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市场调查报告书
商品编码
1762543

专业CRO市场：产业趋势及全球预测 - 依治疗领域、服务类型及重点地区划分

Specialty CROs Market: Industry Trends and Global Forecasts - Distribution by Target Therapeutic Area, Type of Service and Key Geographical Regions
出版日期: | 出版商: Roots Analysis | 英文 321 Pages | 商品交期: 最快1-2个工作天内

价格

专业CRO市场：概览

今年全球专业CRO市场规模达12亿美元。预计在预测期内，该市场将以8.6%的年复合成长率实现丰厚成长。

市场区隔与机会分析依下列参数细分：

目标治疗领域

  • 肿瘤疾病
  • 代谢性疾病
  • 心血管疾病
  • 糖尿病
  • 其他

服务类型

  • 临床前服务
  • 临床服务

主要地区

  • 北美
  • 欧洲
  • 亚太地区
  • 世界其他地区

专业CRO市场：成长与趋势

多年来，生物製药产业在研发外包方式上经历了重大转变。专业合约研究组织（CRO）已成为业界新晋者，目的是突破传统全方位服务 CRO 所面临的限制。儘管全方位服务提供者拥有广泛的能力，但他们往往难以根据小型生物技术公司和新创企业的特定需求量身定制服务。相较之下，专业 CRO 致力于细分市场，提供有针对性的临床或临床前服务专业知识，同时致力于肿瘤学、心臟病学、代谢性疾病和中枢神经系统（CNS）疾病等特定疾病领域。通常外包给这些组织的服务包括药物警戒、标靶验证、製剂开发、细胞系开发、资料管理、专案管理、生物统计学等等。此外，专业 CRO 正日益采用战略模式来拓宽其服务范围并拓展地域覆盖范围，以更佳满足全球生物製药行业不断变化的需求。

专业CRO市场-IMG1

专业CRO市场：关键洞察

本报告分析了全球专业CRO市场的现状，并探讨了潜在的成长机会。报告的主要调查结果包括：

  • CRO提供的丰富服务使其成为药物开发的重要平台。
  • 在对1,000多家CRO进行详细的实质审查后，根据其具体能力和服务范围，确定了200多家专业CRO。
  • 26%的CRO致力于临床前研究，其服务组合能够满足广泛的客户需求。
专业CRO市场-IMG2
  • 毒理学和药理学是最受欢迎的临床前服务，约14%的CRO在其各自的产品组合中提供毒理学和药理学相关服务。
  • 约有32家公司致力于测试模型和基于医学影像/生物标记的分析。
  • 超过40%的专业CRO提供生物统计服务，其次是提供临床监测和专案管理服务的专业CRO。
  • 值得注意的是，医学写作和法规外包非常普遍。
  • 虽然整体市场由少数几家大型CRO公司主导，但专业CRO市场高度分散，美国仍是主要中心。
专业CRO市场-IMG3
  • 新方法和尚未开发的机会领域可能会成为长期发展的关键驱动力。
  • 未来几年，市场可能会保持成长动力，尤其是在专业CRO公司进一步完善其服务组合的情况下。

进入Specialty CROS市场的公司范例

  • Accelovance
  • Almedis
  • Applied Healthcare Resource Management
  • Betagenex
  • Biospective
  • BRI Biopharmaceutical
  • BTS Research
  • Cardialysis
  • CMX Research
  • Crown Bioscience
  • Dorizoe Lifesciences
  • DSP Clinical Research
  • DZS Clinical Services
  • EthosExcel（TM）
  • Fluofarma
  • ICRC-Weyer
  • Impact Pharmaceutical Services
  • IonsGate Preclinical Services
  • KIYATEC
  • MedSource
  • Novella Clinical
  • Physiogenex
  • Profil Institute
  • Redoxis
  • RenaSci
  • Research Dynamics Consulting
  • RxGen
  • SDS Clinical
  • Spirovation
  • Velesco Pharmaceutical Services

目录

第1章 简介

第2章 执行摘要

第3章 简介

  • 历史
  • 传统CRO
  • 专业CRO

第4章 专业CRO：简介

  • 章节概述
  • 专业CRO的重要性

第5章 市场概述

  • 章节概述
  • 方法论
  • 专业CRO：全球格局
  • 具有专业服务能力的专业CRO
  • 致力于治疗领域的专业CRO

第6章 以服务为中心的专业CRO

  • 章节概述
  • 致力于临床前服务能力的CRO
    • BRI Biopharmaceutical Research
    • BTS Research
    • Dorizoe Lifesciences
    • Fluofarma
    • KIYATEC
    • Redoxis
    • Spirovation
    • Velesco Pharmaceutical Services
  • 致力于临床服务能力的CRO
    • Almedis
    • Applied Healthcare Resource Management
    • CMX Research
    • DSP Clinical Research
    • DZS Clinical Services
    • EthosExcel(TM)
    • ICRC-Weyer
    • Impact Pharmaceutical Services
    • Research Dynamics Consulting
    • SDS Clinical

第7章 专业 CRO：治疗领域重点

  • 章节概述
  • 致力于肿瘤学的专业 CRO
    • Accelovance
    • Crown Bioscience
    • MedSource
    • Novella Clinical
  • 致力于心血管/心臟病的专业 CRO
    • Cardialysis
    • IonsGate Preclinical Services
  • 致力于代谢疾病的专业 CRO疾病
    • Betagenex
    • Physiogenex
    • Profil Institute
  • 致力于中枢神经系统（CNS）的专业 CRO
    • Biospective
    • RenaSci
    • RxGen

