CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 1 SCOPE OF REPORT... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ANALYST S CREDENTIALS... 2 RELATED BCC REPORTS... 3 BCC ONLINE SERVICES... 3 DISCLAIMER... 3 CHAPTER TWO: SUMMARY... 4 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 THREE: OVERVIEW... 6 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 FOUR: CLASSIFICATION OF HORMONE THERAPY... 20 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 FIVE: HORMONE THERAPY IN VARIOUS CONDITIONS... 27 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 SIX: REGULATORY ISSUES... 38 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 SEVEN: INDUSTRY STRUCTURE... 44 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 EIGHT: DEMAND AND USE... 53 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 NINE: MARKET ANALYSIS... 58 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 COMBINATION THERAPY (ESTROGEN/ PROGESTERONE)... 62 Market Size... 62 TABLE 31 GLOBAL SALES OF COMBINATION THERAPY (ESTROGEN/PROGESTERONE), THROUGH 2013 ($ MILLIONS)... 62 FIGURE 13 WORLDWIDE SALES OF COMBINATION THERAPY (ESTROGEN/PROGESTERONE), 2006-2013 ($ MILLIONS)... 63 RECOMBINANT GROWTH HORMONE THERAPY... 63
Market Outlook... 63 Market Size... 64 TABLE 32 GLOBAL SALES OF RECOBINANT GROWTH HORMONE THERAPY THROUGH 2013 ($ MILLIONS)... 64 FIGURE 14 WORLDWIDE SALES OF RECOMBINANT GROWTH HORMONE THERAPY, 2006-2013 ($ MILLIONS)... 64 THYROID HORMONE THERAPY... 65 Market Outlook... 65 Market Size... 65 TABLE 33 GLOBAL SALES OF THYROID HORMONE THERAPY, THROUGH 2013 ($ MILLIONS)... 65 FIGURE 15 WORLDWIDE SALES OF THYROID HORMONE THERAPY, 2006-2013 ($ MILLIONS)... 66 TESTOSTERONE HORMONE THERAPY... 67 Market Outlook... 67 Market Size... 67 TABLE 34 GLOBAL SALES OF TESTOSTERONE HORMONE THERAPY, THROUGH 2013 ($ MILLIONS)... 67 FIGURE 16 WORLDWIDE SALES OF TESTOSTERONE HORMONE THERAPY, 2006-2013 ($ MILLIONS)... 68 ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM)... 69 Market Outlook... 69 Market Size... 69 TABLE 35 GLOBAL SALES OF ANTIESTROGEN AND SELECTIVE ESTROGEN RECPTOR MODULATORS, THROUGH 2013 ($ MILLIONS)... 69 FIGURE 17 WORLDWIDE SALES OF ANTIESTROGEN AND SELECTIVE ESTROGEN RECEPTOR MODULATORS, 2006-2013 ($ MILLIONS)... 70 ANTIANDROGEN THERAPY... 70 Market Outlook... 70 Market Size... 71 TABLE 36 GLOBAL SALES OF ANTIANDROGEN THERAPY, THROUGH 2013 ($ MILLIONS)... 71 FIGURE 18 WORLDWIDE SALES OF ANTIANDROGEN THERAPY, 2006-2013 ($ MILLIONS)... 71 AROMATASE INHIBITORS... 72 Market Outlook... 72 Market Size... 73 TABLE 37 GLOBAL SALES OF AROMATASE INHIBITORS, THROUGH 2013 ($ MILLIONS)... 73 FIGURE 19 WORLDWIDE SALES OF AROMATASE INHIBITORS, 2006-2013 ($ MILLIONS)... 73
LUTEINIZING HORMONE-RELEASING HORMONE (LH RH) AGONISTS... 74 Market Outlook... 74 Market Size... 74 TABLE 38 GLOBAL SALES OF LH RH AGONISTS, THROUGH 2013 ($ MILLIONS)... 74 FIGURE 20 WORLDWIDE SALES OF LH RH AGONIST, 2006-2013 ($ MILLIONS)... 75 New Developments... 75 TABLE 39 CLINICAL TRIALS IN THE ESTROGEN REPLACEMENT THERAPY... 76 TABLE 39 (CONTINUED)... 77 TABLE 40 CLINICAL TRIALS IN THE PROGESTEROEN THERAPY... 77 TABLE 40 (CONTINUED)... 78 TABLE 41 CLINICAL TRIALS IN THYROID HORMONE THERAPY... 78 TABLE 42 CLINICAL TRIALS IN TESTOSTERONE REPLACEMENT THERAPY... 79 TABLE 42 (CONTINUED)... 80 TABLE 43 CLINICAL TRIALS IN RECOMBINANT GROWTH HORMONE... 81 TABLE 43 (CONTINUED)... 82 TABLE 44 CLINICAL TRIALS IN ANTIESTROGEN THERAPY... 83 TABLE 44 (CONTINUED)... 84 TABLE 44 (CONTINUED)... 85 TABLE 45 CLINICAL TRIALS IN ESTROGEN RECEPTOR MODULATORS... 85 TABLE 46 CLINICAL TRIALS IN ANTIANDROGEN THERAPY... 86 TABLE 47 CLINICAL TRIALS IN AROMATASE INHIBITORS... 87 TABLE 48 CLINICAL TRIALS IN LH RH AGONISTS... 88 CHAPTER TEN: MARKET BY DISEASE TYPE... 89 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 ELEVEN: PATENT ANALYSIS... 103 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 TWELVE: CURRENT AND FUTURE HORMONE REPLACEMENT THERAPY AND OTHER HORMONE THERAPY MARKET... 111 TABLE 64 LEADING BRANDED DRUGS IN VARIOUS HORMONE THERAPIES... 111 CURRENT AND FUTURE HORMONE (CONTINUED)... 112 CHAPTER THIRTEEN: COMPANY PROFILES... 113 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 APPENDIX... 131 ABBREVIATIONS... 131 ABBREVIATIONS (CONTINUED)... 132