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Early Stage Drug Discovery in Disease Segments - Innovation Focuses on Stem Cell Therapies and Gene Therapies

Published By :

GBI Research

Published Date : Feb 2011

Category :

Biotechnology

No. of Pages : 209 Pages


GBI Researchs new report, Early Stage Drug Development in Disease Segments Innovation Focuses on Stem Cell Therapies and Gene Therapies, provides an in-depth analysis of the unmet needs, drivers and barriers that affect the global Central Nervous System Disorders (CNS), Metabolic Disorders, Immunologic Disorders, Infection, Cardiovascular Disease and Oncology therapeutic markets. 

The report analyzes the early stage drug development that includes drugs under development in the discovery and preclinical stages of development for the above mentioned indications in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. 

Treatment usage patterns, sales value and the annual cost of therapy are forecast until 2017 for the key geographies in the leading therapeutic segments. Further, the report provides competitive benchmarking for the leading companies and analyzes the Mergers and Acquisitions (M&A) and licensing agreements that shape the global market.

The 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.

GBI Research finds that early stage drug development includes drugs under development in the discovery and preclinical stages of development. These studies are conducted in order to assess the safety and efficacy of the drug. This stage of development plays a key role in drug development as it determines potential molecules to be further processed for development by different companies. 

Increased strategies like RAS (Risk Assessment Strategies) issued by the US FDA (Food and Drug Administration) are persuading companies to implement safety scrutiny measures at early stages of development.

The majority of the molecules in the early stages of development are being developed for cancer indications. Molecules under development for breast cancer account for 23% of the total early stage development molecules under development for cancer. This is followed by prostate cancer, accounting for 20%, followed by colon cancer (15%).

Other than Oncology, other therapeutic areas with high activity in Research and Development (R&D) in early development phases include Central Nervous System (CNS) disorders, immunological disorders, and metabolic disorders. CNS disorders accounted for 14% of early stage drugs under development, followed by immunological disorders (13%) and metabolic disorders (10%). Compared to other therapeutic areas, there is less R&D activity in the metabolic disorders (9%) and infectious disease (9%) segments.

Scope

The scope of this report includes - 

  • Coverage of pipeline molecules in various discovery and pre-clinical phases of drug development along with pipeline analysis of the leading therapeutic segments, including Oncology, CNS disorders, immunological disorders, infection, metabolic disorders and cardiovascular disorders.
  • Analysis of the above mentioned disorders market in the leading geographies of the world, which are the US, the UK, Germany, France, Italy, Spain and Japan.
  • Key drivers and barriers that have a significant impact on the market.
  • Competitive benchmarking of leading companies. The key companies studied in this report are Hanall Pharmaceutical Co. Ltd, Patrys Limited, F. Hoffmann-La Roche Ltd, Mirna Therapeutics, Inc. and Aphios Corporation.
  • Key M&A activities and licensing agreements that have taken place between 2005 and 2010 in the global Oncology, CNS disorders, immunological disorders, infection, metabolic disorders and cardiovascular disorders markets.

Reasons to buy

The report will enhance your decision making capability. It will allow you to -

  • Align your product portfolio to the markets with high growth potential.
  • Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth.
  • Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with more efficiency and better safety.
  • Develop key strategic initiatives by understanding the key focus areas of leading companies.
  • Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps.
Table of Contents

1 Table of Contents 4

1.1 List of Tables 6
1.2 List of Figures 8

2 Early Stage Drug Discovery in Disease Segments Introduction 10
2.1 GBI Research Report Guidance 11

3 Early Stage Drug Discovery in Disease Segments - Overview 12
3.1 Drug Discovery and Development 12
3.1.1 Drug Development-Stages 13
3.2 Early Stage Drug Discovery Studies- An overview 15
3.3 Early Stage Drug Discovery Design and Planning 16
3.3.1 Early Stage Drug Discovery Strategic Planning 16
3.3.2 Key Considerations During Early Stage Drug Discovery 16