第8章 案例研究 I：虚拟 CRO

  • 虚拟 CRO 简介
  • Frestedt
  • InSymbiosis
  • Osiris Pharma
  • ProjectPharm
  • The Harte Group
  • VxP Pharma

第9章 案例研究 II：全方位服务 CRO

  • 传统 CRO 简介
  • Covance
  • Medis Research Group
  • Quintiles
  • Triclinium Clinical Trial Project Management

第10章 市场预测

  • 章节概述
  • 预测研究法
  • 2035年全球专业 CRO 市场
  • 2035年全球专业 CRO 市场（依地区）

第11章 未来机会

第12章 结论

第13章 访谈记录

第14章 附录 1：表格资料

第15章 附录 2：公司与组织清单

第16章 附录 3：服务地图词彙表

Product Code: RA10055

SPECIALTY CROS MARKET: OVERVIEW

As per Roots Analysis, the global specialty CROs market valued at USD 1.2 billion in the current year is anticipated to grow at a lucrative CAGR of 8.6% during the forecast period.

The market sizing and opportunity analysis has been segmented across the following parameters:

Target Therapeutic Area

  • Oncological Disorders
  • Metabolic Disorders
  • Cardiovascular Disorders
  • Diabetes
  • Others

Type of Service

  • Preclinical Services
  • Clinical Services

Key Geographical Regions

  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World

SPECIALTY CROS MARKET: GROWTH AND TRENDS

Over the years, the biopharmaceutical industry has undergone a major transformation in its approach towards R&D outsourcing. Specialty contract research organizations (CROs) have become prominent players, addressing limitations often faced with traditional, full-service CROs. While full-service providers offer a broad range of capabilities, they frequently struggle to tailor their services to the specific needs of small-scale biotech companies and start-ups. In contrast, specialty CROs focus on niche segments, delivering expertise in targeted clinical or preclinical services, while concentrating on a particular disease area such as oncology, heart diseases, metabolic disorders, and central nervous system (CNS) conditions. Services commonly outsourced to these organizations include pharmacovigilance, target evaluation, formulation development, cell line development, data management, project management, biostatistics and others. Further, specialty CROs are also increasingly adopting strategic models to broaden their service offerings and expand geographically, aiming to better serve the evolving needs of the global biopharmaceutical sector.

Specialty CROs Market - IMG1

SPECIALTY CROS MARKET: KEY INSIGHTS

The report delves into the current state of the global specialty CROs market and identifies potential growth opportunities within industry. Some key findings from the report include:

  • The wealth of services offered by CROs have made them an indispensable platform for drug development.
  • Over 200 speciality CROs were identified after detailed due diligence of more than 1,000 CROs based on the specific capabilities and the range of services they provide.
  • With 26% of the organizations specializing in preclinical services, the service portfolio of these CROs caters to a wide array of client requirements.
Specialty CROs Market - IMG2
  • Toxicology and pharmacology are the most popular preclinical services, with ~14% of the CROs offering the services related to toxicology and pharmacology in their respective portfolios.
  • Nearly 32 companies specialize in test models and medical imaging / biomarker-based analysis.
  • Over 40% of the speciality CROs offered biostatistics related services, followed by speciality CROs offering clinical monitoring and project management services.
  • Notably, medical writing and regulatory management / submission is also frequently outsourced.
  • Though the overall market is dominated by a handful of bigger CROs, the market within the speciality CRO segment is highly fragmented; US continues to remain the primary hub.
Specialty CROs Market - IMG3
  • Newer approaches / untapped opportunity areas are likely to emerge as key growth drivers in the long-term.
  • Notably, as specialty CROs further establish their service portfolios, it is believed that the market is likely to sustain the growth momentum in the coming years.

Example Players in the Specialty CROS Market

  • Accelovance
  • Almedis
  • Applied Healthcare Resource Management
  • Betagenex
  • Biospective
  • BRI Biopharmaceutical
  • BTS Research
  • Cardialysis
  • CMX Research
  • Crown Bioscience
  • Dorizoe Lifesciences
  • DSP Clinical Research
  • DZS Clinical Services
  • EthosExcel(TM)
  • Fluofarma
  • ICRC-Weyer
  • Impact Pharmaceutical Services
  • IonsGate Preclinical Services
  • KIYATEC
  • MedSource
  • Novella Clinical
  • Physiogenex
  • Profil Institute
  • Redoxis
  • RenaSci
  • Research Dynamics Consulting
  • RxGen
  • SDS Clinical
  • Spirovation
  • Velesco Pharmaceutical Services

SPECIALTY CROS MARKET: RESEARCH COVERAGE

  • Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the specialty CROs market, focusing on key market segments, including [A] target therapeutic area, [B] type of service and [E] key geographical regions.
  • Market Landscape: A comprehensive evaluation of specialty CROs, based on several relevant parameters, such as [A] geographical location, [B] year of establishment and [C] R&D capabilities.
  • Company Profiles: In-depth profiles of specialty CROs focused on specialized preclinical / clinical service offering and particular therapeutic area, based on [A] overview of the company, [B] service portfolio and [C] recent developments and an informed future outlook.
  • Case Study 1: A detailed discussion of the virtually integrated, cross-functional outsourcing approach implemented by virtual CROs.
  • Case study 2: A detailed discussion of the one-stop-shop approach followed by traditional CROs.

