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

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

New York, NY | Posted on February 10th, 2009

Delivery Mechanisms for Large Molecule Drugs

Successes and failures of leading technologies and key drivers for market success

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?

Table of Contents

Delivery Mechanisms for Large Molecule Drugs

Executive summary 10

Introduction 10

Drivers for new platform developments 11

Resistors of change 12

Key emerging technologies 13

Systemic targeting technologies 14

Ease of use systems 15

Conclusions 16

Chapter 1 Introduction 18

Summary 18

Introduction 19

The emergence of large molecule therapeutics 21

Definitions 23

Technology platform definitions 23

Product coverage 25

Market coverage 25

Leading technologies coverage 27

The measures for market success 28

Chapter 2 Drivers of new platform developments 30

Summary 30

Introduction 31

The growth of the large molecule market 32

Therapy area growth drivers 33

Clinical development spend 35

Cost-effective manufacturing 36

Existing failure rates 36

Unmet clinical needs 38

Boosting patient compliance 39

Overcoming stability, bioavailability and toxic effects 40

Improving efficacy 40

Chapter 3 Risk, costs and technology maturity 42

Summary 42

Introduction 43

Risk of failure with new technologies 43

Unknown drug candidate pharmacokinetics 45

Solubility and instability with oral candidates 45

Bioavailability 46

Toxicity and unknown long-term effects 47

The shifting regulatory framework 47

Case study: Insulin delivery and investor confidence 48

The impact of cost and revenue on the decision to innovate 51

Immaturity concerns 52

Maturity of the delivery technologies 52

Chapter 4 Key emerging technologies 58

Summary 58

The forecast market impact 59

Nanotechnology to enhance solubility profiles 60

The evolving nanotechnology industry 61

The development pipeline 63

Leading clinical applications 64

Parenteral delivery systems 66

Dermal platform systems 67

Nanostructured materials; oral and depot system use 68

Novel oral drug delivery systems 68

Investigative nanoshells, nanofilms and active control 69

Advances in microelectronics 71

Existing electronic applications 71

The development pipeline for microelectronics 73

Microchip technologies 73

Inkjet technology for drug delivery 74

Chapter 5 Systemic targeting techniques 78

Summary 78

Introduction 79

Systemic passive targeting techniques 81

Stealth technologies: Immune system evasion 81

PEGylation technologies 83

PEGylation in clinical pipelines 84

Preclinical PEGylation investigation 86

The limitations of PEG 86

Next generation PEGylation 87

Systemic active targeting techniques 88

Antibody techniques 89

Antibody fragments 90

Binding specificity 91

Novel combination technologies to improve targeting 92

Cost-effective manufacture 93

The development pipeline 94

The emergence of IgG4 antibody therapies 94

Small modular Immunopharmaceuticals as antibody alternatives 95

Pipeline novel conjugate technologies 96

Antibody fragments in targeted carrier systems 96

Investigational protein carrier Prodrug complexes 97

Clotting factor conjugate targeting 97

Molecular trojan horse techniques 98

Chapter 6 Ease of use systems 102

Summary 102

Introduction 103

Pulmonary delivery technologies 104

Particle engineering technologies for pulmonary delivery 105

Vaporization techniques and delivery control 106

Applications of electronics 106

Needle-free transdermal delivery 107

Leading technology platforms 109

Needle-free pressure-based systems 110

Microinjection platforms for intra-epidermal delivery 110

EMEA filing for first microinjection system 111

technology platform 112

Electrotransport systems 113

Electroporation in transdermal delivery 113

TransPharma Medical ltd's RF-Microchannel technology 114

Novel approaches to active intra-epidermal delivery 115

Laser drug delivery systems 115

Thermal energy platform 116

Chapter 7 Conclusions 118

Summary 118

Introduction 119

Pharma vs biotech large molecule R&D investment 119

Leading technologies 121

Growth in particle engineering technologies 121

The impact of new routes of administration 122

Large molecule drug delivery market growth and maturity 123

Current and future market impact 127

Therapy area impact 127

Timeline of impact 130

Summary of technology success and impact 133

Appendix 136

Index 136

Methodology 137

Methodology 137

MedTRACK platform identification 137

Glossary 138

List of Figures

Figure 1.1: The role of drug delivery in the product R&D pipeline 20

Figure 1.2: Biopharmaceutical company dependence on large molecule drugs* 22

Figure 1.3: Defining the pathway from proprietary technology to clinical use 24

Figure 2.4: The global pipeline for chemical and biologic drugs, October 2008 33

Figure 2.5: Number of pipeline biologic drug candidates and products, by therapy area, October 2008 34

