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<strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong> – <strong>New</strong> challenges for a maturing market<br />

DMHC2178<br />

Introduction<br />

<strong>Datamonitor</strong> expects the antihypertensive market to exceed $40bn by 2015<br />

across the seven major markets, with novel treatments and the market-leading<br />

ARBs delivering much of this value. However, significant hurdles exist, and<br />

pharmaceutical companies need to carefully design marketing campaigns and<br />

pricing structures for their products.<br />

Key findings and highlights<br />

• The growth rate of the antihypertensive market is declining. These changes reflect the<br />

challenges faced by pharmaceutical companies over the next decade, as brand erosion and<br />

healthcare reforms impact heavily. The slow and declining growth rate does not reflect a<br />

stationary market, but the battle between the drugs that make up the market.<br />

• Cozaar's patent expiry in the US has the potential to alter the structure of the<br />

antihypertensive market dramatically. Threats of generic substitution and money-saving<br />

healthcare strategies which have plagued other markets are now approaching the<br />

successful ARB class, and will have an impact on the whole antihypertensive market.<br />

• Large pharmaceutical companies that have established themselves in the cardiovascular<br />

arena are steering away from development in the antihypertensive market. While still<br />

continuing to enjoy large revenues from its cardiovascular arm, the research and<br />

development of Novartis shows that it is now investing elsewhere.<br />

Reasons to buy<br />

• Quantify the future size and scope of the hypertension market and the potential for new<br />

products<br />

• Analyze options to expand commercial potential through pursuit of new indications<br />

• Formulate successful launch strategies to succeed in a highly competitive market<br />

For more information...<br />

Contact Anne Delaney, R&A DIR<br />

tel: +44 20 7675 7221 fax: +44 20 7675 7016 email: hcmarketing@datamonitor.com


www.datamonitor.com/healthcare<br />

Sample pages from the report<br />

Country Market Assessments<br />

Figure 15:<br />

The tiered co-payment system will lead to greater use of<br />

generics<br />

Average co-payment<br />

of $35-50<br />

Tier 3 – non-preferred brand<br />

Average co-payment<br />

of $20-25<br />

Tier 2 – preferred brand<br />

Country Market Assessments<br />

Average co-payment<br />

Figure of $1012:<br />

Generic companies dominate the US pharmaceutical market in<br />

terms of prescriptions<br />

Tier 1 – generic drugs<br />

Source: <strong>Datamonitor</strong> (DMHC2192)<br />

D A T A M O N I T O R<br />

In addition, some plans include lifestyle drugs or biological products in an extra fourth<br />

tier. With the reduced co-payment being asked for Tier 1 drugs, it is expected that<br />

Medicare Part D beneficiaries – the older, retired population, most of whom have a<br />

relatively low income as they are no longer working - will increasingly look to fill their<br />

prescriptions with generics. Moreover, this patient population usually has a number of<br />

chronic conditions that require pharmaceutical therapy and, therefore, Note: the NRx – new more<br />

prescriptions<br />

TRx – total prescriptions<br />

products for which they will have to co-pay, the greater will be their desire to receive<br />

lower cost generics.<br />

Source: Teva Investor Lunch Presentation, May 2006<br />

Country Market Assessments<br />

D A T A M O N I T O R<br />

Furthermore, a study into a sample of 35 different Medicare Part D plans has found<br />

that there is a wide variation in the drugs covered by the plans. The study assessed<br />

The third message relates to the restructuring of the diagnostic classification of<br />

It should be noted that the Novartis figures include the prescriptions filled under the<br />

152 generic and branded drugs and found that none of the 35 plans covered all 152<br />

hypertension and has generated some debate among leaders in the field. The<br />

Sandoz division. However, this dominance does not translate into sales value,<br />

drugs. However, 32 of the 35 plans covered the top 10 most commonly prescribed<br />

classification applied to blood pressure levels in JNC6 and JNC7 are displayed in<br />

highlighting the price differential between branded and generic products, with<br />

generic drugs. In addition, only half of the 35 plans covered the top 10 branded drugs,<br />

Figure 9.<br />

substantial discounts usually in place 12 to 18 months after patent expiry<br />

<strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong><br />

(<strong>Datamonitor</strong>, DMHC2178 Benchmarking Best Practice at Patent Expiry in the US, DMHC2055).<br />

© <strong>Datamonitor</strong> (Published 09/2006) Interestingly, Page several 54 generics companies appear in the top 10 companies<br />

Figure<br />

according<br />

9: JNC6 and JNC7 compared: classification of blood pressure<br />

This report is a licensed product and is not to be photocopied<br />

to total prescriptions filled under the recently rolled-out Medicare Part D reform, as<br />

levels<br />

shown in Table 5. This further highlights the well-established role of generics in<br />

reducing pharmaceutical expenditure in the US.<br />

<strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong><br />

DMHC2178<br />

© <strong>Datamonitor</strong> (Published 09/2006) Page 42<br />

This report is a licensed product and is not to be photocopied<br />

Source: Chobanian et al., 2003 (NIH Publication No. 04-5230)<br />

D A T A M O N I T O R<br />

In a plenary lecture at the American Heart Association (AHA) Scientific Sessions in<br />

November 2005 entitled “Controversies in the management of hypertension”, Dr<br />

William Cushman of the University of Tennessee College of Medicine in Memphis<br />

tried to explain the rationale behind this change. Dr Cushman highlighted that under<br />

the new definition, NHANES data from 1999–2000 showed that 31% of the US<br />

population is pre-hypertensive, and as such is at significant risk of developing Stage 1<br />

and 2 hypertension and experiencing a cardiovascular event, a comment that has<br />

been backed up by many previous studies (e.g. HOPE).<br />

<strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong><br />

DMHC2178<br />

© <strong>Datamonitor</strong> (Published 09/2006) Page 36<br />

This report is a licensed product and is not to be photocopied<br />

“...I am inclined to think there is a class effect for the ARBs. Of course one cannot be<br />

sure of this 100%, but several advantages of ARBs have been shown<br />

for different components of the same class which of course strongly suggest that they<br />

are due to a class effect...”<br />

Key opinion leader, <strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong> – <strong>New</strong> challenges for a maturing market


<strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong> – <strong>New</strong> challenges for a maturing market<br />

DMHC2178<br />

Table of contents<br />

EXECUTIVE SUMMARY<br />

• Objective of the analysis<br />

• <strong>Datamonitor</strong> insight into the hypertension market<br />

• Summary of key milestones in the<br />

antihypertensives market<br />

MARKET DEFINITION AND OVERVIEW<br />

- Sales figures definition for this report<br />

- Market definition and overview for this report<br />

- Current pharmaceutical market situation<br />

- Strategic scoping and focus<br />

COUNTRY MARKET ASSESSMENTS<br />

• Global market level assessment, opportunities and<br />

threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• US: market level assessment, opportunities and<br />

threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• Japan: market level assessment, opportunities and<br />

threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• France: market level assessment, opportunities<br />

and threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• Germany: opportunities and threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• Italy: market level assessment, opportunities and<br />

threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• Spain: market level assessment, opportunities and<br />

threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• UK: market level assessment, opportunities and<br />

