The Future Of The Biologicals Market: Market Overview, Innovations And Company Profiles

Biopharmaceutical merchandise are the crucial to the future of the pharmaceutical market. Even prior to the marketplace stagnation observed in 2009 due to the recession, conventional pharmaceuticals had been facing drastic consequences from the loss of patent cover for numerous blockbusters, and the continued failure of the R&ampD departments in huge pharma to create replacement candidates.
Although the traditional, small-molecule segment of the market will carry on to hold a larger share, their growth is expected to be in reduced single figures, even though biopharma goods are forecast to grow at rates up to ten% per annum.
This report analyses the 3 main components of the biopharma market place – monoclonal antibodies, therapeutic proteins and vaccines – to present why these groups have this kind of a optimistic future. It gives the most up-to-date discussion of the entire biopharma industry and explores new clinical indications beyond those already targeted.

Key functions of this report

• Monoclonal antibodies will develop on recent marketplace growth as new product candidates come onstream and new indications are confirmed, extending the usefulness of Mabs beyond cancers and autoimmune disease to CNS conditions, infections and others.
• The Therapeutic Proteins class will continue to be dominated by hematopoietic growth element items for cancer-associated neutropenia and anemia.
• Cytokines are another crucial contributor to the Therapeutic Proteins sector, and new uses for them are underneath investigation, including cancers, benign prostatic hyperplasia, gout, wound healing and inflammatory ailments such as Crohn’s.
• Buoyancy in the Vaccines sector is driven by anxiousness above bioterrorism, the ongoing threat of a international influenza pandemic and new targets for prevention.
• The prospect of therapeutic vaccines, specifically against cancers, is another key driver in the vaccines industry.

Scope of this report

• The report offers a realistic picture of the strengths and limitations of the biopharma marketplace, indicating those item groups whose strengths are set to final while staying away from above-optimistic forecasts of development above the up coming 5 many years.
• In terms of R&ampD activity, the report aims to give the reader a point of view on the important study avenues now currently being pursued, while updating the reader with an overview of latest R&ampD developments .
• By covering all the 3 major segments of the biopharma market place, the report provides a far better point of view of the contribution of biopharma to the management of some key diseases than would be gleaned from studying only a single product sort.

Key Marketplace Issues

• Monoclonal antibodies are forecast to grow at a CAGR approaching ten% above the next 5 many years, driven largely by great outcomes in the clinic
• Cancers and immune-associated inflammatory diseases will carry on to be major iuses of Mabs in the course of the 5-year forecast period
• New indications offer you the prospect of major market growth for cytokines these contain cancers and inflammatory ailments
• Other therapeutic proteins this kind of as development components, coagulation elements and erythropoietins, have limited possibilities for development through excpanding indications, and depend as a substitute on product enhancements

Crucial findings from this report

• In terms of market place dimension, therapeutic proteins are the leaders, but monoclonal antibodies (MAbs) are the fastest developing sector
• Cancer nonetheless ranks substantial amongst targets for new MAb advancement, along with treatments for inflammation/immune connected diseases which includes rheumatoid arthritis and several sclerosis
• Cytokines in advanced improvement incorporate therapies for cancers, benign prostatic hyperplasia, gout and inflammatory circumstances this kind of as Crohn’s illness.
• By the end of 2009 there have been 29 monoclonal antibodies accepted and marketed for therapeutic use. This item class is now approaching maturity.
• Therapeutic protein products which have been accomplishment stories contain insulin, erythropoietin, development hormone, the interferons, and the fusion protein Enbrel (etanercept)

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Crucial questions answered

• What indications will be the principal marketplace drivers for Mabs in the course of the following five many years?
• What are the most critical marketplace trends in the vaccines market?
• Will the biopharma market place execute any much better than the general pharma marketplace throughout the next 5 years, and why?
• Which segments of the therapeutic protein industry are probably to see the best development?
• What are the major drivers for M&ampA activity in the biopharma market place?

