U.S. Ethical Drug Market: Strategies for Sustained Growth

TABLE OF CONTENTS

INTRODUCTION

• STUDY GOAL AND OBJECTIVES
• REASONS FOR DOING THE STUDY
• CONTRIBUTIONS OF THE STUDY AND FOR WHOM
• SCOPE AND FORMAT
• METHODOLOGY
• INFORMATION SOURCES
• AUTHOR'S CREDENTIALS
• RELATED BCC WORK CREDENTIALS
• BCC ON-LINE SERVICES
  • INTERNET

• REPORT HIGHLIGHTS
• Summary Table:
  THE U.S. DRUG MARKET AND REVENUE CONTRIBUTIONS FROM EMERGING AND UPDATED STRATEGIC, THROUGH 2008 ($ BILLIONS)
• Summary Figure:
  PERCENTAGE SHARE OF EMERGING MARKETING STRATEGIES, 2003 AND 2008 (%)

• THE U.S. DRUG MARKET
• MARKET COMPONENTS
• SALES TRENDS
  • SALES TRENDS (CONTINUED)
• Figure 1 TRENDS IN ETHICAL, GENERIC AND OTC PHARMACEUTICAL DRUG SALES, 2003-2008 ($ BILLIONS)
  • DRIVING FORCES OF THE DRUG MARKET
    • SCIENTIFIC ADVANCES
    • Biotechnology Drugs
    • Recombinant DNA Technology
    • Hybridoma Cell Technology
    • Steps Involved in Producing Biotechnology Drugs
    • Transgenic Animals for Protein Drug Production
    • Microorganism or Hybridoma Production
    • Recently Developed Biotechnology Drugs
• Table 1 SELECTED LISTING OF RECENTLY DEVELOPED BIOTECHNOLOGY DRUGS
  • MARKET DEMAND
  • Aging Population
  • DRUG DEVELOPMENT TIME
  • FDA Actions to Reduce Drug Approval Time
  • PATENTS
• Figure 2 WORLDWIDE POPULATION PROFILE, RELATIVE PERCENTAGES, 2003 AND 2008 (%)

• Figure 3 RELATIVE SHARE U.S. DOMESTIC PHARMACEUTICAL MARKET, 2003 AND 2008 ($ BILLIONS)
• Figure 3 (CONTINUED)
  • ETHICAL DRUGS
• Table 2 AVERAGE NUMBER OF DETAILING VISITS WITH PHYSICIANS PER YEAR, 1996-2003
  • SUSTAINING GROWTH THROUGH R&D
• Figure 4 R&D EXPENDITURES LEADING PHARMACEUTICAL COMPANIES, 2002 ($ BILLIONS)
  • ETHICAL DRUG APPLICATION APPROVALS
  • Fast Track Approval
• Table 3 ETHICAL DRUG APPROVALS THROUGH NOVEMBER 2003
• Table 3 (CONTINUED)
  • GENERIC DRUGS
• Table 4 U.S. PRESCRIPTION DRUGS SALES, 2003
  • GENERIC DRUG APPROVAL PROCESS
  • BRANDED GENERICS
  • Exploiting 505(b)(2)
• Table 5 BRANDED GENERIC DRUG U.S. SALES, THROUGH 2008 ($ BILLIONS)
  • OVER-THE-COUNTER DRUGS (OTC)
    • OTC DRUGS COVERED BY HEALTH CARE FLEXIBLE SPENDING ACCOUNTS
    • OTC Drugs Covered by Health Care Flexible Spending Accounts (Continued)

• OFF-LABEL USE OF DRUGS
• DEVELOPING NEW INDICATIONS FOR ALREADY APPROVED DRUGS
• RECLASSIFICATION OF PRESCRIPTION DRUGS TO OVER-THE-COUNTER (OTC) STATUS
• OVER-LAPPING PATENTS
• ADVERTISING & PROMOTION
• DISTRIBUTION METHODS
• PRICING
  • PRESCRIPTION ACCESS LITIGATION (PAL)
  • Prescription Access Litigation (Continued)

