Alpha-1 Antitrypsin Deficiency Market Set for Steady Growth Through 2034 - Market Insight, Epidemiology, and Forecast | DelveInsight

Alpha-1 Antitrypsin Deficiency (AATD) is a rare but underdiagnosed genetic disorder that significantly increases the risk of developing chronic obstructive pulmonary disease (COPD), liver disease, and other systemic complications. Caused by mutations in the SERPINA1 gene, AATD results in deficient or dysfunctional alpha-1 antitrypsin (AAT), a key protein that protects tissues from enzyme damage, especially in the lungs.

DelveInsight's latest report, "Alpha-1 Antitrypsin Deficiency - Market Insight, Epidemiology, and Market Forecast - 2034," provides a comprehensive overview of the AATD landscape across major markets, including the US, EU4 (Germany, France, Italy, Spain), the UK, and Japan. The report covers detailed epidemiological segmentation by genotype, disease manifestation (lung vs. liver involvement), and diagnostic trends, as well as historical and forecasted market dynamics.

Early diagnosis and augmentation therapy remain central to current AATD management. However, late or missed diagnoses, limited awareness among clinicians, and underutilization of genetic testing continue to pose significant challenges. New strategies such as targeted screening, family-based testing, and increased awareness in respiratory and hepatology clinics are expected to improve detection rates over time.

The AATD market is projected to expand steadily through 2034, fueled by increasing awareness, advances in diagnostic tools, growing access to genotyping, and a robust pipeline of novel therapies. These include gene therapy approaches, inhaled AAT formulations, and small-molecule drugs aimed at addressing the root genetic cause and improving patient outcomes beyond current plasma-derived therapies.

DelveInsight anticipates a transformative decade ahead for the AATD market, with growing opportunities for biotech innovators and public health initiatives. As precision medicine and rare disease awareness continue to gain traction, the AATD treatment landscape is poised for meaningful evolution in the years ahead.

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Some of the key insights of the Alpha-1 Antitrypsin Deficiency Market Report:
• The Alpha-1 Antitrypsin Deficiency (AATD) market in the 7MM was valued at around USD 830 million in 2023 and is projected to grow significantly through 2034.
• The US dominated the market in 2023, contributing approximately 84% of the total AATD market size in the 7MM.
• By 2034, PROLASTIN/PROLASTIN-C/LYNSPAD is expected to generate the highest revenue among all emerging AATD therapies in the 7MM.
• In 2024, there were an estimated 225,950 prevalent cases of AATD in the 7MM, expected to rise through 2034 due to increasing rates of COPD and liver diseases.
• The US had the highest number of AATD cases, with PiZZ being the most common genotype (~9,940 cases), followed by PiSZ (~610) and other variants (~500).
• Emerging therapies like KB408 and BEAM-302 are gaining attention for their potential as one-time, curative AATD treatments.
• In the US, four FDA-approved augmentation therapies are available: PROLASTIN-C, ARALAST, ZEMAIRA, and GLASSIA.
• Europe offers several augmentation options, including RESPREEZA, PROLASTIN, and ALFALASTIN. In Japan, PROLASTIN-C is marketed as LYNSPAD.
• In May 2025, Beam Therapeutics (Nasdaq: BEAM) announced the FDA granted orphan drug designation to BEAM-302, a liver-targeted lipid nanoparticle therapy using base editing to correct mutations in alpha-1 antitrypsin deficiency (AATD) patients.
• In May 2025, Beam Therapeutics announced that the FDA granted RMAT designation to BEAM-302, a liver-targeted base editing therapy for alpha-1 antitrypsin deficiency (AATD), a genetic disorder causing lung and liver disease with high unmet medical need.
• In March 2025, Beam Therapeutics Inc. (Nasdaq: BEAM) announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for BEAM-302, a treatment for alpha-1 antitrypsin deficiency (AATD).
• In March 2025, the FDA approved an update to GLASSIA's US Prescribing Information to include 1-, 4-, and 5-gram single-dose vials, available from July 2025, aiming to simplify weight-based dosing, reduce waste, and improve convenience for patients, including those who self-infuse.
• In November 2024, Korro Bio announced a submission to the Bellberry HREC for a Phase I/II clinical study of KRRO-110 for AATD.
• Emerging therapies for Alpha-1 Antitrypsin Deficiency include Inhaled Alpha 1-Antitrypsin (AAT), Fazirsiran (ARO-AAT/TAK-999), Alvelestat (MPH-966), SAR447537/INBRX-101, WVE-006, BEAM-302, Alpha-1 AT 15% (SC), KB408, KRRO-110, BMN 349, and others.
• Key companies involved in the treatment of Alpha-1 Antitrypsin Deficiency include Kamada Pharmaceuticals, Arrowhead Pharmaceuticals, Takeda, Mereo BioPharma, AstraZeneca, Sanofi, Inhibrx Biosciences, Wave Life Sciences, Beam Therapeutics, Grifols, Krystal Biotech, and others.

