GAMMAGARD LIQUID Drug Profile

Summary for Tradename: GAMMAGARD LIQUID

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for GAMMAGARD LIQUID
Recent Clinical Trials:	See clinical trials for GAMMAGARD LIQUID

See drug prices for GAMMAGARD LIQUID

Recent Clinical Trials for GAMMAGARD LIQUID

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
ASIS Corporation	Phase 1/Phase 2
Baxalta US Inc.	Phase 3
Baxalta now part of Shire	Phase 3

See all GAMMAGARD LIQUID clinical trials

Pharmacology for GAMMAGARD LIQUID

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. General 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 GAMMAGARD LIQUID Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GAMMAGARD LIQUID Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for GAMMAGARD LIQUID 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
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,016,338	2033-03-11	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,577,154	2029-05-13	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	10,912,714	2038-07-09	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	9,554,968	2033-03-11	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	GAMMAGARD LIQUID	immune globulin infusion (human)	Injection	125105	9,662,450	2029-05-13	Patent claims search

GAMMAGARD LIQUID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gammagard Liquid

Introduction

Gammagard Liquid, an immune globulin intravenous (IGIV) product, is a biologic drug used to treat various immune system disorders. Understanding its market dynamics and financial trajectory is crucial for investors, healthcare professionals, and industry analysts.

Market Leadership and Share

As of March 2018, Gammagard Liquid, manufactured by Shire Pharmaceuticals (now part of Takeda), was the market leader in the IGIV segment, holding a 26.2% market share based on total grams sold. This dominance was followed closely by Gamunex-C by Grifols Therapeutics, Inc., with a 24.6% market share[1].

Historical Market Performance

The market share of Gammagard Liquid has seen significant fluctuations over the years. From 2000 to 2006, its market share grew steadily, from 0.09% in 2005 to 3.01% in 2006. By 2013, it had increased to 16.5%, and by March 2018, it reached 26.2%[1].

Supply and Demand Trends

The overall supply of IGIV products, including Gammagard Liquid, has increased steadily. From 2013 to 2017, the total supply of IGIV products in the U.S. grew from 27,500,000 grams to 44,200,000 grams. Gammagard Liquid's supply specifically increased from 4,527 grams in 2013 to 11,722 grams in 2017[1].

Competitive Landscape

The IGIV market is highly competitive, with several key players. Besides Gammagard Liquid, other significant products include Gamunex-C by Grifols Therapeutics, Inc., Octagam by OCTAPHARMA Pharmazeutika Produktionsges.m.b.H, and PrIGIVen by CSL Behring. Each of these products has a substantial market share, indicating a fragmented but competitive market[1].

Financial Performance

Takeda, the current owner of Gammagard Liquid, has reported strong financial performance driven by its Growth & Launch Products, which include Gammagard Liquid. In the third quarter of fiscal year 2023, Takeda saw revenue growth of +4.6% at the actual exchange rate and flat growth at the constant exchange rate. The company's core operating profit, however, declined by 12.7% due to generic competition and increased investments in R&D and digital technologies[2].

Life-Cycle Management Approvals

Life-cycle management approvals for Gammagard Liquid have been crucial in maintaining its market position. In January 2023, Takeda received life-cycle management approvals for Gammagard Liquid, which supported the forward momentum of its Growth & Launch Products[2].

Global Biologics Market Context

The global market for biologic therapeutic drugs, which includes IGIV products like Gammagard Liquid, is expected to grow significantly. From $452.9 billion in 2023, the market is projected to reach $823.4 billion by 2028, with a compound annual growth rate (CAGR) of 12.7% during the forecast period[3].

Sales Projections and Forecasts

Specific sales estimates for Gammagard Liquid are detailed in reports such as those from GlobalData. These reports provide in-depth analyses of the drug's efficacy, factors impacting sales, and the competitive landscape. For instance, a report on Gammagard Liquid's use in Alzheimer's disease provides global sales estimates and a qualitative and quantitative assessment of the market space[4].

Challenges and Opportunities

Despite its strong market position, Gammagard Liquid faces challenges such as generic competition and the need for continuous innovation. Takeda's investment in R&D and digital technologies is a strategic move to maintain competitiveness. The growing demand for biologic therapeutic drugs and the expanding use of IGIV products in various therapeutic areas present significant opportunities for growth.

Regulatory and Approval Landscape

Regulatory approvals play a critical role in the financial trajectory of biologic drugs. Recent approvals, such as the U.S. FDA approvals for other Takeda products, highlight the company's ability to navigate regulatory environments effectively. This capability is essential for maintaining and expanding the market share of Gammagard Liquid[2].

Conclusion

Gammagard Liquid's market dynamics are characterized by its leadership in the IGIV segment, steady supply growth, and strong financial performance within Takeda's portfolio. Despite facing generic competition and regulatory challenges, the product's life-cycle management approvals and the growing global biologics market present opportunities for continued growth.

Key Takeaways

• Market Leadership: Gammagard Liquid is a leading IGIV product with a significant market share.
• Supply Growth: The supply of Gammagard Liquid has increased steadily from 2013 to 2017.
• Financial Performance: Takeda's financial results are positively impacted by Gammagard Liquid's performance.
• Regulatory Approvals: Life-cycle management approvals are crucial for maintaining market position.
• Global Market Growth: The global biologics market is expected to grow significantly, benefiting Gammagard Liquid.

FAQs

1. What is the current market share of Gammagard Liquid in the IGIV segment?

   • As of March 2018, Gammagard Liquid held a 26.2% market share in the IGIV segment[1].

2. How has the supply of Gammagard Liquid changed over the years?

   • The supply of Gammagard Liquid increased from 4,527 grams in 2013 to 11,722 grams in 2017[1].

3. What are the key challenges faced by Gammagard Liquid?

   • Generic competition and the need for continuous innovation are significant challenges[2].

4. How does Takeda's investment in R&D impact Gammagard Liquid?

   • Takeda's investments in R&D and digital technologies help maintain competitiveness and support the growth of Gammagard Liquid[2].

5. What is the projected growth rate of the global biologics market?

   • The global biologics market is expected to grow at a CAGR of 12.7% from 2023 to 2028[3].

Sources

1. Update on Supply of Immune Globulin Intravenous (IGIV) Products - U.S. Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation[1].
2. Takeda Announces Third-Quarter FY2023 Results - BioSpace[2].
3. Biologic Therapeutic Drugs: Technologies and Global Markets - BCC Research[3].
4. Gammagard Liquid (Alzheimer's disease) - Analysis and Forecasts to 2022 - Research and Markets[4].