Commercial Insight: Antihypertensives - New Challenges For A Maturing Market

Published by: Datamonitor

Published: Sep. 14, 2006 - 206 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the hypertension market

Summary of key milestones in the antihypertensives market

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Sales figures definition for this report

Market definition and overview for this report

Current pharmaceutical market situation

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Global 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

Threats

Increased generic competition

Parallel trade

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

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

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

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

Threats

Continuation of cost-control measures

Formulary access

Take off of generic sector

Limitations on prescriptions dispensed from hospitals to patients in the community

Germany: opportunities and threats

Market level assessment

Opportunities

Pricing freedom which supports innovation

Threats

German healthcare reforms...again

Cost containment measures

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

Ongoing cost-containment measures

Stringent reference pricing system

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 FORECAST ANALYSIS

Assumptions and events

Increasing market size

Increasing use of fixed-dose combinations

Major clinical trials

ONTARGET

DREAM

NAVIGATOR

TROPHY

Outcomes program for Rasilez: ALTITUDE, AVIATOR

New Product Launches

Rasilez (aliskiren) marketed by Novartis

Exforge (valsartan+ amlodipine) marketed by Novartis

Additional Indications

Irbesartan gains congestive heart failure indication

Valsartan gains additional diabetes indication

Diovan gains indications for post-MI use

Micardis (telmisartan) gains type 2 diabetic nephropathy indication

Candesartan gains diabetic retinopathy indication

Patent Expiries

ARB patent expiries

CCB patent expiries

Beta blocker 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 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Case studies

Case Study 1: Novartis - future prospects

Executive summary

Cardio-metabolic franchise overview

Pipeline dynamics of the company

Overall pipeline

Rasilez

Exforge

Life Cycle Management Issues for Novartis.

Conclusion

Case study 2: The loss of patent protection for Cozaar (losartan) in the US market; potential impacts, likely scenarios.

Executive summary

Angiotensin Receptor Blockers (ARBs)

The US ARB market

The US ARB market dynamics

Patent expiries

CHAPTER 6 BIBLIOGRAPHY AND REFERENCES

Bibliography

References

APPENDIX A - MARKET DATA AND MAJOR BRAND FACTS

Global antihypertensive market data

Segmentation by country

Segmentation by class

Major brand facts

C7 BBs

C8 CCBs

C9 ACEs

C9 ARBs

Anatomical Therapeutic Chemical (ATC) classification

APPENDIX B - MARKET FORECAST DATA

US Forecasts

Japan Forecasts

France Forecasts

Germany Forecasts

Italy Forecasts

Spain Forecasts

UK Forecasts

Five Major European Markets Forecasts

Seven Major Markets Forecasts

APPENDIX C

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the cardiovascular disease analysis team

Key therapy team members

Dr Allison Fleetwood, Director, Cardiovascular, Diabetes and Women's Health

Disclaimer

List of Tables

Table 1: 7MM sales of the antihypertensive drug classes, 2005

Table 2: Seven major market sales and market share of the 10 top-selling antihypertensives, 2005

Table 3: Prevalence of obesity in the seven major markets by age (000s), 2003 (all totals have been rounded where applicable)

Table 4: US antihypertensive sales, 2005

Table 5: Five generics companies are among the top 10 companies in terms of prescriptions filled under Medicare Part D

Table 6: The actual generic fill rate varies between therapeutic classes

Table 7: Japan antihypertensive sales, 2005

Table 8: An example of the savings to be realized by using generic drugs

Table 9: France antihypertensive sales, 2005

Table 10: Germany antihypertensive sales, 2005

Table 11: Italy antihypertensive market, 2005

Table 12: Spain antihypertensive market, 2005

Table 13: UK antihypertensive market, 2005

Table 14: The 10 clinical areas of the Quality Outcome Framework, as outlined in the GMS contract, 2005

Table 15: Summary of macro-environmental issues affecting the anthypertensive, 2006

Table 16: Patent expiry dates used in forecasting the antihypertensive market across the seven major markets

Table 17: Sales of selected Novartis marketed cardio-metabolic products, 2005

Table 18: Forecasts for Rasilez (aliskiren)

Table 19: Sales forecasts for Exforge (valsartan plus amlodipine)