To know in detail about the Alpha-1 Antitrypsin Deficiency market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: https://www.delveinsight.com/report-store/alpha-1-antitrypsin-deficiency-a1atd-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Alpha-1 Antitrypsin Deficiency Overview
Alpha-1 Antitrypsin Deficiency (AATD) is a rare, inherited genetic disorder caused by mutations in the SERPINA1 gene, leading to reduced levels or dysfunctional forms of the alpha-1 antitrypsin (AAT) protein. AAT is primarily produced in the liver and plays a critical role in protecting lung tissue from damage caused by neutrophil elastase, an enzyme that can degrade connective tissue during inflammation.

In individuals with AATD, insufficient functional AAT allows unchecked enzyme activity, resulting in progressive lung damage and conditions like chronic obstructive pulmonary disease (COPD), emphysema, and chronic bronchitis. The disorder can also lead to liver diseases, including neonatal hepatitis, cirrhosis, and hepatocellular carcinoma, due to abnormal AAT accumulation in liver cells.

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Alpha-1 Antitrypsin Deficiency Epidemiology
The epidemiology section offers an overview of historical, current, and projected trends in the seven major countries (7MM) from 2020 to 2034. It helps identify the factors influencing these trends by examining various studies and perspectives from key opinion leaders. Additionally, the section provides an in-depth analysis of the diagnosed patient population and future trends.

Alpha-1 Antitrypsin Deficiency Epidemiology Segmentation:
The Alpha-1 Antitrypsin Deficiency market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:
• 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

Alpha-1 Antitrypsin Deficiency Drugs Uptake and Pipeline Development Activities
The Drug Uptake section offers a detailed analysis of the adoption trends of newly launched and upcoming therapies for Alpha-1 Antitrypsin Deficiency throughout the study period. It evaluates patient adoption rates, market penetration, and the commercial performance of each therapy, providing a clear understanding of the factors driving or hindering the market acceptance of these treatments.

The Therapeutics Assessment further highlights the Alpha-1 Antitrypsin Deficiency drugs, demonstrating the most rapid uptake. It examines the underlying drivers contributing to their swift adoption and compares the market share of these therapies to identify those gaining significant traction.

Additionally, the report provides an in-depth overview of the current therapeutic pipeline for Alpha-1 Antitrypsin Deficiency, covering investigational drugs at various stages of development. It profiles the key pharmaceutical and biotech companies actively involved in advancing targeted treatments and presents the latest updates on partnerships, mergers and acquisitions, licensing deals, and other strategic developments shaping the future of Alpha-1 Antitrypsin Deficiency therapeutics.

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Alpha-1 Antitrypsin Deficiency Market Outlook
The Alpha-1 Antitrypsin Deficiency (AATD) treatment market continues to evolve, although significant unmet needs persist, particularly for disease-modifying and liver-specific therapies. Currently, augmentation therapy-the cornerstone of AATD treatment for lung involvement-remains the only approved option designed to supplement deficient AAT protein levels using plasma-derived formulations. Despite its established role, this approach is limited by high costs, lifelong administration, and limited global availability.

