Alpha-1 Antitrypsin Deficiency Market Outlook 2025-2035:
The 7 major Alpha-1 Antitrypsin Deficiency markets reached a value of USD 1.5 Million in 2024. Looking forward, IMARC Group expects the 7MM to reach USD 4.4 Million by 2035, exhibiting a growth rate (CAGR) of 10.05% during 2025-2035. The increased knowledge and capability for diagnosis improved the growth of the Alpha-1 Antitrypsin Deficiency (AATD) market. Treatment advancements, such as augmentation therapy and gene-based approaches, are supporting the growing market demand. Government initiatives and advocacy programs are now enhancing AAT early detection and access to care. Moreover, the increasing incidence of respiratory disorders like COPD associated with AATD further fuels market growth. The encouragement of research and development (R&D) activities results in the availability of new treatment options, sustaining market growth in the future.
Increasing Awareness and Diagnosis Rates: Driving the Alpha-1 Antitrypsin Deficiency Market
Alpha-1 Antitrypsin Deficiency (AATD) market is driven mainly by increasing awareness and diagnosis rates. Various education initiatives organized by healthcare organizations and patient advocacy groups are enhancing disease recognition among healthcare professionals. Improvement in diagnostic techniques, including genetic testing and biomarker development, provides avenues for earlier and more accurate detection. Governments and the private sector carry out campaigns promoting the value of screening, particularly in patients suffering from chronic obstructive pulmonary disease (COPD) and liver disease. Newborn screening programs are being increasingly adopted in some regions, contributing to early diagnosis. Pharmaceutical companies are joining hands with healthcare providers, which is increasing awareness and enabling timely intervention. As more patients are diagnosed with confirmed AATD, the demand for augmentation therapy, gene therapy, and other treatment modalities continues to expand. Telemedicine and digital health platforms have been a strong support for disease education and outreach programs. With advancing diagnostic powers and targeted therapies, this market will continue to expand in the future.
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Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion
The developments in innovative therapies, as well as pharmacological treatments, are the major growth drivers of the AATD market. Companies are focusing on newer advanced biologics like recombinant AAT protein therapies and gene-based therapies for more effective and enduring solutions. Innovations in inhalable AAT formulations and small molecule drugs to target liver as well as lung damage are emerging. The rise of RNA-based therapies and CRISPR gene-editing approaches shows the way toward addressing the genetic root of AATD. More clinical trials for these new therapies, enzyme replacement, and anti-inflammatory agents will create an additional treatment possibility. Fast-track designation and regulatory approvals speed up the timelines for drug development. Increased investments in research and development (R&D), as well as strategic collaborations of biotech firms and research institutions, foster innovation. Increasing awareness paired with new and improved diagnostics promotes early detection, which will lead to higher adoption of treatment. Personalized medicine approaches refine treatment strategies according to individual genetic profiles. An enlarging reimbursement landscape, along with favorable policies in healthcare, is further contributing to market growth.
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Marketed Therapies in Alpha-1 Antitrypsin Deficiency Market
Aralast (Alpha-1 antitrypsin): Takeda
Aralast NP, I ana FDA-approved human-derived Alpha₁-Proteinase Inhibitor that could be used in chronic augmentation therapy in adults with emphysema mostly from severe congenital Alpha₁-antitrypsin deficiency. It works by raising the levels of serum and lungs Alpha₁ Proteinase Inhibitor to help slow down the progression of the disease.
Respreeza (Alpha-1 antitrypsin): CSL Behring
Respreeza is a human alpha₁-proteinase inhibitor approved for maintenance therapy in order to slow down emphysema progression in adults suffering from severe deficiency of alpha₁-proteinase inhibitor. It increases the blood and lung levels of alpha₁-proteinase inhibitor, thereby protecting the lung tissue from damage.
Prolastin C Liquid (Alpha 1 antitrypsin modified process): Grifols
Prolastin C Liquid is a human-derived and FDA-approved Alpha₁-Proteinase Inhibitor for chronic augmentation and maintenance therapy in adults with emphysema due to severe hereditary Alpha₁-antitrypsin deficiency. This ready-to-use formulation is designed to restore Alpha Proteinase Inhibitor levels effectively.
Emerging Therapies in Alpha-1 Antitrypsin Deficiency Market
INBRX 101: Inhibrx/Sanofi
INBRX-101 is a recombinant human Alpha-1 Antitrypsin-Fc fusion protein designed for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). This bioengineered molecule is said to survive longer in circulation than the normal AAT in the body, thereby having fewer opportunities for dosing. The product received a Fast Track designation from the FDA and is currently undergoing clinical trials for safety and efficacy.
