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The Impact of the Phase III Pipeline: Future Projections and Market Disruptions

There are hundreds of drugs in Phase III clinical trials, of which almost 200 of them may gain market approval from the FDA in the coming 5 years. Which drugs will make it and how these drugs impact existing pharmaceutical markets in terms of overall size and competitive share is one of the most difficult forecasting projects in market research.

In this nearly 500-page analysis, Kalorama Information has compiled all the relevant information about the candidates, their value, and their likely impact. And we've made some predictions and estimates of the changing market scenarios in five therapeutic areas.

In particular, this report examines over 500 drugs in Phase III clinical trials and how these new products are expected to perform and affect existing markets. The report looks at five therapeutic categories:

  • Cardiovascular disease,
  • Neuropsychotherapeutic disorders,
  • Infectious disease,
  • Cancer, and
  • Others.

Market opportunity revenues are provided in each segment for approvals anticipated from 2006 to 2010 with specific information related to likely 2006 approvals. For each segment, the report includes an

  • Overview,
  • Descriptions of products in phase III development,
  • Number of approvals expected each year through 2010 by indication within the segment,
  • Market forecasts for those likely to be approved,
  • Which major brands and marketers who are currently active the segment will be affected by these likely new entrants, and
  • What share of the segments these new drugs are likely to take.

This report is the only analysis of its kind available in syndicated form and contains vital intelligence for strategic planners within the industry and analysts and investors interested in the competitive dynamics in the years ahead.


