Alpha-1-proteinase inhibitor (human) - Biologic Drug Details

Summary for alpha-1-proteinase inhibitor (human)

Tradenames:	4
High Confidence Patents:	0
Applicants:	3
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for alpha-1-proteinase inhibitor (human)

Recent Clinical Trials for alpha-1-proteinase inhibitor (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Inhibrx, Inc.	Phase 2
Ain Shams University	PHASE3
University of Dundee	Phase 4

See all alpha-1-proteinase inhibitor (human) clinical trials

Pharmacology for alpha-1-proteinase inhibitor (human)

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 brand-side disclosures

These patents were identified from searching 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 alpha-1-proteinase inhibitor (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for alpha-1-proteinase inhibitor (human) 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.	ARALAST, ARALAST NP	alpha-1-proteinase inhibitor (human)	For Injection	125039	10,123,985	2036-06-08	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ARALAST, ARALAST NP	alpha-1-proteinase inhibitor (human)	For Injection	125039	10,258,661	2036-09-23	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ARALAST, ARALAST NP	alpha-1-proteinase inhibitor (human)	For Injection	125039	10,512,683	2037-03-03	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ARALAST, ARALAST NP	alpha-1-proteinase inhibitor (human)	For Injection	125039	10,842,861	2037-05-23	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ARALAST, ARALAST NP	alpha-1-proteinase inhibitor (human)	For Injection	125039	10,925,920	2038-02-05	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for alpha-1-proteinase inhibitor (human) Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

International Patents for alpha-1-proteinase inhibitor (human)

Country	Patent Number	Estimated Expiration
Japan	2014237653
European Patent Office	1523323
Hong Kong	1219045
Australia	2013306767
Israel	219485

Supplementary Protection Certificates for alpha-1-proteinase inhibitor (human)

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2017 00063	Denmark		PRODUCT NAME: ISOLERET ANTISTOF ELLER FRAGMENT DERAF OMFATTENDE LET KAEDE OG TUNG KAEDE CDR-SEKVENSER IFOELGE EP-B1-2076541 KRAV 1 (SEQ ID NO: 224, 225, 226 OG 146, 147, 148).....; REG. NO/DATE: EU/1/16/1155/001-002 20170719
132018000000041	Italy		PRODUCT NAME: BRODALUMAB(KYNTHEUM); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1155/001-002, 20170719
2018C/005	Belgium		PRODUCT NAME: KYNTHEUM; AUTHORISATION NUMBER AND DATE: EU/1/16/1155/001-002 20170717
2018/003	Ireland		PRODUCT NAME: BRODALUMAB; REGISTRATION NO/DATE: EU/1/16/1155/001-002 20170717
122017000126	Germany		PRODUCT NAME: EIN ISOLIERTER ANTIKOERPER ODER EIN FRAGMENT DAVON, UMFASSEND CDR-SEQUENZEN DER LEICHTEN KETTE UND DER SCHWEREN KETTE NACH EP-B1-2076541 ANSPRUCH 1 (SEQ ID NOS: 224, 225, 226 UND 146, 147, 148), WOBEI DER ANTIKOERPER ODER DAS FRAGMENT DAVON HUMANEN IL-17 REZEPTOR A BINDET; INSBESONDERE EIN ANTIKOERPER, UMFASSEND DIE SEQUENZEN DER VARIABLEN REGION DER LEICHTEN UND SCHWEREN KETTE NACH EP-B1-2076541 ANS; REGISTRATION NO/DATE: EU/1/6/1155/001-002 20170717

Market Dynamics and Financial Trajectory for Alpha-1-Proteinase Inhibitor (Human)

Last updated: March 7, 2026

What is the current market size and growth rate for alpha-1-proteinase inhibitor (human)?

The global market for alpha-1-proteinase inhibitor (A1PI), primarily used to treat alpha-1 antitrypsin deficiency (AATD), was valued at approximately $1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030, reaching roughly $1.9 billion by the end of the period (MarketWatch, 2023). Growth is driven by increasing diagnosis rates, expanding treatment adoption, and treatment of off-label indications.

What are the key factors influencing demand for alpha-1-proteinase inhibitor?

• Increasing Diagnosis of AATD: Current estimates indicate that only 10-15% of AATD cases are diagnosed globally. Rising awareness and improved screening are expected to boost the diagnosed prevalence, which is a primary driver for demand.

• Treatment Efficacy and Approval: As the only FDA-approved therapy for AATD in the form of intravenous infusion, demand hinges on continued regulatory approvals and published clinical evidence supporting efficacy.

