Last updated: January 12, 2025
Introduction to GLASSIA
GLASSIA, also known as Alpha1-Proteinase Inhibitor (Human), is a liquid preparation of purified alpha-1-proteinase inhibitor, or alpha-1-antitrypsin (AAT), derived from human plasma. It is indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of alpha-1-proteinase inhibitor[1].
Clinical Trials Update
Post-Marketing Requirements and Commitments
Following its approval in July 2010, the FDA required Takeda, the manufacturer of GLASSIA, to conduct post-marketing studies. These studies included a post-marketing requirement (PMR) to identify unexpected serious risks related to adverse events, particularly the presence of visible protein aggregates in the product. Additionally, viral nucleic acid testing (NAT) and testing for anti-Alpha1-PI antibodies were mandated[1].
Study 471101 Findings
The primary endpoint of Study 471101, a multicenter study involving 34 subjects with emphysema due to congenital A1PI deficiency, was to evaluate antigenic and functional Alpha1-PI levels in Epithelial Lining Fluid (ELF) after 10-12 weeks of GLASSIA therapy. The study found that GLASSIA augmentation therapy resulted in statistically significant increases in both antigenic and functional Alpha1-PI levels in ELF. Specifically, the median change in antigenic Alpha1-PI levels was 0.5 μM, with a geometric mean ratio of 5.4 (p < 0.001), and the median change in functional Alpha1-PI levels was 0.3 μM, with a geometric mean ratio of 2.3 (p < 0.001)[1].
Safety and Immunogenicity
The study also evaluated the safety and immunogenicity of GLASSIA. The most common serious adverse reaction observed during clinical trials was the exacerbation of chronic obstructive pulmonary disease (COPD). However, the study demonstrated that GLASSIA maintained mean trough antigenic Alpha1-PI levels greater than 11 µM in all treated subjects during Weeks 7–12, and mean steady-state functional PI levels above the 11 µM threshold in 66.7% of the subjects[4].
Mechanism of Action
GLASSIA works by increasing antigenic and functional levels of Alpha1-PI in both the serum and the lung epithelial lining fluid (ELF). This mechanism helps to protect the lungs from the destructive effects of neutrophil elastase, a key factor in the progression of emphysema in AAT-deficient patients[1].
Market Analysis
Global Alpha-1 Antitrypsin Deficiency Augmentation Therapy Market
The global alpha-1 antitrypsin deficiency (AATD) augmentation therapy market is projected to grow significantly. By 2032, the market is expected to reach USD 2,517 million, with a Compound Annual Growth Rate (CAGR) of 6.1% from 2023 to 2032. GLASSIA, along with Prolastin C, is one of the leading treatment options in this market, driving its growth due to its effectiveness in maintaining antigenic and functional Alpha1-PI levels[3].
Market Drivers
Key drivers of the AATD augmentation therapy market include the increasing prevalence of genetic disorders and respiratory diseases, advancements in diagnostic tools, and the effectiveness of current therapies. Hospitals are the primary end-users, driving demand due to the need for genetic and respiratory disorder treatments[3].
Market Restraints and Opportunities
While the market is growing, it faces restraints such as the fact that augmentation therapy is not a cure for AATD and the potential for vein damage from improper administration. However, opportunities exist in using AAT from healthy donors, raising awareness about the condition, and leveraging technological and governmental support to foster market growth[3].
Regional and Segment Analysis
Product Segmentation
The AATD augmentation therapy market is segmented by product, with GLASSIA, Prolastin C, Aralast NP, and Zemaira/Reespreza being the key products. Prolastin C currently commands the largest market share, but GLASSIA is also a significant player[3].
End-User Segmentation
Hospitals are the primary end-users, followed by specialty clinics and pharmacies. The demand from hospitals is driven by the need for comprehensive treatment of genetic and respiratory disorders[3].
Projections and Future Outlook
Market Growth Projections
The global AATD augmentation therapy market is expected to continue growing, driven by the increasing prevalence of genetic and respiratory diseases, advancements in diagnostic and therapeutic technologies, and growing awareness about AATD. By 2032, the market is projected to reach USD 2,517 million, indicating a robust growth trajectory[3].
Technological Advancements
Technological advancements, including new diagnostic tools and potential new treatments in clinical trials, are expected to further drive the market. Over 80 AATD molecules are currently in clinical trials, which could lead to innovative treatments and enhance market dynamics[3].
Key Takeaways
- Clinical Trials: GLASSIA has demonstrated significant increases in antigenic and functional Alpha1-PI levels in ELF, ensuring its efficacy in treating emphysema due to AAT deficiency.
- Market Growth: The global AATD augmentation therapy market is projected to reach USD 2,517 million by 2032, with a CAGR of 6.1%.
- Market Drivers: Increasing prevalence of genetic and respiratory diseases, diagnostic advancements, and therapy effectiveness are key drivers.
- Product Dominance: GLASSIA and Prolastin C are leading treatment options, with hospitals being the primary end-users.
- Future Outlook: Technological advancements and growing awareness about AATD are expected to continue driving market growth.
FAQs
What is GLASSIA used for?
GLASSIA is used for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of alpha-1-proteinase inhibitor (AAT)[1].
What were the key findings of Study 471101?
Study 471101 found statistically significant increases in both antigenic and functional Alpha1-PI levels in ELF after GLASSIA therapy, ensuring its efficacy in treating emphysema due to AAT deficiency[1].
What is the projected market size of the AATD augmentation therapy market by 2032?
The global AATD augmentation therapy market is expected to reach USD 2,517 million by 2032, with a CAGR of 6.1% from 2023 to 2032[3].
What are the primary end-users of AATD augmentation therapy?
Hospitals are the primary end-users, followed by specialty clinics and pharmacies, driven by the need for comprehensive treatment of genetic and respiratory disorders[3].
What are the key drivers of the AATD augmentation therapy market?
Key drivers include the increasing prevalence of genetic disorders and respiratory diseases, advancements in diagnostic tools, and the effectiveness of current therapies[3].
Sources
- FDA Clinical Memo - GLASSIA: Updated to include immunogenicity data from Study 471101 and findings from Epithelial Lining Fluid sub-study[1].
- Glass Manufacturing Market Size, Share and Trends 2025 to 2034: Global glass manufacturing market projections and trends[2].
- Alpha-1 Antitrypsin Deficiency Augmentation Therapy Market Size: Global market size, growth rate, and segment analysis for AATD augmentation therapy[3].
- Augmentation Therapy for Alpha-1 Antitrypsin with Emphysema: Clinical trial details and safety profile of GLASSIA[4].
