Intravenous Immunoglobulin Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (IgG, IgA, IgM, IgE, IgD), By Application (Hypogammaglobulinemia, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Primary Immunodeficiency Diseases, Myasthenia Gravis, Multifocal Motor Neuropathy, and Other Applications) By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 13.41 Billion
CAGR (2026-2031)	7.77%
Fastest Growing Segment	Primary Immunodeficiency Diseases
Largest Market	North America
Market Size (2031)	USD 21.01 Billion

Market Overview

The Global Intravenous Immunoglobulin Market will grow from USD 13.41 Billion in 2025 to USD 21.01 Billion by 2031 at a 7.77% CAGR. Intravenous Immunoglobulin (IVIg) is a specialized blood product derived from the pooled plasma of thousands of healthy donors, primarily utilized to treat patients with primary immunodeficiency diseases and various autoimmune disorders. The market is fundamentally supported by the rising prevalence of diagnosed immunodeficiencies and an aging global population that increasingly requires immune modulation therapy. Furthermore, the expanding clinical application of IVIg for neurological conditions acts as a structural driver for growth, distinct from transient consumption trends or short-term regulatory shifts.

However, the sector encounters a significant challenge regarding the complex and costly logistics of collecting sufficient source plasma to meet escalating international needs. According to the National Blood Authority, in 2024, the total issue of immunoglobulin products in Australia reached approximately 9.3 million grams for the 2023-24 fiscal year, illustrating the intense and growing pressure on supply chains to match consumption. Consequently, the difficulty in rapidly scaling plasma collection infrastructure remains a primary impediment to broader market expansion.

Key Market Drivers

The escalating diagnosis of primary and secondary immunodeficiency disorders constitutes the principal force driving market expansion. As medical systems improve their ability to identify compromised immune systems, a growing number of patients require lifelong immunoglobulin replacement therapies to mitigate infection risks. This reliable patient base creates a sustained demand baseline that plasma fractionators must continually address through increased production capacity. According to CSL Limited, August 2024, in the 'Annual Report 2024', immunoglobulin portfolio sales surged by 20% to reach $5,666 million, reflecting the acute necessity of these biological treatments for diagnosed populations.

Simultaneously, the surging demand for intravenous immunoglobulin in neurological treatments, specifically for autoimmune neuropathies like Chronic Inflammatory Demyelinating Polyneuropathy, significantly broadens the therapeutic scope. Regulatory approvals for formulations in this domain are encouraging utilization, thereby intensifying competition for limited plasma supplies. According to Takeda, January 2024, in the 'FDA Approves Takeda’s HYQVIA...' press release, pivotal trial data revealed a relapse rate of only 15.5% for patients on the therapy compared to 31.7% for the placebo group, validating its efficacy in neuromuscular care. This clinical success directly translates to financial growth for major manufacturers. According to Grifols, in 2024, the biopharmaceutical division recorded revenue of EUR 5,553 million for the preceding fiscal year, a performance heavily attributed to robust immunoglobulin uptake across diverse indications.

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Key Market Challenges

The Global Intravenous Immunoglobulin Market is significantly constrained by the complex and capital-intensive logistics required to harvest sufficient volumes of source plasma. Unlike pharmaceutical sectors that rely on synthetic manufacturing, the IVIg industry is tethered to the biological limits of human donation and the extensive infrastructure needed to collect, test, and transport raw plasma. This dependence creates a rigid supply chain where production capacity cannot be swiftly ramped up to satisfy the surging international demand for immunodeficiency and autoimmune treatments, effectively placing a ceiling on market expansion.

Consequently, this supply-side bottleneck restricts the sector's ability to capitalize on rising diagnosis rates. The volume of raw material required to sustain even a single patient is substantial, creating a perpetual pressure on collection networks to expand at an unsustainable pace. According to the Plasma Protein Therapeutics Association, in 2024, treating a single patient with primary immune deficiency requires approximately 130 plasma donations annually. This distinct high-volume requirement highlights the massive logistical hurdle involved in scaling operations; as clinical needs grow, the industry struggles to proportionally increase collection capacity, thereby directly hampering overall market growth and product availability.

Key Market Trends

The market is significantly evolving through the Technological Optimization of Plasma Fractionation Yields. Faced with the biological constraints of collecting raw plasma, manufacturers are aggressively implementing advanced fractionation techniques to maximize the recovery of immunoglobulin proteins from every liter of donation. This focus on operational efficiency allows companies to decouple production volume from linear increases in plasma collection, thereby stabilizing margins and improving supply resilience. According to Grifols, February 2024, in the 'Grifols closes a record year and accelerates profitable growth for 2024' press release, the execution of their Operational Improvement Plan resulted in a 22% decline in the cost per liter of plasma by December 2023 compared to the peak in July 2022, demonstrating the substantial financial impact of these yield-enhancing technologies.

