发布时间：2008.10

摘要

INTRODUCTION

STUDY GOALS AND OBJECTIVES
 
BCC’s goal in conducting this study is to provide an overview of the current and potential global market for hormone replacement therapy and other hormone therapies. The report determines the market size, market leaders, and factors affecting the market of hormone therapies.
 
The overview of types of diseases and different hormone therapies is also examined along with sale figures over the five-year period from 2008 to 2013. Companies that manufacture and sell hormonal drugs to treat various types of diseases are profiled, and the factors affecting markets for these products and how those markets are likely to change are analyzed. Revenues have been broken down by type of therapy and by region.
 
The key objective of this report is to present a comprehensive analysis of the current market and the future direction of hormone replacement and other hormonal therapies with an emphasis on new developments.
 
REASONS FOR DOING THIS STUDY
 
Due to continuous increase in research and development in the field of hormones and the requirement for safer and more effective pharmaceutical drugs/therapies, companies are investing in clinical trials to develop these products, and to lessen side effects.
 
This study looks at almost all types of therapies/products used in hormone therapies, excluding the parathyroids. It examines the research and development of new products as well as ongoing clinical trials. Changes in R&D or in clinical trial results can have a marked effect on the global market; therefore, it is important to research the hormone therapy sector. Additionally, there is a section covering the use of these drug therapies by disease sector.
 
INTENDED AUDIENCE
 
This study contributes to the areas of market growth and decline in hormonal therapies from the point of view of the manufacturer. Therefore, it will be of interest to the pharmaceutical and biopharmaceutical industries, as well as clinics and hospitals.
 
 
 
SCOPE OF REPORT
 
The scope of this study encompasses global markets for hormonal therapies. BCC analyzes each market and its market leaders; different types of therapies; the regulatory environment; the different disease sectors for the use of hormonal therapies; and market projections and market share. Technological issues include the latest trends and new developments.
 
METHODOLOGY
 
A comprehensive literature search was conducted. The literature included technical newsletters and journals as well as many other sources. Data were collected through interviews and correspondence with various pharmaceutical/biotechnical experts. Projections were based on estimates such as the current number of end users, potential end users, likely unit prices, rates of consumption, and market trends.
 
INFORMATION SOURCES
 
BCC surveyed many companies to obtain data for this study. Included were manufacturers and the end users of the cancer drugs. We gathered the data from the industries; spoke with officials of this industry; and consulted newsletters, company literature, product literature, a host of technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial and trade information and government sources.
 
ANALYST's  CREDENTIALS
 
Shalini Shahani Dewan holds a masters degree in pharmaceutical chemistry. Among the research topics she has covered are studies on compounds of potential pharmaceutical interest from ibuprofen and 2-naphthyl acetic acid. Shahani was awarded a gold medal by the prime minister of India for her work and has worked with top companies in India and in the U.S.  Some of her other reports with BCC include Reagents of Chromatography; Spectroscopy: An Enduring Market; Advanced Drug Delivery Systems; Orthopedic Drugs, Implants and Devices; Imaging Reagents; Contract Manufacturing, Research and Packaging; The Dynamic Media, Sera and Reagent market in Biotechnology; Opportunities in Chiral Technology; Behavioral and Emotional Disorders in Children and Adolescents; and Pharmaceutical Regulatory Industry, and many more.

目录及图表

Chapter-1: SUMMARY
SUMMARY TABLE SALES FOR THE HORMONE REPLACEMENT AND OTHER THERAPIES, THROUGH 2013 ($ MILLIONS) 4
SUMMARY FIGURE SALES FOR THE HORMONE REPLACEMENT AND OTHER THERAPIES, 2006-2013 ($ MILLIONS) 5