KEY QUESTIONS ANSWERED IN THIS REPORT

  • How many companies are currently engaged in this market?
  • Which are the leading companies in this market?
  • What factors are likely to influence the evolution of this market?
  • What is the current and future market size?
  • What is the CAGR of this market?
  • How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

  • The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
  • Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
  • The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

ADDITIONAL BENEFITS

  • Complimentary PPT Insights Packs
  • Complimentary Excel Data Packs for all Analytical Modules in the Report
  • 15% Free Content Customization
  • Detailed Report Walkthrough Session with Research Team
  • Free Updated report if the report is 6-12 months old or older

TABLE OF CONTENTS

1. PREFACE

  • 1.1. Scope of the Report
  • 1.2. Research Methodology
    • 1.2.1. Research Assumptions
    • 1.2.2. Project Methodology
    • 1.2.3. Forecast Methodology
    • 1.2.4. Robust Quality Control
    • 1.2.5. Key Considerations
      • 1.2.5.1. Demographics
      • 1.2.5.2. Economic Factors
      • 1.2.5.3. Government Regulations
      • 1.2.5.4. Supply Chain
      • 1.2.5.5. COVID Impact / Related Factors
      • 1.2.5.6. Market Access
      • 1.2.5.7. Healthcare Policies
      • 1.2.5.8. Industry Consolidation
  • 1.3 Key Questions Answered
  • 1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

  • 3.1. History
  • 3.2. Traditional Contract Research Organizations
    • 3.2.1. Services
    • 3.2.2. Current Industry Environment
  • 3.3. Specialty Contract Research Organizations

4. SPECIALTY CROs: AN INTRODUCTION

  • 4.1. Chapter Overview
  • 4.2. Importance of Specialty CROs

5. MARKET OVERVIEW

  • 5.1. Chapter Overview
  • 5.2. Methodology
  • 5.3. Specialty CROs: Global Landscape
    • 5.3.1. Specialty CROs: The Dramatic Rise
    • 5.3.2. Specialty CROs: Distribution by Nature of Specialization
  • 5.4. Specialty CROs Focused on Specific Service Capability
    • 5.4.1. Landscape is Well Distributed across Preclinical and Clinical Services
    • 5.4.2. Specialty CROs: Popular Preclinical Services
    • 5.4.3. Specialty CROs: Popular Clinical Services
  • 5.5. Specialty CROs Focused on Specific Therapeutic Area(s)
    • 5.5.1. Oncology is the Most Researched Therapeutic Area
    • 5.5.2. CROs Mostly Located in the US; Europe is a Distant Second

