The Worldwide Alpha-1 Antitrypsin Market. Present Situation and Future Prospects

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1 The Worldwide Alpha-1 Antitrypsin Market Present Situation and Future Prospects TABLE OF CONTENTS November 2005

2 TABLE OF CONTENTS Executive Summary 15 Introduction. 33 Description, Background and Clinical Conditions. 45 History of alpha-1 antitrypsin Deficiency Research 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

3 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 National Guidelines Factors affecting market growth Baseline Sales of Alpha-1 Antitrypsin. 103 Market analysis and projection Basis of projection Market Forecast (Data). 106 Western Europe Overview of Europe Demographic Data Prevalence and Incidence Product Registration Product Supply Healthcare Coverage Austria Demographic Data Prevalence and Incidence Product Available Product Registration. 115 Product supply. 115

4 Pricing and Market share 115 Treatment centers 115 Patient Organizations Alpha-1 Antitrypsin Registry. 116 Healthcare organization Factors affecting market growth Baseline Sales of Alpha-1 Antitrypsin. 120 Market analysis and projection Basis of projection Market Forecast (Data). 122 Belgium. 123 Demographic Data Prevalence and Incidence 123 Product Available Product Registration 123 Product supply 124 Pricing and Market share 124 Treatment Centers. 124 Patient Organization Alpha-1 Antitrypsin Registry 125 Healthcare organization Factors affecting market growth Baseline Sales of Alpha-1 Antitrypsin. 127 Market analysis and projection Market Forecast (Data). 128 Basis of projection.. 129

5 Denmark 130 Demographic Data Prevalence and Incidence 130 Product Available Product Registration 130 Treatment Centers 131 Patient Organization Alpha-1 Antitrypsin Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Basis of projection Finland Demographic Data Prevalence and Incidence 139 Product Available Product Registration 139 National Guidelines 140 Treatment Centers Market share Patient Organization Alpha-1 Antitrypsin Registry Healthcare organization Factors affecting market growth..145 Market analysis and projection Market Forecast (Data).. 146

6 France 147 Demographic Data Prevalence and Incidence 147 Product Available Product Registration 148 Product supply 148 Pricing and Market Share Patient Organization Alpha-1 Antitrypsin Registry Healthcare organization Factors affecting market growth Baseline Sales of Alpha-1 Antitrypsin. 154 Market analysis and projection Market Forecast (Data) Basis of Projection Germany 157 Demographic Data Prevalence and Incidence 157 Product Available Product Registration 157 Product supply 159 Price and Market Share Treatment Centers Patient Organization Alpha-1 Registry Detection Healthcare organization Factors affecting market growth.. 165

7 Baseline Sales of Alpha-1 Antitrypsin. 165 Market analysis and projection Market Forecast (Data) Basis of Projection Greece Demographic Data Prevalence and Incidence 168 Product Available Product Registration 168 Price and Market Share Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Basis of Projection Market Forecast (Data) Ireland Demographic Data Prevalence and Incidence 174 Product Available Product Registration 174 Product supply 175 Price and Market Share Treatment Centers Patient Organization Alpha-1 Registry.. 175

8 Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Market analysis and projection Italy Demographic Data Prevalence and Incidence 182 Product Available Product Registration 168 Product supply 183 Price and Market Share Treatment Centers Patient Organization Detection Healthcare organization Factors affecting market growth Baseline Sales of Alpha-1 Antitrypsin Market analysis and projection Basis of Projection Market Forecast (Data) The Netherlands Demographic Data Prevalence and Incidence 195 Product Available Product Registration 195 Price and Market Share Treatment Centers

9 Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Norway. 205 Demographic Data Prevalence and Incidence 205 Product Available Product Registration 205 Price and Market Share Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Portugal 212 Demographic Data Prevalence and Incidence 212 Product Available Product Registration 212 Price and Market Share Treatment Centers Patient Organization Alpha-1 Registry.. 213

10 Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Spain. 220 Demographic Data Prevalence and Incidence 220 Product Available Product Registration 220 Product Supply. 221 Pricing and Market Share Treatment Centers Patient Organization Alpha-1 Registry Detection Healthcare organization Factors affecting market growth Baseline Sales of Alpha-1 Antitrypsin Market analysis and projection Market Forecast (Data) Basis of Projection Sweden. 229 Demographic Data Prevalence and Incidence 229 Product Available Product Registration 229 Pricing and Market Share Treatment Centers

11 Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Switzerland. 238 Demographic Data Prevalence and Incidence 238 Product Available Product Registration 238 Product Supply. 239 Pricing and Market Share Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) United Kingdom 245 Demographic Data Prevalence and Incidence 245 Product Available Product Registration 245 Product Supply. 246 Treatment Centers

12 Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Basis of Projection Eastern Europe. 254 Czech Republic. 256 Demographic Data Prevalence and Incidence 256 Product Available Product Registration 257 Pricing and Market Share Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Hungary 262 Demographic Data Prevalence and Incidence 262 Product Available Product Registration 262 Pricing and Market Share Treatment Centers

13 Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Poland 268 Demographic Data Prevalence and Incidence 268 Product Available Product Registration 268 Pricing and Market Share Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Russia 274 Demographic Data Prevalence and Incidence 274 Product Available Product Registration 274 Pricing and Market Share Treatment Centers Patient Organization Alpha-1 Registry.. 275

14 Healthcare organization Factors affecting market growth Market analysis and projection Other Eastern European Countries South and Central America Asia and Pacific Australia Demographic Data Prevalence and Incidence 283 Product Available Product Registration 287 Pricing and Market Share Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Basis of Projection New Zealand. 297 Demographic Data Prevalence and Incidence 297 Product Available Product Registration 297 Pricing and Market Share Treatment Centers Patient Organization.. 299

15 Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Basis of Projection Japan Demographic Data Prevalence and Incidence 305 Market analysis and projection Other countries in Asia and Pacific Africa and Middle East Israel Demographic Data Prevalence and Incidence 308 Product Available Product Registration 308 Product Supply 309 Pricing and Market Share Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Market Forecast (Data) Other countries in the Middle East. 314

16 South Africa. 315 Demographic Data Prevalence and Incidence 315 Product Available Product Registration 315 Treatment Centers Patient Organization Alpha-1 Registry Healthcare organization Factors affecting market growth Market analysis and projection Other countries in Africa.. 321

17 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 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

18 ANNEXES Table of Contents Talecris Biotherapeutics Prolastin... 4 Baxter BioScience Aralast 16 ZLB Behring Zemaira 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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