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Alpha- Antitrypsin Deficiency - Market Insight, Epidemiology and Market Forecast - 2027

DelveInsight’s ‘Alpha- Antitrypsin Deficiency (AATD) - Market Insights, Epidemiology and Market Forecast-2027’ report delivers an in-depth understanding of the disease, historical & forecasted epidemiology trends in the United States, EU5 (Germany, Spain, Italy, France and United Kingdom), and Japan.
The Report provides the current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted market size of AATD from 2016 to 2027 segmented by the US, EU-5 countries and Rest of the World (RoW). The Report also covers current treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assess underlying potential of the market.

Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain and the United Kingdom)
• Japan

Study Period: 2016-2027

Alpha- Antitrypsin Deficiency (AATD) - Disease Understanding and Treatment Algorithm
The DelveInsight Alpha- Antitrypsin Deficiency (AATD) market report gives the thorough understanding of the AATD by including details such as disease definition, classification, symptoms, etiology, pathophysiology, diagnostic trends. It also provides treatment algorithms and treatment guidelines for AATD in the US, Europe, and Japan.

Alpha- Antitrypsin Deficiency (AATD) Epidemiology
The AATD epidemiology division provide the insights about historical and current patient pool and forecasted trend for every 7 major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed and treatable patient pool and their trends along with assumptions undertaken.
The disease epidemiology covered in the report is segmented into two parts: Population at the risk of developing AATD on the basis of allele [PiSS, PiSZ, PiZZ) and Prevalent cases of AATD in 6 Major Markets [United States and EU5 (Germany, Spain, Italy, France and United Kingdom)]. As AATD is quite rare in Japan, the report features the diagnosed population of AATD in Japan.

According to DelveInsight, the prevalent cases of AATD was 185,860 in 2016 in 6MM and, is expected to increase at a CAGR of XX% during the study period i.e., 2016-2027. Among 6MM, United States account for highest prevalent cases of AATD with 113,808 prevalent cases in 2016 followed by Germany.

Alpha- Antitrypsin Deficiency (AATD) Drug Chapters
This segment of the AATD report encloses the detailed analysis of marketed drugs and late stage (Phase-III) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
AATD is rare disease which is highly under diagnosed and treated by the augmentation therapy products. United States Food and Drug Administration (FDA) has approved four augmentation therapies till date Prolastin-C (Grifols), Aralast NP (Shire), Zemaira (CSL Behring) and Glassia (Kamada Ltd.) and more potential therapies are on the horizon. This report includes detailed chapters of marketed products along with the promising upcoming therapies.

Alpha- Antitrypsin Deficiency (AATD) Market Outlook
The AATD market outlook of the report helps to build the detailed comprehension of the historic, current and forecasted trend of the market by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.
This segment gives a through detail of market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

The report provides global market share of AATD i.e., 6 Major Markets [United States and EU5 (Germany, Spain, Italy, France and United Kingdom)] and Rest of World (RoW). In 2016, global market size of AATD was USD 918.78 million and, is expected to grow at a CAGR of XX% during the forecast period of 2018-2027.
The region-wise market size for MS in US, EU-5 countries (Germany, France, Italy, Spain and the U.K.) and Rest of the World (RoW) shows highest market size in US, followed by Germany, the lowest being in the UK due to the difference of opinion between regulatory authorities and the manufacturer companies owing to the reimbursement policies.

Alpha- Antitrypsin Deficiency (AATD) Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the market or will get launched in the market during the study period from 2016-2027. The analysis covers market uptake by drugs; patient uptake by therapies and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Alpha- Antitrypsin Deficiency (AATD) Report Insights
• Patient Population
• Therapeutic Approaches
• Pipeline Analysis
• Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Alpha- Antitrypsin Deficiency (AATD) Report Key Strengths
• 10 Year Forecast
• 7MM Coverage
• Epidemiology Segmentation
• Drugs Uptake
• Highly Analyzed Market
• Key Cross Competition

Alpha- Antitrypsin Deficiency (AATD) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Detailed Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Benefits
• This DelveInsight report will help to develop Business Strategies by understanding the trends shaping and driving the AATD market
• Organize sales and marketing efforts by identifying the best opportunities for AATD market
• To understand the future market competition in the AATD market.


