市場調査報告書：異常脂質血症治療薬　特許失効による機会

Abstract

Overview

Introduction

Datamonitor expects the antihypertensives market to reach almost $40 billion, across the seven major markets, by 2016. The growth will be driven by the uptake of Novartis' s Tekturna, as well as increased use of ARBs, and their combinations. However, the expiries of some key patents, particularly Pfizer' s Norvasc and Merck' s Cozaar, will restrain market growth.

Scope

Event-driven sales forecasts for 2007-16 across the seven major markets: US, France, Germany, Italy, Spain, UK and Japan.
Country and market specific issues that will impact sales opportunities and market landscape, including key patent expiries and product launches.
Case studies assessing the blockbuster potential of Novartis' s direct renin inhibitor, Tekturna, and the impact of ESC/ESH guideline reform in Europe.
Comprehensive analysis of the current antihypertensives pipeline, including a clinical and commercial assessment of all key emerging therapies.

Highlights

The growth rate of the antihypertensive market is declining. The market is mature and does not present an attractive opportunity for R&D expenditure; consequently Big Pharma are shying away from the pursuit of novel mechanisms of action in favour of developing more efficacious combination therapies.

Cozaar' s patent expiry in the US, has the potential to alter the structure of the antihypertensive market dramatically. Threats of generic substitution and money-saving healthcare strategies which have plagued other markets, are now approaching the successful ARB class, and will have an impact on the whole antihypertensive market.

Novartis is set to strengthen its position in the antihypertensives arena; Tekturna is expected to achieve international blockbuster status and Exforge will achieve sales of at least $800m, set back slightly by the premature expiry of Pfizer' s Norvasc patent.

Reasons to Purchase

Quantify the future size of the antihypertensives market and identify opportunities for new products.
Learn how recent European healthcare reforms and guideline updates will shape the antihypertensives market.
Understand the barriers to uptake for novel antihypertensive agents, and the need for paradigm shift in clinical trial design.

ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the hypertension market
- Contributing experts
- Related reports
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Definition of drug classes included
- Current market situation
  - The antihypertensives market segmented by class
  - The antihypertensives market segmented by country
  - Antihypertensive market landscape
- Market growth and market restraint
  - Factors driving growth of the antihypertensives market
  - Factors restraining growth of the antihypertensives market
- Strategic scope and report focus
  - US antihypertensives market dynamics
  - Consideration of market unmet needs
  - Conflicting evidence from clinical trials and guideline alterations
  - Paradigm shift in antihypertensive R&D
- Defining the unmet need in the antihypertensives market
  - Need beyond cosmetic blood pressure reduction
  - Improved diagnosis
  - Improved blood pressure management
  - Increased uptake of fixed-dose combination therapies
  - Targeting global cardiovascular risk and target organ damage
  - Patient and primary care physician education
CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Seven major market level assessment, opportunities and threats
  - Market level assessment
  - Opportunities
    - Demographic and lifestyle trends continue to dominate the agenda, and have the potential to increase the hypertensive patient population
    - Big Pharma cannot ignore the emerging markets of India and China
    - Novel products are expected, but innovation is lacking in antihypertensive R&D
    - Growing awareness of the metabolic syndrome
    - Increasing co-operation between regulatory bodies
  - Threats
    - Increased generic competition
    - Parallel trade
    - Ongoing cost-containment measures
    - Increasingly conservative regulatory environments
    - Restrictive pricing and reimbursement policies
    - Reduced periods of market exclusivity
    - Mandatory registration of all clinical trial results
- US: market level assessment, opportunities and threats
  - Market level assessment
  - Opportunities
    - Direct-to-consumer (DTC) advertising is legal in the US and has been shown to influence patient prescription choice and increase diagnosis rates
    - Leveraging the JNC7 guidelines to maximize pharmacotherapy
    - Price of drugs
  - Threats
    - The changing healthcare environment in the US will drive future generic use
    - Medicare Part D is expected to lead to greater generic use
    - Patient power
    - Pharmaceutical re-importation issues continue to dog Big Pharma
    - Formularies promote quality, but restrict choice
    - Pricing and reimbursement issues
    - Curbing of DTC advertising will lead to greater emphasis on risk of products
    - Wal-Mart $4 a day generic program introduces further cost competition
- Japan: market level assessment, opportunities and threats
  - Market level assessment
  - Opportunities
    - Ageing population
    - An underdeveloped generics market slows brand erosion
    - Possible introduction of direct-to-consumer advertising
    - Multiple patent extensions and labeling regulations
    - Opening up the Japanese market
    - Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare
    - Reduced product approval time
    - Harmonization of approval process
    - The Internet is an effective means to reach out to patients
  - Threats
    - Despite being underdeveloped, generics are expected to evolve into a significant player in the Japanese healthcare market in the future
    - Flat sum reimbursement
    - Complex regulatory process
    - Biannual price cuts still threaten market growth
    - New healthcare reforms under debate
- France: market level assessment, opportunities and threats
  - Market level assessment
  - Opportunities
    - Innovation encouraged in the pharmaceutical industry
    - Demographic changes provide opportunity for market expansion of chronic illnesses
    - Consumers in France readily recognize the Internet as a source of high-quality medical information
    - Generic consumption in France is particularly low
  - Threats
    - Continuation of cost-control measures
    - Formulary access
    - Take-off of generic sector
    - Limitations on prescriptions dispensed from hospitals to patients in the community
    - Pharmacists are being mandated to drive generic dispensing
- Germany: opportunities and threats
  - Market level assessment
  - Opportunities
    - Pricing freedom which supports innovation
    - ePharmacy and mail-order drugs legalized
  - Threats
    - Cost-containment measures in Germany have led to a healthy generics market
    - German doctors set to receive bonuses for prescribing generics
- Italy: market level assessment, opportunities and threats
  - Market level assessment
  - Opportunities
    - Single agency holds regulatory authority
    - Negligible impact of generics is set to continue
  - Threats
    - Stringent reference pricing system
    - Restructured reimbursement categories
    - Intellectual property to conform with rest of EU
