Psoriasis - Identifying and Commercializing First-in-Class Innovation Market Research Report: Radiant Insights, Inc
GBI Research has released the pharma report: "Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class Innovation", which identifies and assesses first-in-class innovation in the psoriasis development pipeline.
GBI Research has released the pharma report: "Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class Innovation", which identifies and assesses first-in-class innovation in the psoriasis development pipeline.
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<strong>Psoriasis</strong> - <strong>Identify<strong>in</strong>g</strong> <strong>and</strong> <strong>Commercializ<strong>in</strong>g</strong> <strong>First</strong><strong>in</strong>-<strong>Class</strong><br />
<strong>Innovation</strong> <strong>Market</strong> <strong>Research</strong> <strong>Report</strong>:<br />
<strong>Radiant</strong> <strong>Insights</strong>, <strong>Inc</strong><br />
GBI <strong>Research</strong> has released the pharma report: "Frontier Pharma: <strong>Psoriasis</strong> - <strong>Identify<strong>in</strong>g</strong> <strong>and</strong><br />
<strong>Commercializ<strong>in</strong>g</strong> <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> <strong>Innovation</strong>", which identifies <strong>and</strong> assesses first-<strong>in</strong>-class<br />
<strong>in</strong>novation <strong>in</strong> the psoriasis development pipel<strong>in</strong>e.<br />
Over the last decade, a greater underst<strong>and</strong><strong>in</strong>g of the underly<strong>in</strong>g pathophysiology of<br />
psoriasis has <strong>in</strong>creased emphasis on develop<strong>in</strong>g immuneomodulat<strong>in</strong>g therapies, as<br />
opposed to largely symptomatic treatments. This is currently reflected <strong>in</strong> a competitive<br />
market dom<strong>in</strong>ated by multiple disease-modify<strong>in</strong>g biologic therapies (<strong>in</strong>hibitors of TNF-a<br />
<strong>and</strong> IL-12/IL-23) <strong>and</strong> generic small-molecule therapies.<br />
Read Complete <strong>Report</strong> with TOC @ http://www.radiant<strong>in</strong>sights.com/research/frontierpharma-psoriasis-identify<strong>in</strong>g-<strong>and</strong>-commercializ<strong>in</strong>g-first-<strong>in</strong>-class-<strong>in</strong>novation<br />
Despite this, there are significant unmet needs <strong>in</strong> the market, <strong>in</strong>clud<strong>in</strong>g safety concerns<br />
regard<strong>in</strong>g immunomodulation. This is a particularly important issue for the long-term<br />
commercial <strong>and</strong> cl<strong>in</strong>ical success of psoriatic therapeutics, especially for emerg<strong>in</strong>g biologics.<br />
Another unmet need is ease of drug application, as biologic drug delivery is <strong>in</strong>vasive <strong>and</strong><br />
pa<strong>in</strong>ful.<br />
This allows for pipel<strong>in</strong>e programs that offer a more ref<strong>in</strong>ed approach to<br />
immunomodulation <strong>and</strong> ease of drug application to ga<strong>in</strong> market share upon entry. In a<br />
pipel<strong>in</strong>e of over 200 programs, approximately one third exhibits a novel mechanism of<br />
action. Innovative programs target a wide range of molecules implicated <strong>in</strong> immune<br />
signal<strong>in</strong>g, such as cytok<strong>in</strong>es <strong>and</strong> B <strong>and</strong> T cell antigens.<br />
Several promis<strong>in</strong>g first-<strong>in</strong>-class therapies can selectively modulate specific subsets of<br />
immune cells without compromis<strong>in</strong>g the entire immune system. In particular, biologics that<br />
target a subset of T cells, which are strongly implicated <strong>in</strong> autoimmune pathophysiology,<br />
could allow for specificity of immune suppression <strong>and</strong> thereby reduce adverse side effects.<br />
Based on cl<strong>in</strong>ical trials, IL-17-targeted therapies have demonstrated superiority over<br />
currently established therapies <strong>in</strong> achiev<strong>in</strong>g advanced cl<strong>in</strong>ical endpo<strong>in</strong>ts.