Table 20: Kredex: key facts

Table 21: Toprol-XL: key facts

Table 22: Tenormin; key facts

Table 23: Inderal: key facts

Table 24: Norvasc: key facts

Table 25: Plendil: key facts

Table 26: Cardizem LA: key facts

Table 27: Adalat: key facts

Table 28: Altace: key facts

Table 29: Aceon: key facts

Table 30: Accupro: key facts

Table 31: Atacand; key facts

Table 32: Teveten: key facts

Table 33: Avapro: key facts

Table 34: Cozaar: key facts

Table 35: Benicar: key facts

Table 36: Micardis: key facts

Table 37: Diovan: key facts

Table 38: Antihypertensive classifications

Table 39: US antihypertensive sales forecasts ($m; 2005 figures are actuals)

Table 40: Japan antihypertensive sales forecasts ($m; 2005 figures are actuals)

Table 41: France antihypertensive sales forecasts ($m; 2005 figures are actuals)

Table 42: Germany antihypertensive sales forecasts ($m; 2005 figures are actuals)

Table 43: Italy antihypertensive sales forecasts ($m; 2005 figures are actuals)e

Table 44: Spain antihypertensive sales forecasts ($m; 2005 figures are actuals)

Table 45: UK antihypertensive sales forecasts ($m; 2005 figures are actuals)

Table 46: Five major markets antihypertensive sales forecasts ($m; 2005 figures are actuals)

Table 47: Seven major markets antihypertensive sales forecasts ($m; 2005 figures are actuals)

List of Figures

Figure 1: Key milestones expected to have an impact on the 7MM antihypertensives market, 2007 - 2015

Figure 2: 7MM pharmaceutical sales, 2004-05

Figure 3: Comparative antihypertensive market share information for 7MM in terms of sales value and sales volume, split by country, 2005

Figure 4: 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 5: 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 6: 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 7: The growing prevalence of obesity in the US

Figure 8: Generalized distribution chain for parallel traded pharmaceutical products

Figure 9: JNC6 and JNC7 compared: classification of blood pressure levels

Figure 10: Compelling indications for individual drug classes

Figure 11: More than half of all prescriptions dispensed in the US are generics

Figure 12: Generic companies dominate the US pharmaceutical market in terms of prescriptions

Figure 13: Generic use in the US is promoted through a number of channels

Figure 14: The generic fill rates in the US for 2003 varied considerably by state

Figure 15: The tiered co-payment system will lead to greater use of generics

Figure 16: Key pressures facing drug developers

Figure 17: The Japanese generic market is underdeveloped because of a number of factors

Figure 18: The oncology therapy area accounts for the highest share of 1,377 projects in clinical development, from 178 companies.

Figure 19: Novartis's investigational drugs by therapeutic category

Figure 20: Effects of patent expiry on Cozaar (losartan) in the US market

Figure 21: Datamonitor forecasts of the effects of Cozaar's patent expiry on Cozaar (losartan), Diovan (valsartan) and their respective generics, in the US market

Figure 22: Segmentation of the antihypertensives market by country

Figure 23: Segmentation of the antihypertensives market by class

Abstract

Datamonitor expects the antihypertensive market to exceed $40bn by 2015 across the seven major markets, with novel treatments and the market-leading ARBs delivering much of this value. However, significant hurdles exist, and pharmaceutical companies need to carefully design marketing campaigns and pricing structures for their products.

• Event-driven sales forecasts, for the period 2006-2015, for the US, Japan, France, Germany, Italy, Spain and the UK, plus a global overview
• Discussion of individual products in four main classes; beta blockers (BBs), CCBs, ACE inhibitors and the ARBs
• Profiles of the country and market specific issues which will impact future sales in the market including generic erosion and new product launches
• Commercial impact case studies on R&D innovation, clinical trial data and European healthcare reform

The growth rate of the antihypertensive market is declining. These changes reflect the challenges faced by pharmaceutical companies over the next decade, as brand erosion and healthcare reforms impact heavily. The slow and declining growth rate does not reflect a stationary market, but the battle between the drugs that make up the market

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.

Large pharmaceutical companies that have established themselves in the cardiovascular arena are steering away from development in the antihypertensives market. While still continuing to enjoy large revenues from its cardiovascular arm, the research and development of Novartis shows that it is now investing elsewhere.

• Quantify the future size and scope of the hypertension market and the potential for new products
• Analyze options to expand commercial potential through pursuit of new indications
• Formulate successful launch strategies to succeed in a highly competitive market

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