Figure 2.6: Pharma R&D spend 2004-2009e 35

Figure 2.7: Biotech R&D spend ($bn), 2004-2009e 36

Figure 2.8: Pharmacokinetic effects; resistors of market growth and opportunity for new technologies 38

Figure 3.9: Key innovative technologies, clinical drug failures and discontinued products, November 2008 44

Figure 3.10: Development pipeline for insulin devices, human insulins and analogues, October 2008 49

Figure 3.11: Discontinued insulin devices, human insulins and analogues, platforms for delivery, per year 2001-2008 51

Figure 3.12: Key particle engineering technologies; industry size and maturity 54

Figure 3.13: Key route of administration technologies; industry size and maturity 55

Figure 4.14: Investment deals and clinical applications in nanotechnology drug delivery platforms, 2002-Q2 2008 62

Figure 4.15: Product pipeline; large molecule nanotechnology innovations 64

Figure 4.16: Maturity of electronic active delivery platforms in transmembrane and pulmonary delivery systems 72

Figure 5.17: The market advantage of targeted drugs 80

Figure 5.18: Passive targeting strategies for large molecule delivery 81

Figure 5.19: The benefits of PEGylation to improve pharmacological profiles 83

Figure 5.20: Active targeting strategies for large molecule delivery 88

Figure 5.21: The global MAb product pipeline by phase, Q4 2008 89

Figure 5.22: Antibody fragmentation platforms - Competitive advantage 90

Figure 5.23: Antibody fragments: separating targeting domains 92

Figure 6.24: Transdermal and transmembrane active platform technologies, November 2008 108

Figure 6.25: Investment in and maturity of active transdermal delivery 109

Figure 7.26: Big biotech v big pharma large molecule patent applications, 2003-2007, global 120

Figure 7.27: Particle engineering technologies in drug R&D pipelines, by phase, October 2008 122

Figure 7.28: Industry growth and investment, leading innovative drug delivery platforms 124

Figure 7.29: Growth in technology deals; 1998-2007 126

Figure 7.30: Impact of new technology platforms developments on therapy area pipelines 127

Figure 7.31: Therapy area focus of innovative technology product candidates, October 2008 128

Figure 7.32: New medical device technologies, anticipated market impact 129

Figure 7.33: Emerging particle engineering technologies, anticipated market impact 130

Figure 7.34: The impact of new delivery technologies; timeline for success 131

Figure 7.35: Measures of technology success 133

List of Tables

Table 1.1: Nektar's leading innovative technology pipeline 25

Table 1.2: Needle free delivery; Key routes of administration 26

Table 1.3: Technology market coverage 27

Table 2.4: The global pipeline for chemical and biologic drugs, October 2008 37

Table 3.5: Key innovative technologies, clinical drug failures and discontinued products, November 2008 45

Table 3.6: Key route of administration technologies; industry size and maturity 56

Table 4.7: Nanotechnology drug delivery platforms, large molecule vs small molecule applications, November 2008 63

Table 4.8: Nanoparticles as drug delivery carriers 64

Table 4.9: Leading clinical parenteral drug delivery 66

Table 5.10: Clinical PEGylation stealth targeting technologies 84

Table 5.11: Antibody fragment products, clinical applications 93

Table 5.12: Armagen's proprietary CNS product pipeline: Trojan horse conjugate delivery 99

Table 6.13: Small molecule success of membrane transport technologies, November 2008 106

Table 6.14: Clinical use electronic pulmonary delivery technologies 107

Table 6.15: Transdermal and transmembrane active platform technologies, November 2008 108

Table 6.16: Novel electroporation platforms; transdermal alternatives 113

Table 7.17: Innovative technology products in R&D pipelines, October 2008 123

Table 7.18: Industry maturity and investment, leading innovative drug delivery platforms 125

Table 7.19: Growth in technology deals, 1998-2007 126

Table 7.20: Therapy area focus of innovative technology product candidates, October 2008 129

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

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