Introduction
The market for immunoglobulin intravenous (IGIV) products, including GAMMAGARD, GAMMAGARD S/D, and IVEEGAM, is complex and influenced by various factors such as demand, supply, regulatory approvals, and market competition. Here, we delve into the market dynamics and financial trajectory of these biologic drugs.
Market Share and Competition
GAMMAGARD Liquid
GAMMAGARD Liquid, manufactured by Shire Pharmaceuticals (now part of Takeda Pharmaceutical Company), has been a market leader in the IGIV segment. As of March 2018, it held a market share of 26.2% in terms of total grams sold, closely followed by Gamunex-C by Grifols Therapeutics, Inc.[1].
GAMMAGARD S/D
GAMMAGARD S/D, also by Shire Pharmaceuticals, is a solvent/detergent-treated IGIV product. Although it has a smaller market share compared to GAMMAGARD Liquid, it remains a significant player. However, its market share has been declining, with only 1.2% of the market as of March 2018[1].
IVEEGAM
IVEEGAM, previously manufactured by Baxter BioScience, has seen a substantial decline in its market presence. The product was largely discontinued, and by the early 2000s, its market share had significantly diminished[1][3].
Supply and Demand Dynamics
Overall Supply Trends
The total supply of IGIV products in the United States has increased steadily over the years, from 15.2 million grams in 1998 to 28.3 million grams in 2005 and further to 44.2 million grams in 2017. This increase is largely attributed to new market entrants and increased production by existing manufacturers[3].
Impact of New Market Entrants
The entry of new products such as Octagam by Octapharma USA and Flebogamma by Grifols USA has significantly contributed to the increase in IGIV supply. These new entrants, along with increased production of Gamunex by Talecris Biotherapeutics, have helped meet the growing demand for IGIV products[3].
Demand Growth
Demand for IGIV products has risen sharply, driven primarily by off-label uses. While manufacturers estimate annual demand growth between 6-8%, healthcare providers suggest a higher growth rate of 10-15% annually. This growth is particularly driven by the increasing use of IGIV in treating neurological disorders and other off-label indications[3].
Financial Aspects
Pricing and Reimbursement
The cost of IGIV therapy is high, ranging from $5,000 to $10,000 per patient, depending on the number of infusions and the patient's weight. The per-gram cost of IGIV can range from $100 to $350. The pricing in the secondary market is significantly higher than in the authorized distribution channels, reflecting the demand-supply imbalance[4].
Medicare Reimbursement
Medicare reimbursement rates for IGIV purchases have been a critical factor. The introduction of the average sales price (ASP) methodology has led to reduced reimbursement rates, causing some healthcare providers to pay more than the ASP plus 6% to acquire IGIV. This discrepancy can lead to financial strain on healthcare providers[3].
Regulatory and Market Access
FDA Approvals
IGIV products, including GAMMAGARD and GAMMAGARD S/D, are FDA-approved for specific indications such as primary immunodeficiencies, idiopathic thrombocytopenic purpura (ITP), and B-cell chronic lymphocytic leukemia (CLL)[2][4].
Distribution Channels
The distribution of IGIV products occurs through both authorized and secondary channels. The secondary market, characterized by fluctuating prices and product availability, is estimated to exceed 10% of the total grams available for distribution. This secondary market often results in higher prices and access issues for healthcare providers[3].
Market Trends and Future Outlook
Global Market Growth
The global immunoglobulins market is expected to grow at a CAGR of 7.0% from 2020 to 2026, driven by the increasing adoption of IGIV products for treating critical immunological diseases. The intravenous segment is anticipated to capture more than three-fourths of the global immunoglobulin market[5].
Regional Dominance
North America is forecast to dominate the global immunoglobulins market, driven by the rising prevalence of immunological and neurological disorders and significant reimbursement coverage. Asia-Pacific is expected to grow the fastest, driven by expanding healthcare markets and increasing geriatric populations[5].
Discontinuation and Replacement of Products
IVEEGAM and Other Discontinued Products
IVEEGAM, along with other products like Gamimune N, Gammar-P I.V., Panglobulin, and Venoglobulin, has been discontinued or is in the process of being discontinued. These discontinuations are part of the natural cycle of product evolution, with newer products replacing older ones to meet changing market demands and regulatory requirements[3].
Key Takeaways
- Market Leadership: GAMMAGARD Liquid remains a market leader in the IGIV segment, while GAMMAGARD S/D has a smaller but significant market presence.
- Supply and Demand: The supply of IGIV products has increased, but demand continues to outpace supply, driven by off-label uses.
- Financial Considerations: High costs and reimbursement challenges are significant financial factors affecting the market.
- Regulatory and Access Issues: FDA approvals and distribution channel integrity are crucial for market access and pricing stability.
- Future Outlook: The global immunoglobulins market is expected to grow, with North America and Asia-Pacific being key regions.
FAQs
What are the primary indications for GAMMAGARD and GAMMAGARD S/D?
GAMMAGARD and GAMMAGARD S/D are FDA-approved for treating primary immunodeficiencies, idiopathic thrombocytopenic purpura (ITP), and B-cell chronic lymphocytic leukemia (CLL)[2][4].
Why is IVEEGAM no longer a significant player in the market?
IVEEGAM has been largely discontinued, contributing to its diminished market presence. This is part of the broader trend of older products being replaced by newer ones[1][3].
What drives the high cost of IGIV therapy?
The high cost of IGIV therapy is due to the expensive manufacturing process and the administration of the medicine. The per-gram cost can range from $100 to $350, and overall therapy costs can start from $5,000 to $10,000 per patient[4].
How does the secondary market affect IGIV pricing and availability?
The secondary market for IGIV products is characterized by higher prices and fluctuating product availability, often resulting in financial strain on healthcare providers and access issues[3].
What is the expected growth rate of the global immunoglobulins market?
The global immunoglobulins market is expected to grow at a CAGR of 7.0% from 2020 to 2026, driven by increasing adoption for treating critical immunological diseases[5].
Sources
- 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.
- GAMMAGARD S/D, 5 g/vial & 10 g/vial - Health Canada.
- ANALYSIS OF SUPPLY, DISTRIBUTION, DEMAND, AND ACCESS - U.S. Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation.
- IVIG Brands: In-Depth Guide - AmeriPharma Specialty Pharmacy.
- Increasing Adoption Of Immunoglobulins For The Treatment of Critical Immunological Diseases Driving The Market Demand - Fact.MR.
