Delivering New Biopharmaceutical Therapies: Challenges & Opportunities

Date: January 22, 2009
Pages: 150
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US$ 1,040.00
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Publisher: PharmaVision
Report type: Strategic Report
Delivery: E-mail Delivery (PDF), CD-ROM Mail Delivery
ID: DE66D146407EN
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Delivering New Biopharmaceutical Therapies: Challenges & Opportunities
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 excessof 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.
Introduction

“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.

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?
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
Figure 37: New 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)

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
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