Simultaneously, there is a pervasive Growing Adoption of Home-Based IVIG Infusion Therapies, driven by patient demand for convenience and payer preference for cost-effective care settings. This trend is decentralizing administration, shifting treatment from inpatient hospital environments to specialized ambulatory and home infusion networks that offer greater scheduling flexibility and reduced exposure to nosocomial infections. This structural transition is fueling the rapid expansion of independent providers dedicated to remote infusion services. According to Option Care Health, October 2024, in the 'Third Quarter 2024 Financial Results', the company reported net revenue of $1,278.5 million, a 17.0% increase over the prior year, reflecting the surging demand for home and alternate site infusion services across the healthcare landscape.

Segmental Insights

The Primary Immunodeficiency Diseases application segment is emerging as the fastest-growing category in the global intravenous immunoglobulin market. This rapid expansion is principally driven by rising diagnostic rates resulting from improved genetic screening and increased awareness of immune disorders. Additionally, regulatory bodies such as the U.S. Food and Drug Administration continue to approve novel plasma-derived therapies, ensuring broader treatment accessibility for patients requiring lifelong antibody replacement. Consequently, the essential nature of immunoglobulin replacement therapy for managing these chronic conditions anchors the segment’s sustained and robust market progression.

Regional Insights

North America maintains a leading position in the Global Intravenous Immunoglobulin Market due to the high prevalence and diagnosis of immunodeficiency disorders. The region benefits from a well-established healthcare infrastructure and the presence of major plasma fractionation facilities, ensuring consistent product availability. Furthermore, the United States Food and Drug Administration actively supports market expansion through the approval of new clinical indications for immunoglobulin therapies. Favorable reimbursement structures and strong adoption rates for neurological applications also contribute significantly to the sustained demand for these treatments across the region.

Recent Developments

• In March 2025, Grifols reported positive top-line results from a phase 2/3 clinical trial evaluating the efficacy of its intravenous immunoglobulin treatment for post-polio syndrome. The study met its primary endpoint, demonstrating that patients treated with the therapy achieved a statistically significant improvement in physical performance measures compared to those receiving a placebo. This research provided clinical evidence supporting the potential of immunoglobulins to mitigate the functional decline associated with the syndrome, a condition for which no specific pharmaceutical treatments were previously indicated. The findings underscored the company's focus on expanding the clinical applications of its plasma-derived medicines.
• In September 2024, GC Biopharma USA, Inc. officially launched ALYGLO, a 10% intravenous immunoglobulin liquid, in the United States marketplace. The product, indicated for adults with primary humoral immunodeficiency, utilizes a proprietary manufacturing process that employs cation exchange chromatography to remove specific coagulation factors. This launch represented a historic milestone for the company as it introduced its first FDA-approved plasma-derived therapy to American patients. To facilitate widespread access, the company established partnerships with key specialty pharmacies, offering a new therapeutic alternative for individuals suffering from chronic primary immune deficiency diseases.
• In July 2024, Kedrion Biopharma finalized a long-term strategic collaboration with Biotest AG to exclusively commercialize and distribute the intravenous immunoglobulin therapy, Yimmugo, within the United States. This agreement followed the FDA's approval of the product for the treatment of primary immunodeficiencies. Under the terms of the partnership, the company secured rights to market the therapy, which is produced at a newly certified facility in Germany. The initiative was designed to address the increasing demand for immunoglobulin treatments in the U.S. market and to ensure reliable access for patients requiring immune system support through specialized distribution networks.
• In January 2024, Takeda announced that the United States Food and Drug Administration (FDA) had approved its intravenous immunoglobulin therapy, GAMMAGARD LIQUID, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This regulatory decision established the product as the only intravenous immunoglobulin therapy in the U.S. approved for multiple neuromuscular disorder indications. The approval was supported by data from a major clinical trial, which showed a high responder rate among participants. This development significantly expanded the company's plasma-derived therapy portfolio, providing a critical new maintenance treatment option for patients managing this rare, immune-mediated neuromuscular condition.

Key Market Players

• Bio Products Laboratory Ltd.
• Biotest AG
• China Biologic Products Holdings Inc.
• CSL Behring
• Grifols SA
• Kedrion SpA
• Shanghai RAAS Blood Products Co. Ltd
• Octapharma AG
• Takeda Pharmaceutical Company Limited
• Baxter International Inc

By Type	By Application	By Region
IgG IgA IgM IgE IgD	Hypogammaglobulinemia Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Primary Immunodeficiency Diseases Myasthenia Gravis Multifocal Motor Neuropathy and Other Applications	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Intravenous Immunoglobulin Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Intravenous Immunoglobulin Market, By Type:

• IgG
• IgA
• IgM
• IgE
• IgD

• Intravenous Immunoglobulin Market, By Application:

• Hypogammaglobulinemia
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Primary Immunodeficiency Diseases
• Myasthenia Gravis
• Multifocal Motor Neuropathy
• and Other Applications

• Intravenous Immunoglobulin Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE