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Table of Contents for Drug Treatments for Leading Endocrine and Metabolic Diseases



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INTRODUCTION

XX

OBJECTIVES AND GOALS OF THE STUDY

XX

CONTRIBUTION OF THE STUDY AND FOR WHOM

XX

SCOPE AND CONTENT

XX

METHODOLOGY

XXI

INFORMATION SOURCES

XXI

ABOUT THE AUTHOR

XXI

RELATED BCC PUBLICATIONS

XXII

BCC ONLINE SERVICES

XXII

DISCLAIMER

XXIII

EXECUTIVE SUMMARY

XXIV

Summary Table:
GLOBAL MARKETS FOR PRESCRIPTION DRUGS TO TREAT ENDOCRINE AND METABOLIC DISEASES COVERED IN THIS REPORT, THROUGH 2011 ($ MILLIONS)

XXIV

Summary Figure:
GLOBAL MARKETS FOR PRESCRIPTION DRUGS TO TREAT ENDOCRINE AND METABOLIC DISEASES COVERED IN THIS REPORT, THROUGH 2011 ($ MILLIONS)

XXV

OVERVIEW

1

THE ENDOCRINE SYSTEM

1

ROLE OF THE HYPOTHALAMUS IN ENDOCRINE FUNCTION

1

Table 1 HYPOTHALAMIC NEUROHORMONES

2

TYPES AND ACTIVITIES OF NEUROHORMONES PRODUCED BY THE HYPOTHALAMUS

3

ENDOCRINE DISEASES

3

HYPERTENSION

4

Hypertension (Continued)

5

The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure

6

Table 2 EFFECTS OF ANTIHYPERTENSIVE AGENTS ON SELECTED CORONARY RISK FACTORS

7

The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure

8

Table 3 CLASSIFICATION OF BLOOD PRESSURE FOR ADULTS AGE 18 YEARS AND OLDER

8

INFERTILITY

9

Prevalence of Infertility

10

Causes of Infertility

10

Infertility Factors

10

Female Factors

10

Tubal Factors

11

Ovulation Factors

12

Amenorrhea

13

Amenorrhea (Continued)

14

Amenorrhea (Continued)

15

Anovulation

16

Table 4 CLASSIFICATION OF CHRONIC ANOVULATION

17

Luteal Phase Dysfunction

18

Endometriosis

19

Endometriosis (Continued)

20

Fibroids

21

Other and Unknown Factors

21

Cervical Factors

21

The Role of Relaxin

22

Male Factors

22

Varicocele

23

Genetic Factors

23

Microdeletions of the Y-Chromosome

23

Congenital Bilateral Absence of the Vas Deferens

24

A-MYB Gene and its Relation to Male Infertility

24

Reduced Spermatogenesis

24

Hypogonadism

25

Environmental Factors

26

Treatment Protocols

27

THYROID DISORDERS

28

Functions of the Thyroid Hormones

29

Clinical Evaluation of Thyroid Disorders

29

Table 5 LABORATORY EVALUATION OF THYROID DISORDERS

30

Hyperthyroidism

30

Table 6 CLASSIFICATION OF HYPERTHYROIDISM

31

Graves' Disease

31

Hypothyroidism

32

Thyroiditis

32

METABOLIC DISEASES

33

HYPERCHOLESTEROLEMIA

34

Hypercholesterolemia (Continued)

35

Hypercholesterolemia (Continued)

36

Relationship of Cholesterol to Cardiovascular Disease

37

OBESITY

38

Drug Treatment for Obesity

39

Alternative Treatments for Obesity

39

METABOLIC SYNDROME

40

Table 7 BODY MASS INDEX RATIOS AND CLASSIFICATION OF OBESITY

40

METABOLIC SYNDROME (CONTINUED)

41

ENDOCRINE DISEASES - APPLICATIONS AND PRODUCTS

42

HYPERTENSION

42

PRESCRIPTION DRUGS FOR THE TREATMENT OF HYPERTENSION

42

Adrenergic Inhibitors

42

Table 8 SELECTED ADRENERGIC INHIBITORS: PRECAUTIONS AND SIDE EFFECTS

43

The Market for Adrenergic Inhibitors

44

Table 9 GLOBAL MARKET FOR ADRENERGIC INHIBITORS, THROUGH 2011 ($ MILLIONS)

44

Figure 1 GLOBAL MARKET FOR ADRENERGIC INHIBITORS, 2004-2011 ($ MILLIONS)

44

Angiotensin-Converting Enzyme Inhibitors

45

Angiotensin-Converting Enzyme Inhibitors (Continued)

46

Table 10 SELECTED ACE INHIBITORS: PRECAUTIONS AND SIDE EFFECTS

47

The Market for ACE Inhibitors

47

Table 11 GLOBAL MARKET FOR ACE INHIBITORS, THROUGH 2011 ($ MILLIONS)

