Antifungal Drugs: Technologies and Global Markets

Antifungal Drugs: Technologies and Global Markets

REPORT HIGHLIGHTS

• The global market for antifungal therapeutics was valued at $10.7 billion in 2011 and is projected to reach $12.2 billion in 2016, a five-year compound annual growth rate (CAGR) of 2.7%.
• The U.S. market accounted for nearly $4.5 billion in 2011 and is projected to total nearly $4.9 billion in 2016, a CAGR of 1.7%
• The European market totaled $3.6 billion in 2011 and is projected to be worth $3.9 billion in 2016, a CAGR of 1.5%.

REPORT SCOPE

INTRODUCTION

STUDY GOALS AND OBJECTIVES

BCC's goal in conducting this study was to determine the current status of the global human antifungal market and assess its growth potential over the five-year period from 2011 to 2016. This report covers approved human therapeutics with a heavy focus on therapeutics in early development. These new molecular and biological entities are from traditional pharmaceutical sources, naturally derived synthetic chemicals and biological sources as well as the "herbal natural folk medicine" marketplace. If an approved or well-known medicine is being studied in combination with another molecular entity, it is considered a "new therapy" and often has been included for review. New drug and patent applications are presented as the study focuses on new methods of drug administration, drug clinical trials, and discovery and development.

It should be noted that there is a strong emphasis on early research given the critical need for new and more effective medicines; hence, BCC is including a section of medicines intended for human utilization that are in the preclinical (animal) models of testing, and information on new and novel in vitro therapies. Greater than 98% of medicines at the preclinical level are terminated prior to their utilization in humans, and the research in this area is vast. We are limiting this research to therapies that depict a positive result or represent a very rare and novel approach worthy of further review from R&D groups.

Our key objective in this report is to present an in-depth analysis of the current human antifungal market and explore its future direction. In the last five years there has been a vast increase in the number of patent applications filed in this area. Between 1990 and 1999 there were six U.S. patents granted-evidence of the evolution of drug resistance and an increasing mortality rate.[1],[2]

REASONS FOR DOING THIS STUDY

Fungi are highly resistant microbiological eukaryotic microorganisms. In other words, they are becoming drug-resistant to the approved compounds and some therapies later in clinical development. The therapies are designed to eradicate them through the various antifungal mechanisms of action, such as disrupting reproductive capabilities, destroying cell walls, or modifying fungal DNA and cell functioning. It is a given fact that infestations in humans, animals, plants and the environment are on the rise, with many having lethal consequences in both the immunocompetent and the immunocompromised. That being the case, BCC was particularly interested in examining the antifungal market growth of developing products depicting efficacy. We are including data regarding the market shift for those products that are now relegated to over-the-counter (OTC) status previously having only been provided by prescription, and to identify new antifungal research, development, new drug applications and novel approaches to the market.

Previously, BCC examined the antifungal market in its 2003 report, PHM029A - The Market for Antifungal Drugs, in PHM029B - Global Markets for Antifungal Agents and in PHM029C - Antifungal Drugs: Technologies and Global Markets. Due to the rapidly changing market, BCC chose to reexamine the marketplace through another analysis and project its new growth potential. Additionally, PHM029A focused only on human fungal diseases and associated antifungals; PHM029B incorporated the marketplace for antifungals in the veterinary, agricultural and environmental industries; and PHM029C focused on human therapeutics with an intensive focus on human therapeutics in the developmental pipeline. PHM029D is an update of PHM029C.

INTENDED AUDIENCE

This report was prepared as a study of the global antifungal marketplace based on fungal infections and infestations with a focus on human therapeutics. Information is presented on the antifungal industry in general, pharmaceuticals and chemical agents, new technology within the market, new and novel drug applications and market-related issues-in many cases actual revenue is given for the period of 2010 and 2011, with projections of trends and compound annual growth rates (CAGRs) 2011 through 2016.

This study will be of significant interest to hospitals, pharmacies, pharmaceutical companies, biopharmaceutical researchers, pharmaceutical company marketing executives, contract research organizations (CROs), chemists, physicians, nurses, physician assistants, pharmaceutical directors, product managers and representatives, all manner of institutional directors ranging from nursing homes and schools to long-term-care facilities both public and private. It will also be of interest to biologists and those interested in the field of mycology.