Other agents which activate regulatory arms of the immune system have also shown<br />
promis<strong>in</strong>g cl<strong>in</strong>ical profiles. In addition, <strong>in</strong>novative programs that target molecules have<br />
only recently ga<strong>in</strong>ed recognition of their therapeutic value <strong>in</strong> the treatment of psoriasis,<br />
<strong>in</strong>clud<strong>in</strong>g novel angiogenic prote<strong>in</strong>s, signal<strong>in</strong>g transduction prote<strong>in</strong>s <strong>and</strong> novel nuclear<br />
receptors. Despite their recent implication <strong>in</strong> disease pathophysiology, many of these<br />
agents have also demonstrated cl<strong>in</strong>ical utility <strong>in</strong> the treatment of psoriasis <strong>and</strong> are likely to<br />
contribute to a diversified therapeutic l<strong>and</strong>scape.<br />
Scope<br />
- A brief <strong>in</strong>troduction to psoriasis, <strong>in</strong>clud<strong>in</strong>g symptoms, pathophysiology, <strong>and</strong> overview of<br />
pharmacotherapy<br />
- The chang<strong>in</strong>g molecular target l<strong>and</strong>scape between market <strong>and</strong> pipel<strong>in</strong>e <strong>and</strong> particular<br />
focal po<strong>in</strong>ts of <strong>in</strong>novation<br />
Read Complete <strong>Report</strong> with TOC @ http://www.radiant<strong>in</strong>sights.com/research/frontierpharma-psoriasis-identify<strong>in</strong>g-<strong>and</strong>-commercializ<strong>in</strong>g-first-<strong>in</strong>-class-<strong>in</strong>novation<br />
- Overview of how <strong>in</strong>novative products are contribut<strong>in</strong>g to the pipel<strong>in</strong>e <strong>and</strong> market for<br />
psoriasis<br />
- Comprehensive review of the pipel<strong>in</strong>e for first-<strong>in</strong>-class therapies, analyzed on the basis of<br />
phase distribution, molecule type, molecular target, <strong>and</strong> adm<strong>in</strong>istration route<br />
- Identification <strong>and</strong> assessment of first-<strong>in</strong>-class molecular targets with a particular focus on<br />
early-stage programs of which cl<strong>in</strong>ical utility has yet to be evaluated, as well as literature<br />
reviews on novel molecular targets<br />
- Assessment of the licens<strong>in</strong>g <strong>and</strong> co-development deals for psoriasis therapies<br />
Reasons to buy<br />
- Underst<strong>and</strong><strong>in</strong>g of the focal shifts <strong>in</strong> molecular targets <strong>in</strong> the psoriasis pipel<strong>in</strong>e<br />
- Underst<strong>and</strong><strong>in</strong>g of the distribution of pipel<strong>in</strong>e programs by phase of development,<br />
molecule type <strong>and</strong> molecular target<br />
- Scientific <strong>and</strong> cl<strong>in</strong>ical analysis of first-<strong>in</strong>-class developmental programs<br />
- Assessment of the valuations of licensed <strong>and</strong> co-developed psoriasis treatments<br />
- A list of the first-<strong>in</strong>-class therapies potentially open to deal-mak<strong>in</strong>g opportunities.<br />
- Analysis of f<strong>in</strong>ancial valuations on licensed or co-developed first-<strong>in</strong>-class therapies <strong>and</strong><br />
generics
Table of Contents<br />
Table of Contents 4<br />
1.1 List of Tables 6<br />
1.2 List of Figures 6<br />
2 The Case for <strong>Innovation</strong> 7<br />
2.1 Grow<strong>in</strong>g Opportunities for Biologic Products 7<br />
2.2 Diversification of Molecular Targets 7<br />
2.3 Innovative <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Product Developments Rema<strong>in</strong> Attractive 7<br />
2.4 Changes <strong>in</strong> the Cl<strong>in</strong>ical <strong>and</strong> Commercial Environment Will be More Favorable to<br />
Products That Target Niche Indications <strong>and</strong> Patient Populations 8<br />
2.5 <strong>Innovation</strong> <strong>in</strong> <strong>Psoriasis</strong> 8<br />
3 Cl<strong>in</strong>ical <strong>and</strong> Commercial L<strong>and</strong>scape 9<br />
3.1 Disease Introduction 9<br />
3.2 Epidemiology 9<br />
3.3 Etiology 10<br />
Read Complete <strong>Report</strong> with TOC @ http://www.radiant<strong>in</strong>sights.com/research/frontierpharma-psoriasis-identify<strong>in</strong>g-<strong>and</strong>-commercializ<strong>in</strong>g-first-<strong>in</strong>-class-<strong>in</strong>novation<br />
3.3.1 Genetic Predisposition 10<br />
3.3.2 Environmental Factors 10<br />
3.4 Pathophysiology 10<br />
3.4.1 Kerat<strong>in</strong>ocytes 10<br />
3.4.2 Dendritic Cells 11<br />
3.4.3 T-Cells 11<br />
3.4.4 Angiogenesis 11<br />
3.4.5 Growth Factors 11<br />
3.5 Symptoms <strong>and</strong> Co-morbidities 12<br />
3.5.1 Sk<strong>in</strong> Manifestations 12<br />
