THYROID HORMONE THERAPY TABLE 21 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR FIGURE 4 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR

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1 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, ($ 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 Adrenal Cortical Hormones Adrenal Medullary Hormones Kidney Hormones Pancreatic Hormones Liver Hormones Digestive Hormones Gonadal Hormones Gonadal Hormones (Continued) Pineal Hormones TABLE 1 ANATOMICAL CLASSIFICATION OF HORMONES Chemical Classification... 18

2 Peptide Hormones Amine hormones Steroid Hormones TABLE 2 CHEMICAL CLASSIFICATION OF HORMONES HORMONE THERAPY DEFINITION CHAPTER FOUR: CLASSIFICATION OF HORMONE THERAPY ESTROGEN THERAPY TABLE 3 DRUG PRODUCTS USED IN ESTROGEN THERAPY PROGESTERONE/ESTROGEN THERAPY TABLE 4 DRUG PRODUCTS USED IN ESTROGEN/PROGESTERONE COMBINATION THERAPY PROGESTERONE THERAPY TABLE 5 DRUG PRODUCTS USED IN PROGESTERONE THERAPY RECOMBINANT GROWTH HORMONE THERAPY TABLE 6 DRUG PRODUCTS USED IN RECOMBINANT GROWTH HORMONES THYROID HORMONE THERAPY TABLE 7 DRUG PRODUCTS USED IN THYROID HORMONE THERAPY TABLE 7 (CONTINUED) TESTOSTERONE REPLACEMENT THERAPY TABLE 8 DRUG PRODUCTS USED IN TESTOSTERONE REPLACEMENT THERAPY SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMS) TABLE 9 DRUG PRODUCTS USED IN SELECTIVE ESTROGEN RECEPTOR MODULATORS ANTIESTROGEN THERAPY TABLE 10 DRUG PRODUCTS USED IN ANTIESTROGENS ANTIANDROGEN THERAPY TABLE 11 DRUG PRODUCTS USED IN ANTIANDROGEN THERAPY AROMATASE INHIBITOR THERAPY TABLE 12 DRUG PRODUCTS USED IN AROMATASE INHIBITOR THERAPY LUTEINIZING HORMONE-RELEASING HORMONE TABLE 13 DRUG PRODUCTS USED AS LUTEINIZING HORMONE- RELEASING HORMONE (LH RH) CHAPTER FIVE: HORMONE THERAPY IN VARIOUS CONDITIONS MENOPAUSE MENOPAUSE AND HORMONE THERAPY OSTEOPOROSIS OSTEOPOROSIS AND HORMONE THERAPY CANCER... 29

3 CANCER AND HORMONE THERAPY GROWTH HORMONE DEFICIENCIES GROWTH HORMONE DEFICIENCY AND HORMONE THERAPY TURNER S SYNDROME TURNER S SYNDROME AND HORMONE THERAPY KLINEFELTER SYNDROME KLINEFELTER SYNDROME AND HORMONE THERAPY THYROID HORMONE DISORDER: HYPOTHYROIDISM HYPOTHYROIDISM AND HORMONE THERAPY MALE HYPOGONADISM MALE HYPOGONADISM AND HORMONE THERAPY NOONAN SYNDROME NOONAN SYNDROME AND HORMONE THERAPY SHORT BOWEL SYNDROME (SBS) SBS AND HORMONE THERAPY PRADER-WILLI SYNDROME PRADER-WILLI SYNDROME AND HORMONE THERAPY GOITER GOITER AND HORMONE THERAPY CHAPTER SIX: REGULATORY ISSUES NEW DRUG APPROVALS TABLE 14 HORMONE THERAPY DRUGS APPROVED BY FDA (2005 TO JUNE 2008) ALL TYPES OF APPROVALS TABLE 15 HORMONE THERAPY ALL TYPES OF APPROVALS BY FDA (2005 TO JUNE 2008) TABLE 15 (CONTINUED) TABLE 15 (CONTINUED) NEW DRUG APPLICATIONS TABLE 16 NEW DRUG APPLICATIONS (2005 TO JUNE 2008) RECALLS AND SAFETY ALERTS TABLE 17 RECALLS AND SAFETY ALERTS (2005 TO JUNE 2008) CHAPTER SEVEN: INDUSTRY STRUCTURE ESTROGEN REPLACEMENT THERAPY ESTROGEN (ALONE) TABLE 18 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ESTROGEN (ALONE) THERAPY, 2007 (%) FIGURE 1 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ESTROGEN REPLACEMENT THERAPY, 2007 (%) ESTROGEN/PROGESTERONE... 45

