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

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