3.5.2 Psoriatic Arthritis 12<br />
3.5.3 Uveitis 12<br />
3.5.4 Cardiovascular Disease 12<br />
3.5.5 Psychological Impact 12<br />
3.6 Diagnosis of <strong>Psoriasis</strong> 13<br />
3.6.1 Diagnosis of Psoriatic Arthritis 13<br />
3.7 Treatment 13<br />
3.7.1 Pharmacological Therapies 13<br />
3.7.2 Topical Medications 13<br />
3.7.3 Systemic Medications 14
3.7.4 Non-Pharmacological Therapies 14<br />
3.7.5 Comb<strong>in</strong>ation <strong>and</strong> Rotational Therapies 15<br />
3.8 Overview of <strong>Market</strong>ed Products for <strong>Psoriasis</strong> 16<br />
3.8.1 Oral Non-Biologic DMARDs 16<br />
3.8.2 Off-Label Non-Biologic DMARDs 19<br />
3.8.3 Biologics 19<br />
3.8.4 Comparative Efficacy <strong>and</strong> Safety of <strong>Market</strong>ed Products 23<br />
3.8.5 Unmet Need 26<br />
4 Assessment of <strong>Psoriasis</strong> Pipel<strong>in</strong>e <strong>and</strong> <strong>Innovation</strong> 27<br />
4.1 Overview 27<br />
Read Complete <strong>Report</strong> with TOC @ http://www.radiant<strong>in</strong>sights.com/research/frontierpharma-psoriasis-identify<strong>in</strong>g-<strong>and</strong>-commercializ<strong>in</strong>g-first-<strong>in</strong>-class-<strong>in</strong>novation<br />
4.2 Comparative Efficacy <strong>and</strong> Safety of Pipel<strong>in</strong>e Programs 29<br />
4.3 Comparative Distribution of Programs <strong>in</strong> the <strong>Psoriasis</strong> <strong>Market</strong> <strong>and</strong> Pipel<strong>in</strong>e by<br />
Therapeutic Target Family 31<br />
4.4 Comparative Distribution of Programs with <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> <strong>and</strong> Established Molecular<br />
Targets 33<br />
4.5 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Established Molecular Targets 36<br />
4.6 <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Pipel<strong>in</strong>e Programs with Novel Molecular Targets 38<br />
5 <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Target <strong>and</strong> Pipel<strong>in</strong>e Program Evaluation 40<br />
5.1 Cytok<strong>in</strong>es <strong>and</strong> Receptors 40<br />
5.1.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Tumor Necrosis Factor Receptors 40<br />
5.1.2 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Interleuk<strong>in</strong>-6 42<br />
5.1.3 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Interleuk<strong>in</strong>-8 43<br />
5.1.4 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Interleuk<strong>in</strong>-17 44<br />
5.1.5 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Interferon-? 45<br />
5.2 B <strong>and</strong> T Cell Antigens 46<br />
5.2.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Cluster of Differentiation 4 46<br />
5.2.2 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Cluster of Differentiation 28 47<br />
5.3 Intracellular K<strong>in</strong>ases 48<br />
5.3.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Interleuk<strong>in</strong>-1 Receptor-Associated K<strong>in</strong>ase-4 48<br />
5.4 Nuclear Receptors 49<br />
5.4.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Ret<strong>in</strong>oic Acid Receptor-Related Orphan Receptor 49<br />
5.5 Growth Factors 51<br />
5.5.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Transform<strong>in</strong>g Growth Factor-? Receptor 51<br />
5.5.2 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Insul<strong>in</strong> Receptor Substrate 52<br />
5.6 Ion Channels 53
5.6.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Calcium Release-Activated Calcium Channel 53<br />
5.7 Integr<strong>in</strong>s 54<br />
5.7.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Vascular Adhesion Prote<strong>in</strong>-1 54<br />
5.8 Other 55<br />
5.8.1 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g F1F0-Adenos<strong>in</strong>e Triphosphate Synthase 55<br />
5.8.2 Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Catheps<strong>in</strong> S 56<br />
5.9 Conclusion 57<br />
6 Deals <strong>and</strong> Strategic Consolidations 59<br />
6.1 Licens<strong>in</strong>g Agreements 59<br />
6.2 Major Co-development Deals 62<br />
6.3 <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Developmental Programs Not Involved <strong>in</strong> Co-Development or Licens<strong>in</strong>g<br />
Deals 65<br />
7 Appendix 66<br />
Read Complete <strong>Report</strong> with TOC @ http://www.radiant<strong>in</strong>sights.com/research/frontierpharma-psoriasis-identify<strong>in</strong>g-<strong>and</strong>-commercializ<strong>in</strong>g-first-<strong>in</strong>-class-<strong>in</strong>novation<br />
7.1 Abbreviations 66<br />
7.2 References 68<br />
7.3 Methodology 76<br />
7.4 Contact Us 76<br />
7.5 Disclaimer 77<br />
List of Tables<br />