4 TABLE 19 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR COMBINATION (ESTROGEN/ PROGESTERONE) THERAPY, 2007 (%) FIGURE 2 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR COMBINATION (ESTROGEN/ PROGESTERONE) THERAPY, 2007 (%) RECOMBINANT GROWTH HORMONE THERAPY TABLE 20 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR RECOMBINANT GROWTH HORMONE THERAPY, 2007 (%) FIGURE 3 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR RECOMBINANT GROWTH HORMONE THERAPY, 2007 (%) THYROID HORMONE THERAPY TABLE 21 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR THYROID HORMONE THERAPY, 2007 (%) FIGURE 4 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR THYROID HORMONE THERAPY, 2007 (%) TESTOSTERONE HORMONE THERAPY TABLE 22 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR TESTOSTERONE HORMONE THERAPY, 2007 (%) FIGURE 5 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR TESTOSTERONE HORMONE THERAPY, 2007 (%) ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) TABLE 23 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS, 2007 (%) FIGURE 6 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS, 2007 (%) ANTIANDROGENS TABLE 24 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIANDROGENS, 2007 (%) FIGURE 7 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR ANTIANDROGENS, 2007 (%) AROMATASE INHIBITORS TABLE 25 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR AROMATASE INHIBITORS, 2007 (%) FIGURE 8 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR AROMATASE INHIBITORS, 2007 (%) LUTEINIZING HORMONE RELEASING HORMONE (LHRH) AGONISTS TABLE 26 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR LH RH AGONISTS, 2007 (%)... 52

5 FIGURE 9 SHARES OF MANUFACTURERS/DISTRIBUTORS FOR LH RH AGONISTS, 2007 (%) CHAPTER EIGHT: DEMAND AND USE KEY MARKET RESTRAINTS COMPETITION PATENT EXPIRATION TABLE 27 SIGNIFICANT PATENT EXPIRIES COST OF HRT DRUGS LOW AWARENESS KEY MARKET DRIVERS NEW DRUG DELIVERY TECHNOLOGIES GROWING AWARENESS AGING OF THE POPULATION RETURNING CONFIDENCE IN HRT BENEFITS OF HRT OVER NON-HORMONAL DRUGS LIFE EXPECTANCY DTC (DIRECT TO CONSUMER) ADVERTISING STRATEGIES OF MANUFACTURERS Strategies of Manufacturers (Continued) CHAPTER NINE: MARKET ANALYSIS MARKET SIZE TABLE 28 WORLDWIDE SALES OF HORMONE THERAPIES, THROUGH 2013 ($ MILLIONS) FIGURE 10 WORLDWIDE SALES OF HORMONE THERAPIES, ($ MILLIONS) TABLE 29 WORLDWIDE SHARE OF HORMONE THERAPIES, FIGURE 11 WORLDWIDE SHARE OF HORMONE THERAPIES, 2007 (%) ESTROGEN REPLACEMENT THERAPY Market Outlook ESTROGEN Market Size TABLE 30 GLOBAL SALES OF ESTROGEN (ALONE) THERAPY, THROUGH 2013 ($ MILLIONS) FIGURE 12 WORLDWIDE SALES OF ESTROGEN (ALONE) THERAPY, ($ MILLIONS) COMBINATION THERAPY (ESTROGEN/ PROGESTERONE) Market Size TABLE 31 GLOBAL SALES OF COMBINATION THERAPY (ESTROGEN/PROGESTERONE), THROUGH 2013 ($ MILLIONS) FIGURE 13 WORLDWIDE SALES OF COMBINATION THERAPY (ESTROGEN/PROGESTERONE), ($ MILLIONS) RECOMBINANT GROWTH HORMONE THERAPY... 63