Table of Contents
The long term of the biologicals market place
Executive Summary 10
Introduction to biopharmaceuticals 10
Developments in technology and clinical applications 11
Industry evaluation 12
The biopharmaceutical industry 13

Chapter 1 Introduction to biopharmaceuticals 16
Summary 16
Introduction 17
Definition 18
Principal item classes 19
Monoclonal antibodies (MAbs) 19
Therapeutic proteins 21
Hemopoietic growth components 22
Cytokines 23
Blood aspects 24
Vaccines 25
Conventional vaccines 25
Novel vaccine technologies 25
Current standing: employs and markets 26
Monoclonal antibodies 26
Anti-cancer 27
Anti-TNF 30
Industry standing of mAbs 31
Therapeutic proteins 33
Insulin 33
Erythropoietin 33
Growth hormone 34
Cytokines 35
Blood aspects 37
Industry standing of therapeutic proteins 37
Vaccines 39

Chapter two Developments in technological innovation and clinical applications 42
Summary 42
Introduction 43
Monoclonal antibodies 43
Engineering 43
Human antibodies 44
Antibody fragments 44
Conjugated antibodies 45
Antibodies in advanced improvement 46
Pipeline activity 47
Oncology 47
Abagovomab 47
Anyara 48
Humax EGFr 48
Rencarex 49
Ipilimumab 49
Other individuals 50
Inflammation and immunology 52
Benlysta 52
Epratuzumab 53
Ocrelizumab 53
Reslizumab 54
Other folks 55
Other indications 55
Bapineuzumab 56
Otelixizumab 57
Pagibaximab 58
Tanezumab 58
Other people 58
Therapeutic proteins 59
Technological innovation 59
Multikine 60
Cintredekin Besudotox 61
Rilonacept (IL-1 Trap) 62
Prevascar 63
PRX302 63
Hemopoietic development factors 64
Current pipeline activity 65
Replagal 66
Joulferon 68
CYT107 68
Talactoferrin 69
Taspoglutide 70
Vaccines 71
Engineering 72
Heterologous prime-boost schemes 72
New adjuvants 73
New vaccines against existing targets 74
Vaccines against new targets 76
HIV vaccines 76
Cancer vaccines 77
Malaria 78
Tuberculosis 79
Vaccines pipeline 80
Menveo 81
Cervarix 81
Ixiaro/Jespect 82
Stimuvax 82

Chapter three Market place evaluation 86
Summary 86
Introduction 87
Marketplace standing by product group 88
Monoclonal antibodies 88
Therapeutic proteins 90
Cytokines 91
Anti-hemophilia merchandise 92
Growth hormones 93
Vaccines 93
Manufacturing problems 94
Possibilities in emerging markets 94
Adjuvant developments 95
Therapeutic vaccines 95
Influenza 96
Market by geographic region 97
The threat from biosimilars 98
Rationale for biosimilar improvement 99
Selected biosimilar developments and introductions 100
EPO 100
G-CSF 101
Interferons 101
HGH 101
Monoclonal antibodies 102

Chapter 4 The biopharmaceutical market 104
Summary 104
Evolution 105
Amgen, Biogen and Genentech 106
Involvement of large pharma 108
Biopharma specialist organizations 110
M&ampA activity 110
Crucial findings 111
Future M&ampA trends 113

