The Market for Antifungal Drugs

Lynn Gray

Published April 2003

INTRODUCTION

STUDY GOAL AND OBJECTIVES

This report provides an in-depth look at the prescription and over-the-counter (OTC) markets for systemic and topical antifungal drugs. This report focuses on currently available systemic and topical antifungal drugs, as well as novel drugs in development. The dramatic increase in the incidence of fungal infections as well as the problem of drug resistance, and its effect on drug usage are explored. Analysis of products and companies participating in and changing this market is provided, and revenue forecasts are provided through 2007. Forecasts of the current prescription and OTC antifungals market are provided. Forecasts and trends are gleaned from industry sources as well as from considered assessment of emerging products and technologies.

REASONS FOR DOING THE STUDY

The market for antifungal agents is a steadily growing sector driven largely by an expanding population of immunocompromised patients and the rollout of novel products. The loss of patent protection for the top-selling antifungal agent Diflucan (Pfizer) will mix up the market and allow for the likely emergence of newly introduced products, such as Cancidas (Merck) and Vfend (Pfizer), as market leaders. The appearance of acquired immune deficiency syndrome (AIDS) and the increasing number of patients treated with cancer chemotherapy drugs in the past few decades have created an ever-expanding number of immunocompromised individuals who are at risk for opportunistic infections. As a result, opportunistic infections are at the forefront of important and often life-threatening diseases. In addition, an increasing percentage of fungi are developing resistance to available treatments. There exists a need for safer and more effective drugs to treat serious systemic fungal infections, particularly in immunocompromised individuals, and to develop drugs that address drug-resistant organisms. New classes of of antifungal agents are being developed with the first of the products in these new classes introduced in 2001. This report provides an overview of recently introduced and in-development products and their potential impact on the antifungals market. Also discussed are prescription antifungal agents switched from Rx to OTC status and their effect on treatment of diseases and the healthcare system.

CONTRIBUTIONS OF THE STUDY AND FOR WHOM

This report provides an analysis of the prescription market for systemic and topical antifungals, as well as the OTC market for topical antifungal agents. The report information needed to understand the impact of new products on clinical use and the marketplace. This report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investor consultants, and anyone interested in the current and emerging antifungals market, its products, its industry participants, and its future.

SCOPE AND FORMAT

This report focuses on marketed and in-development products to treat fungal diseases. The Overview chapter provides a comprehensive summary of the most clinically significant fungal diseases in humans, their incidence, pathology, and treatment, as well as a discussion of those diseases and organisms for which drug resistance is a problem. Also discussed are the categories of available and emerging antifungal agents and their mechanism of action.

The Products chapter provides detailed discussion of leading antifungal agents and agents in development, how they differ from older products and their potential impact on treatment and the market.

The Applications chapter provides an overview of specific fungal diseases, the agents used to treat them and the markets for these applications.

The Industry chapter provides a breakdown of the worldwide market for antifungal drugs, as well as market share information about leading companies in this sector.

The Company Profiles chapter provides a close look at companies currently participating in the antifungals market and those with products in development.

Trends are assessed based on projected sales for new products and must necessarily be estimates, since the timing of introduction and cost of these agents is not certain.

Included in this report are sales for the year 2001 by antifungal drug class and forecasts from 2002 through 2007, including supporting analyses for projections.

METHODOLOGY

The base year for this study is 2002. Market figures are based on revenues at the manufacturers' level and are projected at 2002 dollar value (i.e., inflation is not computed into the projection figures).

Information to prepare this study was derived from information obtained from product managers, marketing strategists, and research executives. In addition, information also was obtained from others at leading pharmaceutical and biotechnology companies that compete in the market for prescription and OTC antifungal drugs or have products in development for this market.

INFORMATION SOURCES

The information and analysis presented in this report are based on an extensive survey of the pharmaceutical industry as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, pharmaceutical trade associations, and national and world health organizations. Key information from the business literature was used as to obtain expert opinion on commercial potential and market sizes from industry professionals.