47

Figure 2 GLOBAL MARKET FOR ACE INHIBITORS, 2004-2011 ($ MILLIONS)

48

Angiotensin II Receptor Antagonists

48

The Difference Between ACE Inhibitors and Angiotensin II Inhibitors

49

The Market for Angiotensin II Inhibitors

50

Table 12 GLOBAL MARKET FOR ANGIOTENSIN II INHIBITORS, THROUGH 2011 ($ MILLIONS)

50

Figure 3 GLOBAL MARKET FOR ANGIOTENSIN II INHIBITORS, 2004-2011 ($ MILLIONS)

50

Beta Blockers

51

Table 13 SELECTED BETA BLOCKERS: PRECAUTIONS AND SIDE EFFECTS

52

Usage Trends of Beta Blockers

53

The Market for Beta Blockers

53

Table 14 GLOBAL MARKET FOR BETA BLOCKERS, THROUGH 2011 ($ MILLIONS)

53

Figure 4 GLOBAL MARKET FOR BETA BLOCKERS, 2004-2011 ($ MILLIONS)

54

Calcium Channel Blockers

54

Table 15 SELECTED CALCIUM CHANNEL BLOCKERS: PRECAUTIONS AND SIDE EFFECTS

55

Table 15 (CONTINUED)

56

Calcium Channel Blocker Usage

56

The Market for Calcium Channel Blockers

57

Table 16 GLOBAL MARKET FOR CALCIUM CHANNEL BLOCKERS, THROUGH 2011 ($ MILLIONS)

58

Figure 5 GLOBAL MARKET FOR CALCIUM CHANNEL BLOCKERS, 2004-2011 ($ MILLIONS)

58

Combination Products

58

The Market for Combination Antihypertensive Products

59

Table 17 GLOBAL MARKET FOR COMBINATION ANTIHYPERTENSIVE DRUGS, THROUGH 2011 ($ MILLIONS)

59

Figure 6 GLOBAL MARKET FOR COMBINATION ANTIHYPERTENSIVE DRUGS, 2004-2011 ($ MILLIONS)

60

Treatment Regimens

60

The Market for Selected Drugs to Treat Hypertension

61

Table 18 GLOBAL MARKET FOR SELECTED PRESCRIPTION PRODUCTS TO TREAT HYPERTENSION BY PRODUCT, THROUGH 2011 ($ MILLIONS)

61

Table 19 U.S. MARKET FOR PRESCRIPTION PRODUCTS TO TREAT HYPERTENSION, THROUGH 2011 ($ MILLIONS)

62

Figure 7 U.S. MARKET FOR PRESCRIPTION PRODUCTS TO TREAT HYPERTENSION, 2004-2011 ($ MILLIONS)

62

Products in Development for the Treatment of Hypertension

62

Table 20 SELECTED DRUGS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF HYPERTENSION

63

Aliskiren

64

Clevelox

64

Darusentan

64

Imidapril

65

Nebivolol

65

PW2101

65

Tadalafil

66

INFERTILITY

66

ASSISTED REPRODUCTIVE TECHNOLOGIES

66

Table 21 CURRENTLY AVAILABLE ASSISTED REPRODUCTIVE TECHNOLOGIES

67

Table 21 (CONTINUED)

68

Table 22 U.S. ASSISTED REPRODUCTIVE TECHNOLOGY PROCEDURE VOLUMES, THROUGH 2011

68

Table 22 (CONTINUED)

69

Success Rates for ART

69

Table 23 U.S. PREGNANCY SUCCESS RATES FOR ART PROCEDURES, 1998

69

Table 24 U.S. PREGNANCY SUCCESS RATES FOR ART PROCEDURES, NONDONER EGGS, 2003

70

Table 25 U.S. PREGNANCY SUCCESS RATES FOR ART PROCEDURES, DONOR EGGS, 2003

70

Success Rates for ART (Continued)

71

Success Rates for ART (Continued)

72

Semen Processing

73

Intrauterine Insemination

73

In Vitro Fertilization

73

In Vitro Fertilization (Continued)

