波动分析（按服务）
  • 美国细胞与基因治疗受託研究机构)市场规模及趋势分析（按服务），2021 年至 2033 年
  • 计划和临床试验管理
  • 监理策略
  • 数据管理和医学写作
  • 临床监测
  • 品管/GMP合规性
  • 生物统计学和安全监测
  • 病人和机构招募
  • 技术转移
  • 其他的

第六章：美国细胞和基因治疗受託研究机构市场：按适应症的估计和趋势分析

  • 细分仪表板
  • 美国细胞和基因治疗受託研究机构市场按适应症的波动
  • 美国细胞和基因治疗受託研究机构)市场规模和趋势分析（按适应症），2021 年至 2033 年
  • 肿瘤学
  • 中枢神经系统疾病
  • 感染疾病
  • 临床监测
  • 免疫疾病
  • 心血管疾病
  • 呼吸系统疾病
  • 糖尿病
  • 眼科
  • 疼痛管理
  • 其他的

第七章：美国细胞和基因治疗受託研究机构市场：按模式的估计和趋势分析

  • 细分仪表板
  • 美国细胞和基因治疗受託研究机构市场按治疗方式的波动
  • 美国细胞与基因治疗受託研究机构)市场规模及趋势分析（按模式），2021 年至 2033 年
  • 细胞疗法
  • 基因治疗
  • 基因改造细胞疗法

第八章 竞争态势

  • 公司分类
    • 市场领导者
    • 新兴企业
  • 2024 年公司市场占有率/估值分析
  • 公司简介
    • Altasciences
    • Allucent
    • LabCorp
    • Linical
    • Medpace
    • Thermo Fisher Scientific Inc.
    • Precision Medicine Group, LLC.
    • QPS Holdings
    • Syneos Health
    • ICON plc
Product Code: GVR-4-68040-688-5

Market Size & Trends:

The U.S. cell & gene therapy contract research organizations market size was estimated at USD 2.09 billion in 2024 and is projected to reach USD 4.86 billion by 2033, growing at a CAGR of 9.91% from 2025 to 2033. The growth of the market is due to growing complexity of cell- and gene-based therapeutics, rising clinical trial volume in CGT, increased outsourcing by biotech firms, regulatory complexity, among others.

The market is being driven by growing collaboration among scientific innovation, regulatory changes, and evolving sponsor needs. A growing number of advanced therapies-including autologous cell therapies, gene editing interventions, and in vivo viral vector-based treatments-are reaching investigational and clinical stages, often requiring highly tailored preclinical and clinical development programs. Most small-to-midsize biotech firms lack the internal infrastructure to navigate the complex clinical, regulatory, and bioanalytical demands of such therapies, especially those targeting rare or ultra-rare conditions. This gap fuels demand for CROs with niche expertise in translational biology, GMP-compliant sample management, and immunogenicity testing.

Furthermore, an increase in strategic outsourcing models, where sponsors form integrated partnerships with CROs to reduce fixed operational costs and increase scalability, is also one of the factors driving the market growth. The high logistical and patient-specific complexity of therapies such as CAR-T or AAV-based interventions necessitates deep coordination between trial sponsors, clinical sites, and regulatory bodies, prompting sponsors to engage CROs that bring both scientific depth and operational agility. The expansion of academic-industry partnerships, government initiatives supporting rare disease trials, and growing venture capital inflows into cell and gene therapy startups further amplify CRO demand.

U.S. Cell & Gene Therapy Contract Research Organizations Market Report Segmentation

This report forecasts revenue growth at country level 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. cell & gene therapy contract research organizations market report based on type, phase, service, indication, and modality:

  • Type Outlook (Revenue, USD Million, 2021 - 2033)
  • Drug Discovery
    • Target Validation
    • Lead Identification
    • Lead Optimization
  • Preclinical
  • Clinical
    • Phase I
    • Phase II
    • Phase III
    • Phase IV
  • Service Outlook (Revenue, USD Million, 2021 - 2033)
  • Project & Clinical Trial Management
  • Regulatory Strategy
  • Data Management & Medical Writing
  • Clinical Monitoring
  • Quality Management / GMP Compliance
  • Biostatistics & Safety Monitoring
  • Patient & Site Recruitment
  • Technology Transfer
  • Others
  • Indication Outlook (Revenue, USD Million, 2021 - 2033)
  • Oncology
  • CNS Disorders
  • Infectious Diseases
  • Immunological Disorders
  • Cardiovascular Diseases
  • Respiratory Diseases
  • Diabetes
  • Ophthalmology
  • Pain Management
  • Others
  • Modality Outlook (Revenue, USD Million, 2021 - 2033)
  • Cell-Based Therapies
  • Gene Therapies
  • Gene-Modified Cell Therapies

