Key Findings

• Intravenous Immunoglobulin (IVIG) is a blood-derived product used in treating primary and secondary immunodeficiencies, autoimmune diseases, and several neurological and hematological disorders.
• The market is growing due to the increasing prevalence of immune disorders, neurological conditions like Guillain-Barré Syndrome, and chronic inflammatory demyelinating polyneuropathy (CIDP).
• The aging global population, advancements in plasma fractionation technologies, and improved diagnostic capabilities are contributing to the expanded use of IVIG therapies.
• Immunodeficiency diseases account for the largest share of IVIG consumption, while neurological and hematological applications are gaining rapid ground.
• The market is also witnessing increased off-label use of IVIG in rare diseases, though this presents regulatory and reimbursement challenges in many countries.
• North America remains the dominant market, supported by high healthcare expenditure, reimbursement access, and established plasma collection infrastructure.
• Plasma collection is a critical bottleneck; stringent donor requirements and supply-side constraints are prompting investments in donor recruitment and plasma collection centers.
• Key players are expanding global production capacities and engaging in M&A activities to meet growing demand and improve plasma availability.
• Biosimilars and subcutaneous immunoglobulin (SCIG) alternatives are emerging as cost-effective or more convenient options, but IVIG remains the gold standard for many severe indications.
• Companies like Grifols, CSL Behring, Takeda, Octapharma, and Kedrion dominate the global market with vertically integrated plasma-to-product operations.

Market Overview

The global Intravenous Immunoglobulin (IVIG) market plays a vital role in modern immunotherapy by offering treatment for a range of immune-related conditions. IVIG contains pooled, purified IgG antibodies extracted from healthy donors’ plasma and administered intravenously to patients with compromised or dysfunctional immune systems.

IVIG is primarily used in treating immunodeficiency disorders such as X-linked agammaglobulinemia, common variable immunodeficiency (CVID), and hypogammaglobulinemia. Additionally, it is used in neurological diseases like myasthenia gravis, multifocal motor neuropathy, and autoimmune hemolytic anemia. Increasing off-label use in areas such as dermatology, transplant medicine, and infectious diseases is expanding its clinical footprint.

Technological improvements in plasma fractionation, enhanced safety through viral inactivation processes, and patient monitoring have supported the rise in IVIG usage. While demand has consistently risen, the limited availability of donor plasma remains a critical challenge, pushing the industry to innovate in production and donor recruitment strategies.

Intravenous Immunoglobulin Market Size and Forecast

The global IVIG market was valued at USD 14.2 billion in 2024 and is projected to reach USD 24.9 billion by 2031, growing at a CAGR of 8.5% during the forecast period.

This growth is driven by a convergence of factors including the rising prevalence of primary immunodeficiency diseases, increased awareness and diagnosis rates, and the expanding use of IVIG in hematology and neurology. Additionally, government support for rare disease treatment, improvements in diagnostic pathways, and patient advocacy efforts are further propelling market growth.

The rising geriatric population, who are more susceptible to immunodeficiencies and neurological disorders, also contributes to the growing demand. However, the supply-demand imbalance due to limited plasma availability is placing upward pressure on pricing and creating an impetus for investments in donor infrastructure.

Future Outlook

Over the coming years, the IVIG market is expected to evolve toward greater efficiency, accessibility, and global reach. One of the key trends will be the expansion of donor networks and plasma collection infrastructure, especially in emerging regions like Asia-Pacific and Latin America. Countries like China and India are investing in domestic plasma collection to reduce dependency on imports.

Technological innovation will focus on improving the efficiency of plasma fractionation, reducing production lead times, and enhancing product safety through better pathogen elimination techniques. Additionally, digital health platforms will play a role in managing infusion schedules, tracking adverse events, and improving patient adherence to long-term IVIG therapy.

Subcutaneous immunoglobulin (SCIG) options are gaining traction for their home-administration convenience, but IVIG remains essential for acute and severe cases requiring high-dose infusions. Biosimilars and alternative recombinant therapies are in development but face hurdles related to efficacy, regulatory approvals, and market acceptance.

In terms of regulatory landscape, health authorities are expected to tighten guidelines on IVIG usage, particularly for off-label prescriptions, to control costs and improve allocation. Nevertheless, the global outlook remains strong due to the product’s clinical indispensability and the expanding population of immune-compromised patients.

