Alpha 1-Antitrypsin Deficiency Treatment Market - Forecast(2024 - 2030)

Report Code: HCR 0640 Report Format: PDF + Excel

Alpha 1-Antitrypsin Deficiency Treatment Market Overview

Alpha 1-Antitrypsin Deficiency Treatment Market size is estimated to reach $2.6 billion by 2027, growing at a CAGR of 9.4% during the forecast period 2022-2027. Alpha-1 antitrypsin deficiency is a genetic ailment that it is passed down to the patient from his/her Parents. It can bring about severe lung or liver ailments. It may also be termed AAT deficiency. Symptoms frequently involve trouble breathing and jaundice, or yellow, skin. Alpha-1 antitrypsin (AAT) is the prototypical protease inhibitor from the serine protease inhibitor (serpin) superfamily that safeguards lung tissue from proteolytic injury by inhibiting neutrophil elastase. Nearly 1 in 2750 to 1 in 4500 individuals have an autosomal codominant condition that results in a deficiency of circulating AAT. In individuals with AAT deficiency (AATD), AAT is maintained in liver cells, which leads them to liver ailment, and does not arrive at lung tissues by way of circulation, where it usually serves as the primary natural regulator of proteolytic activity in the pulmonary tissues, which thus results in lung ailment. Intravenous infusion of AAT, also termed augmentation therapy, is the only particular treatment accessible for AAT deficiency. Augmentation therapy has been shown to increase levels of alpha1 antitrypsin in the blood and lungs above the threshold required to safeguard lung tissue. Investigations involving inhaled corticosteroids as added treatment in alpha-1-antitrypsin-deficiency-related COPD (Chronic Obstructive Pulmonary Disorder) have been conducted. It has been concluded that in AATD-related COPD patients (ZZ genotype) the inclusion of extra-fine ICS to LABAs reduces airway narrowing, mostly in the small airways, further decreasing dynamic hyperinflation with a marked enhancement in exercise tolerance and dyspnea, recommending that a peripheral inflammatory process contributes to airflow obstruction in these patients.

The burgeoning product pipeline for Alpha 1-Antitrypsin Deficiency is set to drive the Alpha 1-Antitrypsin Deficiency Treatment Market. The increasing awareness regarding Alpha 1-Antitrypsin Deficiency including treatment termed augmentation therapy is set to propel the growth of the Alpha 1-Antitrypsin Deficiency Treatment Market during the forecast period 2022-2027. This represents the Alpha 1-Antitrypsin Deficiency Treatment Industry Outlook.

Report Coverage

The report: Alpha 1-Antitrypsin Deficiency Treatment Market Forecast (2022-2027)”, by Industry ARC, covers an in-depth analysis of the following segments of the Alpha 1-Antitrypsin Deficiency Treatment Market.

By Type Of Treatment: Augmentation Therapy, Bronchodilators, Corticosteroids, Oxygen Therapy, Alpha-1 Proteinase Inhibitor.
By End User: Hospitals, Specialty Clinics, Pharmacies, Others.
By Geography: North America (U.S, Canada and Mexico), Europe (Germany, France, UK, Italy, Spain, Russia and Rest of Europe), Asia-Pacific (China, Japan, South Korea, India, Australia & New Zealand, and Rest of Asia-Pacific), South America (Brazil, Argentina, Chile, Colombia, Rest of South America), and Rest Of The World (Middle East, Africa).

Key Takeaways

  • Geographically, North America Alpha 1-Antitrypsin Deficiency Treatment Market is accounted for the highest revenue share in 2021. The market is also poised to dominate the market over the period 2022-2027 owing to the increasing predominance of respiratory ailments and improved rate of diagnostics for Alpha 1-Antitrypsin Deficiency with treatment termed augmentation therapy in the North American region.
  • Alpha 1-Antitrypsin Deficiency Treatment Market growth is being driven by the increasing predominance of Alpha 1-Antitrypsin Deficiency and the effective distribution network of leading manufacturers of augmentation therapy medications. However, the soaring cost and the reduced diagnostic rate for the ailment are some of the major factors hampering the growth of the Alpha 1-Antitrypsin Deficiency Treatment Market. 
  • Alpha 1-Antitrypsin Deficiency Treatment Market Detailed Analysis on the Strength, Weakness, and Opportunities of the prominent players operating in the market will be provided in the Alpha 1-Antitrypsin Deficiency Treatment Market report. 

