Industry Trend Analysis - Significant Opportunities For Cardiovascular Diseases - JUNE 2017

BMI View: I nnovative medicines treating cardiovascular diseases will generate most of their revenue in developed markets . However, there is also significant demand for cheaper generic alternatives to cardiovascular therapeutics in emerging markets. Latin America represents a considerable growth opportunity given the high levels of obesity and raised blood cholesterol among the region's large and expanding population .

We have previously highlighted that the greatest revenue-earning opportunities for medicines treating cardiovascular diseases exist in developed markets, such as those in Europe and North America. The populations in these regions exhibit a higher risk of cardiovascular disease due to lifestyle habits, while the advanced regulatory environments and higher purchasing power enables greater prospects for innovative medicine sales ( see 'Developed Markets Represent Cardiovascular Disease Medicine Opportunities', March 28 2017). However, we note that certain emerging markets also present significant growth opportunities within this therapeutic area; here we look at opportunities that exist in the Latin America region.

Brazil And Mexico The Biggest Markets
Latin America - Burden Of Cardiovascular Disease (DALYs, mn)
Note: DALYS = Disability-Adjusted Life Years , Grey = No data. Source: BMI's Disease Database

Within the Latin America region, the burden of cardiovascular diseases is felt most acutely by the largest and most populous countries, namely Argentina, Brazil and Mexico, followed by Colombia and Venezuela ( see map above). These top three countries also rank among the highest globally for disability-adjusted life years (DALYs) resulting from cardiovascular disease, with Brazil eighth and Mexico just outside the top 15 markets. Among the most burdensome cardiovascular diseases, and consequently the most important from a therapeutic and revenue-earning point of view, are heart disease, strokes and hypertension.

Brazil The Largest Market
Most Important Cardiovascular Diseases (DALYs, mn)
Note: DALYs = Disability-Adjusted Life Years. Source: BMI ' s Disease Database.

Risk Factors Driving Burden Of Disease

The high level of cardiovascular disease in the Latin America region is driven by behavioural lifestyle habits, resulting in very high levels of blood cholesterol and obesity ( see 'Non-Communicable Risk Factors Highlight Drugmaker Opportunities', March 14 2017). Following a global trend, the prevalence of cardiovascular diseases in Latin America is disproportionately weighted towards men. This can be attributed to men's higher levels of alcohol and tobacco consumption, resulting in elevated levels of blood pressure.

Governments in the region have begun to deal with these behavioural risk factors directly. A sugar tax was imposed in Mexico in 2014 and the Colombian government introduced a similar initiative at the start of 2017. Brazil's government is also debating the introduction of a sugar tax. However, while these initiatives will improve the well-being of the populations - the Mexican sugar tax resulted in a 12% decrease in fizzy drink sales in its first full year - demand for medicines to treat the effects of poor lifestyle will remain strong. Indeed, in emerging markets with rapidly growing populations and increasing rates of urbanisation, this is particularly pertinent.

Poor Lifestyle Habits Leading To Elevated Risk Factors
Prevalence Of High Cholesterol (LHS) & Obesity (RHS, %)
Note: Red line = Global Average, global average prevalence for high cholesterol = 39.2%, global average prevalence for obesity = 16.0%, obesity is defined as body mass index [?] 30, high blood cholesterol is defined as [?]5.0mmol/L. Source: WHO, BMI

Poor Treatment Highlights Need For Direct Action

A comparison of the death rates of cardiovascular diseases in Latin American markets versus more developed nations highlights the need for differing approaches by drugmakers between developed and emerging/frontier markets. In North America and Canada, cardiovascular diseases account for roughly 35% of deaths annually. All non-communicable diseases account for approximately 93-94% of total deaths; treatment of, and therefore patient survival from, infectious diseases such as HIV is very good in these developed healthcare systems. By contrast, the vast majority of Latin American countries exhibit high levels of deaths from communicable diseases, and a high rate of deaths from cardiovascular diseases. Here, Chile is an outlier, with cardiovascular and non-communicable diseases accounting for similar proportions of total deaths as compared to the more developed North American states. Mexico also displays a low death rate from cardiovascular diseases; however, this is driven by the country's high rate of diabetes ( see 'Obesity Burden To Boost Chronic Disease Rates In Mexico', December 6 2016).

Many less affluent Latin American nations show a smaller proportion of deaths resulting from cardiovascular diseases than do more developed states. However, as a proportion of non-communicable disease deaths, cardiovascular diseases can account for as much as 51% (Honduras). This highlights the paucity of diagnosis and treatment prevalent in these countries. In these nations, drugmakers may benefit from on-the-ground prevention programmes and access schemes.

High Cardiovascular Deaths Rate
Cardiovascular Deaths As A Proportion Of Non-Communicable Deaths (%)
Note: Canada is highlighted in red as a reference for developed nations. Source: BMI's Disease Database

We note that there is therefore strong demand - particularly in Brazil, Mexico and Argentina - for medicines to treat cardiovascular diseases, especially those that reduce high blood cholesterol. On a global level, the Latin America region is not overly attractive for innovative product launches given relatively nascent and weak intellectual property laws, a high degree of domestic bias in procurement and a strong preference for generic drugs driven by weak purchasing power ( see 'Americas Pharmaceuticals: Regional Divergence Characterise Risk Profile ' , February 27 2017). However, this provides significant opportunities for generic medicines and legacy products.

Chile Bucks The Trend

We note that, due to its small population, Chile has a low burden resulting from cardiovascular diseases. Moreover, on a per capita basis the country has one of the lowest burdens from these diseases. As we have previously highlighted ( see 'Developed Markets Represent Cardiovascular Disease Medicine Opportunities', March 28 2017), the burden resulting from chronic diseases is often higher in emerging and developing markets due to poorer levels of healthcare infrastructure. As the most affluent country in the region, Chile has a well-developed healthcare system with high levels of access to treatment. As a consequence, the death rate from cardiovascular diseases is well below that of its major Latin America peers, as highlighted above. Despite these positive factors, demand for cardiovascular disease medicines in Chile is high, primarily as a result of the high prevalence of elevated blood cholesterol and obesity. Indeed, the county may exhibit higher demand for innovative medicines treating cardiovascular diseases than its regional peers. The relative attractiveness of Chile for innovative product launches is highlighted in BMI's Innovative Pharmaceutical Risk/Reward Index, where the country is ranked second on account of its attractive pricing regime, business environment and high purchasing power.

Competitive Landscape

  • In March 2017, Sanofi and Regeneron's anti-cholesterol drug Praluent (alirocumab) was launched in Brazil after being approved by Brazil's National Health Surveillance Agency (ANVISA) in August 2016. Praluent was approved by Mexico's Federal Commission for Protection against Sanitary Risks (COFEPRIS) in May 2016; however, the drug is awaiting approval by Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) and Chile's National Drug Agency (ANAMED).

  • Amgen's Repatha (evolocumab), a competitor of Praluent which works by inhibiting the same protein (PSCK9), is reportedly available in a number of Latin American countries including: Argentina, Bolivia, Chile, Colombia, Ecuador, Guatemala and Nicaragua.

  • In April 2016, Argentina's ANMAT became the first major Latin American regulatory agency to approve Novartis' congestive heart failure drug Entresto (sacubitril + valsartan). In October 2016, Mexico's COFEPRIS also approved Entresto. Novartis applied to Brazil's ANVISA for approval in June 2015 and approval is expected in the first half of 2017.