Intravenous Immunoglobulin (IVIg) Market Size, Share, Growth, and Industry Analysis, By Types (IVIg Liquid, IVIg Powder) , Applications (Immunodeficiency, Autoimmune Disease, Acute Infection) and Regional Insights and Forecast to 2033

Intravenous Immunoglobulin (IVIg) Market Size

The Intravenous Immunoglobulin (IVIg) Market size was valued at USD 11,617 million in 2024 and is projected to reach USD 12,302 million in 2025, growing to USD 19,461 million by 2033, at a CAGR of 5.9% during the forecast period (2025–2033).

The US Intravenous Immunoglobulin (IVIg) market is poised for steady growth, driven by rising prevalence of immunodeficiency disorders, increasing geriatric population, and advancements in plasma-derived therapies, supporting market expansion through 2033.

The Intravenous Immunoglobulin (IVIg) market is witnessing significant growth, driven by the increasing prevalence of immunodeficiency disorders, autoimmune diseases, and neurological conditions. IVIg is derived from human plasma and contains antibodies used to treat various immune system deficiencies and inflammatory diseases. Over 50% of IVIg usage is attributed to treating neurological disorders, highlighting its growing therapeutic importance. Growing demand for immunotherapy and advancements in plasma fractionation technologies are propelling market expansion. Increasing adoption of IVIg for off-label indications, such as chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy, is also contributing to market growth. Furthermore, over 60% of IVIg products are administered in hospital settings, underscoring its critical role in patient care.

Intravenous Immunoglobulin (IVIg) Market Trends

The IVIg market is experiencing robust growth due to increasing incidences of primary and secondary immunodeficiency diseases. According to the World Health Organization (WHO), autoimmune diseases affect approximately 3%–5% of the global population, equating to around 230 million to 385 million people worldwide. The growing prevalence of conditions like Kawasaki disease, which affects over 20,000 children annually in the United States alone, is driving demand for IVIg treatments. Furthermore, the increasing number of plasma collection centers is improving supply stability. In the US, there are over 900 licensed plasma collection centers, contributing to increased production capacity. The rising number of clinical trials evaluating the efficacy of IVIg in treating neurological and hematological disorders is further boosting market growth. For instance, more than 100 clinical trials involving IVIg are currently registered on ClinicalTrials.gov, focusing on various immune-related conditions. Additionally, around 70% of IVIg products are used to treat neurological disorders, reinforcing the growing demand for immunoglobulin therapies in this segment.

Intravenous Immunoglobulin (IVIg) Market Dynamics

The Intravenous Immunoglobulin (IVIg) market is driven by increasing demand for immunoglobulin therapies in treating rare and chronic diseases. IVIg products are manufactured from pooled human plasma, with approximately 130 to 150 plasma donations required to produce a single dose for a patient with primary immunodeficiency (PIDD). Over 70% of IVIg products are used for off-label treatments, including autoimmune and neurological disorders. North America and Europe collectively account for over 60% of the global IVIg market, supported by strong healthcare infrastructure and high rates of plasma collection. Additionally, increasing government initiatives to enhance plasma donation and production capacity are contributing to market growth.

DRIVER

"Increasing prevalence of immune disorders"

The growing prevalence of primary immunodeficiency diseases (PIDD) and autoimmune disorders is a key driver of the IVIg market. According to the Immune Deficiency Foundation, approximately 6 million people worldwide suffer from PIDD. In the United States alone, around 500,000 individuals are diagnosed with PIDD. The increasing diagnosis of these disorders, coupled with rising awareness about available treatment options, is driving demand for IVIg therapies. Additionally, the rise in the geriatric population, which is expected to reach 1.5 billion globally by 2050, is contributing to market growth as older adults are more prone to immune system deficiencies. The growing adoption of IVIg in treating neurological disorders, such as multiple sclerosis and chronic inflammatory demyelinating polyneuropathy (affecting about 1–2 people per 100,000 annually), is further propelling market expansion.

RESTRAINT

"High cost of IVIg therapies"

The high cost associated with IVIg therapies remains a significant restraint in the market. The complex plasma collection and fractionation process contributes to elevated production costs. A single IVIg infusion can cost between $5,000 and $10,000, depending on the dosage and frequency of administration. The annual cost for IVIg treatment for chronic conditions like CIDP can exceed $30,000 to $70,000 per patient. Limited reimbursement policies and high out-of-pocket expenses for patients in developing regions further restrict market penetration. Additionally, fluctuations in plasma supply and stringent regulatory requirements for plasma collection and product manufacturing are increasing production costs, limiting market growth.

OPPORTUNITY

"Expanding applications in neurological and autoimmune diseases"

The growing use of IVIg in treating neurological and autoimmune diseases presents significant market opportunities. Clinical studies have demonstrated the efficacy of IVIg in treating conditions such as myasthenia gravis (affecting about 20 out of 100,000 people worldwide), multiple sclerosis (with over 2.8 million cases globally), and Guillain-Barré syndrome (affecting 1 to 2 cases per 100,000 people annually). Expanding indications for IVIg therapies and increasing FDA approvals for new therapeutic applications are creating growth opportunities for manufacturers. The rise in home-based infusion services is also driving market growth, with over 30% of IVIg therapies now administered at home. Furthermore, the development of subcutaneous immunoglobulin (SCIg) products is enhancing patient convenience and improving treatment adherence rates.

