New Drug Futures 2009

Publication Date	April 2009
Publisher	Espicom
Product Type	Report
Pages	450
ISBN Number	978-1-85822-347-6
Product Code	ESP00184

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Summary

The search - and need - for new products has never been greater and what's in the development pipeline has never generated more interest.

Major Therapy Areas Analysed

Anti-infectives
Cardiovascular
CNS
Gastrointestinal
Metabolic
Musculoskeletal
Oncology

Respiratory This 450-page report evaluates, compares and contrasts the prospects for the development compounds that will revolutionise the pharmaceutical industry over the next 5 years and beyond. That is why this analysis is so important!

The Report Provides:

Detailed background and market context for each therapy area covered:

- Addressable patient population
- Current treatments
- Sales drivers
- Sales breakers
- Future treatments
- Market dynamics - winners and losers
- Key drug launches by 2013

Unique sales forecasts by major product to 2013
over 70 key products assessed
Unique evaluation scores for key areas such as novelty of mechanism, clinical data and competition
Critical and detailed appraisal of each product's research and development

The Global Pharma Market in Context

Too few novel products and an aggressive generic sector are taking their toll ... Are there too many prophets of doom ready to write-off the research-based pharma industry in the future?

There is plenty on which to base such anxiety. The research-based industry must achieve a fair price in the face of greater cost control, while the burden of regulation is setting the bar high for successful product introduction. Meanwhile, the generics sector is eating away at ageing and established portfolios.

IT is a fair assessment to say that the industry has rested too much on its laurels and successful product portfolios. for too many years, too few novel medicines have been brought to market, laying the foundations for the industry's current ills.

Can IT Be Different?

The increasing number of biologicals that are coming to market have real potential for clinical and commercial progress, and while there is an innovation gap until new biological products make their market presence felt, there are considerable reasons to view the future more positively. A considered evaluation of the research pipeline shows that the future can be brighter than many pundits predict.
Essential analysis of 110 products that could change the face of the market
over 70 winning drugs have been identified that could be launched by 2013. Products come from over 35 companies, ranging from multinationals and specialty pharma, to biopharmaceuticals and biotechnology companies.

Will They Make IT?

Our estimates assume products will gain approval for the indications we have forecast in the timeframe analysed. However, regulatory demands and pressures on cost and development budgets increasingly mean safe and effective medicines are not brought to market. That is why we provide a unique analysis of each product, examining its novelty of mechanism, clinical data, competitive environment, the experience of the developer and risks associated with development within that therapeutic class.

This Report Is Essential Reading for Industry Planners and Investors

Anyone wanting an insightful analysis of the products and companies that will shape the global pharmaceutical industry over the next 5 years need look no further than this report.