AUTHOR'S CREDENTIALS

Lynn Gray has been a research analyst since 1989 and with BCC since 1996. During that time, she has authored numerous reports in the biomedical field, 18 for BCC alone. BA, University of California, Riverside, 1973.

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TABLE OF CONTENTS

INTRODUCTION	XV
STUDY GOAL AND OBJECTIVES	XV
REASONS FOR DOING THE STUDY	XV
CONTRIBUTIONS OF THE STUDY AND FOR WHOM	XVI
SCOPE AND FORMAT	XVI
METHODOLOGY	XVII
INFORMATION SOURCES	XVII
AUTHOR'S CREDENTIALS	XVII
RELATED BCC WORK CREDENTIALS INCLUDING WORK DONE BY OTHER AUTHORS	XVII
BCC ON-LINE SERVICES	XVIII
INTERNET	XVIII
SUMMARY	XX
Summary Table: U.S. SALES OF ANTIFUNGAL DRUGS, BY CATEGORY, THROUGH 2007 ($ MILLIONS)	XX
Summary Figure: U.S. MARKET FOR ANTIFUNGAL DRUGS, BY CATEGORY, 2001, 2002, AND 2007 ($ MILLIONS)	XXI
OVERVIEW	1
THE CLINICAL THREAT OF FUNGAL INFECTIONS	1
Table 1 INCIDENCE OF DISEASES CAUSED ANNUALLY BY SELECTED FUNGAL PATHOGENS, U.S.	2
Table 2 INCIDENCE OF CANDIDAL BLOODSTREAM ISOLATED IN THE SICU AND NICU (%)	2
Table 3 CANDIDA SPECIES INFECTION INCIDENCE OVER TIME (%)	3
INFECTION SITES	3
Table 4 INCIDENCE OF FUNGAL INFECTIONS BY SITE, 1987-1988 TO 1993-1994 (%)	3
DOMINANT CLINICALLY SIGNIFICANT SPECIES	4
Endemic Mycoses	4
Opportunistic Mycoses	4
Increase in Incidence of Invasive Mycoses	4
Causes of Nosocomial Fungal Infections	5
Patients Most at Risk for Nosocomial Infections	6
Emerging Nosocomial Opportunistic Fungal Infections	6
DIFFICULTY IN DIAGNOSING AND TREATING FUNGAL INFECTIONS	6
Need for Reliable, Standardized Susceptibility Testing	7
Advances in Diagnostics for Fungal Diseases	8
Serodiagnostics	9
THE THREAT OF RESISTANCE	10
A PHARMACOECONOMIC ANALYSIS OF ANTIFUNGAL THERAPY	10
THE EMPIRIC NATURE OF ANTIFUNGAL THERAPY	11
STRATEGIES TO IMPROVE RESPONSE AND DECREASE MORTALITY	11
PRE-EMPTIVE THERAPY	12
TYPES OF FUNGAL INFECTIONS	13
SYSTEMIC FUNGAL INFECTIONS	13
PROGRESSION OF INFECTION	13
DIAGNOSIS OF SYSTEMIC FUNGAL INFECTIONS	13
THE MOST COMMON SYSTEMIC FUNGAL INFECTIONS IN IMMUNOCOMPROMISED PATIENTS	14
GEOGRAPHIC DISTRIBUTION OF SYSTEMIC FUNGAL INFECTIONS	14
THE MOST CLINICALLY SIGNIFICANT SYSTEMIC FUNGAL INFECTIONS	15
Aspergillosis	15
Categories of Infection	16
Noninvasive Disease	16
Primary Superficial Invasive Aspergillosis	17
Invasive Pulmonary Aspergillosis	17
Disseminated Aspergillosis	17