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
  • 1.2. Market Definitions
  • 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 (Model 1)
    • 1.7.2. Value chain based analysis (Model 2)
    • 1.7.3. Multivariate Analysis (Model 3)
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Cell & Gene Therapy Contract Research Organizations Market: Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Ancillary Market Outlook
  • 3.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Dynamics
    • 3.2.1. Market Driver Impact Analysis
    • 3.2.2. Market Restraint Analysis
  • 3.3. Technological Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. U.S. Cell & Gene Therapy Contract Research Organizations Market: Analysis Tools
    • 3.5.1. Porter's Five Forces Analysis
    • 3.5.2. PESTEL Analysis

Chapter 4. U.S. Cell & Gene Therapy Contract Research Organizations Market: Type Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Type Movement Analysis
  • 4.3. U.S. Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Type, 2021 to 2033 (USD Million)
  • 4.4. Drug Discovery
    • 4.4.1. Drug Discovery Market Estimates and Forecasts, 2021 - 2033 (USD million)
    • 4.4.2. Target Validation
      • 4.4.2.1. Target Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.3. Lead Identification
      • 4.4.3.1. Lead Identification Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.4.4. Lead Optimization
      • 4.4.4.1. Lead Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Preclinical
    • 4.5.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6. Clinical
    • 4.6.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.2. Phase I
      • 4.6.2.1. Phase I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.3. Phase II
      • 4.6.3.1. Phase II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.4. Phase III
      • 4.6.4.1. Phase III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 4.6.5. Phase IV
      • 4.6.5.1. Phase IV Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Cell & Gene Therapy Contract Research Organizations Market: Service Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Service Movement Analysis
  • 5.3. U.S. Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Service, 2021 to 2033 (USD Million)
  • 5.4. Project & Clinical Trial Management
    • 5.4.1. Project & Clinical Trial Management Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Regulatory Strategy
    • 5.5.1. Regulatory Strategy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Data Management & Medical Writing
    • 5.6.1. Data Management & Medical Writing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.7. Clinical Monitoring
    • 5.7.1. Clinical Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.8. Quality Management / GMP Compliance
    • 5.8.1. Quality Management / GMP Compliance Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.9. Biostatistics & Safety Monitoring
    • 5.9.1. Biostatistics & Safety Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.10. Patient & Site Recruitment
    • 5.10.1. Patient & Site Recruitment Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.11. Technology Transfer
    • 5.11.1. Technology Transfer Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.12. Others
    • 5.12.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Cell & Gene Therapy Contract Research Organizations Market: Indication Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Indication Movement Analysis
  • 6.3. U.S. Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Indication, 2021 to 2033 (USD Million)
  • 6.4. Oncology
    • 6.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. CNS Disorders
    • 6.5.1. CNS Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Infectious Diseases
    • 6.6.1. Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7. Clinical Monitoring
    • 6.7.1. Clinical Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.8. Immunological Disorders
    • 6.8.1. Immunological Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.9. Cardiovascular Diseases
    • 6.9.1. Cardiovascular Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.10. Respiratory Diseases
    • 6.10.1. Respiratory Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.11. Diabetes
    • 6.11.1. Diabetes Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.12. Ophthalmology
    • 6.12.1. Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.13. Pain Management
    • 6.13.1. Pain Management Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.14. Others
    • 6.14.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Cell & Gene Therapy Contract Research Organizations Market: Modality Estimates & Trend Analysis

  • 7.1. Segment Dashboard
  • 7.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Modality Movement Analysis
  • 7.3. U.S. Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Modality, 2021 to 2033 (USD Million)
  • 7.4. Cell-Based Therapies
    • 7.4.1. Cell-Based Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5. Gene Therapies
    • 7.5.1. Gene Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6. Gene-Modified Cell Therapies
    • 7.6.1. Gene-Modified Cell Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Company Categorization
    • 8.1.1. Market Leaders
    • 8.1.2. Emerging Players
  • 8.2. Company Market Share/Assessment Analysis, 2024
  • 8.3. Company Profiles
    • 8.3.1. Altasciences
      • 8.3.1.1. Company overview
      • 8.3.1.2. Financial performance
      • 8.3.1.3. Service benchmarking
      • 8.3.1.4. Strategic initiatives
    • 8.3.2. Allucent
      • 8.3.2.1. Company overview
      • 8.3.2.2. Financial performance
      • 8.3.2.3. Service benchmarking
      • 8.3.2.4. Strategic initiatives
    • 8.3.3. LabCorp
      • 8.3.3.1. Company overview
      • 8.3.3.2. Financial performance
      • 8.3.3.3. Service benchmarking
      • 8.3.3.4. Strategic initiatives
    • 8.3.4. Linical
      • 8.3.4.1. Company overview
      • 8.3.4.2. Financial performance
      • 8.3.4.3. Service benchmarking
      • 8.3.4.4. Strategic initiatives
    • 8.3.5. Medpace
      • 8.3.5.1. Company overview
      • 8.3.5.2. Financial performance
      • 8.3.5.3. Service benchmarking
      • 8.3.5.4. Strategic initiatives
    • 8.3.6. Thermo Fisher Scientific Inc.
      • 8.3.6.1. Company overview
      • 8.3.6.2. Financial performance
      • 8.3.6.3. Service benchmarking
      • 8.3.6.4. Strategic initiatives
    • 8.3.7. Precision Medicine Group, LLC.
      • 8.3.7.1. Company overview
      • 8.3.7.2. Financial performance
      • 8.3.7.3. Service benchmarking
      • 8.3.7.4. Strategic initiatives
    • 8.3.8. QPS Holdings
      • 8.3.8.1. Company overview
      • 8.3.8.2. Financial performance
      • 8.3.8.3. Service benchmarking
      • 8.3.8.4. Strategic initiatives
    • 8.3.9. Syneos Health
      • 8.3.9.1. Company overview
      • 8.3.9.2. Financial performance
      • 8.3.9.3. Service benchmarking
      • 8.3.9.4. Strategic initiatives
    • 8.3.10. ICON plc
      • 8.3.10.1. Company overview
      • 8.3.10.2. Financial performance
      • 8.3.10.3. Service benchmarking
      • 8.3.10.4. Strategic initiatives