Alpha 1-Antitrypsin Deficiency Treatment Market: Market Share (%) By Region, 2021

Alpha 1-Antitrypsin Deficiency Treatment Market

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Alpha 1-Antitrypsin Deficiency Treatment Market Segment Analysis – By Type Of Treatment:

The Alpha 1-Antitrypsin Deficiency Treatment Market based on the type of treatment can be further segmented into Augmentation Therapy, Bronchodilators, Corticosteroids, Oxygen Therapy, and Alpha-1 Proteinase Inhibitor. The Augmentation Therapy Segment held the largest market share in 2021. This growth is owing to the surging application of augmentation therapy for the treatment of Alpha 1-Antitrypsin Deficiency. Augmentation therapy is also termed replacement therapy. The application of augmentation therapy increases the level of a protein that usually safeguards the lungs from damage which is further propelling the growth of the Augmentation Therapy segment.

Furthermore, the Augmentation Therapy segment is estimated to grow with the fastest CAGR of 10.4% during the forecast period 2022-2027 owing to certain investigations indicating that augmentation therapy can decrease further lung damage and assist people with Alpha 1-Antitrypsin Deficiency to live longer.

Alpha 1-Antitrypsin Deficiency Treatment Market Segment Analysis – By End User:

The Alpha 1-Antitrypsin Deficiency Treatment Market based on end user can be further segmented into Hospitals, Specialty Clinics, Pharmacies, and Others. The Hospitals segment held the largest market share in 2021. This growth is owing to the surging application of augmentation therapy in hospitals for cases of Alpha 1-Antitrypsin Deficiency. The treatment takes around an hour and the patient needs to take it every week. The presence of progressive infrastructure and skilled physicians in hospitals is further propelling the growth of this segment.

Furthermore, the Specialty Clinics segment is estimated to grow with the fastest CAGR of 10.9% during the forecast period 2022-2027 owing to the extensive application of augmentation therapy with uncommon side effects which are normally mild, for the treatment of Alpha 1-Antitrypsin Deficiency in specialty clinics equipped with advanced infrastructure and qualified physicians.

Alpha 1-Antitrypsin Deficiency Treatment Market Segment Analysis – By Geography:

The Alpha 1-Antitrypsin Deficiency Treatment Market based on geography can be further segmented into North America, Europe, Asia-Pacific, South America and Rest of the World. North America (Alpha 1-Antitrypsin Deficiency Treatment Market) held the largest share with 35% of the overall market in 2021. The growth of this region is owing to the surging financing by the key players targeted at furthering the R&D activities in the North American region. Augmentation therapy is typically recommended for the treatment of Alpha 1-Antitrypsin Deficiency. The improved rate of diagnostics for Alpha 1-Antitrypsin Deficiency and the increasing predominance of respiratory ailments in the North American region.

Furthermore, the Europe region is estimated to be the region with the fastest CAGR over the forecast period 2022-2027. This growth is owing to factors like the heightening R&D activities for various respiratory ailments in the European region. The proliferating demand owing to increased awareness among the consumers regarding Alpha 1-Antitrypsin Deficiency Treatment and the expanding population of the elderly or geriatric population which is more susceptible to different types of respiratory ailments are further fuelling the progress of the Alpha 1-Antitrypsin Deficiency Treatment Market in the European region.

Alpha 1-Antitrypsin Deficiency Treatment Market Drivers

Surging Recognition Of Augmentation Therapy Is Projected To Drive The Growth Of Alpha 1-Antitrypsin Deficiency Treatment Market:

Alpha-1 antitrypsin deficiency (AATD) is an under-recognized genetic condition that influences nearly 1 in 2000 to 1 in 5000 individuals and predisposes to early-onset emphysema and liver disease. The intravenous administration of purified AAT to AAT-deficient individuals has been demonstrated to confer biochemical efficiency by increasing the serum AAT level above an epidemiologically established 'protective threshold' while preserving the biochemical characteristics and functional capacity of the protease inhibitor. Though the dearth of a big randomized controlled trial to date has precluded the definitive demonstration of clinical efficacy of intravenous AAT augmentation therapy, substantial evidence backing its application in AAT-deficient individuals with moderate airflow obstruction has gathered. For example, both large observational investigations comparing rates of forced expiratory volume decrease amidst recipients of augmentation therapy versus non-recipients have demonstrated slower rates of decline amidst augmentation therapy recipients, specifically those with moderately serious airflow obstruction. Furthermore, certain evidence recommends that the application of augmentation therapy confers an anti-inflammatory effect. For example, a web-based survey recommended that recipients of augmentation therapy experienced fewer respiratory infections than non-recipients. In spite of its soaring cost, intravenous AAT augmentation therapy remains the only U.S. FDA-approved treatment alternative for patients with AAT deficiency. The surging recognition of augmentation therapy is therefore fuelling the growth of the Alpha 1-Antitrypsin Deficiency Treatment Market during the forecast period 2022-2027.