Diagnosis	17
Treatment	17
Treatment (Continued)	18
Treatment (Continued)	19
The War on Aspergillosis	20
Blastomycosis	20
Categories of Disease	21
Treatment	21
Candidiasis (Systemic)	21
Table 5 DISTRIBUTION OF CANDIDA BLOODSTREAM ISOLATES IN SELECTED GEOGRAPHIC AREAS	22
Categories of Disease	23
Candidemia and Disseminated Candidiasis	24
Endocarditis, Myocarditis and Pericarditis	24
Esophageal Candidiasis	24
Gastrointestinal Candidiasis	24
Hepatic and Hepatosplenic Candidiasis	24
Intertrigo Candidiasis	25
Meningitis (Candidal)	25
Mucocutaneous Candidiasis	25
Neonatal and Congenital Candidiasis	25
Ocular Candidiasis	25
Oropharyngeal Candidiasis	25
Osteoarticular Candidiasis	26
Paronychial Candidiasis	26
Peritonitis (Candidal)	26
Pulmonary Candidiasis	26
Renal Candidiasis	26
Urinary Tract Candidiasis	27
Vulvovaginal Candidiasis	27
Diagnosis	27
Table 6 AVAILABLE LABORATORY TESTS FOR PRESUMPTIVE IDENTIFICATION OF CANDIDA	28
Treatment	28
Table 7 ACTIVITY OF FLUCONAZOLE AND ITRACONAZOLE AGAINST BLOODSTREAM ISOLATES OF CANDIDA SPECIES	29
Resistance Among Candidas Species	29
Table 8 SUSCEPTIBILITY OF NOSOCOMIAL AND COMMUNITY-ACQUIRED CANDIDA BLOODSTREAM ISOLATES (%)	30
Chromomycosis and Phaeohyphomycosis	30
Treatment	31
Coccidioidomycosis	31
Categories of Disease	31
Treatment	32
Cryptococcosis	32
Treatment	33
Histoplasmosis	34
Categories of Disease	35
Acute Primary Histoplasmosis	35
Progressive Disseminated Histoplasmosis	35
Chronic Cavitary Histoplasmosis	35
Diagnosis	36
Treatment	36
Mucormycosis	36
Treatment	37
Mycetoma	37
Treatment	37
Paracoccidioidomycosis	37
Treatment	38
Pneumocystis Carinii Pneumonia	38
Treatment	39
Sporotrichosis	39
Treatment	39
Other Opportunistic Systemic Fungal Infections	40
DERMATOLOGIC FUNGAL INFECTIONS	40
DERMATOPHYTE INFECTIONS	40
Tinea Barbae	41
Treatment	41
Tinea Capitis	41
Treatment	41
Tinea Corporis	42
Treatment	42
Tinea Cruris	42
Treatment	42
Tinea Pedis	43
Treatment	43
Tinea Unguium	43
Treatment	44
YEAST INFECTIONS	44
Candidiasis	44
Treatment	45
Tinea Versicolor	45
Treatment	45
GYNECOLOGIC FUNGAL INFECTIONS	45
CANDIDIASIS	46
Treatment	46
Table 9 DRUGS USED TO TREAT VAGINAL CANDIDIASIS	46
NASO-ORAL FUNGAL INFECTIONS	47
TREATMENT	47
PATIENT POPULATIONS MOST SUSCEPTIBLE TO SYSTEMIC FUNGAL INFECTIONS	47
Table 10 FACTORS PREDISPOSING PATIENTS TO FUNGAL INFECTION	48