Content

Global Pharma Market Shares
- Cardiovascular
- Central Nervous System
- Oncology
- Anti-infectives
- Respiratory
- Gastrointestinal
- Musculoskeletal
- Metabolic
- Others
  - Pharma manufacturers
  - Therapy areas
  - Global trends in the pharmaceutical market
- emerging markets
- Generic competition
- Biosimilar agents to have limited short-term impact
- Pricing and reimbursement
- Payor pressures increasing in the US
- Europe set to remain a tough pricing environment
- Japan
- Pipeline productivity
Anti-Infectives Overview
- Antibiotics
- Antivirals
- Antifungals
  - Addressable patient population
- Bacterial infection
- Fungal infections
- Viral infections
- Human immunodeficiency virus (HIV)
- Hepatitis B (HBV)
- Hepatitis C (HCV)
- Herpes
  - Current treatments
- Bacterial infection
- Fungal infection
- Superficial infection
- Systemic infections
- Viral infections
- Human immunodeficiency virus (HIV)
- Hepatitis B (HBV)
- Hepatitis C (HCV)
- Herpes
  - Sales drivers
  - Sales breakers
  - Future treatments
  - Market dynamics - winners and losers
- Antibiotics
- Antifungals
- Antivirals
  - Key anti-infective drug launches by 2013
- albuferon
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor ratio analysis
- boceprevir
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor ratio analysis
- elvitegravir
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor ratio analysis
- telaprevir
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor ratio analysis
- vicriviroc
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor ratio analysis
- Zeftera
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor ratio analysis
  - Competitor Ratio Analysis Summary
Cardiovascular Overview
- Addressable patient population
- Current treatments
Arrhythmia/Atrial Fibrillation
Dyslipidaemia
Hypertension
Thrombosis
- Sales drivers
- Sales breakers
- Future treatments
Arrhythmia
Dyslipidaemia
Hypertension
Thrombosis
- Market dynamics - winners and losers
- Key cardiovascular drug launches by 2013
Apixaban
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Ave-5530
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Azilsartan Medoxomil
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Brilinta
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Cordaptive/Tredaptive
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Effient
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
Competitor Ratio Analysis
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Multaq
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competito ratio analysis
Octaparine
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Pradaxa
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Sch-530348
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Xarelto
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
Competitor Ratio Analysis Summary
CNS Overview
- Alzheimer's disease
- ADHD
- Depression & anxiety
- Epilepsy
- Insomnia
- Migraine
- Multiple sclerosis
- Pain
- Parkinson's disease
- Schizophrenia
  - Addressable patient population
  - Current treatments
- Alzheimer's disease
- ADHD
- Depression and anxiety
- Epilepsy
- Insomnia
- Migraine
- Multiple sclerosis
- Pain
- Parkinson's disease
- Schizophrenia
  - Sales drivers
  - Sales breakers
  - Future treatments
- Alzheimer's disease
- ADHD
- Depression & anxiety
- Epilepsy
- Insomnia
- Migraine
- Multiple sclerosis
- Pain
- Parkinson's disease
- Schizophrenia
  - Market dynamics - winners and losers
- Alzheimer's disease
- ADHD
- Depression & anxiety
- Epilepsy
- Insomnia
- Migraine
- Multiple sclerosis
- Pain
- Parkinson's disease
- Schizophrenia
  - Key CNS drug launches by 2013
- almorexant
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- bapineuzumab
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- bG-12
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- comfyde
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- dirucotide
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- fingolimod
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- lurasidone
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- neurelan
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Sales forecasts and assumptions
- Competitor ratio analysis
- nuvigil
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- ralfinamide
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- retigabine
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- rikelta
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- Saphris
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- saredutant
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- tapentadol
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- telcagepant
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- valdoxan
