CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 5
CHAPTER 2 TRENDS IN THE GENERICS MARKET 11
Consolidation - size, spread, and (drug) supply 12
Acquisition of Barr allows Teva to extend its lead 13
Mylan still assimilating Merck Generics acquisition 14
Acquisitions to come 16
Sandoz - time for another major acquisition? 16
Mylan - a ticket to the top five? 16
Actavis - up for sale? 17
Convergence between generics companies and innovators 18
Daiichi Sankyo's acquisition of Ranbaxy 19
Pfizer moves beyond own-generics 20
Sanofi-Aventis bags Zentiva 20
GlaxoSmithKline inching into emerging markets via generics 22
Innovator-generic company deals under increasing scrutiny 23
Reverse payments in US 23
Shift in form of compensation offered by branded companies 24
Little opposition to reverse payments 26
EU Commission undertakes dawn raids, to gather settlement data 28
Resistors to generics market entry in the pharmaceutical sector 29
CHAPTER 3 THE MATURE GENERICS MARKETS 38
The US market - reaching the outer limits of growth 39
Wal-Mart reinforces its position in the generics prescription market by targeting the mail order pharmacy sector 40
Generics drive from insurers and PBMs 41
Insurers offer physician rewards to up generics prescription 41
PBMs get personal 42
ANDA approval times on the increase 42
Generic erosion in the US 43
Protonix loses 75% market share within two quarters of generic entry 44
Fosamax lost 75% market share in two quarters 44
Germany - on the road to becoming a commodity market 46
AOK relaunches more competitive drug tenders 46
DAK tenders under scrutiny 47
The UK - reimbursement changes will impact on generics use 48
Mandatory pharmacist substitution to be introduced 48
CHAPTER 4 THE IMMATURE GENERICS MARKETS OF EUROPE 50
Italy experiences setback following bioequivalence issues 51
Spain remains a tough market 51
Teva expands presence in Spain through Bentley acquisition 52
Zydus Cadila moves into Spain 53
France - generics use driven by state and pharmacists 53
Generics penetration has increased for a subset of drugs 53
Pharmacists are driving generics use 55
Wholesaler discounts larger for generics 56
Reference pricing has contributed to growth in generics use 57
CHAPTER 5 JAPAN POISED FOR GROWTH 58
Japan's generics market - international interest mounting 58
Reforms to promote generics use 59
Impact of new form prescriptions 60
Quality over price 62
Amlodipine generics show disappointing uptake 62
Quality control for generics 63
Improving generics distribution should promote uptake 64
Boost to cardiovascular drug generic switch 65
Impact of the generics drive 65
Influx of multinationals as Japanese generics market looks set to grow 66
Teva beefs up Japanese presence with domestic support 67
Mylan to expand in Japan 67
Actavis to expand in Japan 68
Indian companies make bid for Japan 68
CHAPTER 6 EMERGING MARKETS ARE THE NEXT FRONTIER 70
Growth opportunities in emerging markets 72
Central and Eastern Europe - the time to enter is now 74
Latin America - generics use to continue to grow 75
Asia - driving growth of the pharma industry in the future, but unlikely to be a goldmine for generics 76
India - low value high volume market 77
China - a tough generics market to enter, for little reward 77
Middle East and North Africa - easy pickings for foreign entrants? 79
Companies looking to enter emerging markets 80
Teva looking east 81
Sandoz's growth driven by emerging markets 81
Mylan looking to be a top three player in CEE 82
Stada establishing itself through a combination of organic and inorganic growth 83
Actavis has acquired its way into emerging markets 83
Indian generics companies continue to expand aggressively 84
The consequences of India's reliance on Chinese APIs and intermediates 86
Ranbaxy falls foul of FDA 87
CHAPTER 7 BIBLIOGRAPHY 89
Publications and online articles 89
Conference literature 100
Datamonitor resources 100
APPENDIX 102
List of Tables
Table 1: Zentiva's ranking in Central and Eastern Europe, 2006-07 22
Table 2: Generics market in France, 2007 54
Table 3: Generics chosen for quality checking, Japan, 2007 63
Table 4: Exchange rates, 2007 103
List of Figures
Figure 1: Overview of the key trends and events in the global generics market 5
Figure 2: Key trends across the generics industry, 2008 11
Figure 3: Global generics company ranking, 2007 12
Figure 4: Generic erosion of Duoneb revenues in the US, 2007 15
Figure 5: Branded-generic final settlements in the US, FY 2004-07 24
Figure 6: Number of settlements between branded and generics companies in the US, FY 2007 25
Figure 7: Innovator strategies which delay generic entry 30
Figure 8: Agreements between branded and generics companies in the EU, 2000 -08 34
Figure 9: Authorized generic agreements in the EU, 2000-07 36
Figure 10: The mature generics markets - the US, UK and Germany 39
Figure 11: Generic erosion of Protonix sales in the US, 2007-08 44
Figure 12: Fosamax sales erosion in the US, 2007-08 45
Figure 13: Drivers and resistors of generics use in Italy, Spain and France, 2008 50
Figure 14: Pharmaceutical distribution channels in France 56
Figure 15: Wholesaler mark-ups and pharmacy margins in France 57
Figure 16: The Japanese generics market, 2008 58
Figure 17: Market dynamics for first generic to market 70
Figure 18: Drivers and resistors of expansion into emerging markets 72
Figure 19: Generics market size and growth, 2003-06 73
Figure 20: Sandoz's leading position in Central and Eastern Europe, 2007 82
Figure 21: Major acquisitions by Indian generics companies, 2003-07 85
Figure 22: GMP deficiencies in two of Ranbaxy's Indian plants 87