Table 11 SURVEILLANCE STRATEGIES FOR IDENTIFICATION OF FUNGAL INFECTIONS IN AT-RISK PATIENTS	48
PATIENTS WITH ACQUIRED IMMUNE DEFICIENCY SYNDROME	49
Table 12 SIGNIFICANT MYCOSES IN PATIENTS WITH AIDS	49
CANCER PATIENTS	50
Table 13 RISK CATEGORIES FOR INVASIVE FUNGAL INFECTIONS IN CANCER PATIENTS	50
Bone Marrow and Stem Cell Transplant Patients	51
Bone Marrow and Stem Cell Transplant Patients (Continued)	52
CATEGORIES OF SYSTEMIC ANTIFUNGAL DRUGS	53
ALLYLAMINES AND OTHER NONAZOLE ERGOSTEROL BIOSYNTHESIS INHIBITORS	53
ANTIMETABOLITES	53
AZOLES	53
ECHINOCANDINS (GLUCAN SYNTHESIS INHIBITORS)	54
POLYENES	54
CATEGORIES OF TOPICAL ANTIFUNGAL AGENTS	54
THE USE OF LONG-TERM THERAPY	54
TAKING ANTIFUNGAL DRUGS OVER THE COUNTER-GREATER CONVENIENCE BUT ALSO HIGHER COSTS TO CONSUMERS	55
PRODUCTS	56
ANTIFUNGAL AGENTS ON THE MARKET IN 2002	56
Table 14 PRESCRIPTION BRANDED ANTIFUNGAL DRUGS ON THE MARKET, 2002	56
Table 15 SELECTED PRESCRIPTION ANTIFUNGAL DRUGS: WORLDWIDE SALES, 2001 AND 2002 ($ MILLIONS)	57
Table 16 PATENT EXPIRATION OF LEADING ANTIFUNGAL AGENTS	58
Table 17 WORLDWIDE SALES OF PRESCRIPTION SYSTEMIC ANTIFUNGAL DRUGS, BY CATEGORY: THROUGH 2007 ($ MILLIONS)	58
Figure 1 PERCENTAGE OF THE WORLDWIDE PRESCRIPTION ANTIFUNGAL DRUGS, BY CATEGORY, 2002 AND 2007 (%)	59
SYSTEMIC ANTIFUNGAL AGENTS	59
Table 18 PREFERRED DRUGS FOR THE TREATMENT OF SYSTEMIC FUNGALINFECTIONS	60
Table 19 USE OF DRUGS TO TREAT SYSTEMIC FUNGAL INFECTIONS, BY COUNTRY, 2000 (%)	60
ALLYLAMINES AND OTHER NONAZOLE ERGOSTEROL BIOSYNTHESIS INHIBITORS	61
Amorolfine	61
Butenafine	61
Terbinafine	61
ANTIMETABOLITES	62
Flucytosine	62
AZOLES	62
Fluconazole	63
Itraconazole	64
Ketoconazole	64
Voriconazole	65
ECHINOCANDINS	66
Caspofungin	66
Synergistic Effects	67
Shortages	67
Market Potential	67
POLYENES	68
Amphotericin B	68
Lipid Formulations	68
Pharmacoeconomics of Lipid Formulations Versus Conventional Amphotericin B	69
The Market for AmBisome and Amphotec	70
The Market for Amphotericin B Products	70
Table 20 THE MARKET FOR AMPHOTERICIN B PRODUCTS: WORLDWIDE SALES, THROUGH 2007 ($ MILLIONS)	70
OTHERS	70
Griseofulvin	70
TOPICAL ANTIFUNGAL AGENTS	71
ALLYLAMINES AND OTHER NONAZOLE ERGOSTEROL BIOSYNTHESIS INHIBITORS	71
Butenafine	71
Terbinafine	72
AZOLES	72
OTHER PRODUCTS	73
Ciclopirox	73
Lithium Succinate	73
Haloprogin	73
Tolnaftate	73
THE U.S. MARKET FOR PRESCRIPTION TOPICAL ANTIFUNGAL AGENTS	73
