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BUSINESS INSIGHTS The Outlook for Cardiovascular Risk Factors Epidemiology, market and pipeline analysis Figure 1.1: Cardiovascular risk factors Cardiovascular risk factors Immutable Changeable Protective Age Hypertension HDL cholesterol Gender Dyslipidemia Exercise Family history Smoking Estrogen Obesity Moderate alcohol use Diabetes Fibrinogen LVH Cocaine Behavioral factors Source: The Outlook for Cardiovascular Risk Factors “The burden of cardiovascular disease on society will continue to rise as the overall population ages. At the global level, the number of older persons will increase from 606 million in 2000 to 1.9 billion in 2050.” Defend and grow your market share by analyzing opportunities within the risk factors and limit the threat from your competitors with the help of this latest management report... The Outlook for Cardiovascular Risk Factors Epidemiology, market and pipeline analysis Table 6.19: Smoking cessation The Outlook for Cardiovascular Risk Factors: Epidemiology, market and Rx Pipeline, 2003 pipeline analysis, evaluates current and future growth prospects for pharmaceutical companies to 2008 in five major cardiovascular risk factors that Company Brand Generic/code Status can be moderated by pharmacotherapy; hypertension, dyslipidemia, diabetes, GlaxoSmithKline Zyban XL bupropion Phase III obesity and smoking. Sanofi-Synthélabo n/a rimonabant Phase III Phase III Roche Tempium lazabemide (discontinued) Xenova TA-NIC n/a Phase I In the US alone, the direct and indirect costs of cardiovascular disease (CVD) and Nabi NicVAX n/a Phase I stroke in 2003 are estimated at almost $352bn. Reducing these costs by GlaxoSmithKline n/a GW-468816 Phase I Sanofi-Synthélabo n/a SL-25.1131 Phase I appropriately treating cardiovascular risk factors has become a major focus of the n/a = not available pharmaceutical industry and healthcare payors. Use this report to evaluate how pharmaceutical companies can exploit unmet needs in CV risk factor markets Source: The Outlook for Cardiovascular Risk Factors and benefit from substantial companies cost savings within R&D. “The overall smoking cessation market is expanding, This report sets out to define cardiovascular risk factors and how identifying links however, several unmet needs still exist. For example unmet needs in the nicotine abuse market revolve to them sooner, will lead to a decline in CVD, resulting in massive cost savings around the deficiency of neurological treatments for the for both pharmaceutical companies and healthcare payors. Treating risk factors condition. This is likely to be the future direction of is preventive medicine at its most challenging and this report provides nicotine addiction drug developments...” insights into the risk factors that you need to add greater value to your R&D process and product pipelines. Key findings in this report • The global anti-hypertensive market was worth approximately $36.8bn in Figure 4.9: Unmet needs in the 2002. As the only class to remain entirely patent protected, future growth treatment of diabetes within the global anti-hypertensive market will be driven by the Type I diabetes Type II diabetes angiotensin receptor blockers. Drug delivery poor compliance Efficacy poor compliance • Pfizer is developing a single pill combination of Lipitor and its anti- Increasing importance Efficacy Adverse side effects hypertensive Norvasc. Currently in registration in the US, the product, poor compliance poor compliance Adverse side effects Low education/awareness branded Caduet, could generate sales of $1bn in 2008, although it is likely that other combinations of statins and anti-hypertensives will eventually prove poor compliance late diagnosis & poor compliance Low education/awareness Drug delivery late diagnosis & poor compliance poor compliance more effective. Glucose monitoring Glucose monitoring • The prevalance of diabetes is rising rapidly, up from 30 million globally Source: The Outlook for Cardiovascular Risk Factors in 1985 to a forecast 300 million in 2005. This reflects growth of the aging population, adoption of unhealthy diets, obesity and sedentary lifestyles. " A key unmet need in the treatment of diabetes, in particular type I diabetes, is the limited choice of formu- lation. Insulin has been administered by injection for • The current obesity market is worth just less than $800m and has the over 75 years, with many patients requiring three or four potential to expand to around $1.6bn by 2010. Expansion will primarily be injections per day. This is highly inconvenient and driven by the reimbursement and wider availability of anti-obesity therapies, results in low patient compliance. Oral administration of based on the growing realization that treatment leads to a reduction in insulin is preferable but difficult because, as a protein, expensive co-morbidities and mortality. insulin is readily digested...” The answers to your questions... • What is the current and future value of the commercial opportunities Table 3.8: Selected leading and new antidyslipidemic product sales, associated with treating major cardiovascular risk factors? 