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Specialty CROs Market, 2016 - 2025

Published: Feb 12, 2016
Pages: 321
Product Code: RA10055
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The biopharmaceutical industry has been witnessing a significant paradigm shift in R&D outsourcing over the last few years. Specialty CROs have emerged as credible players in the market to overcome the shortcomings of full service / traditional CROs. Often, these full service providers offer a wider portfolio of services but fail to align their efforts to meet the requirements of sponsors, primarily the smaller biotech organisations / start-ups. Specialty CROs, on the other hand, specialize in niche areas catering to either specific clinical / preclinical services or providing services in a particular disease area. Oncology, cardiovascular, metabolic disorders and CNS are some of the popular therapeutic areas that have witnessed a rise in the number of specialty CROs. Typically outsourced services include data management, site monitoring and project management but nowadays core services such as  pharmacovigilance, target evaluation, formulation development, cell line development, toxicology studies and medical imaging are also being outsourced to these CROs. Specialty CROs are increasingly adopting the strategic CRO model to expand their services and geographical presence in an effort to broaden the scope of serving the global biopharmaceutical industry.

 

Despite the widening array of services offered by these CROs, they have found it challenging to gain a higher share in the market, which is currently dominated by larger and more well-established players. Considering that a major proportion of revenues for large CROs is generated by big pharma companies, gaps exist when it comes to providing services to smaller pharma / biotech companies. This provides an opportunity to specialty CROs to offer improved, customized and relatively economical services to newer / smaller clients in the sector.

 

As the demand of novel therapies for various therapeutic areas is expected to rise steadily, we are optimistic about the future of these smaller research firms, which have driven an innovative approach to drug research and development. There are a number of upcoming opportunities that can enrich the service portfolio of speciality CROs gradually strengthening their presence in an otherwise consolidated market. 

 

  • Synopsis
  • Table of
    Contents
  • List of
    Figures
  • List of
    Tables
  • Listed Companies
  • Sample
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  • Download Brochure

 

The “Specialty CROs Market, 2016-2025” report delivers a comprehensive study on Contract Research Organizations (CROs) that provide a specialized set of research capabilities centred on a particular stage of clinical development or a range of services in a focused therapeutic area. The outsourcing model has proven to be extremely beneficial to drug developers catering to the unmet research, clinical development and even regulatory needs of both established players and start-ups in the market. The concept of specialty CROs continues to evolve as these organizations adopt new strategies to provide their sponsors improved services in terms of both quality and efficiency. Novel business models and strategic partnerships among established and emerging players have opened new avenues to effectively tackle issues such as rising development costs, inefficient protocols and unorganized business processes.

 

The report assesses key drivers that have governed the evolution of specialty CROs over the past several years, along with an elaborate discussion on the upcoming trends that will likely shape the market in the coming years. In fact, one of the primary objectives of this study is to develop an understanding of the likely future evolution of the market for specialty CROs over the short-term and long-term.

 

The study presents an in-depth analysis of a diverse set of specialty CROs on some of the key parameters such as geographical location, types of services being offered and focused therapeutic areas. In addition, it captures the potential growth areas that will likely present opportunities for these companies and sustain the pace of growth. It is worth highlighting that despite the fact that established pharmaceutical companies have in-house R&D and clinical development capabilities, the opportunity for specialty CROs is growing. The future evolution of this market will be primarily driven by the relatively fast paced growth of the overall pharma industry and the innovations / developments taking place in R&D. The report provides short-midterm and long-term market forecasts for the period 2016-2020 and 2020-2025, respectively. To add robustness to our forecast model, we have provided three market scenarios. The conservative, base and optimistic scenarios represent three different tracks of market evolution. The research, analysis and insights presented in this report are backed by a comprehensive survey on capabilities of several specialty CROs. For the purpose of our analysis, we also interviewed important stakeholders in this market to solicit their opinions around the future opportunities and challenges that must be considered for a more inclusive growth.

