the future of the Biologicals Market: Market overview, innovations and company profiles
Biopharmaceutical products are the key to the future of the pharmaceutical market. even before the market stagnation seen in 200ninebecause of the recession, traditionalpharmaceuticals were facing drastic consequences from the quickage of patent cover for a lot of blockbusters, and the continued failure of the R&D departments in big pharma to sourcereplacement candidates.
Alalthoughthe traditional, small-molecule segment of the market will continue to hold a larger share, their expansionis expected to be in low single figures, concurrentlybiopharma qualifiedducts are forecast to grow at rates up to ten% every year.
This report analyses the three main components of the biopharma market monoclonal antibodies, therapeutic proteins and vaccines to displaywhy these groups have this kind of surefuture. It provides one of the most up-to-date discussion of all of the biopharma market and explores new clinical indications beyond those alabletargeted.
Key features of this report
? Monoclonal antibodies will build on recent market expansionas new product candidates come onstream and new indications are confirmed, extending the united statesefulness of Mabs beyond cancers and autoimmune disease to CNS conditions, infections and others.
? The Therapeutic Proteins elegancewill remain dominated by hematopoietic expansionfactor products for cancer-related neutropenia and anemia.
? Cytokines are another vitalcontributor to the Therapeutic Proteins sector, and new uses for them are under investigation, including cancers, benign prostatic hyperplasia, gout, wound healing and that duringflammatory diseases this kind ofs Crohn's.
? Buoyancy inside the Vaccines sector is driven by anxiety over bioterrorism, the ongoing risk of a globalinfluenzan epidemic and new targets for prevention.
? the prospect of therapeutic vaccines, especially against cancers, is another major driving forceinside 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 concurrentlyavoiding over-optimistic forecasts of expansionover the next five years.
? in terms of R&D activity, the report aims to offerthe reader a perspective on the actual research avenues now being pursued, concurrentlyupdating the reader with an overview of latest R&D developments .
? By covering all the three major segments of the biopharma market, the report gives an idealer perspective of the contribution of biopharma to the individualagement of a couple of major diseases than can also 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 smartfinally ends up inside the clinic
? Cancers and immune-related inflammatory diseases will remain leading iuses of Mabs during the five-year forecast period
? New indications offer the prospect of major market expansionfor cytokines; these include cancers and that duringflammatory diseases
? Other therapeutic proteins this kind ofs expansionfactors, coagulation factors and erythropoietins, have limited possibilitiesfor expansionthrough excpanding indications, and deplead tostead 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 topamong targets for new MAb development, along side treatments for inflammation/immune related diseases including rheumatoid arthritis and multiple sclerosis
? Cytokines prematurelyd progressioninclude treatments for cancers, benign prostatic hyperplasia, gout and inflammatory conditions this kind ofs Crohn's disease.
? By the highest of 200ninethere were 2ninemonoclonal antibodies approved and marketed for therapeutic use. This product eleganceis not anyw approaching maturity.
? Therapeutic protein products which were success stories include insulin, erythropoietin, expansionhormone, the interferons, and the fusion protein Enbrel (etanercept)
Key questions answered
? What indications will be the fundamentalmarket drivers for Mabs during the next five years?
? What are an vitalmarket trleads toside the vaccines market?
? Will the biopharma market pershapeany better than the entire pharma market during the next five years, and why?
? Which segments of the therapeutic protein market are much more more likely to see the most efficient growth?
? What are the basicdrivers for M&A activity inside 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 research12
The biopharmaceutical industake a look at13
bankruptcy1 Introduction to biopharmaceuticals 16
Summary 16
Introduction 17
Definition 18
Main product lessons19
Monoclonal antibodies (MAbs) 19
Therapeutic proteins 21
Hemopoietic expansionfactors 22
Cytokines 23
Blood factors 24
Vaccines 25
conventionalvaccines 25
Novel vaccine technologies 25
Curhirestatus: uses and markets 26
Monoclonal antibodies 26
Anti-cancer 27
Anti-TNF 30
Market prestigeof mAbs 31
Therapeutic proteins 33
Insulin 33
Erythropoietin 33
expansionhormone 34
Cytokines 35
Blood factors 37
Market prestigeof therapeutic proteins 37
Vaccines 39
bankruptcy2 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 prematurelyd progression46
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 expansionfactors 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
bankruptcy3 Market research86
Summary 86
Introduction 87
Market prestigeby product group 88
Monoclonal antibodies 88
Therapeutic proteins 90
Cytokines 91
Anti-hemophilia qualifiedducts 92
expansionhormones 93
Vaccines 93
Production issues 94
possibilitiesin emerging markets 94
Adjuvant developments 95
Therapeutic vaccines 95
Influenza 96
Market by geographic region 97
The threat from biosimilars 98
Rationale for biosimilar progression99
chosebiosimilar developments and that duringtroductions 100
EPO 100
G-CSF 101
Interferons 101
HGH 101
Monoclonal antibodies 102
bankruptcy4 The biopharmaceutical industake a look at104
Summary 104
Evolution 105
Amgen, Biogen and Genentech 106
Involvement of large pharma 108
Biopharma qualifiedcompanies 110
M&A activity 110
Key findings 111
Future M&A trends 113
bankruptcyfiveCompany profiles 116
Introduction 116
Companies marketing/researching Monoclonal Antibodies: 116
Industake a look atleaders 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 thinking about MAb research 124
Amgen Inc 124
Apogenix GmbH 125
Bioinvent International AB 126
Celldex Therapeutics Inc 127
DebiopdamageGroup 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 interested inside the rapeutic Proteins 138
Industake a look atLeaders 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 interested inside the rapeutic 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
Srentplc 154
Teva Pharmaceutical Industries Ltd 155
ThromboGenics NV 156
ZymoGenetics, Inc. 157
Companies thinking about Vaccines 158
Industake a look atLeaders 158
Merck & Co Inc. 158
GlaxoSmithKline plc 159
Sanofi-Aventis 160
Other companies thinking about 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), 200nine19
Figure 1.2: Diagram of typical antiphysiology 20
Figure 1.3: MAb market 2009, market percentageby use 26
Figure 1.4: Therapeutic proteins market, 200ninemarket, sales by class, $bn 38
Figure 3.5: Evolution of the biologics market 2009-201five87
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, 200nine32
Table 1.4: Huma spreadhormone 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 on the subject of 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 progressionfor novel indications 56
Table 2.14: Therapeutic proteins in progression65
Table 2.15: Therapeutic proteins in progression(continued) 66
Table 2.16: Vaccines in late stage progression80
Table 3.17: Biopharmaceutical market, estimated priceand forecast 2009-2015; $bn 87
Table 3.18: Leading monoclonal antibody products in 200nine89
Table 3.19: Hemopoietic expansionfactors 90
Table 3.20: Cytokines sales. 200nine91
Table 3.21: Anti-hemophilia qualifiedducts sales, 200nine92
Table 3.22: expansionfactor product sales, 2008 93
Table 3.23: Leading vaccine products, sales 2009, $bn 97
Table 3.24: Biologics facing the l. a.unch of biosimilars 100
Table 4.25: Company dependence on biopharmaceuticals 109
Table 4.26: Leading specialist biotech companies 110
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