SCOPE OF REPORT

This study examines human applications both marketed and in the development of antifungal technologies. In an extensive analysis, BCC examines each market segment, presents its current market status, and presents various forecasts for growth over the next five years. Other factors such as Food and Drug Administration (FDA) restrictions, government legislation, fungal resistance, and changes in consumerism such as a greater demand for OTC medications and/or natural and alternative remedies are also highlighted. Our financial and sales analysis focuses on the available figures from 2010 to 2011, with estimates for 2016, including CAGR as a percentage.

METHODOLOGY

Through an extensive industry survey inclusive of online database searches of industry-specific data sources coupled with financial, trade, government and marketing database sources as well as interviews via correspondence or telephone with independent sources comprising companies, government agencies and academic experts, BCC was able to compile data to present our analysis of the antifungal market by market segment.

INFORMATION SOURCES

Of the companies and agencies surveyed, the majority were pharmaceutical or compound manufacturers. Additional information was supplied by known industry or trade sources.

ANALYST CREDENTIALS

Mary Anne Crandall is an expert industry analyst specializing in the pharmaceutical industry for over 20 years. She has completed several in-depth studies on various medical topics requiring both medical expertise and excellent knowledge of the pharmaceutical industry. Ms. Crandall has extensive knowledge in the medical field, has a M.S. in psychology and is currently working on a Ph.D.

