The Future of the Biologicals Market: Market overview, innovations and company profiles now availabl
04/13/2010

Biopharmaceutical products are the key to the future of the pharmaceutical market. Even before the market stagnation seen in 2009 due to the recession, conventional pharmaceuticals were facing drastic consequences from the loss of patent cover for many blockbusters, and the continued failure of the R&D departments in big pharma to produce replacement candidates.

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Biopharmaceutical products are the key to the future of the pharmaceutical market. Even before the market stagnation seen in 2009 due to the recession, conventional pharmaceuticals were facing drastic consequences from the loss of patent cover for many blockbusters, and the continued failure of the R&D departments in big pharma to produce replacement candidates.
Although the conventional, small-molecule segment of the market will continue to hold a larger share, their growth is expected to be in low single figures, while biopharma products are forecast to grow at rates up to 10% per annum.
This report analyses the three main components of the biopharma market – monoclonal antibodies, therapeutic proteins and vaccines – to show why these groups have such a positive future. It provides the most up-to-date discussion of the whole biopharma market and explores new clinical indications beyond those already targeted.

Key features of this report
• Monoclonal antibodies will build on recent market 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 factor products for cancer-related neutropenia and anemia.
• Cytokines are another important contributor to the Therapeutic Proteins sector, and new uses for them are under investigation, including cancers, benign prostatic hyperplasia, gout, wound healing and inflammatory diseases such as Crohn’s.
• Buoyancy in the Vaccines sector is driven by anxiety over bioterrorism, the ongoing risk of a global influenza pandemic and new targets for prevention.
• The prospect of therapeutic vaccines, especially against cancers, is another major driver in the vaccines market.

Scope of this report
• The report gives a realistic picture of the strengths and limitations of the biopharma marketplace, indicating those product groups whose strengths are set to last while avoiding over-optimistic forecasts of growth over the next five years.
• In terms of R&D activity, the report aims to give the reader a perspective on the important research avenues now being pursued, while updating the reader with an overview of recent R&D developments .
• By covering all the three major segments of the biopharma market, the report gives a better perspective of the contribution of biopharma to the management of some major diseases than would be gleaned from studying only a single product type.

Key Market Issues
• Monoclonal antibodies are forecast to grow at a CAGR approaching 10% over the next five years, driven largely by good results in the clinic
• Cancers and immune-related inflammatory diseases will continue to be leading iuses of Mabs during the five-year forecast period
• New indications offer the prospect of major market growth for cytokines; these include cancers and inflammatory diseases
• Other therapeutic proteins such as growth factors, coagulation factors and erythropoietins, have limited opportunities for growth through excpanding indications, and depend instead on product improvements

Key findings from this report
• In terms of market size, therapeutic proteins are the leaders, but monoclonal antibodies (MAbs) are the fastest growing sector
• Cancer still ranks high among targets for new MAb development, along with treatments for inflammation/immune related diseases including rheumatoid arthritis and multiple sclerosis
• Cytokines in advanced development include treatments for cancers, benign prostatic hyperplasia, gout and inflammatory conditions such as Crohn’s disease.
• By the end of 2009 there were 29 monoclonal antibodies approved and marketed for therapeutic use. This product class is now approaching maturity.
• Therapeutic protein products which have been success stories include insulin, erythropoietin, growth hormone, the interferons, and the fusion protein Enbrel (etanercept)

Key questions answered
• What indications will be the main market drivers for Mabs during the next five years?
• What are the most important market trends in the vaccines market?
• Will the biopharma market perform any better than the overall pharma market during the next five years, and why?
• Which segments of the therapeutic protein market are likely to see the best growth?
• What are the major drivers for M&A activity in the biopharma market?

Table of Contents
The future of the biologicals market
Executive Summary 10
Introduction to biopharmaceuticals 10
Developments in technology and clinical applications 11
Market analysis 12
The biopharmaceutical industry 13

Chapter 1 Introduction to biopharmaceuticals 16
Summary 16
Introduction 17
Definition 18
Main product classes 19
Monoclonal antibodies (MAbs) 19
Therapeutic proteins 21
Hemopoietic growth factors 22
Cytokines 23
Blood factors 24
Vaccines 25
Traditional vaccines 25
Novel vaccine technologies 25
Current status: uses and markets 26
Monoclonal antibodies 26
Anti-cancer 27
Anti-TNF 30
Market status of mAbs 31
Therapeutic proteins 33
Insulin 33
Erythropoietin 33
Growth hormone 34
Cytokines 35
Blood factors 37
Market status of therapeutic proteins 37
Vaccines 39