Chapter-2: OVERVIEW
HORMONES 6
DEFINITIONS 6
Hormone 6
Peptide 6
Metabolism 6
INTRODUCTION 6
Classification of Hormones 7
Anatomical Source of the Hormone 7
Hypothalamic Hormones 7
Posterior Pituitary Hormone 8
Anterior Pituitary Hormone 8
Thyroid Hormones 9
Parathyroid Hormones 9
Cardiac Hormones 10
Adrenal Cortical Hormones 10
Adrenal Medullary Hormones 11
Kidney Hormones 11
Pancreatic Hormones 12
Liver Hormones 13
Digestive Hormones 13
Gonadal Hormones 14
Gonadal Hormones (Continued) 15
Pineal Hormones 16
TABLE 1 ANATOMICAL CLASSIFICATION OF HORMONES 17
Chemical Classification 18
Peptide Hormones 18
Amine hormones 18
Steroid Hormones 18
TABLE 2 CHEMICAL CLASSIFICATION OF HORMONES 19
HORMONE THERAPY 19
DEFINITION 19

Chapter-3: CLASSIFICATION OF HORMONE THERAPY
ESTROGEN THERAPY 20
TABLE 3   DRUG PRODUCTS USED IN ESTROGEN THERAPY 20
PROGESTERONE/ESTROGEN THERAPY 21
TABLE 4 DRUG PRODUCTS USED IN ESTROGEN/PROGESTERONE COMBINATION THERAPY 21
PROGESTERONE THERAPY 21
TABLE 5 DRUG PRODUCTS USED IN PROGESTERONE THERAPY 21
RECOMBINANT GROWTH HORMONE THERAPY 22
TABLE 6 DRUG PRODUCTS USED IN RECOMBINANT GROWTH HORMONES 22
THYROID HORMONE THERAPY 22
TABLE 7 DRUG PRODUCTS USED IN THYROID HORMONE THERAPY 22
TABLE 7 (CONTINUED) 23
TESTOSTERONE REPLACEMENT THERAPY 23
TABLE 8 DRUG PRODUCTS USED IN TESTOSTERONE REPLACEMENT THERAPY 23
SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMS) 23
TABLE 9 DRUG PRODUCTS USED IN SELECTIVE ESTROGEN RECEPTOR MODULATORS 24
ANTIESTROGEN THERAPY 24
TABLE 10 DRUG PRODUCTS USED IN ANTIESTROGENS 24
ANTIANDROGEN THERAPY 24
TABLE 11 DRUG PRODUCTS USED IN ANTIANDROGEN THERAPY 25
AROMATASE INHIBITOR THERAPY 25
TABLE 12 DRUG PRODUCTS USED IN AROMATASE INHIBITOR THERAPY 25
LUTEINIZING HORMONE-RELEASING HORMONE 25
TABLE 13 DRUG PRODUCTS USED AS LUTEINIZING HORMONE-RELEASING HORMONE (LH RH) 26

Chapter-4: HORMONE THERAPY IN VARIOUS CONDITIONS
MENOPAUSE 27
MENOPAUSE AND HORMONE THERAPY 27
OSTEOPOROSIS 28
OSTEOPOROSIS AND HORMONE THERAPY 28
CANCER 29
CANCER AND HORMONE THERAPY 30
GROWTH HORMONE DEFICIENCIES 30
GROWTH HORMONE DEFICIENCY AND HORMONE THERAPY 31
TURNER’S SYNDROME 31
TURNER’S SYNDROME AND HORMONE THERAPY 31
KLINEFELTER SYNDROME 32
KLINEFELTER SYNDROME AND HORMONE THERAPY 32
THYROID HORMONE DISORDER: HYPOTHYROIDISM 32
HYPOTHYROIDISM AND HORMONE THERAPY 33
MALE HYPOGONADISM 33
MALE HYPOGONADISM AND HORMONE THERAPY 34
NOONAN SYNDROME 34
NOONAN SYNDROME AND HORMONE THERAPY 35
SHORT BOWEL SYNDROME (SBS) 35
SBS AND HORMONE THERAPY 35
PRADER-WILLI SYNDROME 36
PRADER-WILLI SYNDROME AND HORMONE THERAPY 36
GOITER 36
GOITER AND HORMONE THERAPY 37