List of Tables

  • Table 1 List of abbreviation
  • Table 2 U.S. cell & gene therapy contract research organizations market estimates and forecasts, by type, 2021 - 2033 (USD Million)
  • Table 3 U.S. cell & gene therapy contract research organizations market estimates and forecasts, by service, 2021 - 2033 (USD Million)
  • Table 4 U.S. cell & gene therapy contract research organizations market estimates and forecasts, by indication, 2021 - 2033 (USD Million)
  • Table 5 U.S. cell & gene therapy contract research organizations market estimates and forecasts, by modality, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 U.S. cell & gene therapy contract research organizations market segmentation
  • Fig. 2 Market research process
  • Fig. 3 Information procurement
  • Fig. 4 Primary research pattern
  • Fig. 5 Market research approaches
  • Fig. 6 Market formulation & validation
  • Fig. 7 Commodity flow analysis
  • Fig. 8 Value-Chain-Based Sizing & Forecasting
  • Fig. 9 QFD model sizing & forecasting
  • Fig. 10 Bottom-up approach
  • Fig. 11 Market snapshot
  • Fig. 12 Segment snapshot
  • Fig. 13 Segment snapshot
  • Fig. 14 Segment snapshot
  • Fig. 15 Competitive landscape snapshot
  • Fig. 16 Parent market outlook, 2024 (USD Million)
  • Fig. 17 Ancillary market outlook, 2024 (USD Million)
  • Fig. 18 U.S. Cell & Gene Therapy Contract Research Organizations market dynamics
  • Fig. 19 Total R&D drug pipeline size, 2021 - 2024
  • Fig. 20 Total drug pipeline by development phase, 2024
  • Fig. 21 Porter's five forces analysis
  • Fig. 22 PESTEL analysis
  • Fig. 23 U.S. cell & gene therapy contract research organizations market type outlook: Segment dashboard
  • Fig. 24 U.S. cell & gene therapy contract research organizations market, by type segment: Market share, 2025 & 2033
  • Fig. 25 Drug discovery market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Preclinical market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Clinical market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Target validation market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Lead identification market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Lead optimization market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 U.S. cell & gene therapy contract research organizations market phase outlook: Segment dashboard
  • Fig. 32 U.S. cell & gene therapy contract research organizations market, by phase segment: Market share, 2024 & 2033
  • Fig. 33 Phase I market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Phase II market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Phase III market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Phase IV market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 U.S. cell & gene therapy contract research organizations market service outlook: Segment dashboard
  • Fig. 38 Cell & gene therapy contract research organizations market, by service segment: Market share, 2024 & 2033
  • Fig. 39 Project & clinical trial management market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Regulatory strategy market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Data management & medical writing market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 Clinical monitoring market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 43 Quality management / GMP compliance market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 44 Biostatistics & safety monitoring market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Patient & site recruitment market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Technology transfer market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 48 U.S. cell & gene therapy contract research organizations market indication outlook: Segment dashboard
  • Fig. 49 U.S. cell & gene therapy contract research organizations market, by Indication segment: Market share, 2024 & 2033
  • Fig. 50 Oncology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 51 CNS disorders market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 52 Infectious diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 53 Immunological disorders market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 54 Cardiovascular diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 55 Respiratory diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 56 Diabetes market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 57 Ophthalmology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 58 Pain management market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 59 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 60 U.S. cell & gene therapy contract research organizations market modality outlook: Segment dashboard
  • Fig. 61 U.S. cell & gene therapy contract research organizations market, by Modality segment: Market share, 2024 & 2033
  • Fig. 62 U.S. Cell-based therapies market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 63 Gene therapies market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 64 Gene-modified cell therapies market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 65 Market participant categorization
  • Fig. 66 Heat map analysis