The Future of Generic Drugs and Strategies for Commercial Success

  • ID: 3938848
  • Report
  • Region: Global
  • 83 Pages
  • CBR Pharma Insights
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The Increase in Generic Drug Activity Can Be Primarily Attributed to the Promise of Significant Revenues From Blockbuster Drugs Nearing Patent Expiry

FEATURED COMPANIES

  • Aspen
  • Fresenius Kabi
  • Hospira
  • Lupin
  • Mylan
  • Sandoz
  • MORE

Generic drugs are identical or bioequivalent to branded drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. Generic drugs are usually intended to be interchangeable with an innovator product (branded drug), manufactured without a license from the innovator company (the company holding the patent for the branded drug), and marketed after the expiry date of the patent or other exclusive rights that the innovator product may possess.

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.

In general, generic manufacturers do not pay much for advertising, marketing and promotion, as the efficacy and quality of the drug in treatment has already been well-established. In addition, multiple generic companies are often approved to market the same product. This creates significant competition in the marketplace, often resulting in even lower prices. For this reason, generic drugs are important options that allow greater access to healthcare, and have become increasingly crucial in regions where significant economic and financial instability have created the need to reduce healthcare expenditure.

The report “The Future of Generic Drugs and Strategies for Commercial Success” provides an overview of the generics market and outlines the results of GBI Research’s proprietary industry survey, which examined - among other trends - the therapy areas that will witness the highest levels of genericization in the next five years.

In particular, it provides the following:

  • Provides an analytical review of the main drivers and restraints in the generics market by analyzing industry survey results and a range of secondary and internal research. Additionally, results of the emerging markets which will witness the highest level of genericization in the next five years are also included.
  • Provides an overview of strategies leveraged by generic companies to promote the usage of generic drugs, which include taking advantage of the regulatory policies regarding generic drugs, such as authorized generics (AG) and paragraph IV filing.
  • Discusses the various policies and strategies used by governments to increase generic drug usage. Insights from the industry analysis of the survey are included.
  • Assesses how mergers and acquisitions (M&A) help diversify the portfolio and R&D technologies of a company and improve the value chain of generic drugs.
  • Provide analysis on top generic manufacturers, their recent activities, developments, generic product portfolios and performance within the generic drugs market as well as the outlook of the sector. It also enlists a general SWOT analysis of the company.
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FEATURED COMPANIES

  • Aspen
  • Fresenius Kabi
  • Hospira
  • Lupin
  • Mylan
  • Sandoz
  • MORE

1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 What are Generic Drugs?
2.1.1 Generic Drugs by Type
2.2 The Global Generic Drugs Market
2.2.1 Will the US Continue to Dominate the Global Generic Drugs Market?
2.3 Therapy Areas with Highest Levels of Genericization, 2016-2021
2.4 Entry Strategies for Generic Drugs

3 Generic Drugs Market: Drivers and Restraints
3.1 Factors Driving the Global Generic Drugs Market
3.1.1 The Patent Cliff is a Key Driver of Growth for Generic Drugs
3.1.2 Recent and Upcoming Patent Expiries of Notable Drugs
3.1.3 Will Governments Worldwide Continue Promoting Generic Drug Usage?
3.1.4 Generic Drug Approvals are Reaching Record Numbers in Key Markets
3.1.5 How Will Global Demographic Trends Impact Demand for Generic Drugs
3.1.6 Which Emerging Economies are the Most Promising for Generic Drugs Companies?
3.2 Factors Restraining Growth in the Global Generic Drugs Market
3.2.1 Delayed Launch of Generic Equivalents
3.2.2 Are Generic Drugs Still Negatively Perceived?
3.2.3 Impact of Supplemental Examination Provision of Patent Reform Act on Generics in the US
3.2.4 Pricing Pressures and Rising Costs for Generic Manufacturers

4 Generic Drug Pipeline for Top Small Molecule Drugs in the Market
4.1 Sensipar/Mimpara (cinacalcet)
4.1.1 Key Patent Expiry Dates and Potential Generic Competition
4.1.2 Sensipar/Mimpara Sales Forecast, 2011-2021
4.2 Tarceva (erlotinib)
4.2.1 Key Patent Expiry Dates and Potential Generic Competition
4.2.2 Tarceva Sales Forecast, 2011-2021
4.3 Lyrica (pregabalin)
4.3.1 Key Patent Expiry Dates and Potential Generic Competition
4.3.2 Lyrica Sales Forecast, 2011-2011
4.4 Vesicare (solifenacin)
4.4.1 Key Patent Expiry Dates and Potential Generic Competition
4.4.2 Vesicare Sales Forecast, 2011-2021
4.5 Viagra (sildenafil)
4.5.1 Key Patent Expiry Dates and Potential Generic Competition
4.5.2 Viagra Sales Forecast, 2011-2021
4.6 Vytorin/Inegy (ezetimibe plus simvastatin)
4.6.1 Key Patent Expiry Dates and Potential Generic Competition
4.6.2 Vytorin/Inegy Sales Forecast, 2011-2021
4.7 Truvada (emtricitabine plus tenofovir)
4.7.1 Key Patent Expiry Dates and Potential Generic Competition
4.7.2 Truvada Sales Forecast, 2011-2021
4.8 Zytiga (abiraterone)
4.8.1 Key Patent Expiry Dates and Potential Generic Competition
4.8.2 Zytiga Sales Forecast, 2011-2021
4.9 Benicar (olmesartan)
4.9.1 Key Patent Expiry Dates and Potential Generic Competition
4.9.2 Benicar Sales Forecast, 2011-2021
4.10 Exjade/Asunra (deferasirox)
4.10.1 Key Patent Expiry Dates and Potential Generic Competition
4.10.2 Exjade/Asunra Sales Forecast, 2011-2021

