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PharmaSphere: North American Market Access Strategy

PharmaSphere: North American Market Access Strategy

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Executive Summary

PharmaSphere: North American Market Access Strategy

GlobalData's "PharmaSphere: North American Market Access Strategy" report provides a strategic analysis of the pharmaceutical market landscape in this geographic region, and the impact of the current and emerging market access strategies that the pharmaceutical industry is using for its for new and existing drugs. It discusses the regulatory requirements for pharmaceutical products in North American, key health insurance trends, recent government healthcare reforms, and general industry trends. It also describes the macroeconomic factors that impact the commercialization of new pharmaceutical products. Furthermore, it includes a geographic segmentation of the various markets in North America, including the US, Canada, and Mexico, providing an in-depth analysis of these markets' regulatory frameworks, healthcare systems, health insurance markets, key domestic players, and strategic outlook.


Key Questions Answered

What are the main factors influencing market access in North America?

How do demographic trends impact market access in Canada and Mexico?

What are the important elements of the healthcare systems in the US, Canada, and Mexico?

How important is health technology assessment (HTA)? What are the key processes leading up to a successful HTA in North America?

What are the different pricing and reimbursement procedures adopted by regulators in North America?

How has recent healthcare reform legislation changed market access considerations from the perspective of regulators and pharmaceutical companies?

How have cost-containment pressures impacted the commercialization of new pharmaceutical products?

Reasons To Buy

Identify the key decision makers in various countries in the North American region, including the US, Canada, and Mexico

Understand the key causes, concerns, drivers, and trends that characterize the market access process

Analyze the impact of recent healthcare reform legislation on market access procedures

Identify the key factors in the market access process, such as pricing, reimbursement, co-payments, discounts, and pharma economic guidelines

Understand the impact of macroeconomic factors, such as healthcare expenditures, foreign direct investment (FDI), and population demographics on the market access process

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 8

2.1 Report Scope 8

2.2 Companies Mentioned 9

2.3 Upcoming Reports 9

2.4 Related Reports 10

3 Market Access Policy Evolution 11

3.1 Key Concepts in Market Access 11

3.1.1 Reference Pricing System 13

3.2 Health Technology Assessments 14

3.2.1 Use of Pharmacoeconomics 14

4 United States 16

4.1 Pharmaceutical Market 16

4.1.1 Market Size and Forecast 16

4.1.2 Market Segments and Disease Areas 19

4.2 Health Insurance Market 25

4.2.1 Managed Care 26

4.2.2 US Government-Sponsored Health Insurance Plans 29

4.2.3 Children's Health Insurance Program 34

4.3 Regulatory Landscape 35

4.3.1 Implementation of the ACA 35

4.3.2 Health Insurance Marketplace 39

4.4 Drug Pricing 39

4.4.1 Pricing Policies 39

4.4.2 Types of Funding 42

4.5 Reimbursement 43

4.5.1 Academy of Managed Care Pharmacy Guidance Format 43

4.5.2 Medicare Coverage Policies 45

5 Canada 46

5.1 Pharmaceutical Market 46

5.1.1 Market Size and Forecasts 46

5.1.2 Market Segments and Disease Areas 47

5.2 Health Insurance Market 51

5.2.1 Public Insurance 51

5.2.2 Private Insurance 52

5.3 Regulatory Landscape 54

5.3.1 Canada Health Act 54

5.3.2 National Pharmaceuticals Strategy 55

5.4 Pricing 56

5.4.1 Pricing Policies 56

5.4.2 Patented Drug Price Trends 57

5.5 Reimbursement 59

5.5.1 Reimbursement Policies 59

6 Mexico 62

6.1 Pharmaceutical Market 62

6.1.1 Market Size and Forecasts 62

6.1.2 Market Segments and Disease Areas 63

6.2 Health Insurance Market 66

6.2.1 Public Insurance 66

6.2.2 Private Insurance 68

6.3 Regulatory Landscape 68

6.3.1 COFEPRIS 68

6.4 Pricing 68

6.4.1 Pricing Policies 68

7 Benchmark Ratings 71

7.1 Regional Benchmark Ratings 71

7.1.1 Overview 71

7.2 Key Parameter Trends 72

7.2.1 Macroeconomic Parameters 72

7.2.2 Healthcare Expenditures and Infrastruture Parameters 76

7.2.3 Business Environment 80

7.2.4 Regulatory and Clinical Trial Landscape 82

8 Outlook 84

8.1 Shift in Focus from Prescriber to Payer 84

8.2 Market Access Alters Product Commercialization Strategies 85

9 Appendix 86

9.1 Bibliography 86

9.2 Abbreviations 90

9.3 Research Methodology 96

9.3.1 Coverage 96

9.3.2 Secondary Research 96

9.4 About the Author 97

9.4.1 Aparna Krishnan, Industry Analyst 97

9.4.2 Global Head of Healthcare 97

9.5 About the Industry Dynamics Team 98

9.6 About GlobalData 98

9.7 Disclosure Information 98

9.8 Disclaimer 99

1.2 List of Figures

Figure 1: Historical Sales of Branded Biologics, 2008-2014 and Forecast to 2020 20

Figure 2: Major Disease Areas of Patented Drug Products (%), Canada 50

Figure 3: Annual GDP Growth (%), North America, 2010-2013 73

Figure 4: FDI Levels (%) of GDP, North America, 2010-2013 74

Figure 5: Unemployment Levels (%) of GDP, North America, 2010-2012 75

Figure 6: R&D Expenditures (%) of GDP, North America, 2010-2012 76

Figure 7: Healthcare Expenditures per Capita, North America, 2010-2012 77

Figure 8: Total Healthcare Expenditures (%) of GDP, North America, 2010-2012 78

Figure 9: Out-of-Pocket Healthcare Expenditures (%), North America, 2010-2012 79

Figure 10: Concentration (%) of the Geriatric Population, North America, 2010-2013 80

Figure 11: Governance Index, North America, 2010-2013 81

Figure 12: Ease of Doing Business Index, North America, 2013-2014 82

Figure 13: Intellectual Property Rights Index, North America, 2013-2014 83

1.1 List of Tables

Table 1: 2012 AMCP Guidance Format 44

Table 2: Medicare Coverage: Parts A, B, C, and D 45

Table 3: PharmaCare Plans, 2011 52

Table 4: Annual Change (%) in PMPI, Canada, 2005-2012 57

Table 5: Change (%) in PMPI by Major Therapeutic Class, Canada, 2011-2012 58

Table 6: Levels of Therapeutic Improvement, 2012 61

Table 7: Benchmark Ratings for the North American Region 72

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