Commercial Insight: Antihypertensives â New ... - Datamonitor
Commercial Insight: Antihypertensives â New ... - Datamonitor
Commercial Insight: Antihypertensives â New ... - Datamonitor
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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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