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Global Generics Guide 2nd Edition: Optimizing Geographical and Strategic Positioning in an Evolving Generics Landscape
Datamonitor, Nov 2003, Pages: 366

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Table of Contents

Chapter 1 Executive Summary 4
Scope 4
Datamonitor’s opinion on the current and future generics market 4
The anticipated $84 billion worth of blockbuster products set to lose patent protection by 2008 will drive growth of the US generics market between 2002 and 2008. However, the maturity of the US market means there is little room for organic growth via increased uptake of generics 5
Despite the introduction of cost containment measures resulting in price cuts in mature generics markets such as the UK and Germany, the net benefit of regulatory reform and cost containment measures leading to increased generic penetration will be positive for the European generics industry 6
Among the greatest threats posed to generics companies over the next five years will be the incursion of Indian generics players into western markets. The increased pressure placed on margins as a result of competition from these low cost players is expected to drive companies into higher value market segments 7
In 2008, the best positioned generics companies will be those that have technology platforms enabling them to maintain margins in face of increased competition, and that have international manufacturing and distribution networks that allow them to profit from the growth potential in southern European markets 10

Chapter 2 GENERICS MARKET IN FIGURES, 2002-08 27
Key findings 27
Current positioning: the generics market in 2002 28
Market size and breakdown by country 28
Major players, 2002 32
Future prospects: generics markets, 2003-08 47
Market size and breakdown by country 47
Major players, 2003-08 48

Chapter 3 GENERICS MARKET EVOLUTION 53
Key findings 53
Factors impacting generics market development 54
Patent expiries 54
Regulatory reform 56
Cost containment 56
New market entrants 58
Branded company tactics 60
Generics market strategies for success 61
Portfolio management – The shift towards higher value R&D 63
Geographic expansion – Drivers and resistors 77

Chapter 4 STRATEGIES FOR SUCCESS IN EUROPEAN GENERICS MARKETS, 2002-08 85
Key findings 85
Factors impacting European generics market development 86
Patent expiries 86
Regulatory reform 86
Cost containment 88
New market entrants 93
Branded company tactics 94
Strategies for success in the European generics market 95
Key European players 95
Portfolio management 96
Geographic expansion 97

Chapter 5 STRATEGIES FOR SUCCESS IN THE US GENERICS MARKET, 2002-08 99
Key findings 99
Factors impacting US generics market development 100
Patent expires 100
Regulatory reform 100
Cost containment 104
New market entrants 104
Branded company tactics 106
Strategies for success in the US generics market 108
Portfolio management 108
Geographic expansion 110
Corporate alliances 111

Chapter 6 KEY GENERICS COMPANY PROFILES 112
Key findings 112
Alpharma 113
Company strategy 113
Portfolio and pipeline analysis 121
Andrx 130
Company strategy 130
Portfolio and pipeline analysis 137
Barr 150
Company strategy 150
Portfolio and pipeline analysis 158
Biovail 176
Company strategy 176
Portfolio and pipeline analysis 186
IVAX 204
Company strategy 204
Portfolio and pipeline analysis 211
Mylan 230
Company strategy 230
Portfolio and pipeline analysis 235
Ranbaxy 251
Company strategy 251
Portfolio and pipeline analysis 261
SICOR 275
Company strategy 275
Portfolio and pipeline analysis 284
Stada 295
Company strategy 295
Portfolio and pipeline analysis 303
Teva 315
Company strategy 315
Portfolio and pipeline analysis 325
Watson 344
Company strategy 344
Portfolio and pipeline analysis 351

Chapter 7 APPENDIX 365
Exchange rates 365
Datamonitor’s Competitive Intelligence Business Unit 366


