Delivering New Biopharmaceutical Therapies:
Challenges & Opportunities
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| “Over the last decade, biotech antibodies have provided some of the biggest breakthroughs in medicine. The list includes Avastin, Herceptin, Rituxan and Erbitux for cancer and Enbrel, Humira, and Remicade for immune and inflammatory disorders.” Sidney Taurel, Chairman and Chief Executive Officer Eli Lilly and Company A biopharmaceutical is defined as a medical drug (proteins including antibodies, nucleic acids, DNA, RNA or antisense oligonucleotides) which is produced using biotechnology. In the late 1990s advances in manufacturing and processing revolutionized the production of biopharmaceuticals such as recombinant DNA technology and hybridoma technology. These technological advances have enabled the market place to open up and for smaller players to enter and capitalize on the growing need for targeted, personalized medicine. During the 1960s and 1970s formulation began to assume greater importance. More recently still, the inconvenience of parenteral administration became a focus for attempts to minimize the burden and optimize treatment. Nowadays, any development programme for a new drug will include consideration of the optimal dosage form from the conception of a drug development project. A plethora of delivery platforms have evolved to meet market demands and overcome solubility and pharmacokinetic issues, and will have an important role to play in determining the dosage form that ultimately appears on the market. The biopharm field represents a major opportunity for generic manufacturers with sufficient resources to withstand the relatively high development costs and the technological demand. It is estimated that biosimilars, targeting the six leading biopharm products, could generate revenues in excess of $2 billion within 2-3 years. However, there are considerable challenges facing companies developing and marketing biopharm products. Manufacturing problems will remain a significant hurdle for companies entering this field; the regulation of innovator biopharm products continues to evolve and the harmonization of regulatory processes among the three main national regulatory agencies (the EU, the US and Japan) should make life simpler for biopharm companies seeking to establish a global presence for their products. Biotherapeutics represent 7.5 percent of all drugs on the market; they account for approximately 10 percent of the total expenditure for marketed drugs and their use is growing at more than 20 percent per year. Biotechnology drug candidates account for around 32 percent of all pipeline research programs. In addition, biological drugs are administered in life-saving or end-stage applications, 74 percent more than chemically derived pharmaceuticals. The biopharmaceutical market was estimated to be worth over $79 billion in 2007 with antibodies representing around $27 billion sales and protein products generating almost $52 billion. The biopharma market is growing at an annual rate of around 15% - far higher than pharmaceuticals (c. 6-7% per annum). By 2020 the market is forecast to be worth over $200 billion driven by a shift in usage from conventional drugs to biopharma products, the relatively high cost of biopharma products, the launch of biosimilars and a new generation of biotherapeutics. |
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| Keywords: autoimmune, biogeneric, biopharmaceutical, buccal, cancer, EPO, GH, liposome, fusion protein, interferon, insulin, monoclonal antibody, nasal, nanotechnology, polymer, transdermal, regulation | |
 
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By Paul Evers / Publication Date: 19th January 2009
Contents:
Key Points 2
The Biopharmaceutical Market: Size, Evolution & Prospects 2
Biopharmaceutical Delivery 2
Generic Biopharmaceuticals: Biosimilars 3
Biopharmaceutical Challenges 4
Biopharmaceutical Opportunities 4
Conclusions & Market Trends 5
Chapter 1 The Biopharmaceutical Market: Size, Evolution & Prospects 8
Key Points 8
Introduction 9
The Biopharmaceutical Market 10
Biopharma segments 10
Biopharmaceutical Prospects 12
The Biopharmaceutical Industry 14
Market Conclusions 16
Leading Biopharmaceutical Products 17
Recent M&A Activity 20
M&A Conclusions 23
Companies involved 23
Size of deals 23
Overall Conclusions 24
Chapter 2 Biopharmaceutical Delivery 26
Key Points 26
Introduction 27
Delivery of Biopharmaceuticals 28
Problems associated with biopharma delivery 28
Inclusion of excipients 28
Industry standards 29
Chronic dosing & compliance 29
Optimizing injectable delivery 30
Needle-free injection device technology 30
Auto-injectors 31
Pen injectors 31
Miniaturizing needle delivery 32
Sustained/controlled release injection technology 32
Pegylation 32
Developmental pegylated products 34
Biodegradable Polymers 36
Linear polymer drug delivery system 36
Controlled-release biodegradable polymer drug delivery system: 37
Carboxyl terminal peptide technology 38
Liposomes 39
Self-assembling lipid structures 39
Needle-free injection of solid doses 41
Encapsulated microspheres 42
Long-acting subcutaneous implant 43
ProNeura technology 43
Drug targeting 44