1. Report Introduction 1
2. Alpha Antitrypsin Deficiency Market Overview at a Glance 2
2.1. Market Share Distribution of Alpha Antitrypsin Deficiency in 2016 2
2.2. Market Share Distribution of Alpha Antitrypsin Deficiency in 2027 2
3. Disease Background and Overview: Alpha Antitrypsin Deficiency 11
3.1. Introduction 11
3.2. Symptoms 11
3.3. Etiology 12
3.4. Risk Factors 12
3.5. Genetic Inheritance of Alpha Antitrypsin Deficiency 13
3.6. Pathophysiology 14
3.7. Complications 15
3.8. Diagnosis 16
3.9. Treatment 19
3.10. Diagnostic Delay 20
4. Epidemiology and Patient Population 21
4.1. Prevalent Population of Alpha-1-Antitrypsin Deficiency in 6MM 22
4.2. Prevalent Population of Alpha-1-Antitrypsin Deficiency in 7MM – By Region 23
4.3. Prevalent Population of Alpha-1-Antitrypsin Deficiency in 6MM – Distribution (2016) 24
4.4. Prevalent Population of Alpha-1-Antitrypsin Deficiency in 6MM – Distribution (2027) 24
4.5. Epidemiology of Alpha-1-Antitrypsin Deficiency- By Country 25
4.5.1. United States 25
4.5.1.1. Assumptions and Rationale 25
4.5.1.2. Population at risk of Alpha Antitrypsin Deficiency in United States 26
4.5.1.3. Prevalent Population of Alpha Antitrypsin Deficiency 27
4.5.2. EU5 28
4.5.2.1. Assumptions and Rationale 28
4.5.2.2. Germany 29
4.5.2.2.1. Population at risk of Alpha Antitrypsin Deficiency in Germany 29
4.5.2.2.2. Prevalent Population of Alpha Antitrypsin Deficiency in Germany 31
4.5.2.3. France 32
4.5.2.3.1. Population at risk of Alpha Antitrypsin Deficiency in France 32
4.5.2.3.2. Prevalent Population of Alpha Antitrypsin Deficiency in France 33
4.5.2.4. Italy 34
4.5.2.4.1. Population at risk of Alpha Antitrypsin Deficiency in Italy 34
4.5.2.4.2. Prevalent Population of Alpha Antitrypsin Deficiency in Italy 35
4.5.2.5. Spain 36
4.5.2.5.1. Population at risk of Alpha Antitrypsin Deficiency in Spain 37
4.5.2.5.2. Prevalent Population of Alpha Antitrypsin Deficiency in Spain 38
4.5.2.6. United Kingdom 39
4.5.2.6.1. Population at risk of Alpha Antitrypsin Deficiency in UK 39
4.5.2.6.2. Prevalent Population of Alpha Antitrypsin Deficiency in UK 40
4.5.3. Japan 41
4.5.3.1. Diagnosed Population of Alpha Antitrypsin Deficiency in Japan 42
5. Treatment Algorithm 43
5.1. Management of Alpha-Antitrypsin (AAT) Deficiency with Lung Disease 46
5.2. Management of Alpha-Antitrypsin (AAT) Deficiency with Liver Disease 48
6. Unmet Needs 50
7. Marketed Drugs 52
7.1. Prolastin C: Grifols 52
7.1.1. Drug Description 52
7.1.2. Mechanism of Action 52
7.1.3. Regulatory Milestones 53
7.1.4. Advantages & Disadvantages 53
7.1.5. Product Profile 53
7.1.6. Safety and Efficacy of Prolastin-C 54
7.2. Glassia: Kamada 55
7.2.1. Drug Description 55
7.2.2. Mechanism of Action 55
7.2.3. Regulatory Milestones 55
7.2.4. Advantages & Disadvantages 56
7.2.5. Safety and Efficacy of Glassia 56
7.2.6. Product Profile 57
7.3. Aralast: Shire 58
7.3.1. Drug Description 58
7.3.2. Mechanism of Action 58
7.3.3. Regulatory Milestones 58
7.3.4. Advantages & Disadvantages 59
7.3.5. Safety and Efficacy of Aralast 59
7.3.6. Product Profile 60
7.4. Zemaira: CSL Behring 61
7.4.1. Drug Description 61
7.4.2. Mechanism of Action 61
7.4.3. Regulatory Milestones 61
7.4.4. Advantages & Disadvantages 62
7.4.5. Safety and Efficacy of Zemaira 62
7.4.6. Product Profile 62
7.5. Alfalastin: LFB Biotechnologies 63
7.5.1. Description 63
7.5.2. Regulatory Milestones 63
7.5.3. Advantages and Disadvantages 63
7.5.4. Product Profile 63
7.5.5. Safety and Efficacy 64
7.5.6. Side effects 64
7.6. Trypsone: Grifols 65
7.7. Description 65
7.8. Regulatory Milestones 65
7.9. Advantages and Disadvantages 65
7.10. Product Profile 65
7.11. Efficacy and Safety 66
7.12. Side effects 66
