GBI Research, the leading business intelligence provider, has released its latest report, Preclinical Models - Preclinical CROs will Continue to Improve the Quality and Accuracy of Data for Targeted Therapies that provides key data, information and analysis of the major trends and developments in preclinical studies and preclinical outsourcing business. The report provides a comprehensive insight into key technological developments, new approaches in developing preclinical models. The report talks about the key outsourcing business models and factors that are driving the global preclinical outsourcing market. The report also provides a detailed analysis of global preclinical market in terms of preclinical spending and preclinical outsourced value. The report also provides key alliances and acquisitions related to preclinical studies among CROs.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Researchs team of industry experts.

Preclinical study is a critical stage in drug discovery and development. Preclinical study helps in developing a pharmacological profile of the drug and its acute toxicity. Preclinical testing involves lab and animal testing to determine if the drug is safe and effective enough for human testing and subsequent filing of Investigational New Drug (IND) application with FDA. Preclinical study makes use of systems or models such as in-vitro, in-vivo and in-silico models. These models in combination with screening, bio-imaging techniques and analytical technologies (LC, MS, LC-MS, bioanalysis) used for preclinical efficacy and safety studies.

There are latest advancements in technologies such as biomarker technology and nanotechnology that speed up the entire preclinical R&D process providing high quality preclinical data. Also the new approaches such as transgenic animal models, systems biology model and simulation models have provided solutions to various problems associated with preclinical research.

Pharmaceutical companies outsource their preclinical work to CROs to cut R&D costs; share associated risks; improve the preclinical data quality and to access specialized resources, talent pool and technology. Preclinical CROs are forming strategic partnerships and adopting innovative outsourcing business models. Global preclinical Spending is growing proportionately with the pharmaceutical R&D spending. The United States and top nine European Countries are the major preclinical outsourcing markets.

Scope

The scope of the report includes -

• Role of preclinical studies in drug discovery and development process
• Overview of current preclinical models, including in-vitro, in-vivo, in-silico models and supporting technologies
• Key technological developments and new approaches in developing preclinical models including case studies
• Outsourcing preclinical studies to CROs covering reasons for outsourcing, trends and key outsourcing business models including case studies
• Market characterization of global preclinical outsourcing market including preclinical spending and preclinical outsourced value
• Preclinical outsourcing market forecast, 2009-2016
• Geographical analysis including top nine European countries and the United States.
• Key drivers and restraints that have a significant impact on the market
• Competitive benchmarking of 16 leading CROs, covering their preclinical service offerings and recent deals in preclinical research

Reasons to buy

The report will enhance your decision making capability in a more rapid and time sensitive manner. It will allow you to -

Table of Contents

1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 7

2 Preclinical Models Introduction 8
2.1 GBI Research Report Guidance 8

3 Preclinical Models- Market Overview 9
3.1 Drug Discovery and Development- An overview 9
3.1.1 Drug Discovery 10
3.1.2 Preclinical Study/Development 10
3.1.3 Clinical Development 11
3.2 Preclinical Studies- An overview 12
3.3 Preclinical Study Design and Planning 12
3.3.1 Preclinical Study - Strategic Planning 12
3.3.2 Key Considerations during Preclinical Study Design 13
3.4 Preclinical Studies- In-house 14
3.5 Preclinical Studies- Outsourced 14
3.5.1 Independent Contracting 14
3.5.2 Complete Outsourcing 14
3.6 Role of a CRO 15
3.7 Regulatory Aspects of Preclinical Studies 16
3.7.1 The Principles of Good Laboratory Practice 16
3.7.2 NIH and AAALAC 16

4 Preclinical Models- Preclinical Outsourcing Models 17
4.1 Reasons for Outsourcing Preclinical Studies 17
4.1.1 Optimizing Cost 18
4.1.2 Achieving Speed and Flexibility 18
4.1.3 Access to Specialty Resources, Technological Advancements, Equipment and Facilities 18
4.1.4 Minimizing the Risks Associated with the Early Stages of the Drug Discovery Development Process 18
4.1.5 Focus on Core Competencies 19
4.2 Preclinical Outsourcing Process 19
4.2.1 Steps Involved In Outsourcing a Preclinical Project 19
4.2.2 Criteria for Selecting a Contract Research Organization 21
4.2.3 Preclinical Outsourcing Business Models 22
4.3 Outsourcing Trends 23
4.3.1 Strategic Partnerships and R&D collaborations with Pharmaceutical Companies 23
4.3.2 Capacity Concerns 24
4.3.3 Innovative Management of Outsourcing Projects 24
4.3.4 Strategic Shift in Funding and Payment Patterns 24
4.3.5 Emergence of One-Stop-Shop CROs and Boutique Providers 24
4.4 Case Studies 25
4.4.1 Early Stage Preclinical Project 25
4.4.2 Long Term Partnerships with Drug Discovery and Preclinical Service Providers 26

