Generic Drugs: World Market 2014-2024

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Generic Drugs: World Market 2014-2024 & Future Prospects for

Leading Companies

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Contents

1. Executive Summary

1.1 Overview of Findings

1.2 Structure of the Report

1.3 Research and Analysis Methods

1.4 Glossary of Terms in this Report

2. Introduction to Generic Drugs

2.1 The Pharmaceutical Industry: a Very Brief Overview

2.2 What are Generic Drugs?

2.2.1 The Early History of Generic Drugs

2.2.2 The Hatch-Waxman Act and the Rise of Generics

2.3 Criteria for Demonstrating Bioequivalence

2.4 Authorised, Branded and Unbranded Generics

2.5 Classification of Generic Drugs Markets

2.6 Generic Substitution and the Decline of Big Pharma

2.6.1 The 'Evergreening' of Pharmaceuticals

2.7 Regulation of Generic Drugs

2.7.1 Regulation in the US

2.7.1.1 Obtaining FDA Approval: NDAs and ANDAs

2.7.1.2 The Hatch-Waxman Act Title I: Promotion of Generic Drugs

2.7.1.3 The Hatch-Waxman Act Title II: Incentives for the Branded Industry

2.7.1.4 The Impact of the Hatch-Waxman Act on the US Market

2.7.1.5 Me First: Timing as a Crucial Factor

1. Executive Summary

2. Introduction to Generic Drugs

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Contents

2.7.2 Regulation in Europe

2.7.2.1 EU Marketing Approval Procedures

2.7.2.2 The 8+2+1 Rule: EU Data Exclusivity

2.7.2.3 Supplementary Protection Certificates

2.7.2.4 Variation Between European Countries

2.7.2.5 Towards Harmonisation of Standards

2.7.2.6 A Unitary European Patent System

2.7.3 Regulation in Japan

2.7.4 Regulation in China

2.8 Compulsory Licensing

2.9 Scope of this Report

3. Generic Drugs: World Market 2014-2024

3.1 The World Generic Drugs Market in 2012 and 2013

3.2 World Generic Drugs Market: Sales Forecast 2014-2024

3.3 Geographical Breakdown of the World Generic Drugs Market

3.4 World Generic Drugs Market: National Markets Forecast 2014-2024

3.5 World Generic Drugs Market: Regional Markets Forecast 2014-2024

3.6 How Will National Market Shares Change to 2024?

3.7 How Will Regional Market Shares Change to 2024?

3.8 World Generic Drugs Market: Drivers and Restraints 2014-2024

3. Generic Drugs: World Market 2014-2024

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Contents

4. Leading Generic Drug Manufacturers

4.1 World Generic Drugs Market: Top 10 Companies

4.2 Novartis

4.2.1 Novartis: Revenue Shares by Segment

4.2.2 Novartis: Generic Drugs Sales Forecast 2014-2024

4.2.3 Novartis: Recent Developments

4.2.3.1 Loss of Enoxaparin Exclusivity Hits Sandoz Profits in 2012

4.2.3.2 Emphasis on Difficult-to-Manufacture Products

4.2.3.3 FDA Quality Concerns at Sandoz Manufacturing Plants

4.2.3.4 Acquisition of Fougera Pharmaceuticals in 2012

4.2.4 Novartis: Generic Drug Market Prospects to 2024

4.3 Teva

4.3.1 Teva: Revenue Shares by Segment

4.3.2 Teva: Generic Drugs Sales Forecast 2014-2024

4.3.3 Teva: Recent Developments

4.3.3.1 Expansion Through Acquisitions

4.3.3.2 High-Value Generics to Drive Teva’s Generics Growth

4.3.3.3 Generic Viagra to Launch in 2017

4.3.3.4 Teva’s Shift Towards Innovation

4.3.3.5 Copaxone Faces Generic Competition

4.3.4 Teva: Generic Drug Market Prospects to 2024

4.4 Actavis

4.4.1 Actavis: Revenue Shares by Segment

4.4.2 Actavis: Generic Drugs Sales Forecast 2014-2024

4. Leading Generic Drug Manufacturers 2014

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Contents

4.4.3 Actavis: Recent Developments

4.4.3.1 Actavis Rejects Valeant and Mylan Merger Offers

4.4.3.2 Actavis Acquires Warner Chilcott

4.4.3.3 Actavis’s Biosimilar Ambitions

4.4.3.4 Exiting the Chinese Generics Market

4.4.4 Actavis: Generic Drug Market Prospects to 2024

4.5 Mylan

4.5.1 Mylan: Revenue Shares by Segment

4.5.2 Mylan: Generic Drugs Sales Forecast 2014-2024

4.5.3 Mylan: Recent Developments

4.5.3.1 Mylan to Double Manufacturing Capacity by 2016

4.5.3.2 Mylan Acquires Rights to GSK’s Advair, Diskus and Seretide

4.5.3.3 Launch of Generic Copaxone in 2014

4.5.3.4 Acquisition of Agila Expands Mylan’s Injectables Business

4.5.3.5 Mylan Working with India’s Biocon on Biosimilars

4.5.4 Mylan: Generic Drug Market Prospects to 2024

4.6 Abbott

4.6.1 Abbott: Revenue Shares by Segment

4.6.2 Abbott: Generic Drugs Sales Forecast 2014-2024

4.6.3 Abbott: Recent Developments

4.6.3.1 Abbott Retains Established Products After Spinning Off AbbVie

4.6.3.2 Acquisition of Solvay Pharmaceuticals and Piramal Healthcare Solutions

4.6.4 Abbott: Generic Drug Market Prospects to 2024

