Commercial and Pipeline Insight: Systemic Antifungals

Published by: Datamonitor

Published: Nov. 14, 2007 - 393 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious & Respiratory Disease pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the systemic fungal infection market

Predictable, heavy losses continue but rejuvenation in sight

Patients, drugs, diagnostics and pathogens change market focus

Unmet need will require more inventive trial design to fulfil

Changing spectrum of clinical attractiveness

New blood in top ranks, but Pfizer will increase its lead

Contributing experts

Related reports

Upcoming related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current market situation

Geographical bias

High market concentration of brand sales

Key companies, strategies and approaches

Disease background

The fungal family tree - a history of succession

Pathogens and patients - linking immunocompromise to species

From Candida to Aspergillus and beyond - changing fungal epidemiology

The pathogens of the future: Fusarium and Scedosporium

Patients - drivers of demand

Transplant patients - driving the need for patient and pathogen-specific drug indications

Cancer - a core sector for years to come

HIV - HAART reducing demand, but facing increased azole resistance

Children and neonates - a dearth of basic information

The antifungal drug explosion - new challenges, new opportunities

Amphotericin B - saving lives

Ketoconazole - oral opportunities

Fluconazole - a pharmacological revolution

Caspofungin - a new class and a sign of things to come

Lipid amphotericins - setting the pharmacoeconomic standard

Diagnostics - shaping new management strategies

Conventional technologies - still invaluable tools

Molecular diagnostics: changing the outlook for drug use

Changing treatment paradigms: towards pre-emptive and targeted therapy

Prophylaxis - an indication under threat

Pre-emptive therapy - led by diagnostic advance

Empiric therapy - not enough any more

Directed therapy - the importance of specific and costly indications

Current unmet need - significant, numerous, and specific

Mortality

Pediatric data

More specific data and indications

Clinical trial design

Dealing with limited patient populations

Finding other ways of growing the sample size

Making sure the right patients are included

Confounding underlying disease

Making sure the group is comparable

Avoiding mortality (in all its forms) as an endpoint

Reconsidering trial duration: too short, or too long?

Adequately measuring diagnosis and response

Staying with the times: get molecular

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Seven major markets

Key facts

Opportunities and threats

Genericization of the first wave of safer drugs

Pharmacoeconomic analysis: influencing key decision makers

Which pathogen to look for next?

The commercial flipside: are antifungals worth it?

New treatment guidelines: The IDSA guidelines go international

United States

Key facts

Opportunities and threats

Broader FDA initiatives decrease time to market, but antibiotic scrutiny increases

DTC advertising - ideal for the acute sector, but not for antifungals

Pricing and reimbursement

Japan

Key facts

Opportunities and threats

The threat of foreign competition: enough to force domestic change?

Price cuts - still dominating pricing and reimbursement in Japan

Increasing uptake of generics

Lengthy approval process slows down access to the Japanese market

5EU

Key facts

Opportunities and threats

EMEA drug approval process harmonization

Smaller companies helped by European regulators

France

Opportunities and threats

Germany

Opportunities and threats

Italy

Opportunities and threats

Spain

Opportunities and threats

UK

Opportunities and threats

CHAPTER 4 DRUG ANALYSES AND FORECASTS

7MM overview

Regional contributions

Corporate performance

Pfizer to remain the leader of the pack

Merck and Johnson and Johnson need new options

Astellas and Schering Plough: On the way up with simple propositions

Azoles

Key impact summary

Azole analysis - historical and future outlook and comparative forecasts

Azoles as a proportion of total market value

Regional variations: azole value slump limited to US

Class composition - currently marketed products, new and recent launches and generics

Textbook generic displacement

Generic incursion beginning to stabilize

Marketed product overviews

Diflucan (fluconazole)

Prodif (fosfluconazole)

Sporanox (itraconazole)

Nizoral (ketoconazole)

Noxafil (posaconazole)

Vfend (voriconazole)

Pipeline products

Isavuconazonium chloride (BAL8557)

Others [not forecast]

Echinocandins

Key impact summary

Echinocandin analysis - historical and future outlook

Echinocandins as a proportion of total market value

Class composition - new launches detract from the incumbent

Regional variations: Japan leads the way

Brand overview - a tale of two territories

Marketed product overviews

Cancidas (caspofungin)

Mycamine (micafungin)

Eraxis (anidulafungin)

Pipeline products [not forecast]

HMR-3270 (aminocandin)

