Delivery Mechanisms for Large Molecule Drugs

Successes and Failures of Leading Technologies and Key Drivers for Market Success

Publication Date	January 2009
Publisher	Business Insights
Product Type	Report
Pages	138
ISBN Number	not applicable
Product Code	RBI00275

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Summary

Emerging drug delivery technologies aim to improve measures of safety, efficacy, convenience and compliance in both new and existing drug candidates and products. For currently marketed products, reformulations with new delivery technologies will extend the period of patent protection. New formulas will be key to boosting sales volume of large molecule products in chronic diseases where patient compliance surrounding dosing strategies and ease of administration are limitations on market growth. In R&D pipelines, novel applications 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.

'Delivery Mechanisms for Large Molecule Drugs' is a report published by Business Insights that examines the future of the drug delivery technologies market, and the short, mid, and long-term growth dynamics which will underpin investment decisions. This report will measure the performance of leading drug delivery technologies applied within clinical R&D pipelines and identify when specific therapy area populations are set to benefit from emerging innovations. The market success of new technologies is forecast by their ability to fulfill unmet medical need, the maturity of the technology in clinical application, and the level of commercial interest and investment landscape.

Key Findings

Nanotechnology will have the greatest impact on the drug delivery market. However, the immaturity of the technology is likely to delay marketed presence over the next 7-10 years.

Antibody fragmentation and PEGylation technologies are the leading targeted large molecule particle engineering formulas with marketed drug product presence. However, antibody fragments have suffered 33 candidate failures compared with 12 PEGylated products.

Active transdermal technologies have generated the greatest number of technologies and devices amongst large molecule delivery innovations, with 16 clinical and 8 preclinical drug/device combination products and 49 stand-alone devices.

Electronic delivery is set to have the greatest impact upon the device industry. Electronic device control is more advanced within the field of pulmonary delivery than transdermal delivery, with the average pulmonary-based product in early clinical phase I compared to late-stage preclinical investigation for transdermal. There are, however, 25 transmembrane electroporation technologies currently being developed,

in comparison to 12 for electronic active pulmonary delivery.

Use this report to.

Understand the drivers of new delivery platform developments with this report's analysis of therapy area growth drivers, clinical development spend and unmet clinical need.
Identify the risks and opportunities associated with emerging delivery technologies by measuring the risk potential and maturity of innovative platforms.
Evaluate the latest developments in systemic targeting technologies by using this report's analysis of innovations and pipeline progress for the latest active and passive targeting techniques.
Discover which technologies have the greatest potential within large molecule product markets in the future with this report's comparative analysis of growth metrics for leading platforms and an evaluation of their established clinical drug application.
Assess recent innovations in pulmonary delivery technologies and needle-free

transdermal delivery with this report's analysis of clinical and preclinical developments and commercial potential.

Explore issues including.

High failure rates for new technologies. The high failure rates of drugs to which pioneering delivery techniques have been applied have made investors cautious.

Unknown clinical safety and efficacy profiles have made it harder to determine appropriate parameters for success in clinical application.

Immaturity of technologies. Many of the technology platforms profiled in this report are in the early stages of application to clinical drug candidates. Those that have achieved success in marketed drug candidates already have 'next generation' alternatives in technology pipelines.

Unknown clinical pharmacokinetics. Many of these platforms remain in such an immature stage that they have yet to be applied to drug candidates. In vivo experimental use in drug candidates can never accurately predict success once a technology has reached maturity. Even for those technologies with established use in R&D pipelines, long-term clinical efficacy remains unknown.

Regulation of the new technologies. While the clinical performance of new particle engineered drug molecules or active delivery devices remain unknown, regulatory bodies only have existing data-measure demands on which to benchmark their expectations. This framework will be shifted in line with emerging clinical performance datasets.

Discover

Which delivery technologies will have the greatest impact on the large molecule market in the short, mid, and long-term?
How mature are the different delivery technologies and what is their pipeline presence in terms of application to R&D drugs?
Will particle engineering technologies drive injectable formulas to dominate the market?
Which therapy areas will benefit most from growth in the different technologies?
How can the risk-profiles associated with clinical use be most effectively minimized?
What are the leading novel platforms?
Who are the targets for out-licensing and co-development of platforms for clinical use?
What are the leading technology platforms within different classifications and how have they achieved their growth?

Content

Delivery Mechanisms for Large Molecule Drugs
Executive summary
Introduction
Drivers for new platform developments
Resistors of change
Key emerging technologies
Systemic targeting technologies
Ease of use systems
Conclusions
Chapter 1 Introduction
- Summary
- Introduction
- The emergence of large molecule therapeutics
- Definitions
- Technology platform definitions
- Product coverage
- Market coverage
- Leading technologies coverage
- The measures for market success
Chapter 2 Drivers of new platform developments
- 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
Chapter 3 Risk, costs and technology maturity
- 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
Chapter 4 Key emerging 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
Chapter 5 Systemic targeting techniques
- 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
Chapter 6 Ease of use systems
- 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
Chapter 7 Conclusions
- 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
- Appendix
- Index
- Methodology
- Methodology
- MedTRACK platform identification
- Glossary
List of Figures
- 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