Delivery Mechanisms for Large Molecule Drugs: Successes and failures of leading technologies and key drivers for market success

Delivery Mechanisms for Large Molecule Drugs: Successes and failures of leading technologies and key drivers for market success published by Business Insights in January, 2009. This report consists of 138 pages and the price starts from US $ 3835.

Introduction

Large molecule drug markets have emerged as a key contender for R&D investment where small molecule pipelines are seeing growing generic pressures and reduced new drug approvals. Biotechnology companies, with a strong pipeline presence of large molecule biologic drugs, have benefited from strengthened market positioning. However, with drug failure rates for this immature industry high existing large molecule delivery is focused on the established parenteral route. Emerging drug delivery technologies are looking to improve measures of safety, efficacy, convenience and compliance in both new and existing drug candidates and products. For marketed products reformulations with new delivery technologies will extend the period of patent protection. In chronic diseases where patient compliance surrounding dosing strategies and ease of administration are key, limitations on further market growth these new formulas will be key to boosting volume sales of large molecule products. In R&D pipelines novel application of delivery technologies will expose new methods to reformulate failed or discontinued drugs and mask their unfavorable effects, expanding the market of potential drug candidates.

Table of Contents

• Introduction
• Drivers for new platform developments
• Resistors of change
• Key emerging technologies
• Systemic targeting technologies
• Ease of use systems
• Conclusions

• Summary

• Introduction
• The emergence of large molecule therapeutics

• Definitions
• Technology platform definitions
• Product coverage
• Market coverage
• Leading technologies coverage
• The measures for market success

• Summary
• Introduction

• The growth of the large molecule market
• Therapy area growth drivers

• Clinical development spend
• Cost-effective manufacturing
• Existing failure rates

• Unmet clinical needs
• Boosting patient compliance
• Overcoming stability, bioavailability and toxic effects
• Improving efficacy

• Summary
• Introduction

• Risk of failure with new technologies
• Unknown drug candidate pharmacokinetics
  • Solubility and instability with oral candidates
  • Bioavailability
  • Toxicity and unknown long-term effects
• The shifting regulatory framework
• Case study: Insulin delivery and investor confidence

• The impact of cost and revenue on the decision to innovate
• Immaturity concerns
• Maturity of the delivery technologies

• Summary
• The forecast market impact

• Nanotechnology to enhance solubility profiles
• The evolving nanotechnology industry
• The development pipeline
• Leading clinical applications
• Parenteral delivery systems
• Dermal platform systems
• Nanostructured materials; oral and depot system use
• Novel oral drug delivery systems
• Investigative nanoshells, nanofilms and active control

• Advances in microelectronics
• Existing electronic applications
• The development pipeline for microelectronics
• Microchip technologies
• Inkjet technology for drug delivery

• Summary
• Introduction

• Systemic passive targeting techniques
• Stealth technologies: Immune system evasion
• PEGylation technologies
  • PEGylation in clinical pipelines
• Preclinical PEGylation investigation
  • The limitations of PEG
• Next generation PEGylation

• Systemic active targeting techniques
• Antibody techniques
• Antibody fragments
  • Binding specificity
  • Novel combination technologies to improve targeting
  • Cost-effective manufacture
• The development pipeline
  • The emergence of IgG4 antibody therapies
  • Small modular Immunopharmaceuticals as antibody alternatives
  • Pipeline novel conjugate technologies
  • Antibody fragments in targeted carrier systems
  • Investigational protein carrier Prodrug complexes
  • Clotting factor conjugate targeting
  • Molecular trojan horse techniques

• Summary
• Introduction

• Pulmonary delivery technologies
• Particle engineering technologies for pulmonary delivery
• Vaporization techniques and delivery control
  • Applications of electronics

• Needle-free transdermal delivery
• Leading technology platforms
• Needle-free pressure-based systems
  • Microinjection platforms for intra-epidermal delivery
  • EMEA filing for first microinjection system
  • technology platform
• Electrotransport systems
  • Electroporation in transdermal delivery
  • TransPharma Medical ltd' s RF-Microchannel technology
• Novel approaches to active intra-epidermal delivery
  • Laser drug delivery systems
• Thermal energy platform

• Summary

• Introduction
• Pharma vs biotech large molecule R&D investment

• Leading technologies
• Growth in particle engineering technologies
• The impact of new routes of administration
• Large molecule drug delivery market growth and maturity