Chapter five Company profiles 116
Introduction 116
Organizations marketing and advertising/researching Monoclonal Antibodies: 116
Business leaders 116
Abbott Laboratories 116
Bayer Schering Pharma Ag 117
Biogen Idec Inc. 118
Genzyme Corporation 118
Imclone Techniques Inc. 120
UCB S.A. 121
F. Hoffmann-La Roche Ltd 122
Medarex Inc. 123
Other businesses concerned in MAb investigation 124
Amgen Inc 124
Apogenix GmbH 125
Bioinvent International AB 126
Celldex Therapeutics Inc 127
Debiopharm Group 128
Genmab A/S 129
Glycotope GmbH 130
ImmunoGen Inc 131
Innate Pharma 132
Pfizer Inc. 133
Seattle Genetics Inc. 134
Tolerx Inc. 135
Trubion Pharmaceuticals Inc. 136
Wilex AG 137
Firms concerned in Therapeutic Proteins 138
Sector Leaders 138
CSL Behring 138
Eli Lilly &amp Co. 139
Ipsen 140
Merck Serono S.A. 140
Novartis AG 141
Novo Nordisk A/S 143
Baxter International Inc 144
Other firms concerned in Therapeutic Protein investigation 144
Agennix AG 144
Akebia Therapeutics, Inc. 145
Biovitrum AB 146
Cytheris SA 147
Dyax Corp 147
ERYtech Pharma 148
Helix BioPharma Corp. 149
Human Genome Sciences Inc. 149
Immutep S.A. 150
H. Lundbeck A/S 152
Octapharma AG 152
Phosphagenics Restricted 153
Proteon Therapeutics, Inc. 154
Shire plc 154
Teva Pharmaceutical Industries Ltd 155
ThromboGenics NV 156
ZymoGenetics, Inc. 157
Businesses concerned in Vaccines 158
Sector Leaders 158
Merck &amp Co Inc. 158
GlaxoSmithKline plc 159
Sanofi-Aventis 160
Other organizations involved in Vaccine Investigation 161
Advaxis Inc 161
Hawaii Biotech, Inc. 162
ImmunoVaccine Technologies Inc. 163
Intercell AG 164
Soligenix, Inc. 165
Stallergenes 166
Tripep AB 167
Vical Inc 167
Xcellerex, Inc 169
Index 170

List of Figures
Figure 1.1: Worldwide biopharmaceutical marketplace ($ bn), 2009 19
Figure 1.2: Diagram of typical antibody construction 20
Figure 1.3: MAb market 2009, industry share by use 26
Figure 1.four: Therapeutic proteins market, 2009 market place, sales by class, $ bn 38
Figure three.5: Evolution of the biologics market place 2009-2015 87
Figure three.six: Geographic breakdown of the global biopharmaceutical marketplace 98

List of Tables
Table 1.1: Marketed Anti-TNF MAbs 31
Table 1.two: International marketplace forecast for mAbs, 2009-2015, $ bn 32
Table 1.3: mAb industry leaders, 2009 32
Table 1.four: Human growth hormone merchandise 35
Table 1.5: Accepted cytokines 36
Table 1.six: Blood factors for hemophilia remedy 37
Table 1.7: International therapeutic proteins market place and forecast, $ bn 38
Table 1.8: Major vaccine product sales, 2009 $ bn 40
Table 1.9: Worldwide vaccines industry and forecast, 2009-2015, $ bn 40
Table 2.10: MAbs near to marketplace launch, 2010 46
Table 2.11: Anti-cancer monoclonal antibody products in Phase III trials 47
Table 2.12: Immune system connected monoclonal antibody goods in Phase III trials 52
Table 2.13: mAb products in clinical development for novel indications 56
Table 2.14: Therapeutic proteins in improvement 65
Table two.15: Therapeutic proteins in advancement (continued) 66
Table two.16: Vaccines in late stage improvement 80
Table three.17: Biopharmaceutical marketplace, estimated worth and forecast 2009-2015 $ bn 87
Table 3.18: Top monoclonal antibody items in 2009 89
Table 3.19: Hemopoietic growth components 90
Table three.20: Cytokines sales. 2009 91
Table 3.21: Anti-hemophilia merchandise sales, 2009 92
Table 3.22: Growth factor item sales, 2008 93
Table 3.23: Major vaccine products, sales 2009, $ bn 97
Table 3.24: Biologics facing the launch of biosimilars 100
Table four.25: Firm dependence on biopharmaceuticals 109
Table 4.26: Leading specialist biotech businesses 110

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