4.7 Pfizer

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Contents

4.7.1 Pfizer: Revenue Shares by Segment

4.7.2 Pfizer: Generic Drugs Sales Forecast 2014-2024

4.7.3 Pfizer: Recent Developments

4.7.3.1 Pfizer Spins Off Animal Health into Zoetis

4.7.3.2 Pfizer Restructures into Three Business Units

4.7.4 Pfizer: Generic Drug Market Prospects to 2024

4.8 Fresenius Kabi

4.8.1 Fresenius Kabi: Revenue Shares by Segment

4.8.2 Fresenius Kabi: Generic Drugs Sales Forecast 2014-2024

4.8.3 Fresenius Kabi: Recent Developments

4.8.3.1 InnoPharma Licensing Deal Bolsters Portfolio Grown Via Past Acquisitions

4.8.3.2 FDA Manufacturing Quality Concerns at Fresenius Kabi Plants

4.8.3.3 Fresenius Kabi’s Joint Venture with PT Soho Global Health

4.8.4 Fresenius Kabi: Generic Drug Market Prospects to 2024

4.9 Hospira

4.9.1 Hospira: Revenue Shares by Segment

4.9.2 Hospira: Generic Drugs Sales Forecast 2014-2024

4.9.3 Hospira: Recent Developments

4.9.3.1 Mayne Pharma and Orchid: Expansion Through Acquisitions

4.9.3.2 Javelin Pharma’s Dyloject Fails to Deliver

4.9.3.3 Manufacturing Concerns and Remediation Efforts

4.9.4 Hospira: Generic Drug Market Prospects to 2024

4.10 Aspen

4.10.1 Aspen: Revenue Shares by Segment

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Contents

4.10.2 Aspen: Generic Drugs Sales Forecast 2014-2024

4.10.3 Aspen: Recent Developments

4.10.3.1 Acquisition of GSK Anti-Thrombosis Brands

4.10.3.2 Aspen Acquires Merck MSD’s Dutch API Plant

4.10.4 Aspen: Generic Drug Market Prospects to 2024

4.11 Sanofi

4.11.1 Sanofi: Revenue Shares by Segment

4.11.2 Sanofi: Generic Drugs Sales Forecast 2014-2024

4.11.3 Sanofi: Recent Developments

4.11.3.1 Acquisitions in Emerging Markets

4.11.3.2 Sanofi’s “Brazil Generics Issue”

4.11.4 Sanofi: Generic Drug Market Prospects to 2024

5. US Generics Market 2014-2024

5.1 US Generic Drugs Market: Overview

5.2 US Generic Drugs Market: Generic Penetration by Volume

5.3 The US Generic Drugs Market: Revenue Forecast 2014-2024

5.4 US Generic Drugs Market: Drivers and Restraints

5.5 US Generic Drugs Market: Leading Companies

5.6 US Generic Drugs Market: Trends and Developments

5.6.1 High Consumer Acceptance of Generic Medicines

5.6.2 Affordable Care Act: Expanding Medicare Coverage

5.6.3 A US Biosimilars Market?

5.6.4 The ANDA Backlog

5. The US Generic Drugs Market 2014-2024

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Contents

5.6.5 Generic Drug User Fee Amendments (GDUFA) 2012

5.6.6 Falling Generic Drug Prices

5.6.7 Shortages of Generic Drugs Will Restrain the Market

5.6.8 An End to ‘Pay for Delay’?

5.7 US Generic Drugs Market: Conclusions

6. Leading European Generics Markets 2014-2024

6.1 The European Generic Drugs Market: Overview

6.1.1 Europe’s Mature and Developing Generics Markets

6.1.2 Pricing Systems and Generic Penetration

6.1.2.1 The Effects of Tendering for Generic Medicines

6.1.2.2 Lower Patient Co-payments Drive Demand for Generics

6.1.3 Will Europe Move Towards Free-Pricing Systems?

6.1.4 Challenges in the European Regulatory Environment

6.1.5 Ending Pay For Delay in Europe

6.1.6 FDA and EMA Joint Data Sharing and Inspections

6.2 EU5 Generic Drugs Market Forecast 2014-2024

6.3 German Generic Drugs Market: Overview

6.3.1 German Generic Drugs Market: Sales Forecast 2014-2024

6.3.2 German Generic Drugs Market: Generic Penetration by Volume

6.3.3 German Generic Drugs Market: Generic Penetration by Value

6.3.4 German Generic Drugs Market: Leading Companies

6.4 French Generic Drugs Market: Overview

6.4.1 French Generic Drugs Market: Sales Forecast 2014-2024

6. Leading European Generics Markets 2014-2024

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Contents

6.4.2 French Generic Drugs Market: Generic Penetration by Volume

6.4.3 French Generic Drugs Market: Generic Penetration by Value

6.5 UK Generic Drugs Market: Overview

6.5.1 UK Generic Drugs Market: Sales Forecast 2014-2024

6.5.2 UK Generic Drugs Market: Generic Penetration by Volume

6.5.3 UK Generic Drugs Market: Generic Penetration by Value

6.5.4 UK Generic Drugs Market: Trends and Developments

6.5.4.1 Cost Pressures and Demand-Side Policies Drive UK Generic Penetration

6.5.4.2 Reducing Generic Drug Prices: the Drug Tariff System

6.5.4.3 The Increasing Role of Pharmacists

6.6 Italian Generic Drugs Market: Overview

6.6.1 Italian Generic Drugs Market: Sales Forecast 2014-2024

6.6.2 Italian Generic Drugs Market: Generic Penetration by Volume

6.6.3 Italian Generic Drugs Market: Generic Penetration by Value

