This cutting edge & insightful report can be used to interpret & assess the potential of new biopharmaceuticals. It provides opinions & market projections to:

gain an in-depth understanding of the technological manufacturing & delivery issues which face companies developing the new generation of biopharmaceuticals;
evaluate the different options available for the efficient delivery of biopharmaceuticals now & in the future;
identify the key regulatory & production issues which face pharma & delivery specialists advancing the next generation biopharmaceuticals;
assess the therapeutic potential of new biopharmaceuticals targeting cancer, diabetes & immuno-inflammatory disorders;
identify which companies are developing biosimilars & discover which products & why they are most susceptible for copycat versions;
analyze how the biopharmaceutical market is evolving & the influence that delivery, regulation & biosimilars will have on the future development of biotherapeutics.

KEY FINDINGS:

The biopharmaceutical market is estimated to be worth around $79 billion in 2007 growing by 15% per annum, focusing on two key areas, monoclonal antibodies ($27 billion) and biological active proteins ($52 billion) and driven by improvements in manufacturing technologies and advances in biotechnology and drug delivery platforms.
Most biopharmaceutical products, being large molecules, have hitherto been given by injection. Companies have focused on new technologies to optimize injectable delivery such as needle free devices, sustained/controlled release and long-acting subcutaneous implants. However, alternative routes of delivery are now being explored including transdermal drug delivery systems, (iontophoresis, micro needle array, electroporation), pulmonary delivery, oral delivery, nasal delivery and nanotechnology platforms.
The generic sector of the pharmaceutical market has been evolving to keep abreast with changing market conditions, and a growing interest in developing biopharmaceuticals. Several leading biopharmaceutical companies generate sales in excess of US$1 billion per annum which has attracted the attention of generic specialists who are now embarking on the development of generic copies of biopharm products, referred to as ""biosimilars".
The expertise required to choose, design, execute and monitor biopharmaceutical production processes is radically different from that involved in synthetic drug production and is the province of molecular biologists rather than pharmaceutical chemists. This has resulted in rapid advances in manufacturing processes and increased the need for outsourcing to access specialist technologies.
The advent of medicines tailored to individual genotypes is brought a significant step closer by the link between genetic profiling and biopharm products with highly specific biological activities.
The biopharmaceutical market sector is growing faster than pharmaceuticals overall and is set to represent 15% to 25% of all pharmaceuticals within five years, generating global sales in excess of US$200 billion by 2020.

Key Questions This Report Answers:

Which companies and academic institutes are actively involved in biopharmaceutical research?
What are the key areas of therapeutic focus for biotherapeutics in the near- and long-term?
What are the key obstacles companies and delivery technologist need to overcome to commercialize biotherapeutics?
How will the delivery technologies drive the development of innovative biological agents in the future?
Which delivery technologies and platforms are likely to win in the near-term and the long-term, and why?
Where are the market opportunities now and in the future?
What do we predict will be the value of the biotherapeutics by 2015 and 2020?

Companies Mentioned:

Abbott Laboratories, Acambis, Access Pharmaceuticals, Acusphere, Advanced BioScience Laboratories, Aegis Therapeutics, Affymax, Alkermes, ALZA Corporation, Amgen, Amylin, Aphios, Aradigm, Arius Research, AS Biotech AG, AstraZeneca, Aurigene, AVRA Labs, Bayer Schering, Bioceuticals, Biocon, Biogen Idec, BioGeneriX AG, BioPartners, BioSante Pharmaceuticals, Bristol-Myers Squibb, Calando Pharmaceuticals, Camurus, Cangene Corporation, Cenotcor, Chugai, CoGenesys, Controlled Therapeutics, CT Arzneimittel, Dr. Reddy's, Dragon Pharmaceuticals, Eisai, Elan Pharmaceuticals, Eli Lilly & Company, Emisphere Technologies, Enzon Pharmaceuticals, Flamel Technologies, GeneMedix, Genentech, Generex Biotechnology Corporation, Genzyme, GlaxoSmithKline, Glide Pharma, GVK Bio, Hospira, ImClone, Inovio Biomedical Corporation, Intercell AG, Iomai Corporation, Johnson & Johnson, Kirin, Lonza, MacroGenics, MDRNA (formerly Nastech Pharmaceuticals), MedImmune (acquired by AstraZeneca), Medincell S.A., Merck Serono, Mirus Bio Corporation (acquired by Roche), Modigene, Momenta Pharmaceuticals, Nanotechnology Victoria Ltd, Neose Technologies, Novartis, Novo Nordisk, Novopharm, OctoPlus NV, Oramed Pharmaceuticals, Orexo, Pfizer, Phage Biotechnology, Protox Therapeutics, Ranbaxy, Ratiopharm, Raven Biotechnologies, Roche, Sanmar Specialties, sanofi-aventis, Schering-Plough, Sciele Pharmaceuticals, Sequus, Serenex, SGX Pharmaceuticals, Shasun Chemicals, Shionogi, Shire Pharmaceuticals, Sirtris Pharmaceuticals, Stada Arzneimittel AG, Syngene, Talceris, Tanabe, Teva Pharmaceutical Industries Ltd, TheraJect, Titan Pharmaceuticals, TransPharma, UCB, VGX Pharmaceuticals, Vyteris, Wockhardt, Wyeth, Zenyaku Kogyu