Chapter 2 Developments in technology and clinical applications 42
Summary 42
Introduction 43
Monoclonal antibodies 43
Technology 43
Human antibodies 44
Antibody fragments 44
Conjugated antibodies 45
Antibodies in advanced development 46
Pipeline activity 47
Oncology 47
Abagovomab 47
Anyara 48
Humax EGFr 48
Rencarex 49
Ipilimumab 49
Others 50
Inflammation and immunology 52
Benlysta 52
Epratuzumab 53
Ocrelizumab 53
Reslizumab 54
Others 55
Other indications 55
Bapineuzumab 56
Otelixizumab 57
Pagibaximab 58
Tanezumab 58
Others 58
Therapeutic proteins 59
Technology 59
Multikine 60
Cintredekin Besudotox 61
Rilonacept (IL-1 Trap) 62
Prevascar 63
PRX302 63
Hemopoietic growth factors 64
Recent pipeline activity 65
Replagal 66
Joulferon 68
CYT107 68
Talactoferrin 69
Taspoglutide 70
Vaccines 71
Technology 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 3 Market analysis 86
Summary 86
Introduction 87
Market status by product group 88
Monoclonal antibodies 88
Therapeutic proteins 90
Cytokines 91
Anti-hemophilia products 92
Growth hormones 93
Vaccines 93
Production issues 94
Opportunities 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 development 99
Selected biosimilar developments and introductions 100
EPO 100
G-CSF 101
Interferons 101
HGH 101
Monoclonal antibodies 102

Chapter 4 The biopharmaceutical industry 104
Summary 104
Evolution 105
Amgen, Biogen and Genentech 106
Involvement of big pharma 108
Biopharma specialist companies 110
M&A activity 110
Key findings 111
Future M&A trends 113

Chapter 5 Company profiles 116
Introduction 116
Companies marketing/researching Monoclonal Antibodies: 116
Industry leaders 116
Abbott Laboratories 116
Bayer Schering Pharma Ag 117
Biogen Idec Inc. 118
Genzyme Corporation 118
Imclone Systems Inc. 120
UCB S.A. 121
F. Hoffmann-La Roche Ltd 122
Medarex Inc. 123
Other companies involved in MAb research 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
Companies involved in Therapeutic Proteins 138
Industry Leaders 138
CSL Behring 138
Eli Lilly & Co. 139
Ipsen 140
Merck Serono S.A. 140
Novartis AG 141
Novo Nordisk A/S 143
Baxter International Inc 144
Other companies involved in Therapeutic Protein research 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 Limited 153
Proteon Therapeutics, Inc. 154
Shire plc 154
Teva Pharmaceutical Industries Ltd 155
ThromboGenics NV 156
ZymoGenetics, Inc. 157
Companies involved in Vaccines 158
Industry Leaders 158
Merck & Co Inc. 158
GlaxoSmithKline plc 159
Sanofi-Aventis 160
Other companies involved in Vaccine Research 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: Global biopharmaceutical market ($bn), 2009 19
Figure 1.2: Diagram of typical antibody structure 20
Figure 1.3: MAb market 2009, market share by use 26
Figure 1.4: Therapeutic proteins market, 2009 market, sales by class, $bn 38
Figure 3.5: Evolution of the biologics market 2009-2015 87
Figure 3.6: Geographic breakdown of the global biopharmaceutical market 98

List of Tables
Table 1.1: Marketed Anti-TNF MAbs 31
Table 1.2: Global market forecast for mAbs, 2009-2015, $bn 32
Table 1.3: mAb market leaders, 2009 32
Table 1.4: Human growth hormone products 35
Table 1.5: Approved cytokines 36
Table 1.6: Blood factors for hemophilia treatment 37
Table 1.7: Global therapeutic proteins market and forecast, $bn 38
Table 1.8: Leading vaccine product sales, 2009; $bn 40
Table 1.9: Global vaccines market and forecast, 2009-2015, $bn 40
Table 2.10: MAbs near to market launch, 2010 46
Table 2.11: Anti-cancer monoclonal antibody products in Phase III trials 47
Table 2.12: Immune system related monoclonal antibody products in Phase III trials 52
Table 2.13: mAb products in clinical development for novel indications 56
Table 2.14: Therapeutic proteins in development 65
Table 2.15: Therapeutic proteins in development (continued) 66
Table 2.16: Vaccines in late stage development 80
Table 3.17: Biopharmaceutical market, estimated value and forecast 2009-2015; $bn 87
Table 3.18: Leading monoclonal antibody products in 2009 89
Table 3.19: Hemopoietic growth factors 90
Table 3.20: Cytokines sales. 2009 91
Table 3.21: Anti-hemophilia products sales, 2009 92
Table 3.22: Growth factor product sales, 2008 93
Table 3.23: Leading vaccine products, sales 2009, $bn 97
Table 3.24: Biologics facing the launch of biosimilars 100
Table 4.25: Company dependence on biopharmaceuticals 109
Table 4.26: Leading specialist biotech companies 110

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