LIST OF TABLES
Table 1: Size of key generics markets, 2001-02 28
Table 2: Dependence on US market for sales in 2002 34
Table 3: Sales breakdown of 24 of the leading generics companies, 2002 37
Table 4: Growth in generics sales of 24 leading generics companies, 2001-02 40
Table 5: Operating costs and profitability of leading generics companies, 2001-02 42
Table 6: Forecast growth of the global generics market by region, 2002-08 47
Table 7: Forecast ethical sales of 13 of the leading generics companies, 2002-08 49
Table 8: Key biological products facing patent expiry to 2006 65
Table 9: Forecast ethical sales of profiled companies broken down by portfolio, 2002-08 71
Table 10: Selected financial data for Alpharma, 2001–02 118
Table 11: Alpharma’s M&A activity, 1998–2001 119
Table 12: Geographical distribution of Alpharma’s sales, 2001–02 120
Table 13: Alpharma’s ethical sales, 2001–02 121
Table 14: Alpharma’s forecast ethical sales, 2003–08 122
Table 15: Alpharma’s US commodity generics portfolio and pipeline 124
Table 16: Forecast sales of Alpharma’s US commodity generics, 2003-08 126
Table 17: Alpharma’s recently launched US specialty generics, 2003 127
Table 18: Forecast sales of Alpharma’s US specialty generics products, 2003–08 128
Table 19: Forecast sales of Alpharma’s branded portfolio, 2003–08 129
Table 20: Selected financial data for Andrx, 2001–02 134
Table 21: Andrx’s pharmaceutical sales, 2001–02 137
Table 22: Andrx’s forecast pharmaceutical sales, 2003–08 138
Table 23: Selected marketed and pipeline products in Andrx’s commodity generics portfolio, 2003 140
Table 24: Forecast sales of Andrx’s commodity generics portfolio, 2003–08 141
Table 25: Selected products in Andrx’s specialty generics portfolio, 2003 142
Table 26: Andrx’s specialty generics pipeline, 2003 143
Table 27: Forecast sales of Andrx’s specialty generics portfolio, 2003–08 145
Table 28: Andrx’s supergenerics forecast, 2003-08 148
Table 29: Forecast sales of Andrx’s branded portfolio, 2003–08 149
Table 30: Selected financial data for Barr, 2001–02 156
Table 31: Breakdown of Barr’s sales by portfolio, 2001–02 158
Table 32: Barr’s forecast sales by portfolio, 2003–08 160
Table 33: Selected commodity generics launches, 2001–03 163
Table 34: Products disclosed in Barr’s commodity generics pipeline 165
Table 35: Forecast sales of Barr’s commodity generics, 2003–08 166
Table 36: Selected specialty generics launches, 2002–03 167
Table 37: Barr’s disclosed specialty generic pipeline products 169
Table 38: Forecast sales of Barr’s specialty generics portfolio, 2003-08 171
Table 39: Barr’s proprietary R&D projects, 2003 174
Table 40: Forecast sales of Barr’s proprietary products, 2003–08 175
Table 41: Selected financial data for Biovail, 2001–02 182
Table 42: Biovail’s geographical sales breakdown, 2001–02 185
Table 43: Biovail’s revenues by source, 2001–02 186
Table 44: Biovail’s forecast sales by portfolio, 2003-08 187
Table 45: Forecast sales of Biovail’s bioequivalent products, 2003-08 189
Table 46: Biovail’s supergeneric products, 2003 189
Table 47: Key disclosed products in Biovail’s supergenerics pipeline, 2003 191
Table 48: Forecast sales of Biovail’s supergenerics, 2003–08 195
Table 49: Sales of Biovail’s branded products, 2001–02 196
Table 50: Biovail’s key branded pipeline products, 2003 202
Table 51: Forecast sales of branded portfolio, 2003-08 203
Table 52: Selected financial data for IVAX, 2001–02 208
Table 53: Breakdown of IVAX’s sales by region, 2001-02 210
Table 54: Breakdown of IVAX’s sales by product type, 2001–02 211
Table 55: IVAX’s forecast sales by product type, 2003–08 212
Table 56: Selected marketed commodity generics, 2003 215
Table 57: Selected IVAX commodity generics pipeline products, 2003 216
Table 58: Forecast sales of IVAX’s selected commodity generics, 2003–08 218
Table 59: IVAX’s selected specialty generics, 2003 219
Table 60: IVAX’s specialty generics pipeline, 2003 220
Table 61: Forecast sales of selected specialty generics, 2003-08 221
Table 62: Sales of IVAX’s supergeneric portfolio, 2001–02 222
Table 63: IVAX’s supergeneric pipeline, 2003 224
Table 64: Forecast sales of supergeneric portfolio, 2003-08 225
Table 65: Sales of IVAX’s branded product portfolio, 2001–02 226
Table 66: Branded pipeline products, 2003 227
Table 67: Forecast sales of IVAX’s proprietary products, 2003–08 228
Table 68: Selected financial data for Mylan, 2001–02 233
Table 69: Mylan’s sales breakdown by portfolio, 2001–02 236