6.7 Spanish Generic Drugs Market: Overview

6.7.1 Spanish Generic Drugs Market: Sales Forecast 2014-2024

6.7.2 Spanish Generic Drugs Market: Generic Penetration by Volume

6.7.3 Spanish Generic Drugs Market: Generic Penetration by Value

7. Leading Asia-Pacific Generics Markets 2014-2024

7.1 Japanese Generic Drugs Market: Overview

7.1.1 Japanese Generic Drugs Market: Sales Forecast 2014-2024

7.1.2 Japanese Generic Drugs Market: Generic Penetration by Volume

7.1.3 Japanese Generic Drugs Market: Generic Penetration by Value

7. Leading Asia-Pacific Generics Markets 2014-2024

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Contents

7.1.4 Japanese Generic Drugs Market: Leading Companies

7.1.5 Japanese Generic Drugs Market: Trends and Developments

7.1.5.1 Government Initiatives Driving Generic Penetration

7.1.5.2 Japanese Attitudes to Generic Drugs

7.1.5.3 Generic Substitution by Pharmacists

7.2 Chinese Generic Drugs Market: Overview

7.2.1 Chinese Generic Drugs Market: Sales Forecast 2014-2024

7.2.2 Chinese Generic Drugs Market: Generic Penetration by Volume

7.2.3 Chinese Generic Drugs Market: Generic Penetration by Value

7.2.4 Chinese Generic Drugs Market: Trends and Developments

7.2.4.1 Compulsory Licensing of Generic Drugs

7.2.4.2 Expansion of Healthcare Coverage and Reimbursement

7.2.4.3 Growth Opportunities in Branded Generics

7.2.4.4 Price Controls and the Anhui Model

7.3 Indian Generic Drugs Market: Overview

7.3.1 Indian Generic Drugs Market: Sales Forecast 2014-2024

7.3.2 Indian Generic Drugs Market: Leading Companies

7.3.3 Indian Generic Drugs Market: Trends and Developments

7.3.3.1 Drug Prices Control Order 2013

7.3.3.2 Expansion of Healthcare Provision

7.3.3.3 Manufacturing Quality Failures

8. Emerging Generics Markets 2014-2024

8.1 Emerging Markets: A Key Growth Opportunity

8. Emerging Generics Markets 2014-2024

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Contents

8.2 Russian Generic Drugs Market: Overview

8.2.1 Russian Generic Drugs Market: Sales Forecast 2014-2024

8.2.2 Russian Generic Drugs Market: Trends and Developments

8.2.2.1 Pharma2020, Healthcare and Industry Reform

8.2.2.2 Self-Medication and Russian Pharmacy

8.3 Brazilian Generic Drugs Market: Overview

8.3.1 Brazilian Generic Drugs Market: Sales Forecast 2014-2024

8.3.2 Brazilian Generic Drugs Market: Trends and Developments

8.3.2.1 Increasing Access to Medicines

8.3.2.2 Foreign Companies Entering the Brazilian Market

8.4 Mexican Generic Drugs Market: Overview

8.4.1 Mexican Generic Drugs Market: Sales Forecast 2014-2024

8.4.2 Mexican Generic Drugs Market: Trends and Developments

8.4.2.1 International Interest in Mexico

8.4.2.2 Government Initiatives Driving Generic Use

8.5 South Korean Generic Drugs Market: Overview

8.5.1 South Korean Generic Drugs Market: Sales Forecast 2014-2024

8.5.2 South Korean Generic Drugs Market: Trends and Developments

8.5.2.1 The Evolution of Pharmaceutical Price Controls

8.5.2.2 KORUS FTA: The South Korea – US Free Trade Agreement

8.5.2.3 EU-Korea Free Trade Agreement

8.6 Turkish Generic Drugs Market: Overview

8.6.1 Turkish Generic Drugs Market: Sales Forecast 2014-2024

8.6.2 Turkish Generic Drugs Market: Trends and Developments

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Contents

8.6.2.1 Regulatory Aspects of Generics in Turkey

8.6.2.2 HTP: Transforming Turkish Healthcare Provision

8.6.2.3 Price Controls in the Turkish Pharma Market

8.6.2.4 Draft Patent Law Amendments

9. Qualitative Analysis of the Generic Drugs Market 2014-2024

9.1 SWOT Analysis of the Generic Drugs Market

9.2 Strengths

9.2.1 Strong Political Support for Domestic Generic Industries

9.2.2 Improving Regulatory Processes

9.2.3 Global Presence and Manufacturing Capacity

9.2.4 Higher Growth Rates than Innovative Pharma

9.3 Weaknesses

9.3.1 Highly Competitive Industry with Low Profit Margins

9.3.2 Patent Extension and Exclusivity Create Uncertainty in Product Launch

9.3.3 Manufacturing Safety and Quality Concerns

9.3.4 Perceptions of Generic Drugs as Unsafe or Low Quality

9.4 Opportunities

9.4.1 Patent Expiration of Innovator Drugs

9.4.2 Increasing Demand for Generics due to Demographic Trends

9.4.3 High Growth in Emerging Markets

9.4.4 Biosimilars and Complex or Branded Generics

9.5 Threats

9.5.1 Price Controls by Governments

9. Qualitative Analysis of the Generic Drugs Market 2014-2024

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Contents

9.5.2 Decline in Pipeline of Drugs Nearing Patent Expiry

9.5.3 Defensive Patenting Strategies

9.5.4 Consolidation Among Pharmacies and Healthcare Payers

