Frontier Pharma Parkinsons Disease - Identifying and Commercializing First-in-Class Innovation Analysis & Forecast.pdf
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<strong>Frontier</strong> <strong>Pharma</strong> <strong>Park<strong>in</strong>sons</strong> <strong>Disease</strong> - <strong>Identify<strong>in</strong>g</strong> <strong>and</strong> <strong>Commercializ<strong>in</strong>g</strong> <strong>First</strong>-<strong>in</strong>-<br />
<strong>Class</strong> <strong>Innovation</strong> <strong>Analysis</strong> & <strong>Forecast</strong><br />
In the United States, almost 1.5 million people are reported to be affected by Park<strong>in</strong>son’s<br />
disease (PD), where<strong>in</strong> 60,000 patients cont<strong>in</strong>ue to be diagnosed with the condition every year,<br />
cost<strong>in</strong>g the U.S. economy US$14 billion on an annual basis <strong>in</strong> the direct <strong>and</strong> <strong>in</strong>direct expenses.<br />
Browse the full Global Park<strong>in</strong>son’s <strong>Disease</strong> Market Report : http://www.mrrse.com/frontierpharma-park<strong>in</strong>sons-disease<br />
At present, 302 products are be<strong>in</strong>g actively developed <strong>in</strong> the therapeutic pipel<strong>in</strong>e of<br />
Park<strong>in</strong>son’s disease over a number of stages.<br />
However, the mechanisms of action applied on the exist<strong>in</strong>g products compared to the ones <strong>in</strong><br />
the pipel<strong>in</strong>e shows severe differences. The exist<strong>in</strong>g symptomatic treatments employed for PD<br />
target neuromodulatory receptors; whereas, the current product pipel<strong>in</strong>e features a<br />
widespread array of neuroprotective therapies focus<strong>in</strong>g on dysfunctional disease procedures.<br />
The availability of n<strong>in</strong>ety first-<strong>in</strong>-class products that holds 37% of the overall therapies <strong>in</strong><br />
pipel<strong>in</strong>e is one of the major reason beh<strong>in</strong>d the diversity <strong>in</strong> the MoA for both, exist<strong>in</strong>g products<br />
<strong>and</strong> pipel<strong>in</strong>e products.<br />
S<strong>in</strong>ce, the global PD <strong>in</strong>dustry is driven by first-<strong>in</strong>-class products compared to the non-first-<strong>in</strong>class<br />
ones; the development of this market is widely impacted by this factor. Although the<br />
first-<strong>in</strong>-class products <strong>and</strong> therapies have <strong>in</strong>dicated high abrasion rate <strong>in</strong> past, they have the<br />
potential to modify the global PD treatment market for good.<br />
As the global market for Park<strong>in</strong>son’s disease is ris<strong>in</strong>g at a rapid pace, let’s take a look at the<br />
future prospects the market is go<strong>in</strong>g to deal with:<br />
· The overall revenue generated from sales <strong>in</strong> the PD markets of the U.S., Germany, France,<br />
Italy, the U.K., Spa<strong>in</strong>, <strong>and</strong> Japan is expected to register a slight decl<strong>in</strong>e from around US$2.7<br />
billion <strong>in</strong> 2010 to an estimate of US$2.6 billion by 2020.
· The dom<strong>in</strong>ant dopam<strong>in</strong>e agonists, rop<strong>in</strong>irole <strong>and</strong> pramipexole, are expected to trigger the<br />
sales significantly. The <strong>in</strong>creas<strong>in</strong>g usage of Agilect, the MAO-B <strong>in</strong>hibitor, <strong>and</strong> the resurgence of<br />
UCB’s Leganto/Neupro <strong>in</strong> the U.S. market with an even wider employment <strong>in</strong> the European<br />
market are also projected to drive the market growth.<br />
· In spite of the <strong>in</strong>creased uptake of some key therapies currently functional <strong>in</strong> the market <strong>and</strong><br />
the announcement to launch 3 new agents (GlaxoSmithKl<strong>in</strong>e’s IPX-066, Newron<br />
<strong>Pharma</strong>ceuticals’ saf<strong>in</strong>amide, <strong>and</strong> Kyowa Hakko Kir<strong>in</strong>’s istradefyll<strong>in</strong>e) by 2020, the sales of<br />
current agents <strong>and</strong> their impact on the market of emerg<strong>in</strong>g therapies is likely to be<br />
suppressed by generic competition.<br />
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Table of Contents:<br />
1 Table of Contents 2<br />
1.1 List of Tables 3<br />
1.2 List of Figures 3<br />
2 Executive Summary 5<br />
2.1 Highly Innovative <strong>and</strong> Diverse Pipel<strong>in</strong>e 5<br />
2.2 Alignment of <strong>Innovation</strong> to <strong>Disease</strong> Processes <strong>and</strong> Genetics 5<br />
2.3 Deals L<strong>and</strong>scape Present Substantial Investment Opportunities 5<br />
3 The Case for <strong>Innovation</strong> 6<br />
3.1 Grow<strong>in</strong>g Opportunities for Biologic Products 7<br />
3.2 Diversification of Molecular Targets 7<br />
3.3 Innovative <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Product Developments Rema<strong>in</strong> Attractive 7
3.4 Regulatory <strong>and</strong> Reimbursement Policy Shifts Favor <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Product <strong>Innovation</strong> 8<br />