 

Example Highlights

  1. Over the last few years, a structural transformation in the primary CRO business model to a more strategic approach has revolutionized R&D outsourcing. Newer players providing specific capabilities in the R&D value chain have witnessed a gradual acceptance.
  2. During our research, we have identified over 200 specialty CROs after detailed due diligence of more than 1,000 CROs based on their specific capabilities and the range of services they provide. These specialty CROs collectively cater to the multitude of research services required by drug developers.
  3. The US, with ~115 speciality CROs, has emerged as the primary hub of specialty CROs; this is followed by Europe with ~60 CROs. India and China, where CROs offer a relatively higher cost optimized service portfolio, are emerging as new destinations; the level of activity, however, has been fairly limited so far.
  4. Though the broader contract research market is highly consolidated and dominated by a handful of bigger CROs, the market within the specialty CRO segment is highly fragmented. This is unlikely to change as biotech companies will continue to prefer outsourcing specific requirements of the clinical trials instead of outsourcing the entire clinical trial programme to an individual CRO.
  5. We expect the overall market of specialty CROs to more than double in the coming decade, growing at a CAGR of 8.6%. Specific areas of growth are likely to be driven by novel services and upcoming technologies resulting in cost optimization and improved outputs.
  6. Some of the niche opportunity areas / approaches include Health Economics and Outcomes Research (HEOR), adaptive trial designs, and eClinical solutions. Specifically, these areas typify a growing unmet need and represent untapped areas making outsourcing an attractive option.

 

 

Research Methodology

Most of the data presented in this report has been gathered by secondary research.We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

 

The secondary sources of information include:

  • Annual reports
  • Investor presentations
  • SEC filings
  • Industry databases
  • News releases from company websites
  • Government policy documents
  • Other analysts’ opinion reports 

 

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

 

Chapter Outlines

Chapter 2 provides an executive summary of the insights captured during our research. The summary offers a high level view on the present scenario of the specialty CRO market and where it is headed in the mid-long term.

 

Chapter 3 provides a general introduction to CROs. In this chapter, we have discussed, in detail, the evolution of CROs. We have also presented a highly comprehensive CRO services map to highlight the range of services being offered by a large number of CROs operating in different locations worldwide.

 

Chapter 4 presents specific details on specialty CROs. It provides information about the functioning of specialty CROs along with the specific areas of specialization. We have also discussed the advantages that specialty CROs bring over conventional CROs, focusing on new business models, strategic partnerships and relatively more efficient / integrated business processes.

 

Chapter 5 provides a holistic global landscape of specialty CROs that we identified in our research. This chapter highlights key aspects of these companies such as their geographical location, year of establishment and R&D capabilities (categorized in terms of specific therapeutic areas and services capabilities offered).

 

Chapter 6 provides profiles of 18 specialty CROs focused on specialized preclinical / clinical service offering. Each company profile includes an overview of the company, service portfolio, collaborations and associated developments that have recently taken place.

 

Chapter 7 provides profiles of 12 specialty CROs focused on a particular therapeutic area. Each company profile includes an overview of the company, service portfolio, collaborations and associated developments that have recently taken place.

 

Chapter 8 is a case study on virtual CROs. We have discussed, in detail, the virtually integrated, cross-functional outsourcing approach implemented by these organizations. In this chapter, we have also focused on various clinical research partnership models that are applied by CROs and their sponsors. The case study also includes profiles of six virtual CROs, some of which are leading players in the market.

 

Chapter 9 is a case study on full-service CROs. The one-stop-shop approach followed by traditional CROs has been captured in detail in this section. The case study includes profiles of four CROs, some of which are leading players in the market.

 

Chapter 10 presents a detailed ten year forecast highlighting the future potential for specialty CROs. Due to the uncertainty surrounding some of the key assumptions, we have presented three different evolution scenarios for the overall market.

 

Chapter 11 highlights important trends that provide opportunities to specialty CRO to consolidate their presence in this competitive market; amongst others, these include Health Economics and Outcomes Research (HEOR) studies, adaptive trials, eClinical solutions and risk-based monitoring (RBM).

 

Chapter 12 is a collection of transcript of interviews conducted with key players during the course of this study.

 

Chapter 13 summarises the overall report. In this chapter, we have provided a recap of the key takeaways and our overall opinion on where the market is headed in the mid-long term.

 

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

 

Chapter 15 is an appendix, which provides a list of companies and organizations mentioned in the report.

 

Chapter 16 is an appendix, which provides a glossary of the CRO services map.