4 Early Stage Drug Discovery in Disease Segments - Technology Landscape 18
4.1 Current System 18
4.1.1 Overview 18
4.1.2 Key Technologies 18
4.1.3 In-vitro ADMET Screening Models 19
4.1.4 In vivo ADMET Screening Models 20
4.1.5 In silico ADMET Screening models 21
4.2 Trends in Technology Models 22
4.2.1 Recent Technology Developments 22

5 Early Stage Drug Discovery in Disease Segments - Drug Discovery and Development A Challenge to Pharmaceutical Companies 27
5.1 Drug Discovery & Development Process 27
5.1.1 Drug Discovery Process 27

6 Early Stage Drug Discovery in Therapeutic Segments 28
6.1 Central Nervous System Disorders 31
6.1.1 Alzheimers disease 31
6.1.2 Parkinsons disease 37
6.1.3 Multiple Sclerosis 42
6.1.4 Schizophrenia 47
6.2 Metabolic Disorders 52
6.2.1 Diabetes 52
6.2.2 Obesity 59
6.3 Immunological Disorders 65
6.3.1 Rheumatoid Arthritis 65
6.3.2 Crohns Disease 72
6.3.3 Systemic Lupus Erythematosus (SLE) 77
6.3.4 Allergy 82
6.4 Infections 87
6.4.1 HIV/AIDS 87
6.4.2 Hepatitis A, B, C 96
6.5 Cardiovascular Diseases 104
6.5.1 Hypertension 104
6.5.2 Dyslipidemia 109
6.5.3 Pulmonary Arterial Hypertension (PAH) 114
6.5.4 Myocardial Infarction 119
6.6 Oncology 124
6.6.1 Bladder Cancer 124
6.6.2 Lung Cancer 129
6.6.3 Non-Small Cell Lung Cancer (NSLC) 137
6.6.4 Breast Cancer 143
6.6.5 Colon Cancer 154
6.6.6 Melanoma 163
6.6.7 Ovarian Cancer 170
6.6.8 Prostate Cancer 177

7 Early Stage Drug Discovery in Disease Segments Top Five Pharmaceutical Players in Early Stage Drug Discovery 186
7.1 Introduction 186
7.2 Hanall Pharmaceutical 187
7.2.1 Company Overview 187
7.2.2 Pipeline 187
7.3 Patrys Limited 188
7.3.1 Company Overview 188
7.3.2 Pipeline 189
7.4 F. Hoffmann-La Roche Ltd. 189
7.4.1 Company Overview 189
7.4.2 Pipeline 190
7.5 Mirna Therapeutics 190
7.5.1 Company Overview 190
7.5.2 Pipeline 191
7.6 Aphios Corporation 191
7.6.1 Company Overview 191
7.6.2 Pipeline 192

8 Early Stage Drug Discovery in Disease Segments Strategic Consolidations 193
8.1 R&D Licensing Agreements 193
8.1.1 Deals by Indication 193
8.1.2 Deals by Geography 194
8.1.3 Deal Summaries by Therapeutic Class 195

9 Early Stage Drug Discovery in Disease Segments Appendix 202
9.1 Market Definitions 202
9.2 Abbreviations 202
9.3 Research Methodology 207
9.3.1 Coverage 207
9.3.2 Secondary Research 207
9.3.3 Primary Research 208
9.3.4 Expert Panel Validation 208
9.4 Contact Us 208
9.5 Disclaimer 208
9.6 Sources 209

