Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets - GBI Research Reports

Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets

Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets - GBI Research Reports
Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets
Published Apr 20, 2012
70 pages — Published Apr 20, 2012
Price US$ 3,500.00  |  Buy this Report Now

About This Report

  
Abstract:

Summary

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.

Scope

- Market analysis identifying the key advantages for developing supergenerics and the market drivers for product development.
- Data and analysis regarding novel technologies and delivery platforms that have been developed to enhance the safety and efficacy and/or ease the administration of single molecules and combination therapies.
- Assess how supergenerics can improve manufacturing efficiencies through the adoption of continuous manufacturing processes.
- Key challenges faced by supergeneric organization with respect to the regulatory hurdles and IP protection of supergeneric products
- The competitive landscape of leading supergeneric organizations their products, technologies and partnership activities including: Access Pharmaceuticals, Adamas Pharmaceutical, Adventrx Pharmaceuticals, Azaya therapeutics, Cynapsus Therapeutics, Durect Corporation, Enzon Pharmacetuicals, Insys Therapetuics, KemPharm, Nektar Therapeutics, NuPathe, Pearl Therapeutics, PharmaEngine, Pulmatrix, Regulon, Supernus Pharmaceuticals, Talon Therapeutics and Zogenix.

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

  
Source:
Document ID
GBIHC234MR
Industry
Format:
PDF Adobe Acrobat
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Sections

TitleStarting PageNumber of Pages
Table of Contents34
  List of Tables51
  List of Figures61
Introduction713
  Generics, Supergenerics and New Chemical Entities71
  Key Advantages for Development of Supergenerics81
  Drivers for Supergeneric Organizations91
    High Unmet Clinical Need101
    Product Differentiation111
    Decline in R&D Productivity122
    Increased Generic Competition141
    Patent Expiration and Freedom to Operate151
    Rise in the Number of Paper New Drug Applications152
    Shift towards Orphan Drugs and Biopharmaceuticals171
    Aging Population181
    Emerging Markets181
    Healthcare Reform and Cost-effective Treatments191
  Report Guidance191
Strategies for Developing and Differentiating Supergenerics2025
  Therapeutic Strategies for Supergenerics201
  Supergenerics Improving Delivery and Clinical Profile211
    Oncology212
      Supergeneric Camptosar231
      Supergeneric Eloxatine241
      Supergeneric Navelbine251
      Supergeneric Platinol261
      Supergeneric Taxol261
      Supergeneric Taxotere261
    Central Nervous System and Pain272
    Alzheimer s Disease and Dementia291
      Extended Release Memantine/Domepezil291
    Parkinson s Disease291
      Supergeneric Requip Implant291
      Supergeneric Amantadine291
      Supergeneric Apomorphine301
    Schizophrenia301
      Supergeneric Clozaril301
      Supergeneric Loxapine301
      Supergeneric Risperdal311
    Epilepsy311
      Supergeneric Trileptal XR311
      Supergeneric Topomax311
    Depression321
      Supergeneric Wellbutrin XL321
    Migraine321
    Attention Deficit Hyperactivity Disorder331
    Pain331
      Prodrugs331
      Transdermal Patches331
      Controlled Release341
    Respiratory343
      Supergeneric Advair371
      Supergeneric Singulair371
      Supergeneric Robinul381
    Therapeutic Conclusions381
  Supergenerics Improving Manufacturing Efficiency391
    Quality by Design391
    Regulatory Support for Continuous Manufacturing Processes402
    Reducing Manufacturing Costs421
    Pharma Investment in Continuous Manufacturing431
    Manufacturing Conclusions441
    Overall Conclusions441
Regulatory and Legislative Implications455
  Introduction451
  US Regulation of Supergenerics451
    505 (b)(1) New Drug Approval451
    505 (b)(2) New Drug Approval (Paper New Drug Approval)451
    505 (j) Approved New Drug Approval451
    Paper New Drug Application461
  European Regulation of Supergenerics471
    Hybrid Medicinal Product471
    Patent Implications for Supergenerics481
    Conclusions491
Supergeneric Organization Strategies5015
  Access Pharmaceuticals501
  Adamas Pharmaceutical511
  Adventrx Pharmaceuticals521
  Azaya Therapeutics531
  Cynapsus Therapeutics531
  Durect Corporation541
  Enzon Pharmaceuticals551
  Insys Therapeutics561
  KemPharm Inc561
  Nektar Therapeutics571
  NuPathe Inc581
  Pearl Therapeutics591
  PharmaEngine Inc601
  Pulmatrix Inc.611
  Regulon Inc.611
  Supernus Pharmaceuticals611
  Talon Therapeutics621
  Zogenix Inc.632
Future Outlook651
Appendix665
  Abbreviations663
    Sources681
  Methodology691
    Primary Research691
    Secondary Research691
  Contacts Us701
  Disclaimer701

Table Of Contents

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Cite this Report

  
MLA:
GBI Research Reports. "Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets" Apr 20, 2012. Alacra Store. May 07, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Growth-Strategies-for-Supergenerics-Organizations-Opportunities-in-Addressing-Unmet-Medical-Needs-and-Providing-Cost-Effective-Solutions-for-Product-Development-in-Emerging-Markets-2115-399>
  
APA:
GBI Research Reports. (2012). Growth Strategies for Supergenerics Organizations - Opportunities in Addressing Unmet Medical Needs and Providing Cost-Effective Solutions for Product Development in Emerging Markets Apr 20, 2012. New York, NY: Alacra Store. Retrieved May 07, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Growth-Strategies-for-Supergenerics-Organizations-Opportunities-in-Addressing-Unmet-Medical-Needs-and-Providing-Cost-Effective-Solutions-for-Product-Development-in-Emerging-Markets-2115-399>
  
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