• Market Penetration in Emerging Markets: Limited access and awareness restrict growth in developing countries. Growth depends on local drug approval and healthcare infrastructure development.

• Off-label Use: Emerging evidence suggests potential off-label applications in conditions involving protease imbalance, possibly expanding the market beyond traditional AATD.

How does competitive positioning shape the market landscape?

The market is concentrated among four primary suppliers:

Manufacturer	Market Share (2022)	Key Products	Notes
CSL Behring	75%	Zemaira, Glassia	Dominates due to early approval and robust supply chain
Grifols	15%	Prolastin-C, Privigen	Focuses on expanding formulations and regional presence
Kamada	5%	Kamada-1, IgA-deficient plasma-derived	Smaller share but growing through niche indications
Others	5%	Multiple regional products	Include biosimilar entrants, with potential for market shifts

The entry of biosimilars could disrupt market shares post-patent expirations, which are currently anticipated around 2028 for Zemaira.

What are the key financial metrics and investment opportunities?

• Pricing Trends: The average annual treatment cost for a patient ranges between $150,000 and $250,000, depending on dosing frequency and formulation. High-cost structure limits accessibility but sustains revenue streams.

• Revenue Growth: CSL Behring’s Zemaira and Glassia generate combined revenues of approximately $900 million in 2022, representing 75% of the market. Growth in their revenues aligns with increased patient uptake.

• R&D and Pipeline Development: Several companies are investing in biosimilars and extended-release formulations. Biosimilars could reduce prices by 20–30%, impacting revenues by 2028.

• Regulatory and Reimbursement Dynamics: Coverage remains high in developed markets; however, reimbursement policies and healthcare cost controls could constrain future revenue growth.

• Potential Market Expansion: Efforts to expand indications to include other protease-related conditions or prophylactic strategies could generate incremental sales.

What are the risks affecting the financial trajectory?

• Patent Expiry and Biosimilar Competition: Expiration of key patents around 2028 threatens revenue streams, prompting accelerated biosimilar development.

• Pricing and Reimbursement Pressures: Payers in the US and Europe are increasingly scrutinizing high-cost biologics, which could lead to price reductions.

• Supply Chain Disruptions: The complex plasma-derived manufacturing process is susceptible to supply chain risks, potentially impacting availability and revenue.

• Regulatory Hurdles in Emerging Markets: Approval delays and registration requirements limit expansion prospects in developing economies.

How does market competition influence future growth?

Market leaders’ dominance stems from established manufacturing capacity, regulatory approvals, and supply reliability. Biosimilar entrants, once approved, could capture 30–50% of the market share within five years post-approval, exerting downward pressure on prices and revenues.

Key Takeaways

• The alpha-1-proteinase inhibitor (human) market is nearing $1.2 billion, with solid annual growth projections driven by increased diagnosis and treatment adoption.
• Market share remains concentrated among a few companies, with biosimilar competition anticipated around 2028.
• High treatment costs sustain revenue but pose barriers in cost-sensitive markets; reimbursement policies could influence growth.
• Pipeline developments include biosimilars and extended-release formulations, which could disrupt current pricing and market share.
• Risks such as supply chain vulnerabilities, regulatory delays, and market entry barriers in emerging economies should influence strategic planning.

FAQs

1. When will biosimilars likely enter the alpha-1-proteinase inhibitor market?
   Biosimilars are expected to seek approval around 2028, following patent expirations for key products, possibly disrupting market dynamics within five years.

2. How significant is unmet need in the diagnosis of AATD?
   Approximately 85-90% of cases remain undiagnosed globally, representing a substantial future market expansion potential if diagnosis rates improve.

3. What is the impact of regulatory policies on market growth?
   Favorable approvals in emerging markets could significantly expand the patient base, while reimbursement constraints in mature markets may limit revenue growth.

4. Are there alternative therapies under development?
   No widely approved alternatives exist; current R&D focuses on biosimilars, extended-release formulations, and novel delivery methods.

5. How will pricing trends evolve in the next five years?
   Pricing remains stable in developed markets due to limited biosimilar competition, but downward pressure may occur post-2028 with biosimilar market entries.

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References

[1] MarketWatch. (2023). Alpha-1-Proteinase Inhibitor (Human) Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Global Immunoglobulin and Plasma Protein Market Reports.
[3] FDA. (2022). Approved Drug List for Alpha-1-Proteinase Inhibitor.