5 Preclinical Models- Technology Landscape 27
5.1 Current System 27
5.1.1 Overview 27
5.1.2 Key Technologies 27
5.1.3 In-Vitro ADMET Screening Models 28
5.1.4 In-vivo ADMET Screening Models 29
5.1.5 In-silico ADMET Screening models 30
5.2 Trends in Technology Models 31
5.2.1 Recent Technology Developments 31
5.2.2 New Approaches 33
5.3 Case Studies-Preclinical Models (Technological Developments) 35
5.3.1 Apredicas Customized In-vitro ADMET Screening Assays 35
5.3.2 AVEO Pharmaceuticals Breakthrough with Transgenic Mouse Model for Human Breast Cancer 36
5.3.3 In-vitro Models for Dermal Corrosion / Irritation and Eye Irritation by Charles River 37
5.3.4 Preclinical Models of Hepatocellular Carcinoma and Biomarker Strategy by Pfizer 38
5.3.5 SimuGens HT-Stream, a Preclinical Toxicogenomics System/Model 39
5.3.6 A Validated Physiologically Based Mathematical Model of Pathogenesis in the Non-Obese Diabetic Mouse by Entelos 39
5.3.7 Simulation Modeling to Treat Spinal Cord Injuries by Novartis 40
5.3.8 Recent Development in Preclinical Imaging by Caliper Life Sciences 41

6 Preclinical Models- Market Characterization 42
6.1 Global Spending on Prehuman/Preclinical Studies 42
6.2 Preclinical Spending by Geography 43
6.3 Global Preclinical Outsourcing Market 44
6.4 Key Market Drivers and Restraints 45
6.4.1 Market Drivers 45
6.4.2 Key Restraints 46

7 Preclinical Models- Geographical Analysis 47
7.1 Germany 47
7.2 The UK 48
7.3 Switzerland 49
7.4 Italy 50
7.5 France 51
7.6 Belgium 52
7.7 Denmark 53
7.8 Spain 54
7.9 Sweden 55
7.10 The US 56

8 Preclinical Models- Company Profiling 57
8.1 Charles River Laboratories International, Inc. 57
8.1.1 Business Overview 57
8.1.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 58
8.2 Cyprotex Discovery Ltd. 59
8.2.1 Business Overview 60
8.2.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 60
8.3 Shanghai ChemPartner 61
8.3.1 Business Overview 61
8.3.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 61
8.4 Covance, Inc. 62
8.4.1 Business Overview 62
8.4.2 Recent M&A Deals and Alliances in Preclinical Research 63
8.5 PPD, Inc. 64
8.5.1 Business Overview 64
8.5.2 Recent M&A Deals and Alliances in Preclinical Research 64
8.6 Ricerca Biosciences, LLC 65
8.6.1 Business Overview 65
8.6.2 Recent M&A Deals and Strategic Alliances 65
8.7 Caliper Life Sciences 66
8.7.1 Business Overview 66
8.7.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 67
8.8 GVK BIO 68
8.8.1 Business Overview 68
8.8.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 69
8.9 MPI Research 70
8.9.1 Business Overview 70
8.9.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 70
8.10 MDS 71
8.10.1 Business Overview 71
8.11 MD Biosciences 72
8.11.1 Business Overview 72
8.11.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 72
8.12 Aptuit 73
8.12.1 Business Overview 73
8.12.2 Recent M&A Deals and Strategic Alliances in Preclinical Research 73
8.13 ITR Canada 74
8.13.1 Business Overview 74
8.14 Advinus Therapeutics 75
8.14.1 Business Overview 75
8.14.2 Recent M&A Deals and Strategic Alliances 76
8.15 Jubilant Biosys 77
8.15.1 Business Overview 77
8.15.2 Major M&A Deals and Strategic Alliances 78
8.16 AMRI 79
8.16.1 Business Overview 79
8.16.2 Recent Deals in Preclinical Research 79