• ACTIONS OF GENERIC DRUG COMPANIES
• COUNTERFEIT DRUGS
  • POTENTIAL ANTI-COUNTERFEITING REGULATIONS
• GOVERNMENT REGULATIONS
  • HATCH-WAXMAN ACT
  • OFFICE OF THE INSPECTOR GENERAL (OIG)
  • STATE LIMITS FOR MEDICAID PRESCRIBING
  • PROPOSED MEDICARE PRESCRIPTION BENEFITS
• IMPACT OF INCREASING COST OF DRUGS
• Table 6 AVERAGE ANNUAL RATE INCREASE IN PRESCRIPTION DRUG EXPENDITURES (%)
  • INCREASED COST TO THE ELDERLY
  • INCREASES IN CO-PAYMENTS
  • COMPETITION
  • PATENT EXPIRATIONS
    • CURRENT PATENT EXPIRATION STATUS
• Table 7 TOP SELLING DRUGS WITH PATENT EXPIRATION BETWEEN 2003 AND 2008
• Table 7 (CONTINUED)
  • IMPACT OF FORMULARIES
  • STATE DISCOUNT PROGRAMS
  • OTHER PHARMACEUTICAL BENEFITS PROGRAMS
  • IMPORTATION OF DRUGS FROM CANADA AND MEXICO
    • CANADIAN INTERNET RX SALES TO U.S. PROJECTED TO GROW
• Table 8 COMPARISON OF U.S. AND CANADIAN PRICES FOR SELECTED PRESCRIPTION DRUGS ($ U.S.)
  • DRUGS FROM MEXICO

