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Speciality CROs Market, 2016 - 2025

  • February 2016
  • -
  • Roots Analysis Private Ltd.
  • -
  • 321 pages

INTRODUCTION
The biopharmaceutical industry has been witnessing a significant paradigm shift in R&D outsourcing over the last few years. Speciality 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. Speciality CROs, on the other hand, specialise 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 speciality 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. Speciality 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 speciality CROs to offer improved, customised 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.

SCOPE OF THE REPORT
The “Speciality CROs Market, 2016-2025” report delivers a comprehensive study on Contract Research Organisations (CROs) that provide a specialised 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 speciality CROs continues to evolve as these organisations 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 unorganised business processes.

The report assesses key drivers that have governed the evolution of speciality 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 speciality CROs over the short-term and long-term.

The study presents an in-depth analysis of a diverse set of speciality 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 speciality 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 speciality CROs. For the purposes 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.

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 speciality 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 speciality CROs. It provides information about the functioning of speciality CROs along with the specific areas of specialisation. We have also discussed the advantages that speciality 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 speciality 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 (categorised in terms of specific therapeutic areas and services capabilities offered).

Chapter 6 provides profiles of 18 speciality CROs focused on specialised 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 speciality 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 organisations. 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 speciality 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 speciality 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 organisations mentioned in the report.

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

EXAMPLE HIGHLIGHTS
1. Over the last few years, a structural transformation in the primary CRO business model to a more strategic approach has revolutionised 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 speciality CROs after detailed due diligence of more than 1,000 CROs based on their specific capabilities and the range of services they provide. These speciality 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 speciality CROs; this is followed by Europe with ~60 CROs. India and China, where CROs offer a relatively higher cost optimised 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 speciality 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 speciality 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 optimisation 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.

Table Of Contents

Speciality CROs Market, 2016 - 2025
Executive Summary
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. Speciality Contract Research Organisations

4. SPECIALITY CROs: AN INTRODUCTION
4.1. Chapter Overview
4.2. Importance of Speciality CROs

5. MARKET OVERVIEW
5.1. Chapter Overview
5.2. Methodology
5.3. Speciality CROs: Global Landscape
5.3.1. Speciality CROs: The Dramatic Rise
5.3.2. Speciality CROs: Distribution by Nature of Specialisation
5.4. Speciality CROs Focused On a Specific Service Capability
5.4.1. Landscape is Well Distributed across Preclinical and Clinical Services
5.4.2. Speciality CROs: Popular Preclinical Services
5.4.3. Speciality CROs: Popular Clinical Services
5.5. Speciality 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. SPECIALITY 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 and Materials
6.2.1.2.2. Bioanalytical Assays for Clinical Trials
6.2.1.2.3. Clinical Trial Equipment Rental and PK Sample Collection Kit
6.2.1.2.4. Cynomologus and Rhesus Monkey Hepatocytes and Blood Products
6.2.1.2.5. Drug Candidate Early In Vitro and In Vivo Screening
6.2.1.2.6. In Vitro DMPK and ADME
6.2.1.2.7. In Vivo DMPK and ADME
6.2.1.2.8. Patient Tumour-Derived Xenograft Models at Oncographâ„¢
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. Customised 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. MDappsâ„¢

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. Customised 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. EthosExcelâ„¢
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. SPECIALITY CROs: FOCUSED ON THERAPEUTIC AREAS
7.1. Chapter Overview
7.2. Speciality 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 Centre
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 and 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 and 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. Speciality 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. Speciality 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 and 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. Speciality 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 Optimisation Services
7.5.3.2.4. Toxicology and Safety Pharmacology
7.5.3.2.5. Supporting Technologies and 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 Optimisation 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 / Organisational 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 Characterisation
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 Lyophilised 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 and Market Access
9.2.2.6. Lead Optimisation
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 Speciality CROs Market, 2015-2025
10.4. Regional Speciality 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, Speciality CRO Market Remains Fragmented
12.5. The Market of Speciality 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

List of Figures
Figure 4.1 Speciality CROs: Benefits
Figure 4.2 Speciality CROs: Areas of Specialisation
Figure 5.1 Speciality CROs: Distribution on the Basis of Year of Foundation
Figure 5.2 Speciality CROs: Distribution by Nature of Specialisation
Figure 5.3 Speciality CRO Services: Stage of Development
Figure 5.4 Speciality CROs: Focused Preclinical Services
Figure 5.5 Speciality CROs: Focused Clinical Services
Figure 5.6 Speciality CROs: Distribution by Focused Therapeutic Areas
Figure 5.7 Speciality CROs: Geographical Distribution by Therapeutic Area
Figure 6.1 Speciality 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: Customised 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 Speciality 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 Speciality CROs Market, Short-Midterm (2015-2020): Base Scenario (USD Billion)
Figure 10.2 Overall Speciality 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 Speciality CROs: Future Opportunities

List of Tables
Table 5.1 Speciality CROs: Global Landscape
Table 5.2 List of Speciality CROs and their Service Capabilities
Table 5.3 Speciality 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 Speciality CROs: Distribution by Year of Foundation
Table 14.2 Speciality CROs: Distribution by Nature of Specialisation
Table 14.3 Speciality CRO Services: Stage of development
Table 14.4 Speciality CROs: Focused Preclinical Services
Table 14.5 Speciality CROs: Focused Clinical Services
Table 14.6 Speciality CROs: Distribution by Focused Therapeutic Areas
Table 14.7 Speciality 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 Speciality CROs Market, Short-Midterm (2015-2020): Base Scenario (USD Billion)
Table 14.11 Overall Speciality 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 Speciality CROs Market, Short-Midterm (2015-2020): Conservative Scenario (USD Billion)
Table 14.14 Overall Speciality 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 Speciality CROs Market, Short-Midterm (2015-2020): Optimistic Scenario (USD Billion)
Table 14.17 Overall Speciality 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 Speciality CROs Market: Comparative Market Evolution Scenarios, 2015, 2020 and 2025 (USD Billion)

Companies Mentioned
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 Sante 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 and 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 Organisations
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 and 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 and 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 and 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. EthosExcelâ„¢
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 Farmaceutico
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 Organisation
335. Xenometrics
336. Xerox Corp
337. Xstrahl
338. YAKUMED
339. 2KMM

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