Polyenes

Key impact summary

Polyene analysis - historical and future outlook

Polyenes as a proportion of total market value

Regional variations

Class composition

Brand overview

Marketed product overviews

Abelcet (Amphotericin B Lipid Complex)

AmBisome (liposomal AmB)

Other branded polyenes [not forecast]

Pipeline products

SinuNase & BiOral Amphotericin B (AmB Oral and Nasal cochleates)

NKTR-024 (amphotericin B inhalation powder)

Discontinued/withdrawn products

Others

Group overview

Others as a proportion of total market value

Regional sales composition

Branded versus generic and new launch composition

Pipeline products

Mycograb (efungumab)

Others [not forecast]

Forecast methodology

CHAPTER 5 FORECAST ASSUMPTIONS

Patent expiries and generic incursion

Approvals and launches

Other studies

New guidelines

BIBLIOGRAPHY

Presentations

Books

Journal papers

Epidemiology

Trial design and data

Cost efficacy

Diagnosis and Diagnostics

Presentations

Websites

Datamonitor reports

APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS

Summary systemic fungal disease market data

APPENDIX B - MARKET FORECAST DATA

Seven major markets

M5EU

US

Japan

France

Germany

Italy

Spain

UK

APPENDIX C

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the Infectious & Respiratory Disease analysis team

About the Antibacterials analysis team

Key therapy team members

Holger Rovini, Head of Respiratory and Infectious Diseases

Disclaimer

List of Tables

Table 1: Datamonitor product groupings for the systemic fungal infections market

Table 2: 7MM antifungal sales by region by volume and value (%), 2006

Table 3: Key players in the market for systemic fungal infection, 2007

Table 4: Antifungal volume sales leader board by rank, sales and share, 2006

Table 5: Antifungal value sales leader board by rank, sales and share, 2006

Table 6: Predominant and emerging opportunistic fungal pathogens of clinical significance, 2007

Table 7: Types of immunocompromise, causes and associated fungal pathogens

Table 8: Stratified risk groups for invasive Aspergillosis

Table 9: Examples of risk factors associated with invasive fungal infections

Table 10: Galactomannan testing for invasive aspergillosis in hematologic malignancy and allogeneic bone marrow transplant patients

Table 11: Nosocomial bloodstream infection organism distribution in the US, 2004

Table 12: Mortality due to invasive mycoses

Table 13: 7MM antifungal leading brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 14: 7MM leading antifungal brands by volume sales (SUm), 2006 and CAGR growth, 2002-06

Table 15: 7MM pportunities and threats in the antifungals market, 2007

Figure 23: Healthcare spending as a proportion of GDP in the 7MM, 2004

Table 16: The pharmacoeconomics of prophylaxis

Table 17: Definition for Immune Reconstitution Inflammatory Response in Mycoses

Table 18: US leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 19: US leading brands by volume sales (SUm), 2006 and CAGR growth, 2002-06

Table 20: United States: summary of opportunities and threats in the antifungals market, 2007

Table 21: Japan leading brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 22: Japan leading brands by volume sales 2006 (SUm) and CAGR growth, 2002-06

Table 23: Japan: summary of opportunities and threats in the antifungals market, 2007

Table 24: 5EU leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 25: 5EU leading antifungal brands by volume sales (SUm), 2006

Table 26: 5EU Opportunities and Threats in the antifungals market, 2007

Table 27: France leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 28: France leading antifungal brands by volume sales (SUm), 2006

Table 29: France: opportunities and threats in the antifungals market, 2007

Table 30: Germany leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 31: Germany leading antifungal brands by volume sales (SUm), 2006 and CAGR growth, 2002-06

Table 32: Germany: opportunities and threats in the antifungals market. 2007

Table 33: Italy leading antifungal brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 34: Italy leading brands by volume sales 2006 (SUm) and CAGR growth, 2002-06

Table 35: Italy: opportunities and threats in the antifungal market, 2007

Table 36: Spain leading brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 37: Spain leading brands by volume sales (SUm), 2006 and CAGR growth, 2002-06

Table 38: Spain: opportunities and threats in the antifungal market, 2007

Table 39: UK leading brands by value sales ($m), 2006 and CAGR growth, 2002-06

Table 40: UK leading brands by volume sales (SUm), 2006 and CAGR growth, 2002-06

Table 41: UK opportunities and threats in the antifungal market, 2007

Table 42: 7MM antifungal sales - indexed volume and value sales and average pricing, 2002-06