6 Market Outlook Market Size TABLE 32 GLOBAL SALES OF RECOBINANT GROWTH HORMONE THERAPY THROUGH 2013 ($ MILLIONS) FIGURE 14 WORLDWIDE SALES OF RECOMBINANT GROWTH HORMONE THERAPY, ($ MILLIONS) THYROID HORMONE THERAPY Market Outlook Market Size TABLE 33 GLOBAL SALES OF THYROID HORMONE THERAPY, THROUGH 2013 ($ MILLIONS) FIGURE 15 WORLDWIDE SALES OF THYROID HORMONE THERAPY, ($ MILLIONS) TESTOSTERONE HORMONE THERAPY Market Outlook Market Size TABLE 34 GLOBAL SALES OF TESTOSTERONE HORMONE THERAPY, THROUGH 2013 ($ MILLIONS) FIGURE 16 WORLDWIDE SALES OF TESTOSTERONE HORMONE THERAPY, ($ MILLIONS) ANTIESTROGENS AND SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) Market Outlook Market Size TABLE 35 GLOBAL SALES OF ANTIESTROGEN AND SELECTIVE ESTROGEN RECPTOR MODULATORS, THROUGH 2013 ($ MILLIONS) FIGURE 17 WORLDWIDE SALES OF ANTIESTROGEN AND SELECTIVE ESTROGEN RECEPTOR MODULATORS, ($ MILLIONS) ANTIANDROGEN THERAPY Market Outlook Market Size TABLE 36 GLOBAL SALES OF ANTIANDROGEN THERAPY, THROUGH 2013 ($ MILLIONS) FIGURE 18 WORLDWIDE SALES OF ANTIANDROGEN THERAPY, ($ MILLIONS) AROMATASE INHIBITORS Market Outlook Market Size TABLE 37 GLOBAL SALES OF AROMATASE INHIBITORS, THROUGH 2013 ($ MILLIONS) FIGURE 19 WORLDWIDE SALES OF AROMATASE INHIBITORS, ($ MILLIONS)... 73

7 LUTEINIZING HORMONE-RELEASING HORMONE (LH RH) AGONISTS Market Outlook Market Size TABLE 38 GLOBAL SALES OF LH RH AGONISTS, THROUGH 2013 ($ MILLIONS) FIGURE 20 WORLDWIDE SALES OF LH RH AGONIST, ($ MILLIONS) New Developments TABLE 39 CLINICAL TRIALS IN THE ESTROGEN REPLACEMENT THERAPY TABLE 39 (CONTINUED) TABLE 40 CLINICAL TRIALS IN THE PROGESTEROEN THERAPY TABLE 40 (CONTINUED) TABLE 41 CLINICAL TRIALS IN THYROID HORMONE THERAPY TABLE 42 CLINICAL TRIALS IN TESTOSTERONE REPLACEMENT THERAPY TABLE 42 (CONTINUED) TABLE 43 CLINICAL TRIALS IN RECOMBINANT GROWTH HORMONE TABLE 43 (CONTINUED) TABLE 44 CLINICAL TRIALS IN ANTIESTROGEN THERAPY TABLE 44 (CONTINUED) TABLE 44 (CONTINUED) TABLE 45 CLINICAL TRIALS IN ESTROGEN RECEPTOR MODULATORS TABLE 46 CLINICAL TRIALS IN ANTIANDROGEN THERAPY TABLE 47 CLINICAL TRIALS IN AROMATASE INHIBITORS TABLE 48 CLINICAL TRIALS IN LH RH AGONISTS CHAPTER TEN: MARKET BY DISEASE TYPE TABLE 49 GLOBAL SALES OF HORMONE THERAPY BY TYPE OF DISEASE, THROUGH 2013 ($ MILLIONS) FIGURE 21 GLOBAL SALES OF HORMONE THERAPY BY TYPE OF DISEASE, ($ MILLIONS) TABLE 50 MARKET SHARE OF VARIOUS TYPES OF DISEASES, 2007 (%) FIGURE 22 MARKET SHARE OF VARIOUS TYPES OF DISEASES, 2007 (%) MENOPAUSE TABLE 51 GLOBAL SALES OF HRT IN MENOPAUSE MARKET, THROUGH 2013 ($ MILLIONS) FIGURE 23 GLOBAL SALES OF HRT IN MENOPAUSE MARKET, ($ MILLIONS) OSTEOPOROSIS... 93

