The Worldwide Alpha-1 Antitrypsin Market Present Situation and Future Prospects 2005-2015 TABLE OF CONTENTS November 2005
TABLE OF CONTENTS Executive Summary 15 Introduction. 33 Description, Background and Clinical Conditions. 45 History of alpha-1 antitrypsin Deficiency Research... 55 Products Commercially Available. 56 Products and Therapies in Development.. 63 North America. 74 Canada 76 Demographic Data.. 76 Prevalence and Incidence 76 Treatment centers. 77 Patient Organizations.. 77 Alpha-1 Antitrypsin Registry.. 77 National Guidelines for Augmentation Therapy 77 Health Care Organization.. 77 Product Available.. 80 Product Registration 81 Pricing 81 Market share.. 81 Factors affecting market growth. 82 Baseline Sales of Alpha-1 Antitrypsin. 82 Market analysis and projection 82 Market Forecast (Data). 84 Basis of Projection. 85 United States.. 86 Demographic Data.. 86 Prevalence and Incidence 86 Product Available.. 86
Product Registration 88 Product supply. 88 Price and Market share 89 Distribution 89 Treatment centers 89 Patient Organizations.. 91 Alpha-1 Antitrypsin Registry (AIR).. 92 Healthcare organization. 93 Detection... 100 National Guidelines.... 100 Factors affecting market growth.. 102 Baseline Sales of Alpha-1 Antitrypsin. 103 Market analysis and projection... 104 Basis of projection.... 104 Market Forecast (Data). 106 Western Europe... 108 Overview of Europe..... 109 Demographic Data.. 109 Prevalence and Incidence.. 109 Product Registration.. 110 Product Supply.... 113 Healthcare Coverage.. 113 Austria.... 114 Demographic Data.. 114 Prevalence and Incidence.. 114 Product Available.. 114 Product Registration. 115 Product supply. 115
Pricing and Market share 115 Treatment centers 115 Patient Organizations.... 116 Alpha-1 Antitrypsin Registry. 116 Healthcare organization... 116 Factors affecting market growth.. 119 Baseline Sales of Alpha-1 Antitrypsin. 120 Market analysis and projection.. 120 Basis of projection.. 120 Market Forecast (Data). 122 Belgium. 123 Demographic Data.. 123 Prevalence and Incidence 123 Product Available.. 123 Product Registration 123 Product supply 124 Pricing and Market share 124 Treatment Centers. 124 Patient Organization.. 125 Alpha-1 Antitrypsin Registry 125 Healthcare organization.. 125 Factors affecting market growth.. 126 Baseline Sales of Alpha-1 Antitrypsin. 127 Market analysis and projection.... 127 Market Forecast (Data). 128 Basis of projection.. 129
Denmark 130 Demographic Data.. 130 Prevalence and Incidence 130 Product Available.. 130 Product Registration 130 Treatment Centers 131 Patient Organization.. 132 Alpha-1 Antitrypsin Registry.. 132 Healthcare organization... 132 Factors affecting market growth.. 135 Market analysis and projection... 135 Market Forecast (Data).. 137 Basis of projection.. 138 Finland.. 139 Demographic Data.. 139 Prevalence and Incidence 139 Product Available.. 139 Product Registration 139 National Guidelines 140 Treatment Centers.. 141 Market share.. 141 Patient Organization.. 141 Alpha-1 Antitrypsin Registry.. 141 Healthcare organization.. 141 Factors affecting market growth..145 Market analysis and projection... 145 Market Forecast (Data).. 146
France 147 Demographic Data.. 147 Prevalence and Incidence 147 Product Available.. 147 Product Registration 148 Product supply 148 Pricing and Market Share.. 148 Patient Organization.. 148 Alpha-1 Antitrypsin Registry.. 149 Healthcare organization... 149 Factors affecting market growth.. 153 Baseline Sales of Alpha-1 Antitrypsin. 154 Market analysis and projection... 154 Market Forecast (Data).. 155 Basis of Projection... 156 Germany 157 Demographic Data.. 157 Prevalence and Incidence 157 Product Available.. 157 Product Registration 157 Product supply 159 Price and Market Share.. 159 Treatment Centers... 159 Patient Organization.. 159 Alpha-1 Registry.. 159 Detection.. 160 Healthcare organization... 160 Factors affecting market growth.. 165