8. Emerging Therapies 67
8.1. Inhaled AAT (Glassia IH): Kamada Ltd. 67
8.2. Regulatory Milestones 67
8.3. Product Development Activities 67
8.4. Clinical Development 68
8.5. Product Profile 69
9. Alpha Antitrypsin Deficiency: Global Market Analysis 70
9.1. Global Market Size of AATD 73
9.2. Global Percentage Share of drugs marketed for AATD 74
9.3. Global Market Sales of AATD by Products 76
9.4. Global Treated Population for AATD 77
10. Alpha Antitrypsin Deficiency: Country-Wise Market Analysis 78
10.1. United States 78
10.1.1. Market Size of AATD in United States 78
10.1.2. Percentage Share of drugs marketed for AATD in United States 81
10.1.3. Market Sales of Alpha Antitrypsin Deficiency by Products in United States 83
10.1.4. Treated Population of AATD in United States 84
10.2. EU-5 85
10.2.1. Germany 85
10.2.1.1. Market Size of AATD in Germany 85
10.2.1.2. Percentage Share of drugs marketed for AATD in Germany 87
10.2.1.3. Market Sales of Alpha Antitrypsin Deficiency by Products in Germany 89
10.2.1.4. Treated Population of AATD in Germany 90
10.2.2. France 91
10.2.2.1. Market Size of AATD in France 91
10.2.2.2. Percentage Share of drugs marketed for AATD in France 93
10.2.2.3. Market Sales of Alpha Antitrypsin Deficiency by Products in France 95
10.2.2.4. Treated Population of AATD in France 96
10.2.3. Italy 97
10.2.3.1. Market Size of AATD in Italy 97
10.2.3.2. Percentage Share of drugs marketed for AATD in Italy 99
10.2.3.3. Market Sales of Alpha Antitrypsin Deficiency by Products in Italy 101
10.2.3.4. Treated Population of AATD in Italy 102
10.2.4. Spain 103
10.2.4.1. Market Size of AATD in Spain 103
10.2.4.2. Percentage Share of drugs marketed for AATD in Spain 105
10.2.4.3. Market Sales of Alpha Antitrypsin Deficiency by Products in Spain 107
10.2.4.4. Treated Population of AATD in Spain 108
10.2.5. United Kingdom 109
10.2.5.1. Market Size of AATD in United Kingdom 109
10.2.5.2. Percentage Share of drugs marketed for AATD in United Kingdom 112
10.2.5.3. Market Sales of Alpha Antitrypsin Deficiency by Products in UK 114
10.2.5.4. Treated Population of AATD in UK 115
10.3. Rest of the World (RoW) 116
11. Grifols Initiatives towards Alpha Anti-trypsin deficiency 118
12. USFDA Initiatives for patients with Alpha-1 Antitrypsin Deficiency (AATD) 119
13. Market Drivers 121
14. Market Barriers 122
15. Appendix 124
16. Report Methodology 124
16.1. Sources Used 124
17. Consulting Services 126
18. Disclaimer 127
19. About DelveInsight 127
List of Tables and Figures
Table 1: Total Prevalent Population of Alpha-1-Antitrypsin Deficiency in 6 MM (2016-2027) 22
Table 2: Prevalent Population of Alpha-1-Antitrypsin Deficiency in 7MM (2016-2027) 23
Table 3: Population at risk of Alpha Antitrypsin Deficiency in United States (2016-2027) 26
Table 4: Prevalent Population of Alpha Antitrypsin Deficiency in United States (2016-2027) 27
Table 5: Population at risk of Alpha Antitrypsin Deficiency in Germany (2016-2027) 30
Table 6: Prevalent Population of Alpha Antitrypsin Deficiency in Germany (2016-2027) 31
Table 7: Population at risk of Alpha Antitrypsin Deficiency in France (2016-2027) 33
Table 8: Prevalent Population of Alpha Antitrypsin Deficiency in France (2016-2027) 33
Table 9: Population at risk of Alpha Antitrypsin Deficiency in Italy (2016-2027) 35
Table 10: Prevalent Population of Alpha Antitrypsin Deficiency in Italy (2016-2027) 35
Table 11: Population at risk of Alpha Antitrypsin Deficiency in Spain (2016-2027) 37
Table 12: Prevalent Population of Alpha Antitrypsin Deficiency in Spain (2016-2027) 38
Table 13: Population at risk of Alpha Antitrypsin Deficiency in United Kingdom (2016-2027) 40