5 Strategies to Promote Generic Drug Usage by Companies
5.1 Authorized Generics
5.1.1 Diovan
5.1.2 Colcrys
5.2 Paragraph IV Certification
5.2.1 Baraclude
5.2.2 Copaxone
5.3 Super Generics
5.3.1 Super Generics: Intravail

6 Government Policies and Strategies to Promote Generic Drug Usage
6.1 Compulsory Licensing
6.1.1 Voluntary Licensing
6.1.2 Compulsory Licensing in the US
6.1.3 Compulsory Licensing in the EU
6.1.4 Compulsory Licensing in Asia-Pacific
6.1.5 Impact of Compulsory Licensing on Competition
6.1.6 Impact of Compulsory Licensing on Innovation
6.1.7 Impact of Compulsory Licensing on Pricing and Economies
6.1.8 CL Case Study- Nexavar
6.2 Generic Substitution
6.2.1 Impact of Generic Substitution in the US
6.2.2 Generic Substitution in the EU
6.2.3 Generic Substitution in Asia-Pacific
6.3 Tendering Generic Drugs
6.4 Parallel Trade
6.5 Impact of the Affordable Care Act on Generic Drugs
6.6 Physician Incentives for Prescribing
6.6.1 Legal Issues Regarding Physician Incentives

7 Mergers and Acquisitions in the Global Generic Drugs Market
7.1 Mergers and Acquisitions to Improve the Value Chain
7.1.1 Optimizing R&D
7.1.2 Increased Access to Active Pharmaceutical Ingredients and Formulations
7.1.3 Enhancing Marketing and Distribution Channels for Generic Drugs
7.2 Geographical Expansion Through Mergers and Acquisitions
7.3 Strategic Planning
7.4 Major Deals in the Global Generic Drugs Market and their Impact

8 Top Global Generic Drug Companies
8.1 Teva - Leading Generic Drugs Company in the World
8.1.1 Overview
8.1.2 Main Business Segments and Focus
8.1.3 Recent Activity in the Generics Market
8.1.4 Teva: SWOT Analysis
8.2 Sandoz
8.2.1 Recent Activity in the Generic Drugs Market
8.2.2 Sandoz: SWOT Analysis
8.3 Mylan
8.3.1 Recent Activity in the Generic Drugs Market
8.3.2 Mylan: SWOT Analysis
8.4 Sun Pharma
8.4.1 Recent Activity in the Generic Drugs Market
8.4.2 Sun Pharma: SWOT Analysis
8.5 Aspen
8.5.1 Recent Activity in the Generic Drugs Market
8.5.2 Aspen Pharmacare, SWOT analysis
8.6 Hospira
8.6.1 Recent Activity in the Generic Drugs Market
8.6.2 Hospira: Drugs SWOT analysis
8.7 Fresenius Kabi
8.7.1 Recent Activity in the Generic Drugs Market
8.7.2 Fresenius Kabi: SWOT analysis
8.8 Lupin
8.8.1 Recent Activity in the Generic Drugs Market
8.8.2 Lupin: SWOT analysis

9 Conclusion

10 Appendix
10.1 Industry Survey Results, Therapy Areas with Highest Levels Of Genericization, 2016-2021
10.2 Industry Survey Results, Therapy Areas with Highest Levels of Genericization, R&D Expert Panel vs Commercial Expert Panel, 2016-2021
10.3 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level
10.4 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, R&D Expert Panel vs Commercial Expert Panel
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
10.6 Industry Survey Results, Leading Emerging Markets for Generic Drug Manufacturers, 2016-2021
10.7 Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs Globally
10.8 Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs, R&D Expert Panel vs Commercial Expert Panel
10.9 Industry Survey Results: Do Physicians in Developed Markets Regard Generic Drugs to be as Safe and Effective as Branded Drugs?
10.10 Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generic Sector
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
10.12 Industry Survey Results: The Impact of Compulsory Licensing on Innovator Companies in Emerging Markets
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
10.14 Industry Survey results, Most Important Factors Contributing to Surge in M&A Activity in Generic Drugs Market
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
10.16 Industry Survey Results: Market Dynamics Affected by Continued Consolidation in the Generic Drugs Market
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
10.18 Bibliography
10.19 Contact Us
10.20 Disclaimer