Table 70: Mylan’s forecast sales by portfolio, 2003–08 236
Table 71: Mylan’s selected commodity generics launches, 2001–03 239
Table 72: Selected commodity generics in Mylan’s pipeline, 2003 240
Table 73: Forecast sales of Mylan’s commodity generics products, 2003–08 241
Table 74: Mylan’s key specialty generics, 2002–03 242
Table 75: Selected products in Mylan’s specialty generics pipeline, 2003 243
Table 76: Forecast sales of Mylan’s specialty generics, 2003–08 244
Table 77: Selected products in Mylan’s biogenerics portfolio, 2003 245
Table 78: Forecast sales of Mylan’s biogenerics portfolio, 2003–08 247
Table 79: Sales of Mylan’s branded drugs, 2001–02 247
Table 80: Mylan’s branded pipeline projects, 2003 248
Table 81: Forecast sales of branded portfolio, 2003–08 249
Table 82: Selected financial data for Ranbaxy, 2001–02 256
Table 83: Ranbaxy’s finished dosage sales by region, 2001–02 261
Table 84: Forecast sales of Ranbaxy’s finished dosage pharmaceuticals, 2003–08 262
Table 85: Ranbaxy’s selected US commodity generics, 2003 265
Table 86 Ranbaxy’s US commodity generics pipeline, 2003 267
Table 87: Forecast sales of US generics portfolio, 2003-08 268
Table 88: Ranbaxy’s US specialty generics portfolio, 2003 269
Table 89: Forecast sales of disclosed US specialty generics, 2003–08 270
Table 90: Ranbaxy’s US supergenerics portfolio, 2003 271
Table 91: Ranbaxy’s US supergenerics pipeline, 2003 272
Table 92: Forecast sales of Ranbaxy’s US supergeneric portfolio and pipeline, 2003-08 273
Table 93: Ranbaxy’s proprietary pipeline, 2003 274
Table 94: Selected financial data for SICOR, 2001–02 280
Table 95: SICOR’s sales by country, 2001–02 282
Table 96: SICOR’s finished dose pharmaceutical sales, 2001–02 284
Table 97: Forecast sales of SICOR’s ethical pharmaceutical products, 2003–08 285
Table 98: SICOR’s selected marketed specialty generics, 2003 287
Table 99: Forecast sales of SICOR’s specialty generics products, 2003–08 289
Table 100: Sales of SICOR’s biogenerics portfolio, 2001–02 290
Table 101: SICOR’s biogenerics pipeline, 2003 291
Table 102: Forecast sales of SICOR’s biogeneric products, 2003–08 293
Table 103: Forecast sales of SICOR’s branded portfolio, 2003–08 294
Table 104: Stada’s key financial measures, 2001–02 299
Table 105: Stada’s sales by portfolio, 2001–02 303
Table 106: Forecast sales of Stada’s portfolio, 2003–08 304
Table 107: Stada’s commodity generics portfolio, 2002 305
Table 108: Stada’s expected commodity generics pipeline, 2003 308
Table 109: Forecast sales for Stada’s commodity generics portfolio, 2002-08 309
Table 110: Forecast sales for Stada’s specialty generics portfolio, 2003–08 310
Table 111: Stada’s biogenerics pipeline, 2003 311
Table 112: Forecast sales for Stada’s biogenerics portfolio, 2003–08 312
Table 113: Sales of Stada’s branded portfolio, 2001–02 312
Table 114: Forecast sales for Stada’s branded portfolio, 2003–08 314
Table 115: Selected financial data for Teva, 2001–02 320
Table 116: Teva’s sales by region, 2001–02 323
Table 117: Teva’s European operations 324
Table 118: Teva’s pharmaceutical sales by portfolio, 2001–02 325
Table 119: Forecast sales by portfolio, 2002-08 326
Table 120: Selected commodity generics launched by Teva, 2002–03 328
Table 121: Teva’s selected pipeline commodity generics, 2003 329
Table 122: Forecast sales of Teva’s commodity portfolio and pipeline products, 2003–08 332
Table 123: Teva’s selected marketed and pipeline specialty generics, 2003 334
Table 124: Forecast sales of Teva’s specialty generics products, 2003–08 335
Table 125: Teva’s branded product portfolio, 2001–02 336
Table 126: Teva’s branded product pipeline, 2003 340
Table 127: Forecast sales of Teva’s branded portfolio and pipeline, 2003–08 343
Table 128: Selected financial data for Watson, 2001–02 347
Table 129: Watson’s sales by portfolio, 2001–02 351
Table 130: Watson’s forecast sales by portfolio, 2003–08 352
Table 131: Watson’s recently launched commodity generics products, 2001–03 354
Table 132: Forecast sales of commodity generics portfolio, 2003-08 355
Table 133: Watson’s recently launched specialty generics products, 2002–03 356
Table 134: Selected specialty generics pipeline products, 2003 357
Table 135: Forecast sales of Watson’s specialty generics portfolio, 2003-08 359
Table 136: Sales of Watson’s branded products, 2001–02 360
Table 137: Watson’s branded pipeline products, 2003 362
Table 138: Forecast sales of Watson’s branded portfolio, 2003–08 364
Table 139: Exchange rates, 2002 365

