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美國細胞和基因治療受託研究機構市場規模、佔有率和趨勢分析報告：按類型、服務、適應症、模式和細分市場預測，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個工作天內

價格

市場規模與趨勢：

預計 2024 年美國細胞和基因治療受託研究機構市場價值為 20.9 億美元，到 2033 年將達到 48.6 億美元，2025 年至 2033 年的複合年成長率為 9.91%。

市場成長歸因於細胞和基因治療日益複雜、CGT 臨床試驗量不斷增加、生物技術公司外包不斷增加以及監管日益複雜等因素。

市場驅動力源自於科學創新、監管變革和申辦者需求的不斷成長，而這些需求又推動著合作的不斷增加。越來越多的先進治療方法，包括自體細胞療法、基因編輯干預和基於體內病毒載體的療法，已進入臨床實驗和臨床階段，通常需要高度協調的臨床前和臨床開發項目。大多數中小型生物技術公司缺乏內部基礎設施來滿足此類療法（尤其是針對罕見和極罕見疾病的療法）複雜的臨床、監管和生物分析需求。這種缺口推動了對擁有轉化生物學、符合GMP標準的樣本管理和免疫抗原性測試等專業技能的合約研究組織（CRO）的需求。

此外，策略性外包模式的興起，即申辦方與合約研究組織 (CRO) 建立一體化夥伴關係關係，以降低固定營運成本並提高擴充性，也推動了市場成長。 CAR-T 和基於腺相關病毒 (AAV) 的治療方法等物流和患者個體化程度較高的療法，需要臨床試驗贊助者、臨床機構和監管機構之間的密切協調，這促使臨床試驗贊助者選擇既具備科學深度又具備業務靈活性的 CRO。產學合作的不斷擴大、政府支持罕見疾病臨床試驗的舉措，以及創業投資流入細胞和基因療法新興企業企業的不斷增加，進一步推動了對 CRO 的需求。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章美國細胞和基因治療受託研究機構市場：變數、趨勢和範圍

  • 市場體系展望
  • 美國細胞與基因治療受託研究機構市場動態
  • 技術格局
  • 定價模式分析
  • 美國細胞與基因治療受託研究機構市場：分析工具

第4章：美國細胞和基因治療受託研究機構市場：按類型估計和趨勢分析

  • 細分儀表板
  • 美國細胞與基因治療受託研究機構市場類型波動
  • 美國細胞與基因治療受託研究機構)市場規模及趨勢分析（按類型），2021 年至 2033 年
  • 藥物研發
    • 目標檢驗
    • 線索識別
    • 先導藥物最適化
  • 臨床前
  • 臨床
    • 第一階段
    • 第二階段
    • 第三階段
    • 第四階段

第5章美國細胞和基因治療受託研究機構市場：按服務分類的估計和趨勢分析

  • 細分儀表板
  • 美國細胞和基因治療受託研究機構市場波動分析（按服務）
  • 美國細胞與基因治療受託研究機構)市場規模及趨勢分析（按服務），2021 年至 2033 年
  • 計劃和臨床試驗管理
  • 監理策略
  • 數據管理和醫學寫作
  • 臨床監測
  • 品管/GMP合規性
  • 生物統計學和安全監測
  • 病人和機構招募
  • 技術轉移
  • 其他

第6章：美國細胞和基因治療受託研究機構市場：按適應症的估計和趨勢分析

  • 細分儀表板
  • 美國細胞和基因治療受託研究機構市場按適應症的波動
  • 美國細胞和基因治療受託研究機構)市場規模和趨勢分析（按適應症），2021 年至 2033 年
  • 腫瘤學
  • 中樞神經系統疾病
  • 感染疾病
  • 臨床監測
  • 免疫疾病
  • 心血管疾病
  • 呼吸系統疾病
  • 糖尿病
  • 眼科
  • 疼痛管理
  • 其他

第7章：美國細胞和基因治療受託研究機構市場：按模式的估計和趨勢分析

  • 細分儀表板
  • 美國細胞和基因治療受託研究機構市場按治療方式的波動
  • 美國細胞與基因治療受託研究機構)市場規模及趨勢分析（按模式），2021 年至 2033 年
  • 細胞療法
  • 基因治療
  • 基因改造細胞療法

第8章 競爭態勢

  • 公司分類
    • 市場領導者
    • 新興企業
  • 2024 年公司市場佔有率/估值分析
  • 公司簡介
    • 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