74

Table 26 EFFECT OF PREVIOUS UNSUCCESSFUL IVF ATTEMPTS ON LIVE BIRTH RATE PER CYCLE

75

Table 27 EFFECT OF AGE OF WOMAN ON IVF LIVE BIRTH RATE PER CYCLE

75

Table 28 EFFECT OF CAUSE OF IVF INFERTILITY ON LIVE BIRTH RATE PER CYCLE

76

Table 29 U.S. IN VITRO FERTILIZATION PROCEDURE VOLUMES, THROUGH 2006

76

Ooplasmic Transfer

77

Gamete Intrafallopian Tube Transfer

78

Zygote Intrafallopian Transfer

78

Table 30 U.S. GAMETE INTRAFALLOPIAN TRANSFER AND ZYGOTE INTRAFALLOPIAN TRANSFER PROCEDURE VOLUMES, THROUGH 2006

79

Tubal Embryo Transfer

79

Intracytoplasmic Sperm Injection

80

U.S. FERTILITY CLINICS SERVE THE WORLD MARKET

80

THE FUTURE OF BIOTECH IN REPRODUCTIVE TECHNOLOGY

81

LEGAL ENVIRONMENT

81

THE INFERTILITY TREATMENT MARKET

81

Current Status of the Infertility Market

81

Fertility Treatment Market Projections

82

Table 31 U.S. MARKET FOR INFERTILITY TREATMENT, THROUGH 2011 ($ MILLIONS)

82

Table 32 U.S. COSTS OF INFERTILITY DIAGNOSTICS AND TREATMENTS, 2005 ($)

83

FERTILITY DRUGS

83

Table 33 SELECTED PHARMACEUTICAL AGENTS FOR THE TREATMENT OF FEMALE INFERTILITY

83

Table 33 (CONTINUED)

84

Major Participants in the Fertility Drug Market

84

Table 34 MANUFACTURERS OF FERTILITY DRUGS AND THEIR PRODUCTS

84

Table 34 (CONTINUED)

85

Genetically Engineered Products Take Over the Market

85

Increasing Focus on the Treatment of Male Infertility

86

Leading Fertility Drugs

86

Table 35 LEADING FERTILITY DRUGS BY INDICATION

87

Bromocryptine Mesylate

87

Cetrotide

87

Chlorotriansene

88

Clomiphene Citrate

88

Danazol

89

Estrogens

89

Estradiol Valerate

90

Esterified Estrogens

90

Estrone

90

Estropipate

90

Ethinyl Estradiol

91

Gonadorelin Acetate

91

Gonadotropins

91

Table 36 GONADOTROPIN USAGE IN SELECTED COUNTRIES (ESTIMATED NUMBER OF AMPOULES PER 1,000 INHABITANTS)

92

Recombinant Follicle-Stimulating Hormones

92

Recombinant Follicle-…(Continued)

93

Gonadotropin, Chorionic

94

Gonadotropin-Releasing Hormone Antagonist

95

Luteinizing Hormone-Releasing Hormone Antagonist

95

Goserelin Acetate

96

Leuprolide Acetate

96

Menotropins

97

Nafarelin Acetate

98

Ovidrel/Ovitrelle

98

Progesterone

98

Progesterone (Continued)

99

Quinestrol

100

Urofollitropin

100

The Global Market for Fertility Drugs

101

Table 37 GLOBAL SALES OF SELECTED FERTILITY DRUGS, THROUGH 2011

102

Table 38 GEOGRAPHIC SHARES OF INFERTILITY PHARMACEUTICALS, THROUGH 2011 ($ MILLIONS)

102

Leading Global Marketers of Fertility Drugs

102

Figure 8 INFERTILITY DRUGS: GLOBAL SUPPLIER MARKET SHARES, 2005 (PERCENT)

103

Fertility Drugs in Development

104

Table 39 FERTILITY DRUGS IN PHASE II OR LATER DEVELOPMENT

104

FSH-CTP

104

Visanne

105

Vitropin

105

Ovarian Implants as a Treatment for Infertility

105

THYROID DISEASE

106

HYPERTHYROIDISM

107

Drugs Used to Treat Hyperthyroidism

108

The Market for Drugs to Treat Hyperthyroidism

109

Table 40 GLOBAL MARKET FOR PRODUCTS TO TREAT HYPERTHYRODISM, THROUGH 2011 ($ MILLIONS)

109

Products in Development for the Treatment of Hyperthyroidism

110

HYPOTHYROIDISM

110

Drugs Used to Treat Hypothyroidism

111

Table 41 DRUGS USED TO TREAT HYPOTHYROIDISM

112

Levothyroxine

112

Liothyronine

112

Liotrix

113

Natural Thyroid

113

Synthroid Gains FDA Approval Decades After its Market Introduction

113

The Market for Prescription Drugs to Treat Hypothyroidism

114

Table 42 GLOBAL SALES OF SELECTED DRUGS TO TREAT HYPOTHYROIDISM, THROUGH 2011

114

Prescription Products in Development for the Treatment of Hypothyroidism

114

METABOLIC DISEASES - APPLICATIONS AND PRODUCTS

115

HYPERCHOLESTEROLEMIA

115

PRESCRIPTION DRUGS FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA

115

Table 43 CLASSES OF LIPID-LOWERING DRUGS

115

Table 43 (CONTINUED)

116

Bile Acid-Binding Resins

117

Hydroxymethylglutaryl-CoA Reductase Inhibitors

117

U.S. Marketed Statin Drugs

117

Table 44 STATIN DRUGS AVAILABLE GLOBALLY AND THEIR GENERIC AVAILABILITY IN THE U.S.

