The Future of Generic Drugs and Strategies for Commercial Success

The Future of Generic Drugs and Strategies for Commercial Success


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Executive Summary

The Future of Generic Drugs and Strategies for Commercial Success

Summary

GBI Research's latest report "The Future of Generic Drugs and Strategies for Commercial Success" discusses trends in the global generic drugs market, and the evolving business strategies being adopted and leveraged by generic drug companies around the world. GBI Research conducted an extensive and targeted industry survey of experts from top global generic drug companies, to gather opinions on the trends and future commercial prospects of the generic drugs market. The findings from the survey and results from extensive data analysis and secondary research efforts have been triangulated with GBI's own analytical views to provide an objective assessment that is comprehensive in outlook.

The generic drugs market has seen rapid expansion for more than 30 years, and consistently achieves higher annual growth rates than the overall pharmaceutical market. The increase in generic drug activity can be primarily attributed to the promise of significant revenues from blockbuster drugs nearing patent expiry. In the US - the largest generic drugs market by revenue - the number of generic drug approvals hit a record high in 2015, due to a new program that aimed to speed up approvals. There has also recently been a surge in the number of industry-transforming mergers and acquisitions, with companies looking to consolidate their position in this highly lucrative market.

The results of GBI's latest industry survey provide insightful analyses from different expert panels, including R&D and commercial, and highlight trends observed in key geographical markets. The survey examined key commercial issues and recent developments in the generic drugs market, such as the reasons behind the surge in mergers and acquisitions, and the likely effects on market dynamics. It covered important factors currently driving or restraining the market, prospects for key therapy areas expected to exhibit significant levels of genericization in the coming years, and the most promising emerging markets for generic companies in terms of revenue potential. Additionally, the survey examined common business strategies and regulations being leveraged by global generic drug companies for market expansion.

The report covers key small molecule drugs whose patents will expire in the coming years, providing an in-depth assessment of potential generic competition, expected launch dates and the overall impact on global branded revenues to 2021. The top global generic drug companies by revenue are also examined, including financial performance and recent activity within the market.

This new report adds to our unique portfolio of trusted industry analyses, which enable our clients to assess the most promising commercial areas in the market and identify key business opportunities.

Scope

- What is the current value of the generic drugs market, and how will market dynamics change in the coming years?

- Will the US continue to dominate the market?

- Which therapy areas will witness the highest level of genericization in the next five years?

Drivers and restraints in the generics industry:

- What are the most important factors promoting generic drug usage at a global level?

- What are the most important factors hindering or delaying generic drug approvals?

- Will governments worldwide continue their efforts to promote generic drug usage?

- How will global demographic trends impact demand for generic drugs?

- Which emerging economies are the most promising for generic drugs companies?

- Are generic drugs still negatively perceived?

- How are pricing pressures and rising costs affecting generic drug manufacturers?

Generic drugs pipeline for top small molecule drugs in the market:

- What will be the revenue impact for key small molecule drugs whose patents expire in the near future?

- What are the key patent expiry dates for these small molecules and what level of generic competition should they expect?

Strategies for commercial success:

- What are the most popular strategies or regulations being adopted and leveraged by generic drug manufacturers?

- What governmental policies are significantly influencing generic drug usage?

- What will be the impact of compulsory licenses in emerging markets?

Mergers and acquisitions in the global generic drugs market:

- What are the most important factors contributing to the surge in M&A activity in the generic drugs market?

- How will market dynamics be affected by continued consolidation in the generic drugs market?

- What have been the most important transactions in the generic drugs industry in recent years?

Top global generic drugs companies:

- How have top generic drugs companies performed in recent years?

- What are the prospects for top generic drugs companies?

Key Reasons to Purchase

This report will allow you to -

- Gain insightful analyses and understanding of market dynamics: This report comprehensively describes and assesses the most important factors driving and restraining the generic drugs market. It assesses pertinent commercial and regulatory aspects of the industry by combining survey results with proprietary in-house expertise and extensive secondary research efforts.