Chapter-5: REGULATORY ISSUES
NEW DRUG APPROVALS 38
TABLE 14 HORMONE THERAPY DRUGS APPROVED BY FDA (2005 TO JUNE 2008) 38
ALL TYPES OF APPROVALS 39
TABLE 15 HORMONE THERAPY ALL TYPES OF APPROVALS BY FDA (2005 TO JUNE 2008) 39
TABLE 15 (CONTINUED) 40
TABLE 15 (CONTINUED) 41
NEW DRUG APPLICATIONS 41
TABLE 16 NEW DRUG APPLICATIONS (2005 TO JUNE 2008) 42
RECALLS AND SAFETY ALERTS 42
TABLE 17 RECALLS AND SAFETY ALERTS (2005 TO JUNE 2008) 43

Chapter-6: INDUSTRY STRUCTURE
ESTROGEN REPLACEMENT THERAPY 44
ESTROGEN (ALONE) 44
TABLE 18 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ESTROGEN (ALONE) THERAPY, 2007 (%) 44
FIGURE 1 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ESTROGEN REPLACEMENT THERAPY, 2007 (%) 44
ESTROGEN/PROGESTERONE 45
TABLE 19 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR COMBINATION (ESTROGEN/ PROGESTERONE) THERAPY, 2007 (%) 45
FIGURE 2 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR COMBINATION (ESTROGEN/ PROGESTERONE) THERAPY, 2007 (%) 45
RECOMBINANT GROWTH HORMONE THERAPY 46
TABLE 20 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR RECOMBINANT GROWTH HORMONE THERAPY, 2007 (%) 46
FIGURE 3 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR RECOMBINANT GROWTH HORMONE THERAPY, 2007 (%) 46
THYROID HORMONE THERAPY 47
TABLE 21 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR THYROID HORMONE THERAPY, 2007 (%) 47
FIGURE 4 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR THYROID HORMONE THERAPY, 2007 (%) 47
TESTOSTERONE HORMONE THERAPY 48
TABLE 22 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR TESTOSTERONE HORMONE THERAPY, 2007 (%) 48
FIGURE 5 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR TESTOSTERONE HORMONE THERAPY, 2007 (%) 48
ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) 49
TABLE 23 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS, 2007 (%) 49
FIGURE 6 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS, 2007 (%) 49
ANTIANDROGENS 50
TABLE 24 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIANDROGENS, 2007 (%) 50
FIGURE 7 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIANDROGENS, 2007 (%) 50
AROMATASE INHIBITORS 51
TABLE 25 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR AROMATASE INHIBITORS, 2007 (%) 51
FIGURE 8 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR AROMATASE INHIBITORS, 2007 (%) 51
LUTEINIZING HORMONE RELEASING HORMONE (LHRH) AGONISTS 52
TABLE 26 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR LH RH AGONISTS, 2007 (%) 52
FIGURE 9 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR LH RH AGONISTS, 2007 (%) 52

Chapter-7: DEMAND AND USE
KEY MARKET RESTRAINTS 53
COMPETITION 53
PATENT EXPIRATION 54
TABLE 27 SIGNIFICANT PATENT EXPIRIES 54
COST OF HRT DRUGS 54
LOW AWARENESS 55
KEY MARKET DRIVERS 55
NEW DRUG DELIVERY TECHNOLOGIES 55
GROWING AWARENESS 55
AGING OF THE POPULATION 55
RETURNING CONFIDENCE IN HRT 56
BENEFITS OF HRT OVER NON-HORMONAL DRUGS 56
LIFE EXPECTANCY 56
DTC (DIRECT TO CONSUMER) ADVERTISING 56
STRATEGIES OF MANUFACTURERS 56
Strategies of Manufacturers (Continued) 57

