The Alpha-1 Antitrypsin Deficiency Market Size in the 7MM Reached USD 830 million in 2023 and is expected to increase with a significant CAGR by 2034, estimates DelveInsight

DelveInsight's "Alpha-1 Antitrypsin Deficiency Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Alpha-1 Antitrypsin Deficiency, historical and forecasted epidemiology as well as the Alpha-1 Antitrypsin Deficiency therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Alpha 1 Antitrypsin Deficiency Market Report
• Among the 7MM, the US accounted for approximately 59%, EU4 and the UK for 40%, and Japan for 1% of the total prevalent cases of Alpha-1 Antitrypsin Deficiency in 2020.
• The total diagnosed prevalent cases of Alpha-1 Antitrypsin Deficiency in the United States is estimated to be ~10,700 in 2023. The cases are expected to increase by 2034.
• Among EU4 and the UK, in 2023, the UK accounted for the highest Alpha-1 Antitrypsin Deficiency cases, followed by Germany.
• As per estimates, in 2020, in the US, comorbidity associated with lung diseases was most common, occurring in around 77% of the total Alpha-1 Antitrypsin Deficiency cases, followed by other diseases occurring in around 15% of the cases, while 8% of the cases had liver diseases.
• The leading Alpha 1 Antitrypsin Deficiency Companies such as Kamada Pharmaceuticals, Arrowhead Pharmaceuticals, Takeda, Mereo BioPharma, AstraZeneca, Sanofi, Inhibrx Biosciences, Wave Life Sciences, Beam Therapeutics, Grifols, Krystal Biotech and others.
• Promising Alpha 1 Antitrypsin Deficiency Therapies such as Inhaled Alpha 1-Antitrypsin (AAT), Fazirsiran (ARO-AAT/TAK-999), Alvelestat (MPH-966), VX-864, INBRX-101, Belcesiran (DCR-A1AT), and others.

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Alpha 1 Antitrypsin Deficiency Epidemiology Segmentation in the 7MM
• Total Prevalent Cases of Alpha-1 Antitrypsin Deficiency
• Total Diagnosed Prevalent Cases of Alpha-1 Antitrypsin Deficiency
• Genotype-specific Prevalent Cases of Alpha-1 Antitrypsin Deficiency
• Comorbidity-associated Cases of Alpha-1 Antitrypsin Deficiency

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Marketed Alpha-1 Antitrypsin Deficiency Drugs
• PROLASTIN-C LIQUID/LYNSPAD: Grifols
PROLASTIN-C LIQUID is an A1-PI indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of A1-PI. PROLASTIN increases the antigenic and functional levels of serum and antigenic lung epithelial lining fluid levels of A1-PI. PROLASTIN-C LIQUID is the first ready-to-infuse liquid formulation of an A-1 antitrypsin deficiency replacement therapy manufactured in the US. It requires less preparation time than the lyophilized product and less volume for infusion compared to others.

• GLASSIA: Kamada Pharmaceuticals/Takeda
GLASSIA is an intravenous AAT product that is indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of A1-PI. GLASSIA increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha-1 Proteinase Inhibitor (A1-PI).

Emerging Alpha-1 Antitrypsin Deficiency Drugs
• Inhaled Alpha 1-Antitrypsin (AAT): Kamada Pharmaceuticals
Inhaled AAT, an investigational medicine researched for Alpha-1 Antitrypsin Deficiency patients, aims to replace the deficient AAT protein in the lung. It acts as an immunomodulator (serine peptidase inhibitor) that prevents inflammation and tissue degradation by regulating the imbalance of proteases and antiproteases in the lungs. Inhaled AAT received positive scientific advice from the EMA that reconfirmed the overall design of the ongoing study and acknowledged the statistically and clinically meaningful improvement in lung functioning. In March 2016, Kamada submitted an MAA to EMA for the inhaled AAT to treat Alpha-1 Antitrypsin Deficiency. However, later, in 2017, it was withdrawn due to insufficient data. Currently, the company is conducting a Phase III clinical trial to evaluate the safety and efficacy of Kamada AAT for Inhalation in the EU and has completed Phase II and II/III trials in the US and EU, respectively. As per the news released in Q2 2024 report, Kamada Pharmaceuticals has filed an IND amendment with the FDA consisting of a revised Statistical Analysis Plan (SAP) and study protocol, which, if approved, may allow for the acceleration of the program of its ongoing pivotal Phase III InnovAATe clinical trial for the inhaled AAT.