- Assess the generic drugs pipeline for top small molecule drugs in the market: Our study provides prospects for these drugs beyond their patent expiries, including potential generic competition, expected launch dates and revenue forecasts to 2021.

- Evaluate the strategies used by companies to promote generic drug usage: This report provides insights regarding the various commercial strategies being adopted and leveraged by generic drug companies to promote their therapies.

- Understand government policies and strategies to promote generic drug usage: This report assesses current strategies and regulations implemented by governments in key geographic markets to promote generic drug usage.

- Gain insight on mergers and acquisitions in the global generic drugs market: This report describes industry-transforming mergers and acquisitions that have occurred in recent years, the reasons behind the recent surge in these types of transactions, and their likely impact on market dynamics.



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1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 6

2 Introduction 8

2.1 What are Generic Drugs? 8

2.1.1 Generic Drugs by Type 9

2.2 The Global Generic Drugs Market 9

2.2.1 Will the US Continue to Dominate the Global Generic Drugs Market? 9

2.3 Therapy Areas with Highest Levels of Genericization, 2016-2021 10

2.4 Entry Strategies for Generic Drugs 11

3 Generic Drugs Market: Drivers and Restraints 13

3.1 Factors Driving the Global Generic Drugs Market 15

3.1.1 The Patent Cliff is a Key Driver of Growth for Generic Drugs 15

3.1.2 Recent and Upcoming Patent Expiries of Notable Drugs 15

3.1.3 Will Governments Worldwide Continue Promoting Generic Drug Usage? 16

3.1.4 Generic Drug Approvals are Reaching Record Numbers in Key Markets 17

3.1.5 How Will Global Demographic Trends Impact Demand for Generic Drugs 17

3.1.6 Which Emerging Economies are the Most Promising for Generic Drugs Companies? 18

3.2 Factors Restraining Growth in the Global Generic Drugs Market 19

3.2.1 Delayed Launch of Generic Equivalents 20

3.2.2 Are Generic Drugs Still Negatively Perceived? 21

3.2.3 Impact of Supplemental Examination Provision of Patent Reform Act on Generics in the US 22

3.2.4 Pricing Pressures and Rising Costs for Generic Manufacturers 23

4 Generic Drug Pipeline for Top Small Molecule Drugs in the Market 24

4.1 Sensipar/Mimpara (cinacalcet) 24

4.1.1 Key Patent Expiry Dates and Potential Generic Competition 24

4.1.2 Sensipar/Mimpara Sales Forecast, 2011-2021 24

4.2 Tarceva (erlotinib) 25

4.2.1 Key Patent Expiry Dates and Potential Generic Competition 25

4.2.2 Tarceva Sales Forecast, 2011-2021 26

4.3 Lyrica (pregabalin) 26

4.3.1 Key Patent Expiry Dates and Potential Generic Competition 26

4.3.2 Lyrica Sales Forecast, 2011-2011 27

4.4 Vesicare (solifenacin) 28

4.4.1 Key Patent Expiry Dates and Potential Generic Competition 28

4.4.2 Vesicare Sales Forecast, 2011-2021 28

4.5 Viagra (sildenafil) 29

4.5.1 Key Patent Expiry Dates and Potential Generic Competition 29

4.5.2 Viagra Sales Forecast, 2011-2021 30

4.6 Vytorin/Inegy (ezetimibe plus simvastatin) 30

4.6.1 Key Patent Expiry Dates and Potential Generic Competition 30

4.6.2 Vytorin/Inegy Sales Forecast, 2011-2021 31

4.7 Truvada (emtricitabine plus tenofovir) 31

