Bulk Pharmaceutical Actives

TABLE OF CONTENTS

INTRODUCTION

• OBJECTIVES AND GOALS OF STUDY
• REASONS FOR STUDY AND ITS CONTRIBUTION
• SCOPE AND CONTENT OF STUDY
• AUDIENCE FOR THE STUDY
• STUDY METHODOLOGY AND INFORMATION SOURCES
• RELATED BCC WORK CREDENTIALS
• RELATED BCC PUBLICATIONS
• BCC ON-LINE SERVICES

SUMMARY

• MAJOR FINDINGS:

OVERVIEW

• WHY BULK PHARMACEUTICAL ACTIVES ARE IMPORTANT
• WORLDWIDE FORMULATED DRUG SALES
• CURRENT STATE OF THE WORLDWIDE DRUG INDUSTRY
  • TOP PHARMACEUTICAL COMPANIES
  • TRENDS WITHIN THE WORLDWIDE DRUG INDUSTRY
  • VIRTUAL PHARMACEUTICAL COMPANIES
  • TRENDS IN VARIOUS DRUG CATEGORIES
  • INTERNET IMPACT ON PURCHASING BY WHOLESALERS AND SUPPLY COMPANIES
  • MARKET FORECASTS
  • GEOGRAPHIC SHARES OF FORMULATED DRUG SALES

• The Changing U.S. Pharmaceutical Market
  • The Impact of Health Maintenance Organizations (HMOs)

• SHORTAGES OF DRUGS AND DRUG COMPONENTS
• HISTORY OF PHARMACEUTICAL ACTIVES
• NUMBERS OF PHARMACEUTICAL ACTIVES
• BULK ACTIVES VALUE AS A PERCENT OF DRUG SALES
  • RULES OF THUMB
  • ESTIMATED VALUE OF BULK ACTIVES

• MAJOR BULK PHARMACEUTICAL ACTIVES MARKET
• MAJOR PRESCRIPTION BULK ACTIVES
  • OMEPRAZOLE
  • ERYTHROPOIETIN ALFA
  • FLUOXETINE
  • LORATADINE
  • ATORVASTATIN
  • LANSOPRAZOLE
  • ETHINYL ESTRIADIOL
  • SIMVASTATIN
  • SERTALINE
  • CONJUGATED ESTROGENIC SUBSTANCES

• MAJOR OTC ACTIVES
  • ACETAMINOPHEN
  • ASPIRIN
  • VITAMIN C
  • CALCIUM CARBONATE
  • VITAMIN E
  • IBUPROFEN
  • RANITIDINE
  • FERROUS SULFATE
  • CIMETIDINE
  • NIACINAMIDE

• MAJOR PRODUCT CATEGORIES
• PHARMACEUTICAL ACTIVES AS FINE CHEMICALS

THE BULK PHARMACEUTICAL ACTIVES INDUSTRY

• INDUSTRY STRUCTURE OVERVIEW
• GLOBAL NATURE OF THE INDUSTRY
• RAW MATERIALS AND INTERMEDIATES SUPPLIERS
• CRUDE AND VALUE-ADDED BULK PHARMA PRODUCTION
• CAPTIVE, MERCHANT AND TOLL BULK PRODUCTION
  • CHANGING MARKET DYNAMICS
  • A MOVE TOWARDS OUTSOURCING
  • Captive, Merchant and Toll Shares of Bulk Production
  • TYPES OF BULK PRODUCERS
  • Captive Producers
  • Merchant Producers
  • Toll Producers

• BULK PHARMA DISTRIBUTION CHANNELS
• DRUG FORMULATORS
• NONMEDICAL MARKETS FOR BULK PHARMACEUTICALS
• REGULATIONS
  • DRUG MASTER FILES
  • Good Manufacturing Practices (GMP) Requirements
  • INTERNATIONAL STANDARDS (ISO) CERTIFICATION

• PATENTS
• INTERNATIONAL ASPECTS OF THE INDUSTRY
  • GEOGRAPHIC DISTRIBUTION OF BULK PRODUCTION
  • GEOGRAPHIC DISTRIBUTION OF BULK CONSUMPTION
  • INTERNATIONAL INDUSTRY STRUCTURE
  • Multinational Production of Bulk Actives
  • Mergers With Bulk Active Companies in Other Countries
  • International Joint Ventures
  • INTERNATIONAL BULK PRODUCERS
  • United States
  • Brazil
  • China
  • Germany
  • India
  • Ireland
  • Italy
  • Japan
  • Portugal