9.6 Porter’s Five Forces Analysis of the Generic Drugs Market

9.6.1 Rivalry Among Competitors [High]

9.6.2 Threat of New Entrants [High]

9.6.3 Power of Suppliers [Low]

9.6.4 Power of Buyers [Medium]

9.6.5 Threat of Substitutes [Low]

10. Research Interviews

10.1 Interview with Professor Joshua P. Cohen, PhD, Research Assistant Professor, Tufts Center

for the Study of Drug Development, Boston, Massachusetts, USA

10.1.1 The US Generic Drugs Market

10.1.2 Challenges for the Generic Drugs Industry

10.1.3 The Future of the Generic Drugs Market?

10.2 Interview with David Gaugh, R.Ph., Senior Vice President of Science and Regulatory Affairs,

Generic Pharmaceutical Association, Washington DC, USA

10.2.1 The US Generic Drugs Market

10.2.2 Challenges for the Generic Drugs Industry

10.2.3 The Future of the Generic Drugs Market?

10.3 Interview with Pieter Dylst, PhD, Post-doctoral Researcher, Katholieke Universiteit Leuven,

Leuven, Belgium

10.3.1 The European Generic Drugs Market

10. Research Interviews

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Contents

10.3.2 The Future of the Generics Industry

11. Conclusions

11.1 The World Generic Drugs Market in 2012 and 2013

11.2 World Generic Drugs Market Forecast 2014-2024

11.3 Generic Penetration by Volume in Leading National Markets

11.4 Leading National Markets

11.5 Leading Generic Drug Manufacturers

11.6 The Future of the Generic Drugs Market?

Appendix A

Supplementary Information: Patent Expiries by Year

11. Conclusions

Appendix A

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Contents

Table 1.1 Currency Exchange Rates, 2012-2013

Table 2.1 Types of Drug Names, 2014

Table 3.1 World Generic Drugs Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2012-

2024

Table 3.2 World Generic Drugs Market Forecast: Revenues ($bn) and Market Shares (%) by

National Market, 2012-2013

Table 3.3 World Generic Drugs Market Forecast: Revenues ($bn) and Market Shares (%) by

Region, 2012-2013

Table 3.4 World Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by

National Market, 2012-2024

Table 3.5 World Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by

Regional Market, 2012-2024

Table 3.6 Market Shares (%) of Leading National Generic Drugs Markets, 2012, 2018 and 2024

Table 3.7 Market Shares (%) of Leading Regional Generic Drugs Markets, 2012, 2018 and 2024

Table 4.1 Top 10 Generic Drug Manufacturers: Generic Drugs Revenue ($bn), Market Share (%),

2012-2013

Table 4.2 Top 10 Generic Drug Manufacturers: Generic Drugs Revenue ($bn), Market Share (%),

2018 and 2024

Table 4.3 Novartis: Overview, 2012-2013

Table 4.4 Novartis: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.5 Novartis: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.6 Teva: Overview, 2012-2013

Table 4.7 Teva: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.8 Teva: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

List of Tables

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Table 4.9 Actavis: Overview, 2012-2013

Table 4.10 Actavis: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.11 Actavis: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.12 Mylan: Overview, 2012-2013

Table 4.13 Mylan: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.14 Mylan: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.15 Abbott: Overview, 2012-2013

Table 4.16 Abbott: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.17 Abbott: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.18 Pfizer: Overview, 2012-2013

Table 4.19 Pfizer: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.20 Pfizer: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.21 Fresenius Kabi: Overview, 2012-2013

Table 4.22 Fresenius Kabi: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.23 Fresenius Kabi: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.24 Hospira: Overview, 2012-2013

Table 4.25 Hospira: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.26 Hospira: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.27 Aspen: Overview, 2012-2013

Table 4.28 Aspen: Revenue ($bn), Revenue Shares (%) by Segment, 2013

Table 4.29 Aspen: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

Table 4.30 Sanofi: Overview, 2012-2013

Table 4.31 Sanofi: Revenue ($bn), Revenue Shares (%) by Segment, 2012

Table 4.32 Sanofi: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

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Table 5.1 US Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Table 5.2 US Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2024