Key Points
The Biopharmaceutical Market: Size, Evolution & Prospects
Biopharmaceutical Delivery
Generic Biopharmaceuticals: Biosimilars
Biopharmaceutical Challenges
Biopharmaceutical Opportunities
Conclusions & Market Trends
Chapter 1 The Biopharmaceutical Market: Size, Evolution & Prospects
- Key Points
- Introduction
- The Biopharmaceutical Market
- Biopharma segments
- Biopharmaceutical Prospects
- The Biopharmaceutical Industry
- Market Conclusions
- Leading Biopharmaceutical Products
- Recent M&A Activity
- M&A Conclusions
- Companies involved
- Size of deals
- Overall Conclusions
Chapter 2 Biopharmaceutical Delivery
- Key Points
- Introduction
- Delivery of Biopharmaceuticals
- Problems associated with biopharma delivery
- Inclusion of excipients
- Industry standards
- Chronic dosing & compliance
- Optimizing injectable delivery
- Needle-free injection device technology
- Auto-injectors
- Pen injectors
- Miniaturizing needle delivery
- Sustained/controlled release injection technology
- Pegylation
- Developmental pegylated products
- Biodegradable Polymers
- Linear polymer drug delivery system
- Controlled-release biodegradable polymer drug delivery system:
- Carboxyl terminal peptide technology
- Liposomes
- Self-assembling lipid structures
- Needle-free injection of solid doses
- Encapsulated microspheres
- Long-acting subcutaneous implant
- ProNeura technology
- Drug targeting
- Targeting fusion proteins
- Transdermal delivery
- Iontophoresis
- Microneedle array
- Electroporation
- Pulmonary delivery
- Oral delivery
- Cobalamin-based delivery technology
- Oramed's oral insulin technology
- Eligen technology
- Buccal spray
- Nasal delivery
- Improved delivery of vaccines
- Small world, big landscape: nanotechnology
- SuperFluid nanotechnology platforms
- Self-assembled polyaminoacid nanoparticles
- Biodegradable calcium phosphate nanoparticles
- Biodegradable nanospheres
- RONDEL (RNAi/Oligonucleotide Nanoparticle Delivery)
- Delivery Conclusions
Chapter 3 Generic Biopharmaceuticals: Biosimilars
- Key Points
- Introduction
- Definitions
- Erythropoietin
- Granulocyte-colony stimulating factor
- Interferons
- Interferon alpha
- Interferon beta
- Human growth hormone
- Recombinant human insulin
- Monoclonal antibodies
- Leading Companies
- Sandoz
- Momenta Pharmaceuticals
- BioPartners
- Stada Arzneimittel AG
- Teva Pharmaceutical Industries Ltd
- Acquisitions
- Biosimilar approval
- BioGeneriX AG
- Cangene
- Phage Biotechnology
- GeneMedix
- Dr. Reddy's
- Biosimilar Conclusions
Chapter 4 Biopharmaceutical Challenges
- Key Points
- Introduction
- Manufacturing Issues
- Bacterial system utilizing Escherichia coli
- Yeasts: Sacchromyces cerevisiae, Pichia pastoris, Hansenula polymorpha
- Mammalian cells
- In-House versus Outsourced Production
- Outsourcing
- Contract manufacturing
- Regulatory Obstacles
- Harmonized Regulation
- Global submission of a new drug application
- Global GMP compliance
- Communicating with regulators
- How biosimilars differ from other generics
- Comparability is a central challenge
- EMEA regulation of biosimilars
- FDA regulation of biosimilars
- Assessment of bioequivalence of biosimilars
- Delivery Problems
- Cost Issues
- Safety Problems
- Product Novelty as a Threat
