Biologics Pipelines: Who Has the Next Promising Recombinant Proteins?

Biologics Pipelines: Who Has the Next Promising Recombinant Proteins? published by Decision Resources, Inc. in April, 2008. This report consists of 40 Pages and the price starts from US $ 2250.

Introduction

Therapeutic recombinant protein development has added a broad range of new products to the pharmaceutical armamentarium and led to a burgeoning biotechnology industry that is growing much faster than the smallmolecule- based pharmaceutical industry. New market leaders may soon emerge that are able to reap the benefits afforded by the development of multiple types of recombinant proteins. Success in future therapeutic protein markets will require flexibility, insight, and, most important, the ability to develop affordable biologics for patients, physicians, and payers - all of whom are clamoring for value-for-money drugs.

• Biologics markets are evolving into a complex mix of brands, next-generation brands, biosimilars, and second-generation biosimilars. What opportunities are emerging in this rapidly growing market? What market trends will drive this growth? What new business strategies will companies need to stay competitive?
• Recombinant proteins enjoy significant market success, with sales expected to increase from 9% to 10% of the worldwide drug market over the next five years (i.e., from $54.5 billion in 2007 to $75.8 billion in 2012). What company' s top position in this market is in jeopardy, and what is this company doing to stay one step ahead of the competition? What lies ahead in the recombinant protein market, and who is the current trendsetter?
• Hundreds of recombinant proteins are in clinical development across diverse therapeutic areas. Which ones are in late-stage clinical development? Which ones show the most promise for future success?

• A review of the evolving therapeutic protein market: technology market segments, top-selling brands, market leaders, impact of safety concerns.
• There were 142 recombinant proteins in clinical development in March 2007: overview of seven therapeutic categories, including blood-related disorders, cardiovascular and central nervous system diseases, cancer, and type 1 and 2 diabetes; companies, indications, and current development.
• Decision Resources analysts give their opinion on the status of recombinant proteins in development for various disease indications: delivery improvements for insulin; a new pegylated interferon for the treatment of lupus nephritis; development of biosimilars for cancer treatments; a new drug to treat acute ischemic stroke.
• Companies cannot afford to rest on the laurels of their past success: gauging when and how to enter a therapeutic recombinant protein market will be the key to success. An example of a trendsetting company that is forging a new path to success in tomorrow' s competitive biologics landscape.

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Biologic Markets
• Blood-Related Disorders
  • Alfimeprase (Nuvelo/Amgen' s Cardiovascular Fibrinolytic)
  • Desmoteplase (Paion/Forest/Lundbeck' s Bat-Plasminogen Activator)
  • Micera (Roche' s Methoxy Polyethylene Glycol-Epoetin Beta)
  • Nplate (Amgen' s Romiplostim)
  • Tifacogin (Novartis' s Tissue Factor Pathway Inhibitor)
  • Viprinex (Neurobiological Technologies' Ancrod)
• Cardiovascular Recombinant Proteins
• Recombinant Proteins for Central Nervous System Diseases
• Cancer-Related Recombinant Protein Drugs
  • Aflibercept (Sanofi-Aventis/Regeneron/Bayer HealthCare' s Vascular Endothelial Growth Factor Trap)
  • Onconase (Alfacell/Par Pharmaceutical' s Ranpirnase)
  • TransMID (Xenova/Nycomed/Sosei' s Transferrin-CRM107, or Tf-CRM107)
  • Biosimilar G-CSFs
  • Complexity in the Marketplace
• Antidiabetic Recombinant Proteins
  • Novel Glucagon-Like Peptide 1 Analogues
  • Alkermes/Amylin/Eli Lilly' s Exenatide LAR
  • New Delivery Angles
    • Pfizer' s Exubera
    • Novo Nordisk/Aradigm' s AERx Inhaled Insulin
    • Eli Lilly/Alkermes' s AIR Inhaled Insulin
    • MannKind' s Technosphere Inhaled Insulin
    • Generex Biotechnology' s Oral-Lyn, a Buccal Insulin
• Musculoskeletal Recombinant Proteins
• Phase III Recombinant Proteins for Other Diseases
  • Albuferon (Albinterferon Alfa-2b)
  • ZymoGenetics/Merck Serono' s Atacicept (TACI-Ig)
• Changing of the Guard
  • Amgen Feels the Heat as Pressures Mount
  • Evolving Business Strategies and a Rising Star
• Decision Resources, Inc., Analysts Featured
  • Mary Argent-Katwala, Ph.D., Therapeutic Area Director, Onkos
  • Marcus Bain, Ph.D., Analyst, Metabolic and Cardiovascular Disorders
  • Madhuri Borde, Ph.D., Project Director, Treatment Algorithms
  • Sami R. Fam, Ph.D., Analyst, Cognos
  • Michael Latwis, M.B.A., Corporate Analyst, Pharmaview
  • John M. Lebbos, M.D., Vice President, Decision Resources, Inc.
  • Andrew Merseth, Senior Business Analyst
  • Jonathan W. Searles, Analyst, Cognos
  • Amy H. Whiting, Ph.D., Analyst, Immune and Inflammatory Disorders
  • Donny Wong, Ph.D., Principal Analyst, Metabolic Disorders

• 1. Select Recombinant Proteins in Late-Stage Clinical Development for Blood-Related Disorders
• 2. Select Cardiovascular Recombinant Proteins in Clinical Development
• 3. Select Central Nervous System Recombinant Proteins in Clinical Development
• 4. Select Anticancer Recombinant Proteins in Clinical Development
• 5. Recombinant Protein Development Programs Announced by Major Biosimilar Developers
• 6. Select Antidiabetic Recombinant Proteins in Phase III Development
• 7. Select Musculoskeletal Recombinant Proteins in Clinical Development
• 8. Select Recombinant Proteins in Phase III Development

• 1. Evolving Pharmaceutical Market Segments Based on Technology, 2000-2012
• 2. Top-Selling Recombinant Protein Brands, 2007
• 3. Number of Recombinant Proteins in Clinical Development, 2007
• 4. Recombinant Proteins in Clinical Development by Therapeutic Category, 2007
• 5. Rho Kinase Pathway: The GTPase Molecular Switch
• 6. Sales of Five Amgen Brands, 2002-2013
• 7. Role of GLP-1 in Glucose Metabolism
• 8. Amgen Financial Analysis, 1988-2006

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