Proliferating Application Of Aralast For Treatment Of Alpha-Antitrypsin Deficiency Is Expected To Boost The Growth Of The Alpha 1-Antitrypsin Deficiency Treatment Market:

Alpha-antitrypsin (AAT) is a serine protease inhibitor, which inhibits the proteolytic enzyme elastase. Individuals with a deficiency of AAT may establish clinical manifestations that involve a decrease in lung function. Deficiency of AAT can result in numerous clinical manifestations, most typically chronic obstructive pulmonary disease in the form of emphysema. However, patients with this genetic ailment may also establish dysfunctions of additional organs like the liver and/or skin. There are nearly 100 alleles related to the gene encoding for AAT, where the estimated prevalence of this disorder is nearly as common as cystic fibrosis; however, misdiagnosis continues to be an issue. Augmentation therapy utilizing intravenous AAT has been demonstrated to decrease the forced expiratory volume in one-second decline, related to AAT deficiency. Restoration of serum AAT concentrations above 11 microM has correlated with a decreased level of ailment progression. The normal dosing regimen of intravenous AAT is 60 mg/kg given every week. Although a dosage consolidation of 250 mg/kg given every 28 days has been explored, long-term efficacy has not been determined. Aralast is one of three certified human plasma-derived treatment alternatives utilized to avert the progression of emphysema related to AAT deficiency ailment. The proliferating application of aralast for the treatment of alpha-antitrypsin deficiency is therefore driving the growth of the Alpha 1-Antitrypsin Deficiency Treatment Market during the forecast period 2022-2027.

Alpha 1-Antitrypsin Deficiency Treatment Market Challenges

Challenge Of Detecting Alpha-1 Antitrypsin Deficiency Is Hampering The Growth Of The Alpha 1-Antitrypsin Deficiency Treatment Market:

Alpha-1 antitrypsin deficiency (AATD) is relatively typical but under-recognized. Indeed, lesser than 10% of the supposed 100,000 Americans with AATD have been diagnosed currently, with typical reports of long delays between initial symptoms and first detection and the requirement to observe numerous physicians prior to diagnosis. Because detection can confer advantages (for example, recognition of at-risk family members, lower smoking likelihood, consideration of augmentation therapy), targeted detection of AATD in at-risk groups like all symptomatic adults with COPD has been signed. Two accepted approaches to detection have been examined: population-based screening (in which testing is carried out in a group for whom no increased hazard of having AATD exists) and targeted detection or case-finding (in which testing is confined to those with an attributable condition such as COPD or chronic liver disease). Investigations to date have recommended that population-based screening is not cost-effective, whereas targeted detection of AATD has been advocated by official society guidelines. Endeavors to improve the detection of AATD individuals have involved different approaches, inclusive of educational campaigns, provision of free test kits, issuance of reminders with medical reports or within an electronic medical record, and empowering respiratory therapists to conduct testing for AATD in pulmonary function laboratories. These kinds of programs have recognized individuals with a serious deficiency of alpha-1 antitrypsin in up to 12% of subjects, with considerable variation across series by testing criteria. Overall, the persistence of under-recognition of AATD underscores the requirement for continued endeavors to optimize the detection of this potentially debilitating genetic ailment. These issues are thus hampering the growth of the Alpha 1-Antitrypsin Deficiency Treatment Market.

Alpha 1-Antitrypsin Deficiency Treatment Industry Outlook:

Collaborative agreements, mergers and acquisitions, product launches, joint ventures and geographical expansions are key strategies adopted by players in the Alpha 1-Antitrypsin Deficiency Treatment Market. Key companies of this market are:

  1. Pfizer Inc.
  2. Baxter International Inc.
  3. AstraZeneca Plc.
  4. Grifols S.A.
  5. Teva Pharmaceutical Industries
  6. Boehringer Ingelheim
  7. Kamada Ltd.
  8. Shire plc.
  9. Glaxosmithkline Pharmaceuticals Limited
  10. CSL Behring

Recent Developments

  • In November 2021, Grifols declared a novel home infusion treatment service for patients with alpha-1 antitrypsin deficiency (AATD) in Spain. This novel service targets to boost treatment access and the comfort of its administration within Grifols’ AlfaCare program. It provides a combined, personalized program inclusive of training, emotional support, and assistance to AATD patients by way of specialized professionals.
  • In July 2021, Grifols and OrphanPacific, Inc., declared the commencement of the commercialization of Lynspad™ (intravenous infusion 1000mg), an alpha-1 proteinase inhibitor to treat serious alpha-1 antitrypsin deficiency (AATD) in the country. Japan’s Ministry of Health, Labour and Welfare (MHLW) authorized manufacturing and marketing endorsement on January 22, 2021. Grifols developed Lynspad™ (marketed as Prolastin-C® in other markets) and designated OrphanPacific as the Appointed Marketing Authorization Holder (AMAH) to acquire manufacturing and marketing authorization for the AATD treatment in Japan under the Foreign Exceptional Approval System, an approach for a firm aiming to commercialize an overseas-manufactured product in Japan without a license to manufacture and distribute pharmaceutical products in the country.
  • In April 2021, Kamada Ltd. declared an amendment to the GLASSIA® [Alpha1-Proteinase Inhibitor (Human)] license agreement with Takeda. Compatible with the amendment, upon finishing of the transition of GLASSIA manufacturing to Takeda, anticipated by the end of 2021, Kamada will transfer to Takeda the GLASSIA U.S. Biologics License Application (BLA). In consideration for the BLA transfer, Kamada will accept a $2 million payment from Takeda.