6. SPECIALTY CROs: FOCUSED ON SERVICES

  • 6.1. Chapter Overview
  • 6.2. CROs Focused on Preclinical Service Capabilities
    • 6.2.1. BRI Biopharmaceutical Research
      • 6.2.1.1. Company Overview
      • 6.2.1.2. Focused Clinical Expertise
        • 6.2.1.2.1. API / Clinical Product QC, Dosing Solutions & Materials
        • 6.2.1.2.2. Bioanalytical Assays for Clinical Trials
        • 6.2.1.2.3. Clinical Trial Equipment Rental & PK Sample Collection Kit
        • 6.2.1.2.4. Cynomologus & Rhesus Monkey Hepatocytes & Blood Products
        • 6.2.1.2.5. Drug Candidate Early In Vitro & In Vivo Screening
        • 6.2.1.2.6. In Vitro DMPK & ADME
        • 6.2.1.2.7. In Vivo DMPK & ADME
        • 6.2.1.2.8. Patient Tumor-Derived Xenograft Models at Oncograph(TM)
        • 6.2.1.2.9. Strategic Development of Botanical Drugs
    • 6.2.2. BTS Research
      • 6.2.2.1. Company Overview
      • 6.2.2.2. Focused Clinical Expertise
        • 6.2.2.2.1. Custom Services
        • 6.2.2.2.2. Disease Models
        • 6.2.2.2.3. In Vitro Services
        • 6.2.2.2.4. IND Process
        • 6.2.2.2.5. Medical Devices
        • 6.2.2.2.6. Pharmacology Services
        • 6.2.2.2.7. Toxicology Services
      • 6.2.2.3. Additional Information
        • 6.2.2.3.1. Recent Developments
        • 6.2.2.3.2. Acquisitions
    • 6.2.3. Dorizoe Lifesciences
      • 6.2.3.1. Company Overview
      • 6.2.3.2. Focused Clinical Expertise
        • 6.2.3.2.1. Services and Capabilities
        • 6.2.3.2.2. Customized Services
    • 6.2.4. Fluofarma
      • 6.2.4.1. Company Overview
      • 6.2.4.2. Focused Clinical Expertise
        • 6.2.4.2.1. Assay Development Services
        • 6.2.4.2.2. Cell-based screening services
        • 6.2.4.2.3. In Vitro Drug Profiling Services and Mechanism of Action (MOA) Studies
        • 6.2.4.2.4. Predictive Toxicology Services
        • 6.2.4.2.5. In Vivo Studies
        • 6.2.4.2.6. Biomarker Analysis Services
      • 6.2.4.3. Additional Information
        • 6.2.4.3.1. Collaborations
        • 6.2.4.3.2. Recent Developments
    • 6.2.5. KIYATEC
      • 6.2.5.1. Company Overview
      • 6.2.5.2. Focused Clinical Expertise
        • 6.2.5.2.1. Drug Response Profiling (DRP) Services
      • 6.2.5.3. Additional Information
        • 6.2.5.3.1. Recent Developments
        • 6.2.5.3.2. Funding
    • 6.2.6. Redoxis
      • 6.2.6.1. Company Overview
      • 6.2.6.2. Focused Clinical Expertise
        • 6.2.6.2.1. In Vivo Models
        • 6.2.6.2.2. In Vitro Services
      • 6.2.6.3. Additional Information
        • 6.2.6.3.1. Collaborations
        • 6.2.6.3.2. Recent Developments
        • 6.2.6.3.3. Funding
    • 6.2.7. Spirovation
      • 6.2.7.1. Company Overview
      • 6.2.7.2. Focused Clinical Expertise
        • 6.2.7.2.1. Clinical Assessment
        • 6.2.7.2.2. Functional Screening and Lead Selection
        • 6.2.7.2.3. Target ID and Primary Screening
      • 6.2.7.3. Additional Information
        • 6.2.7.3.1. Facilities
    • 6.2.8. Velesco Pharmaceutical Services
      • 6.2.8.1. Company Overview
      • 6.2.8.2. Focused Clinical Expertise
        • 6.2.8.2.1. Analytical Method Development
        • 6.2.8.2.2. cGMP Manufacturing
        • 6.2.8.2.3. Drug Formulation Development
        • 6.2.8.2.4. Instrumentation
        • 6.2.8.2.5. Pharmaceutical Consulting
  • 6.3. CROs Focused on Clinical Service Capabilities
    • 6.3.1. Almedis
      • 6.3.1.1. Company Overview
      • 6.3.1.2. Focused Clinical Expertise
        • 6.3.1.2.1. Biostatistics
        • 6.3.1.2.2. Clinical Monitoring
        • 6.3.1.2.3. International Clinical Trials
        • 6.3.1.2.4. Local Studies
        • 6.3.1.2.5. Data Management
        • 6.3.1.2.6. Medical Writing
        • 6.3.1.2.7. Training Programs
    • 6.3.2. Applied Healthcare Resource Management
      • 6.3.2.1. Company Overview
      • 6.3.2.2. Focused Clinical Services
      • 6.3.2.3. Additional Information
        • 6.3.2.3.1. Collaborations
    • 6.3.3. CMX Research
      • 6.3.3.1. Company Overview
      • 6.3.3.2. Focused Clinical Expertise
        • 6.3.3.2.1. CRO Services
        • 6.3.3.2.2. Investigator Network
        • 6.3.3.2.3. Investigator-Led Trials (ILTs)
        • 6.3.3.2.4. MDapps(TM)
    • 6.3.4. DSP Clinical Research
      • 6.3.4.1. Company Overview
      • 6.3.4.2. Focused Clinical Expertise
        • 6.3.4.2.1. Data Management
        • 6.3.4.2.2. Monitoring
        • 6.3.4.2.3. Project Management
        • 6.3.4.2.4. Site Management
        • 6.3.4.2.5. Statistics and Medical Writing
        • 6.3.4.2.6. Others
      • 6.3.4.3. Additional Information
        • 6.3.4.3.1. Collaboration
        • 6.3.4.3.2. Recent Developments
    • 6.3.5. DZS Clinical Services
      • 6.3.5.1. Company Overview
      • 6.3.5.2. Focused Clinical Services
        • 6.3.5.2.1. Biostatistics Support and Consulting
        • 6.3.5.2.2. Clinical Data Management
        • 6.3.5.2.3. Clinical Monitoring
        • 6.3.5.2.4. Clinical Project Management
        • 6.3.5.2.5. ClinPlus(R) eClinical Platform
        • 6.3.5.2.6. Customized FSP Models
        • 6.3.5.2.7. DZS Clinical Sourcing and Staffing
        • 6.3.5.2.8. Medical Coding
        • 6.3.5.2.9. Medical Writing
        • 6.3.5.2.10. Statistical Programming and CDISC Implementation
        • 6.3.5.2.11. SOP Authoring
    • 6.3.6. EthosExcel(TM)
      • 6.3.6.1. Company Overview
      • 6.3.6.2. Focused Clinical Expertise
        • 6.3.6.2.1. Clinical Trial Services
        • 6.3.6.2.2. Clinical Trial Resourcing
        • 6.3.6.2.3. Diversity Consulting
        • 6.3.6.2.4. Investigator and Trial Site Facilitation Services
        • 6.3.6.2.5. Site Management
    • 6.3.7. ICRC-Weyer
      • 6.3.7.1. Company Overview
      • 6.3.7.2. Focused Clinical Expertise
        • 6.3.7.2.1. Biostatistics
        • 6.3.7.2.2. Clinical Data Management
        • 6.3.7.2.3. Medical Review
        • 6.3.7.2.4. Medical Writing
        • 6.3.7.2.5. Safety Writing and Pharmacovigilance
        • 6.3.7.2.6. Scientific Consulting
      • 6.3.7.3. Additional Information
        • 6.3.7.3.1. Expansion of Service Portfolio
    • 6.3.8. Impact Pharmaceutical Services
      • 6.3.8.1. Company Overview
      • 6.3.8.2. Focused Clinical Expertise
        • 6.3.8.2.1. Drug Development Consulting
        • 6.3.8.2.2. Early Phase Clinical Trial Management
        • 6.3.8.2.3. Medical Writing
        • 6.3.8.2.4. Project and Program Management
        • 6.3.8.2.5. Regulatory Affairs
        • 6.3.8.2.6. Regulatory Operations
    • 6.3.9. Research Dynamics Consulting
      • 6.3.9.1. Company Overview
      • 6.3.9.2. Focused Clinical Expertise
        • 6.3.9.2.1. Clinical Monitoring
        • 6.3.9.2.2. Consulting
        • 6.3.9.2.3. GCP Auditing
        • 6.3.9.2.4. Investigator Recruitment
        • 6.3.9.2.5. Project Management
        • 6.3.9.2.6. Site Management
      • 6.3.9.3. Additional Information
        • 6.3.9.3.1. Collaborations
    • 6.3.10. SDS Clinical
      • 6.3.10.1. Company Overview
      • 6.3.10.2. Focused Clinical Expertise
        • 6.3.10.2.1. Clinical Trial Services
        • 6.3.10.2.2. Consulting Services

