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The Top 10 Pharmaceutical Companies in BRIC

From: Business Insight

Summary

  • Brazil, China, Russia and India (BRIC) represent attractive new avenues for global pharmaceutical companies for expansion. Attractive features of these markets include high investment potential, untapped disease therapy areas, changing disease patterns and increasing awareness of the importance of healthcare.
  • The pharmaceutical industry in the BRIC markets was valued at $58bn in 2009 at a year-on-year growth of 11.1%. These markets grew at a consolidated CAGR of 20.7% during 2005–09.
  • China was the largest of the BRIC markets in 2009 with pharmaceutical sales of $26.1bn generated at a year-on-year growth of 28.5%. In the eleventh five-year plan, the Chinese government has underscored healthcare development as a priority and to this end has formed a National List of Essential Medicines (NLEM) reimbursable under the government’s insurance scheme.
  • The Brazilian market posted sale of $13.1bn in 2009 with year-on-year growth of 5.4%. The country suffered minimally from the economic downturn and it sustained growth. The government’s increased healthcare initiative and ANVISA’s improved regulatory policies are propelling pharmaceutical sales growth in Brazil.
  • The Russian pharmaceutical market was valued at $10.6bn in 2009 which was a year on year decline of 9.7% due to depreciation of the ruble as a result of the economic downturn. The current Russian President has announced a series of initiatives and fund allotments to concentrate efforts to improve the domestic pharmaceutical industry.
  • The Indian pharmaceutical market was valued at $8.3bn in 2009 at a year-on-year growth of 6.3%. The country is witnessing robust growth of its domestic industry and its economy has remained stable during the economic downturn.

Introduction

Brazil, Russia, China and India (BRIC) have demonstrated sustained economic growth over the past five years. However, the Russian economy declined at 7.9% in 2009 due to the impact of the global economic downturn of 2008. Brazil was among the last country to fall into recession due to its decreased reliance on exports to the developed markets whereas the Russian economy was the first among the BRIC nations to experience the recession. The BRIC countries demonstrate similar demographic and economic patterns. Aging populations, decreased or controlled population growth, rapidly increasing gross domestic product (GDP), increasing healthcare expenditure and a growing burden of chronic diseases are the major underlying factors influencing healthcare trends in the BRIC markets. Stringent price control of drugs, check on counterfeit drugs’ market, increased public and private insurance schemes and regulatory reforms are some of the measures undertaken by the BRIC countries to modernize their healthcare provision. In 2009, the BRIC countries had the following statistics:

  • China had the largest pharmaceutical market among the BRIC countries with a 45% of total BIRC pharmaceutical sales equivalent to $26.1bn. The market has been expanding at a rapid pace indicated by a CAGR of 27.9% during 2005–09. General anti-infective products were the largest therapy area in the country with sales of $7bn;
  • Brazil had a 22.6% share of BRIC pharmaceutical sales equivalent to sales of $13.1bn in 2009. Alimentary tract and metabolism was the leading drug class in the country with sales of $2.3bn.. The Brazilian pharmaceutical market had a robust 18% CAGR during 2005–09;
  • Russia had 18.2% of the consolidated $58bn sales from the BRIC pharmaceutical markets. The Russian ruble reported significant depreciation in the past year due to the economic crisis, thus demonstrating a 9.7% decrease in year-on-year sales in US$. Alimentary tract and metabolism was the largest selling drug class in the country with $1.8bn sales;
  • The Indian pharmaceutical market was worth $8.3bn in 2009 equivalent to 14.2% of the consolidated BRIC market sales. The country recorded a strong CAGR of 12.2% during the period 2005–09. Similar to the Brazilian and Russian markets, alimentary tract and metabolism was the leading drug class in India.

The following chapter provides an insight into the prevailing demographics, health status and the regulatory systems in the BRIC countries.

Brazil

Brazil is the largest Latin American country by area and population and has the world’s ninth largest GDP by purchasing power parity (2008) according to the World Bank. It was one of the last countries to be hit by the economic downturn in 2008 and has shown a rapid return to growth. Brazil experiences extreme regional differences, especially in social indicators including health, infant mortality and nutrition. The richer South and Southeast regions normally have much better indicators than the poorer North and Northeast.

Of the total population, 26.8% is below 15 years of age and only 9.6% of the population above 60 years of age indicating high birth rates. However, this trend is expected to gradually reverse leading to an increase in the geriatric population (>60 years) due to increases in life expectancy at birth, rising healthcare awareness, improving healthcare infrastructure and decreased death and birth rates. Table 1 gives an overview of Brazil’s demographic trends in 2009.

Table 1: Demographic indicators for Brazil, 2009

Table 1: Demographic indicators for Brazil, 2009
Indicators
Population (million) 199
Population growth (%) 1.2
Population over 60 years (% of total population) 9.6
Life expectancy at birth (Years) 72

Source: US Census Bureau and World Bank

Brazilian economic policies facilitated a rapid recovery of the country from the economic downturn and reduced export dependence on developed economies. Poverty (PPP $2 per day) has fallen markedly, from 22% in 2003 to 9% in 2008. Social inequality in Brazil fell markedly between 2001 and 2007, and is at a 30-year low. The Brazilian government has now embarked upon a new program called Program for the Acceleration of Growth (PAC) for infrastructure development to reinforce economic growth. Table 2 presents the key economic indicators driving Brazil’s economy in 2009.

Table 2: Key economic indicators for Brazil, 2009

Table 2: Key economic indicators for Brazil, 2009
Indicators
GDP (PPP) 13,230
GDP, real growth (%) 5
GDP (per capita) 8,205
Unemployment rate (% of total labor force) 8

Source: World Bank

Health status

The Brazilian healthcare system is a balance of private and public healthcare providers. The public health service provider United Health System (Sistema Unico de Saude, SUS) funded by the federal government, state health secretariat and municipalities, caters to the low income strata of the population. Under this system, patients have free access to medical care.