118

Fibric Acids

118

Nicotinic Acid and Derivatives

118

Probucol

119

Currently Marketed Antihyperlipidemic Drugs

119

Table 45 ANTIHYPERLIPIDEMIC DRUGS ON THE MARKET

119

Table 45 (CONTINUED)

120

Leading Products

120

Combination Products

121

Research and Development

121

Statin Drugs Show Promise in Treating Prostate Cancer

121

The Entry of Generic Versions of Blockbuster Cholesterol Drugs

121

Blockbuster Cholesterol Drugs (Continued)

122

The Medicare (Part D) Drug Benefit and Statin Drugs

123

THE MARKET FOR PRESCRIPTION DRUGS TO TREAT HYPERCHOLESTEROLEMIA

123

Table 46 GLOBAL MARKET FOR PRODUCTS TO TREAT HYPERCHOLESTEROLEMIA BY PRODUCT, THROUGH 2011 ($ MILLIONS)

124

Table 47 U.S. MARKET FOR PRODUCTS TO TREAT HYPERCHOLESTEROLEMIA, THROUGH 2011 ($ MILLIONS)

124

PRODUCTS IN DEVELOPMENT FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA

125

Table 48 SELECTED DRUGS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND RELATED CONDITIONS

125

AGI-1067

126

Avasimibe

126

CETi-1

127

ETC-216

127

ETC-588

127

ETC-642

128

FM-VP4

128

KS 01-019

128

Lipitor/Torcetrapib

128

MK-524B

129

OBESITY

129

MARKETED DRUGS FOR THE TREATMENT OF OBESITY

129

Meridia

129

Xenical

130

Other Products

130

THE MARKET FOR DRUGS TO TREAT OBESITY

131

Table 49 GLOBAL MARKET FOR PRESCRIPTION PRODUCTS TO TREAT OBESITY BY PRODUCT, THROUGH 2011 ($ MILLIONS)

131

Table 50 U.S. MARKET FOR PRESCRIPTION PRODUCTS TO TREAT OBESITY, THROUGH 2011 ($ MILLIONS)

132

DRUGS IN DEVELOPMENT FOR THE TREATMENT OF OBESITY

132

Cannabinoid (CB1) Antagonists

133

Table 51 DRUGS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF OBESITY

134

Acomplia

134

ADP356

136

AOD9604

137

ATL-962

137

Cetilistat

137

CP 945598

137

GI 181771

138

HMR 1426

138

P 57

138

Peptide YY3-36

138

S-2367

138

Symlin

139

Tesofensine

139

TM30338

140

Drugs for Other Indications Prescribed Off-Label for the Treatment of Obesity

140

Discontinued Products in Development

140

GlaxoSmithKline Submits Application for an Over-the-Counter Version of Xenical

140

COMPANY PROFILES

141

ABBOTT LABORATORIES

141

BUSINESS OVERVIEW

141

FINANCIAL INFORMATION

141

PRODUCTS

141

CORPORATE STRATEGY

142

AMYLIN PHARMACEUTICALS, INC.

142

BUSINESS OVERVIEW

143

FINANCIAL INFORMATION

143

PRODUCTS

143

CORPORATE STRATEGY

144

ARENA PHARMACEUTICALS, INC.

144

BUSINESS OVERVIEW

145

FINANCIAL INFORMATION

145

PRODUCTS

145

Table 52 ARENA PHARMACEUTICALS DRUG-DEVELOPMENT PIPELINE

146

CORPORATE STRATEGY

146

ATHEROGENICS, INC.

147

BUSINESS OVERVIEW

147

FINANCIAL INFORMATION

147

PRODUCTS

147

CORPORATE STRATEGY

148

BRISTOL-MYERS SQUIBB

149

BUSINESS OVERVIEW

149

FINANCIAL INFORMATION

149

PRODUCTS

149

CORPORATE STRATEGY

150

FERRING PHARMACEUTICALS AS

150

BUSINESS OVERVIEW

150

CORPORATE STRATEGY

151

GLAXOSMITHKLINE, PLC

151

BUSINESS OVERVIEW

151

FINANCIAL INFORMATION

152

PRODUCTS

152

KING PHARMACEUTICALS, INC.

152

BUSINESS OVERVIEW

152

FINANCIAL INFORMATION

152

PRODUCTS

153

CORPORATE STRATEGY

153

KOS PHARMACEUTICALS, INC.

154

BUSINESS OVERVIEW

154

PRODUCTS

154

CORPORATE STRATEGY

155

MERCK & COMPANY, INC.

156

BUSINESS OVERVIEW

156

FINANCIAL INFORMATION

156

PRODUCTS

156