Table 21 THE MARKET FOR PRESCRIPTION TOPICAL ANTIFUNGAL PRODUCTS: U.S. SALES, THROUGH 2007 ($ MILLIONS)	74
GENERIC ANTIFUNGAL DRUGS	74
Table 22 ANTIFUNGAL AGENTS AMONG THE TOP-SELLING PRESCRIPTION GENERIC DRUGS IN THE U.S., 2001	74
Table 23 ESTIMATES OF MARKET SHARE OF PRESCRIPTION GENERIC ANTI-FUNGAL DRUGS, U.S., THROUGH 2007	75
OVER-THE-COUNTER ANTIFUNGAL AGENTS	75
Table 24 THE MARKET FOR OTC TOPICAL ANTIFUNGAL DRUGS: U.S. SALES, THROUGH 2007 ($ MILLIONS)	76
RX-TO-OTC SWITCHES	76
Table 25 RX-TO-OTC SWITCHES OF ANTIFUNGAL DRUGS, BY MANUFACTURER AND YEAR, 1975-2002	77
Rx-to-OTC Switches (Continued)	78
Potential Rx-to-OTC Switches	79
Table 26 ANTIFUNGAL RX-TO-OTC SWITCH CANDIDATES	79
Potential Rx-to-OTC Switches (Continued)	80
The Market for Rx-to-OTC Switches	81
Table 27 MARKET FOR BRAND NAME OTC ANTIFUNGALS CONTAINING RX-TO-OTC SWITCHED INGREDIENTS: U.S., THROUGH 2007 ($ MILLIONS)	81
The Market for Generic OTC Switched Ingredients	82
Table 28 MARKET FOR OTC GENERIC ANTIFUNGALS CONTAINING RX-TO-OTC SWITCHED INGREDIENTS: U.S., THROUGH 2007 ($ MILLIONS)	82
Table 29 THE MARKET FOR RX-TO-OTC ANTIFUNGAL DRUGS: U.S., THROUGH 2007 ($ MILLIONS)	83
Figure 2 THE MARKET FOR RX-TO-OTC ANTIFUNGAL DRUGS: U.S., 2002 AND 2007 (%)	83
Competitor Analysis	83
Table 30 OTC ANTIFUNGALS MANUFACTURER MARKET SHARE BY REVENUES, 2001 (%)	84
Figure 3 OTC ANTIFUNGALS MANUFACTURER MARKET SHARE BY REVENUES, 2001 (%)	84
Table 31 LEADING SUPPLIERS OF RX-TO-OTC SWITCHED ANTIFUNGALS, 2001	85
ANTIFUNGAL AGENTS IN DEVELOPMENT	85
Table 32 ANTIFUNGAL DRUGS IN CLINICAL DEVELOPMENT	85
Table 32 (CONTINUED)	86
SYSTEMIC AGENTS	86
Allylamines	87
Butenafine	87
Azoles	87
Second-Generation Azoles	87
Posaconazole	87
Ravuconazole	87
Azoles Used in Combination with Immunosuppressants	88
Echinocandins	88
Anidulafungin	88
Anidulafungin (Continued)	89
Caspofungin	90
Micafungin	90
Other Systemic Agents	90
MBI 226	91
Oramed	91
P-113	91
PLD-118	92
UK-292-663	93
The Possibility of an Antifungal Vaccine	93
TOPICAL AGENTS	94
EcoNail	94
Extina	94
Mentax	95
THE ROLE OF GENOMICS AND PROTEOMICS IN THE DEVELOPMENT OF NEW ANTIFUNGAL DRUGS	95
OBSTACLES TO THE DEVELOPMENT OF ANTIFUNGAL DRUGS	95
Obstacles to the Development of Antifungal Drugs (Continued)	96
APPLICATIONS	97
DERMATOLOGIC FUNGAL INFECTIONS	97
ONYCHOMYCOSIS	97
Table 33 AVERAGE WHOLESALE PRICE OF ITRACONAZOLE AND TERBINAFINE FOR THE TREATMENT OF ONYCHOMYCOSIS ($)	97
