Immune globulin intravenous (human)-ifas - Biologic Drug Details

Summary for immune globulin intravenous (human)-ifas

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for immune globulin intravenous (human)-ifas

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

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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

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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 immune globulin intravenous (human)-ifas Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for immune globulin intravenous (human)-ifas Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for immune globulin intravenous (human)-ifas Derived from Patent Text Search

No patents found based on company disclosures

Immune globulin intravenous (human)-ifas Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Intravenous Immunoglobulin (IVIG)

Introduction to IVIG

Intravenous Immunoglobulin (IVIG), also known as immune globulin intravenous (human), is a biologic drug derived from the plasma of thousands of donors. It is used to treat a variety of conditions, including primary and secondary immunodeficiency disorders, autoimmune diseases, and inflammatory conditions. The market for IVIG is experiencing significant growth, driven by several key factors.

Market Growth Drivers

Increasing Prevalence of Immunodeficiency Disorders

The rising prevalence of immunodeficiency disorders and autoimmune diseases is a major driver of the IVIG market. As more patients are diagnosed and treated, the demand for IVIG therapies increases, contributing to market growth[1].

Advancements in Plasma Collection and Purification

Technological advancements in plasma collection and purification have improved the efficiency and safety of IVIG production. These advancements have enabled the production of higher-quality IVIG products, which in turn have expanded the therapeutic applications of IVIG[1].

Expanded Applications and Personalized Medicine

IVIG is being used in novel immunomodulatory treatments, and there is a growing trend towards personalized medicine. This expansion of applications and the move towards personalized treatments are expected to further propel the market[1].

Market Size and Growth Projections

The global IVIG market was valued at USD 12.66 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.50% during the forecast period. This growth is anticipated to continue until 2032, driven by increasing healthcare expenditure, a rise in the geriatric population, and the expanding off-label use of IVIG[4].

Regional Market Dynamics

Asia-Pacific Region

The Asia-Pacific region is expected to see significant growth in the IVIG market due to its large population, particularly in countries like India and China. This region is characterized by high demand for IVIG treatments, which is driving market growth. Local and international pharmaceutical companies are actively producing and distributing IVIG products, leading to a competitive market that stimulates innovation and reduces prices[4].

Competitive Landscape

The IVIG market is highly competitive, with both branded and generic products available. Major players in the market are constantly upgrading their technologies to ensure efficiency, integrity, and safety. Strategies such as partnerships, product upgrades, and collaborations are common among these players as they seek to gain a competitive edge and capture a significant market share[4].

Financial Aspects of IVIG Treatment

Cost of Treatment

IVIG treatment is relatively expensive. On average, the cost of IVIG treatment in the US is approximately $9,720 per month for a patient undergoing 4 to 5 infusions. This translates to around $41,796 per month, making it a significant financial burden for patients and their families[2].

Cost Management Strategies

To manage the high costs associated with IVIG treatment, several strategies are being employed. Shifting from hospital-based IVIG therapy to home-based subcutaneous immunoglobulin (SCIG) therapy has been shown to reduce costs significantly. Studies have indicated that delivering IVIG in the home setting can result in annual savings of $18,876 to $26,136 per patient[5].

Impact of Distribution Channels

The expansion of distribution channels, including hospital and specialty pharmacies, has contributed significantly to the growth of the IVIG market. These channels ensure wider availability and accessibility of IVIG products, which in turn increases demand and market growth[1].

Regulatory and Reimbursement Factors

Regulatory policies and reimbursement systems play a crucial role in the IVIG market. Changes in these factors can significantly impact the market dynamics. For instance, favorable reimbursement policies can increase the adoption of IVIG treatments, while stringent regulations can pose challenges to market growth[4].

Innovations and Growth Initiatives

Companies like ADMA Biologics are focusing on innovations such as biologic production yield enhancement and label expansion for their products. These initiatives aim to capture additional immune globulin production yields and expand the therapeutic indications of their products, further strengthening their market position[3].

Financial Performance of Key Players

ADMA Biologics, for example, reported significant financial growth in 2023, with total revenues increasing by 48% compared to the previous year. The company's adjusted EBITDA also showed a substantial improvement, reflecting the growing commercial success of their IVIG products[3].

Patient Preferences and Outcomes

Patients with primary immunodeficiencies often prefer home-based SCIG therapy over hospital-based IVIG therapy due to its convenience and cost-effectiveness. Studies have shown that home-based therapy can improve adherence and reduce the incidence of serious bacterial infections, leading to better patient outcomes[5].

Challenges and Opportunities

High Cost and Potential Side Effects

Despite its benefits, IVIG therapy is associated with high costs and potential side effects. These challenges need to be addressed through cost management strategies and continuous innovation in product development[4].

Supply Constraints

The availability of plasma, the raw material for IVIG production, can be a constraint. Companies are working on initiatives to enhance production yields from the same quantities of plasma, which could help mitigate these supply constraints[3].

Key Takeaways

• The IVIG market is growing at a CAGR of 7.50% driven by increasing prevalence of immunodeficiency disorders and advancements in plasma collection and purification.
• The Asia-Pacific region is expected to see significant growth due to its large population and high demand for IVIG treatments.
• IVIG treatment is expensive, but cost management strategies such as home-based SCIG therapy can reduce costs.
• Regulatory policies and reimbursement systems significantly impact the market dynamics.
• Innovations in production yield enhancement and label expansion are key growth initiatives for companies in this market.

FAQs

Q: What is the average cost of IVIG treatment in the US? A: The average cost of IVIG treatment in the US is approximately $9,720 per month for a patient undergoing 4 to 5 infusions, which translates to around $41,796 per month[2].

Q: How does the cost of IVIG treatment compare between hospital and home settings? A: Delivering IVIG in the home setting can result in annual savings of $18,876 to $26,136 per patient compared to hospital-based therapy[5].

Q: What are the key drivers of the IVIG market growth? A: The key drivers include the increasing prevalence of immunodeficiency disorders, advancements in plasma collection and purification, and the expansion of distribution channels[1].

Q: Which region is expected to see significant growth in the IVIG market? A: The Asia-Pacific region is expected to see significant growth due to its large population and high demand for IVIG treatments[4].

Q: How are companies addressing the high cost and supply constraints associated with IVIG production? A: Companies are focusing on innovations such as biologic production yield enhancement and cost management strategies like home-based SCIG therapy to address these challenges[3][5].

Sources

1. Mordor Intelligence: Intravenous Immunoglobulin Market - IVIG - Share, Trends & Growth.
2. AmeriPharma Specialty Care: Cost of IVIG Treatment.
3. ADMA Biologics: ADMA Biologics Announces Fourth Quarter and Full Year 2023 Financial Results.
4. Polaris Market Research: Intravenous immunoglobulin Market Size & Growth Analysis 2032.
5. The American Journal of Managed Care: Managing Cost of Care and Healthcare Utilization in Patients Using Immunoglobulin Agents.