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