2001-2008 • Which combination statins/anti-hypertensives have greatest sales potential? Forecast Sales ($m) sales ($m) Brand Generic Marketer 2001 2002 2003 2005 2008 • How are leaders of the dyslipidemia market protecting their products from Lipitor atorvastatin Pfizer 6,448 7,972 9,203 10,887 11,187 Zocor simvastatin Merck & Co. 5,245 5,580 6,072 5,426 3,151 Bristol-Myers Pravachol Crestor pravastatin Squibb rosuvastatin AstraZeneca 2,101 n/l 2,266 n/l 2,306 300 2,119 1,292 726 2,973 patent challenges? Schering- Zetia ezetimibe Plough n/l 23 204 471 1,268 • Which non-injectable insulins will be first-to-market in the diabetes sector? • Which pipeline anti-hypertensives are the most promising? Source: The Outlook for Cardiovascular Risk Factors "The global antidyslipidemic market was worth • What impact will the landmark ALLHAT study have on treatment practices in $22,879m in 2002, up from approximately $11.1bn in the hypertension market? 1997. With the increasing prevalence of dyslipidemia and the introduction of third-generation statins and other promising antidyslipidemics from 2002 onwards, the market is set to continue experiencing healthy growth to over $32bn in 2008...” Top 5 reasons to order your copy today... Figure 2.5: Global anti-hypertensive market 1. Identify growing commercial opportunities associated with segmented by class, 2002 increased management of cardiovascular risk factors by healthcare payors. Centrally-acting, 1.5% Diuretic, 4.7% 2. Quantify current and future patient potential in the seven Alpha blocker, 6.1% Beta blocker, 11.9% ACE inhibitor, 29.4% major national markets. 3. Assess the impact of late-stage pipeline developments on ARB, 20.1% CCB, 26.4% sales of your products. 4. Prepare to respond to forthcoming patent expiries of Source: The Outlook for Cardiovascular Risk Factors leading products. "The global anti-hypertensive market was worth 5. Compare in-house forecasts against leading and new approximately $36.8bn in 2002, indicative of a nearly 6% rise since 2001. These results are fairly impressive in product sales to 2008 detailed in this report. view of the large size of the market and the high degree of generic penetration, with only one class of anti-hypertensive drugs, ARBs, retaining full patent protection...” Sample information from the report CHAPTER 5: OBESITY Market analysis The current hospital and retail obesity market is worth just less than $800m. As one of the fastest growth segments of the pharmaceutical market, it has the potential to expand to around $1.6bn by 2010. Such expansion will primarily be driven by the reimbursement and wider availability of anti-obesity therapies, based on the growing realization that treatment leads to a reduction in expensive co-morbidities and mortality. However, value growth will be hindered by the expiry of the current market leading drug’s (Xenical) US patent in 2004. Despite the market’s growth potential, few companies have successfully managed to generate sales from the ethical drug treatment of obesity. Drug therapy There is an enormous potential for developing safe, inert and efficacious short- and long-term drug treatments for obesity. Until this happens, physicians must treat obesity on an individual basis and allow patients who respond well to current drug therapies and tolerate their adverse effects to continue to benefit from current pharmacotherapy. However, scientists have established five classes of drugs that could potentially treat obesity and weight gain: · Appetite suppressants - drugs that act centrally on the noradrenergic and serotoninergic pathways in the brain to reduce hunger perception, increase satietyand inhibit food intake. · Fat absorption inhibitors - drugs that reduce energy intake through a peripheral route. · Metabolic enhancers - drugs that act through peripheral mechanisms to increase thermogenesis without the need for an increase in physical