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
  - Competitor Ratio Analysis Summary
Gastrointestinal Overview
- Acid-related disorders
- Inflammatory bowel disease
- Irritable bowel syndrome
  - Addressable patient population
- Acid-related disorders
- Irritable bowel syndrome
  - Current treatments
- Acid-related disorders
- Inflammatory bowel disease
- Irritable bowel syndrome
  - Sales drivers
- Acid-related disorders
- Inflammatory bowel disease
- Irritable bowel syndrome
  - Sales Breakers
- Acid-related disorders
- Inflammatory bowel disease
- Irritable bowel syndrome
  - Future treatments
- Acid-related disorders
- Inflammatory bowel disease
- Irritable bowel syndrome
  - Market dynamics - winners and losers
  - Key gastrointestinal drug launches by 2013
- adX10059
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- kapidex dr
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- linaclotide
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- rezular
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- vedolizumab
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
  - Competitor Ratio Analysis Summary
Metabolic Overview
- Insulins
- Non-insulin diabetes agents
- Obesity
  - Addressable patient population
- Type II diabetes
- Type I diabetes
- Obesity
  - Current treatments
- Diabetes
- Insulins
- Non-insulin diabetes agents
- Obesity
  - Sales drivers
- Diabetes
- Obesity
  - Sales breakers
- Diabetes
- Obesity
  - Future treatments
- Insulins
- Non insulin diabetes agents
- Obesity
  - Market dynamics - winners and losers
- Insulins
- Non-insulin diabetes agents
- Obesity
  - Key metabolic drug launches by 2013
- alogliptin
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- byetta lar
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- dapagliflozin
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- lixisenatide
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- lorcaserin
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- metaglidasen
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- onglyza
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- velneperit
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- victoza
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
  - Competitor Ratio Analysis Summary
Musculoskeletal Overview
- Addressable patient population
Rheumatoid Arthritis
Osteoarthritis
Osteoporosis
- Current treatments
Rheumatoid Arthritis
Osteoarthritis
Osteoporosis
- Sales drivers
- Sales breakers
- Future treatments
Rheumatoid Arthritis
Osteoarthritis
Osteoporosis
- Market dynamics - winners and losers
- Key musculoskeletal drug launches by 2013
Actemra
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Azerra - Ra
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Denosumab
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Fablyn/Oporia
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Golimumab
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Ocrelizumab
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Viviant
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
- Competitor Ratio Analysis Summary
Oncology Overview
- Addressable patient population
- Current treatments
Chemotherapy
Alkylating Agents
Anti-Metabolites
Topoisomerase Inhibitors
Antimitotics
Targeted Therapies
Hormonal Therapies
Supportive Care
- Oncology sales drivers
- Oncology sales breakers
- Future treatments
Oncology Supportive Care
- Market dynamics - winners and losers
- Key oncology drug launches by 2013
Afinitor
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Aflibercept
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Armala
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Arzerra
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Bosutinib
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Deforolimus
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Elesclomol
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Eribulin
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Ipilimumab
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Pertuzumab
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Pixantrone
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
Zactima
Novelty/Rationale for Mechanism of Action
Proof of Concept/Clinical Data
Management/Clinical Expertise
Competition within The Marketplace/Gaining Share of Voice
Risks Associated with Developing A Drug within A Therapeutic Class
Filings and Approval
Sales Forecasts and Assumptions
Competitor Ratio Analysis
- Competitor Ratio Analysis Summary
Respiratory Overview
- Asthma
- Rhinitis
- COPD
  - Addressable patient population
- Asthma
- COPD
- Rhinitis
  - Current treatments
- Asthma
- COPD
- Rhinitis
  - Future treatments
- Asthma
- COPD
- Rhinitis
  - Respiratory sales drivers
- Asthma
- COPD