Chapter-8: MARKET ANALYSIS
MARKET SIZE 58
TABLE 28 WORLDWIDE SALES OF HORMONE THERAPIES, THROUGH 2013 ($ MILLIONS) 58
FIGURE 10 WORLDWIDE SALES OF HORMONE THERAPIES, 2006-2013 ($ MILLIONS) 59
TABLE 29 WORLDWIDE SHARE OF HORMONE THERAPIES, 2007 60
FIGURE 11 WORLDWIDE SHARE OF HORMONE THERAPIES, 2007 (%) 60
ESTROGEN REPLACEMENT THERAPY 61
Market Outlook 61
ESTROGEN 61
Market Size 61
TABLE 30 GLOBAL SALES OF ESTROGEN (ALONE) THERAPY, THROUGH 2013 ($ MILLIONS) 61
FIGURE 12 WORLDWIDE SALES OF ESTROGEN (ALONE) THERAPY, 2006-2013 ($ MILLIONS) 62

Chapter-9: MARKET BY DISEASE TYPE
TABLE 49 GLOBAL SALES OF HORMONE THERAPY BY TYPE OF DISEASE, THROUGH 2013 ($ MILLIONS) 89
FIGURE 21 GLOBAL SALES OF HORMONE THERAPY BY TYPE OF DISEASE, 2006-2013 ($ MILLIONS) 90
TABLE 50 MARKET SHARE OF VARIOUS TYPES OF DISEASES, 2007 (%) 90
FIGURE 22 MARKET SHARE OF VARIOUS TYPES OF DISEASES, 2007 (%) 91
MENOPAUSE 91
TABLE 51 GLOBAL SALES OF HRT IN MENOPAUSE MARKET, THROUGH 2013 ($ MILLIONS) 92
FIGURE 23 GLOBAL SALES OF HRT IN MENOPAUSE MARKET, 2006-2013 ($ MILLIONS) 92
OSTEOPOROSIS 93
TABLE 52 GLOBAL SALES OF HRT IN OSTEOPOROSIS MARKET, THROUGH 2013 ($ MILLIONS) 93
FIGURE 24 GLOBAL SALES OF HRT IN OSTEOPOROSIS MARKET, 2006-2013 ($ MILLIONS) 93
HYPOTHYROIDISM 94
TABLE 53 GLOBAL SALES OF HRT IN HYPOTHYROID MARKET, THROUGH 2013 ($ MILLIONS) 94
FIGURE 25 GLOBAL SALES OF HRT IN HYPOTHYROID MARKET, 2006-2013 ($ MILLIONS) 95
MALE HYPOGONADISM 95
TABLE 54 GLOBAL SALES OF HRT IN THE MALE HYPOGONADISM MARKET, THROUGH 2013 ($ MILLIONS) 95
FIGURE 26 GLOBAL SALES OF HRT IN THE MALE HYPOGINADISM MARKET, 2006-2013 ($ MILLIONS) 96
KLINEFELTER SYNDROME 96
TABLE 55 GLOBAL SALES OF HRT IN KLINEFELTER SYNDROME MARKET, THROUGH 2013 ($ MILLIONS) 97
FIGURE 27 GLOBAL SALES OF HRT IN KLINEFELTER SYNDROME MARKET, 2006-2013 ($ MILLIONS) 97
TURNER’S SYNDROME 98
TABLE 56 GLOBAL SALES OF HRT IN TURNER’S SYNDROME MARKET, THROUGH 2013 ($ MILLIONS) 98
FIGURE 28 GLOBAL SALES OF HRT IN TURNER’S SYNDROME MARKET, 2006-2013 ($ MILLIONS) 99
GROWTH HORMONE DEFICIENCY 99
TABLE 57 GLOBAL SALES OF HRT IN GROWTH HORMONE DEFICIENCY MARKET, THROUGH 2013 ($ MILLIONS) 100
FIGURE 29 GLOBAL SALES OF HRT IN GROWTH HORMONE DEFECIENCY MARKET, 2006-2013 ($ MILLIONS) 101
CANCER 101
TABLE 58 GLOBAL SALES OF HRT IN CANCER MARKE, THROUGH 2013 ($ MILLIONS) 102
FIGURE 30 GLOBAL SALES OF HRT IN CANCER MARKET, 2006-2013 ($ MILLIONS) 102