  • Executive Summary
    • SCOPE AND METHODOLOGY
    • POTENTIAL MARKET OPPORTUNITY
      • Table Number of Phase III Products, Number of Anticipated Approvals through 2010, and Potential Market Opportunity by Therapeutic Area
    • ISSUES AND TRENDS AFFECTING MARKET
    • LEADING COMPETITORS
  • Introduction Drugs in Phase III Development
    • INTRODUCTION
    • DRUG D ELOPMENT OVERVIEW
      • Phases of Drug Development
        • Table Phases of Clinical Drug Development
      • Benefits and Risks of Phase III Development
      • Randomization
      • Clinical Trial Protocol
    • ORPHAN DRUGS
    • FAST TRACK DRUG STATUS
    • BIOTECHNOLOGY DRUG DEVELOPMENT
    • MERGERS, ACQUISITIONS, AND COLLABORATIONS
    • CONTRIBUTORS TO R&D SUCCESS
    • R&D SPENDING
      • Contract Research Organizations
  • Cardiovascular Drugs: Phase III Development Analysis
    • OVERVIEW
      • Heart
      • Circulatory System
      • Cardiac Cycle
      • Coronary Circulation
      • Cardiac Myocytes
      • Contraction
      • Cardiac Energy Metabolism
      • Cardiac Output
      • Conditions
      • Incidence of Conditions
        • Table Estimated World Prevalence, Incidence and Mortality of Selected Cardiovascular Conditions and Diseases
    • PRODUCTS IN DEVELOPMENT
      • Table Cardiovascular Drugs in Development
      • Table Number of Cardiovascular Drugs in Phase III Development and Potential Approvals through 2010 by Indication
      • Table Anticipated Cardiovascular Drug Approvals by Year 2006-2010
    • MARKET SIZE AND GROWTH
      • Table Potential Market Opportunity for Cardiovascular Drugs in Late Stage Development, 2006-2010
      • Table Potential Market Opportunity for Cardiovascular Drugs in Late Stage Development by Indication, 2006-2010
    • COMPETITIVE ANALYSIS
      • Table Competitive Analysis of Cardiovascular Drug Development Anticipated Peak Sales Performance of Drugs withAnticipated 2006 Approvals
      • Table Competitive Impact: Cardiovascular Drug Development (Potential Competitor Impact vs. Current Market Leaders)
  • Neuropsychotherapeutic Drugs: Phase III Development Analysis
    • OVERVIEW
      • Structural Organization of the Neurological System
    • TYPES OF NEUROPSYCHOTHERAPEUTIC DISEASES AND DISORDERS
      • Table Classification of Neurologic Conditions and Diseases by Segment
      • Alzheimer's Disease and Dementia
      • Traumatic Brain Injury
      • Cerebrovascular Disease and Stroke
      • Cerebral Palsy
      • Parkinson's Disease
      • Huntington's Disease
      • Myasthenia Gravis
      • Tic and Tourette's Syndrome
      • Periodic Limb Movement Disorder and Restless Leg Syndrome
      • Seizures
      • Multiple Sclerosis
      • Amyotrophic Lateral Sclerosis
      • Spinal Cord Injury
      • Guillian-Barre Syndrome
      • Bell's Palsy
      • Anxiety Disorders
      • Attention Deficit Hyperactivity Disorder
      • Bipolar Disorder
      • Borderline Personality Disorder
      • Depression
      • Eating Disorders
      • Obsessive-Compulsive Disorder
      • Schizophrenia
      • Sleep Disorders
      • Substance Abuse
      • Incidence of Conditions
        • Table Estimated World Prevalence, Incidence and Mortality of Selected Neurological Conditions and Diseases
    • PRODUCTS IN DEVELOPMENT
      • Table Neurological Drugs in Development
      • Table N r of Neurolog l Drug Phase Develo nt an Potential Approvals through 2010 by Indication
      • Table Anticipated Neurological Drug Approvals by Indication and Year 2006-2010
    • MARKET SIZE AND GROWTH
      • Table Potential Market Opportunity for Neurological Drugs in Late Stage Development, 2006-2010
      • Table Potential Market Opportunity for Neurological Drugs in Late Stage Development by Indication, 2006-2010
    • COMPETITIVE ANALYSIS
      • Table Competitive Analysis of Neurological Drug Development Anticipated Peak Sales Performance of Drugs with Anticipated 2006 Approvals
      • Table Competitive Impact: Neurological Drug Development (Potential Competitor Impact vs. Current Market Leaders)
  • Infectious Disease: Phase III Development Analysis
    • OVERVIEW
    • CONDITIONS
      • Fungi
        • Table Fungal Infections: Sources and Traditional Treatments
      • Viruses
      • Hepatitis
      • Herpes Simplex
      • Epstein-Barr Virus (Mononucleosis)
      • Influenza
      • Other Significant Viruses
      • Incidence of Conditions
        • Table Estimated World Prevalence, Incidence and Mortality of Selected Infectious Disease and Conditions