 

 1. PREFACE

1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
 
2. EXECUTIVE SUMMARY
 
3. INTRODUCTION
3.1. History
3.2. Traditional Contract Research Organisations
3.2.1. Services
3.2.2. Current Industry Environment
3.3. Specialty Contract Research Organisations
 
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 Specialisation
5.4. Specialty CROs Focused On a 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™
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
6.2.4.2.1. Cell-based screening services
6.2.4.2.2. In Vitro Drug Profiling Services and Mechanism of Action (MOA) Studies
6.2.4.2.3. Predictive Toxicology Services
6.2.4.2.4. In Vivo Studies
6.2.4.2.5. 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™
 
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® 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™
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®
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
9.3.2.3. Clinical Trial Phase Expertise
9.3.2.4. 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, 2015-2025
10.4. Regional Specialty CROs Market, 2015 – 2025
 
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. Raf Magar, President, CRO and Outcomes Research, AHRM
13.3. Jeffrey P. Kiplinger, President, Averica Discovery Services
 
14. APPENDIX 1: TABULATED DATA
 
15. APPENDIX 2: LIST OF COMPANIES AND ORGANISATIONS
 
16. APPENDIX 3: SERVICE MAP GLOSSARY
 
 
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, 2010-H1 2015 (USD Million)
 
Figure 10.1 Overall Specialty CROs Market, Short-Midterm (2015-2020): Base Scenario (USD Billion)
 
Figure 10.2 Overall Specialty CROs Market, Long Term (2020-2025): Base Scenario (USD Billion)
 
Figure 10.3 Regional Market Forecast, 2015, 2020 And 2025: Base Scenario (USD Billion)
 
Figure 11.1 Specialty CROs: Future Opportunities
 
 
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, 2010-H1 2015 (USD Million)
 
Table 14.10 Overall Specialty CROs Market, Short-Midterm (2015-2020): Base Scenario (USD Billion)
 
Table 14.11 Overall Specialty CROs Market, Long Term (2020-2025): Base Scenario (USD Billion)
 
Table 14.12 Regional Market Forecast, 2015, 2020 and 2025: Base Scenario (USD Billion)
 
Table 14.13 Overall Specialty CROs Market, Short-Midterm (2015-2020): Conservative Scenario (USD Billion)
 
Table 14.14 Overall Specialty CROs Market, Long Term (2020-2025): Conservative Scenario (USD Billion)
 
Table 14.15 Regional Market Forecast, 2015, 2020 and 2025: Conservative Scenario (USD Billion)
 
Table 14.16 Overall Specialty CROs Market, Short-Midterm (2015-2020): Optimistic Scenario (USD Billion)
 
Table 14.17 Overall Specialty CROs Market, Long Term (2020-2025): Optimistic Scenario (USD Billion)
 
Table 14.18 Regional Market Forecast, 2015, 2020 and 2025: Optimistic Scenario (USD Billion)
 
Table 14.19 Specialty CROs Market: Comparative Market Evolution Scenarios, 2015, 2020 and 2025 (USD Billion)
 

 

The following companies and organisations have been mentioned in this report.

 