LIST OF FIGURES
Figure 1: Growth of major generics markets, 2001-02 7
Figure 2: Forecast portfolio breakdown of 11 generics companies’ total sales, 2002-08 9
Figure 3: Evolution in generics company strategies 10
Figure 4: Growth of major generics markets, 2001-02 29
Figure 5: Regional breakdown of generics market, 2002 30
Figure 6: Generic penetration in Europe 31
Figure 7: Market share of 12 of the leading generics players in 2002 32
Figure 8: Growth in market share of 22 leading generics companies, 2001-02 33
Figure 9: Geographic breakdown of sales of selected generics companies 35
Figure 10: Sales growth and dependence on US market, 2002 36
Figure 11: Generics sales growth and total revenue growth of leading generics companies, 2001-02 38
Figure 12: Growth in generics sales, 2001-02 41
Figure 13: Profitability of selected leading generics companies, 2002 43
Figure 14: Comparison of operating costs of selected leading generics companies, 2002 44
Figure 15: Liquidity of selected leading generics companies in 2002 45
Figure 16: Market shares of 13 leading generics companies, 2008 48
Figure 17: Forecast growth in generics sales (2002-08) compared with dependence on US market in 2002 51
Figure 18: Growth in ethical and generics sales of 11 leading generics companies, 2002-08 52
Figure 19: Value of blockbusters facing primary US patent expiry over next five years 55
Figure 20: Targets of effective cost containment strategies 57
Figure 21: Evolution in generics company strategies 61
Figure 22: Generics R&D strategies 63
Figure 23: Expected shift toward high value products, 2002-08 70
Figure 24: Portfolio breakdown of 11 generics companies’ total sales, 2002-08 71
Figure 25: Total forecast sales of 11 leading generics companies product portfolios, 2002-08 72
Figure 26: Evolution in portfolio structures, 2002-08 73
Figure 27: Breakdown of forecast 2008 sales of products in known therapeutic areas by portfolio 75
Figure 28: Drivers and resistors to geographic expansion 77
Figure 29: Geographic expansion strategies of key generics players 78
Figure 30: Impact of SPC expiry on generic erosion of Eli Lilly’s Prozac 80
Figure 31: US generics market approaching saturation 82
Figure 32: Pharmaceutical prices and generic penetration in Europe. 97
Figure 33: Forecast ethical sales by portfolio, 2003–08 123
Figure 34: Selected corporate alliances for Andrx, 1998–2003 135
Figure 35: Andrx’s pharmaceutical sales by portfolio, 2002 and 2008 139
Figure 36: Selected corporate alliances, 1998–2003 157
Figure 37: Forecast growth in Barr’s sales, 2002–08 161
Figure 38: Barr’s sales breakdown by portfolio, 2002 and 2008 162
Figure 39: Selected corporate alliances, 1998–2003 183
Figure 40: Forecast sales by portfolio, 2003–08 188
Figure 41: Selected corporate alliances, 1998-2003 209
Figure 42: IVAX’s forecast sales by portfolio, 2003–08 213
Figure 43: IVAX’s portfolio structure, 2002 & 2008 214
Figure 44: Mylan’s selected corporate alliances, 1998–2003 234
Figure 45: Mylan’s forecast sales by portfolio, 2003–08 238
Figure 46: Ranbaxy’s selected corporate alliances, 1998–2003 258
Figure 47: Ranbaxy’s finished dosage sales, 2002 260
Figure 48: Ranbaxy’s forecast pharmaceutical sales by region, 2003–08 264
Figure 49: SICOR’s selected corporate alliances, 1998–2003 281
Figure 50: SICOR’s sales by country, 2002 283
Figure 51: SICOR’s sales by portfolio, 2002 and 2008 286
Figure 52: Stada’s alliance network, 1998-2003 301
Figure 53: Stada’s sales by region, 2002 302
Figure 54: Evolution of Stada’s portfolio focus, 2002–08 305
Figure 55: Stada’s commodity generics revenue by region, 2002 307
Figure 56: Teva’s selected corporate alliances, 1998–2003 322
Figure 57: Teva’s forecast sales by portfolio, 2003–08 327
Figure 58: Watson’s selected corporate alliances, 1998–2003 349
Figure 59: Watson’s forecast sales by portfolio, 2003–08 353




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