- Spain: market level assessment, opportunities and threats
  - Market level assessment
  - Opportunities
    - Underdeveloped generics market both an opportunity and a threat
  - Threats
    - R&D activity expected to decline
    - Reference pricing systems (RPS) likely to have an impact on branded revenues
- UK: market level assessment, opportunities and threats
  - Market level assessment
  - Opportunities
    - NICE guidance advises against the use of beta-blockers
    - GMS contact improvements
  - Threats
    - Pharmaceutical Price Regulation Scheme (PPRS) implements periodic price cuts
    - Cost containment measures encourage continued high use of generics
- Summary of environmental issues affecting antihypertensive market size
CHAPTER 4 PIPELINE DYNAMICS ANALYSIS
- Outlook for developmental antihypertensives
- Pipeline overview
- Pipeline agents by phase of development
- Pipeline antihypertensives segmented by mechanism of action
- Pipeline activity segmented by company
  - Companies developing key novel antihypertensive agents
    - Novartis
    - Daiichi Sankyo
    - Gilead
    - Takeda
CHAPTER 5 COMPARATIVE ASSESSMENT OF KEY PIPELINE PRODUCTS
- Overview
- Key pipeline product positioning
  - Darusentan
    - Mechanism of action
    - Clinical assessment
    - Commercial assessment
  - Exforge (valsartan/amlodipine)
    - Mechanism of action
    - Clinical assessment
    - Commercial Assessment
  - Olmesartan/amlodipine
    - Mechanism of action
    - Clinical assessment
    - Commercial Assessment
  - Zanipress (enalapril/lercanidipine)
    - Mechanism of action
    - Clinical assessment
    - Commercial assessment
  - CYT006-AngQb
    - Mechanism of action
    - Clinical assessment
    - Commercial assessment
CHAPTER 6 FORECAST ANALYSIS
- Overview
- Changes in medical practice
  - Increased use of ambulatory BP monitoring and home BP monitoring
  - Assessment of overall cardiovascular risk
  - Physician incentives to control blood pressure
  - Pressure to increase compliance through the use of single-pill combination products
- Major clinical trials
  - ONTARGET
  - DREAM
  - TROPHY
  - Outcomes program for Rasilez: ALTITUDE, AVIATOR
- New product launches
  - Tekturna/Rasilez (aliskiren) marketed by Novartis
  - Exforge (valsartan+ amlodipine) marketed by Novartis
- Additional indications
  - Irbesartan gains congestive heart failure indication
  - Valsartan gains additional diabetes indication
  - Micardis (telmisartan) gains type 2 diabetic nephropathy indication
- Patent expiries
  - ARB patent expiries
  - CCB patent expiries
  - Betablocker patent expiries
  - ACE inhibitor patent expiries
  - Other patent expiries
- Data definitions, limitations and assumptions
  - Standard units
  - Japanese market data
  - Derivation of sales forecasts and pricing trends
- Forecasts
- Forecast methodology
CHAPTER 7 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
- Introduction
- Case Study 1: Aliskiren - up to the hype?
  - Introduction
  - Mechanism of action
  - Aliskiren
  - Clinical development of aliskiren
  - Key Phase III Trials with aliskiren
  - Aliskiren in combination with a diuretic
  - Aliskiren versus CCB and their combination
  - Aliskiren versus ACEI and their combination
  - Efficacy - As good, but no better
  - Benign side-effect profile - Not good enough
  - Long duration of action - The saving grace?
  - The negative-feedback conundrum
  - End organ protection
    - Prevention of organ damage with ACEIs and ARBs
    - Additional benefit from renin inhibition?
  - Summary of key advantages:
  - Can Novartis justify price premium?
  - Datamonitor assessment
- Case study 2: ESC/ESH GUIDELINES
  - Emphasis on the assessment of total cardiovascular risk
  - Consideration of absolute risk versus relative cardiovascular risk
  - Targeting end-organ damage
  - Recommendation for lifestyle modification
  - First-line treatment strategy
  - Managing hypertension and comorbidities
  - Treatment of specific patient groups
  - Opinion leader SWOT analysis
    - Strengths:
    - Weaknesses:
    - Potential barriers to uptake:
  - Commercial implications and further work
  - Implication for clinical trial design
CHAPTER 8 BIBLIOGRAPHY AND REFERENCES
- Bibliography
- References
APPENDIX A - MARKET DATA AND MAJOR BRAND FACTS
- Mechanisms of action
  - Beta blockers
  - Calcium channel blockers
  - Diuretics
  - Angiotensin converting enzyme inhibitors
  - Angiotensin-II receptor blockers (ARBs)
- Seven major market antihypertensive market data
  - Segmentation by country
  - Segmentation by class
- Major brand facts
  - C7 Betablockers
  - C8 Calcium channel blockers
  - C9 Angiotensin converting enzyme inhibitors
  - C9 Angiotensin II receptor blockers
  - Anatomical Therapeutic Chemical (ATC) classification
APPENDIX B - MARKET FORECAST DATA
- US Forecasts
- Japan Forecasts
- France Forecasts
- Germany Forecasts
- Italy Forecasts
- Spain Forecasts
- UK Forecasts
- Report methodology
- About Datamonitor
  - About Datamonitor Healthcare
  - About the cardiovascular disease analysis team