List of Table


Table 1: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Alzheimers Disease, December 2010 32
Table 2: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Parkinsons Disease, December 2010 38
Table 3: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Multiple Sclerosis, December 2010 44
Table 4: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Schizophrenia, December 2010 49
Table 5: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Diabetes, December 2010 54
Table 6: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Obesity, December 2010 61
Table 7: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Rheumatoid Arthritis Therapeutics, December 2010 67
Table 8: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Crohns Disease, December 2010 74
Table 9: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in SLE, December 2010 79
Table 10: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Allergy, December 2010 84
Table 11: Early Stage Drug Discovery in Disease Segments, Global, Patent Expiries of Major Marketed Drugs in HIV/AIDS, December 2010 91
Table 12: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in HIV/AIDS, December 2010 92
Table 13: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Hepatitis Therapeutics, December 2010 99
Table 14: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Hypertension Therapeutics, December 2010 106
Table 15: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Dyslipidemia Therapeutics, December 2010 111
Table 16: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in PAH Therapeutics, December 2010 117
Table 17: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in PAH Therapeutics (%), December 2010 117
Table 18: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Myocardial Infarction Therapeutics, December 2010 121
Table 19: Early Stage Drug Discovery in Disease Segments, Bladder Cancer Therapeutics, Prevalence by Country, 2009 124
Table 20: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Bladder Cancer Therapeutics, December 2010 126
Table 21: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Bladder Cancer Therapeutics (%), December 2010 127
Table 22: Early Stage Drug Discovery in Disease Segments, Lung Cancer Categorized by Disease Stage, December 2010 129
Table 23: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Lung Cancer Therapeutics, December 2010 133
Table 24: Early Stage Drug Discovery in Disease Segments, Global, NSCLC Treatment by Stage of the Disease, December 2010 138
Table 25: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in NSLC Therapeutics, December 2010 140
Table 26: Early Stage Drug Discovery in Disease Segments, Breast Cancer Stage Classification, December 2010 143
Table 27: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Breast Cancer, December 2010 148
Table 28: Early Stage Drug Discovery in Disease Segments, Global, Global, Staging of Colon Cancer, December 2010 155
Table 29: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Colon Cancer Therapeutics, December 2010 158
Table 30: Early Stage Drug Discovery in Disease Segments, Global, Staging of Melanoma, December 2010 164
Table 31: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Melanoma, December 2010 166
Table 32: Early Stage Drug Discovery in Disease Segments, Global, Staging of Ovarian Cancer, December 2010 171
Table 33: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Ovarian Cancer Therapeutics, December 2010 172
Table 34: Early Stage Drug Discovery in Disease Segments, Global, Staging of Prostate Cancer, December 2010 177
Table 35: Early Stage Drug Discovery in Disease Segments, Global, Early Stage R&D Pipeline by Phase in Prostate Cancer Therapeutics, December 2010 179
Table 36: Early Stage Drug Discovery in Disease Segments, Hanall Pharmaceutical Pipeline Products, December 2010 187
Table 37: Early Stage Drug Discovery in Disease Segments, Patrys Limited Pipeline Products, December 2010 189
Table 38: Early Stage Drug Discovery in Disease Segments, F. Hoffmann-La Roche Ltd. Pipeline Products, December 2010 190
Table 39: Early Stage Drug Discovery in Disease Segments, Mirna Therapeutics, Inc. Pipeline Products, December 2010 191
Table 40: Early Stage Drug Discovery in Disease Segments, Aphios Corporation, Inc. Pipeline Products, December 2010 192
Table 41: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Therapeutic Class, Metabolic Disorders (%), 20052010 195
Table 42: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Therapeutic Class, Immunological Disorders (%), 20052010 196
Table 43: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Therapeutic Class, Cardiovascular Disorders (%), 20052010 198
Table 44: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Therapeutic Class, Infections, 20052010 199
Table 45: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Therapeutic Class, Oncology, 20052010 200
Table 46: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Therapeutic Class, Central Nervous System Disorders, 20052010 201