7. SPECIALTY CROs: FOCUSED ON THERAPEUTIC AREAS

  • 7.1. Chapter Overview
  • 7.2. Specialty CROs Focused on Oncology
    • 7.2.1. Accelovance
      • 7.2.1.1. Company Overview
      • 7.2.1.2. Focused Clinical Expertise
        • 7.2.1.2.1. CRO Services
        • 7.2.1.2.2. Patient Recruitment
        • 7.2.1.2.3. Clinical Call Center
      • 7.2.1.3. Additional Information
        • 7.2.1.3.1. Collaborations
        • 7.2.1.3.2. Site Expansion
    • 7.2.2. Crown Bioscience
      • 7.2.2.1. Company Overview
      • 7.2.2.2. Focused Clinical Expertise
        • 7.2.2.2.1. Biotherapeutics
        • 7.2.2.2.2. Drug Discovery
        • 7.2.2.2.3. Metabolic Diseases
        • 7.2.2.2.4. Oncology
      • 7.2.2.3. Additional Information
        • 7.2.2.3.1. Collaborations
        • 7.2.2.3.2. Service Expansion
        • 7.2.2.3.3. Site Expansion
        • 7.2.2.3.4. Recent Developments
        • 7.2.2.3.5. Funding
    • 7.2.3. MedSource
      • 7.2.3.1. Company Overview
      • 7.2.3.2. Focused Clinical Expertise
        • 7.2.3.2.1. Clinical Data Management and Biostatistics
        • 7.2.3.2.2. Clinical Support
        • 7.2.3.2.3. Clinical Trial Monitoring
        • 7.2.3.2.4. Project Management
        • 7.2.3.2.5. Regulatory Affairs Management
        • 7.2.3.2.6. Study Start-Up
    • 7.2.4. Novella Clinical
      • 7.2.4.1. Company Overview
      • 7.2.4.2. Focused Clinical Expertise
        • 7.2.4.2.1. Clinical Monitoring
        • 7.2.4.2.2. Data Management
        • 7.2.4.2.3. Data Monitoring Committees
        • 7.2.4.2.4. Investigator Strategy & Site Coordination (ISSC)
        • 7.2.4.2.5. Medical Monitoring
        • 7.2.4.2.6. Medical Writing
        • 7.2.4.2.7. Project Management
        • 7.2.4.2.8. Quality Assurance
        • 7.2.4.2.9. Regulatory Affairs
        • 7.2.4.2.10. Safety Management
        • 7.2.4.2.11. Steering Committees & Clinical Advisory Boards
        • 7.2.4.2.12. Training
        • 7.2.4.2.13. Clinical Staffing
        • 7.2.4.2.14. Expertise in Oncology across Various Phases of Clinical Trials
  • 7.3. Specialty CROs Focused on Cardiovascular / Cardiology
    • 7.3.1. Cardialysis
      • 7.3.1.1. Company Overview
      • 7.3.1.2. Focused Clinical Expertise
        • 7.3.1.2.1. Trial Services
        • 7.3.1.2.2. Core Laboratory
        • 7.3.1.2.3. Network of Partners
      • 7.3.1.3. Additional Information
    • 7.3.2. IonsGate Preclinical Services
      • 7.3.2.1. Company Overview
      • 7.3.2.2. Focused Clinical Expertise
        • 7.3.2.2.1. Cell Based Assays
        • 7.3.2.2.2. Isolated Tissue Based Assays
        • 7.3.2.2.3. In Vivo Models
  • 7.4. Specialty CROs Focused on Metabolic Disorders
    • 7.4.1. Betagenex
      • 7.4.1.1. Company Overview
      • 7.4.1.2. Focused Clinical Expertise
        • 7.4.1.2.1. Experimental Services
        • 7.4.1.2.2. Consulting Services
      • 7.4.1.3. Additional Information
    • 7.4.2. Physiogenex
      • 7.4.2.1. Company Overview
      • 7.4.2.2. Focused Clinical Expertise
        • 7.4.2.2.1. Research Services
        • 7.4.2.2.2. Consultancy Services
      • 7.4.2.3. Additional Information
        • 7.4.2.3.1. Collaborations
        • 7.4.2.3.2. Recent Developments
    • 7.4.3. Profil Institute
      • 7.4.3.1. Company Overview
      • 7.4.3.2. Focused Clinical Expertise
        • 7.4.3.2.1. Clinical Development
        • 7.4.3.2.2. Clinical Research
        • 7.4.3.2.3. Data Management and Statistical Services
        • 7.4.3.2.4. Monitoring, Quality & Compliance
        • 7.4.3.2.5. Recruitment Services
        • 7.4.3.2.6. Regulatory Affairs
        • 7.4.3.2.7. Scientific Services
        • 7.4.3.2.8. Experience in Metabolic Disorders
      • 7.4.3.3. Additional Information
        • 7.4.3.3.1. Collaborations
  • 7.5. Specialty CROs Focused on CNS
    • 7.5.1. Biospective
      • 7.5.1.1. Company Overview
      • 7.5.1.2. Focused Clinical Expertise
        • 7.5.1.2.1. Image Processing Technology
        • 7.5.1.2.2. Rodent Models
        • 7.5.1.2.3. Animal Imaging
        • 7.5.1.2.4. Human Imaging and Clinical Trials
        • 7.5.1.2.5. Histology and IHC
    • 7.5.2. RenaSci
      • 7.5.2.1. Company Overview
      • 7.5.2.2. Focused Clinical Expertise
        • 7.5.2.2.1. Experimental Services
        • 7.5.2.2.2. Consultancy Services
      • 7.5.2.3. Additional Information
        • 7.5.2.3.1. Recent Developments
    • 7.5.3. RxGen
      • 7.5.3.1. Company Overview
      • 7.5.3.2. Focused Clinical Expertise
        • 7.5.3.2.1. Efficacy Models
        • 7.5.3.2.2. Custom Model Development
        • 7.5.3.2.3. Pharmacokinetics, Pharmacodynamics and Delivery Optimization Services
        • 7.5.3.2.4. Toxicology and Safety Pharmacology
        • 7.5.3.2.5. Supporting Technologies & Capabilities
      • 7.5.3.3. Additional Information
        • 7.5.3.3.1. Collaboration
        • 7.5.3.3.2. Funding
        • 7.5.3.3.3. Recent Developments