3.5 Susta<strong>in</strong>ed <strong>Innovation</strong> 8<br />
3.6 GBI Research Report Guidance 9<br />
4 Cl<strong>in</strong>ical <strong>and</strong> Commercial L<strong>and</strong>scape 10<br />
4.1 Epidemiology 10<br />
4.2 <strong>Disease</strong> Etiology 11<br />
4.2.1 Exposure to Environmental Tox<strong>in</strong>s 11<br />
4.2.2 Genetic Causes of Familial Park<strong>in</strong>son’s <strong>Disease</strong> 11<br />
4.2.3 Susceptibility Genes for Park<strong>in</strong>son’s <strong>Disease</strong> 13<br />
4.3 <strong>Disease</strong> Pathophysiology 13<br />
4.3.1 Basal Ganglia Anatomy <strong>and</strong> Physiology 13<br />
4.3.2 Processes Underly<strong>in</strong>g Neurodegeneration <strong>in</strong> Park<strong>in</strong>son’s <strong>Disease</strong> 16<br />
4.4 <strong>Disease</strong> Symptoms 20<br />
4.5 Co-morbidities <strong>and</strong> Complications 20<br />
4.6 Diagnosis 21<br />
4.6.1 <strong>Class</strong>ification 21<br />
4.7 Prognosis <strong>and</strong> <strong>Disease</strong> Stag<strong>in</strong>g 23<br />
4.8 Treatment Options 24<br />
4.8.1 <strong>Pharma</strong>cological Treatment 24<br />
4.8.2 Non-pharmacological Treatments 28<br />
4.9 Marketed Product Overview 28<br />
4.10 Overview of Marketed Products for Park<strong>in</strong>son’s <strong>Disease</strong> 29
4.11 Efficacy <strong>and</strong> Safety of Marketed Products 31<br />
4.12 Treatment Algorithm 33<br />
4.13 Current Unmet Needs 35<br />
5 Assessment of Pipel<strong>in</strong>e Product <strong>Innovation</strong> 37<br />
5.1 Park<strong>in</strong>son’s <strong>Disease</strong> Pipel<strong>in</strong>e by Molecule Type, Phase <strong>and</strong> Therapeutic Targets 37<br />
5.2 Comparative Distribution of Programs between the Park<strong>in</strong>son’s <strong>Disease</strong> Market <strong>and</strong><br />
Pipel<strong>in</strong>e by Therapeutic Target Family 41<br />
6 Signal<strong>in</strong>g Network, Park<strong>in</strong>son’s <strong>Disease</strong> Genetics <strong>and</strong> <strong>Innovation</strong> Alignment 46<br />
6.1 The Complexity of Signal<strong>in</strong>g Network <strong>in</strong> Central Nervous System 46<br />
6.2 Signal<strong>in</strong>g Pathways, <strong>Disease</strong>-Caus<strong>in</strong>g Mutations <strong>and</strong> <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Molecular Target<br />
Integration 47<br />
6.3 <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Target Matrix Assessment 51<br />
7 <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Target <strong>and</strong> Pipel<strong>in</strong>e Program Evaluation 54<br />
7.1 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g ?-synucle<strong>in</strong> 54<br />
7.2 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g LRRK2 57<br />
7.3 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Glial Cell-Derived Neurotrophic Factor 60<br />
7.4 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Progranul<strong>in</strong> 63<br />
7.5 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Cerebral Dopam<strong>in</strong>e Neurotrophic Factor 66<br />
7.6 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Mesencephalic Astrocyte-Derived Neurotrophic<br />
Factor 68<br />
7.7 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Tyros<strong>in</strong>e Receptor K<strong>in</strong>ase B 70<br />
7.8 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Metabotropic Glutamate Receptor 4 73
7.9 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Metabotropic Glutamate Receptor 8 75<br />
7.10 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g C-jun-N-Term<strong>in</strong>al K<strong>in</strong>ases 76<br />
7.11 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g DJ-1 79<br />
7.12 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Reactive Oxygen Species 80<br />
7.13 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Heat Shock Transcription Factor 1 82<br />
7.14 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Heat Shock Prote<strong>in</strong> 90 84<br />
7.15 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Growth Hormone Secretagogue Receptor 86<br />
7.16 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Prote<strong>in</strong> Phosphatase 2A 88<br />
7.17 Overview of Pipel<strong>in</strong>e Programs Target<strong>in</strong>g Cytochrome P450 2D6 90<br />
7.18 Conclusion 91<br />
8 Deals <strong>and</strong> Strategic Consolidations 93<br />
8.1 Industry-wide <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Deals 93<br />
8.2 Park<strong>in</strong>son’s <strong>Disease</strong> Deals L<strong>and</strong>scape 95<br />
8.3 Licens<strong>in</strong>g Deals 95<br />
8.3.1 Molecule Type 97<br />
8.3.2 Mechanism of Action 97<br />
8.4 Co-development Deals 100<br />
8.4.1 Mechanism of Action 101<br />
8.5 <strong>First</strong>-<strong>in</strong>-<strong>Class</strong> Programs Not Involved <strong>in</strong> Licens<strong>in</strong>g or Co-Development Deals 103<br />
9 Appendix 106<br />
9.1 Abbreviations 106
9.2 References 108<br />
9.3 Contact Us 121<br />
9.4 Disclaimer 121<br />
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