Worldwide Prescription Drug Market 2004
Global Trends, Market & BusinessTrends, Sales and Distribution

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Published by: Fuji-Keizai, USA and MRG, Inc.

Available in English or Japanese
November 2003, Pages: 133

Hard Copy Print Edition $998.00 USD
PDF Single-Departmental License $1,495.00 USD
PDF Corporate-Wide License $1,995.00 USD

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TABLE OF CONTENTS

1. Major Disease Populations in the Developed World
1.1 Disease Based Pharmaceutical Planning
1.2 The Size of Major Disease Populations
1.3 Relationship of 'Modern' Lifestyle to Health Risk Factors

2. Regulatory Issues By Disease: Drug Development & Sales
2.1 Government Drug Regulatory Organizations
2.2 The Basic Drug Development and Approval Processes
2.3 North America
2.3.1The FDA's Drug Review Steps
2.4 European Union (EU)
2.4.1 Overview of the Drug Approval Process in the European Union
2.4.2 Principle of 'Mutual Recognition'
2.4.3 The Centralized Drug Approval Procedure
2.4.4 Decentralized Drug Approval Procedure
2.5 Japan
2.5.1 Japan's Drug Approval Process
2.5.2 Approval Applications for Drugs Manufactured in Foreign Countries
2.5.3 Priority Review System
2.5.4 Orphan Drugs
2.6 Analysis of Regional Issues to Consider
2.6.1 North America
2.6.2 Europe
2.6.3 Japan

3. Current Drug Patent Expiration Date and New Drug Pipeline in Development By Disease
3.1 Near Term Drug Patent Expirations are making an Impact
3.2 Prescription Drug Development Pipeline for Mid-2003

4. Price, Cost & Distribution Structure
4.1 Price/Cost Structure
4.2 Distribution Structure and Case Study
4.2.1 Distribution Structure
4.2.2 Distribution Case Study

5. Strategic Alliances and M&As By Disease
5.1 Review of Recent Pharmaceutical Strategic Alliances and M&As
5.2 Review of Strategic Alliances and M&As by Disease
5.3 Summary: Strategic Alliances and M&As
5.4 About the Data Tables

6. WW Rx Drug Market Size and Forecast by Disease
6.1 Worldwide Prescription Drug Market Size
6.2 Selected WW human Drug Market Size by Disease and Revenues
6.2.1 Top Six Market Segments and Sub-Segments

7. Top Selling Rx Drugs by Revenue and Pharmaceutical Companies
7.1 The Top Selling 20 Rx Drugs and Companies
7.1.1 Top Selling 20 Rx Drugs by Disease Categories
7.1.2 Top Selling 20 Rx Drugs by Major Pharma Companies
7.2 Top Selling 276 Rx Drugs by Disease
7.2.1 Summary of Top Disease Categories by WW Revenues

8. Conclusions and Thoughts
8.1 Disease Demographics
8.1.1 Epidemiology Based Pharmaceutical Planning
8.1.2 Reviewing Patient Populations
8.1.3 Health Risk Factors Lead to Sickness & Death
8.2 Key Points about Global Regulators and Issues
8.2.1 Need for Government Drug Regulatory Approval
8.2.2 Regional Drug Development and Approval Processes
8.2.3 Regulatory Trends
8.3 Drug Patent Expiration Dates and New Drug Pipeline
8.3.1 Patent Expirations Looming to Cause Big Losses
8.3.2 Current Drug Development Pipeline is Inadequate
8.4 Price/Cost & Distribution Structures
8.4.1 Price/Cost Structure
8.4.2 Distribution Structure
8.5 Strategic Alliances and M&As
8.5.1 Alliance Deal Trends
8.6 Prescription Drug Market Size
8.7 Top Selling Rx Drugs and Companies
8.8 Final Thoughts

9. Appendix
9.1 Pharmaceutical Business Glossary
9.2 Contacts to Top 50 Pharma Companies
9.3 Links to Worldwide Drug Regulatory Organizations