Table 6.1 EU5 Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2024

Table 6.2 German Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 6.3 German Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Table 6.4 German Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Table 6.5 French Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 6.6 French Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Table 6.7 French Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Table 6.8 UK Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2024

Table 6.9 UK Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Table 6.10 UK Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Table 6.11 Italian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 6.12 Italian Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Table 6.13 Italian Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Table 6.14 Spanish Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 6.15 Spanish Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Table 6.16 Spanish Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Table 7.1 Japanese Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%),

2012-2024

Table 7.2 Japanese Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

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Table 7.3 Japanese Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Table 7.4 Chinese Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 7.5 Chinese Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Table 7.6 Chinese Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Table 7.7 Indian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 8.1 Russian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 8.2 Brazilian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 8.3 Mexican Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 8.4 South Korean Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%),

2012-2024

Table 8.5 Turkish Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

Table 9.1 SWOT Analysis of the Generic Drugs Market, 2014-2024

Table 9.2 World 65+ Population Forecast: Size (m), AGR (%), CAGR (%), 2013-2024

Table 11.1 Generic Penetration by Volume in Leading National Markets (%), 2013

Table A.1 Selected Significant Patent Expiries, 2012-2016

Table A.2 Selected Significant Patent Expiries, 2010




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Contents




Figure 2.1 EU Data Exclusivity For Generics: Possible Scenarios, 2014

Figure 3.1 World Generic Drugs Market Forecast: Revenue ($bn), AGR (%), 2012-2024

Figure 3.2 World Generic Drugs Market: Revenues ($bn) by National Market, 2013

Figure 3.3 World Generic Drugs Market: Market Shares (%) by National Market, 2013

Figure 3.4 World Generic Drugs Market: Revenues ($bn) by Region, 2013

Figure 3.5 World Generic Drugs Market: Market Shares (%) by Region, 2013

Figure 3.6 World Generic Drugs Market: Revenues ($bn) by National Market, 2012-2024

Figure 3.7 World Generic Drugs Market: Revenues ($bn) by Regional Market, 2012-2024




Figure 3.11 World Generic Drugs Market: Market Shares (%) by Regional Market, 2012



Figure 3.14 World Generic Drugs Market: Drivers and Restraints, 2014-2024

Figure 4.1 Top 10 Generic Drug Manufacturers: Market Shares (%), 2013



Figure 4.4 Novartis: Revenue Shares (%) by Segment, 2012

List of Figures

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Figure 4.5 Novartis: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.6 Teva: Revenue Shares (%) by Segment, 2012

Figure 4.7 Teva: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.8 Actavis: Revenue Shares (%) by Segment, 2012

Figure 4.9 Actavis: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.10 Mylan: Revenue Shares (%) by Segment, 2012

Figure 4.11 Mylan: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.12 Abbott: Revenue Shares (%) by Segment, 2012

Figure 4.13 Abbott: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.14 Pfizer: Revenue Shares (%) by Segment, 2012

Figure 4.15 Pfizer: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.16 Fresenius Kabi: Revenue Shares (%) by Segment, 2012

Figure 4.17 Fresenius Kabi: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.18 Hospira: Revenue Shares (%) by Segment, 2012

Figure 4.19 Hospira: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.20 Aspen: Revenue Shares (%) by Segment, 2013

Figure 4.21 Aspen: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 4.22 Sanofi: Revenue Shares (%) by Segment, 2012

Figure 4.23 Sanofi: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

Figure 5.1 US Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 5.2 US Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 5.3 US Generic Drugs Market: Drivers and Restraints, 2014-2024

Figure 6.1 EU5 Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 6.2 German Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

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Figure 6.3 German Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 6.4 German Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Figure 6.5 French Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 6.6 French Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 6.7 French Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Figure 6.8 UK Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 6.9 UK Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 6.10 UK Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Figure 6.11 Italian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 6.12 Italian Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 6.13 Italian Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Figure 6.14 Spanish Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 6.15 Spanish Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 6.16 Spanish Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Figure 7.1 Japanese Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 7.2 Japanese Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 7.3 Japanese Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Figure 7.4 Chinese Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 7.5 Chinese Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

Figure 7.6 Chinese Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

Figure 7.7 Indian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 8.1 Russian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 8.2 Brazilian Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 8.3 Mexican Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

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Figure 8.4 South Korean Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 8.5 Turkish Generic Drugs Market Forecast: Revenues ($bn), AGR (%), 2012-2024

Figure 9.1 World 65+ Population Forecast: Size (m), 2013-2024

Figure 9.2 Porter’s Five Forces Analysis of the Generic Drugs Market, 2014-2024

Figure 11.1 Generic Penetration by Volume in Leading National Markets (%), 2013

Abbott Laboratories (Abbott)

AbbVie

Aché Laboratórios Farmacêuticos S.A. (Aché)

Actavis (Foshan) Pharmaceuticals Co., Ltd (subsidiary of Actavis)

Actavis plc (Actavis)

Actelion Pharmaceuticals

Advanced Medical Optics (subsidiary of Abbott)

Agila Specialties (acquired by Mylan)

Alcon (part of Novartis)

Alembic Pharmaceuticals

Allergan

Altra Investments

Amgen

Amphastar Pharmaceuticals

APP Pharmaceuticals (acquired by Fresenis Kabi)

Arrow Group (part of Actavis)

Ascent Pharmahealth (acquired by Actavis)

