Paul Thomen

Monday, 29 April 2013

Argentina Healthcare, Regulatory and Reimbursement 2020

Value of Argentina’s Pharmaceutical Market to Almost Triple in Value over One Decade, Says GlobalData Analysis

Argentina’s pharmaceutical market is expected to grow from a value of around US$5.6 billion in 2012 to US$15 billion by 2020, thanks to a strong presence of domestic laboratories, high-quality manufacturing capabilities and favorable clinical trial regulations, cites new analysis by research and consulting firm GlobalData.

According to the new report*, domestic laboratories account for over 50% of the Argentine pharmaceutical market. Key domestic companies include Roemmers and Bagó, while multinationals such as Bayer, Novartis, Roche, Abbott and GlaxoSmithkline (GSK) also operate in the country.

The trend towards domestic pharma production has existed for several decades in Argentina. Local players are provided with government benefits such as favorable tariff protection, while raw material import costs historically undercut the transfer pricing generally applicable for multinationals. This gives domestic players a competitive advantage in Argentina.

The Argentine government enacted a law as part of the Health Emergency Act, enforcing physicians to include generic names of prescribed products, enabling pharmacies to use generic substitution. The resultant increase in generic sales led to the growth of Argentine generic drug manufacturers.

Argentina’s regulations governing intellectual property rights have also historically provided a distinct advantage to domestic companies, who were free to manufacture and sell products similar to patented versions. However, since Argentina became a signatory of Trade Related Intellectual Property rights (TRIPS) and General Agreement on Tariffs and Trade (GATT), local manufacturers could be negatively affected by restrictions on the manufacture and sale of patented products.

Argentina is also considered a favorable destination for cost-effective clinical trials within the Latin American region, and was one of the first Latin American countries to implement the recommendations of the WHO’s Good Manufacturing Practices and Control standards, endorsing compliance to an international set of quality standards for pharmaceutical production. Clinical trial standards are also similar to the International Conference on Harmonization – Good Clinical Practice (ICH-GCP) standards.

However, Argentina’s pharmaceutical industry faces some barriers. Argentine pharmaceutical companies lack the vast production capacities of Chinese and Indian companies, and are unable to compete with lower prices offered by them. Argentina also faces stiff challenges from other Latin American countries such as Mexico and Brazil, who have strengthened their pharmaceutical industries over the last decade.

In addition, the research and development (R&D) efforts of domestic pharmaceutical companies do not hold a fruitful history, and  although investment has increased over the past few years, no local players have been able to develop new chemical entities, making it difficult for domestic companies to compete with innovative multinationals.

The Argentine medical devices market is predicted to grow at a more modest rate, from approximately US$1.7 billion in 2012 to US$2.4 billion in 2020.

This report provides an essential source of information and analysis on the Argentina’s healthcare, regulatory and reimbursement landscape, identifying key trends in the market and providing insights into the demographic, regulatory, and reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GlobalData’s team of industry experts.

Reasons to buy

The report will enhance your decision-making capability and allow you to -
- Develop business strategies by understanding the trends shaping and driving the healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical and medical devices market segments and companies likely to impact the healthcare market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnerships
- Identify, understand and capitalize on the opportunities and challenges in the healthcare market

Table of Content

1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 10
2.1 GlobalData Report Guidance 10
3 Overview of Pharmaceutical and Medical Device Market 11
3.1 Pharmaceutical Market 11
3.1.1 Market Overview 11
3.1.2 Supply Channels 14
3.1.3 Market Segments 15
3.1.4 Overview of Major Therapeutic Areas 19
3.1.5 Major Players 27
3.2 Medical Device Market 47
3.2.1 Market Overview 47
3.2.2 Overview of Top Five Segments 49
3.2.3 Diagnostic Market 65
3.2.4 Major Players 67
3.3 Market Drivers and Barriers 89
3.3.1 Drivers 89
3.3.2 Barriers 90
4 Market Access 91
4.1 Reimbursement and Payer Landscape 91
4.1.1 Overview of Healthcare System 91
4.1.2 Reimbursement Process 94
4.1.3 Patient Share in Healthcare Spending 95
4.1.4 Pricing Policies 96
4.2 Regulatory Landscape 96
4.2.1 Overview of Regulatory Agencies 96
4.2.2 Market Authorization Procedure for Pharmaceutical Products 97
4.2.3 New Medical Device Approval Process 98
4.2.4 Exports and Imports 98
4.2.5 Intellectual Property Rights 99
4.2.6 Clinical Trial Regulations 102
4.2.7 Pharmaceutical Advertising Regulations 103
4.2.8 Pharmacy Regulations 103
4.2.9 Prescription by Active Ingredient Name 103
4.2.10 Labeling and Packaging Regulations 104
5 Country Analysis 105
5.1 Political Environment 105
5.1.1 Political Structure 105
5.1.2 Analysis of Current Political Environment 105
5.1.3 Healthcare Policy Initiatives 106
5.2 Economic Landscape 106
5.3 Economic Indicators 107
5.3.1 Gross Domestic Product 107
5.3.2 Gross National Income 110
5.3.3 Inflation 111
5.3.4 Currency Exchange Rate 114
5.3.5 Foreign Direct Investment 115
5.3.6 Foreign Exchange Reserves 116
5.3.7 Trade Balance 117
5.3.8 General Government Structural Balance 119
5.3.9 General Government Gross Debt 120
5.3.10 Major Industries 120
5.4 Demographics 121
5.4.1 Population 121
5.4.2 Education and Literacy 136
5.4.3 Employment 137
5.4.4 Disease Burden 138
5.5 Healthcare Infrastructure 140
5.5.1 Healthcare Facilities 140
5.5.2 Healthcare Parameters 141
5.5.3 Environmental Health 141
5.5.4 Healthcare Personnel 143
5.6 Healthcare Expenditure 144
5.6.1 Overview 144
5.6.2 Share of Public and Private Sector 145
5.7 Trade Associations 146
5.7.1 Argentina Association of Hospital Pharmacists 146
5.7.2 Industrial Chamber of Argentine Pharmaceutical Laboratories 146
5.7.3 Association of Medical Specialties Distributors 146
5.8 Trade Fairs 146
6 Opportunities and Challenges 147
6.1 Opportunities 147
6.2 Challenges 147
7 Appendix 149
7.1 Abbreviations 149
7.2 Bibliography 151
7.3 Methodology 154
7.3.1 Coverage 154
7.3.2 Secondary Research 154
7.3.3 Forecasting 155
7.3.4 Expert Panel Validation 155
7.4 Contact Us 155
7.5 Disclaimer 155

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