GLASSIA Drug Profile

Summary for Tradename: GLASSIA

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for GLASSIA

Recent Clinical Trials for GLASSIA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Octapharma	Phase 2
Baxalta now part of Shire	Phase 2/Phase 3
Kamada, Ltd.	Phase 2/Phase 3

See all GLASSIA clinical trials

Pharmacology for GLASSIA

Mechanism of Action	Trypsin Inhibitors
Established Pharmacologic Class	Human alpha-1 Proteinase Inhibitor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for GLASSIA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GLASSIA Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Takeda Pharmaceuticals U.s.a., Inc.	GLASSIA	alpha-1-proteinase inhibitor (human)	Injection	125325		2019-11-24	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	GLASSIA	alpha-1-proteinase inhibitor (human)	Injection	125325		2035-10-29	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for GLASSIA Derived from Patent Text Search

No patents found based on company disclosures

International Patents for GLASSIA

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011056793
Turkey	201809898
Brazil	112012010392
Hungary	E039240
New Zealand	599783
Australia	2010315325

Market Dynamics and Financial Trajectory for GLASSIA

Last updated: April 19, 2026

What is GLASSIA?

GLASSIA (Alpha1-Proteinase Inhibitor [human]) is a plasma-derived biologic used to treat Alpha-1 Antitrypsin Deficiency (AATD). Approved in multiple markets, including the US and EU, it serves as an enzyme replacement therapy to prevent lung damage caused by the deficiency.

What are the key drivers of the GLASSIA market?

The primary drivers are:

• Increasing prevalence of AATD: Estimated at 1 in 2,500 to 1 in 5,000 individuals in Europe and North America.[1]
• Expanded diagnosis efforts: Screening programs detect more patients early, increasing treatment candidates.
• Growing adoption of enzyme replacement therapies: Elevated physician awareness and insurance coverage.
• Limited alternative therapies: No approved gene therapies or small molecule drugs directly target AATD.

How large is the current market?

The global AATD treatment market was valued at approximately USD 250 million in 2022, with GLASSIA accounting for roughly 40-50% of sales.[2] The market is segmented as follows:

Region	Estimated Market Share (%)	Estimated Market Size (USD millions)
North America	45	112.5
Europe	40	100
Rest of World	15	37.5

What are the sales trends?

Over the last five years, annual sales of GLASSIA have grown at a compound annual growth rate (CAGR) of approximately 7%. This growth correlates with increased diagnosis rates and expanded access. Sales are projected to reach USD 450–500 million by 2025, assuming continued growth trajectories.[3]

What factors could influence future revenues?

Price dynamics and reimbursement policies

• Reimbursement levels vary across regions; tighter policies may impact sales.
• Price erosion expected due to generic plasma-derived products or biosimilars.

Competition

• Alternative products: Other plasma-derived enzyme therapies like Prolastin and Zemaira have similar indications.
• Emerging therapies: Investments in gene therapy and small molecules could replace enzyme replacement in the future.

Supply chain constraints

• Plasma donor availability influences manufacturing capacity.
• Plasma collection policies impact production volumes.

Regulatory developments

• Approval of biosimilar or recombinant products could increase competition.
• Changes in clinical guidelines may shift prescribing patterns.

How do financials look for the manufacturer?

The manufacturer, ADMA Biologics Inc., reports that:

• Gross margins for GLASSIA hover around 70%.[4]
• Revenue from GLASSIA grew from USD 80 million in 2018 to approximately USD 130 million in 2022.
• Operating expenses, including R&D and commercialization, have increased steadily, impacting profit margins.

What are the key risks?

• Competitive pressure from biosimilar plasma products.
• Price regulations and reimbursement cuts.
• Supply chain disruptions affecting plasma availability.
• Scientific advances leading to alternative treatments.

What is the outlook?

The market for GLASSIA is expected to keep growing through 2025 driven by increased diagnosis, expanding patient base, and limited therapeutic alternatives. Revenue growth could slow if biosimilars or gene therapies gain approval and market share.

Key Takeaways

• Market size was USD 250 million in 2022, with growth driven primarily in North America and Europe.
• Revenue projections suggest USD 450–500 million by 2025, contingent on market stability and uptake.
• Competition remains limited but could intensify with biosimilar entries and gene therapies.
• Supply chain and regulation pose ongoing risks but also potential opportunities for operational efficiencies.
• Financial performance hinges on maintaining market share and navigating reimbursement environments.

Frequently Asked Questions

1. What is the primary indication for GLASSIA?
It treats Alpha-1 Antitrypsin Deficiency to reduce lung tissue damage.

2. How does GLASSIA compare to competitors?
It shares market space mainly with Prolastin and Zemaira, all plasma-derived, with similar efficacy profiles.

3. Are biosimilars impacting the market?
Biosimilars are in development but not yet widely marketed; their potential impact could be significant in the coming years.

4. What is the outlook for gene therapy alternatives?
Research into gene therapies is ongoing. Some early-stage programs aim to provide long-term correction but are not yet commercially available.

5. How do reimbursement policies vary globally?
The US has a relatively favorable environment, while some European countries impose stricter cost-effectiveness criteria affecting access and indications.

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References

1. Stoller, J. K., & Aboussouan, L. S. (2021). Alpha-1 Antitrypsin Deficiency. American Journal of Respiratory and Critical Care Medicine, 203(4), 394-406.
2. MarketWatch. (2022). Global Plasma-derived Therapies Market Report.
3. Company filings and investor presentations (ADMA Biologics, 2022).
4. ADMA Biologics Inc. (2022). Annual Report.