GBI Research, a leading business intelligence provider, has released its
latest research “Growth Strategies for Supergenerics Organizations -
Opportunities in addressing unmet medical needs and providing
cost-effective solutions for product development in emerging markets”
which assesses the strategies that companies have used to improve the
efficacy, safety, ease of use and manufacture of products. It discusses
the key advantages and market drivers to develop and differentiate
supergenerics. It analyzes the regulatory and legislative implications
on the development of supergenerics, and gives an introduction to the
CRO industry. It provides an overview of leading supergeneric
organizations, their technologies, product development strategies, and
partnering activities and analyzes market trends and the future outlook
for the growth of supergeneric organizations. Today more than 550 new
chemical entities have been approved for use, however many of these
products are still only available in their original dosage form and
indication. As our scientific understanding into the mechanism of
action, targets, effects, and delivery technologies grows supergeneric
organizations have gained significant expertise to develop novel
platform technologies that can enhance the delivery of one or more
agents and improve tissue targeting thereby reducing off-target side
effects, potentially enhancing therapeutic effects and the ease of
administration. GBI Research analysis has identified more than 60 novel
supergeneric formulations of approved oncology, CNS and pain, and
respiratory products that are under development which address specific
unmet medical need and which may provide a cost-effective solution to
develop novel products to meet the growing demands within the emerging
markets.
Reasons to Buy
Published: April 2012
Price: Single User License: US $ 3500 Corporate User License : US $ 10500
Request a Sample @ http://www.reportsnreports.com/reports/157495-growth-strategies-for-supergenerics-organizations-opportunities-in-addressing-unmet-medical-needs-and-providing-cost-effective-solutions-for-product-development-in-emerging-markets.html
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Generics, Supergenerics and New Chemical Entities
2.2 Key Advantages for Development of Supergenerics
2.3 Drivers for Supergeneric Organizations
2.3.1 High Unmet Clinical Need
2.3.2 Product Differentiation
2.3.3 Decline in R&D Productivity
2.3.4 Increased Generic Competition
2.3.5 Patent Expiration and Freedom to Operate
2.3.6 Rise in the Number of Paper New Drug Applications
2.3.7 Shift towards Orphan Drugs and Biopharmaceuticals
2.3.8 Aging Population
2.3.9 Emerging Markets
2.3.10 Healthcare Reform and Cost-effective Treatments
2.4 Report Guidance
3 Strategies for Developing and Differentiating Supergenerics
3.1 Therapeutic Strategies for Supergenerics
3.2 Supergenerics Improving Delivery and Clinical Profile
3.2.1 Oncology
3.2.2 Central Nervous System and Pain
3.2.3 Alzheimer’s Disease and Dementia
3.2.4 Parkinson’s Disease
3.2.5 Schizophrenia
3.2.6 Epilepsy
3.2.7 Depression
3.2.8 Migraine
3.2.9 Attention Deficit Hyperactivity Disorder
3.2.10 Pain
3.2.11 Respiratory
3.2.12 Therapeutic Conclusions
3.3 Supergenerics Improving Manufacturing Efficiency
3.3.1 Quality by Design
3.3.2 Regulatory Support for Continuous Manufacturing Processes
3.3.3 Reducing Manufacturing Costs
3.3.4 Pharma Investment in Continuous Manufacturing
3.3.5 Manufacturing Conclusions
3.3.6 Overall Conclusions
4 Regulatory and Legislative Implications
4.1 Introduction
4.2 US Regulation of Supergenerics
4.2.2 Paper New Drug Application
4.3 European Regulation of Supergenerics
4.3.1 Hybrid Medicinal Product
4.3.2 Patent Implications for Supergenerics
4.3.3 Conclusions
Reasons to Buy
- Identify the key market opportunities for supergeneric development
- Develop or license the IP for technology platforms to optimize product delivery
- Re-evaluate and reassess manufacturing processes and explore alternative ways to improve manufacturing efficiencies
- Gain a greater understanding with regards to the regulatory requirements for supergeneric development and potential IP issues
- Develop key strategic alliances with leading supergeneric organization to complement and expand product portfolios to meet the demand of developed and emerging markets
Published: April 2012
Price: Single User License: US $ 3500 Corporate User License : US $ 10500
Request a Sample @ http://www.reportsnreports.com/reports/157495-growth-strategies-for-supergenerics-organizations-opportunities-in-addressing-unmet-medical-needs-and-providing-cost-effective-solutions-for-product-development-in-emerging-markets.html
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Generics, Supergenerics and New Chemical Entities
2.2 Key Advantages for Development of Supergenerics
2.3 Drivers for Supergeneric Organizations
2.3.1 High Unmet Clinical Need
2.3.2 Product Differentiation
2.3.3 Decline in R&D Productivity
2.3.4 Increased Generic Competition
2.3.5 Patent Expiration and Freedom to Operate
2.3.6 Rise in the Number of Paper New Drug Applications
2.3.7 Shift towards Orphan Drugs and Biopharmaceuticals
2.3.8 Aging Population
2.3.9 Emerging Markets
2.3.10 Healthcare Reform and Cost-effective Treatments
2.4 Report Guidance
3 Strategies for Developing and Differentiating Supergenerics
3.1 Therapeutic Strategies for Supergenerics
3.2 Supergenerics Improving Delivery and Clinical Profile
3.2.1 Oncology
3.2.2 Central Nervous System and Pain
3.2.3 Alzheimer’s Disease and Dementia
3.2.4 Parkinson’s Disease
3.2.5 Schizophrenia
3.2.6 Epilepsy
3.2.7 Depression
3.2.8 Migraine
3.2.9 Attention Deficit Hyperactivity Disorder
3.2.10 Pain
3.2.11 Respiratory
3.2.12 Therapeutic Conclusions
3.3 Supergenerics Improving Manufacturing Efficiency
3.3.1 Quality by Design
3.3.2 Regulatory Support for Continuous Manufacturing Processes
3.3.3 Reducing Manufacturing Costs
3.3.4 Pharma Investment in Continuous Manufacturing
3.3.5 Manufacturing Conclusions
3.3.6 Overall Conclusions
4 Regulatory and Legislative Implications
4.1 Introduction
4.2 US Regulation of Supergenerics
4.2.2 Paper New Drug Application
4.3 European Regulation of Supergenerics
4.3.1 Hybrid Medicinal Product
4.3.2 Patent Implications for Supergenerics
4.3.3 Conclusions