Companies Listed

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Aspen Pharmacare Holdings Limited (Aspen)

Astellas Pharma

AstraZeneca

Aurobindo

Aventis (part of Sanofi)

Barr Pharmaceuticals (acquired by Teva)

Bayer AG (Bayer)

Bedford Laboratories (currently part of Boehringer Ingelheim)

Bergamo Ltda

Biocon Limited (Biocon)

Bioniche Pharma Holdings Ltd (acquired by Mylan)

BMP Sunstone (acquired by Sanofi)

Boehringer Ingelheim

Bolar Pharmaceutical (now Circa Pharmaceuticals, part of Actavis)

Cephalon (acquired by Teva)

Chattem (acquired by Sanofi)

Chiron Corporation (part of Novartis)

CIBA VISION (part of Novartis)

Cipla

Claris Lifesciences Ltd (Claris)

Compañía Internacional de Comercio, S.A.P.I. de C.V. (CISCA) (acquired by Taisho)

Corporación Infarmasa (Infarmasa) (acquired by Teva)

Cubist Pharmaceuticals

Dabur Pharma (acquired by Fresenis Kabi)

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Daiichi Sankyo Brazil (subsidiary of Daiichi Sankyo)

Daiichi Sankyo Co., Ltd.

Dalim BioTech

Dey Pharma (now Mylan Specialty, subsidiary of Mylan)

Dr. Reddy's Laboratories

Ebewe Pharma (acquired by Novartis)

Eden Biopharm Group (part of Actavis)

Egis Pharmaceuticals

Eisai

Elder Pharmaceuticals

Eli Lilly and Company (Lilly)

Elyson Pharmaceutical

EMS Sigma Pharma

Endo Pharmaceuticals

Eon Labs (acquired by Novartis)

Eurofarma Laboratories

F. Hoffmann-La Roche Ltd. (Roche)

Facet Biotech (acquired by Abbott)

Farmacias Similares

Fenwal (acquired by Fresenis Kabi)

Filaxis (acquired by Fresenis Kabi)

Forest Laboratories

Foshan Chanbende Development

Fougera Pharmaceuticals (acquired by Novartis)

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Fresenius Kabi (division of Fresenius SE & Co. KGaA)

Fresenius SE & Co. KGaA

Fuji Pharma Co., Ltd.

Gedeon Richter

Genzyme (acquired by Sanofi)

Gilead Sciences

GlaxoSmithKline (GSK)

Greenstone (subsidiary of Pfizer)

Grupo Imperial (acquired by Taisho)

Grupo Sanborns

Grupo Uriach

H. Lundbeck A/S (Lundbeck)

Handok Pharmaceutical (acquired by Teva)

Harris Interactive Inc.

Helvepharm (part of Sanofi)

Hexal (acquired by Novartis)

Hisun-Pfizer Pharmaceuticals (Pfizer / Zhejiang Hisun joint venture)

Hospira, Inc. (Hospira)

Ilsung Pharmaceuticals

IMS Health

InnoPharma Inc.

Itero Biopharmaceuticals

Janssen Pharmaceutica (part of Johnson & Johnson)

Javelin Pharmaceuticals (acquired by Hospira)

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Johnson & Johnson (J&J)

Kmart

KMS Pharmaceutical

Kos Pharmaceuticals (acquired by Abbott)

Kosei (acquired by Taisho)

Kowa Company

Krka Pharmaceuticals

Labesfal (acquired by Fresenis Kabi)

Laboratoires Servier (Servier)

Laboratorio Sanderson (acquired by Fresenis Kabi)

Laboratório Teuto Brasileiro (Teuto) (part-owned by Pfizer)

Laboratorios Best

Laboratorios Kendrick (acquired by Sanofi)

Lek (acquired by Novartis)

Lupin Pharmaceutical

Matrix Laboratories (part of Mylan)

Mayne Pharma (acquired by Hospira)

Medis (part of Actavis)

Medley (acquired by Sanofi)

Merck & Co. (Merck)

Merck KGaA

Microdose (acquired by Teva)

Momenta Pharmaceuticals

MSD (subsidiary of Merck)

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Mustafa Nevzat Pharmaceuticals (MN Pharma)

Mylan Inc. (Mylan)

Mylan Laboratories Limited (subsidiary of Mylan)

Mylan Seiyaku (subsidiary of Mylan)

Mylan Technologies Inc. (subsidiary of Mylan)

Natco Pharma

Nestlé

Neurosearch A/S

Nexus Pharmaceuticals

Nichi-Iko (acquired by Sanofi)

Nippon Chemiphar Co. Ltd.