4.7.1 Key Patent Expiry Dates and Potential Generic Competition 32

4.7.2 Truvada Sales Forecast, 2011-2021 32

4.8 Zytiga (abiraterone) 33

4.8.1 Key Patent Expiry Dates and Potential Generic Competition 33

4.8.2 Zytiga Sales Forecast, 2011-2021 33

4.9 Benicar (olmesartan) 34

4.9.1 Key Patent Expiry Dates and Potential Generic Competition 34

4.9.2 Benicar Sales Forecast, 2011-2021 34

4.10 Exjade/Asunra (deferasirox) 35

4.10.1 Key Patent Expiry Dates and Potential Generic Competition 35

4.10.2 Exjade/Asunra Sales Forecast, 2011-2021 35

5 Strategies to Promote Generic Drug Usage by Companies 36

5.1 Authorized Generics 37

5.1.1 Diovan 38

5.1.2 Colcrys 38

5.2 Paragraph IV Certification 39

5.2.1 Baraclude 40

5.2.2 Copaxone 40

5.3 Super Generics 40

5.3.1 Super Generics: Intravail 41

6 Government Policies and Strategies to Promote Generic Drug Usage 42

6.1 Compulsory Licensing 42

6.1.1 Voluntary Licensing 42

6.1.2 Compulsory Licensing in the US 42

6.1.3 Compulsory Licensing in the EU 42

6.1.4 Compulsory Licensing in Asia-Pacific 42

6.1.5 Impact of Compulsory Licensing on Competition 44

6.1.6 Impact of Compulsory Licensing on Innovation 45

6.1.7 Impact of Compulsory Licensing on Pricing and Economies 45

6.1.8 CL Case Study- Nexavar 45

6.2 Generic Substitution 45

6.2.1 Impact of Generic Substitution in the US 45

6.2.2 Generic Substitution in the EU 46

6.2.3 Generic Substitution in Asia-Pacific 46

6.3 Tendering Generic Drugs 46

6.4 Parallel Trade 47

6.5 Impact of the Affordable Care Act on Generic Drugs 48

6.6 Physician Incentives for Prescribing 49

6.6.1 Legal Issues Regarding Physician Incentives 49

7 Mergers and Acquisitions in the Global Generic Drugs Market 50

7.1 Mergers and Acquisitions to Improve the Value Chain 51

7.1.1 Optimizing R&D 51

7.1.2 Increased Access to Active Pharmaceutical Ingredients and Formulations 52

7.1.3 Enhancing Marketing and Distribution Channels for Generic Drugs 52

7.2 Geographical Expansion Through Mergers and Acquisitions 53

7.3 Strategic Planning 53

7.4 Major Deals in the Global Generic Drugs Market and their Impact 53

8 Top Global Generic Drug Companies 57

8.1 Teva - Leading Generic Drugs Company in the World 57

8.1.1 Overview 57

8.1.2 Main Business Segments and Focus 57

8.1.3 Recent Activity in the Generics Market 58

8.1.4 Teva: SWOT Analysis 58

8.2 Sandoz 58

8.2.1 Recent Activity in the Generic Drugs Market 59

8.2.2 Sandoz: SWOT Analysis 59

8.3 Mylan 59

8.3.1 Recent Activity in the Generic Drugs Market 59

8.3.2 Mylan: SWOT Analysis 60

8.4 Sun Pharma 60

8.4.1 Recent Activity in the Generic Drugs Market 60

8.4.2 Sun Pharma: SWOT Analysis 61

8.5 Aspen 61

8.5.1 Recent Activity in the Generic Drugs Market 61

8.5.2 Aspen Pharmacare, SWOT analysis 62

8.6 Hospira 62

8.6.1 Recent Activity in the Generic Drugs Market 62

8.6.2 Hospira: Drugs SWOT analysis 63

8.7 Fresenius Kabi 63

8.7.1 Recent Activity in the Generic Drugs Market 63

8.7.2 Fresenius Kabi: SWOT analysis 64

8.8 Lupin 64

8.8.1 Recent Activity in the Generic Drugs Market 64

8.8.2 Lupin: SWOT analysis 65

9 Conclusion 66

10 Appendix 67

10.1 Industry Survey Results, Therapy Areas with Highest Levels Of Genericization, 2016-2021 67

10.2 Industry Survey Results, Therapy Areas with Highest Levels of Genericization, R&D Expert Panel vs Commercial Expert Panel, 2016-2021 67