WVE-006: Wave Life Sciences
WVE-006 is the first-in-class, GalNAc-conjugated RNA editing oligonucleotide created by Wave Life Sciences for alpha-1 antitrypsin deficiency (AATD) treatment. It modifies the SERPINA1 Z allele mRNA through a single nucleotide substitution to restore the functional wild-type levels of alpha-1 antitrypsin (M-AAT) protein and reduce levels of dysfunctional Z-AAT protein.
Drug Name | Company Name | MOA | ROA |
INBRX 101 | Inhibrx/Sanofi | Alpha 1-antitrypsin replacements | Intravenous |
WVE-006 | Wave Life Sciences | Alpha 1-antitrypsin modulators; RNA modulators | Subcutaneous |
Detailed list of emerging therapies in Alpha-1 Antitrypsin Deficiency is provided in the final report…
Leading Companies in the Alpha-1 Antitrypsin Deficiency Market:
The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global Alpha-1 Antitrypsin Deficiency market, several leading companies are at the forefront of developing integrated platforms to enhance the management of Alpha-1 Antitrypsin Deficiency. Some of the major players include Grifols, Arrowhead Pharmaceuticals, Takeda Pharmaceuticals USA, Sanofi, and others. These companies are driving innovation in the Alpha-1 Antitrypsin Deficiency market through continuous research, diagnostic tools, and expanding their product offerings to meet the growing demand for Alpha-1 Antitrypsin Deficiency.
Key Players in Alpha-1 Antitrypsin Deficiency Market:
The key players in the Alpha-1 Antitrypsin Deficiency market who are in different phases of developing different therapies are Grifols, Vertex Pharmaceuticals, Kamada, Inhibrx, Sanofi, CSL Behring, Arrowhead Pharmaceuticals, Takeda Pharmaceuticals USA, Dicerna Pharmaceuticals, Wave Life Sciences, and others.
Regional Analysis:
The major markets for Alpha-1 Antitrypsin Deficiency include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for Alpha-1 Antitrypsin Deficiency while also representing the biggest market for its treatment. Alpha-1 Antitrypsin Deficiency (AATD) research has made strides in recent years, with gene therapy touted as a potential treatment option, particularly gene repair technologies like CRISPR and adeno-associated virus vectors. Further studies on AAT have centered not only on replacement therapies but also on treatments for many inflammatory and immune-mediated diseases. Vitamin D also serves an immunomodulatory role by upregulating the expression of alpha-1 antitrypsin in human T cells.
Recent Developments in Alpha-1 Antitrypsin Deficiency Market:
· In February 2025, Grifols announced the completion of participant recruitment for the second cohort of its Phase 1/2 study (NCT04722887). This study is focused on evaluating the safety and tolerability of one of two different dose levels of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% (Alpha-1 15%) as an SC treatment option for AAT deficiency. It also compares SC injection to IV infusion of Liquid Alpha1-Proteinase Inhibitor (Human).
· In October 2024, Wave Life Sciences reported positive proof-of-mechanism results from the ongoing Phase 1b/2a RestorAATion-2 study evaluating WVE-006 for alpha-1 antitrypsin deficiency (AATD). WVE-006 is a GalNAc-conjugated, subcutaneously administered A-to-I RNA editing oligonucleotide (AIMer), developed using Wave’s advanced oligonucleotide chemistry platform.
· In May 2024, Sanofi completed its acquisition of Inhibrx, Inc., adding SAR447537 (formerly INBRX-101) to its rare disease pipeline. SAR447537 is a human-recombinant protein promising safety by normalizing serum AAT levels in patients with alpha-1 antitrypsin deficiency, but with less frequent dosing monthly instead of weekly, reinforcing Sanofi’s capture of innovating treatments.
Key information covered in the report.
Base Year: 2024
Historical Period: 2019-2024
Market Forecast: 2025-2035
Countries Covered
- United States
- Germany
- France
- United Kingdom
- Italy
- Spain
- Japan
Analysis Covered Across Each Country
- Historical, current, and future epidemiology scenario
- Historical, current, and future performance of the Alpha-1 Antitrypsin Deficiency market
- Historical, current, and future performance of various therapeutic categories in the market
- Sales of various drugs across the Alpha-1 Antitrypsin Deficiency market
- Reimbursement scenario in the market
- In-market and pipeline drugs
Competitive Landscape:
This report offers a comprehensive analysis of current Alpha-1 Antitrypsin Deficiency marketed drugs and late-stage pipeline drugs.
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In-Market Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
Late-Stage Pipeline Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
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