Table 43: Forecast 7MM antifungal sales by volume, value and region, 2006-2016

Table 44: Forecast new launches, existing products and generics by regional contribution, and CAGR (2006-16)

Table 45: Forecast regional sales by new launch, existing product and generic contribution, and CAGR (2006-16)

Table 46: Ranking and shares 2006/16 - Key players by volume and value

Table 47: Market growth by key player, volume and value sales, 2006-16

Table 48: Indexed 7MM azole class sales versus rest of antifungal market, 2002-06

Table 49: Forecast 7MM azole class sales versus rest of antifungal market sales, 2006-2016

Table 50: Indexed azole class sales by region, 2002-06

Table 51: Forecast azole class sales by region, 2006-2016

Table 52: Forecast 7MM azole sales - new launches, existing products and generics, 2006-2016

Table 53: Indexed 7MM azole class sales - key brands and generics, 2002-06

Table 54: Forecast 7MM azole class sales - key brands and generics, 2006-2016

Table 55: Indexed 7MM generic azole volume and value sales, 2002-06

Table 56: Forecast 7MM azole generic sales by molecule and combined brands, 2006-2016

Table 57: Diflucan: Key facts

Table 58: Prodif: Key facts

Table 59: Sporanox: Key facts

Table 60: Nizoral: Key facts

Table 61: Noxafil: Key facts

Table 62: Noxafil (posaconazole) trial data overview, 2007

Table 63: Vfend: Key facts

Table 64: Isavuconazonium chloride: Key facts

Table 65: UR-9825: Key facts

Table 66: E1224: Key facts

Table 67: Ravuconazole: Key facts

Table 68: SSY-726: Key facts

Table 69: Indexed 7MM echinocandin class sales versus rest of antifungal market by volume and value, 2002-06

Table 70: Forecast 7MM echinocandin class sales versus rest of antifungal market by volume and value, 2006-2016

Table 71: Forecast 7MM echinocandin sales - new launches, existing products and generics 2006-2016

Table 72: Indexed echinocandin class volume and value sales by region, 2002-06

Table 73: Forecast 7MM echinocandin sales by region, 2006-2016

Table 74: Key echinocandin brands - indexed 7MM volume and value sales, 2002-06

Table 75: Forecast 7MM echinocandin brand and combined generic sales, 2006-2016

Table 76: Cancidas: Key facts

Table 77: Mycamine: Key facts

Table 78: Eraxis: Key facts

Table 79: HMR-3270: Key facts

Table 80: Indexed 7MM polyene class sales versus rest of antifungal market, 2002-06, 2002-06

Table 81: Forecast 7MM polyene sales versus rest of antifungal market by volume and value sales, 2006-2016

Table 82: Indexed 7MM polyene class sales by region, 2002-06

Table 83: Forecast 7MM polyene volume and value sales by region, 2006-2016

Table 84: Forecast 7MM polyene sales - new launches, existing products and generics, 2006-2016

Table 85: Indexed 7MM polyene class volume and value sales - key brands and generics, 2006

Table 86: Forecast 7MM volume and value polyene brand sales and combined generics, 2006-2016

Table 87: Abelcet: Key facts

Table 88: AmBisome: Key facts

Table 89: Other amphotericin B products

Table 90: SinuNase & BiOral Amphotericin B - Amphotericin B Oral and Nasal cochleates: Key facts

Table 91: NKTR-024 - amphotericin B inhalation powder: Key facts

Table 92: Indexed 7MM other class volume and value sales versus rest of antifungal market, 2002-06,

Table 93: Indexed Other 7MM volume and value sales by region, 2002-06

Table 94: Forecast 7MM volume and value sales of other antifungals by region, 2006-2016

Table 95: Indexed 7MM combined other branded products volume and value sales versus combined generic products, 2002-06

Table 96: Forecast 7MM volume and value Other brand sales and combined generics, 2006-2016

Table 97: Mycograb: Key facts

Table 98: Abelcet patent expiry, 2007-2016

Table 99: AmBisome patent expiry, 2007-2016

Table 100: Caspofungin patent expiry, 2007-2016

Table 101: Diflucan generic incursion, 2007-2016

Table 102: Eraxis patent expiry, 2007-2016

Table 103: Mycamine patent expiry, 2007-2016

Table 104: Noxafil patent expiry I, 2007-2016

Table 105: Vfend patent expiry I, 2007-2016

Table 106: BioOral (amphotericin B cochleate) Launch, 2007-2016

Table 107: SinuNase (amphotericin B cochleate) Launch, 2007-2016

Table 108: BAL8557 Launch, 2007-2016

Table 109: Eraxis: launch, 2007-2016

Table 110: Mycamine: launch, 2007-2016

Table 111: Mycograb: launch, 2007-2016

Table 112: Noxafil: Intravenous formulation launch, 2007-2016

Table 113: Cancidas pharmacoeconomic studies: Caspofungin versus AmB - cost-efficacy, suspected fungal infection/neutropenic fever