PARONYCHIA	98
TINEA DISEASES	98
Tinea Pedis	98
Table 34 THE MARKET FOR OTC TOPICAL ANTIFUNGAL DRUGS TO TREAT TINEA PEDIS: U.S., THROUGH 2007 ($ MILLIONS)	99
VAGINAL FUNGAL INFECTIONS	99
Table 35 DOSING REGIMENS OF ANTIFUNGAL AGENTS USED TO TREAT VAGINAL CANDIDIASIS	100
Table 36 LEADERS IN THE U.S. OTC VAGINAL ANTIFUNGALS MARKET: SALES AND UNIT VOLUME, 2001 ($ MILLIONS, RETAIL)	101
THE U.S. MARKET FOR OTC VAGINAL ANTIFUNGAL TREATMENTS	101
Table 37 THE U.S. MARKET FOR OTC VAGINAL ANTIFUNGAL DRUGS, THROUGH 2007 ($ MILLIONS)	102
INDUSTRY	103
REGIONAL SALES OF ANTIFUNGAL DRUGS	103
Table 38 PERCENTAGE OF SALES OF ANTIFUNGAL DRUGS BY GEOGRAPHIC REGION, 2001 (%)	103
Figure 4 PERCENTAGE OF SALES BY GEOGRAPHIC REGION, 2001	103
LEADERS IN THE PRESCRIPTION ANTIFUNGAL DRUG MARKET	104
Figure 5 MARKET SHARES OF LEADING COMPANIES IN THE ANTIFUNGAL DRUG MARKET, 2001 AND 2007	104
COMPANY PROFILES	105
BRISTOL-MYERS SQUIBB COMPANY	105
BUSINESS OVERVIEW	105
FINANCIAL INFORMATION	105
PRODUCTS	105
COMPANY STRATEGY	106
CONNETICS CORPORATION	106
BUSINESS OVERVIEW	106
FINANCIAL INFORMATION	106
PRODUCTS	107
COMPANY STRATEGY	107
Company Strategy (Continued)	108
DEMEGEN, INC.	109
BUSINESS OVERVIEW	109
FINANCIAL INFORMATION	109
PRODUCTS	109
Table 39 DEMEGEN'S PRODUCT PIPELINE	110
CORPORATE STRATEGY	110
FUJISAWA PHARMACEUTICAL COMPANY, LTD.	110
BUSINESS OVERVIEW	110
FINANCIAL INFORMATION	111
PRODUCTS	111
Table 40 FUJISAWA'S PRODUCT PIPELINE	112
Table 40 (CONTINUED)	113
GILEAD SCIENCES INC.	113
BUSINESS OVERVIEW	113
FINANCIAL INFORMATION	114
PRODUCTS	114
Table 41 GILEAD'S PRODUCT PIPELINE	115
CORPORATE STRATEGY	115
INTERMUNE, INC.	116
BUSINESS OVERVIEW	116
FINANCIAL INFORMATION	116
PRODUCTS	117
Table 42 INTERMUNE'S PRODUCT PIPELINE	117
JOHNSON & JOHNSON	118
BUSINESS OVERVIEW	118
FINANCIAL INFORMATION	118
PRODUCTS	119
CORPORATE STRATEGY	119
MACROCHEM CORPORATION	119
BUSINESS OVERVIEW	119
FINANCIAL INFORMATION	119
PRODUCTS	120
Table 43 MACROCHEM'S PRODUCT PIPELINE	121
CORPORATE STRATEGY	121
MICROLOGIX BIOTECH INC.	121
BUSINESS OVERVIEW	121
FINANCIAL INFORMATION	121
PRODUCTS	122
Table 44 MICROLOGIX'S PRODUCT PIPELINE	123
COMPANY STRATEGY	123
Company Strategy (Continued)	124
MYLAN LABORATORIES, INC.	125
BUSINESS OVERVIEW	125
FINANCIAL INFORMATION	125
PRODUCTS	126
CORPORATE STRATEGY	126
NOVARTIS	127
BUSINESS OVERVIEW	127
FINANCIAL INFORMATION	127