  - Respiratory sales breakers
- Asthma
- COPD
  - Market dynamics - winners and losers
  - Key respiratory drug launches by 2013
- aclidinium bromide
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- daxas
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- Glycopyrronium bromide
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- indacaterol
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
  - Competitor Ratio Analysis Summary
Acronyms
Footnotes
Index of Tables
- Table 1 Estimated 2007 market value by therapeutic category, and forecast market value by therapeutic category, 2008-2013 (US$ billion)
- Table 2 Generics in major European markets
- Table 3 Number of hospital-treated infections in key markets (millions)
- Table 4 Top ten antibiotics worldwide (based on 2007 sales)
- Table 5 Major drugs used in the treatment of fungal infection
- Table 6 Major drugs used in the treatment of HIV infection
- Table 7 Major drugs used in the treatment of HBV infection
- Table 8 Major drugs used in the treatment of hepatitis C
- Table 9 Major drugs used in the treatment of herpes infection
- Table 10 Success rates of drug development by therapeutic area
- Table 11 Mid- to late-stage antibiotic drugs in development
- Table 12 Mid- to late-stage antifungal drugs in development
- Table 13 Mid- to late-stage antiviral drugs in development
- Table 14 ACHIEVE 2/3 results (ITT basis)
- Table 15 Forecast sales of Albuferon (US$m)
- Table 16 SVR rates of all ITT patients at weeks 24 and 48, HCV SPRINT-1 study
- Table 17 Forecast sales of boceprevir (US$m)
- Table 18 Forecast sales of elvitegravir (US$m)
- Table 19 Interim analysis of study 107 in prior treatment-failure patients
- Table 20 Forecast sales of telaprevir (US$m)
- Table 21 Forecast sales of vicriviroc (US$m)
- Table 22 Forecast sales of Zeftera (US$m)
- Table 23 Cardiovascular conditions and current therapies available
- Table 24 Major drugs used in the treatment of arrhythmia/AF
- Table 25 Major drugs used in the treatment of dyslipidaemia
- Table 26 Major drugs used in the treatment of hypertension
- Table 27 Major antiplatelet agents used in the treatment of thrombosis
- Table 28 Major LMWHs used in the treatment of thrombosis
- Table 29 Major US cardiovascular patent expiries expected in 2008-2013
- Table 30 Mid- to late-stage drugs for the treatment of arrhythmia
- Table 31 Mid- to late-stage drugs in development for the treatment of dyslipidaemia
- Table 32 Mid- to late-stage drugs in development for the treatment of hypertension
- Table 33 Mid- to late-stage drugs in development for the treatment or prevention of thrombosis
- Table 34 Phase III EXPANSE programme
- Table 35 Forecast sales of apixaban (US$m)
- Table 36 Forecast sales of AVE-5530 (US$m)
- Table 37 Forecast sales of azilsartan medoxomil (US$m)
- Table 38 28-day results of DISPERSE trial with Brilinta
- Table 39 Forecast sales of Brilinta (US$m)
- Table 40 Percentage change from baseline in lipids across weeks 12 through 24
- Table 41 Forecast sales of Cordaptive (US$m)
- Table 42 Key efficacy results from the TRITON-TIMI 38 study
- Table 43 Key safety data from the TRITON-TIMI 38 study
- Table 44 Forecast sales of Effient (US$m)
- Table 45 Forecast sales of idrabiotaparinux (US$m)
- Table 46 Phase III programme for Multaq
- Table 47 Forecast sales of Multaq (US$m)
- Table 48 Forecast sales of octaparine (US$m)
- Table 49 RE-VOLUTION clinical trial programme
- Table 50 RE-NOVATE major results
- Table 51 RE-MOBILIZE results
- Table 52 PETRO results
- Table 53 Forecast sales of Pradaxa (US$m)
- Table 54 PCI cohort: bleeding results
- Table 55 CABG cohort: bleeding results
- Table 56 PCI cohort: cardiac events
- Table 57 Forecast sales of SCH-530348 (US$m)
- Table 58 RECORD 3: major efficacy endpoints
- Table 59 RECORD 3: major safety endpoints
- Table 60 RECORD 1: key results
- Table 61 RECORD 2: key results
- Table 62 ODIXa-DVT study: major results
- Table 63 EINSTEIN-DVT study: major results
- Table 64 Xarelto late-stage development summary
- Table 65 Forecast sales of Xarelto (US$m)
- Table 66 Worldwide prevalence of CNS disorders
- Table 67 Major drugs marketed for the treatment of Alzheimer's disease
- Table 68 Major drugs marketed for ADHD
- Table 69 Major drugs marketed for the treatment of depression
- Table 70 Major drugs marketed for the treatment of epilepsy
- Table 71 Major drugs marketed for the treatment of insomnia
- Table 72 Major drugs marketed for the treatment of migraine
- Table 73 Major drugs used in the treatment of multiple sclerosis
- Table 74 Major drugs used in the treatment of neuropathic pain
- Table 75 Major drugs used in the treatment of Parkinson's disease
- Table 76 Major drugs used in the treatment of schizophrenia
- Table 77 Mid- to late-stage drugs in development for Alzheimer's disease