Table 114: Cancidas trials: prophylaxis, high-risk liver transplant/leukemia, 2007-2016

Table 115: Cancidas trials: prophylaxis/pre-emptive indications, candidiasis/aspergillosis, 2007-2016

Table 116: Cancidas trials: prophylaxis/pre-emptive indications, critical care indications, 2007-2016

Table 117: Cancidas trials: therapeutic Phase II trial data, pediatric febrile neutropenia I, 2007-2016

Table 118: Eraxis trial data: Anidulafungin/Voriconazole combination trial, 2007-2016

Table 119: Mycamine trial data: Micafungin/Voriconazole combination trial in Aspergillus, 2007-2016

Table 120: New IDSA Guidelines - Aspergillus, 2007

Table 121: New IDSA Guidelines - Blastomycosis/Sporotrichosis/Histoplasmosis, 2007

Table 122: New IDSA Guidelines - Candidiasis, 2007

Table 123: New IDSA Guidelines - Endemic mycoses, 2007

Table 124: New IDSA Guidelines - Prophylaxis, 2007

Table 125: Summary Market Data

Table 126: Seven major market systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 127: M5EU systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 128: US systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 129: Japan systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 130: France systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 131: Germany systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 132: Italy systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 133: Spain systemic fungal infection drug sales ($m) forecasts, 2007-16

Table 134: UK systemic fungal infection drug sales ($m) forecasts, 2007-16

List of Figures

Figure 1: Pharmaceutical sales by therapy area across the seven major markets ($ billion)

Figure 2: Indexed 7MM antifungal market sales by class, 2002-06

Figure 3: Performance of the US, 5EU and Japan antifungal markets, 2002-06

Figure 4: Key brand share of the antifungal market, 2006

Figure 5: Key player shares of core branded antifungal sales (%), 2006

Figure 6: The changing paradigms of the antifungals market, 1950s-2000s

Figure 7: Changing spectrum of invasive candidiasis species: episodes per 1,000 admissions, 1988-1992

Figure 8: Changing spectrum of invasive moulds: incidence per 1,000 patient days, 2000-03

Figure 9: Implications of changes in the management of underlying conditions

Figure 10: Milestones in organ transplant, 1950s-2000s

Figure 11: Timeline of fungal infection risk in solid organ transplant recipients

Figure 12: Availability of neonate data for fluconazole

Figure 13: The antifungal drug explosion - drug development since the 1950s

Figure 14: Cellular targets of antifungal classes

Figure 15: Increased hospital costs associated with Candidemia

Figure 16: (1-3) â-D-Glucan as a marker for invasive mycoses - cutting the time to diagnosis

Figure 17: Fungal infection as a continuum and therapeutic options

Figure 18: Questioning the value of Noxafil as an aspergillosis prophylactic

Figure 19: Prophylaxis, empiric and pre-emptive therapy in the context of duration of neutropenia

Figure 20: Unmet need in invasive fungal disease - high Candida Blood Stream Infection mortality in high-risk patient groups, 2007

Figure 21: Suboptimal diagnosis and outcome measurement reduces potential trial participant population in invasive aspergillosis

Figure 22: 7MM antifungal sales by leading brands versus rest of market by indexed value and volume sales and average price, 2002-06

Figure 24: Key pricing controls used globally, 2006

Figure 25: Net Present Value - why the antifungal pipeline differs from other infectious disease paradigms

Figure 26: Antifungal treatment scenarios - more creative trials with major clinical appeal

Figure 27: US antifungal sales by leading brands versus rest of market by indexed value and volume sales and average price, 2002-06

Figure 28: Decrease of FDA's mean total approval time, 1995-2005

Figure 29: Generic impact of fluconazole and itraconazole patent expiries versus other generic and branded sales on the US antifungals market, 2002-06

Figure 30: Japanese sales by leading brands versus rest of market by indexed value and volume sales and average price, 2002-06

Figure 31: 5EU sales by leading antifungal brands versus rest of market by indexed value and volume sales and average price, 2002-06