Table 14: Prevalent Population of Alpha Antitrypsin Deficiency in United Kingdom (2016-2027) 40
Table 15: Diagnosed Population of Alpha Antitrypsin Deficiency in Japan (2016-2027) 42
Table 16: Global Market Size of Alpha Antitrypsin Deficiency in USD Million (2016-2027) 73
Table 17: Global Percentage share of Drugs marketed for AATD (2017) 74
Table 18: Global Percentage share of Drugs marketed for AATD (2027) 75
Table 19: Global Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 76
Table 20: Global Treated Population of Alpha Antitrypsin Deficiency (2016-2027) 77
Table 21: United States Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 80
Table 22: Percentage share of Drugs marketed for AATD in United States (2017) 81
Table 23: Percentage share of Drugs marketed for AATD in United States (2027) 82
Table 24: US Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 83
Table 25: Treated Population of Alpha Antitrypsin Deficiency in the United States (2016-2027) 84
Table 26: Germany Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 86
Table 27: Percentage share of Drugs marketed for AATD in Germany (2017) 87
Table 28: Percentage share of Drugs marketed for AATD in Germany (2027) 88
Table 29: Germany Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 89
Table 30: Treated Population of Alpha Antitrypsin Deficiency in the Germany (2016-2027) 90
Table 31: France Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 92
Table 32: Percentage share of Drugs marketed for AATD in France (2017) 93
Table 33: Percentage share of Drugs marketed for AATD in France (2027) 94
Table 34: France Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 95
Table 35: Treated Population of Alpha Antitrypsin Deficiency in France (2016-2027) 96
Table 36: Italy Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 98
Table 37: Percentage share of Drugs marketed for AATD in Italy (2017) 99
Table 38: Percentage share of Drugs marketed for AATD in Italy (2027) 100
Table 39: Italy Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 101
Table 40: Treated Population of Alpha Antitrypsin Deficiency in Italy (2016-2027) 102
Table 41: Spain Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 104
Table 42: Percentage share of Drugs marketed for AATD in Spain (2017) 105
Table 43: Percentage share of Drugs marketed for AATD in Spain (2027) 106
Table 44: Spain Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 107
Table 45: Treated Population of Alpha Antitrypsin Deficiency in Spain (2016-2027) 108
Table 46: United Kingdom Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 111
Table 47: Percentage share of Drugs marketed for AATD in UK (2018) 112
Table 48: Percentage share of Drugs marketed for AATD in UK (2027) 113
Table 49: UK Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 114
Table 50: Treated Population of Alpha Antitrypsin Deficiency in the United Kingdom (2016-2027) 115
Table 51:RoW Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 117
Figure 1: Pathogenesis of Alpha Antitrypsin Deficiency 15
Figure 2: Diagnostic Algorithm of Alpha Antitrypsin Deficiency 18
Figure 3: General Treatment of Alpha Antitrypsin Deficiency 19
Figure 4: Total Prevalent Population of Alpha-1-Antitrypsin Deficiency in 6 MM (2016-2027) 22
Figure 5: Prevalent Population of Alpha-1-Antitrypsin Deficiency in 7MM (2016-2027) 23
Figure 6: Population at risk of Alpha Antitrypsin Deficiency in United States (2016-2027) 26
Figure 7: Prevalent Population of Alpha Antitrypsin Deficiency in United States (2016-2027) 27
Figure 8: Population at risk of Alpha Antitrypsin Deficiency in Germany (2016-2027) 29
Figure 9: Prevalent Population of Alpha Antitrypsin Deficiency in Germany (2016-2027) 31