List of Tables
Table 1: Generic Drugs by Type
Table 2: Generic Drug Entry Strategies
Table 3: Branded Drugs for which Authorized Generics Were Launched in US in 2015
Table 4: Selection of Branded Drugs for which First-Time Generics Have Been Launched in the US in 2015
Table 5: Super Generics Approved in the US, 2010-2014
Table 6: Super Generics Under Development in the US, 2016
Table 7: Teva, SWOT Analysis
Table 8: Sandoz, SWOT Analysis
Table 9: Mylan, SWOT Analysis
Table 10: Sun Pharma, SWOT Analysis
Table 11: Aspen, SWOT Analysis
Table 12: Hospira, SWOT Analysis
Table 13: Fresenius Kabi, SWOT Analysis
Table 14: Lupin, SWOT Analysis

List of Figures
Figure 1: Industry Survey Results, Therapy Areas with Highest Genericization, 2016-2021
Figure 2: Industry Survey Results, Therapy Areas with Highest Genericization, R&D Expert Panel vs Commercial Expert Panel, 2016-2021
Figure 3: Industry Survey Results, Most Important Factors Promoting Generic Drug Usage Globally
Figure 4: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, R&D Expert Panel vs Commercial Expert Panel
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
Figure 6: ANDAs Filed and Approved by FDA, 2008-2014
Figure 7: Industry Survey Results, Leading Emerging Markets for Generic Drug Manufacturers, 2016-2021
Figure 8: Industry Survey Results, Most Important Factors Hindering or Delaying Approval of Generic Drugs Globally
Figure 9: Industry Survey Results, Most Important Factors Hindering or Delaying Approval of Generic Drugs, R&D Expert Panel vs Commercial Expert Panel
Figure 10: Industry Survey Results, Do Physicians in Developed Markets Regard Generic Drugs to be as Safe and Effective as Branded Drugs? (%)
Figure 11: Sensipar, Global Revenue ($m), 2011-2021
Figure 12: Tarceva, Global Revenue ($m), 2011-2021
Figure 13: Lyrica, Global Revenue ($m), 2011-2021
Figure 14: Vesicare, Global Revenue ($m), 2011-2021
Figure 15: Viagra, Global Revenue ($m), 2011-2021
Figure 16: Vytorin, Global Revenue ($m), 2011-2021
Figure 17: Truvada, Global Revenue ($m), 2011-2021
Figure 18: Zytiga, Global Revenue ($m), 2011-2021
Figure 19: Benicar - , Global Revenue ($m), 2011-2021
Figure 20: Exjade, Global Revenue ($m), 2011-2021
Figure 21: Industry Survey, Most Popular Strategies or Regulations Leveraged by Companies in Generic Sector
Figure 22: Industry Survey, Most Popular Strategies or Regulations Leveraged by Companies in Generics Sector, North American Panel vs European Panel vs Asian Panel
Figure 23: Industry Survey, Impact of Compulsory Licensing on Innovator Companies in Emerging Markets
Figure 24: Industry Survey, Impact of Compulsory Licensing on Innovator Companies in Emerging Markets, North American Panel vs European Panel vs Asian Panel
Figure 25: Industry Survey, Most Important Factors Contributing to Surge in M&A Activity in Generic Drugs Market
Figure 26: 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
Figure 27: Industry Survey, Market Dynamics Affected by Continued Consolidation in Generics Market
Figure 28: Industry Survey Results, Market Dynamics Affected By Continued Consolidation in Generics Market, North American Panel vs European Panel vs Asian Panel
Figure 29: Industry Survey Results, Therapy Areas with Highest Levels of Genericization, 2016-2021
Figure 30: Industry Survey Results, Therapy Areas with Highest Levels of Genericization, R&D Expert Panel vs Commercial Expert Panel, 2016-2021
Figure 31: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level
Figure 32: Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, R&D Expert Panel vs Commercial Expert Panel
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
Figure 34: Industry Survey Results, Leading Emerging Markets for Generic Drug Manufacturers, 2016-2021
Figure 35: Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs Globally
Figure 36: Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs, R&D Expert Panel vs Commercial Expert Panel
Figure 37: Industry Survey Results: Do Physicians in Developed Markets Regard Generic Drugs to be as Safe and Effective as Branded Drugs?
Figure 38: Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generic Sector
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
Figure 40: Industry Survey results: The impact of compulsory licensing on innovator companies in emerging markets
Figure 41: Industry Survey results: The impact of compulsory licensing on innovator companies in emerging markets, North American panel vs. European panel vs. Asian panel
Figure 42: Industry Survey results: The most important factors contributing towards the surge in M&A activity within the generic drugs market
Figure 43: 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
Figure 44: Industry Survey Results: Market dynamics affected by continued consolidation in the generic drugs market
Figure 45: Industry Survey Results, North American Panel vs European Panel vs Asian Panel, Market Dynamics Affected by Continued Consolidation in the Generic Drugs Market

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  • Aspen
  • Fresenius Kabi
  • Hospira
  • Lupin
  • Mylan
  • Sandoz
  • Sun Pharma
  • Teva
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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