Figure 32: 7MM antifungal sales by region: - indexed volume and value sales and average pricing, 2002-06

Figure 33: Forecast 7MM antifungal sales by volume, value and region, 2006-2016

Figure 34: Forecast new launches, existing products and generics by regional contribution, and CAGR (2006-16)

Figure 35: Forecast 7MM antifungals sales by region - new launch, existing product and generic contribution, 2006-2016

Figure 36: Key events impacting the azole class, s2002-2016

Figure 37: Events impacting Azole class members, 2007-2016

Figure 38: Indexed 7MM azole class sales versus rest of antifungal market sales , 2002-06

Figure 39: Forecast 7MM azole class sales versus rest of antifungal market, 2006-2016

Figure 40: Indexed 7MM azole sales by region, 2002-062002-06

Figure 41: Forecast 7MM azole class sales by region, 2006-16

Figure 42: Forecast 7MM azole sales - new launches, existing products and generics, 2006-2016

Figure 43: Indexed 7MM azole class sales - key brands and generics, 2002-06

Figure 44: Forecast 7MM azole class sales - key brands and generics, 2006-2016

Figure 45: Indexed 7MM generic azole volume and value sales, 2002-06

Figure 46: Forecast 7MM azole generic sales by molecule and combined brands, 2006-2016

Figure 47: Diflucan 7MM key metrics - indexed volume and value sales, and average pricing, 2002-06

Figure 48: Prodif 7MM key metrics - indexed volume and value sales, and average pricing, 2002-06

Figure 49: Sporanox 7MM key metrics - indexed volume and value sales, and average pricing, 2002-06

Figure 50: Nizoral 7MM key metrics - indexed volume and value sales, and average pricing, 2002-06

Figure 51: Noxafil 7MM key metrics - indexed volume and value sales, and average pricing, 2002-06

Figure 52: Vfend 7MM key metrics - indexed volume and value sales, and average pricing 2002-06

Figure 53: Key events impacting the echinocandin class events, 2001-2016

Figure 54: Events impacting echinocandin class members, 2007-2016

Figure 55: Indexed 7MM echinocandin sales versus rest of antifungal market sales, 2002-06

Figure 56: Forecast echinocandin sales versus rest of antifungal market 7MM by volume and value, 2006-2016

Figure 57: Forecast 7MM volume and value echinocandin sales -new launches, existing products and generics, 2006-2016

Figure 58: Total echinocandin sales by region, , 2002-06

Figure 59: Forecast 7MM echinocandin sales by region, 2006-2016

Figure 60: Key echinocandin brands and generics - indexed 7MM sales, 2002-06

Figure 61: Forecast 7MM echinocandin brand and combined generic sales, 2006-2016

Figure 62: Cancidas 7MM key metrics - indexed volume and value sales and average pricing, 2002-06

Figure 63: Indexed US branded echinocandin volume and value sales, 2002-06

Figure 64: Mycamine 7MM key metrics - indexed volume and value sales and average pricing, 2002-06

Figure 65: Indexed US echinocandin wholesale pricing tactics by quarter, Q2 2005-Q2 2007

Figure 66: Eraxis 7MM key metrics - indexed volume and value sales, and average pricing 2002-06

Figure 67: Indexed first five quarter volume and value sales, Mycamine versus Eraxis, Q2 2005-Q2 2006

Figure 68: Key events impacting the polyene class, 2002-2014

Figure 69: Events impacting polyene class members, 2007-2016

Figure 70: Indexed 7MM polyene class sales versus rest of antifungal market, 2002-06

Figure 71: Forecast 7MM polyene sales versus rest of antifungal market: key metrics - volume and value sales and average pricing, 2006-2016

Figure 72: Indexed 7MM polyene class sales by region, 2002-06

Figure 73: Forecast 7MM volume and value polyene sales by region, 2006-2016

Figure 74: Forecast 7MM polyene sales - new launches, existing products and generics, 2006-2016

Figure 75: Indexed 7MM polyene class sales - key brands and generics, 2006-

Figure 76: Forecast 7MM volume and value polyene brand sales and combined generics, 2006-2016

Figure 77: Abelcet 7MM key metrics - indexed volume and value sales and average pricing 2002-06

Figure 78: AmBisome 7 Major Markets key metrics - indexed volume and value sales and average pricing 2002-06

Figure 79: AmBisome - indexed volume sales by region, 2002-06

Figure 80: Forecast 7MM volume and value Others brand sales and combined generics, 2006-16

Abstract

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