    • PRODUCTDS IN EVELOPMENT
      • Table Infectious Diseases Therapies in Development
      • Table Number of Infectious Disease Therapies in Phase III Development and Potential Approvals through 2010 by Indication
      • Table Anticipated Infectious Disease Product Approvalsby Indication and Year 2006-2010
    • MARKET SIZE AND GROWTH
      • Table Potential Market Opportunity for InfectiousDiseaseDrugs inLate Stage Development, 2006-2010
      • Table Potential Market Opportunity for Infectious Disease Drugs in Late Stage Development by Indication, 2006-2010
    • COMPETITIVE ANALYSIS
      • Table Competitive Analysis of InfectiousDiseaseProductDevelopment Anticipated Peak Sales Performance of Drugs with Anticipated 2006 Approvals
      • Table Competitive Impact: Infectious Disease Drug Development (Potential Competitor Impact vs. Current Market Leaders)
  • Cancer Drugs: Phase III Development Analysis
    • OVERVIEW
      • Biochemistry of Cancer Cells
      • Carcinogen Metabolism
      • Causes of Cancer Growth
        • Table Viruses Associated with Cancer in Humans
      • Types of Cancer
        • Table Types of Leukemia, Incidence, Characteristics, Manifestations
        • Table Types of Primary Lung Cancer,Risk Factors, Frequency
        • Table Classification of Non-Hodgkin’s Lymphomas
        • Table Malignant Conditions of the Skin
      • Incidence of Conditions
        • Table Estimated World Incidence and Mortality of Selected Cancers (thousands)
    • PRODUCTS IN DEVELOPMENT
      • Table Cancer Drugs in Development
      • Table Adjunctive Cancer Drugs in Development
      • Table Number of Cancer Drugs in Phase III Development and Potential Approvals through 2010 by Cancer Type
      • Table Anticipated Cancer Drug Approvals by Cancer Type/Indication and Year 2006-2010
    • MARKET SIZE AND GROWTH
      • Table Potential Market Opportunity for Cancer Drugs in Late Stage Development, 2006-2010
      • Table Potential Market Opportunity for Cancer Drugs in Late Stage Development by Indication, 2006-2010
    • COMPETITIVE ANALYSIS
      • Table Competitive Analysis of Cancer Drug Development Anticipated Peak Sales Performance of Drugs with Anticipated 2006 Approvals
      • Table Competitive Impact: Cancer Drug Development (Potential Competitor Impact vs. Current Market Leaders)
  • Other Drugs: Phase III Development Analysis
    • OVERVIEW
    • CONDITIONS
      • Types of Conditions, Diseases and Disorders
        • Table Other Conditions and Diseases by Segment
      • Incidence of Conditions
        • Table Estimated World Prevalence, Incidence and Mortality of Selected Conditions and Diseases
    • PRODUCTS IN DEVELOPMENT
      • Table Other Drugs in Development
      • Table Number of Other Drugs in Phase III Development and Potential Approvals through 2010 by Major Therapy Area
      • Table Anticipated Other Drug Approvals by Therapy Area and Year 2006-2010
    • MARKET SIZE AND GROWTH
      • Table Potential Market Opportunity for Other Drugs in Development, 2006-2010
      • Table Potential Market Opportunity for Other Drugs in Late Stage Development by Indication, 2006-2010
    • COMPETITIVE ANALYSIS
      • Table Competitive Analysis of Other Drugs in Development Anticipated Peak Sales Performance of Drugs with Anticipated 2006 Approvals
      • Table Competitive Impact: Other Drug Development (Potential Competitor Impact vs. Current Market Leaders)
  • Market Summary
    • OVERVIEW
    • POTENTIAL MARKET OPPORTUNITY
      • Table Number of Phase III Developments by Drug Type
      • Table Number of Phase III Products in Development by Company and Segment
  • Company Profiles
    • INTRODUCTION
    • ALZA CORPORATION
    • ASTRAZENECA, PLC
    • BRISTOL-MYERS SQUIBB COMPANY/ONCOLOGY
    • CEPHALON, INC.
    • CIMA LABS
    • COLLAGENEX PHARMACEUTICALS, INC.
    • CUBIST PHARMACEUTICALS, INC.
    • CV THERAPEUTICS, INC.
    • DOV PHARMACEUTICALS
    • ELI LILLY & COMPANY
    • FOREST LABORATORIES, INC.
    • GENENTECH, INC.
    • GLAXOSMITHKLINE
    • INSITE VISION
    • JOHNSON & JOHNSON
    • MERCK AND COMPANY, INC.
    • MGI PHARMA, INC.
    • NEUROCRINE BIOSCIENCES, INC.
    • NEW RIVER PHARMACEUTICALS
    • NOVARTIS PHARMACEUTICALS CORPORATION
    • PFIZER, INC.
    • POZEN
    • ROCHE
    • SANOFI-AVENTIS
    • SERONO INTERNATIONAL, S.A.
    • SHIRE CORPORATION
    • SIGMA-TAU PHARMACEUTICALS, INC.
    • THE MEDICINES COMPANY
    • TIBOTEC THERAPEUTICS
  • Company Directory

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