LIST OF TABLES

Table 1. Summary of Patient Populations Sorted by New Patients
Table 2. Summary of Patient Populations Sorted by Total Existing Patients
Table 3. Estimated Patient Populations by Disease in the Developed World
Table 4. Top Health Risk Factors Leading to Death in the Developed World
Table 5. Relationship of Drug Regulation and Drug Development by Disease
Table 6. Review of Drug Patent Expirations by Disease Category
Table 7. Review of Drug Patent Expirations by Year
Table 8. Current Drug Patent Expiration Dates Sorted by Disease
Table 9. Drug Pipeline Summary by R&D Phase for 2003
Table 10. Drug Pipeline Summary by Disease for 2003
Table 11. Prescription Drugs in Late Stage Development by Disease (2003)
Table 12. Rx Drug Price/Cost Structure Tiers by Region
Table 13. US Pricing Example for Brand Name Prescription Drugs
Table 14. US Major Wholesale Drug Distributor Channel
Table 15. US Retail Pharmacy Channel Breakdown
Table 16. Major Pharmaceutical Distributors by International Region
Table 17. Summary: Pharma Strategic Alliances and M&As by Category
Table 18. Summary: Pharma Strategic Alliances and M&As by Disease
Table 19. Strategic Alliances and M&As by Disease, 2003
Table 20. Strategic Alliances and M&As by Disease, 2002
Table 21. Strategic Alliances and M&As by Disease, 2001
Table 22. Strategic Alliances and M&As by Disease, 2000
Table 23. Total Audited World Rx Drug Sales by Regions, 2002
Table 24. Estimated WW Rx Drug Sales by Regions, 2002E-2005E
Table 25. Top 10 Products in 2002 Worldwide Pharmaceutical Sales
Table 26. Estimated Top 276 Human Prescription Drug WW Market Size Sorted by Revenues ($M) and Disease Segments (Summary), 2002-2005E
Table 27. Top 276 Human Prescription Drug WW Market Size Sorted by CAGR and Disease Segments (Summary), 2002-2005E
Table 28. Top 276 Human Prescription Drug WW Market Size by Disease Breakdown (Detail) ($M) 2002-2005E
Table 29. Top Selling 20 Rx Drugs by WW Revenues 2002 ($M)
Table 30. Summary: Top Disease Categories by WW Revenues (2002)
Table 31. Definition of Disease Categories Used in this Section
Table 32. Rx Drugs Sorted by Disease Indication and WW Revenues


LIST OF ILLUSTRATIONS

Figure 1. Drug Development and Approval Process
Figure 2. USA FDA New Drug Approval Process Flowchart
Figure 3. EU Centralized Drug Approval Procedure Flowchart
Figure 4. EU Decentralized New Drug Approval Procedure Flowchart
Figure 5. Japan MHLW New Drug Approval Procedure
Figure 6. An Rx Drug Distribution Structure
Figure 7. Summary: Pharma Strategic Alliances and M&As by Category
Figure 8. Summary: Selected M&As by Valuation ($M)
Figure 9. Summary: Pharma Strategic Alliances and M&As by Disease
Figure 10. Estimated Top 276 Human Prescription Drug WW Market Size by Revenues ($M) and Disease Segments, 2002E-2005E
Figure 11. Comparison of Disease Segment Market Shares for the Selected WW Human Prescription Drug Market, 2002 and 2005
Figure 12. Estimated Market Size by the 'Cardiovascular' Segment Revenues, 2002-2005
Figure 13. Estimated Market Size by 'CNS' Segment Revenues, 2002-2005
Figure 14. Estimated Market Size by 'Infections' Sub-Segment Revenues, 2002-2005
Figure 15. Estimated Market Size by 'Respiratory & Allergy' Sub-Segment Revenues, 2002-2005
Figure 16. Estimated Market Size by the 'Gastrointestinal' Sub-Segment Revenues, 2002-2005
Figure 17. Estimated Market Size by the 'Cancer' Sub-Segment Revenues, 2002-2005


Target Diseases

Major Disease	Disease Breakdown
Cancer	Colorectal cancer, Breast cancer, Lung/airway cancers, Prostate cancer, Bladder cancer, Lymphomas, Multiple myeloma, Stomach cancer, Melanoma and other skin cancers, Uterine cancer, Pancreas cancer, Leukemia, Liver cancer, Ovarian cancer, Mouth and throat cancers, Esophagus cancer, Cervical cancer
Cardiovascular	Ischemic heart disease (angina heart attack), Cerebrovascular disease (stroke), Other cardiovascular diseases, Hypertensive heart disease (angina, CHD), Inflammatory heart disease (from Infection)
Central Nervous System (CNS)	Migraine, Depressive disorders, Alcohol use disorders, Alzheimer and other dementias, Insomnia (primary), Drug use disorders, Epilepsy, Bipolar disorder, Schizophrenia, Panic disorder, Obsessive-compulsive disorder, Post-traumatic stress disorder, Parkinson disease, Multiple sclerosis
Gastro-Intestinal	Misc. digestive diseases, GERD, etc, Peptic ulcer disease, Cirrhosis of the liver, Appendicitis
Infections	Tuberculosis, STDs excluding HIV, Chlamydia, Gonorrhea, Syphilis, HIV/AIDS, Diarrheal diseases, Childhood diseases, Pertussis, Measles, Tetanus, Poliomyelitis, Diphtheria, Meningitis, Streptococcus pneumoniae, Meningococcemia without, Hemophilus influenzae, Hepatitis B, Hepatitis C, Malaria, Lower respiratory infections including Influenza, pneumonia, or others
Metabolic	Diabetes
Musculo-skeletal	Osteoarthritis, Rheumatoid arthritis
Respiratory	Asthma, Chronic obstructive pulmonary disease
Skin	Skin diseases
Urogenital	Benign prostatic hypertrophy, Renal failure

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