10.3 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level 68

10.4 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, R&D Expert Panel vs Commercial Expert Panel 68

10.5 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, European Panel vs North American Panel vs Asia Panel 69

10.6 Industry Survey Results, Leading Emerging Markets for Generic Drug Manufacturers, 2016-2021 69

10.7 Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs Globally 70

10.8 Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs, R&D Expert Panel vs Commercial Expert Panel 70

10.9 Industry Survey Results: Do Physicians in Developed Markets Regard Generic Drugs to be as Safe and Effective as Branded Drugs? 71

10.10 Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generic Sector 71

10.11 Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generics Sector, North American Panel vs European Panel vs Asian Panel 72

10.12 Industry Survey Results: The Impact of Compulsory Licensing on Innovator Companies in Emerging Markets 72

10.13 Industry Survey Results: The Impact of Compulsory Licensing on Innovator Companies in Emerging Markets, North American panel vs. European panel vs. Asian panel 73

10.14 Industry Survey results, Most Important Factors Contributing to Surge in M&A Activity in Generic Drugs Market 73

10.15 Industry Survey Results, The Most Important Factors Contributing to the Surge in M&A Activity in the Generic Drugs Market, North American panel vs. European panel vs. Asian panel 74

10.16 Industry Survey Results: Market Dynamics Affected by Continued Consolidation in the Generic Drugs Market 74

10.17 Industry Survey Results, North American Panel vs European Panel vs Asian Panel, Market Dynamics Affected by Continued Consolidation in the Generic Drugs Market 75

10.18 Bibliography 75

10.19 Contact Us 83

10.20 Disclaimer 83

1.2 List of Figures

Figure 1: Industry Survey Results, Therapy Areas with Highest Genericization, 2016-2021 10

Figure 2: Industry Survey Results, Therapy Areas with Highest Genericization, R&D Expert Panel vs Commercial Expert Panel, 2016-2021 11

Figure 3: Industry Survey Results, Most Important Factors Promoting Generic Drug Usage Globally 13

Figure 4: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, R&D Expert Panel vs Commercial Expert Panel 14

Figure 5: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, European Panel vs North American Panel vs Asia Panel 15

Figure 6: ANDAs Filed and Approved by FDA, 2008-2014 17

Figure 7: Industry Survey Results, Leading Emerging Markets for Generic Drug Manufacturers, 2016-2021 18

Figure 8: Industry Survey Results, Most Important Factors Hindering or Delaying Approval of Generic Drugs Globally 19

Figure 9: Industry Survey Results, Most Important Factors Hindering or Delaying Approval of Generic Drugs, R&D Expert Panel vs Commercial Expert Panel 20

Figure 10: Industry Survey Results, Do Physicians in Developed Markets Regard Generic Drugs to be as Safe and Effective as Branded Drugs? (%) 22

Figure 11: Sensipar, Global Revenue ($m), 2011-2021 25

Figure 12: Tarceva, Global Revenue ($m), 2011-2021 26

Figure 13: Lyrica, Global Revenue ($m), 2011-2021 27

Figure 14: Vesicare, Global Revenue ($m), 2011-2021 29

Figure 15: Viagra, Global Revenue ($m), 2011-2021 30

Figure 16: Vytorin, Global Revenue ($m), 2011-2021 31

Figure 17: Truvada, Global Revenue ($m), 2011-2021 32

Figure 18: Zytiga, Global Revenue ($m), 2011-2021 33

Figure 19: Benicar*, Global Revenue ($m), 2011-2021 34

Figure 20: Exjade, Global Revenue ($m), 2011-2021 35

Figure 21: GBI Industry Survey, Most Popular Strategies or Regulations Leveraged by Companies in Generic Sector 36