In the United States, four FDA-approved augmentation therapies are available: PROLASTIN-C (Grifols), ARALAST (Takeda), ZEMAIRA (CSL Behring), and GLASSIA (Kamada/Takeda). Meanwhile, Europe offers a broader range of options, including RESPREEZA (marketed as ZEMAIRA in the US), PROLASTIN, PROLASTINA, PROLASPLAN, PLITALFA, and ALFALASTIN, though their availability varies by country. Japan's AATD treatment landscape is more limited due to the condition's low prevalence, with LYNSPAD (PROLASTIN-C liquid) being the only approved augmentation therapy.

Beyond augmentation, treatment remains largely symptomatic, with bronchodilators, corticosteroids, and antibiotics used to manage lung complications such as COPD and emphysema. In advanced stages, surgical interventions like lung volume reduction or transplantation may be required. However, these come with significant risks, including infection and organ rejection.

No therapies have yet been approved to treat the liver manifestations of AATD, leaving a critical gap in care. Supportive approaches focus on nutritional management and liver health maintenance, underscoring the need for innovative therapies targeting the underlying molecular mechanisms.

Looking ahead, the AATD market is poised for gradual expansion, driven by growing disease awareness, advances in genetic testing, and research into next-generation therapies such as gene therapy, RNA-based interventions, and recombinant AAT products. As the therapeutic landscape shifts from symptomatic to potentially curative strategies, the AATD market holds considerable potential for innovation and growth through 2034.

Alpha-1 Antitrypsin Deficiency Market Drivers
• Increased awareness among healthcare professionals and patients, along with improved access to genetic testing, is driving earlier and more accurate diagnosis of AATD. This is expanding the diagnosed patient pool and boosting demand for targeted therapies, especially augmentation treatments.
• Ongoing R&D into gene therapies, RNA-based treatments, and recombinant AAT formulations is fueling the market's growth potential. Novel therapies aimed at liver manifestations and disease modification offer promising avenues for long-term disease management and commercial expansion.

Alpha-1 Antitrypsin Deficiency Market Barriers
• Augmentation therapies are expensive and require lifelong intravenous administration, limiting patient access, particularly in low-resource settings or countries without reimbursement frameworks. This significantly restricts widespread adoption.
• Despite liver involvement being a major clinical concern in AATD, no approved treatments are currently available. The absence of liver-specific therapies underscores a significant unmet need and hinders the holistic management of the disease.

Scope of the Alpha-1 Antitrypsin Deficiency Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan].
• Key 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.
• Key Alpha-1 Antitrypsin Deficiency Therapies: Alpha 1-Antitrypsin (AAT), Fazirsiran (ARO-AAT/TAK-999), Alvelestat (MPH-966), SAR447537/INBRX-101, WVE-006, BEAM-302, Alpha-1 AT 15% (SC), KB408, KRRO-110, BMN 349, and others.
• Alpha-1 Antitrypsin Deficiency Therapeutic Assessment: Alpha-1 Antitrypsin Deficiency currently 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.
• 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. Alpha-1 Antitrypsin Deficiency Market Report Introduction
2. Executive Summary for Alpha-1 Antitrypsin Deficiency
3. SWOT analysis of Alpha-1 Antitrypsin Deficiency
4. Alpha-1 Antitrypsin Deficiency Patient Share (%) Overview at a Glance
5. Alpha-1 Antitrypsin Deficiency Market Overview at a Glance
6. Alpha-1 Antitrypsin Deficiency Disease Background and Overview
7. Alpha-1 Antitrypsin Deficiency Epidemiology and Patient Population
8. Country-Specific Patient Population of Alpha-1 Antitrypsin Deficiency
9. Alpha-1 Antitrypsin Deficiency Current Treatment and Medical Practices
10. Alpha-1 Antitrypsin Deficiency Unmet Needs
11. Alpha-1 Antitrypsin Deficiency Emerging Therapies
12. Alpha-1 Antitrypsin Deficiency Market Outlook
13. Country-Wise Alpha-1 Antitrypsin Deficiency Market Analysis (2020-2034)
14. Alpha-1 Antitrypsin Deficiency Market Access and Reimbursement of Therapies
15. Alpha-1 Antitrypsin Deficiency Market Drivers
16. Alpha-1 Antitrypsin Deficiency Market Barriers
17. Alpha-1 Antitrypsin Deficiency Appendix
18. Alpha-1 Antitrypsin Deficiency Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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