8. CASE STUDY I: VIRTUAL CROs

  • 8.1. Introduction to Virtual CROs
  • 8.2. Frestedt
    • 8.2.1. Company Overview
    • 8.2.2. Service Portfolio
      • 8.2.2.1. Clinical Research
      • 8.2.2.2. Regulatory Affairs
      • 8.2.2.3. Quality Systems
  • 8.3. InSymbiosis
    • 8.3.1. Company Overview
    • 8.3.2. Service Portfolio
      • 8.3.2.1. Drug Discovery
      • 8.3.2.2. Lead Optimization and Efficacy Model
      • 8.3.2.3. Non-Clinical Safety Studies and Bioanalysis
      • 8.3.2.4. Regulatory IND / IMPD filings
      • 8.3.2.5. Document Management
      • 8.3.2.6. Phase I / II/ III Clinical Studies
      • 8.3.2.7. Collaborations
    • 8.3.3. Additional Information
      • 8.3.3.1. Recent Developments
  • 8.4. Osiris Pharma
    • 8.4.1. Company Overview
    • 8.4.2. Service Portfolio
      • 8.4.2.1. Program Management
      • 8.4.2.2. Consultancy
      • 8.4.2.3. Non-clinical Assessment and Management
      • 8.4.2.4. Preclinical Toxicology and Safety Studies
      • 8.4.2.5. Communication and Monitoring
      • 8.4.2.6. Writing and Reviewing of Reports
      • 8.4.2.7. Other Services
  • 8.5. ProjectPharm
    • 8.5.1. Company Overview
    • 8.5.2. Service Portfolio
      • 8.5.2.1. Virtual CRO
      • 8.5.2.2. Project Management Consulting / Organizational Project Management
      • 8.5.2.3. Vendor Selection
      • 8.5.2.4. Financial Audits
      • 8.5.2.5. Training
      • 8.5.2.6. Rescue Studies
      • 8.5.2.7. Study Start-Up
  • 8.6. The Harte Group
    • 8.6.1. Company Overview
    • 8.6.2. Service Portfolio
      • 8.6.2.1. Virtual CRO
      • 8.6.2.2. Consultation
      • 8.6.2.3. Clinical Trial Project Management
      • 8.6.2.4. Integrated Project Delivery and Accountability
  • 8.7. VxP Pharma
    • 8.7.1. Company Overview
    • 8.7.2. Service Portfolio
      • 8.7.2.1. Chemical Development
      • 8.7.2.2. Preclinical
      • 8.7.2.3. Preformulation and Solid State Chemistry
      • 8.7.2.4. Analytical and Bioanalytical
        • 8.7.2.4.1. Analytical Method Development and Validation
        • 8.7.2.4.2. Extractables and Leachables Studies
        • 8.7.2.4.3. Particle Size Determination
        • 8.7.2.4.4. Container-API Compatibility
        • 8.7.2.4.5. Material Characterization
        • 8.7.2.4.6. Forced Degradation and Stability Studies
        • 8.7.2.4.7. Drug Device Compatibility Studies
        • 8.7.2.4.8. Microbial Testing
        • 8.7.2.4.9. Bioanalytical Testing
      • 8.7.2.5. Formulation Development and Clinical Trial materials
      • 8.7.2.6. Parenteral and Lyophilized Clinical Trial Materials
      • 8.7.2.7. Clinical Packaging and Distribution
      • 8.7.2.8. Commercial Services