TECHNOLOGY

• GOODS FLOW IN DRUG MANUFACTURE
• TECHNOLOGY SHARES OF BULK ORGANIC DRUG MANUFACTURE
• SYNTHESIS
  • THE MAJOR ROLE OF SYNTHESIS IN BULK DRUG PRODUCTION
  • UNNATURAL AND BIODUPLICATED SYNTHETIC DRUGS
  • CATALYSTS FOR DRUG SYNTHESIS
  • Precious Metal Catalysts
  • Phase-transfer Catalysts
  • Biocatalysts/Enzymes

• FERMENTATION
  • DRUGS MADE BY FERMENTATION
  • RECOMBINANT FERMENTATION

• NATURAL SOURCE EXTRACTION
  • OVERALL CONTRIBUTION OF NATURAL SOURCE EXTRACTION
  • PLANT-DERIVED DRUGS
  • Drugs Made by Plant-Source Extraction
  • Suppliers of Plant Materials for Pharmaceutical Use
  • ANIMAL-DERIVED DRUGS
  • By-products from Livestock Industry Source Drugs
  • Antibodies Extracted From Animals
    • Polyclonal Antibodies
    • Monoclonal Antibodies

• HUMAN-EXTRACT DRUGS

• CELL CULTURE
  • ANIMAL CELL CULTURE
  • PLANT CELL CULTURE

• CHIRAL TECHNOLOGY
• COMBINATORIAL CHEMISTRY
• ANTISENSE MOLECULES

PRODUCTS

• PRODUCT OVERVIEW
  • VOLUME BY PRINCIPAL PRODUCT CATEGORIES
  • PRODUCT CATEGORY SHARES OF BULK PRODUCTION
  • BULK PRODUCTION OF NERVOUS SYSTEM AGENTS
  • PAINKILLERS
  • ANTIDEPRESSANTS
  • ANTICONVULSANTS
  • SEDATIVES
  • NEURODEGENERATIVE DISEASE AGENTS
  • ANTIPSYCHOTICS
  • ANTIADDICTION DRUGS
  • PRODUCERS OF BULK ACTIVES FOR TREATING NERVOUS SYSTEM AGENTS

• NUTRIENTS AND VITAMINS
  • VITAMINS
  • Bulk Vitamin Producers
  • Vitamin Manufacturing Methods
  • MINERALS
  • AMINO ACIDS

• ANTI-INFECTIVE AGENTS
  • ANTIBACTERIALS
  • ANTIVIRALS
  • ANTIFUNGALS/ANTIPROTOZOALS

• GASTROINTESTINAL DRUGS
  • ACID/ULCERS/HEARTBURN/REFLUX AGENTS
  • ANTINAUSEA AGENTS
  • OTHER GASTROINTESTINAL AGENTS

• CHOLESTEROL REDUCERS
• DIABETES AGENTS
• RESPIRATORY
  • COUGH AND COLD MEDICATIONS
  • ALLERGY AGENTS
  • ASTHMA AGENTS

• CARDIOVASCULAR AGENTS
  • ANTIHYPERTENSIVES
  • Calcium Channel Blockers
  • Angiotensin Converting Enzyme Inhibitors (ACE)
  • Beta-Blockers
  • Diuretics
  • Vasodilators
  • ARRYTHMIA AGENTS

• CANCER TREATMENT AGENTS
  • Antimetabolites
  • Hormone Antagonists
  • Steroid Synthesis Inhibitors
  • Topoisomerase Inhibitors
  • Other Agents

• OTHERS
  • STEROIDS
  • Glucorcorticoids
  • Sex Steroids
  • DERMATOLOGICALS
  • OPHTHALMIC PRODUCTS
  • BLOOD MODIFIERS
  • MONOCLONAL ANTIBODIES
  • ERECTILE DYSFUNCTION THERAPIES