  1. Abiogenesis Clinpharm
  2. Accell Clinical Research
  3. Accelovance
  4. Aclires
  5. Acquipharma
  6. Afraxis
  7. Agence Africaine de Recherche en Santé Humaine
  8. Agility Clinical
  9. Agilux Laboratories
  10. AHRM
  11. AIT Bioscience
  12. Aklima Clinical Research
  13. Alera Labs 
  14. Alimentix
  15. Alliance Pharma
  16. Allied Clinical Management
  17. Allostem Therapeutics
  18. Almedis
  19. Alpha CRO
  20. Alpha Stats
  21. Altair Clinical
  22. Altiora CRO
  23. Altree Healthcare
  24. Alturas Analytics
  25. Amarex Clinical Research
  26. Amclin Life Sciences
  27. American Physical Therapy Association
  28. AMSlab
  29. Anolinx
  30. APEX Research
  31. Appletree CI Group
  32. Applied Clinical Research & Consulting Group
  33. Applied Healthcare Resource Management
  34. Apricus Biosciences
  35. ARAC
  36. Arete Clinical Research
  37. Argonaut Private Equity
  38. Aris Global
  39. Arkios BioDevelopment International
  40. Association for Assessment and Accreditation of Laboratory Animal Care International
  41. Association of Clinical Research Organizations
  42. Association of Clinical Research Professionals
  43. Aston University
  44. Athena Discovery
  45. Atlantic Bone Screen
  46. Atuka
  47. Audubon PM Associates
  48. Auxilis Pharma
  49. Averica Discovery Services
  50. Avitacor
  51. Axonal
  52. B. McLaughlin Associates
  53. Banook Group
  54. Betagenex
  55. Biaffin GmbH & Co
  56. Biogen
  57. BioLink Life Sciences
  58. BioPharma Services
  59. Bio-Quant
  60. BioSkin CRO 
  61. Biospective
  62. Biotrofix Preclinical CRO
  63. Bordeaux University
  64. Boston Biomedical Associates
  65. Boston Regulatory Consulting
  66. BRI Biopharmaceutical Research
  67. BTS Research
  68. Burrill & Company
  69. Cambridge Biomedical
  70. Canadian Council of Animal Care
  71. CAP Trials
  72. Cardialysis
  73. Cardiomedex
  74. CDIB Capital Investment
  75. Center Point Clinical Services
  76. Cerafor
  77. Charles River Laboratories
  78. Chimera Biotec
  79. Cica Biomedical
  80. CIDP Biotech India
  81. Cirion Clinical Trial Services
  82. CirQuest Labs
  83. ClinAudits
  84. ClinBAY
  85. ClinDatrix
  86. Clinical Research Consulting
  87. Clinilabs
  88. CliniRx Tangent Research
  89. ClinIST Research Education and Consulting
  90. Clinitrial CRO
  91. ClinROC
  92. Clinvest
  93. CMX Research
  94. CNBE
  95. Concentrics Research
  96. Courante Oncology
  97. Covance
  98. CPR Pharma Services 
  99. CRC Pharma
  100. CRDE
  101. Creagen Biosciences
  102. CRO Solutions
  103. Cros NT
  104. Crown Bioscience
  105. Crownbio Taicang Biologics Division
  106. Crystal Pharmatech
  107. Cu Tech
  108. CuriRX
  109. Cyprotex
  110. Cytespace Africa
  111. DATATRAK International
  112. David H Murdock Research Institute
  113. DaVita Clinical Research
  114. DiaVacs
  115. Dinox
  116. Diverse Lynx
  117. DOCRO
  118. Dorizoe Lifesciences
  119. DSP Clinical Research
  120. DZS Clinical Services
  121. EarlyPhase Sciences
  122. Eastern Clinical Trials
  123. Eckert & Ziegler Vitalea Science
  124. Ecron Acunova
  125. Elucid Bioimaging
  126. EmpiriStat 
  127. EMRI CRO Greece
  128. Encore Health Services
  129. Ephoran
  130. ERA Clinical
  131. Erudita Biotechnical
  132. EthosExcel™
  133. Euprotec
  134. European Cardiovascular Research Institute
  135. European Food Safety Authority
  136. European Medical Writers Association
  137. Federation of European Laboratory Animal Science Association
  138. Fermish
  139. First Clinical Network
  140. Flow Contract Site Laboratory
  141. FlowMetric
  142. FluoFarma
  143. Foster Delivery Services
  144. Frenova Renal Research
  145. Frestedt
  146. Frontline Monitors
  147. Gadea Grupo Farmacéutico
  148. Gateway Pharmacology Laboratories
  149. Getz Pharma Research
  150. Global Specimen Solutions
  151. Greenville Health System
  152. Gubra
  153. Harlan Laboratories
  154. Health Canada
  155. Health Sciences Authority
  156. HealthLinx
  157. Hengrui Medicine
  158. HJ-Clinical Trial Consultancy
  159. Horizon Discovery
  160. Hospital Italiano of Buenos Aires
  161. Huntingdon Life Sciences
  162. IBT Management Corporation
  163. ICE Bioscience
  164. ICRC-Weyer
  165. IMMR
  166. Impact Pharmaceutical Services
  167. Inamed
  168. Inclinix
