Expansion in IVIG Therapies Boost Awareness and Investment Opportunities

4 Min Read

Personalized Treatments, Greater Convenience, and Increased Demand Fuel Growth

Intravenous immunoglobulin (IVIG) is a medical treatment that involves administering a pooled antibody solution, through intravenous IV or drip, to treat a variety of conditions.¹ Collected from the plasma of healthy donors, the ultimate goal of IVIG therapy is to normalize a compromised immune system.²

Traditionally administered for the treatment of immunodeficiencies, IVIG is now increasingly being utilized for a wider array of health issues – extending beyond the normalization of compromised immune systems. Trends show the therapy being leveraged for treating autoimmune and inflammatory conditions, neurological disorders, and dermatological conditions. Additionally, IVIG is used in treating chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis, Guillain-Barre syndrome, and some forms of autoimmune encephalitis.³

Increases in use cases, combined with growing awareness and popularity with patients and medical providers, translate to rising opportunities for investors: The U.S. IVIG market is forecasted at a compound annual growth rate (CAGR) of 7.7% through 2030, with market value set to reach $10.42 billion by 2030.⁴

Healthcare Investor Insights

Impacts Contributing to the Growing IVIG Market

Personalization, Innovations, Increasing Need, and Insurance Coverage Drive Investment Opportunities

Personalization: Medical personalization is an emerging practice that uses a person’s genetic profile to inform decisions about their health.⁵ Advancing through data collected from the Human Genome Project, this valuable information can help doctors make the best choices to prevent, diagnose, prescribe, and manage the right treatments for their patients.⁶

This trend is also a noteworthy market driver. In the case of IVIG, the ability to research an individual’s biomarkers allows researchers to explore and identify which patients may benefit from IVIG therapy. Administration of IVIG treatment can then be tailored to fit specific patient needs, based on individual factors like disease severity, treatment response, and potential side effects.

At-home Infusion Therapy: Defined by the administration of medication through a needle or catheter outside of a hospital or medical facility, at-home infusion therapy is delivered by nurses or specially trained medical professionals.⁷ This careful supervision provides patients with an opportunity to receive care in the safety and convenience of their own homes.⁸

A shift that began during the COVID-19 pandemic, at-home therapies continue to rise in popularity and are especially beneficial to patients with weakened immune systems. Innovations supporting this trend include new forms of IVIG, like Subcutaneous Immunoglobulin (SCIG), which heightens immune response while also reducing the frequency of infection.⁹ The convenience of these treatments is equally beneficial, particularly for the advancing age of the American population. The number of individuals aged 65 and older is set to nearly double in the U.S. over the next three decades, rising to 23% by 2060.¹⁰

Increase in Medical Need: The aging U.S. population, and increases in chronic conditions, like Primary
Immunodeficiency Diseases (PIDD) and other immunodeficiency disorders, also influence the demand for IVIG.¹¹

A notable contributor to IVIG usage, PIDD is an interesting example. A 2023 Immune Deficiency Foundation article cites common variable immune deficiency (CVID) as one of the most commonly diagnosed forms of PIDD in adults today, occurring in 1 in 25,000 individuals.¹² With immunodeficiency disorders like PIDD on the rise, we see an influx of novel drugs launching to meet patient needs. This year alone, the FDA has approved five new drugs, two of which are administered intravenously.¹³

Insurance Coverage Availability: Increasing initiatives for the introduction of drugs by leading players in the IVIG market, along with the availability of insurance coverage, inspire IVIG market growth in North America.¹⁴

For instance, in June 2021, CSL Behring, a subsidiary of the CSL Limited (and one of IVIG’s most notable market share leaders), received an approval from the Centers of Medicare & Medicaid Services (CMS) to cover Hizentra under Medicare Part B.¹⁵ Used in treating primary immune deficiency (Pl), Hizentra is a maintenance therapy for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Hizentra’s approval for insurance coverage is a noteworthy landmark in paving the way for more affordable IVIG and new SCIG treatments.¹⁶

IVIG Landscape and Challenges

Competitive Landscape, Rapid Innovations, and High Costs Present Considerations for Investors

Competitive Landscape: Highly Current IVIG global market share is consolidated into a handful of major players, including:¹⁷

• Grifols, S.A.
• CSL Limited
• Takeda Pharmaceutical Company Limited

The rising research and development focus of these three players, as they aim to expand product portfolios, further supports the growing market share. In early 2023, Takeda Pharmaceutical Company Limited shared it will invest $910.7 million in a new manufacturing facility for plasma-derived therapies in Japan, in an effort to expand its manufacturing capacity.

Domestic markets are dominated by:¹⁸

• Accredo
• KabaFusion
• Option Care Health
• Coram CVS Specialty Infusion Services

Combined global and domestic competition contribute to rapid IVIG growth strategies, accelerated research and development, and more IVIG products. This is evident in the current pace of advancements. For example, in spring 2023, Takeda Pharmaceutical Company Limited received FDA approval to expand the use of their Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase, Hyqvia. (Hyqvia is used for the treatment of primary immunodeficiency.) And, just one year later, Grifols announced their launch of FDA-approved Yimmugo, an IVIG therapy for treating primary immunodeficiencies.¹⁹

Risks and Restraints: While the increase in immunological disorders and uptick of available drugs for treatment fuel the IVIG market, a higher cost for care remains. According to a 2023 article published by AmeriPharma Specialty Care, a single IVIG infusion can cost from $100 to more than $350 per gram. With treatments requiring many patients to receive four to five infusions per month, that cost can quickly add up to more than $40,000 per month.²⁰

The Fast-moving IVIG Market Fuels Continued Investment Opportunities

Medical innovations and the push for R&D position the IVIG market for steady growth. Contact us today to learn more about this emerging market. We’ll connect you with experienced advisors who can help you leverage analysis and strategic insights to build conviction in your investments.

Resources:

¹Intravenous Immunoglobulin (IVIG). Vijay B. Arumugham; Appaji Rayi. (2024)
²Ibid.
³Market Analysis: U.S. Intravenous Immunoglobulin Market Size, Share & Trends Report U.S. Intravenous Immunoglobulin Market Size, Share & Trends Analysis Report, 2023 – 2030. Grandview Research.
⁴Ibid.
⁵Personalized Medicine, Human Genome Institute (2024).
⁶Ibid.
⁷Infusion Therapy Market Overview (H1 2023). HarrisWilliams.com.
⁸Ibid.
⁹Goyal, N. A., Karam, C., Sheikh, K. A., & Dimachkie, M. M. (2021). Subcutaneous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy. Muscle & nerve, 64(3), 243–254.
¹⁰Infusion Therapy Market Overview (H1 2023). HarrisWilliams.com.
¹¹Immunoglobulin Market Size, 2024-2032. Fortune Business Insights.
¹²Common variable immune deficiency (CVID). PrimaryImmune.org.
¹³Infusion Therapy Market Overview (H1 2023). HarrisWilliams.com.
¹⁴Immunoglobulin Market Size, 2024-2032. Fortune Business Insights.
¹⁵Ibid.
¹⁶Ibid.
¹⁷Ibid.
¹⁸Infusion Therapy Market Update: Perspectives and Research on the Infusion Industry (August 7, 2024). BournePartners.com.
¹⁹Market Analysis: U.S. Intravenous Immunoglobulin Market Size, Share & Trends Report U.S. Intravenous Immunoglobulin Market Size, Share & Trends Analysis Report, 2023 – 2030. Grandview Research.
²⁰Immunoglobulin Market Size, 2024-2032. Fortune Business Insights.