- Table 78 Mid- to late-stage drugs in development for ADHD
- Table 79 Mid- to late-stage drugs in development for the treatment of depression and anxiety
- Table 80 Mid- to late-stage drugs in development for the treatment of epilepsy
- Table 81 Mid- to late-stage drugs in development for the treatment of insomnia
- Table 82 Mid- to late-stage drugs in development for the treatment of migraine
- Table 82 Mid- to late-stage drugs in development for the treatment of multiple sclerosis
- Table 83 Mid- to late-stage drugs in development for the treatment of pain
- Table 84 Mid- to late-stage drugs in development for the treatment of Parkinson's disease
- Table 85 Mid- to late-stage drugs in development for the treatment of schizophrenia
- Table 86 Almorexant Phase II data
- Table 87 Forecast sales of almorexant (US$m)
- Table 88 Forecast sales of bapineuzumab (US$m)
- Table 89 Forecast sales of BG-12 (US$m)
- Table 90 Ciltyri Phase III programme
- Table 91 Ciltyri Phase III data
- Table 92 Forecast sales of Ciltyri (US$m)
- Table 93 Forecast sales of Comfyde (US$m)
- Table 1 Forecast sales of dirucotide (US$m)
- Table 94 Forecast sales of fingolimod (US$m)
- Table 95 Forecast sales of lurasidone (US$m)
- Table 96 Forecast sales of Neurelan (US$m)
- Table 97 Average baseline sleep latency and change from baseline at final visit (MWT and MSLT in minutes)
- Table 98 Clinical Global Impression of Change (CGI-C; percentage of patients who improved at final visit)
- Table 99 Forecast sales of Nuvigil (US$m)
- Table 100 Ralfinamide Phase II: efficacy in peripheral neuropathic pain
- Table 101 Ralfinamide Phase II: efficacy in NCET
- Table 101 Forecast sales of ralfinamide (US$m)
- Table 102 Forecast sales of retigabine (US$m)
- Table 103 Rikelta Phase II clinical data
- Table 104 Forecast sales of Rikelta (US$m)
- Table 105 Forecast sales of Saphris (US$m)
- Table 106 Saredutant in MDD: safety in Phase III completed studies
- Table 107 Forecast sales of saredutant (US$m)
- Table 108 Forecast sales of tapentadol (US$m)
- Table 109 Results from placebo-controlled Phase III trial
- Table 110 Results from Phase III trial with comparison to Zomig
- Table 111 Two-hour response rates with telcagepant versus Maxalt and placebo
- Table 112 Sustained pain freedom results with telcagepant versus Maxalt and placebo
- Table 112 Forecast sales of telcagepant (US$m)
- Table 113 Valdoxan dose-ranging trial
- Table 114 Summary of efficacy studies for Valdoxan in treatment of MDD included in original MAA submission
- Table 115 Forecast sales of Valdoxan (US$m)
- Table 116 Major drugs used in the treatment of acid-related GI disorders
- Table 117 Major drugs used in the treatment of IBD
- Table 118 Major drugs marketed for the treatment of IBS
- Table 119 Mid- to late-stage drugs in development for the treatment of GORD and related disorders
- Table 120 Mid- to late-stage drugs in development for the treatment of IBD
- Table 121 Mid- to late-stage drugs in development for IBS
- Table 122 Forecast sales of ADX10059 in GORD (US$m)
- Table 123 Forecast sales of Kapidex DR (US$m)
- Table 124 Forecast sales of linaclotide (US$m)
- Table 125 Forecast sales of Rezular (US$m)
- Table 126 Forecast sales of vedolizumab (US$m)
- Table 127 Major insulin products used in the treatment of diabetes
- Table 128 Major non-insulin agents for the treatment of Type II diabetes
- Table 129 Major drugs marketed for the treatment of obesity
- Table 130 Mid- to late-stage insulins in development
- Table 131 Mid- to late-stage non insulin diabetes agents in development
- Table 132 Mid- to late-stage drugs in development for the treatment of obesity
- Table 133 Phase III alogliptin data summary
- Table 134 Forecast sales of alogliptin (US$m)
- Table 135 Forecast sales of Byetta LAR (US$m)
- Table 136 Mean changes from baseleine at week 12
- Table 137 Forecast sales of dapagliflozin (US$m)
- Table 138 Forecast sales of lixisenatide (US$m)
- Table 139 Weight change: day 85 - baseline (completer analysis)
- Table 140 Lorcaserin Phase IIb Adverse Events >5% in Any Group
- Table 141 Forecast sales of lorcaserin (US$m)
- Table 142 Forecast sales of metaglidasen (US$m)
- Table 143 Forecast sales of Onglyza (US$m)
- Table 144 Forecast sales of velneperit (US$m)
- Table 145 Key LEAD 3 data
- Table 146 Key LEAD 4 data
- Table 147 Key LEAD 6 data
- Table 148 Forecast sales of Victoza (US$m)
- Table 149 Major DMARDs used in the treatment of rheumatoid arthritis
- Table 150 Major drugs used in the treatment of osteoarthritis
- Table 151 Major drugs used in the treatment of osteoporosis
- Table 152 Mid- to late-stage drugs in development for the treatment of rheumatoid arthritis
- Table 153 Mid- to late-stage drugs in development for the treatment of osteoarthritis
