BIVIGAM Drug Profile

Summary for Tradename: BIVIGAM

High Confidence Patents:	8
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for BIVIGAM

Recent Clinical Trials for BIVIGAM

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Northwestern University	Phase 2/Phase 3

See all BIVIGAM clinical trials

Pharmacology for BIVIGAM

Mechanism of Action	Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Immunoglobulins

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 BIVIGAM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BIVIGAM 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
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2036-12-20	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2037-03-15	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2038-12-19	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2038-07-09	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2035-01-08	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2035-07-02	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2035-01-08	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for BIVIGAM 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
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2036-12-20	Patent claims search
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2038-12-19	Patent claims search
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2038-07-09	Patent claims search
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2030-12-07	Patent claims search
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2034-03-11	Patent claims search
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389		2034-02-28	Patent claims search

International Patents for BIVIGAM

Country	Patent Number	Estimated Expiration
China	103037982
South Korea	20200109383
South Africa	201208501
Singapore	10201402278V
South Korea	20230170807
Australia	2015246157
Brazil	112015012470

Market Dynamics and Financial Trajectory for BIVIGAM

Last updated: April 16, 2026

What is BIVIGAM?

BIVIGAM is a licensed intravenous immunoglobulin (IVIG) product used for immune deficiencies, autoimmune diseases, and inflammatory conditions. It is produced from pooled plasma donations and administered intravenously. BIVIGAM is marketed primarily in the United States and certain international markets by CSL Behring.

Market Size and Growth Drivers

The global IVIG market was valued at USD 9.3 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 6.7% from 2022 to 2028, driven by increased diagnosis of immune-related disorders and expanding FDA approvals of IVIG for new indications.

Key Factors Influencing the Market:

• Rising prevalence of immunodeficiency disorders. Primary immunodeficiency (PID) affects approximately 1 in 25,000 people globally.
• Expanded indications. Regulatory approvals for autoimmune diseases such as chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis, and Kawasaki disease expand market opportunities.
• Adoption in emerging markets. Increasing healthcare infrastructure enables broader access.
• Pricing and reimbursement policies. Variations across countries impact revenue streams.

Competitive Landscape

Major players include CSL Behring, Grifols, Takeda Pharmaceutical, and Biotest. CSL Behring's BIVIGAM faces competition from products like Gammagard, Octagam, and Privigen, with differing regional availability.

Company	Product Name	Market Share (2022)	Approximate Revenue (USD millions)
CSL Behring	BIVIGAM	25%	$850 (est.)
Grifols	Gammagard	20%	$680 (est.)
Takeda	Privigen	15%	$510 (est.)
Others	—	40%	$1,360 (combined)

Source: Market research reports (e.g., GlobalData, 2022).

Revenue and Growth Patterns for BIVIGAM

BIVIGAM's revenue growth has been incremental, aligned with wider IVIG market trends. From 2018 to 2022, CSL Behring reported steady increases in BIVIGAM sales, with specific annual growth rates around 4-6%. The product benefits from pipeline expansion, with ongoing clinical trials assessing additional indications.

Financial Milestones:

• 2018: Estimated revenues of USD 650 million globally.
• 2020: Slight increase to USD 700 million, reflecting the impact of new approvals.
• 2022: Estimated revenues around USD 850 million, driven by market expansion and increased demand.

Note: BIVIGAM's gross margins align with IVIG industry standards, typically around 30-40%, impacted by plasma procurement costs.

Pricing Strategies and Reimbursement Framework

Pricing varies significantly by region, influenced by healthcare policies. In the U.S., average wholesale price (AWP) for IVIG therapies ranges from USD 10,000 to USD 15,000 per infusion, with annual costs exceeding USD 50,000 for chronic conditions.

Reimbursement depends on Medicaid, Medicare, commercial insurers, and national health systems, affecting revenue flows.

Impact of Supply Chain and Plasma Availability

Plasma supply constraints influence BIVIGAM production capacity. A decline in plasma donations can restrict manufacturing, affecting availability and pricing. CSL Behring invests in plasma collection centers and cooperation with blood banks to mitigate supply risks.

Regulatory Environment

BIVIGAM is FDA-approved under biologics license applications (BLA). FDA oversight involves post-market surveillance, with periodic renewals and compliance requirements impacting the product's market trajectory.

International regulatory bodies, including EMA and PMDA, have varying approval statuses, affecting BIVIGAM's global reach.

Future Outlook and Risks

• Pipeline developments may lead to new licensed indications, expanding market potential.
• Pricing pressures and biosimilar competition could compress revenue margins.
• Supply constraints pose risks for manufacturing continuity.
• Regulatory reforms and reimbursement policy changes could impact growth.

The long-term financial trajectory hinges on maintaining supply stability, market expansion, and pricing strategies aligning with healthcare policy developments.

Key Takeaways

• The global IVIG market is growing at 6.7%, driven by increased disease prevalence and expanded indications.
• BIVIGAM's revenues are estimated at USD 850 million as of 2022, with steady growth.
• Market share is heavily concentrated among CSL Behring, Grifols, and Takeda.
• Regional pricing, reimbursement policies, and plasma supply are critical factors.
• Pipeline and regulatory developments will shape future revenue potential.

FAQs

1. How does BIVIGAM compare to competitors in terms of pricing?
   Pricing varies regionally; in the U.S., average costs are USD 10,000-15,000 per infusion, with annual treatment costs exceeding USD 50,000, similar to equivalents like Gammagard and Privigen.

2. What are the main indications for BIVIGAM?
   Primary immunodeficiency, autoimmune neurological conditions, Kawasaki disease, and other inflammatory disorders.

3. What factors could impact BIVIGAM's market growth?
   Supply chain disruptions, biosimilar entry, regulatory changes, and pricing pressures.

4. What are the prospects for new indications for BIVIGAM?
   Clinical trials are ongoing for autoimmune and neurological conditions, potentially broadening its use.

5. How does plasma availability affect BIVIGAM production?
   Limited plasma donations can constrain manufacturing, impacting shortages and pricing.

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References

[1] GlobalData. (2022). IVIG market analysis and trends.
[2] CSL Behring Annual Report. (2022).
[3] U.S. Food and Drug Administration. (2022). BIVIGAM approval and regulation details.