Look Towards A New Future

Apr 30, 2012

Growth Strategies for Supergenerics Organizations - Opportunities in addressing unmet medical needs and providing cost-effective solutions for product development in emerging markets

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
  • 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
Report Details
 Published: April 2012
Price: Single User License: US $ 3500        Corporate User License : US $ 10500

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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