COMPANY PROFILES

• ABBOTT LABORATORIES
• ALBANY MOLECULAR RESEARCH INC. (AMRI)
• ALBEMARLE
• ALCHEM LABORATORIES CORP.
• ALFA CHEMICALS ITALIANA
• ALPHARMA INC.
• ALPS PHARMACEUTICAL
• ASCOT FINE CHEMICALS (DIVISION OF ASCOT PLC)
• AVECIA
• BACHEM AG
• BASF AG
• BAYER
• BELL AROMATICS
• BIAZZI GROUP
• BIOCHIMICA OPOS S.P.A
• BOEHRINGER INGELHEIM
• BOMBAY DRUGS & PHARMA LTD.
• CAMBREX
• CASCADE BIOCHEM LTD.
• CATALYTICA (DIVISION OF ASTRAZENECA)
• CHEMI S.P.A.
• CIPLA LTD.
• CLARIANT CORP.
• CLARION PHARMACEUTICAL CO.
• DAIICHI PHARMACEUTICAL CO. LTD.
• DEGUSSA CORP. (DIVISION OF DEGUSSA-HULS CORP.)
• DIOSYNTH B.V.
• DOW CHEMICAL CO.
• DSM ANDENO B.V.
• EASTMAN CHEMICAL CO.
• ERREGIERRE INDUSTRIA CHEMCIA S.P.A.
• EUTICALS S.P.A.
• FABBRICA ITALIANA SINTETICI S.P.A.
• FARMHISPANIA S.A.
• GANES CHEMICALS
• GENZYME PHARMACEUTICALS (DIVISON OF GENZYME CORP.)
• GREAT LAKES CHEMICAL CORP.
• HOECHST MARION ROUSSELL
• HOFFMAN-LA ROCHE INC. (DIVISION OF ROCHE)
• HONEYWELL (ALLIEDSIGNAL DIVISION)
• HOVIONE
• HYBRIDON INC.
• ICN PHARMACEUTICALS INC.
• JIAOZUO CHEMICAL PHARMACEUTICAL FACTORY
• JOHNSON MATTHEY INC.
• KALI UND SALZ GMBH
• KEMWELL PVT. LTD.
• LABORATORI MAG S.P.A.
• LAPORTE ORGANICS FRANCIS S.P.A.
• LONZA SPECIAL FINE CHEMICALS
• MACFARLAN SMITH LTD.
• MALLADI DRUGS & PHARMACEUTICALS LTD.
• MALLINCKRODT
• MEHTA PHARMACEUTICALS PVT. LTD
• MERCK KGAA
• MOEHS S.A.
• MOREPEN LABORATORIES LTD.
• NICHOLAS PIRAMAL INDIA LTD.
• ORION CORP./FERMION
• PFANSTIEHL LABORATORIES
• PROLIGO
• RECORDATI INDUSUTRIA CHIMICA E FARMACEUTICA S.P.A.
• REILLY INDUSTRIES INC.
• RHODIA CHIREX
• SECO COMPANY LTD.
• SICOR S.P.A.
• SIEGFRIED AG
• SIFA CHEMICALS AG
• SIGMA ALDRICH
• SINOCHEM NINGBO I/E CORP.
• SINTOFARM S.P.A.
• SNPE GROUP
• SYNTHELABO
• TESSENDERLO CHEMIE
• TEVA PHARMACEUTICAL INDUSTRIES LTD.
• TOMITA PHARMACEUTICAL COMPANY LTD.
• VERA PHARMA LTD.
• YAMAKAWA CHEMICAL INDUSTRY COMPANY LTD.