Table 1: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Interferon-? Inhibitors, Pipel<strong>in</strong>e<br />
Development 46<br />
Table 2: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> F1F0-Adenos<strong>in</strong>e Triphosphate Synthase<br />
Modulators, Pipel<strong>in</strong>e Development 56<br />
Table 3: Abbreviations 66<br />
List of Figures<br />
Figure 1: <strong>Psoriasis</strong>, Global, Treatment Algorithm 15<br />
Figure 2: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Comparative Safety <strong>and</strong> Efficacy, 2013 - 1 24<br />
Figure 3: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Comparative Safety <strong>and</strong> Efficacy, 2013 - 2 25<br />
Figure 4: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Pipel<strong>in</strong>e Overview, 2013 28<br />
Figure 5: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Comparative Safety <strong>and</strong> Efficacy of Pipel<strong>in</strong>e Products,<br />
2013 30<br />
Figure 6: <strong>Psoriasis</strong>, Global, Comparative Distribution of <strong>Market</strong>ed <strong>and</strong> pipel<strong>in</strong>e Products by<br />
Target Family 31
Figure 7: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Pipel<strong>in</strong>e, Comparative Distribution of Programs by<br />
Established <strong>and</strong> <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Targets, 2013 35<br />
Figure 8: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Pipel<strong>in</strong>e Products with Established Targets, 2013 37<br />
Figure 9: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Pipel<strong>in</strong>e Products with <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Targets, 2013 39<br />
Figure 10: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Tumor Necrosis Factor-? Receptor<br />
Modulators, Pipel<strong>in</strong>e Development 41<br />
Figure 11: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Interleuk<strong>in</strong>-6 Inhibitors, Pipel<strong>in</strong>e<br />
Development 43<br />
Read Complete <strong>Report</strong> with TOC @ http://www.radiant<strong>in</strong>sights.com/research/frontierpharma-psoriasis-identify<strong>in</strong>g-<strong>and</strong>-commercializ<strong>in</strong>g-first-<strong>in</strong>-class-<strong>in</strong>novation<br />
Figure 12: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Interleuk<strong>in</strong>-8 Inhibitors, Pipel<strong>in</strong>e<br />
Development 44<br />
Figure 13: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Interleuk<strong>in</strong>-17 Inhibitors, Pipel<strong>in</strong>e<br />
Development 45<br />
Figure 14: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Cluster of Differentiation 4 Modulators,<br />
Pipel<strong>in</strong>e Development 47<br />
Figure 15: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Cluster of Differentiation 28 Modulators,<br />
Pipel<strong>in</strong>e Development 48<br />
Figure 16: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Interleuk<strong>in</strong>-1 Receptor Associated<br />
K<strong>in</strong>ase-4 Inhibitors, Pipel<strong>in</strong>e Development 49<br />
Figure 17: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Ret<strong>in</strong>oic Acid Receptor-Related Orphan<br />
Receptor Inhibitors, Pipel<strong>in</strong>e Development 50<br />
Figure 18: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Transform<strong>in</strong>g Growth Factor-? Receptor<br />
Modulators, Pipel<strong>in</strong>e Development 52<br />
Figure 19: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Insul<strong>in</strong> Receptor Substrate Modulators,<br />
Pipel<strong>in</strong>e Development 53<br />
Figure 20: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Calcium Release-Activated Calcium<br />
Channel, Pipel<strong>in</strong>e Development 54<br />
Figure 21: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Vascular Adhesion Prote<strong>in</strong>-1 Inhibitors,<br />
Pipel<strong>in</strong>e Development 55<br />
Figure 22: <strong>Psoriasis</strong> <strong>Market</strong>, Global, <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Catheps<strong>in</strong> S Inhibitors, Pipel<strong>in</strong>e<br />
Development 57<br />
Figure 23: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Licens<strong>in</strong>g Agreement Analysis 1, 2006-2014 59<br />
Figure 24: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Licens<strong>in</strong>g Agreement Analysis 2, 2006-2014 60<br />
Figure 25: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Licens<strong>in</strong>g Agreement Deal Analysis, 2006-2014 61<br />
Figure 26: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Co-Development Deal Analysis, 2006-2014 - 1 62<br />
Figure 27: <strong>Psoriasis</strong> <strong>Market</strong>, Global, Co-Development Deal Analysis, 2006-2014 - 2 64
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