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]
- 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 62: Noxafil (posaconazole) trial data overview, 2007
- 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 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 89: Other amphotericin B products
- 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 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) β-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
- Table 58: Prodif: Key facts
- Figure 48: Prodif 7MM key metrics - indexed volume and value sales,
and average pricing, 2002-06
- Table 59: Sporanox: Key facts
- Figure 49: Sporanox 7MM key metrics - indexed volume and value sales,
and average pricing, 2002-06
- Table 60: Nizoral: Key facts
- Figure 50: Nizoral 7MM key metrics - indexed volume and value sales,
and average pricing, 2002-06
- Table 61: Noxafil: Key facts
- Figure 51: Noxafil 7MM key metrics - indexed volume and value sales,
and average pricing, 2002-06
- Table 63: Vfend: Key facts
- Figure 52: Vfend 7MM key metrics - indexed volume and value sales, and
average pricing 2002-06
- 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
- 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
- Table 76: Cancidas: Key facts
- 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
- Table 77: Mycamine: Key facts
- 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
- Table 78: Eraxis: Key facts
- 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
- Table 79: HMR-3270: Key facts
- 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
- Table 87: Abelcet: Key facts
- Figure 77: Abelcet 7MM key metrics - indexed volume and value sales
and average pricing 2002-06
- Table 88: AmBisome: Key facts
- 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
- Table 90: SinuNase & BiOral Amphotericin B - Amphotericin B Oral
and Nasal cochleates: Key facts
- Table 91: NKTR-024 - amphotericin B inhalation powder: Key facts
- Figure 80: Forecast 7MM volume and value Others brand sales and
combined generics, 2006-16
- Table 97: Mycograb: Key facts
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