Targeting fusion proteins 44
Transdermal delivery 45
Iontophoresis 45
Microneedle array 46
Electroporation 49
Pulmonary delivery 50
Oral delivery 52
Cobalamin-based delivery technology 52
Oramed’s oral insulin technology 53
Eligen technology 54
Buccal spray 55
Nasal delivery 56
Improved delivery of vaccines 57
Small world, big landscape: nanotechnology 58
SuperFluid nanotechnology platforms 60
Self-assembled polyaminoacid nanoparticles 61
Biodegradable calcium phosphate nanoparticles 62
Biodegradable nanospheres 62
RONDEL (RNAi/Oligonucleotide Nanoparticle Delivery) 62
Delivery Conclusions 64
Chapter 3 Generic Biopharmaceuticals: Biosimilars 67
Key Points 67
Introduction 68
Definitions 69
Erythropoietin 73
Granulocyte-colony stimulating factor 74
Interferons 75
Interferon alpha 75
Interferon beta 76
Human growth hormone 76
Recombinant human insulin 77
Monoclonal antibodies 78
Leading Companies 78
Sandoz 79
Momenta Pharmaceuticals 80
BioPartners 81
Stada Arzneimittel AG 82
Teva Pharmaceutical Industries Ltd 82
Acquisitions 83
Biosimilar approval 84
BioGeneriX AG 85
Cangene 85
Phage Biotechnology 86
GeneMedix 87
Dr. Reddy's 88
Biosimilar Conclusions 89
Chapter 4 Biopharmaceutical Challenges 91
Key Points 91
Introduction 92
Manufacturing Issues 92
Bacterial system utilizing Escherichia coli 93
Yeasts: Sacchromyces cerevisiae, Pichia pastoris, Hansenula polymorpha 93
Mammalian cells 93
In-House versus Outsourced Production 95
Outsourcing 97
Contract manufacturing 98
Regulatory Obstacles 99
Harmonized Regulation 100
Global submission of a new drug application 102
Global GMP compliance 103
Communicating with regulators 105
How biosimilars differ from other generics 106
Comparability is a central challenge 106
EMEA regulation of biosimilars 108
FDA regulation of biosimilars 109
Assessment of bioequivalence of biosimilars 110
Delivery Problems 111
Cost Issues 112
Safety Problems 113
Product Novelty as a Threat 115
Our Opinion 116
Chapter 5 Biopharmaceutical Opportunities 119
Key Findings 119
New Frontiers in Clinical Efficacy 120
Product Novelty as an Opportunity 121
Manufacturing Opportunities 122
Towards Personalized Medicine 123
Geographic Opportunities 127
Our Opinion 128
Chapter 6 Market Trends & Conclusions 130
Key Points 130
Market Trends 131
M&A Trends 135
Product Trends 136
Delivery Trends 138
Inhalation survives Exubera 138
Transdermals 139
Market forecasts 144
Market forecast 2008-2014 144
Global biopharmaceutical market in 2020 145
Bibliography & Endnotes 147
List of Tables:
List of Figures
Figure 1: Antibody market segment, 2007 11
Figure 2: Therapeutic proteins market segment, 2007 12
Figure 3: Biopharma opportunities 14
Figure 4: Leading biopharmaceutical companies, 2007 15
Figure 5: Needle-free injection devices 30
Figure 6: Pegylation technology 33
Figure 7: Octoplus biodegradable delivery system 37
Figure 8: Modigene’s CPT technology 39
Figure 9: Camurus’ FluidCrystal NP technology 40
Figure 10: Glide Pharma’s solid dose injector 41
Figure 11: Titan’s ProNeura technology 43
Figure 12: Protox’ INxin technology platform 44
Figure 13: Protox’ PORxin technology platform 44
Figure 14: Vyteris’ Smart Patch technology 46
Figure 15: TheraJect MAT technology 47
Figure 16: TransPharma RF technology 48
Figure 17: Inovio’s electroporation technology 50
Figure 18: Aradigm’s AERx technology 51
Figure 19: Access’ cobalamin-based nanopolymer delivery platform 52
Figure 20: Oral insulin nanopolymer delivery platform 53
Figure 21: Emisphere’s Eligen technology 55
Figure 22: Generex’ RapidMist technology 56
Figure 23: Inovio’s electroporation technology 58
Figure 24: NanoVictoria proprietary nanoMAP patch 60
Figure 25: Calando’s RONDEL technology 63
Figure 26: Biotech drug approvals, 1982-2007 71
Figure 27: Risk minimization - make vs. buy decision 96
Figure 28: Capital conservation - buy vs. make decision 97
Figure 29: ICH Harmonization – minimizing regulatory biopharma issues 101
Figure 30: Market sales opportunities for cancer biopharmaceuticals, 2007 121
Figure 31: Global production capabilities, 2004-2011 123
Figure 32: Molecular profiling aiding personalized medicine 124
Figure 33: Shift in the traditional medicine approach 125
Figure 34: Cancer mortality in Asia and North America 128
Figure 35: Annual growth of pharmaceutical and biopharmaceutical market, 2004-2011 132
Figure 36: Global sales of 100 best selling drugs 2007& 2012 133
Figure 37: New therapeutics entering clinical study, 1993-2006 143
List of Tables
Table 1: Biopharma drivers & resistors 13
Table 2: Leading biotechnology players, 2007 16
Table 3: Leading biopharmaceutical products, 2007 17
Table 4: Major acquisitions, 2007 24
Table 5: Commercialized pegylated products, 2007 34
Table 6: Glide Pharma’s biopharma applications 42
Table 7: Aphios’ SuperFluids protein nanoparticles technology 61
Table 8: Patent expiration of leading biopharmaceuticals, 2007 72
Table 9: Revenue of leading biopharmaceuticals, 2007 72
Table 10: Cost-effective production of biopharma – contract services 99
Table 11: Shifting of global economic growth, 2007-2017 127
Table 12: Forecast of pipeline biopharmaceuticals 2008-2014 (US$m) 144
Table 13: Forecast of pipeline biopharmaceuticals 2015-2020 (US$m) 145