• Chapter 1 Introduction
  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Intended Audience
  • Scope of Report
  • Methodology
  • Information Sources
  • Analyst Credentials
  • Related BCC Reports
  • BCC Online Services
  • Disclaimer
• Chapter 2 Summary
  • Summary Table Global Market Forecast for Human Antifungal Therapeutics
  • by Geographic Region, through 2016 ($ Millions)
  • Summary Figure Global Sales of Human Antifungals, 2011 and 2016 ($ Millions)
• Chapter 3 Overview
  • History and Current State of Antifungals
  • Types of Pathogenic Fungi
  • Definition of The Industry
  • Concepts in The Industry
  • Importance of The Industry
  • Product Life Cycles
  • Table 1 Drug Development Lifecycle following Discovery of New Drug
  • Development of Antifungals
  • Fda-Approved Antifungals
  • Azole Antifungals
  • Echinocandins
  • Polyenes
  • Allylamines
  • Miscellaneous Antifungals
  • Future Developments
  • Human Clinical Development, 2009 to 2011
  • New Drug Activity
  • Table 2 Clinical Trials of All New Drug Therapies and Combinations by All
  • Date Fields, 2009-2011
  • Table 3 Selected Global Clinical Trials of All New Drug Therapies That
  • Either Are Completed or Estimated to Be Completed between 2009 and 2012
  • Active or Completed Studies Posted or Updated, 2009 to 2011
  • Table 4 Active or Completed Studies, 2009-2011
• Chapter 4 Introduction to Industry Applications of Antifungal Medicinal
  • Therapeutics
  • Scope of Applications: Human Healthcare
  • Human Fungal Infections
  • Risk Factors for Developing Fungal Infections
  • Table 5 Risk Factors Associated with Human Fungal Infections
  • Fungal Species That Cause Infection in Humans
  • Candidiasis
  • Cutaneous Candidiasis
  • Chronic Mucocutaneous Candidiasis
  • Gi Tract Candidiasis
  • Respiratory Tract Candidiasis
  • Genitourinary Tract Candidiasis
  • Hepatosplenic Candidiasis
  • Systemic Candidiasis
  • Candidemia
  • Disseminated Candidiasis
  • Aspergillosis
  • Blastomycosis
  • Coccidioidomycosis
  • Cryptococcosis
  • Dermatophytosis
  • Histoplasmosis
  • Onychomycosis
  • Paracoccidioidomycosis
  • Pseudallescheriasis
  • Sporotrichosis
  • Zygomycosis
  • Table 6 Incidence of Common Fungal Diseases
  • More Rare Fungal Infections and Disorders
  • Literature Review
  • Fungal Drug Resistance
  • Current Drug Resistance S: A Global View
  • Mdr Species
  • Literature Review
  • Table 7 Common Reasons for Fungal Resistance
  • Strategies to Improve Response and Decrease Mortality
  • Literature Review
• Chapter 5 Human Antifungal Agents
  • Table 8 Global Market Forecast for Human Antifungal Consumption by
  • Product Type, through 2016 ($ Millions)
  • Classes of Antifungals
  • Echinocandins
  • Literature Review
  • Azoles
  • Literature Review
  • Polyenes
  • Literature Review
  • Other
  • Table 9 Global Antifungal Pharmaceutical Sales: Triazoles and
  • Echinocandins Versus Other Antifungals through 2016 ($ Millions)
  • Table 10 Pharmaceutical Antifungals by Class/Mechanism of Action (%)
  • Figure 1 Percentage of Recognized Antifungal Drugs (%)
  • Table 11 Major Antifungal Agents by Class and Average Sales Price per
  • Dosage, 2009
  • Table 12 Fungal Infection and Traditional Pharmaceutical Remedy
  • Table 13 Type of Candidal Infection and Pharmaceutical Treatment
  • Side Effects
  • Table 14 Life-Threatening Side Effects from Antifungal Pharmaceuticals
  • Otc Antifungal Preparations
  • Table 15 Common Fungal Infections and Otc Routes of Administration
  • Natural Antifungal Remedies
  • Types of Natural Antifungal Remedies
  • Herbal Remedies
  • Enzyme-Based Antifungal Agents
  • Table 16 Common Natural Antifungals
  • Summary of Selected Natural Antifungals
  • Aloe
  • Literature Review
  • Curcumin
  • Literature Review
  • Mint
  • Literature Review
  • Wild Marjoram
  • Literature Review
  • Radish
  • Literature Review
  • Parnafungins
  • Literature Review
  • Ginseng
  • Literature Review
  • Walnut
  • Literature Review
  • Pau D'arco
  • Literature Review
  • Garlic
  • Literature Review
  • Grapefruit Seed
  • Literature Review
  • Olive Leaf
  • Literature Review
  • Goldenseal
  • Literature Review
  • Oregano
  • Literature Review
  • Tea Tree
  • Literature Review
  • Natural Remedies in Earlier Development
  • Literature Review
  • Laboratory Testing and Histopathology for Fungal Infections in
  • Humans
  • Specimen Examination
  • Cultures
  • Blood Serology
  • Alternative Healthcare Approaches to Testing and Diagnosis of Fungal Infections