• PRODUCT LIFE CYCLES
• REVENUE CONTRIBUTION FROM EACH STRATEGY
• Table 9 REVENUE CONTRIBUTION TO U.S. DRUG SLAES FROM MARKETING STRATEGIES FOR SUSTAINED GROWTH, THROUGH 2008
• Figure 5 REVENUE CONTRIBUTION FROM MARKETING STRATEGIES FOR SUSTAINED GROWTH, 2003 AND 2008 (%)
• Figure 5 (CONTINUED)
  • NEW INDICATIONS FOR APPROVED DRUGS
    • CONTINUING TESTING AFTER A NEW DRUG IS APPROVED
    • RECENTLY APPROVED NEW DRUG INDICATIONS
• Table 10 RECENT NEW DRUG INDICATIONS, 2003
  • CHIRAL DRUG DEVELOPMENT
• Table 11 REVENUE CONTRIBUTION FROM CHIRAL DRUG DEVELOPMENT, THROUGH 2008 ($ BILLIONS)
  • RECENT EXAMPLES OF RACEMATIC PRODUCT LIFE EXTENSIONS
  • IMPROVED CHEMICAL ENTITIES (ICES)
  • COMBINATION DRUGS
• Table 12 REVENUE CONTRIBUTION FROM COMBINATION DRUG DEVELOPMENT, THROUGH 2008 ($ MILLIONS)
  • OFF-LABEL DRUG USE
    • MOVEMENT TOWARD OFF-LABEL USE
• Table 13 ESTIMATED PERCENTAGE OF OFF-LABEL DRUG USE BY PATIENT TYPE (%)
• Table 14 REVENUE CONTRIBUTION FROM OFF-LABEL DRUG USE, THROUGH 2008 ($ BILLIONS)
  • MEASURING PATIENT-REPORTED OUTCOMES (PROS)
  • MEDICAID REIMBURSEMENT STANDARDS FOR OFF-LABEL DRUG USE
  • OTHER PUBLICATIONS FOR OFF-LABEL DRUG USE
  • ARGUMENTS AGAINST OFF-LABEL DRUG USE
  • Fenfluramine and Phentermine (Fen-Phen)
  • Encainide and Flecainide
  • RX TO OTC SWITCHES
• Table 15 REVENUE CONTRIBUTION FROM RX TO OTC SWITCHES, THROUGH 2008 ($ BILLIONS)
  • RECLASSIFICATION OF ETHICAL DRUGS TO OTC
• Table 16 PERCENTAGE OF U.S. DRUG SALES FROM RX TO OTC SWITCHES (%)
  • RECENTLY APPROVED RX TO OTC SWITCHED DRUGS
• Figure 6 NUMBER OF RECENTLY APPROVED RX TO OTC SWITCHES
  • RX TO OTC APPROVAL
  • DRUGS SUCCESSFULLY SWITCHED
• Table 17 SELECTED LIST OF PHARMACEUTICAL DRUGS SUCCESSFULLY SWITCHED TO OTC STATUS
  • THIRD PARTIES PETITIONING FDA FOR RX TO OTC SWITCHES
  • Challenge from National Consumers League
  • Probable Future Switches
  • Emergency Contraception Drugs
  • Plan B
  • Preven
  • Asthma Treatments
  • PATENT PROTECTION/EXTENSION EFFORTS
• Table 18 2008 SALES PROJECTIONS FOR DRUGS WITH PATENT EXPIRATION BETWEEN 2003 AND 2008 ($ MILLIONS)
• Table 19 REVENUE CONTRIBUTION FROM MULTIPLE PATENT/EXTENSION EFFORTS, THROUGH 2008 ($ BILLIONS)
  • FILING MULTIPLE PATENT APPPLICATIONS FOR SAME DRUG
• Table 20 SELECTED LIST OF PATENTS EXPIRATIONS*
• Table 21 MULTIPLE PATENT ANALYSIS-SELECTED BLOCKBUSTER DRUGS
  • LEGAL MANUEVERING TO PREVENT GENERIC COMPETITION
  • Patent Infringement Suits Under Attack
  • Multiple Patent Protection Strategy Challenged
  • ENTERING INTO MARKETING ALLIANCES
  • PAYING FOR DRUG USE/EVALUATION
• Table 22 ANNUAL EXPENDITURES BY PHARMACEUTICAL COMPANIES FOR PAYMENT INCENTIVES TO DOCTORS, THROUGH 2008 ($ BILLIONS)
  • ESTIMATED VALUE OF PAYMENT INCENTIVES TO DOCTORS
• Table 23 REVENUE FROM PAYMENT INCENTIVES TO DOCTORS, THROUGH 2008 ($ BILLIONS)
  • EFFORTS TO LIMIT PAYMENTS AND GIFTS
  • PROVIDING DOCTORS WITH DISCOUNTS FOR DRUGS
  • DRUG REBATES
  • TACTICS TO BOOST OFF-LABEL USE
  • ADVERTISING AND PROMOTION STRATEGIES
• Table 24 PROMOTIONAL EXPENDITURES FOR ETHICAL DRUGS MARKETING, THROUGH 2008 ($ BILLIONS)
  • DIRECT TO CONSUMER ADVERTISING
  • Volume of Direct-to-Consumer Advertising
• Table 25 TRENDS IN DTC ADVERTISING EXPENDITURES, THROUGH 2008 ($ BILLIONS)
  • Revenue Contribution from DTC Advertising
• Table 26 ESTIMATED REVENUE CONTRIBUTION FROM DTC ADVERTISING, THROUGH 2008 ($ BILLIONS)
  • FDA DTC Guidelines
  • PRE-APPROVAL ADVERTISING
  • DETAILING STRATEGIES
    • ELECTRONIC (INTERNET) DETAILING
• Table 27 SELECTED LISTING OF PHARMACEUTICAL COMPANIES USING e-DETAILING
  • Suppliers of e-detailing Services
  • RxCentric Incorporated
  • PharmiWeb
  • Lathian Systems Incorporated
  • Revenue Contribution of E-Detailing
  • BLITZ DETAILING
  • PRICING PRACTICES
    • OIG COMPLIANCE PROGRAM GUIDANCE
    • OIG Compliance Program Guidance (Continued)
    • Revenue Contribution from Pricing Strategies