- Our Opinion
Chapter 5 Biopharmaceutical Opportunities
- Key Findings
- New Frontiers in Clinical Efficacy
- Product Novelty as an Opportunity
- Manufacturing Opportunities
- Towards Personalized Medicine
- Geographic Opportunities
- Our Opinion
Chapter 6 Market Trends & Conclusions
- Key Points
- Market Trends
- M&A Trends
- Product Trends
- Delivery Trends
- Inhalation survives Exubera
- Transdermals
- Market forecasts
- Market forecast 2008-2014
- Global biopharmaceutical market in 2020
- Bibliography & Endnotes
List of Figures
- Figure 1: Antibody market segment, 2007
- Figure 2: Therapeutic proteins market segment, 2007
- Figure 3: Biopharma opportunities
- Figure 4: Leading biopharmaceutical companies, 2007
- Figure 5: Needle-free injection devices
- Figure 6: Pegylation technology
- Figure 7: Octoplus biodegradable delivery system
- Figure 8: Modigene's CPT technology
- Figure 9: Camurus' FluidCrystal NP technology
- Figure 10: Glide Pharma's solid dose injector
- Figure 11: Titan's ProNeura technology
- Figure 12: Protox' INxin technology platform
- Figure 13: Protox' PORxin technology platform
- Figure 14: Vyteris' Smart Patch technology
- Figure 15: TheraJect MAT technology
- Figure 16: TransPharma RF technology
- Figure 17: Inovio's electroporation technology
- Figure 18: Aradigm's AERx technology
- Figure 19: Access' cobalamin-based nanopolymer delivery platform
- Figure 20: Oral insulin nanopolymer delivery platform
- Figure 21: Emisphere's Eligen technology
- Figure 22: Generex' RapidMist technology
- Figure 23: Inovio's electroporation technology
- Figure 24: NanoVictoria proprietary nanoMAP patch
- Figure 25: Calando's RONDEL technology
- Figure 26: Biotech drug approvals, 1982-2007
- Figure 27: Risk minimization - make vs. buy decision
- Figure 28: Capital conservation - buy vs. make decision
- Figure 29: ICH Harmonization - minimizing regulatory biopharma issues
- Figure 30: Market sales opportunities for cancer biopharmaceuticals, 2007
- Figure 31: Global production capabilities, 2004-2011
- Figure 32: Molecular profiling aiding personalized medicine
- Figure 33: Shift in the traditional medicine approach
- Figure 34: Cancer mortality in Asia and North America
- Figure 35: Annual growth of pharmaceutical and biopharmaceutical market, 2004-2011
- Figure 36: Global sales of 100 best selling drugs 2007& 2012 ($ million)
- Figure 37: New cancer therapeutics entering clinical study, 1993-2006
List of Tables
- Table 1: Biopharma drivers & resistors
- Table 2: Leading biotechnology players, 2007
- Table 3: Leading biopharmaceutical products, 2007
- Table 4: Major acquisitions, 2007
- Table 5: Commercialized pegylated products, 2007
- Table 6: Glide Pharma's biopharma applications
- Table 7: Aphios' SuperFluids protein nanoparticles technology
- Table 8: Patent expiration of leading biopharmaceuticals, 2007
- Table 9: Revenue of leading biopharmaceuticals, 2007
- Table 10: Cost-effective production of biopharma - contract services
- Table 11: Shifting of global economic growth, 2007-2017
- Table 12: Forecast of pipeline biopharmaceuticals 2008-2014 (US$m)
- Table 13: Forecast of pipeline biopharmaceuticals 2015-2020 (US$m)

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