Table 3: Key healthcare infrastructure indicators, 2009

Table 3: Key healthcare infrastructure indicators, 2009
Healthcare infrastructure indicators
Healthcare expenditure (% of GDP) 8.4
Healthcare expenditure (per capita) ($) 606
Physician desity (per 1000 person) 2
Hopital bed density (per 1000 person) 2
Healthcare expenditure (Public, % of total health expenditure) 41.6
Out-of-pocket healthcare expenditure (% of private healthcare expenditure) 59

Source: World Bank

The private sector caters to the more affluent classes and provides insurance to patients. It accounts for 58% of the total healthcare expenditure. Of the total private expenditure, out-of-pocket payments form 59%. Table 3 gives an overview of the healthcare infrastructure indicators in Brazil in 2009.

The healthcare status of Brazil closely emulates the disease burden pattern of the developed countries with increased incidence of deaths due to causes including cardiovascular and cerebrovascular disorders. Table 4 lists the top 10 causes of deaths in Brazil in 2004.

Table 4: Top ten causes of deaths in Brazil

 

Table 4: Top ten causes of deaths in Brazil
Causes Deaths (‘000s) Deaths (%)
All causes 122 100
Ischemic heart disease 139 11
Cerebrovascular disease 129 11
Perinatal condition 70 6
Violence 57 5
Diabetes 53 4
Lower respiratory infections 51 4
Chronic obstructive pulmonary disease 46 4
Hypertensive heart disease 36 3
Road traffic accidents 34 3
Inflammatory heart disease 22 2

Source: World Health Organization

Regulatory framework

The Ministry of Health controls the regulatory system in Brazil. The Brazilian national health surveillance agency (ANVISA: Agencia Nacional de Vigilancia Sanitaria) was created in 1999 as the FDA equivalent drug regulatory body in Brazil. The agency controls approval, marketing, delivery and usage of drugs across the country. The Drug Market Regulation Chamber (CMED) controls drug prices and the National Institute of Industrial Property (INPI) manages intellectual property rights. The drug patent registration in the country follows the ‘pipeline’ mechanism and patents registered thus are called pipeline patents. Under the law, drug patents registered prior to 1996 in other countries will be automatically registered in Brazil as well, granting protection of 20 years under TRIPS. The only condition for such registration is absence of the product in the market prior to 1996. An adverse event notification system has been created within ANVISA called NOTIVISA (Notification System in Health Surveillance). ANVISA monitors and validates advertisements and information leaflets targeted at advertising drugs to patients and prescribers through partnerships with local universities. The CMED of ANVISA regulates pricing in Brazil. Pricing of innovative drugs is decided based on that present in nine reference markets. Generics are priced at 35% of that of branded drugs. One of the main drawbacks of the Brazilian price system is regarding the tax on medicines. The ALANAC (Brazilian Association for National Companies) says that such taxes are amongst the highest in the world.

Pharmaceutical drugs registered in Brazil are grouped into the following categories

  • Generics: Drugs available in the same dosage form containing the same active ingredient and administered in the same way as that of the reference drug. Additionally, bioequivalence studies are conducted by ANVISA prior to a product’s approval;
  • Similar drugs or similares: Drugs which have the same active ingredients, dosage form with equivalent therapeutic efficacy but is not bioequivalent to the reference drug;
  • Original drug: Innovative drugs with approved safety, efficacy and therapeutic profile.

The Brazilian pharmaceutical market is crowded by generics and similares. In a bid to promote the growth of the pharmaceutical industry the federal government has improved the drug approval process with respect to generics. New products have to now provide data on bioequivalence studies and comply with GMP standards of manufacturing.

Russia

Russia is the largest country in the world by area with a population of 140 million. The average life expectancy at birth is low when compared to other developed nations and comparable to the African nations diseased by the HIV/AIDS epidemic. The total life expectancy is 68 years on an average and it is 59 years and 73 years for male and female respectively. Russia has had a declining population since 1990 due to high death rates and low death rates. Increased mortality rates have resulted from high prevalence of cardiovascular diseases, HIV/AIDS, tuberculosis and cancer. Table 5 gives a overview of the demographic indicators in Russia in 2009.

Table 5: Demographic indicators of Russia, 2009

 

Table 5: Demographic indicators of Russia, 2009
Indicators
Population (million) 140
Population growth (%) -0.1
Population over 60 years (% of total population) 17.9
Life expectancy at birth (Years) 68

Source: US Census Bureau and World Bank

The Russian economy is recovering from the economic downturn, but at a rate lower than that anticipated. The downturn in Russia was triggered by plummeting oil prices and a credit crisis in Russian banks. The Central Bank of Russia spent close to $200bn in late 2008 to prevent the devaluation of the ruble. The government also announced a $200bn bailout plan to increase market liquidity and help Russian firms to overcome foreign debts. Table 6 presents the key economic indicators of Russia’s economy in 2009.

Table 6: Key economic indicators for Russia, 2009

 

Table 6: Key economic indicators for Russia, 2009
Indicators
GDP (PPP) 18,702
GDP, real growth (%) 5.6
GDP (per capita) 11,832
Unemployment rate (% of total labor force) 6.2

Source: World Bank

Health status

The economic crisis led to depreciation of the ruble and thus an increase in imported drug prices. Consequently, the household healthcare budget and out-of-pocket spending has increased. 75% of households have at least one member with one or more chronic illness and the fall in affordability has impacted the overall healthcare scenario. Table 7 gives an overview of the healthcare infrastructure indicators in Russia in 2009.

 

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