• Table 28 STRATEGIES FOR SUSTAINED GROWTH USED BY TOP TEN U.S. ETHICAL DRUG COMPANIES
  • LEADING PRESCRIPTION DRUG COMPANIES
• Table 29 PHARMACEUTICAL SALES VOLUME TOP TEN COMPANIES, 2002 ($ BILLIONS)
• Table 30 TOP TEN PHARMACEUTICL COMPANIES SALES AS PERCENTAGE OF WORLDWIDE SALES, 2002
• Figure 7 TOP TEN PHARMACEUTICL COMPANIES SALES AS PERCENTAGE OF WORLDWIDE SALES, 2002
  • PFIZER INC.
• Table 31 PFIZER'S MAJOR DRUGS
  • Pfizer Inc. (Continued)
  • GLAXOSMITHKLINE
• Table 32 SELECTED LISTING GLAXOSMITHKLINE CONSUMER HEALTH PRODUCTS
  • MERCK & COMPANY, INC.
• Table 33 MERCK REVENUE BY THERAPEUTIC SEGMENT, 2002 ($ BILLIONS)
  • ASTRAZENECA PLC
  • AstraZeneca Pharmaceuticals LP
• Table 34 MAJOR PRODUCTS, ASTRAZENECA
  • AVENTIS SA
  • Aventis Pharmaceuticals Inc.
  • JOHNSON & JOHNSON
  • Johnson & Johnson (Continued)
• Table 35 J&J's LEADING DRUGS
  • ALZA CORPORATION
  • ORTHO-MCNEIL
• Table 36 ORTHO-MCNEIL SELECTED PRODUCT LISTING
  • CENTOCOR, INC.
  • JANSSEN PHARMACEUTICALS
  • NOVARTIS INTERNATIONAL AG
  • Novartis Corporation
• Table 37 NOVARTIS' LEADING PRODUCTS
  • BRISTOL-MYERS SQUIBB COMPANY
  • WYETH
• Table 38 WYETH'S LEADING PRODUCTS
  • ELI LILLY AND COMPANY
  • LEADING BIOTECHNOLOGY DRUG COMPANIES
    • AMGEN INC.
• Table 39 AMGEN'S PRODUCT LINE
  • GENENTECH, INC.
  • Oncology
  • Immunological Disease
  • Vascular Medicine
  • SERONO INTERNATIONAL S.A.
  • Serono, Inc.
  • CHIRON
  • LEADING GENERIC DRUG COMPANIES
    • MYLAN LABORATORIES INCORPORATED
    • BARR LABORATORIES
    • ALPHARMA INCORPORATED
    • PHARMACEUTICAL RESOURCES
    • DR. REDDY'S LABORATORIES LIMITED

• RECENT GENERIC DRUG APPROVALS
  • RECENT GENERIC DRUG APPROVALS (CONTINUED)
  • RECENT GENERIC DRUG APPROVALS (CONTINUED)
  • RECENT GENERIC DRUG APPROVALS (CONTINUED)
  • RECENT GENERIC DRUG APPROVALS (CONTINUED)
  • RECENT GENERIC DRUG APPROVALS (CONTINUED)
  • RECENT GENERIC DRUG APPROVALS (CONTINUED)

LIST OF TABLES

Summary Table:
THE U.S. DRUG MARKET AND REVENUE CONTRIBUTIONS FROM EMERGING AND UPDATED STRATEGIC, THROUGH 2008 ($ BILLIONS)

Table 1 SELECTED LISTING OF RECENTLY DEVELOPED BIOTECHNOLOGY DRUGS

Table 2 AVERAGE NUMBER OF DETAILING VISITS WITH PHYSICIANS PER YEAR, 1996-2003

Table 3 ETHICAL DRUG APPROVALS THROUGH NOVEMBER 2003

Table 4 U.S. PRESCRIPTION DRUGS SALES, 2003

Table 5 BRANDED GENERIC DRUG U.S. SALES, THROUGH 2008 ($ BILLIONS)

Table 6 AVERAGE ANNUAL RATE INCREASE IN PRESCRIPTION DRUG EXPENDITURES (%)

Table 7 TOP SELLING DRUGS WITH PATENT EXPIRATION BETWEEN 2003 AND 2008

Table 8 COMPARISON OF U.S. AND CANADIAN PRICES FOR SELECTED PRESCRIPTION DRUGS ($ U.S.)

Table 9 REVENUE CONTRIBUTION TO U.S. DRUG SLAES FROM MARKETING STRATEGIES FOR SUSTAINED GROWTH, THROUGH 2008

Table 10 RECENT NEW DRUG INDICATIONS, 2003

Table 11 REVENUE CONTRIBUTION FROM CHIRAL DRUG DEVELOPMENT, THROUGH 2008 ($ BILLIONS)

Table 12 REVENUE CONTRIBUTION FROM COMBINATION DRUG DEVELOPMENT, THROUGH 2008 ($ MILLIONS)

Table 13 ESTIMATED PERCENTAGE OF OFF-LABEL DRUG USE BY PATIENT TYPE (%)