• Current and future market impact
• Therapy area impact
• Timeline of impact

• Summary of technology success and impact

• Index
• Methodology

• Methodology
• MedTRACK platform identification

• Glossary

• Figure 1.1: The role of drug delivery in the product R&D pipeline
• Figure 1.2: Biopharmaceutical company dependence on large molecule drugs*
• Figure 1.3: Defining the pathway from proprietary technology to clinical use
• Figure 2.4: The global pipeline for chemical and biologic drugs, October 2008
• Figure 2.5: Number of pipeline biologic drug candidates and products, by therapy area, October 2008
• Figure 2.6: Pharma R&D spend 2004-2009e
• Figure 2.7: Biotech R&D spend ($bn), 2004-2009e
• Figure 2.8: Pharmacokinetic effects; resistors of market growth and opportunity for new technologies
• Figure 3.9: Key innovative technologies, clinical drug failures and discontinued products, November 2008
• Figure 3.10: Development pipeline for insulin devices, human insulins and analogues, October 2008
• Figure 3.11: Discontinued insulin devices, human insulins and analogues, platforms for delivery, per year 2001-2008
• Figure 3.12: Key particle engineering technologies; industry size and maturity
• Figure 3.13: Key route of administration technologies; industry size and maturity
• Figure 4.14: Investment deals and clinical applications in nanotechnology drug delivery platforms, 2002-Q2 2008
• Figure 4.15: Product pipeline; large molecule nanotechnology innovations
• Figure 4.16: Maturity of electronic active delivery platforms in transmembrane and pulmonary delivery systems
• Figure 5.17: The market advantage of targeted drugs
• Figure 5.18: Passive targeting strategies for large molecule delivery
• Figure 5.19: The benefits of PEGylation to improve pharmacological profiles
• Figure 5.20: Active targeting strategies for large molecule delivery
• Figure 5.21: The global MAb product pipeline by phase, Q4 2008
• Figure 5.22: Antibody fragmentation platforms  Competitive advantage
• Figure 5.23: Antibody fragments: separating targeting domains
• Figure 6.24: Transdermal and transmembrane active platform technologies, November 2008
• Figure 6.25: Investment in and maturity of active transdermal delivery
• Figure 7.26: Big biotech v big pharma large molecule patent applications, 2003-2007, global
• Figure 7.27: Particle engineering technologies in drug R&D pipelines, by phase, October 2008
• Figure 7.28: Industry growth and investment, leading innovative drug delivery platforms
• Figure 7.29: Growth in technology deals; 1998-2007
• Figure 7.30: Impact of new technology platforms developments on therapy area pipelines
• Figure 7.31: Therapy area focus of innovative technology product candidates, October 2008
• Figure 7.32: New medical device technologies, anticipated market impact
• Figure 7.33: Emerging particle engineering technologies, anticipated market impact
• Figure 7.34: The impact of new delivery technologies; timeline for success
• Figure 7.35: Measures of technology success

• Table 1.1: Nektar' s leading innovative technology pipeline
• Table 1.2: Needle free delivery; Key routes of administration
• Table 1.3: Technology market coverage
• Table 2.4: The global pipeline for chemical and biologic drugs, October 2008
• Table 3.5: Key innovative technologies, clinical drug failures and discontinued products,November 2008
• Table 3.6: Key route of administration technologies; industry size and maturity
• Table 4.7: Nanotechnology drug delivery platforms, large molecule vs small molecule applications, November 2008
• Table 4.8: Nanoparticles as drug delivery carriers
• Table 4.9: Leading clinical parenteral drug delivery
• Table 5.10: Clinical PEGylation stealth targeting technologies
• Table 5.11: Antibody fragment products, clinical applications
• Table 5.12: Armagen' s proprietary CNS product pipeline: Trojan horse conjugate delivery
• Table 6.13: Small molecule success of membrane transport technologies, November 2008
• Table 6.14: Clinical use electronic pulmonary delivery technologies
• Table 6.15: Transdermal and transmembrane active platform technologies, November 2008
• Table 6.16: Novel electroporation platforms; transdermal alternatives
• Table 7.17: Innovative technology products in R&D pipelines, October 2008
• Table 7.18: Industry maturity and investment, leading innovative drug delivery platforms
• Table 7.19: Growth in technology deals, 1998-2007
• Table 7.20: Therapy area focus of innovative technology product candidates, October 2008

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