Global Generics Guide 3rd Edition: Benchmarking Generics Company Capabilities and Strategy

The parts in red are Strategies.
Report Style: Report
Published: 21 December 2004
Price: $7,600
Introduction
With cost-containment a focus for all healthcare payers, the growth of the generics market is outpacing the branded sector by a considerable margin. However, the operating environment for generics is becoming increasingly competitive pushing existing players further up the pharmaceutical value chain. Brand and generics companies alike must be prepared for this new competition.
Scope of this report
Capabilities and portfolio analysis of the top 20 generics companies operating in each of the US, Germany, UK, France, Spain and Italy
Case study-based insight into the effectiveness of 15 portfolio management, marketing and growth strategies available to generics players
Strategic profiles of 20 leading generics companies, including growth strategy, competitive positioning and alliance network analysis
Analysis of the country-specific patent expiries for global blockbuster drugs
Research and analysis highlights
With 79.7% of 2003 blockbuster sales potentially exposed to generic competition by 2010, equating to $103.7 billion worth of products at 2003 sales value, the growth opportunities in the generics sector are significant. However, understanding how different country dynamics shape the competitive landscape is critical to evaluating risk and return.
Effective portfolio management is critical to future success in the generics market. Maintaining breadth of portfolio and low cost supply is critical for commodity generics players, forcing many players to evaluate higher value generic sectors, thus generating new competitors to brand pharma.
In the US, the generic injectables sector retains high barriers to entry, but in Europe, competitive analysis suggests that the market place is more crowded. As such, injectable products may represent a less valuable proposition to European generics players than US analysis would suggest.
Key reasons to read this report
Identify the optimal portfolio management strategy for your company and the implications of those of your rivals
Identify the likely rivals to your brand or generic in each of the six major markets
Assess the implications of generics company strategic development on the success of your late stage lifecycle management strategies
TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY	3
Scope	3
Datamonitor's opinion on the current and future generics market	3
With 79.7% of 2003 blockbuster sales potentially exposed to generic competition by 2010, equating to $103.7 billion worth of products at 2003 sales value, the growth opportunities in the generics sector are significant. However, understanding how different country dynamics shape the competitive landscape is critical to evaluating risk and return	4
Effective portfolio management is critical to future success in the generics market. Maintaining breadth of portfolio and low cost supply is critical for commodity generics players, forcing many players to evaluate higher value generic sectors, thus generating new competitors to brand pharma	6
In the US, the generic injectables sector retains high barriers to entry, but in Europe, competitive analysis suggests that the market place is more crowded. As such, injectable products may represent a less valuable proposition to European pharma than US analysis would suggest	8
CHAPTER 2 GENERICS MARKET DYNAMICS	21
Key findings	21
Global market sizes	22
Future market potential	26
Company positioning	28
Geographic focus of major generics companies	30
Country-specific analysis	31
US	32
Overview	32
Company positioning by product type	34
Major companies' strategic areas of focus	38
Future market potential	41
UK	43
Overview	43
Major companies' strategic areas of focus	43
Future market potential	47
Germany	48
Overview	48
Company positioning by product type	50
Major companies' strategic areas of focus	53
Future market potential	57
France	59
Overview	59
Company positioning by product type	61
Major companies' strategic areas of focus	64
Future market potential	66
Spain	68
Overview	68
Company positioning by product type	69
Major companies' strategic areas of focus	72
Future market potential	75
Italy	77
Overview	77
Company positioning by product type	78
Major companies' strategic areas of focus	82
Future market potential	84
CHAPTER 3 KEY GENERICS STRATEGIES FOR SUCCESS	86
Key findings	86
Overview	87
Portfolio management strategies	87
Commodity generics focus	87
Case study - Apotex	89
Case study - Sandoz	89
Outlook	90
Paragraph IV challenges	91
Terms of 180-day exclusivity	93
Potential revision of 180-day exclusivity provision	93
30-month stays	94
An increasingly favourable environment for patent challenges	95
Launching generics "at-risk"	96
The threat from 'authorized generics'	97
Case study - Barr Laboratories	98
Case study - Teva	99
Case study - Ranbaxy	99
Case study - Dr Reddy's	100
Outlook	100
Specialty generics focus	101
Modified-release generics	101
Injectable generics	105
Inhalable generics	109
Topical generics	110
Transdermal generics	112
Products requiring regulatory support or handling restrictions	113
Outlook	115
Supergenerics focus	115
Is there a market for supergenerics?	116
Regulatory situation	117
Outlook	122
Biogenerics focus	123
Uncertainty over regulatory situation	124
Progress with the US regulatory pathway	125
The EU regulatory pathway - one step ahead	127
Early approvals - limited to first generation products?	128
Cost and marketing of biogenerics	129
Biogenerics development in the less regulated markets	130
Companies well-placed to lead the biogenerics market	131
Outlook	134
Branded/innovative products focus	136
Key companies involved in in-house R&D	137
Key companies involved in branded product licensing/acquisitions	141
Outlook	145
Niche markets	146
Case study - Impax	147
Outlook	147
Therapeutic focus	148
Case study - Barr, seizing the opportunity in women's health	149
Case study - NeuraxPharm, entirely focused on CNS generics	150
Case study - Alpharma in Germany	151
Case study - Teva	151
Outlook	151
Marketing Strategies	152
Branded generics	152
Specialty branded generics	153
Branded generics in specific geographic markets such as Germany	157
'Authorized' or 'friendly' generics	159
Case study - Mylan, strongly opposed to authorized generics	161
Case study - GSK's settlement with Par, authorizing generic Paxil	162
Case study - STADA's "early entry" with mirtazapine in Germany	163
Generic alliances	164
Case study - Teva and Alpharma partnering on gabapentin	164
Case study - licensing of first-to-file status for omeprazole	166
Case study - Mayne Pharma licensing paclitaxel	167
Growth Strategies	168
Vertical integration	168
Advantages of integration	168
Advantages of out-sourcing API	170
Geographical growth	172
US companies	174
Other companies	177
Growth through Mergers and Acquisitions	180
Partnerships	183
API sourcing partnerships	183
Marketing partnerships	185
Partnerships case study - Teva	186
CHAPTER 4 STRATEGIC COMPANY PROFILES	190
Financial measures	190
Benchmarking by profitability	190
Benchmarking by operating costs	192
Benchmarking by financial strength	194
Profiles of leading companies	196
Teva Pharmaceutical Industries	196
Sandoz	198
IVAX Pharmaceuticals	200
Merck KGaA	202
Watson Pharmaceuticals	204
ratiopharm	206
Hexal	207
Barr Pharmaceuticals	209
Mylan Laboratories	211
Apotex	213
Alpharma	215
Ranbaxy	217
STADA	219
Par Pharmaceutical	222
PLIVA	224
Mayne Pharma	226
Taro Pharmaceuticals	227
Gedeon Richter	228
Andrx	230
Dr Reddy's	231
CHAPTER 5 APPENDIX	234