threats<br />

- Market level assessment<br />

- Opportunities<br />

- Threats<br />

• Summary of environmental issues affecting<br />

antihypertensive market size<br />

FORECAST ANALYSIS<br />

• Assumptions and events<br />

- Increasing market size<br />

- Increasing use of fixed-dose combinations<br />

- Major clinical trials<br />

- <strong>New</strong> Product Launches<br />

- Additional Indications<br />

- Patent Expiries<br />

• Data definitions, limitations and assumptions<br />

- Standard units<br />

- Japanese market data<br />

- Derivation of sales forecasts and pricing trends<br />

• Forecasts<br />

• Forecast methodology<br />

COMMERCIAL IMPACT AND LIFECYCLE<br />

MANAGEMENT: CASE STUDIES<br />

• Introduction<br />

• Case studies<br />

- Case Study 1: Novartis - future prospects<br />

- Case study 2: The loss of patent protection for<br />

Cozaar (losartan) in the US market; potential<br />

impacts, likely scenarios.<br />

BIBLIOGRAPHY AND REFERENCES<br />

• Bibliography<br />

• References<br />

APPENDIX A - MARKET DATA AND MAJOR BRAND<br />

FACTS<br />

• Global antihypertensive market data<br />

- Segmentation by country<br />

- Segmentation by class<br />

• Major brand facts<br />

- Anatomical Therapeutic Chemical (ATC)<br />

classification<br />

For more information...<br />

Contact Anne Delaney, R&A DIR<br />

tel: +44 20 7675 7221 fax: +44 20 7675 7016 email: hcmarketing@datamonitor.com


www.datamonitor.com/healthcare<br />

APPENDIX B - MARKET FORECAST DATA<br />

• US Forecasts<br />

• Japan Forecasts<br />

• France Forecasts<br />

• Germany Forecasts<br />

• Italy Forecasts<br />

• Spain Forecasts<br />

• UK Forecasts<br />

• Five Major European Markets Forecasts<br />

• Seven Major Markets Forecasts<br />

APPENDIX C<br />

TABLES<br />

Table 1: 7MM sales of the antihypertensive drug<br />

classes, 2005<br />

Table 2: Seven major market sales and market share of<br />

the 10 top-selling antihypertensives, 2005<br />

Table 3: Prevalence of obesity in the seven major<br />

markets by age (000s), 2003 (all totals have<br />

been rounded where applicable)<br />

Table 4: US antihypertensive sales, 2005<br />

Table 5: Five generics companies are among the top 10<br />

companies in terms of prescriptions filled under<br />

Medicare Part D<br />

Table 6: The actual generic fill rate varies between<br />

therapeutic classes<br />

Table 7: Japan antihypertensive sales, 2005<br />

Table 8: An example of the savings to be realized by<br />

using generic drugs<br />

Table 9: France antihypertensive sales, 2005<br />

Table 10: Germany antihypertensive sales, 2005<br />

Table 11: Italy antihypertensive market, 2005<br />

Table 12: Spain antihypertensive market, 2005<br />

Table 13: UK antihypertensive market, 2005<br />

Table 14: The 10 clinical areas of the Quality Outcome<br />

Framework, as outlined in the GMS contract,<br />

2005<br />

Table 15: Summary of macro-environmental issues<br />

affecting the anthypertensive, 2006<br />

Table 16: Patent expiry dates used in forecasting the<br />

antihypertensive market across the seven<br />

major markets<br />

Table 17: Sales of selected Novartis marketed<br />

cardio-metabolic products, 2005<br />

Table 18: Forecasts for Rasilez (aliskiren)<br />

Table 19: Sales forecasts for Exforge (valsartan plus<br />

amlodipine)<br />

Table 20: Kredex: key facts<br />

Table 21: Toprol-XL: key facts<br />

Table 22: Tenormin; key facts<br />

Table 23: Inderal: key facts<br />

Table 24: Norvasc: key facts<br />

Table 25: Plendil: key facts<br />

Table 26: Cardizem LA: key facts<br />

Table 27: Adalat: key facts<br />

Table 28: Altace: key facts<br />

Table 29: Aceon: key facts<br />

Table 30: Accupro: key facts<br />

Table 31: Atacand; key facts<br />

Table 32: Teveten: key facts<br />

Table 33: Avapro: key facts<br />

Table 34: Cozaar: key facts<br />

Table 35: Benicar: key facts<br />

Table 36: Micardis: key facts<br />

Table 37: Diovan: key facts<br />

Table 38: Antihypertensive classifications<br />

Table 39: US antihypertensive sales forecasts<br />

($m; 2005 figures are actuals)<br />

Table 40: Japan antihypertensive sales forecasts<br />