PRODUCTS	128
CORPORATE STRATEGY	128
PFIZER CORPORATION	128
BUSINESS OVERVIEW	128
FINANCIAL INFORMATION	128
LEADING PRODUCTS	129
CORPORATE STRATEGY	130
SCHERING-PLOUGH CORPORATION	131
BUSINESS OVERVIEW	131
FINANCIAL INFORMATION	131
LEADING PRODUCTS	131
Table 45 SCHERING-PLOUGH'S PRODUCT PIPELINE	132
CORPORATE STRATEGY	133
VERSICOR, INC.	133
BUSINESS OVERVIEW	133
FINANCIAL INFORMATION	133
LEADING PRODUCT CANDIDATES	133
Table 46 VERSICOR'S PRODUCT PIPELINE	134
CORPORATE STRATEGY	134
Corporate Strategy (Continued)	135
LIST OF TABLES
Summary Table: WORLDWIDE SALES OF ANTIFUNGAL DRUGS, BY CATEGORY, THROUGH 2007 ($ MILLIONS)	XX
Table 1 INCIDENCE OF DISEASES CAUSED ANNUALLY BY SELECTED FUNGAL PATHOGENS, U.S.	2
Table 2 INCIDENCE OF CANDIDAL BLOODSTREAM ISOLATED IN THE SICU AND NICU (%)	2
Table 3 CANDIDA SPECIES INFECTION INCIDENCE OVER TIME (%)	3
Table 4 INCIDENCE OF FUNGAL INFECTIONS BY SITE, 1987-1988 TO 1993-1994 (%)	3
Table 5 DISTRIBUTION OF CANDIDA BLOODSTREAM ISOLATES IN SELECTED GEOGRAPHIC AREAS	22
Table 6 AVAILABLE LABORATORY TESTS FOR PRESUMPTIVE IDENTIFICATION OF CANDIDA	28
Table 7 ACTIVITY OF FLUCONAZOLE AND ITRACONAZOLE AGAINST BLOODSTREAM ISOLATES OF CANDIDA SPECIES	29
Table 8 SUSCEPTIBILITY OF NOSOCOMIAL AND COMMUNITY-ACQUIRED CANDIDA BLOODSTREAM ISOLATES (%)	30
Table 9 DRUGS USED TO TREAT VAGINAL CANDIDIASIS	46
Table 10 FACTORS PREDISPOSING PATIENTS TO FUNGAL INFECTION	48
Table 11 SURVEILLANCE STRATEGIES FOR IDENTIFICATION OF FUNGAL INFECTIONS IN AT-RISK PATIENTS	48
Table 12 SIGNIFICANT MYCOSES IN PATIENTS WITH AIDS	49
Table 13 RISK CATEGORIES FOR INVASIVE FUNGAL INFECTIONS IN CANCER PATIENTS	50
Table 14 PRESCRIPTION BRANDED ANTIFUNGAL DRUGS ON THE MARKET, 2002	56
Table 15 SELECTED PRESCRIPTION ANTIFUNGAL DRUGS: WORLDWIDE SALES, 2001 AND 2002 ($ MILLIONS)	57
Table 16 PATENT EXPIRATION OF LEADING ANTIFUNGAL AGENTS	58
Table 17 WORLDWIDE SALES OF PRESCRIPTION SYSTEMIC ANTIFUNGAL DRUGS, BY CATEGORY: THROUGH 2007 ($ MILLIONS)	58
Table 18 PREFERRED DRUGS FOR THE TREATMENT OF SYSTEMIC FUNGALINFECTIONS	60
Table 19 USE OF DRUGS TO TREAT SYSTEMIC FUNGAL INFECTIONS, BY COUNTRY, 2000 (%)	60
Table 20 THE MARKET FOR AMPHOTERICIN B PRODUCTS: WORLDWIDE SALES, THROUGH 2007 ($ MILLIONS)	70
Table 21 THE MARKET FOR PRESCRIPTION TOPICAL ANTIFUNGAL PRODUCTS: U.S. SALES, THROUGH 2007 ($ MILLIONS)	74