  - Disclaimer
- List of Tables
  - Table 1: Seven major market antihypertensive sales ($m), 2006.
  - Table 2: Sales of antihypertensives across the seven major markets by country Sales of Antihypertensives by Country($m), 2006.
  - Table 3: Seven major market sales and market share of the 10 top-selling antihypertensives, 2006
  - Table 4: Prevalence of obesity in the seven major markets by age (000s), 2003 (all totals have been rounded where applicable)
  - Table 5: US antihypertensive sales, 2006
  - Table 6: Five generics companies are among the top 10 companies in terms of prescriptions filled under Medicare Part D, 2006
  - Table 7: The actual generic fill rate varies between therapeutic classes, 2006
  - Table 8: Wal-Mart is selling many generic antihypertensives for less than the mean price per standard unit in the US in 2006
  - Table 9: Japan antihypertensive sales, 2006
  - Table 10: An example of the savings to be realized by using generic drugs in the Japanese market, 2006
  - Table 11: France antihypertensive sales, 2005
  - Table 12: Germany antihypertensive sales, 2005
  - Table 13: Italy antihypertensive market, 2006
  - Table 14: Spain antihypertensive market, 2006
  - Table 15: UK antihypertensive market, 2006
  - Table 16: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005
  - Table 17: Summary of macro-environmental issues affecting the antihypertensive market, 2007
  - Table 18: The antihypertensive R&D pipeline, 2007
  - Table 19: Patent expiry dates used in forecasting the antihypertensive market across the seven major markets, 2007-2016
  - Table 20: Effects of Circulating RAS and Tissue RASe
  - Table 21: Kredex: key facts
  - Table 22: Toprol-XL: key facts
  - Table 23: Tenormin; key facts
  - Table 24: Inderal: key facts
  - Table 25: Norvasc: key facts
  - Table 26: Plendil: key facts
  - Table 27: Cardizem LA: key facts
  - Table 28: Adalat: key facts
  - Table 29: Altace: key facts
  - Table 30: Aceon: key facts
  - Table 31: Accupro: key facts
  - Table 32: Atacand; key facts
  - Table 33: Teveten: key facts
  - Table 34: Avapro: key facts
  - Table 35: Cozaar: key facts
  - Table 36: Benicar: key facts
  - Table 37: Micardis: key facts
  - Table 38: Diovan: key facts
  - Table 39: Antihypertensive classifications
  - Table 40: US Antihypertensives $ (000s)Sales Forecast 2006-2016
  - Table 41: Japan Antihypertensives $ (000s)Sales Forecast 2006-2016
  - Table 42: France Antihypertensives $ (000s)Sales Forecast 2006-2016
  - Table 43: Germany Antihypertensives $ (000s)Sales Forecast 2006-2016
  - Table 44: Italy Antihypertensives $ (000s)Sales Forecast 2006-2016
  - Table 45: Spain Antihypertensives $ (000s)Sales Forecast 2006-2016
  - Table 46: US Antihypertensives $ (000s)Sales Forecast 2006-2016
- List of Figures
  - Figure 1: Growth in the antihypertensives market by country, 2003-06
  - Figure 2: Proportion of population aged 20-39 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004
  - Figure 3: Proportion of population aged 40-59 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004
  - Figure 4: Proportion of population aged 60-79 years, 2004 and 2015, and prevalence of hypertension in this age group in the seven major markets, 2004
  - Figure 5: The growing prevalence of obesity in the US, 2005-2015
  - Figure 6: Generalized distribution chain for parallel traded pharmaceutical products
  - Figure 7: JNC6 and JNC7 compared: classification of blood pressure levels
  - Figure 8: Compelling indications for individual drug classes
  - Figure 9: More than half of all prescriptions dispensed in the US are generics, 1994-2005
  - Figure 10: Generic companies dominate the US pharmaceutical market in terms of prescriptions
  - Figure 11: Generic use in the US is promoted through a number of channels
  - Figure 12: The generic fill rates in the US for 2003 varied considerably by state
  - Figure 13: The tiered co-payment system will lead to greater use of generics
  - Figure 14: Key pressures facing drug developers, 1990-2004
  - Figure 15: Wal-Mart' s $4 generic drug program web-page
  - Figure 16: The Japanese generic market is underdeveloped because of a number of factors
  - Figure 17: Pipeline antihypertensive agents segmented by phase of development, 2007
  - Figure 18: Pipeline antihypertensive agents segmented by mechanism of action, 2007
  - Figure 19: The nature of the compounds in the antihypertensives pipeline, 2006
  - Figure 20: Nature of antihypertensive developmental compounds according to company type, 2007
  - Figure 21: Pipeline maturity index for antihypertensive agents, 2007
  - Figure 22: Comparative assessment of pipeline antihypertensive agents
  - Figure 23: Segmentation of the antihypertensives market by country, 2007
  - Figure 24: Segmentation of the antihypertensives market by class, 2007

主な特許失効による異常脂質血症治療薬の新たな機会

Pipeline/Commercial Insight: Antihypertensives New class opportunity offset by key patent expiries

Abstract

Overview

Introduction

Scope

Highlights

Reasons to Purchase

Table of Contents