Intravenous Immunoglobulin Market Trends

• Increased Diagnosis of Rare Immune Disorders
  Growing awareness and improved diagnostic tools for primary immune deficiency and autoimmune disorders are expanding the eligible patient pool for IVIG therapy. Initiatives by patient advocacy groups and rare disease registries are enabling earlier interventions, which is boosting long-term demand for IVIG infusions.
• Expansion of Plasma Collection Networks
  To meet rising demand, companies are investing in new plasma donation centers across the U.S., EU, and Asia. Automated apheresis systems and donor incentives are being used to streamline collection. These developments are critical to securing the raw material supply needed to sustain IVIG production.
• Rise in Neurology and Hematology Applications
  Beyond immunodeficiencies, IVIG is increasingly being used to treat neurological conditions like Guillain-Barré syndrome and CIDP. Hematological indications such as immune thrombocytopenia (ITP) are also contributing to demand. These applications require high-dosage infusions, leading to greater plasma consumption per patient.
• Shift Toward Home-Based Therapy
  IVIG infusion through home healthcare services is gaining momentum due to patient comfort and cost savings. This trend is being supported by portable infusion devices, nursing networks, and insurance coverage policies. However, monitoring and adverse reaction management remain critical in non-clinical settings.
• Development of Recombinant and Synthetic Alternatives
  Efforts are ongoing to develop recombinant immunoglobulin therapies that do not rely on donor plasma. These innovations aim to reduce supply dependency and standardize production quality. Although currently in early stages, they represent long-term competition to traditional IVIG products.

Market Growth Drivers

• Rising Prevalence of Immunodeficiency and Autoimmune Diseases
  Increasing incidence of primary and secondary immunodeficiencies, as well as autoimmune conditions like lupus and multiple sclerosis, is significantly driving the demand for IVIG. The aging population is also more susceptible to these conditions, further expanding the treatment base.
• Government and Reimbursement Support
  Many governments and private insurers recognize IVIG as a life-saving therapy and cover it under national health schemes or insurance plans. This financial accessibility plays a crucial role in the sustained demand for IVIG, especially in developed markets.
• Advancements in Plasma Fractionation and Safety
  Innovations in fractionation techniques have improved yield, processing speed, and safety. Enhanced viral inactivation methods reduce the risk of transmissible infections, making IVIG products safer and more reliable for chronic administration.
• Increasing Off-label Use and Expanding Indications
  While IVIG is approved for several indications, it is frequently used off-label in dermatology, infectious disease, and transplantation medicine. Though regulatory scrutiny is increasing, this trend reflects IVIG’s broad immunomodulatory potential, contributing to its growth.
• Global Expansion of Plasma-Derived Product Manufacturers
  Companies are increasing their global footprint through new manufacturing sites, partnerships, and acquisitions. This expansion aims to improve supply chain resilience and meet rising demand from both high-income and developing nations.

Challenges in the Market

• Plasma Supply Constraints
  The availability of donor plasma is limited due to strict eligibility criteria, regional regulations, and declining donor participation in some regions. These supply constraints affect production capacity and pricing, limiting market scalability.
• High Cost of Therapy
  IVIG is among the most expensive biological therapies due to its complex production process and reliance on human donors. This presents affordability challenges in emerging markets and pressures healthcare budgets even in developed countries.
• Regulatory and Reimbursement Variability
  Reimbursement and regulatory guidelines for IVIG use vary significantly across regions. In some countries, restrictive policies around off-label use can limit market growth and create inconsistencies in patient access.
• Risk of Adverse Reactions
  While generally safe, IVIG therapy can cause side effects such as thrombosis, renal dysfunction, and anaphylaxis. These risks require careful patient monitoring and limit use in certain populations, particularly those with pre-existing comorbidities.
• Competition from SCIG and Biosimilars
  Subcutaneous immunoglobulin (SCIG) products are emerging as preferred options for long-term therapy due to convenience and steady absorption. At the same time, biosimilar entries are expected to impact pricing dynamics and brand loyalty in the IVIG market.

Intravenous Immunoglobulin Market Segmentation

By Application

• Primary Immunodeficiency
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Guillain-Barré Syndrome
• Multifocal Motor Neuropathy
• Immune Thrombocytopenia (ITP)
• Myasthenia Gravis
• Kawasaki Disease
• Others

By End User

• Hospitals
• Clinics
• Home Healthcare
• Specialty Centers

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Specialty Pharmacies

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa

Leading Players

• Grifols, S.A.
• CSL Behring
• Takeda Pharmaceutical Company Limited
• Octapharma AG
• Kedrion Biopharma
• ADMA Biologics
• China Biologic Products Holdings, Inc.
• Bio Products Laboratory (BPL)
• LFB Group
• Emergent BioSolutions Inc.

Recent Developments

• Grifols expanded its global plasma center network by opening new collection sites in North America and Europe to support increased IVIG production.
• Takeda announced positive trial results for its IVIG product in the treatment of CIDP, reinforcing its leadership in neurological immunotherapy.
• CSL Behring launched a home infusion platform to support its IVIG patients, offering digital tracking tools and virtual nurse support.
• Octapharma began construction of a new fractionation facility in Austria to increase global production capacity for its immunoglobulin portfolio.
• Kedrion Biopharma entered a strategic partnership in India to expand its IVIG product distribution and build local plasma infrastructure.