Novartis International AG (Novartis)

Novast Laboratories

Novo Nordisk

Orchid Chemicals & Pharmaceuticals (now Hospira Healthcare India, part of Hospira)

Oriel Therapeutics (acquired by Novartis)

Otsuka Pharmaceutical

Parenteral Drugs India Ltd

Patriot Pharma (part of Johnson & Johnson)

Pfizer, Inc. (Pfizer)

PGT Healthcare (Procter & Gamble / Teva joint venture)

Pharmacia & Upjohn

PharmaDerm (now part of Novartis)

Pharmagenus (division of Grupo Uriach)

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Piramal Healthcare Solutions (acquired by Abbott)

PT Ethica Industry Farmasi (subsidiary of Fresenius Kabi / PT Soho Global Health

PT Soho Global Health

Purdue Pharma

Ranbaxy Farmaceutica (subsidiary of Daiichi Sankyo)

Ranbaxy Laboratories Limited (Ranbaxy) (acquired by Daiichi Sankyo)

Ratiopharm (acquired by Teva)

Ribbon (acquired by Fresenis Kabi)

S.E. Massengill Co. (now part of Prestige Brands)

Sabex Holdings (acquired by Novartis)

Salomon, Levin and Elstein (subsidiary of Teva)

Sandoz (part of Novartis)

Sanofi Mexico (subsidiary of Sanofi)

Sanofi Pasteur (acquired by Sanofi)

Sanofi S.A. (Sanofi)

Sawai Pharmaceutical Co., Ltd. (Sawai)

Schein Pharmaceutical (part of Actavis)

Shelys (part of Aspen)

Shire

Sicor (acquired by Teva)

Sigma Pharmaceuticals (acquired by Aspen)

Solvay Pharmaceuticals (acquired by Abbott)

South African Druggists (SA Druggists, part of Aspen)

Specifar Pharmaceuticals S.A. (acquired by Actavis)

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STADA Arzneimittel

STARLIMS (acquired by Abbott)

Strides Arcolab

Sun Pharmaceutical Industries (Sun Pharma)

Sunovion Pharmaceuticals, Inc. (subsidiary of Dainippon Sumitomo Pharma)

Swisse Wellness ( (acquired by Teva)

Synthélabo (part of Sanofi)

Synthon

Taisho Pharmaceutical Co., Ltd. (majority owned by Teva/Kowa joint venture)

Taiyo (acquired by Teva)

Takeda Pharmaceutical

Target Corporation (Target)

Tecnofarma (acquired by Valeant)

Teva Pharmaceutical Industries (Teva)

Teva Seiyaku (subsidiary of Teva)

The Rohatyn Group

TheraDoc (part of Hospira)

Theramex (acquired by Teva)

Torrent Pharmaceuticals

Towa Pharmaceutical Co. Ltd. (Towa)

UDL Laboratories (part of Mylan)

Uteron Pharma S.A. (acquired by Actavis)

Valeant Pharmaceuticals

Veropharm

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Vitacilina Corporation of America (VitaCorp) (acquired by Taisho)

Wal-Mart Stores, Inc. (Walmart)

Warner Chilcott (acquired by Actavis)

Watson Pharmaceuticals (part of Actavis)

Winthrop Pharmaceuticals (part of Sanofi)

Wockhardt

Wyeth Pharmaceuticals (part of Pfizer)

Xenon Pharmaceuticals

Zentiva (acquired by Sanofi)

Zhejiang Chiral Medicine Chemicals Co., Ltd

Zhejiang Hisum Pharmaceutical

Zoetis

Zydus Cadila

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Other Organisations Mentioned in This Report

American Pharmaceutical Association (APhA)

Assogenerici (Italy)

Blue Cross Blue Shield Association (BCBSA)

British Generic Manufacturers Association (BGMA)

Centers for Medicare and Medicaid Services (US)

China Food and Drug Administration (CFDA)

Congressional Budget Office (US)

Depart of Health (UK)

Department of Pharmaceuticals (India)

European Commission

European Generic Medicines Association (EGA)

European Medicines Agency (EMA)

Farmácia Popular (Popular Drugstores) (Brazil)

Federal Commission for the Protection against Sanitary Risk (COFEPRIS) (Mexico)

Federal Health Monitoring System (Germany)

Federal Joint Committee (Germany)

General Directorate of Pharmaceuticals and Pharmacy (GDPP) (Turkey)

Generic Pharmaceutical Association (GPhA) (US)

Generics and Biosimilars Initiative (GaBi)

German Association of Pharmacists (ABDA)

International Union of Pure and Applied Chemistry

Katholieke Universiteit Leuven (KU Leuven)

Leonard Davis Institute for Health Economics (University of Pennsylvania)

Other Organisations Mentioned in This Report

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Mexican Institute of Social Security

Ministry of Health (Turkey)

Ministry of Health and Welfare (South Korea)

Ministry of Health, Labour and Welfare (MHLW) (Japan)

Ministry of Industry and Trade (Russia)

National Development and Reform Commission (NDRC) (China)

National Health Service (NHS) (UK)

National Pharmaceutical Pricing Authority (NPPA) (India)

Pan American Health Organization (PAHO)

Pharmaceutical and Medical Devices Agency (PMDA) (Japan)

Pharmaceutical Manufacturers Association of Turkey (IEIS) (Turkey)

Progenericos (Brazil)

Public Health Institution (Turkey)

Seguro Popular (Popular Insurance) (Mexico)

Servicio Sanitario Nazionale (SSN) (Italy)

Social Security Institution (SSI) (Turkey)

State Intellectual Property Office (China)

Statutory Health Insurance (SHI) (Germany)

Tufts Center for the Study of Drug Development

Turkish Association of Research-Based Pharmaceutical Companies (AIFD) (Turkey)

Unified Health System (SUS) (Brazil)