($m; 2005 figures are actuals)<br />

Table 41: France antihypertensive sales forecasts<br />

($m; 2005 figures are actuals)<br />

Table 42: Germany antihypertensive sales forecasts<br />

($m; 2005 figures are actuals)<br />

Table 43: Italy antihypertensive sales forecasts<br />

($m; 2005 figures are actuals)<br />

Table 44: Spain antihypertensive sales forecasts<br />

($m; 2005 figures are actuals)<br />

Table 45: UK antihypertensive sales forecasts<br />

($m; 2005 figures are actuals)<br />

Table 46: Five major markets antihypertensive sales<br />

forecasts ($m; 2005 figures are actuals)<br />

Table 47: Seven major markets antihypertensive sales<br />

forecasts ($m; 2005 figures are actuals)<br />

FIGURES<br />

Figure 1: Key milestones expected to have an impact on<br />

the 7MM antihypertensives market,<br />

2007 - 2015<br />

Figure 2: 7MM pharmaceutical sales, 2004-05<br />

Figure 3: Comparative antihypertensive market share<br />

information for 7MM in terms of sales value and<br />

sales volume, split by country, 2005<br />

Figure 4: Proportion of population aged 20-39 years,<br />

2004 and 2015, and prevalence of<br />

hypertension in this age group in the seven<br />

major markets, 2004<br />

“...I think that the GMS contract for GPs influences their practice, so things like<br />

targets are determined by the GMS contract and not so much by the BHS guidelines,<br />

because that's what they get paid for - their GMS targets...”<br />

Key opinion leader, <strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong> – <strong>New</strong> challenges for a maturing market


<strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong> – <strong>New</strong> challenges for a maturing market<br />

DMHC2178<br />

Figure 5: Proportion of population aged 40-59 years,<br />

2004 and 2015, and prevalence of<br />

hypertension in this age group in the seven<br />

major markets, 2004<br />

Figure 6: Proportion of population aged 60-79 years,<br />

2004 and 2015, and prevalence of<br />

hypertension in this age group in the seven<br />

major markets, 2004<br />

Figure 7: The growing prevalence of obesity in the US<br />

Figure 8: Generalized distribution chain for parallel<br />

traded pharmaceutical products<br />

Figure 9: JNC6 and JNC7 compared: classification of<br />

blood pressure levels<br />

Figure 10: Compelling indications for individual drug<br />

classes<br />

Figure 11: More than half of all prescriptions dispensed in<br />

the US are generics<br />

Figure 12: Generic companies dominate the US<br />

pharmaceutical market in terms of prescriptions<br />

Figure 13: Generic use in the US is promoted through a<br />

number of channels<br />

Figure 14: The generic fill rates in the US for 2003 varied<br />

considerably by state<br />

Figure 15: The tiered co-payment system will lead to<br />

greater use of generics<br />

Figure 16: Key pressures facing drug developers<br />

Figure 17: The Japanese generic market is<br />

underdeveloped because of a number of<br />

factors<br />

Figure 18: The oncology therapy area accounts for the<br />

highest share of 1,377 projects in clinical<br />

development, from 178 companies.<br />

Figure 19: Novartis's investigational drugs by therapeutic<br />

category<br />

Figure 20: Effects of patent expiry on Cozaar (losartan) in<br />

the US market<br />

Figure 21: <strong>Datamonitor</strong> forecasts of the effects of Cozaar's<br />

patent expiry on Cozaar (losartan), Diovan<br />

(valsartan) and their respective generics, in the<br />

US market<br />

Figure 22: Segmentation of the antihypertensives market<br />

by country<br />

Figure 23: Segmentation of the antihypertensives market<br />

by class<br />

For more information...<br />

Contact Anne Delaney, R&A DIR<br />

tel: +44 20 7675 7221 fax: +44 20 7675 7016 email: hcmarketing@datamonitor.com


www.datamonitor.com/healthcare<br />

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<strong>Commercial</strong> <strong>Insight</strong>: <strong>Antihypertensives</strong> – <strong>New</strong> challenges for a maturing market<br />

DMHC2178<br />

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