APPENDIX 1

LIST OF TABLES

SUMMARY TABLE VALUE OF ACTIVE INGREDIENTS, THROUGH 2005

1 ESTIMATED WORLDWIDE SALES OF FORMULATED DRUGS, 1999

2 ESTIMATED WORLDWIDE SALES OF TOP 15 DRUGS, 1999

3 TOP PHARMACEUTICAL COMPANIES WORLDWIDE

4 WORLDWIDE PHARMACEUTICAL MARKET SALES, THROUGH 2005

5 BULK ACTIVE VALUE OF FORMULATED DRUG SALES

6 ACTIVE INGREDIENTS VALUE OF WORLDWIDE FORMULATED DRUG SALES, THROUGH 2005

7 MAJOR BULK PHARMACEUTICALS MARKET SHARE, 1999

8 OVERALL CAPTIVE, MERCHANT AND TOLL SHARES OF BULK PRODUCTION, THROUGH 2005

9 OTC AND PRESCRIPTION SHARES OF CAPTIVE BULK PRODUCTION, THROUGH 2005

10 OTC AND PRESCRIPTION SHARES OF MERCHANT BULK PRODUCTION, THROUGH 2005

11 OTC AND PRESCRIPTION SHARE OF TOLL BULK PRODUCTION, THROUGH 2005

12 TOLL BULK PHARMACEUTICAL PRODUCERS

13 SELECTED LIST OF BULK PHARMACEUTICAL DISTRIBUTORS

14 GEOGRAPHIC DISTRIBUTION OF BULK PRODUCTION, THROUGH 2005

15 SELECTED LISTING OF BULK PHARMACEUTICAL PRODUCERS IN THE U.S.*

16 SELECTED LISTING OF INDIAN PHARMACEUTICAL COMPANIES

17 SELECTED LIST OF ASCHIFARMA MEMBERS

18 SELECTED LISTING OF BIOLOGICAL DRUGS PRODUCED BY SYNTHETIC DUPLICATION

19 PHARMACEUTICALS AND STARTING MATERIALS MADE BY FERMENTATION*

20 PHARMACEUTICALS AND STARTING MATERIALS DERIVED FROM PLANTS

21 SELECTED LIST OF SUPPLIERS OF PLANT MATERIALS FOR PHARMACEUTICAL USE

22 SELECTED CHEMICALLY-RELATED PHARMACEUTICAL FAMILIES

23 ESTIMATED WORLDWIDE PRODUCTION OF BULK PHARMACEUTICAL ACTIVES, THROUGH 2005

24 WORLDWIDE PRODUCTION VOLUME OF NERVOUS SYSTEM BULK PHARMACEUTICAL ACTIVES, THROUGH 2005

25 WORLDWIDE* BULK PRODUCTION VOLUME OF NUTRIENTS AND VITAMINS USED AS BULK PHARMACEUTICAL ACTIVES, THROUGH 2005

26 COMMERCIAL MANUFACTURING METHODS FOR VITAMINS

27 ANTI-INFECTIVE BULK ACTIVE PRODUCTION VOLUMES, THROUGH 2005

28 ANTIBIOTICS MADE BY FERMENTATION

29 ORIGINS OF SEMISYNTHETIC ANTIBIOTICS

30 PRODUCTION VOLUMES OF BULK ACTIVES USED IN GASTROINTESTINAL DRUGS, THROUGH 2005

31 PRODUCTION VOLUMES OF BULK ACTIVES USED IN CHOLESTEROL REDUCTION DRUGS THROUGH 2005

32 PRODUCTION VOLUMES OF BULK ACTIVES USED IN DIABETES DRUGS, THROUGH 2005

33 PRODUCTION VOLUMES OF BULK ACTIVES USED IN RESPIRATORY DRUGS, THROUGH 2005

34 PRODUCTION VOLUMES OF BULK ACTIVES USED IN CARDIOVASCULAR DRUGS, THROUGH 2005

35 PRODUCTION VOLUMES OF BULK ACTIVES USED IN CANCER DRUGS, THROUGH 2005

LIST OF FIGURES

1 GEOGRAPHIC SALES OF FORMULATED DRUGS, 1999

2 MAJOR BULK PHARMACEUTICALS MARKET SHARE, 1999

3 BASIC STRUCTURE OF THE BULK PHARMACEUTICAL INDUSTRY

4 OTC AND PRESCRIPTION SHARES OF CAPTIVE BULK PRODUCTION, 2000 AND 2005

5 OTC AND PRESCRIPTION SHARES OF MERCHANT BULK, PRODUCTION, 2000-2005

6 OTC AND PRESCRIPTION SHARE OF TOLL BULK PRODUCTION, 2000-2005

7 GEOGRAPHIC DISTRIBUTION OF BULK PRODUCTION, 2000 AND 2005

8 GOODS FLOW IN DRUG MANUFACTURE

9 ESTIMATED WORLDWIDE PRODUCTION OF BULK PHARMACEUTICAL ACTIVES, 2000 AND 2005