Baseline Sales of Alpha-1 Antitrypsin. 165 Market analysis and projection... 165 Market Forecast (Data).. 166 Basis of Projection... 167 Greece... 168 Demographic Data.. 168 Prevalence and Incidence 168 Product Available.. 168 Product Registration 168 Price and Market Share... 169 Treatment Centers... 169 Patient Organization.. 169 Alpha-1 Registry.. 169 Healthcare organization... 169 Factors affecting market growth.. 171 Market analysis and projection... 171 Basis of Projection... 171 Market Forecast (Data).. 173 Ireland.. 174 Demographic Data.. 174 Prevalence and Incidence 174 Product Available.. 174 Product Registration 174 Product supply 175 Price and Market Share.... 175 Treatment Centers... 175 Patient Organization.. 175 Alpha-1 Registry.. 175
Healthcare organization... 177 Factors affecting market growth.. 180 Market analysis and projection... 180 Market Forecast (Data).. 181 Market analysis and projection... 181 Italy.. 182 Demographic Data.. 182 Prevalence and Incidence 182 Product Available.. 182 Product Registration 168 Product supply 183 Price and Market Share.. 183 Treatment Centers... 183 Patient Organization.. 186 Detection.. 187 Healthcare organization... 188 Factors affecting market growth.. 192 Baseline Sales of Alpha-1 Antitrypsin... 192 Market analysis and projection... 192 Basis of Projection... 192 Market Forecast (Data).. 194 The Netherlands.. 195 Demographic Data.. 195 Prevalence and Incidence 195 Product Available.. 195 Product Registration 195 Price and Market Share.. 196 Treatment Centers... 196
Patient Organization.. 196 Alpha-1 Registry.. 196 Healthcare organization... 197 Factors affecting market growth.. 202 Market analysis and projection... 203 Market Forecast (Data).. 204 Norway. 205 Demographic Data.. 205 Prevalence and Incidence 205 Product Available.. 205 Product Registration 205 Price and Market Share... 206 Treatment Centers... 206 Patient Organization.. 206 Alpha-1 Registry.. 207 Healthcare organization... 207 Factors affecting market growth.. 209 Market analysis and projection... 210 Market Forecast (Data).. 211 Portugal 212 Demographic Data.. 212 Prevalence and Incidence 212 Product Available.. 212 Product Registration 212 Price and Market Share... 213 Treatment Centers... 213 Patient Organization.. 213 Alpha-1 Registry.. 213
Healthcare organization... 213 Factors affecting market growth.. 217 Market analysis and projection... 217 Market Forecast (Data).. 219 Spain. 220 Demographic Data.. 220 Prevalence and Incidence 220 Product Available.. 220 Product Registration 220 Product Supply. 221 Pricing and Market Share... 221 Treatment Centers... 221 Patient Organization.. 222 Alpha-1 Registry.. 222 Detection.. 222 Healthcare organization... 223 Factors affecting market growth.. 226 Baseline Sales of Alpha-1 Antitrypsin.... 226 Market analysis and projection... 226 Market Forecast (Data).. 227 Basis of Projection.... 227 Sweden. 229 Demographic Data.. 229 Prevalence and Incidence 229 Product Available.. 229 Product Registration 229 Pricing and Market Share.. 230 Treatment Centers... 230
Patient Organization.. 230 Alpha-1 Registry.. 230 Healthcare organization... 232 Factors affecting market growth.. 235 Market analysis and projection... 235 Market Forecast (Data).. 237 Switzerland. 238 Demographic Data.. 238 Prevalence and Incidence 238 Product Available.. 238 Product Registration 238 Product Supply. 239 Pricing and Market Share... 239 Treatment Centers... 239 Patient Organization.. 239 Alpha-1 Registry.. 239 Healthcare organization... 239 Factors affecting market growth.. 241 Market analysis and projection... 242 Market Forecast (Data).. 244 United Kingdom 245 Demographic Data.. 245 Prevalence and Incidence 245 Product Available.. 245 Product Registration 245 Product Supply. 246 Treatment Centers... 246
Patient Organization.. 246 Alpha-1 Registry.. 246 Healthcare organization... 248 Factors affecting market growth.. 250 Market analysis and projection... 251 Market Forecast (Data).. 252 Basis of Projection.... 253 Eastern Europe. 254 Czech Republic. 256 Demographic Data.. 256 Prevalence and Incidence 256 Product Available.. 256 Product Registration 257 Pricing and Market Share... 257 Treatment Centers... 257 Patient Organization.. 257 Alpha-1 Registry.. 257 Healthcare organization... 257 Factors affecting market growth.. 259 Market analysis and projection... 260 Market Forecast (Data).. 261 Hungary 262 Demographic Data.. 262 Prevalence and Incidence 262 Product Available.. 262 Product Registration 262 Pricing and Market Share... 263 Treatment Centers... 263