- Table 154 Mid- to late-stage drugs in development for the treatment of osteoporosis
- Table 155 Roche's Phase III programme for Actemra
- Table 156 Forecast sales of Actemra (US$m)
- Table 157 Forecast sales of Arzerra in rheumatoid arhritis (US$m)
- Table 158 Phase III denosumab versus Fosamax head-to-head safety results
- Table 159 Forecast sales of denosumab (US$m)
- Table 160 Analysis of time-to-first new/worsening radiographic vertebral fracture
- Table 161 Forecast sales of Fablyn (US$m)
- Table 162 Golimumab RA Phase III programme
- Table 163 Anti-TNF agents in the treatment of RA
- Table 164 Forecast sales of golimumab (US$m)
- Table 165 Forecast sales of ocrelizumab (US$m)
- Table 166 Forecast sales of Viviant (US$m)
- Table 167 Leading sites of new cancer cases and deaths worldwide 2007
- Table 168 Major alkylating agents used in the treatment of cancer
- Table 169 Major anti-metabolites used in the treatment of cancer
- Table 170 Major topoisomerase inhibitors used in the treatment of cancer
- Table 171 Major antimitotic agents used in the treatment of cancer
- Table 172 Targeted agents used in the treatment of cancer
- Table 173 Major hormonal therapies used in the treatment of cancer
- Table 174 Major drugs used in the supportive care of cancer
- Table 175 Mid- to late-stage agents in development for the treatment of cancer (excluding cancer vaccines)
- Table 176 Mid- to late-stage drugs in development for supportive care indications
- Table 177 Key growth drivers within the oncology market
- Table 178 Forecast sales of Afinitor (US$m)
- Table 179 Regulatory submissions for aflibercept
- Table 180 Forecast sales of aflibercept (US$m)
- Table 181 Forecast sales of Armala (US$m)
- Table 182 Phase I/II NHL trial results summary
- Table 183 Forecast sales of Arzerra in CLL (US$m)
- Table 184 Forecast sales of Arzerra in NHL (US$m)
- Table 185 Forecast sales of Bosutinib (US$m)
- Table 186 Forecast sales of deforolimus (US$m)
- Table 187 Phase IIb study results of elesclomol in metastatic melanoma
- Table 188 Forecast sales of elesclomol (US$m)
- Table 189 Forecast sales of eribulin (US$m)
- Table 190 Forecast sales of ipilimumab (US$m)
- Table 191 Forecast sales of pertuzumab (US$m)
- Table 192 Forecast sales of pixantrone (US$m)
- Table 193 Zactima Phase III programme in NSCLC
- Table 194 Forecast sales of Zactima (US$m)
- Table 195 Major drugs used in the treatment of asthma
- Table 197 Major drugs used in the treatment of COPD
- Table 196 Major drugs used in the treatment of rhinitis
- Table 198 Mid- to late-stage drugs in development for the treatment of asthma
- Table 199 Mid- to late-stage drugs in development for the treatment of COPD
- Table 200 Adverse events in ACCLAIM studies, compared to Spiriva
- Table 201 Forecast sales of aclidinium bromide (US$m)
- Table 202 Incidence of side effects following Daxas treatment
- Table 203 Forecast sales of Daxas (US$m)
- Table 204 Forecast sales of glycopyrronium bromide (US$m)
- Table 205 Forecast sales of indacaterol (US$m)
- Drug Candidates Ranked by CRA Score
Index of Charts
- Figure 1 Forecast worldwide prescription pharmaceutical market, 2008-2013
- Figure 2 Estimated world prescription pharmaceutical market by therapeutic category, 2007 (total value US$554 billion)
- Figure 3 Forecast world prescription pharmaceutical market by therapeutic category, 2013 (total value US$672 billion)
- Figure 4 Major US patent expiries with worldwide sales in year prior to generic competition, 2008-2013
- Figure 5 Medicare Part D Risk Corridors for 2008-2011
- Figure 6 Worldwide pharmaceutical R&D spend versus US NME and BLA approvals
- Figure 7 Average peak sales (US$m) per NME/BLA launch
- Figure 8 Estimated 2007 worldwide prescription anti-infectives market
- Figure 9 US antibiotic prescriptions by class, 2007
- Figure 10 Anti-HIV market by drug class on the basis of 2007 sales
- Figure 11 Worldwide cardiovascular market 2007
- Figure 12 Thrombosis market by percentage of patient
- Figure 13 Estimated 2007 worldwide prescription CNS market
- Figure 14 Efficacy of bapineuzumab in ApoE4 non-carriers (MITT) ADAS-Cog by dose (mg/kg)
- Figure 15 Lurasidone Phase II efficacy data: PANSS total score change
- Figure 16 Worldwide prescription gastrointestinal market 2007
- Figure 17 Worldwide metabolic market 2007
- Figure 18 Non-insulin treatments for diabetes by value, 2007
- Figure 19 Incidence of Type I diabetes in children aged 0-14 years
- Figure 20 Increasing prevalence of obesity in the US
- Figure 21 Rates of obesity in five major European countries
- Figure 22 Diabetes treatment in the US in diagnosed patients, 2004-2006
- Figure 23 Worldwide musculoskeletal sales 2007
- Figure 24 Worldwide oncology sales 2007
- Figure 25 Drugs in development for cancer*
- Figure 26 Worldwide respiratory market 2007