United Nations' Department of Economic and Social Affairs

United States Adopted Name (USAN) Council

University of Amsterdam

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US Census Bureau

US Federal Trade Commission

US Food and Drug Administration (FDA)

US Patent and Trademark Office

Veteran Affairs Medical Center, Philadelphia

World Health Organization (WHO)

World Trade Organization (WTO)

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Generic Drugs: World Market 2014-2024 & Future Prospects for Leading Companies

Table 4.14 Mylan: Generic Drugs Revenue ($bn), AGR (%), CAGR (%), 2012-2024

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024Mylan ($bn) 6.0 5.8 6.5 7.2 8.0 8.8 9.5 10.2 10.9 11.7 12.5 13.3 14.2 Annual Growth Rate (%) -3.0 12.0 11.5 11.0 9.5 8.0 7.7 7.3 7.0 6.8 6.7 6.5CAGR (%, 2012-2018 and 2018-2024)

8.0 7.0

CAGR (%, 2012-2024) 7.5

Figure 4.11 Mylan: Generic Drugs Revenue ($bn), AGR (%), 2012-2024

4.5.3 Mylan: Recent Developments

4.5.3.1 Mylan to Double Manufacturing Capacity by 2016

Mylan is expanding its manufacturing capacity across a range of types of formulation as part of its

long-term growth strategy. The company reportedly invested $305m in 2012 and around $350m in

2013 to approximately double production capacity across various formulations between 2012 and

2016. The company has expanded its US transdermal patch manufacturing facility in St. Albans,

Vermont, which doubles its capacity from 105 million units in 2012 to 206 million units in 2013.

Mylan has also doubled its semi-solid and aerosol capacity and further plans to expand its oral

-4.0

-2.0

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024AG

R (%

)

Sale

s ($

bn)

Year Sales ($bn) AGR (%)

Source: visiongain 2014




Figure 6.3 German Generic Drugs Market: Generic Penetration by Volume (%), 2000-2013

6.3.3 German Generic Drugs Market: Generic Penetration by Value

Table 6.4 and Figure 6.4 illustrate the trend in generic penetration by proportion of total

pharmaceutical sales from 2000-2013 for the German market. Generic penetration by value is

relatively high in the German market.

Table 6.4 German Generic Drugs Market: Generic Penetration by Value (%), 2000-2013

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013Generic penetration by proportion of total pharmaceutical sales (%)

31.9 30.0 29.9 30.4 34.3 34.6 35.9 36.4 36.8 35.9 34.7 35.3 36.7 37.8

0102030405060708090

100

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013Gen

eric

pen

etra

tion

by v

olum

e of

pr

escr

iptio

ns (%

)

Year Generic penetration byvolume of prescriptions (%)

Source: visiongain 2014; Gesund-heits-bericht-erstat-tung des Bundes (Federal Health Monitoring System,

Germany) (2000-2012 figures). The 2013 figure is visiongain’s estimate.

Source: visiongain 2014; Gesund-heits-bericht-erstat-tung des Bundes (Federal Health Monitoring System,

Germany) (2000-2012 figures). The 2013 figure is visiongain’s estimate.



introduced a law to encourage public-private partnerships, stimulate hospital construction and

improve healthcare provision. The government has expanded the Seguro Popular ('Popular

Insurance') programme, whereby government-sponsored public healthcare is available to

nationals. As of 2013 nearly every Mexican is covered by the public health system. Consequently,

public institutions such as the Mexican Institute of Social Security have embraced the move

towards generics, and public expenditure on medicines has been increasing steadily.

Counterfeiting of drugs continues to pose a significant threat to revenues from generic drugs during

the forecast period. Counterfeit drugs are estimated to cost drug companies around $1.5bn in

sales.

8.4.1 Mexican Generic Drugs Market: Sales Forecast 2014-2024

Visiongain estimates that in 2012 the Mexican generic drugs market generated revenues of

$3.4bn, representing 2.0% of the world market. Sales for 2013 increased to $3.8bn, up 14% on

2012. Table 8.3 and Figure 8.3 show visiongain’s forecast for the Mexican generic drugs market

from 2012 to 2024.

Visiongain predicts that the Mexican market will grow at a CAGR of 12.6% over 2012-2018 to

reach revenues of $6.8bn in 2018. Growth will be driven by increasing healthcare coverage and

rising demand for generic medicines to treat a growing burden of chronic disease. Improvements in

the regulatory environment in Mexico will also encourage the development of the generics market.

In the second half of the forecast period, price controls will limit growth, but growth is expected to

remain high due to unmet medical need and increasing generic penetration. We predict that

Mexican generic drug sales will grow at a CAGR of 8.5% over 2018-2024 to reach revenues of

$11.2bn in 2024, representing an overall CAGR of 10.5% over 2012-2024.

Table 8.3 Mexican Generic Drugs Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2024

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024Mexico ($bn) 3.4 3.8 4.3 4.9 5.5 6.2 6.8 7.5 8.2 8.9 9.6 10.4 11.2 Annual Growth Rate (%) 14.0 13.5 13.0 12.5 11.7 10.8 10.0 9.3 8.7 8.0 7.8 7.5CAGR (%, 2012-2018 and 2018-2024)

12.6 8.5

CAGR (%, 2012-2024) 10.5


Generic Drugs: World Market 2014-2024

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