Patient Organization.. 263 Alpha-1 Registry.. 263 Healthcare organization... 263 Factors affecting market growth.. 265 Market analysis and projection... 266 Market Forecast (Data).. 267 Poland 268 Demographic Data.. 268 Prevalence and Incidence 268 Product Available.. 268 Product Registration 268 Pricing and Market Share... 269 Treatment Centers... 269 Patient Organization.. 269 Alpha-1 Registry.. 269 Healthcare organization... 269 Factors affecting market growth.. 271 Market analysis and projection... 271 Market Forecast (Data).. 273 Russia 274 Demographic Data.. 274 Prevalence and Incidence 274 Product Available.. 274 Product Registration 274 Pricing and Market Share... 275 Treatment Centers... 275 Patient Organization.. 275 Alpha-1 Registry.. 275
Healthcare organization... 275 Factors affecting market growth.. 276 Market analysis and projection... 275 Other Eastern European Countries...... 278 South and Central America... 281 Asia and Pacific..... 282 Australia..... 282 Demographic Data.. 283 Prevalence and Incidence 283 Product Available.. 283 Product Registration 287 Pricing and Market Share... 287 Treatment Centers... 287 Patient Organization.. 288 Alpha-1 Registry.. 289 Healthcare organization... 290 Factors affecting market growth.. 293 Market analysis and projection... 294 Market Forecast (Data).. 295 Basis of Projection... 296 New Zealand. 297 Demographic Data.. 297 Prevalence and Incidence 297 Product Available.. 297 Product Registration 297 Pricing and Market Share... 298 Treatment Centers... 299 Patient Organization.. 299
Alpha-1 Registry.. 299 Healthcare organization... 299 Factors affecting market growth.. 301 Market analysis and projection... 302 Market Forecast (Data).. 303 Basis of Projection... 304 Japan.. 305 Demographic Data.. 305 Prevalence and Incidence 305 Market analysis and projection... 305 Other countries in Asia and Pacific... 306 Africa and Middle East.. 307 Israel.. 308 Demographic Data.. 308 Prevalence and Incidence 308 Product Available.. 308 Product Registration 308 Product Supply 309 Pricing and Market Share... 309 Treatment Centers... 309 Patient Organization.. 309 Alpha-1 Registry.. 309 Healthcare organization... 309 Factors affecting market growth.. 311 Market analysis and projection... 312 Market Forecast (Data).. 313 Other countries in the Middle East. 314
South Africa. 315 Demographic Data.. 315 Prevalence and Incidence 315 Product Available.. 315 Product Registration 315 Treatment Centers... 318 Patient Organization.. 318 Alpha-1 Registry.. 318 Healthcare organization... 318 Factors affecting market growth.. 320 Market analysis and projection... 320 Other countries in Africa.. 321
LIST OF TABLE and CHARTS Table 1 Potential Patients Forecast Most Likely Scenario.. 20 Table 2 Worldwide Volume Forecast (Grams) Most Likely Scenario.. 21 Table 3 Worldwide Dollars Forecast Most Likely Scenario.. 22 Table 4 Potential Patients Forecast Pessimistic Scenario.. 23 Table 5 Worldwide Volume Forecast (Grams) Pessimistic Scenario.. 24 Table 6 Worldwide Dollars Forecast Pessimistic Scenario.. 25 Table 7 Potential Patients Forecast Optimistic Scenario.. 26 Table 8 Worldwide Volume Forecast (Grams) Optimistic Scenario.. 27 Table 9 Worldwide Dollars Forecast Optimistic Scenario.. 28 Chart 1 Number of Potential Patients in the top ten Countries. 29 Chart 2 Forecast of the Alpha-1 Antitrypsin Market in the U.S. 2005 to 2015 (dollars). 30 Chart 3 Forecast of the Alpha-1 Antitrypsin Market in Europe 2005 to 2015 (dollars). 31 Chart 4 Forecast of the Alpha-1 Antitrypsin Market in Europe 2005 to 2015 (Grams). 32 Table 10 Prevalence and Incidence of the Alpha-1 Antitrypsin Deficiency by Region.. 35 Table Theoretical Global Alpha-1 Antitrypsin Market without Manufacturing Constraints... 42
ANNEXES Table of Contents Talecris Biotherapeutics Prolastin... 4 Baxter BioScience Aralast 16 ZLB Behring Zemaira... 29 Grifols SA Trypsone. 43 Laboratoire Français du Fractionnement et des Biotechnologies (LFB) Alfalastin.. 50 Kamada (Israel) Alapha-1 Antitrypsin. 60 United Kingdom - National Health Services Guidelines. 72 Italy - Ministry of Health Guidelines 76 Active Ingredients & Indications of Alpha-1 Antitrypsin 84 Key Articles on Augmentation Therapy.. 86 Useful Websites... 89
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