• Fazirsiran (ARO-AAT/TAK-999): Arrowhead Pharmaceuticals and Takeda
Fazirsiran is an investigational RNA interference therapy designed to reduce the production of mutant alpha-1 antitrypsin protein (Z-AAT) as the first potential treatment for liver disease associated with Alpha-1 Antitrypsin Deficiency. In October 2020, Takeda Pharmaceuticals and Arrowhead Pharmaceuticals announced a collaboration and licensing agreement to develop fazirsiran to treat Alpha-1 Antitrypsin Deficiency. The drug has received BTD, FTD and ODD from the US FDA to treat AAT-associated liver disease. Currently, Arrowhead Pharma is advancing fazirsiran in two Phase III studies, REDWOOD (NCT05677971) in patients with Alpha-1 Antitrypsin Deficiency-associated liver disease with METAVIR Stage F2-F4 Fibrosis and another trial (NCT06165341) for patients with Alpha-1 Antitrypsin Deficiency-associated liver disease with METAVIR Stage F1 Fibrosis.

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Alpha-1 Antitrypsin Deficiency Drugs Market Insights
Neutrophil elastase inhibitors specifically target and block the activity of neutrophil elastase. This action helps prevent the breakdown of elastin and other connective tissues in the lungs, slowing the progression of emphysema and preserving lung function. By regulating neutrophil elastase levels, these inhibitors help restore the normal balance between proteases and antiproteases that are disrupted in the treatment of Alpha-1 Antitrypsin Deficiency. Mereo Biopharma's Alvelestat, a neutrophil elastase inhibitor is in development for Alpha-1 Antitrypsin Deficiency-associated lung disease.

Alpha-1 Antitrypsin Deficiency Market Outlook
Alpha-1 antitrypsin deficiency is a genetic disorder that can lead to lung and liver disease. Early diagnosis and appropriate medical care are important for managing the condition and improving the quality of life for individuals with Alpha-1 Antitrypsin Deficiency. The current treatment landscape lacks curative and disease-modifying therapies. Augmentation therapy, also called replacement therapy, is approved for treating alpha-1-related lung disease. Several off-label drugs are used for symptomatic relief and managing lung-related complications like COPD or emphysema; bronchodilators, corticosteroids, and antibiotics are commonly used. In the severe stage of the disease, a surgical option like lung volume reduction surgery and bullectomy is recommended, and patients with very advanced emphysema may require lung transplant surgery, which involves removing a damaged lung and replacing it with a healthy lung; however, it involves many risks, including infection and rejection. Alpha-1 Antitrypsin Deficiency is commonly associated with liver disease; however, no therapy has yet been approved to address liver-associated disease. Treatment is designed to maintain normal nutrition and to provide the liver and the body with essential nutrients. IV replacement therapy, majorly used to manage lung diseases, utilizes AAT protein from healthy human donors' blood plasma to augment the alpha-1 levels in the blood and lungs diagnosed with emphysema.

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Scope of the Alpha 1 Antitrypsin Deficiency Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Alpha 1 Antitrypsin Deficiency Companies- Kamada Pharmaceuticals, Arrowhead Pharmaceuticals, Takeda, Mereo BioPharma, AstraZeneca, Sanofi, Inhibrx Biosciences, Wave Life Sciences, Beam Therapeutics, Grifols, Krystal Biotech and others.
• Alpha 1 Antitrypsin Deficiency Therapies- Inhaled Alpha 1-Antitrypsin (AAT), Fazirsiran (ARO-AAT/TAK-999), Alvelestat (MPH-966), VX-864, INBRX-101, Belcesiran (DCR-A1AT), and others.
• Alpha 1 Antitrypsin Deficiency Therapeutic Assessment: Alpha 1 Antitrypsin Deficiency current marketed and Alpha 1 Antitrypsin Deficiency emerging therapies
• Alpha 1 Antitrypsin Deficiency Market Dynamics: Alpha 1 Antitrypsin Deficiency market drivers and Alpha 1 Antitrypsin Deficiency market barriers
• Alpha 1 Antitrypsin Deficiency Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Alpha 1 Antitrypsin Deficiency Unmet Needs, KOL's views, Analyst's views, Alpha 1 Antitrypsin Deficiency Market Access and Reimbursement

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Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Alpha-1 Antitrypsin Deficiency Market Overview at a Glance
5. Epidemiology and Market Forecast Methodology
6. Key Events
7. Disease Background and Overview
8. Alpha-1 Antitrypsin Deficiency Epidemiology and Patient Population
9. Alpha-1 Antitrypsin Deficiency Patient Journey
10. Alpha-1 Antitrypsin Deficiency Marketed Drugs
11. Emerging Alpha-1 Antitrypsin Deficiency Drugs
12. AATD: Seven Major Market Analysis
13. Alpha-1 Antitrypsin Deficiency Unmet Needs
14. SWOT Analysis
15. KOL Views
16. Market Access and Reimbursement
16.4. Market Access and Reimbursement of AATD
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

About Us

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