  • Cam Testing and Specialized Laboratories
  • Questionnaire for Symptoms
• Chapter 6 Common Environmental Fungi
  • Molds and The Human Issues They Produce
  • Why Environmental Mold Is A Unique Problem
  • Health Risks Due to Environmental Fungi and Mold
  • Table 17 Common Health Symptoms Based on Environmental Fungi and Molds
  • Table 18 Risk Factors Association with Environmental Mold Reactions
  • Table 19 Common Source Locations for Environmental Molds
  • Environmental Molds
  • Alternaria
  • Literature Review
  • Aspergillus
  • Literature Review
  • Cladosporium
  • Literature Review
  • Penicillium
  • Literature Review
  • Eurotium
  • Literature Review
  • Rhizopus
  • Literature Review
  • Mucor
  • Literature Review
  • Geotrichum
  • Literature Review
  • Fusarium
  • Literature Review
  • Stachybotrys
  • Literature Review
  • Wallemia
  • Literature Review
  • Trichothecium
  • Literature Review
  • Scopulariopsis Brevicaulis
  • Literature Review
  • Scytalidium Dimidiatum
  • Literature Review
  • Trichoderma
  • Literature Review
  • Paecilomyces Variotii
  • Literature Review
• Chapter 7 Government Regulatory Agencies and Professional Associations
  • Government Regulations
  • Fda
  • Table 20 Antifungal Warning Letters for The Human Segment from The Fda
  • to Manufacturers, 1997-2011
  • Epa
  • Usda
  • Food and Agriculture Organization of The United Nations
  • Professional Associations
  • Medical and Veterinary Associations
  • Agricultural Associations
  • Other Environmental Associations
• Chapter 8 Antifungal Companies
  • Human Healthcare
  • Pharmaceutical Manufacturers
  • Table 21 Major Global Manufacturers of Human Antifungal Pharmaceuticals
  • Figure 2 Global Antifungal Pharmaceutical Manufacturers by Country (%)
  • Major Pharmaceutical Manufacturer Profiles
  • Table 22 Competitive Market Share by Percent, 2011 (%)
  • Figure 3 Competitive Market Share by Percent, 2011 (%)
  • Astellas Pharma, Inc.
  • Bayer Healthcare
  • Enzon Pharmaceuticals
  • Galderma Pharma Sa/Galderma Sa
  • Gilead Sciences, Inc.
  • Medicis Pharmaceutical Corp.
  • Novartis International Ag
  • Pfizer, Inc.
  • Taro Pharmaceutical Industries, Ltd.
  • Teva Pharmaceutical Industries, Ltd.
  • Otc Antifungal Manufacturers
  • Pharmaceutical Otc Market
  • Table 23 Major Human Otc Antifungal Manufacturers and Products
  • Major Pharmaceutical-Based Otc Manufacturer Profiles
  • Alva-Amco Pharmacal
  • Blaine Labs
  • Dartmouth Pharmaceuticals
  • Del Laboratories
  • Ganeden Biotech
  • Kramer Laboratories
  • Novartis International Ag
  • Ortho Mcneil
  • Pedinol Pharmacal, Inc.
  • Stiefel Laboratories
  • Tarmac Products
  • Alternative Otc Manufacturers
  • Table 24 Commonly Available Alternative Antifungals
  • Major Alternative Otc Manufacturer Profiles
  • Aquaflora
  • Crystal Star Herbal Nutrition
  • Enzymedica
  • Forest Herbs Research
  • Garden of Life
  • Michael's Naturopathic Programs
  • Nature's plus
  • Now Foods
  • Nutrition Now
  • Prosymbiotics
  • Pure Essence Laboratories
  • Rainbow Light
  • Renew Life
  • Solaray
  • Vitanica
• Chapter 9 Antifungal Industry
  • Antifungal Market Trends: Human Healthcare
  • Accelerating Antifungal Drug Development
  • Table 25 New Prescription Antifungals, 2005-january 2012
  • Increased Types of Testing
  • Need to Increase Use and Acceptance of Newer Drugs
  • Experimental Research: Clinical Trials Performed and Selected
  • Preclinical and in Vivo Studies
  • A General Overview of Non-Pharmaceutical Antifungal Technologies
  • Laser and Photodynamic Therapy
  • Studies
  • Literature Review
  • Mabs
  • Diagnostics and Assays
  • Literature Review
  • Computer Modeling Technology
  • Literature Review
  • R&d Section: An Overview of Products in Development
  • Table 26 Antifungals in Development
  • Trends in Class Used and Administration Method
  • Table 27 Pharmaceutical Antifungals by Route of Administration, 2011 (%)
  • Figure 4 Pharmaceutical Antifungals by Route of Administration, 2011 (%)
  • Table 28 Global Market Forecast for Antifungal Pharmaceutical Products by
  • Route of Administration, through 2016 ($ Millions)
  • Utilization of Otc and Natural/Alternative Antifungal Agents
  • Shifting Market from Prescription to Otc
  • Market Demand for Otc Products
• Chapter 10 Patent Analysis
  • Purpose of A Patent Analysis
  • Due Care in Reviewing The Patent Analysis
  • New Antifungal Patents Issued