Figure 10: Population at risk of Alpha Antitrypsin Deficiency in France (2016-2027) 32
Figure 11: Prevalent Population of Alpha Antitrypsin Deficiency in France (2016-2027) 33
Figure 12: Population at risk of Alpha Antitrypsin Deficiency in Italy (2016-2027) 34
Figure 13: Prevalent Population of Alpha Antitrypsin Deficiency in Italy (2016-2027) 35
Figure 14: Population at risk of Alpha Antitrypsin Deficiency in Spain ( (2016-2027) 37
Figure 15: Prevalent Population of Alpha Antitrypsin Deficiency in Spain (2016-2027) 38
Figure 16: Population at risk of Alpha Antitrypsin Deficiency in United Kingdom (2016-2027) 39
Figure 17: Prevalent Population of Alpha Antitrypsin Deficiency in United Kingdom (2016-2027) 40
Figure 18: Diagnosed Population of Alpha Antitrypsin Deficiency in Japan (2016-2027) 42
Figure 19: Global Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 73
Figure 20: Global Percentage share of Drugs marketed for AATD (2017) 74
Figure 21: Global Percentage share of Drugs marketed for AATD (2027) 75
Figure 22: Global Market Sales of Alpha Antitrypsin Deficiency by Therapies in USD, Million (2016-2027) 76
Figure 23: Global Treated Population of Alpha Antitrypsin Deficiency (2016-2027) 77
Figure 24: United States Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 80
Figure 25: Percentage share of Drugs marketed for AATD in United States (2017) 81
Figure 26: Percentage share of Drugs marketed for AATD in United States (2027) 82
Figure 27: US Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 83
Figure 28: Treated Population of Alpha Antitrypsin Deficiency in the United States (2016-2027) 84
Figure 29: Germany Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 86
Figure 30: Percentage share of Drugs marketed for AATD in Germany (2017) 87
Figure 31: Percentage share of Drugs marketed for AATD in Germany (2027) 88
Figure 32: Germany Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 89
Figure 33: Treated Population of Alpha Antitrypsin Deficiency in the Germany (2016-2027) 90
Figure 34: France Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 92
Figure 35: Percentage share of Drugs marketed for AATD in France (2017) 93
Figure 36: Percentage share of Drugs marketed for AATD in France (2027) 94
Figure 37: France Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 95
Figure 38: Treated Population of Alpha Antitrypsin Deficiency in the France (2016-2027) 96
Figure 39: Italy Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 98
Figure 40: Percentage share of Drugs marketed for AATD in Italy (2017) 99
Figure 41: Percentage share of Drugs marketed for AATD in Italy (2027) 100
Figure 42: Italy Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 101
Figure 43: Treated Population of Alpha Antitrypsin Deficiency in the Italy( 2016-2027) 102
Figure 44: Spain Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 104
Figure 45: Percentage share of Drugs marketed for AATD in Spain (2017) 105
Figure 46: Percentage share of Drugs marketed for AATD in Spain (2027) 106
Figure 47: Spain Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 107
Figure 48: Treated Population of Alpha Antitrypsin Deficiency in the Spain (2016-2027) 108
Figure 49: United Kingdom Market Size of Alpha Antitrypsin Deficiency in USD, Million (2016-2027) 111
Figure 50: Percentage share of Drugs marketed for AATD in UK (2018) 112
Figure 51: Percentage share of Drugs marketed for AATD in UK (2027) 113
Figure 52: United Kingdom Market Sales of Alpha Antitrypsin Deficiency by Products in USD, Million (2016-2027) 114
Figure 53: Treated Population of Alpha Antitrypsin Deficiency in the UK (2016-2027) 115

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