9. CASE STUDY II: FULL SERVICE CROs

  • 9.1. Introduction to Traditional CROs
  • 9.2. Covance
    • 9.2.1. Company Overview
    • 9.2.2. Service Portfolio
      • 9.2.2.1. Analytical Services
      • 9.2.2.2. Clinical Development
      • 9.2.2.3. Clinical Testing
      • 9.2.2.4. Consulting
      • 9.2.2.5. Health Economics & Market Access
      • 9.2.2.6. Lead Optimization
      • 9.2.2.7. Manufacturing Services
      • 9.2.2.8. Research
      • 9.2.2.9. Safety Assessment
    • 9.2.3. Collaborations
  • 9.3. Medis Research Group
    • 9.3.1. Company Overview
    • 9.3.2. Focused Clinical Expertise
      • 9.3.2.1. Biostatistics
      • 9.3.2.2. Data Management
      • 9.3.2.3. Medical Writing
      • 9.3.2.4. Oncology Expertise
      • 9.3.2.5. Pharmacovigilance
      • 9.3.2.6. Proofreading and Translation
      • 9.3.2.7. RDC System ODM QuaSi(R)
      • 9.3.2.8. Regulatory Services
      • 9.3.2.9. Scientific Consulting
      • 9.3.2.10. Study Documentation
      • 9.3.2.11. Study Management
      • 9.3.2.12. Study Monitoring
      • 9.3.2.13. Clinical Trial Phase Expertise
      • 9.3.2.14. Additional Information
  • 9.4. Quintiles
    • 9.4.1. Company Overview
    • 9.4.2. Service Portfolio
      • 9.4.2.1. Clinical Trial Execution
      • 9.4.2.2. Consulting
      • 9.4.2.3. Laboratories
      • 9.4.2.4. Real-World and Late Phase
      • 9.4.2.5. Patient and Provider Engagement
      • 9.4.2.6. Product Marketing and Sales
      • 9.4.2.7. Technology Solutions
      • 9.4.2.8. Portfolio and Strategic Planning
    • 9.4.3. Financial Performance
    • 9.4.4. Collaborations
    • 9.4.5. Recent Developments
  • 9.5. Triclinium Clinical Trial Project Management
    • 9.5.1. Company Overview
      • 9.5.1.1. Focused Clinical Expertise
      • 9.5.1.2. Additional Information
        • 9.5.1.2.1. Collaborations

10. MARKET FORECAST

  • 10.1. Chapter Overview
  • 10.2. Forecast Methodology
  • 10.3. Global Specialty CROs Market, Till 2035
  • 10.4. Regional Specialty CROs Market, Till 2035

11. FUTURE OPPORTUNITIES

  • 11.1. Chapter Overview
  • 11.2. The Changing Scenario of Outsourcing
  • 11.3. Health Economics and Outcomes Research (HEOR) Studies
  • 11.4. Adaptive Trial Design
  • 11.5. eClinical Solutions
  • 11.6. Risk Based Monitoring (RBM)
  • 11.7. Digital CRO (dCRO)

12. CONCLUSION

  • 12.1. A Widening Portfolio of Services Governed by Industry Constraints
  • 12.2. Closer Working Collaboration is the Key to Success
  • 12.3. Within Therapeutic Areas, Oncology is the Flagbearer
  • 12.4. Due to Several Niche Offerings, Specialty CRO Market Remains Fragmented
  • 12.5. The Market of Specialty CROs is Likely to Sustain the Growth Momentum
  • 12.6. Untapped Opportunity Areas will Emerge as Key Growth Drivers in the Long-Term
  • 12.7. Concluding Remarks

13. INTERVIEW TRANSCRIPTS

  • 13.1. Chapter Overview
  • 13.2. President, CRO and Outcomes Research, Company A
  • 13.3. President, Company B

