Biopharmaceutical products are the key to the future regarding the pharmaceutical market. Even prior to the market stagnation seen in 2009 due to the recession, conventional pharmaceuticals were facing drastic consequences from the loss of patent close for many blockbusters, and the continued failure regarding the R and amp;D departments in large pharma to make replacement candidates. Consequently the conventional, small-molecule segment regarding the market shall continue to hold a larger share, their growth is expected to be in little lone figures, while biopharma products are forecast to grow at rates up to 10% per annum. This report analyses the 3 primary components regarding the biopharma market monoclonal antibodies, therapeutic proteins and vaccines to display howcome these groups have such a positive future. It gives the greatest up-to-date discussion regarding the whole biopharma market and explores new clinical indications beyond those already targeted.
Key features of this report. Monoclonal antibodies shall build on recent market growth as new product candidates return onstream and new indications are confirmed, extending the usefulness of Mabs beyond cancers and autoimmune sickness to CNS conditions, infections and others. The Therapeutic Proteins class shall continue to molecule diagram 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 below investigation, within cancers, benign prostatic hyperplasia, gout, wound healing and inflammatory diseases for example Crohn's. Buoyancy within 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, mostly against cancers, is another primary driver within the vaccines market. The report gives a realistic picture regarding the strengths and limitations regarding the biopharma marketplace, indicating those product groups whose strengths are set to final while avoiding over-optimistic forecasts of growth over the next 5 years. In terms of R and amp;D activity, the report aims to release the reader a perspective on the important studies avenues now being pursued, while updating the reader with an overview of recent R and amp;D developments. By covering all the 3 primary segments regarding the biopharma market, the report gives an improved perspective regarding the contribution of biopharma to the management of some primary diseases than should be gleaned from studying only a lone product type. Monoclonal antibodies are forecast to grow at a CAGR approaching 10% over the next 5 years, driven largely by good conclusions within the clinic Cancers and immune-related inflammatory diseases shall continue to be leading iuses of Mabs during the five-year forecast period New indications release the prospect of primary market growth for cytokines; these with cancers and inflammatory diseases Other therapeutic proteins for example 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 between targets for new MAb development, along with treatments for inflammation or immune related diseases within rheumatoid arthritis and multiple sclerosis Cytokines in advanced development with treatments for cancers, benign prostatic hyperplasia, gout and inflammatory conditions for example 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 with insulin, erythropoietin, growth hormone, the interferons, and the fusion protein Enbrel etanercept.
Key questions answered. What indications should be the primary market drivers for Mabs during the next 5 years? What are the greatest important market trends within the vaccines market? Shall the biopharma market perform any better than the overall pharma market during the next 5 years, and why? Which segments regarding the therapeutic protein market are likely to look the greatest growth? What are the primary drivers for M and amp;A activity within the biopharma market?. Table of Contents The future regarding the biologicals market Executive Summary 10 Introduction to biopharmaceuticals 10 Developments in technology and clinical applications 11 Market analysis 12 The biopharmaceutical sector 13. Chapter two Introduction to biopharmaceuticals 16 Summary 16 Introduction 17 Definition 18 Primary product classes 19 Monoclonal antibodies MAbs 19 Therapeutic proteins 21 Hemopoietic growth factors 22 Cytokines 23 Blood factors 24 Vaccines 25 General 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 3 Developments in technology and clinical applications 42 Summary 42 Introduction 43 Monoclonal antibodies 43 Technology 43 Person 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 or Jespect 82 Stimuvax 82.
Chapter 4 Market analysis 86 Summary 86 Introduction 87 Market status by product team 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 5 The biopharmaceutical sector 104 Summary 104 Evolution 105 Amgen, Biogen and Genentech 106 Involvement of large pharma 108 Biopharma specialist businesses 110 M and amp;A activity 110 Key findings 111 Future M and amp;A trends 113. Chapter six Business profiles 116 Introduction 116 Businesses marketing or researching Monoclonal Antibodies: 116 Sector leaders 116 Abbott Laboratories 116 Bayer Schering Pharma Ag 117 Biogen Idec Inc. 118 Genzyme Corporation 118 Imclone Processes Inc. Hoffmann-La Roche Ltd 122 Medarex Inc.
123 Other businesses involved in MAb studies 124 Amgen Inc 124 Apogenix GmbH 125 Bioinvent Worldwide AB 126 Celldex Therapeutics Inc 127 Debiopharm Team 128 Genmab A or S 129 Glycotope GmbH 130 ImmunoGen Inc 131 Innate Pharma 132 Pfizer Inc. 133 Seattle Genetics Inc. 135 Trubion Pharmaceuticals Inc. 136 Wilex AG 137 Businesses involved in Therapeutic Proteins 138 Sector Leaders 138 CSL Behring 138 Eli Lilly and amp; Co. 139 Ipsen 140 Merck Serono S.
140 Novartis AG 141 Novo Nordisk A or S 143 Baxter Worldwide Inc 144 Other businesses involved in Therapeutic Protein studies 144 Agennix AG 144 Akebia Therapeutics, Inc. 145 Biovitrum AB 146 Cytheris SA 147 Dyax Corp 147 ERYtech Pharma 148 Helix BioPharma Corp. 149 Person Genome Sciences Inc. Lundbeck A or 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 Businesses involved in Vaccines 158 Sector Leaders 158 Merck and amp; Co Inc. 158 GlaxoSmithKline plc 159 Sanofi-Aventis 160 Other businesses involved in Vaccine Studies 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 regarding the biologics market 2009-2015 87 Figure 3. 6: Geographic breakdown regarding 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: Person 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 price 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. 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: Business dependence on biopharmaceuticals 109 Table 4. 26: Leading specialist biotech businesses 110.
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