activity. · Fat mobilizers drugs - that act peripherally to reduce fat mass or decreasetriglyceride synthesis. · Gene therapy antibodies - that can induce adipocyte cell death. Pipeline analysis Weaknesses of existing therapies, the increasing prevalence of obesity and the opportunity to treat obese patients at younger ages has provided the incentive for numerous companies to conduct R&D in this area. Several investigational approaches to weight loss are currently being examined in clinical trials, ranging from the creation of new appetite suppressants to agents that act as fat blockers and drugs that hasten burning of stored body fat. A considerable amount of research is being expended on the class of drugs known as ß3-adrenergic receptor agonists (or ß3-agonists), which offer expedited energy burning without additional physical exertion. The low number of marketed and phase III anti-obesity drugs reflects the high scientific hurdles that pharmaceutical companies have faced in developing truly novel and improved therapies. In contrast, the larger number of drugs in phases I and II of development suggest not only that scientific advances are now being made, but that the pharmaceutical industry has not been deterred from investing in this potentially lucrative market. New technologies have enabled new targets for obesity drug development to be identified, some of which are derived from genome-based research. However, the most exciting developments in this area are still undergoing preclinical trials (e.g. small-molecule insulin mimetics). Table of contents The Outlook for Cardiovascular Risk Factors: Epidemiology, market and pipeline analysis CHAPTER 1: DEFINING CARDIOVASCULAR RISK CHAPTER 4: DIABETES What is a risk factor? Overview of diabetes How do risk factors contribute to cardiovascular • Pathophysiology and etiology disease? Epidemiology • Ethics and practicalities of preventive therapy Drug therapy • Impact of an aging population Market analysis Outlook for the diabetes market CHAPTER 2: HYPERTENSION • Unmet needs Classification of hypertension - Drug delivery Epidemiology - Efficacy Drug therapy - Side effects • Impact of ALLHAT study on anti-hypertensive therapy - Awareness and education Market analysis - Glucose monitoring • Norvasc (amlodipine) - Pipeline analysis • Cozaar/Hyzaar (losartan/losartan HCTZ) • Diovan/Co-Diovan (valsartan/valsartan HCTZ) CHAPTER 5: OBESITY Outlook for the hypertension market Overview of obesity • Unmet needs • Pathophysiology and etiology • Pipeline analysis Epidemiology - Benicar (olmesartan) Drug therapy - Inspra (eplerenone) Market analysis - Vanlev (omapatrilat) Outlook for the obesity market - ALT-711 • Improving long-term drug safety • Pipeline analysis CHAPTER 3: DYSLIPIDEMIA - Topamax (topiramate) Overview of dyslipidemia - Axokine • Which markers are the best indicators of - P57 cardiovascular risk? Epidemiology CHAPTER 6: SMOKING CESSATION Drug therapy Overview of smoking cessation • Statins • Pathophysiology • Fibrates Epidemiology • Bile acid sequestrants/inhibitors Drug therapy • Nicotinic acid derivatives Market analysis • Fish oil derivatives Outlook for the smoking cessation market Market analysis • Unmet needs Outlook for the dyslipidemia market • Pipeline analysis • Unmet needs - Zyban XL (bupropion) • Pipeline analysis - Rimonabant • Livalo (pitavastatin) - TA-NIC • Caduet (atorvastatin + amlodipine) - NicVAX FAX BACK TO: +44 (0) 207 900 6688 or scan and e-mail to firstname.lastname@example.org I would like to order the following report... 1 Company details 3 (Please use BLOCK CAPITALS) Company name: ________________________________________________________ ______________________________________________________ EU companies (except UK) must supply VAT / BTW / MOMS / MWST / IVA / FPA number: ______________________________________________________ _____________________________________________________________________________________________ Hard Copy (extra £50/€75/$95) Interactivity (extra £50/€75/$95) Please allow 28 days for delivery Search, customize & translate content Purchase Order Number (if required)_____________________________________ Please select a license type: 2 Payment method 4 GB£ EUR US$ Please indicate your preferred currency: GB£ EUR US$ Single User 1495 2160 2875 (eCopy) Total order value is ____________________________ Access permitted for one individual only I will forward a check payable to Business Insights Limited. 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"The Outlook for Cardiovascular Risk Factors"