14. APPENDIX 1: TABULATED DATA

15. APPENDIX 2: LIST OF COMPANIES AND ORGANISATIONS

16. APPENDIX 3: SERVICE MAP GLOSSARY

List of Tables

  • Table 5.1 Specialty CROs: Global Landscape
  • Table 5.2 List of Specialty CROs and their Service Capabilities
  • Table 5.3 Specialty CROs: Classification by Therapeutic Areas
  • Table 6.1 BTS Research: Animal Models for Immune and Inflammatory Diseases
  • Table 6.2 BTS Research: Animal Models for Oncology
  • Table 6.3 BTS Research: Animal Models for CNS
  • Table 7.1 Accelovance China: Services
  • Table 7.2 MedSource: Research Experience in Oncology by Type of Indication
  • Table 7.3 Physiogenex: Animal Models for Diabetes
  • Table 7.4 Physiogenex: Technology Platform for Diabetes
  • Table 7.5 Physiogenex: Animal Models for Dyslipidemia
  • Table 7.6 Physiogenex: Technology Platform for Dyslipidemia
  • Table 7.7 Physiogenex: Animal Models for NAFLD/NASH
  • Table 7.8 Physiogenex: Technology Platform for NAFLD/NASH
  • Table 7.9 Physiogenex: Animal Models for Obesity
  • Table 7.10 Physiogenex: Technology Platform for Obesity
  • Table 7.11 Physiogenex: Animal Models for Nutraceuticals
  • Table 7.12 Physiogenex: Technology Platforms for Nutraceuticals
  • Table 8.1 VxP Pharma: Systems Suitable for E/L testing
  • Table 14.1 Specialty CROs: Distribution by Year of Foundation
  • Table 14.2 Specialty CROs: Distribution by Nature of Specialization
  • Table 14.3 Specialty CRO Services: Stage of Development
  • Table 14.4 Specialty CROs: Focused Preclinical Services
  • Table 14.5 Specialty CROs: Focused Clinical Services
  • Table 14.6 Specialty CROs: Distribution by Focused Therapeutic Areas
  • Table 14.7 Specialty CROs: Geographical Distribution by Therapeutic Area
  • Table 14.8 Novella Clinical: Oncological Trial Experience (%)
  • Table 14.9 Quintiles: Service Revenue, Since 2015 (USD Million)
  • Table 14.10 Overall Specialty CROs Market, Short-Midterm: Base Scenario (USD Billion)
  • Table 14.11 Overall Specialty CROs Market, Long Term Since 2020: Base Scenario (USD Billion)
  • Table 14.12 Regional Market Forecast: Base Scenario (USD Billion)
  • Table 14.13 Overall Specialty CROs Market, Short-Midterm: Conservative Scenario (USD Billion)
  • Table 14.14 Overall Specialty CROs Market, Long Term Since 2020: Conservative Scenario (USD Billion)
  • Table 14.15 Regional Market Forecast: Conservative Scenario (USD Billion)
  • Table 14.16 Overall Specialty CROs Market, Short-Midterm: Optimistic Scenario (USD Billion)
  • Table 14.17 Overall Specialty CROs Market, Long Term Since 2020: Optimistic Scenario (USD Billion)
  • Table 14.18 Regional Market Forecast: Optimistic Scenario (USD Billion)
  • Table 14.19 Specialty CROs Market: Comparative Market Evolution Scenarios (USD Billion)

List of Figures

  • Figure 4.1 Specialty CROs: Benefits
  • Figure 4.2 Specialty CROs: Areas of Specialization
  • Figure 5.1 Specialty CROs: Distribution on the Basis of Year of Foundation
  • Figure 5.2 Specialty CROs: Distribution by Nature of Specialization
  • Figure 5.3 Specialty CRO Services: Stage of Development
  • Figure 5.4 Specialty CROs: Focused Preclinical Services
  • Figure 5.5 Specialty CROs: Focused Clinical Services
  • Figure 5.6 Specialty CROs: Distribution by Focused Therapeutic Areas
  • Figure 5.7 Specialty CROs: Geographical Distribution by Therapeutic Area
  • Figure 6.1 Specialty CROs: Focused Capabilities
  • Figure 6.2 BTS Research: Services for Custom Monoclonal and Polyclonal Antibody
  • Figure 6.3 Dorizoe Lifesciences: Dosage Forms
  • Figure 6.4 Dorizoe Lifesciences: Formulation Development Protocol
  • Figure 6.5 Dorizoe Lifesciences: Customized Services
  • Figure 6.6 Spirovation: Samples and Biomarkers used for Biomarker Evaluation
  • Figure 6.7 Velesco Pharmaceutical Services: Portfolio
  • Figure 6.8 ICRC-Weyer: Biostatistical Services
  • Figure 6.9 ICRC-Weyer: Safety Writing and Pharmacovigilance
  • Figure 6.10 Impact Pharmaceuticals: Medical Writing
  • Figure 7.1 Specialty CROs: Focused Therapeutic Area(S)
  • Figure 7.2 Novella Clinical: EDC and Supporting Systems
  • Figure 7.3 Novella Clinical: Project Management Cycle
  • Figure 7.4 Novella Clinical: Oncological Trial Experience (%)
  • Figure 7.5 Physiogenex: Preclinical Services for First Level Phenotyping and Screening
  • Figure 7.6 Profil Institute: Expertise in Anti-Diabetes Compounds
  • Figure 7.7 Profil Institute: Expertise in Anti-Obesity Compounds and Devices
  • Figure 7.8 Biospective: Rodent Models
  • Figure 7.9 Biospective: Imaging Services For 1.5 and 3T MRI and Brain Pet Studies
  • Figure 7.10 Biospective: Therapeutic Areas for Human Imaging
  • Figure 7.11 Biospective: Services for Quantitative Image Analysis
  • Figure 7.12 Biospective: Stains for Histology and Immunochemistry Studies
  • Figure 8.1 Frestedt: Service Portfolio
  • Figure 8.2 ProjectPharm: Consulting Services
  • Figure 8.3 The Harte Group: Clinical Trial Project Management Services
  • Figure 8.4 VxP Pharma: GLP Radiolabelling Studies
  • Figure 8.5 VxP Pharma: Mammalian and Viral Cell Banks
  • Figure 9.1 Quintiles: Service Revenue (USD Million)
  • Figure 10.1 Overall Specialty CROs Market, Short-Midterm: Base Scenario (USD Billion)
  • Figure 10.2 Overall Specialty CROs Market, Long Term Since 2020 Base Scenario (USD Billion)
  • Figure 10.3 Regional Market Forecast: Base Scenario (USD Billion)
  • Figure 11.1 Specialty CROs: Future Opportunities