Table 22 ANTIFUNGAL AGENTS AMONG THE TOP-SELLING PRESCRIPTION GENERIC DRUGS IN THE U.S., 2001	74
Table 23 ESTIMATES OF MARKET SHARE OF PRESCRIPTION GENERIC ANTI-FUNGAL DRUGS, U.S., THROUGH 2007	75
Table 24 THE MARKET FOR OTC TOPICAL ANTIFUNGAL DRUGS: U.S. SALES, THROUGH 2007 ($ MILLIONS)	76
Table 25 RX-TO-OTC SWITCHES OF ANTIFUNGAL DRUGS, BY MANUFACTURER AND YEAR, 1975-2002	77
Table 26 ANTIFUNGAL RX-TO-OTC SWITCH CANDIDATES	79
Table 27 MARKET FOR BRAND NAME OTC ANTIFUNGALS CONTAINING RX-TO-OTC SWITCHED INGREDIENTS: U.S., THROUGH 2007 ($ MILLIONS)	81
Table 28 MARKET FOR OTC GENERIC ANTIFUNGALS CONTAINING RX-TO-OTC SWITCHED INGREDIENTS: U.S., THROUGH 2007 ($ MILLIONS)	82
Table 29 THE MARKET FOR RX-TO-OTC ANTIFUNGAL DRUGS: U.S., THROUGH 2007 ($ MILLIONS)	83
Table 30 OTC ANTIFUNGALS MANUFACTURER MARKET SHARE BY REVENUES, 2001 (%)	84
Table 31 LEADING SUPPLIERS OF RX-TO-OTC SWITCHED ANTIFUNGALS, 2001	85
Table 32 ANTIFUNGAL DRUGS IN CLINICAL DEVELOPMENT	85
Table 33 AVERAGE WHOLESALE PRICE OF ITRACONAZOLE AND TERBINAFINE FOR THE TREATMENT OF ONYCHOMYCOSIS ($)	97
Table 34 THE MARKET FOR OTC TOPICAL ANTIFUNGAL DRUGS TO TREAT TINEA PEDIS: U.S., THROUGH 2007 ($ MILLIONS)	99
Table 35 DOSING REGIMENS OF ANTIFUNGAL AGENTS USED TO TREAT VAGINAL CANDIDIASIS	100
Table 36 LEADERS IN THE U.S. OTC VAGINAL ANTIFUNGALS MARKET: SALES AND UNIT VOLUME, 2001 ($ MILLIONS, RETAIL)	101
Table 37 THE U.S. MARKET FOR OTC VAGINAL ANTIFUNGAL DRUGS, THROUGH 2007 ($ MILLIONS)	102
Table 38 PERCENTAGE OF SALES OF ANTIFUNGAL DRUGS BY GEOGRAPHIC REGION, 2001 (%)	103
Table 39 DEMEGEN'S PRODUCT PIPELINE	110
Table 40 FUJISAWA'S PRODUCT PIPELINE	112
Table 41 GILEAD'S PRODUCT PIPELINE	115
Table 42 INTERMUNE'S PRODUCT PIPELINE	117
Table 43 MACROCHEM'S PRODUCT PIPELINE	121
Table 44 MICROLOGIX'S PRODUCT PIPELINE	123
Table 45 SCHERING-PLOUGH'S PRODUCT PIPELINE	132
Table 46 VERSICOR'S PRODUCT PIPELINE	134
LIST OF FIGURES
Summary Figure: U.S. MARKET FOR ANTIFUNGAL DRUGS, BY CATEGORY, 2001, 2002, AND 2007 ($ MILLIONS)	XXI
Figure 1 PERCENTAGE OF THE WORLDWIDE PRESCRIPTION ANTIFUNGAL DRUGS, BY CATEGORY, 2002 AND 2007 (%)	59
Figure 2 THE MARKET FOR RX-TO-OTC ANTIFUNGAL DRUGS: U.S., 2002 AND 2007 (%)	83
Figure 3 OTC ANTIFUNGALS MANUFACTURER MARKET SHARE BY REVENUES, 2001 (%)	84
Figure 4 PERCENTAGE OF SALES BY GEOGRAPHIC REGION, 2001	103
Figure 5 MARKET SHARES OF LEADING COMPANIES IN THE ANTIFUNGAL DRUG MARKET, 2001 AND 2007	104