  • Table 29 U.S. Antifungal Patent Trends, 1990-2009 (Number of Patents Issued)
  • Table 30 New U.S. Antifungal Patents Issued, 2007-2012
  • Table 31 Assignees of Two or More U.S. Patents for Antifungal Products, 2007-2011
  • Table 32 U.S. Patent Trends by Country, 2007-2011 (Quantity/%)
  • Figure 5 U.S. Patent Trends by Country, 2007-2011 (%)
  • Trends in Patent Applications
  • Table 33 U.S. Patent Applications by Antifungal Mechanism of Action, 2007-2011
  • Figure 6 U.S. Patent Applications by Antifungal Mechanism of Action, 2007
  • through 2011 (%)
  • Table 34 New U.S. Patent Applications, 2007-2011
  • Table 35 Recent Trends in Patent Applications for Antifungals by Mechanism of Action, 2007-2011
  • Table 36 U.S. Patent Application Trends by Country, 2007-2011
  • Figure 7 U.S. Antifungal Patent Applications by Country 2007-2011 (%)
  • Patent Expirations
  • Table 37 Patent Expirations 2006-2018
• Chapter 11 Appendix
  • Table 38 Pharmaceutical Companies
• List of Tables
  • Summary Table Global Market Forecast for Human Antifungal Therapeutics
  • by Geographic Region, through 2016 ($ Millions)
  • Table 1 Drug Development Lifecycle following Discovery of New Drug
  • Table 2 Clinical Trials of All New Drug Therapies and Combinations by All
  • Date Fields, 2009-2011
  • Table 3 Selected Global Clinical Trials of All New Drug Therapies That Either
  • Are Completed or Estimated to Be Completed between 2009 and 2012
  • Table 4 Active or Completed Studies, 2009-2011
  • Table 5 Risk Factors Associated with Human Fungal Infections
  • Table 6 Incidence of Common Fungal Diseases
  • Table 7 Common Reasons for Fungal Resistance
  • Table 8 Global Market Forecast for Human Antifungal Consumption by
  • Product Type, through 2016 ($ Millions)
  • Table 9 Global Antifungal Pharmaceutical Sales: Triazoles and
  • Echinocandins Versus Other Antifungals through 2016 ($ Millions)
  • Table 10 Pharmaceutical Antifungals by Class/Mechanism of Action (%)
  • Table 11 Major Antifungal Agents by Class and Average Sales Price per Dosage, 2009
  • Table 12 Fungal Infection and Traditional Pharmaceutical Remedy
  • Table 13 Type of Candidal Infection and Pharmaceutical Treatment
  • Table 14 Life-Threatening Side Effects from Antifungal Pharmaceuticals
  • Table 15 Common Fungal Infections and Otc Routes of Administration
  • Table 16 Common Natural Antifungals
  • Table 17 Common Health Symptoms Based on Environmental Fungi and Molds
  • Table 18 Risk Factors Association with Environmental Mold Reactions
  • Table 19 Common Source Locations for Environmental Molds
  • Table 20 Antifungal Warning Letters for The Human Segment from The Fda to
  • Manufacturers, 1997-2011
  • Table 21 Major Global Manufacturers of Human Antifungal Pharmaceuticals
  • Table 22 Competitive Market Share by Percent, 2011 (%)
  • Table 23 Major Human Otc Antifungal Manufacturers and Products
  • Table 24 Commonly Available Alternative Antifungals
  • Table 25 New Prescription Antifungals, 2005-january 2012
  • Table 26 Antifungals in Development
  • Table 27 Pharmaceutical Antifungals by Route of Administration, 2011 (%)
  • Table 28 Global Market Forecast for Antifungal Pharmaceutical Products by
  • Route of Administration, through 2016 ($ Millions)
  • Table 29 U.S. Antifungal Patent Trends, 1990-2009 (Number of Patents Issued)
  • Table 30 New U.S. Antifungal Patents Issued, 2007-2012
  • Table 31 Assignees of Two or More U.S. Patents for Antifungal Products, 2007-2011
  • Table 32 U.S. Patent Trends by Country, 2007-2011 (Quantity/%)
  • Table 33 U.S. Patent Applications by Antifungal Mechanism of Action, 2007-2011
  • Table 34 New U.S. Patent Applications, 2007-2011
  • Table 35 Recent Trends in Patent Applications for Antifungals by Mechanism of Action, 2007-2011
  • Table 36 U.S. Patent Application Trends by Country, 2007-2011
  • Table 37 Patent Expirations 2006-2018
  • Table 38 Pharmaceutical Companies
• List of Figures
  • Summary Figure Global Sales of Human Antifungals, 2011 and 2016 ($ Millions)
  • Figure 1 Percentage of Recognized Antifungal Drugs (%)
  • Figure 2 Global Antifungal Pharmaceutical Manufacturers by Country (%)
  • Figure 3 Competitive Market Share by Percent, 2011 (%)
  • Figure 4 Pharmaceutical Antifungals by Route of Administration, 2011 (%)
  • Figure 5 U.S. Patent Trends by Country, 2007-2011 (%)
  • Figure 6 U.S. Patent Applications by Antifungal Mechanism of Action, 2007
  • through 2011 (%)
  • Figure 7 U.S. Antifungal Patent Applications by Country 2007-2011 (%)