8 TABLE 52 GLOBAL SALES OF HRT IN OSTEOPOROSIS MARKET, THROUGH 2013 ($ MILLIONS) FIGURE 24 GLOBAL SALES OF HRT IN OSTEOPOROSIS MARKET, ($ MILLIONS) HYPOTHYROIDISM TABLE 53 GLOBAL SALES OF HRT IN HYPOTHYROID MARKET, THROUGH 2013 ($ MILLIONS) FIGURE 25 GLOBAL SALES OF HRT IN HYPOTHYROID MARKET, ($ MILLIONS) MALE HYPOGONADISM TABLE 54 GLOBAL SALES OF HRT IN THE MALE HYPOGONADISM MARKET, THROUGH 2013 ($ MILLIONS) FIGURE 26 GLOBAL SALES OF HRT IN THE MALE HYPOGINADISM MARKET, ($ MILLIONS) KLINEFELTER SYNDROME TABLE 55 GLOBAL SALES OF HRT IN KLINEFELTER SYNDROME MARKET, THROUGH 2013 ($ MILLIONS) FIGURE 27 GLOBAL SALES OF HRT IN KLINEFELTER SYNDROME MARKET, ($ MILLIONS) TURNER S SYNDROME TABLE 56 GLOBAL SALES OF HRT IN TURNER S SYNDROME MARKET, THROUGH 2013 ($ MILLIONS) FIGURE 28 GLOBAL SALES OF HRT IN TURNER S SYNDROME MARKET, ($ MILLIONS) GROWTH HORMONE DEFICIENCY TABLE 57 GLOBAL SALES OF HRT IN GROWTH HORMONE DEFICIENCY MARKET, THROUGH 2013 ($ MILLIONS) FIGURE 29 GLOBAL SALES OF HRT IN GROWTH HORMONE DEFECIENCY MARKET, ($ MILLIONS) CANCER TABLE 58 GLOBAL SALES OF HRT IN CANCER MARKE, THROUGH 2013 ($ MILLIONS) FIGURE 30 GLOBAL SALES OF HRT IN CANCER MARKET, ($ MILLIONS) CHAPTER ELEVEN: PATENT ANALYSIS TOTAL PATENTS PATENTS BY YEAR TABLE 59 TOTAL NUMBER OF PATENTS IN EACH YEAR, FIGURE 31 NUMBER OF PATENTS, PATENTS BY TYPE TABLE 60 NUMBER OF PATENTS BY TYPE, FIGURE 32 NUMBER OF PATENTS BY TYPE, FIGURE 33 NUMBER OF PATENTS, SHARE BY TYPE OF HORMONE, (%)

9 FIGURE 33 (CONTINUED) PATENTS BY COUNTRY TABLE 61 TOTAL NUMBER OF PATENTS BY COUNTRY, FIGURE 34 TOTAL NUMBER OF PATENTS BY COUNTRY, PATENTS BY COMPANY TABLE 62 NUMBER OF PATENTS BY COMPANY, FIGURE 35 NUMBER OF PATENTS BY COMPANY, PATENTS BY ASSIGNEE TABLE 63 NUMBER OF PATENTS BY ASSIGNEE TYPE, FIGURE 36 NUMBER OF PATENTS BY ASSIGNEE, CHAPTER TWELVE: CURRENT AND FUTURE HORMONE REPLACEMENT THERAPY AND OTHER HORMONE THERAPY MARKET TABLE 64 LEADING BRANDED DRUGS IN VARIOUS HORMONE THERAPIES CURRENT AND FUTURE HORMONE (CONTINUED) CHAPTER THIRTEEN: COMPANY PROFILES ABBOTT LABORATORIES INC ACRUX LIMITED ASCEND THERAPEUTICS ASTRAZENECA PLC AUXILIUM PHARMACEUTICALS, INC BARR PHARMACEUTICALS, INC BAYER SCHERING PHARMA AG BIOSANTE PHARMACEUTICALS CANGENE CORPORATION COLUMBIA LABORATORIES, INC ELI LILLY & CO EMD SERONO, INC FERRING PHARMACEUTICALS GALEN LTD GENENTECH GENESCIENCE PHARMACEUTICALS INC IMPAX LABORATORIES, INC INDEVUS PHARMECEUTICALS, INC IPSEN SA JHP PHARMACEUTICALS KING PHARMACEUTICALS, INC KV PHARMACEUTICALS MYLAN, INC NOVARTIS NOVO NORDISK NYCOMED U.S

10 ORION CORPORATION PADDOCK LABORATORIES, INC PAR PHARMACEUTICAL COMPANIES, INC PFIZER INC SANOFI AVENTIS SOLVAY PHARMACEUTICALS SYNERX PHARMA UNIGENE LABORATORIES, INC UNIMED PHARMACEUTICALS, INC WARNER CHILCOTT WATSON LABS WYETH APPENDIX ABBREVIATIONS ABBREVIATIONS (CONTINUED)