  169. Innova CRO
  170. Innovaderm Research
  171. InrexTest
  172. Institute for Translational Oncology Research
  173. InSymbiosis
  174. Integral Biosystems
  175. International Drug Development Institute
  176. Ionic Transport Assays
  177. IonsGate Preclinical Services
  178. IPSEN
  179. Iris Pharma
  180. Jasco Pharmaceuticals
  181. JV AgroBiotech
  182. KalVista Pharmaceuticals
  183. Karolinska Development
  184. KCAS
  185. KCRI
  186. Kiyatec
  187. Klinikos Consulting
  188. KPS
  189. LabCorp Clinical Trials
  190. Lekoko PMC
  191. LEMI
  192. Life Science Alley
  193. Lilly Asia Ventures
  194. Lotus Clinical Research
  195. LU Bioscience
  196. Marsico Lung Institute
  197. MCT
  198. Medelis
  199. Medepha
  200. Medicines and Healthcare Products Regulatory Agency
  201. Medicon Valley Inhalation Consortium
  202. Medis Research Group
  203. MedSource
  204. Merck Serono
  205. Mercodia
  206. Michigan Life Science and Innovation Center
  207. MicroConstants
  208. Midwest Melanoma Partnership
  209. miRagen Therapeutics
  210. MMS Holdings
  211. Modoc Research Services
  212. Molecular Imaging
  213. Molecular Response
  214. Montrium
  215. NAMSA Medvance
  216. Nanjing Biotech Innovation Corporation
  217. National Cancer Institute
  218. National Institutes of Health
  219. National Resource Center for Mutant Mice
  220. Neuregenix
  221. NeuroDiscovery
  222. Neuron Experts
  223. NeuroSciences
  224. New England Research Institute
  225. New York State Center of Excellence in Bioinformatics and Life Sciences
  226. NexMed
  227. Next Generation Clinical Research
  228. Novella Clinical
  229. NSF International
  230. Numira
  231. Nutrition Coordinating Center
  232. Octagon Research Solutions
  233. Oncotherapeutics
  234. Oneiric International
  235. OnkoDataMed
  236. OnPoint CRO
  237. OrbiMed Advisors
  238. Orbis Data Solutions
  239. Organon
  240. Osiris Pharma
  241. Oss lab
  242. P3 Research
  243. Pacific Nutritional Research
  244. PAIRimmune
  245. Panacea Pharmaceuticals
  246. Pfizer
  247. PharmaLegacy 
  248. PharmaPhase Management
  249. PharSafer Associates
  250. Phenotype Expertise
  251. PhylogenX
  252. Physiogenex
  253. PhysioStim
  254. Pioneer Clinical Data
  255. Pneumolabs
  256. Preclinical Oncology Services
  257. Profil Institut für Stoffwechselforschungh
  258. ProjectPharm
  259. Prologue Research
  260. Prometrika
  261. ProNoxis
  262. ProQinase
  263. ProTrials
  264. Provonix
  265. QED Clinical Services
  266. QuailCRO
  267. Quanticate
  268. Quest Diagnostics
  269. Quintiles
  270. Redoxis
  271. Renaissance Associates
  272. RenaSci
  273. Research Dynamics Consulting Group
  274. Research Point Clinical
  275. Roche
  276. RxGen
  277. SAGE Labs
  278. Sahana Clinical Research
  279. SBH Sciences
  280. SCIderm
  281. Scimega
  282. SDS Clinical
  283. Servier
  284. Shanghai Institute of Materia Medica
  285. Shin Nippon Biomedical Laboratories
  286. Simbec Research
  287. Skills Alliance
  288. SMS-oncology
  289. Spirovation
  290. Sristek
  291. Stat Pro
  292. Surpass
  293. SwedenBIO
  294. Symbiance 
  295. Symmetry Biosciences
  296. Synchrogenix
  297. SynCon International 
  298. Synergo BioPharma
  299. Synergy
  300. Synsight
  301. Sysmex Corporation
  302. TAB Clinical Trials
  303. Tandem Labs
  304. TCNSC
  305. Team WomenMN
  306. Techtrials International
  307. TFS Trial Form Support
  308. The CID Group
  309. The Harte Group
  310. The Medical Affairs Company
  311. The Total Approach
  312. Therapeutic Goods Administration
  313. Therinova
  314. Tillväxtverket
  315. Topstone Research
  316. Toxikon Corporation
  317. Translational Research Institute
  318. Trial-IN
  319. Triclinium Clinical Research 
  320. Tufts University
  321. Universidad de Valladolid
  322. University College Dublin
  323. University of Erlangen
  324. Vanton Research Laboratory
  325. Velesco Pharmaceutical Services
  326. Vinnova
  327. VirtualScopics
  328. Visionar Preclinical
  329. Voxcan
  330. VR Analytical
  331. VxP Pharma
  332. Wildcat Pharmaceutical Development Center
  333. William Harvey Research
  334. World Health Organization
  335. Xenometrics
  336. Xerox Corp
  337. Xstrahl
  338. YAKUMED
  339. 2KMM

 

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