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1. Alpha 1-Antitrypsin Deficiency Treatment Market Overview
    1.1 Definitions and Scope
2. Alpha 1-Antitrypsin Deficiency Treatment Market - Executive Summary
3. Alpha 1-Antitrypsin Deficiency Treatment Market – Market Landscape
    3.1 Company Benchmarking - Key Companies
    3.2 Financial Analysis - Key Companies
    3.3 Market Share Analysis - Key Companies
    3.4 Patent Analysis
    3.5 Pricing Analysis (Comparison of General Price Offerings in the Market)
4. Alpha 1-Antitrypsin Deficiency Treatment Market – Startup Company Scenario (Premium)
    4.1 Investment
    4.2 Revenue
    4.3 Venture Capital and Funding Scenario
5. Alpha 1-Antitrypsin Deficiency Treatment Market – Industry Market Entry Scenario Premium (Premium)
    5.1 Regulatory Scenario
    5.2 New Business and Ease of Doing business index
    5.3 Case Studies of Successful Ventures
6. Alpha 1-Antitrypsin Deficiency Treatment Market - Market Forces
    6.1 Market Drivers
    6.2 Market Constraints
    6.3 Porters five force model
        6.3.1 Bargaining power of suppliers
        6.3.2 Bargaining powers of customers
        6.3.3 Threat of new entrants
        6.3.4 Rivalry among existing players
        6.3.5 Threat of substitutes
7. Alpha 1-Antitrypsin Deficiency Treatment Market – By Strategic Analysis
    7.1 Value Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle Analysis
8. Alpha 1-Antitrypsin Deficiency Treatment Market – By Type Of Treatment (Market Size –$Million/$Billion) 
    8.1 Augmentation Therapy
    8.2 Bronchodilators
    8.3 Corticosteroids
    8.4 Oxygen Therapy
    8.5 Alpha-1 Proteinase Inhibitor
9. Alpha 1-Antitrypsin Deficiency Treatment Market – By End User (Market Size –$Million/$Billion) 
    9.1 Hospitals
    9.2 Specialty Clinics
    9.3 Pharmacies
    9.4 Others
10. Alpha 1-Antitrypsin Deficiency Treatment Market - By Geography (Market Size -$Million/Billion)
    10.1 North America
        10.1.1 U.S
        10.1.2 Canada
        10.1.3 Mexico
    10.2 Europe
        10.2.1 Germany
        10.2.2 France
        10.2.3 UK
        10.2.4 Italy
        10.2.5 Spain
        10.2.6 Russia
        10.2.7 Rest of Europe
    10.3  Asia-Pacific
        10.3.1 China
        10.3.2 Japan
        10.3.3 South Korea
        10.3.4 India
        10.3.5 Australia & New Zealand
        10.3.6 Rest of Asia-Pacific
    10.4 South America
        10.4.1 Brazil
        10.4.2 Argentina
        10.4.3 Chile
        10.4.4 Colombia
        10.4.5 Rest of South America
    10.5 Rest Of The World
        10.5.1 Middle East
        10.5.2 Africa
11. Alpha 1-Antitrypsin Deficiency Treatment Market - Market Entropy
    11.1 New product launches
    11.2 M&A's, collaborations, JVs and partnerships
12. Alpha 1-Antitrypsin Deficiency Treatment Market – Industry Competition Landscape (Premium)
    12.1  Market Share Analysis
        12.1.1 Global Market Share – Key Companies
        12.1.2 Market Share by Region – Key Companies
        12.1.3 Market Share by Countries – Key Companies
    12.2  Competition Matrix
    12.3  Best Practices for Companies
13. Alpha 1-Antitrypsin Deficiency Treatment Market – Key Company List by Country Premium (Premium)
14. Alpha 1-Antitrypsin Deficiency Treatment Market - Company Analysis
    14.1  Company 1
    14.2  Company 2
    14.3  Company 3
    14.4  Company 4
    14.5  Company 5
    14.6  Company 6
    14.7  Company 7
    14.8  Company 8
    14.9  Company 9
    14.10 Company 10
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