Table 14 REVENUE CONTRIBUTION FROM OFF-LABEL DRUG USE, THROUGH 2008 ($ BILLIONS)

Table 15 REVENUE CONTRIBUTION FROM RX TO OTC SWITCHES, THROUGH 2008 ($ BILLIONS)

Table 16 PERCENTAGE OF U.S. DRUG SALES FROM RX TO OTC SWITCHES (%)

Table 17 SELECTED LIST OF PHARMACEUTICAL DRUGS SUCCESSFULLY SWITCHED TO OTC STATUS

Table 18 2008 SALES PROJECTIONS FOR DRUGS WITH PATENT EXPIRATION BETWEEN 2003 AND 2008 ($ MILLIONS)

Table 19 REVENUE CONTRIBUTION FROM MULTIPLE PATENT/EXTENSION EFFORTS, THROUGH 2008 ($ BILLIONS)

Table 20 SELECTED LIST OF PATENTS EXPIRATIONS*

Table 21 MULTIPLE PATENT ANALYSIS-SELECTED BLOCKBUSTER DRUGS

Table 22 ANNUAL EXPENDITURES BY PHARMACEUTICAL COMPANIES FOR PAYMENT INCENTIVES TO DOCTORS, THROUGH 2008 ($ BILLIONS)

Table 23 REVENUE FROM PAYMENT INCENTIVES TO DOCTORS, THROUGH 2008 ($ BILLIONS)

Table 24 PROMOTIONAL EXPENDITURES FOR ETHICAL DRUGS MARKETING, THROUGH 2008 ($ BILLIONS)

Table 25 TRENDS IN DTC ADVERTISING EXPENDITURES, THROUGH 2008 ($ BILLIONS)

Table 26 ESTIMATED REVENUE CONTRIBUTION FROM DTC ADVERTISING, THROUGH 2008 ($ BILLIONS)

Table 27 SELECTED LISTING OF PHARMACEUTICAL COMPANIES USING e-DETAILING

Table 28 STRATEGIES FOR SUSTAINED GROWTH USED BY TOP TEN U.S. ETHICAL DRUG COMPANIES

Table 29 PHARMACEUTICAL SALES VOLUME TOP TEN COMPANIES, 2002 ($ BILLIONS)

Table 30 TOP TEN PHARMACEUTICL COMPANIES SALES AS PERCENTAGE OF WORLDWIDE SALES, 2002

Table 31 PFIZER'S MAJOR DRUGS

Table 32 SELECTED LISTING GLAXOSMITHKLINE CONSUMER HEALTH PRODUCTS

Table 33 MERCK REVENUE BY THERAPEUTIC SEGMENT, 2002 ($ BILLIONS)

Table 34 MAJOR PRODUCTS, ASTRAZENECA

Table 35 J&J's LEADING DRUGS

Table 36 ORTHO-MCNEIL SELECTED PRODUCT LISTING

Table 37 NOVARTIS' LEADING PRODUCTS

Table 38 WYETH'S LEADING PRODUCTS

Table 39 AMGEN'S PRODUCT LINE  

LIST OF FIGURES

Summary Figure:
PERCENTAGE SHARE OF EMERGING MARKETING STRATEGIES, 2003 AND 2008 (%)

Figure 1 TRENDS IN ETHICAL, GENERIC AND OTC PHARMACEUTICAL DRUG SALES, 2003-2008 ($ BILLIONS)

Figure 2 WORLDWIDE POPULATION PROFILE, RELATIVE PERCENTAGES, 2003 AND 2008 (%)

Figure 3 RELATIVE SHARE U.S. DOMESTIC PHARMACEUTICAL MARKET, 2003 AND 2008 ($ BILLIONS)

Figure 4 R&D EXPENDITURES LEADING PHARMACEUTICAL COMPANIES, 2002 ($ BILLIONS)

Figure 5 REVENUE CONTRIBUTION FROM MARKETING STRATEGIES FOR SUSTAINED GROWTH, 2003 AND 2008 (%)

Figure 6 NUMBER OF RECENTLY APPROVED RX TO OTC SWITCHES

Figure 7 TOP TEN PHARMACEUTICL COMPANIES SALES AS PERCENTAGE OF WORLDWIDE SALES, 2002