Chapter-10: PATENT ANALYSIS
TOTAL PATENTS 103
PATENTS BY YEAR 103
TABLE 59 TOTAL NUMBER OF PATENTS IN EACH YEAR, 2005–2008 103
FIGURE 31 NUMBER OF PATENTS, 2005-2008 104
PATENTS BY TYPE 104
TABLE 60 NUMBER OF PATENTS BY TYPE, 2005-2008 104
FIGURE 32 NUMBER OF PATENTS BY TYPE, 2005-2008 105
FIGURE 33 NUMBER OF PATENTS, SHARE BY TYPE OF HORMONE, 2005-2008 (%) 105
FIGURE 33 (CONTINUED) 106
PATENTS BY COUNTRY 106
TABLE 61 TOTAL NUMBER OF PATENTS BY COUNTRY, 2005-2008 106
FIGURE 34 TOTAL NUMBER OF PATENTS BY COUNTRY, 2005-2008 107
PATENTS BY COMPANY 107
TABLE 62 NUMBER OF PATENTS BY COMPANY, 2005-2008 108
FIGURE 35 NUMBER OF PATENTS BY COMPANY, 2005-2008 109
PATENTS BY ASSIGNEE 109
TABLE 63 NUMBER OF PATENTS BY ASSIGNEE TYPE, 2005–2008 110
FIGURE 36 NUMBER OF PATENTS BY ASSIGNEE, 2005–2008 110

Chapter-11: CURRENT AND FUTURE HORMONE REPLACEMENT THERAPY AND “OTHER” HORMONE THERAPY MARKET
TABLE 64 LEADING BRANDED DRUGS IN VARIOUS HORMONE THERAPIES 111
CURRENT AND FUTURE HORMONE…(CONTINUED) 112

Chapter-12: COMPANY PROFILES
ABBOTT LABORATORIES INC. 113
ACRUX LIMITED 113
ASCEND THERAPEUTICS 114
ASTRAZENECA PLC 114
AUXILIUM PHARMACEUTICALS, INC. 115
BARR PHARMACEUTICALS, INC. 115
BAYER SCHERING PHARMA AG 116
BIOSANTE PHARMACEUTICALS 116
CANGENE CORPORATION 117
COLUMBIA LABORATORIES, INC. 117
ELI LILLY & CO. 118
EMD SERONO, INC. 118
FERRING PHARMACEUTICALS 118
GALEN LTD. 119
GENENTECH 119
GENESCIENCE PHARMACEUTICALS INC. 120
IMPAX LABORATORIES, INC. 120
INDEVUS PHARMECEUTICALS, INC. 121
IPSEN SA 121
JHP PHARMACEUTICALS 122
KING PHARMACEUTICALS, INC. 122
KV PHARMACEUTICALS 123
MYLAN, INC. 123
NOVARTIS 124
NOVO NORDISK 124
NYCOMED U.S. 125
ORION CORPORATION 125
PADDOCK LABORATORIES, INC. 126
PAR PHARMACEUTICAL COMPANIES, INC. 126
PFIZER INC. 127
SANOFI AVENTIS 127
SOLVAY PHARMACEUTICALS 128
SYNERX PHARMA 128
UNIGENE LABORATORIES, INC. 128
UNIMED PHARMACEUTICALS, INC. 129
WARNER CHILCOTT 129
WATSON LABS 130
WYETH 130

Chapter-13: APPENDIX
ABBREVIATIONS 131
ABBREVIATIONS (CONTINUED) 132