List of Chart


Figure 1: Early Stage Drug Discovery in Disease Segments, Series of Research Activities Leading to Drug Discovery, December 2010 12
Figure 2: Early Stage Drug Discovery in Disease Segments, Stages of Drug Development, December 2010 15
Figure 3: Early Stage Drug Discovery in Disease Segments, Preclinical ADMET Studies, December 2010 22
Figure 4: Early Stage Drug Discovery in Disease Segments, Recent Technological Developments in Early Stage Development, December 2010 26
Figure 5: Early Stage Drug Discovery in Disease Segments by Therapy, December 2010 28
Figure 6: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in Different Therapeutic Segments December 2010 30
Figure 7: Early Stage Drug Discovery in Disease Segments, Early Stage R&D pipeline in Alzheimers Disease (%), December 2010 35
Figure 8: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Alzheimers Disease (%), December 2010 36
Figure 9: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in Parkinsons Disease (%), December 2010 40
Figure 10: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Parkinsons Disease (%), December 2010 41
Figure 11: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in Multiple Sclerosis (%), December 2010 45
Figure 12: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Multiple Sclerosis (%), December 2010 46
Figure 13: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in Schizophrenia (%), December 2010 50
Figure 14: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Schizophrenia (%), December 2010 51
Figure 15: Early Stage Drug Discovery in Disease Segments, Early Stage R&D pipeline in Diabetes (%), December 2010 57
Figure 16: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Diabetes (%), December 2010 58
Figure 17: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in Obesity (%), December 2010 63
Figure 18: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Obesity (%), December 2010 64
Figure 19: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in Rheumatoid Arthritis Therapeutics (%), December 2010 70
Figure 20: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Rheumatoid Arthritis (%), December 2010 71
Figure 21: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in Crohns Disease (%), December 2010 75
Figure 22: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Crohns Disease (%), December 2010 76
Figure 23: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in SLE (%), December 2010 80
Figure 24: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in SLE (%), December 2010 81
Figure 25: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Allergy(%), December 2010 85
Figure 26: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Allergy (%), December 2010 86
Figure 27: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline in HIV/AIDS Therapeutics (%), December 2010 94
Figure 28: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in HIV/AIDS (%), December 2010 95
Figure 29: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Hepatitis Therapeutics (%), December 2010 102
Figure 30: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Hepatitis Therapeutics (%), December 2010 103
Figure 31: Early Stage Drug Discovery in Disease Segments, Early Stage R&D pipeline by Phase in Hypertension Therapeutics (%), December 2010 107
Figure 32: Early Stage Drug Discovery in Disease Segments , Early Stage R&D Pipeline by Mechanism of Action in Hypertension Therapeutics (%), December 2010 108
Figure 33: Early Stage Drug Discovery in Disease Segments , Early Stage R&D Pipeline by Phase in Dyslipidemia Therapeutics (%), December 2010 112
Figure 34: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Dyslipidemia Therapeutics (%), December 2010 113
Figure 35: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in PAH (%), December 2010 118
Figure 36: Early Stage Drug Discovery in Disease Segments , Early Stage R&D Pipeline by Phase in Myocardial Infarction (%), December 2010 122
Figure 37: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Myocardial Infarction (%), December 2010 123
Figure 38: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Bladder Cancer Therapeutics (%), December 2010 127
Figure 39: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Lung Cancer Therapeutics (%), December 2010 135
Figure 40: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Lung Cancer Therapeutics (%), December 2010 136
Figure 41: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in NSLC Therapeutics (%), December 2010 141
Figure 42: Early Stage Drug Discovery in Disease Segments , Early Stage R&D Pipeline by Mechanism of Action in NSLC Therapeutics (%), December 2010 142
Figure 43: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Breast Cancer Therapeutics (%), December 2010 152
Figure 44: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Breast Cancer Thereapeutics (%), December 2010 153
Figure 45: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Colon Cancer Therapeutics (%), December 2010 161
Figure 46: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Colon Cancer Therapeutics (%), December 2010 162
Figure 47: Early Stage Drug Discovery in Disease Segments , Early Stage R&D Pipeline by Phase in Melanoma Therapeutics (%), December 2010 168
Figure 48: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Melanoma Therapeutics (%), December 2010 169
Figure 49:Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Ovarian Cancer Therapeutics (%), December 2010 174
Figure 50: Early Stage Drug Discovery in Disease Segments , Early Stage R&D Pipeline by Mechanism of Action in Ovarian Cancer Therapeutics(%), December 2010 175
Figure 51: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Phase in Prostate Cancer Therapeutics (%), December 2010 183
Figure 52: Early Stage Drug Discovery in Disease Segments, Early Stage R&D Pipeline by Mechanism of Action in Ovarian Cancer Therapeutics (%), December 2010 184
Figure 53: Early Stage Drug Discovery in Disease Segments, Top Five Pharmaceutical Players in Early Stage Drug Develpment, December 2010 186
Figure 54: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Indication (%), 20052010 193
Figure 55: Early Stage Drug Discovery in Disease Segments, Major Licensing Agreements by Geography (%), 20052010 194

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