9 Preclinical Models- Appendix 80
9.1 Market Definitions 80
9.2 List of Abbreviations 81
9.3 Research Methodology 82
9.3.1 Coverage 82
9.3.2 Secondary Research 82
9.3.3 Primary Research 83
9.3.4 Expert Panel Validation 83
9.4 Contact Us 83
9.5 Disclaimer 83
9.6 Sources 84

List of Tables

Table 1: Preclinical Models, Global Prehuman/Preclinical Spending, ($m), 2009-2016 42
Table 2: Preclinical Models, Preclinical Spending by Geography, 2009 43
Table 3: Preclinical Models, Global Preclinical Outsourcing Market, ($m), 2009-2016 44
Table 4: Preclinical Models, Germany, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 47
Table 5: Preclinical Models, The UK, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 48
Table 6: Preclinical Models, Switzerland, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 49
Table 7: Preclinical Models, Italy, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 50
Table 8: Preclinical Models, France, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 51
Table 9: Preclinical Models, Belgium, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 52
Table 10: Preclinical Models, Denmark, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 53
Table 11: Preclinical Models, Spain, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 54
Table 12: Preclinical Models, Sweden, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 55
Table 13: Preclinical Models, The US, Total R&D, Preclinical R&D & Outsourced Preclinical R&D Spending, $m, 2009 56

List of Figures

Figure 1: Drug Discovery and Development Process 9
Figure 2: Preclinical Models, Preclinical Services Offered by a CRO 15
Figure 3: Preclinical Models, Reasons for Outsourcing Preclinical Studies 17
Figure 4: Preclinical Models, Key Factors Considered for Selecting a CRO for Preclinical Outsourcing 21
Figure 5: Preclinical Models, Preclinical Outsourcing Models & In-house Preclinical R&D 22
Figure 6: Preclinical Models, Preclinical ADMET Studies- Current System 27
Figure 7: Preclinical Models, New Approaches for Conducting Preclinical Studies 33
Figure 8: Preclinical Models, Global Preclinical Spending, ($m), 2009-2016 42
Figure 9: Preclinical Models, Preclinical Spending by Geography, 2009 43
Figure 10: Preclinical Models, Global Preclinical Outsourcing Market, ($m), 2009-2016 44
Figure 11: Preclinical Models, Key Market Drivers and Restraints for Preclinical Outsourcing 45
Figure 12:Preclinical Models, Germany, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 47
Figure 13: Preclinical Models, The UK, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 48
Figure 14: Preclinical Models, Switzerland, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 49
Figure 15: Preclinical Models, Italy, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 50
Figure 16:Preclinical Models, France, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 51
Figure 17: Preclinical Models, Belgium, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 52
Figure 18: Preclinical Models, Denmark, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 53
Figure 19:Preclinical Models, Spain, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 54
Figure 20:Preclinical Models, Sweden, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 55
Figure 21: Preclinical Models, The US, Total R&D, Preclinical R&D and Outsourced Preclinical R&D Spending, $m, 2009 56
Figure 22:Preclinical Models, Charles River Laboratories International, Inc - Corporate Profile 57
Figure 23: Preclinical Models, Cyprotex Discovery Ltd. - Corporate Profile 59
Figure 24: Preclinical Models, Shanghai ChemPartner- Corporate Profile 61
Figure 25: Preclinical Models, Covance, Inc - Corporate Profile 62
Figure 26: Preclinical Models, PPD, Inc - Corporate Profile 64
Figure 27: Preclinical Models, Ricerca Biosciences, LLC - Corporate Profile 65
Figure 28: Preclinical Models, Caliper Life Sciences, Inc - Corporate Profile 66
Figure 29: Preclinical Models, GVK BIO- Corporate Profile 68
Figure 30: Preclinical Models, MPI Research - Corporate Profile 70
Figure 31: Preclinical Models, MDS, Inc - Corporate Profile 71
Figure 32: Preclinical Models, MD Biosciences- Corporate Profile 72
Figure 33: Preclinical Models, Aptuit, Inc. - Corporate Profile 73
Figure 34: Preclinical Models, ITR Canada, Inc - Corporate Profile 74
Figure 35: Preclinical Models, Advinus Therapeutics, Inc - Corporate Profile 75
Figure 36: Preclinical Models, Jubilant Biosys, Inc - Corporate Profile 77
Figure 37: Preclinical Models, Albany Molecular Research, Inc (AMRI)- Corporate Profile 79