Figure 22: GBI Industry Survey, Most Popular Strategies or Regulations Leveraged by Companies in Generics Sector, North American Panel vs European Panel vs Asian Panel 37

Figure 23: GBI Industry Survey, Impact of Compulsory Licensing on Innovator Companies in Emerging Markets 43

Figure 24: GBI Industry Survey, Impact of Compulsory Licensing on Innovator Companies in Emerging Markets, North American Panel vs European Panel vs Asian Panel 44

Figure 25: GBI Industry Survey, Most Important Factors Contributing to Surge in M&A Activity in Generic Drugs Market 50

Figure 26: GBI Industry Survey, Most Important Factors Contributing to Surge in M&A Activity in Generic Drugs Market, North American Panel vs European Panel vs Asian Panel 51

Figure 27: GBI Industry Survey, Market Dynamics Affected by Continued Consolidation in Generics Market 54

Figure 28: GBI Industry Survey Results, Market Dynamics Affected By Continued Consolidation in Generics Market, North American Panel vs European Panel vs Asian Panel 55

Figure 29: Industry Survey Results, Therapy Areas with Highest Levels of Genericization, 2016-2021 67

Figure 30: Industry Survey Results, Therapy Areas with Highest Levels of Genericization, R&D Expert Panel vs Commercial Expert Panel, 2016-2021 67

Figure 31: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level 68

Figure 32: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, R&D Expert Panel vs Commercial Expert Panel 68

Figure 33: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, European Panel vs North American Panel vs Asia Panel 69

Figure 34: Industry Survey Results, Leading Emerging Markets for Generic Drug Manufacturers, 2016-2021 69

Figure 35: Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs Globally 70

Figure 36: Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs, R&D Expert Panel vs Commercial Expert Panel 70

Figure 37: Industry Survey Results: Do Physicians in Developed Markets Regard Generic Drugs to be as Safe and Effective as Branded Drugs? 71

Figure 38: Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generic Sector 71

Figure 39: Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generics Sector, North American Panel vs European Panel vs Asian Panel 72

Figure 40: Industry Survey results: The impact of compulsory licensing on innovator companies in emerging markets 72

Figure 41: GBI Industry Survey results: The impact of compulsory licensing on innovator companies in emerging markets, North American panel vs. European panel vs. Asian panel 73

Figure 42: GBI Industry Survey results: The most important factors contributing towards the surge in M&A activity within the generic drugs market 73

Figure 43: GBI Industry Survey results: Most Important Factors Contributing to Surge in M&A Activity in Generic Drugs Market, North American Panel vs European Panel vs Asian Panel 74

Figure 44: GBI Industry Survey Results: Market dynamics affected by continued consolidation in the generic drugs market 74

Figure 45: GBI Industry Survey Results, North American Panel vs European Panel vs Asian Panel, Market Dynamics Affected by Continued Consolidation in the Generic Drugs Market 75

1.1 List of Tables

Table 1: Generic Drugs by Type 9

Table 2: Generic Drug Entry Strategies 11

Table 3: Branded Drugs for which Authorized Generics Were Launched in US in 2015 38

Table 4: Selection of Branded Drugs for which First-Time Generics Have Been Launched in the US in 2015 39

Table 5: Super Generics Approved in the US, 2010-2014 40

Table 6: Super Generics Under Development in the US, 2016 41

Table 7: Teva, SWOT Analysis 58

Table 8: Sandoz, SWOT Analysis 59

Table 9: Mylan, SWOT Analysis 60

Table 10: Sun Pharma, SWOT Analysis 61

Table 11: Aspen, SWOT Analysis 62

Table 12: Hospira, SWOT Analysis 63

Table 13: Fresenius Kabi, SWOT Analysis 64

Table 14: Lupin, SWOT Analysis 65

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