Report: Generics Series: Generics Trends in the Seven Major Markets and Beyond TOC

CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Key findings
CHAPTER 2 TRENDS IN THE GENERICS MARKET
- Consolidation - size, spread, and (drug) supply
  - Acquisition of Barr allows Teva to extend its lead
  - Mylan still assimilating Merck Generics acquisition
  - Acquisitions to come
    - Sandoz - time for another major acquisition?
    - Mylan - a ticket to the top five?
    - Actavis - up for sale?
- Convergence between generics companies and innovators
  - Daiichi Sankyo' s acquisition of Ranbaxy
  - Pfizer moves beyond own-generics
  - Sanofi-Aventis bags Zentiva
  - GlaxoSmithKline inching into emerging markets via generics
- Innovator-generic company deals under increasing scrutiny
  - Reverse payments in US
    - Shift in form of compensation offered by branded companies
    - Little opposition to reverse payments
  - EU Commission undertakes dawn raids, to gather settlement data
    - Resistors to generics market entry in the pharmaceutical sector
CHAPTER 3 THE MATURE GENERICS MARKETS
- The US market - reaching the outer limits of growth
  - Wal-Mart reinforces its position in the generics prescription market by targeting the mail order pharmacy sector
  - Generics drive from insurers and PBMs
    - Insurers offer physician rewards to up generics prescription
    - PBMs get personal
  - ANDA approval times on the increase
  - Generic erosion in the US
    - Protonix loses 75% market share within two quarters of generic entry
    - Fosamax lost 75% market share in two quarters
- Germany - on the road to becoming a commodity market
  - AOK relaunches more competitive drug tenders
  - DAK tenders under scrutiny
- The UK - reimbursement changes will impact on generics use
  - Mandatory pharmacist substitution to be introduced
CHAPTER 4 THE IMMATURE GENERICS MARKETS OF EUROPE
- Italy experiences setback following bioequivalence issues
- Spain remains a tough market
  - Teva expands presence in Spain through Bentley acquisition
  - Zydus Cadila moves into Spain
- France - generics use driven by state and pharmacists
  - Generics penetration has increased for a subset of drugs
  - Pharmacists are driving generics use
  - Wholesaler discounts larger for generics
  - Reference pricing has contributed to growth in generics use
CHAPTER 5 JAPAN POISED FOR GROWTH
- Japan' s generics market - international interest mounting
  - Reforms to promote generics use
  - Impact of new form prescriptions
  - Quality over price
    - Amlodipine generics show disappointing uptake
    - Quality control for generics
  - Improving generics distribution should promote uptake
  - Boost to cardiovascular drug generic switch
  - Impact of the generics drive
  - Influx of multinationals as Japanese generics market looks set to grow
    - Teva beefs up Japanese presence with domestic support
    - Mylan to expand in Japan
    - Actavis to expand in Japan
    - Indian companies make bid for Japan
CHAPTER 6 EMERGING MARKETS ARE THE NEXT FRONTIER
- Growth opportunities in emerging markets
  - Central and Eastern Europe - the time to enter is now
  - Latin America - generics use to continue to grow
  - Asia - driving growth of the pharma industry in the future, but unlikely to be a goldmine for generics
    - India - low value high volume market
    - China - a tough generics market to enter, for little reward
  - Middle East and North Africa - easy pickings for foreign entrants?
- Companies looking to enter emerging markets
  - Teva looking east
  - Sandoz' s growth driven by emerging markets
  - Mylan looking to be a top three player in CEE
  - Stada establishing itself through a combination of organic and inorganic growth
  - Actavis has acquired its way into emerging markets
  - Indian generics companies continue to expand aggressively
    - The consequences of India' s reliance on Chinese APIs and intermediates
    - Ranbaxy falls foul of FDA
CHAPTER 7 BIBLIOGRAPHY
- Publications and online articles
- Conference literature
- Datamonitor resources
APPENDIX
- List of Tables
Table 1: Zentiva' s ranking in Central and Eastern Europe, 2006-07
Table 2: Generics market in France, 2007
Table 3: Generics chosen for quality checking, Japan, 2007
Table 4: Exchange rates, 2007
- List of Figures
Figure 1: Overview of the key trends and events in the global generics market
Figure 2: Key trends across the generics industry, 2008
Figure 3: Global generics company ranking, 2007
Figure 4: Generic erosion of Duoneb revenues in the US, 2007
Figure 5: Branded-generic final settlements in the US, FY 2004-07
Figure 6: Number of settlements between branded and generics companies in the US, FY 2007
Figure 7: Innovator strategies which delay generic entry
Figure 8: Agreements between branded and generics companies in the EU, 2000 -08
Figure 9: Authorized generic agreements in the EU, 2000-07
Figure 10: The mature generics markets - the US, UK and Germany
Figure 11: Generic erosion of Protonix sales in the US, 2007-08
Figure 12: Fosamax sales erosion in the US, 2007-08
Figure 13: Drivers and resistors of generics use in Italy, Spain and France, 2008
Figure 14: Pharmaceutical distribution channels in France
Figure 15: Wholesaler mark-ups and pharmacy margins in France
Figure 16: The Japanese generics market, 2008
Figure 17: Market dynamics for first generic to market
Figure 18: Drivers and resistors of expansion into emerging markets
Figure 19: Generics market size and growth, 2003-06
Figure 20: Sandoz' s leading position in Central and Eastern Europe, 2007
Figure 21: Major acquisitions by Indian generics companies, 2003-07
Figure 22: GMP deficiencies in two of Ranbaxy' s Indian plants

Generics Series: Generics Trends in the Seven Major Markets and Beyond

Table of Contents