CHALLENGE

"Limited plasma supply"

The availability of plasma, which is the primary raw material for IVIg production, remains a significant challenge. Plasma collection is a time-consuming process, and the increasing global demand for plasma-derived products is putting pressure on supply chains. According to the Plasma Protein Therapeutics Association (PPTA), approximately 130 plasma donations are needed to treat one patient with CIDP for a year. In the US, plasma donation rates have increased by 5% annually over the past five years, but demand continues to outpace supply. Regulatory challenges related to plasma collection, including donor eligibility criteria and safety standards, are further complicating supply issues, affecting market stability.

Segmentation Analysis

The Intravenous Immunoglobulin (IVIg) market is segmented based on type and application, which provides a detailed understanding of the market's structure and growth opportunities. By type, the market includes IVIg Liquid and IVIg Powder, each catering to specific patient needs and medical scenarios. By application, the market is divided into Immunodeficiency, Autoimmune Disease, and Acute Infection, reflecting the diverse clinical use cases of IVIg products. This segmentation allows for targeted product development and marketing strategies, helping manufacturers and healthcare providers address the distinct needs of different patient groups. Analyzing these segments offers insights into demand patterns, competitive landscape, and future growth potential.

By Type

• IVIg Liquid: IVIg Liquid is one of the most widely used forms of intravenous immunoglobulin due to its ease of administration and immediate bioavailability. In 2024, IVIg Liquid accounted for approximately 70% of the total IVIg market share, valued at around USD 8.5 billion. Its high adoption rate is driven by the increasing prevalence of primary and secondary immunodeficiency diseases and autoimmune disorders. Moreover, the improved stability and extended shelf life of liquid formulations have contributed to their growing preference among healthcare providers. Leading manufacturers such as CSL Behring and Grifols have been focusing on expanding production capacity to meet the increasing global demand for IVIg Liquid products.
• IVIg Powder: IVIg Powder represents a smaller but steadily growing segment within the IVIg market. In 2024, IVIg Powder held approximately 30% of the total market share, valued at around USD 3.6 billion. Its advantages include longer shelf life and ease of storage and transportation, which make it a preferred choice in regions with limited healthcare infrastructure. The demand for IVIg Powder is particularly strong in developing markets, where cold chain logistics pose a challenge. Additionally, powder formulations are often used for patients requiring high-dose immunoglobulin therapy over an extended period. Manufacturers are investing in research to improve solubility and reduce preparation time to increase the adoption of IVIg Powder.

By Application

• Immunodeficiency: Immunodeficiency remains the largest application segment in the IVIg market, accounting for over 45% of total revenue in 2024. The rising incidence of primary immunodeficiency diseases (PIDs), including common variable immunodeficiency (CVID) and X-linked agammaglobulinemia, has driven the demand for IVIg treatments. According to the World Health Organization (WHO), more than 6 million people globally are affected by immunodeficiency disorders, with North America and Europe accounting for a significant portion of diagnosed cases. IVIg therapy is essential for maintaining adequate immune function in these patients, reducing the frequency and severity of infections. Increased awareness and early diagnosis of immunodeficiency disorders have further boosted market growth in this segment.
• Autoimmune Disease: The autoimmune disease segment is expected to grow rapidly, driven by the increasing prevalence of conditions such as Guillain-Barré syndrome, Kawasaki disease, and myasthenia gravis. In 2024, the segment accounted for around 35% of the total market revenue, valued at approximately USD 4.2 billion. IVIg therapy is widely used to modulate immune responses and prevent autoimmune attacks on healthy tissues. The American Autoimmune Related Diseases Association (AARDA) estimates that over 50 million Americans are living with autoimmune diseases, highlighting the strong demand for effective treatments. Innovations in formulation and dosage have improved the safety and efficacy of IVIg for autoimmune disorders, contributing to market expansion.
• Acute Infection: The acute infection segment represents a smaller but growing portion of the IVIg market, accounting for around 20% of total revenue in 2024. IVIg therapy is used as a last resort in severe bacterial and viral infections, particularly in immunocompromised patients. The COVID-19 pandemic significantly increased the demand for IVIg products for treating severe respiratory infections and related complications. Furthermore, IVIg is used to manage sepsis and toxic shock syndrome, where conventional antibiotics have limited effectiveness. The increased occurrence of antibiotic-resistant infections and emerging viral diseases is expected to drive further demand for IVIg in the treatment of acute infections.

Regional Outlook

The Intravenous Immunoglobulin (IVIg) market exhibits significant regional variation, driven by differences in healthcare infrastructure, disease prevalence, and regulatory frameworks. North America holds the largest market share, followed by Europe and Asia-Pacific, while the Middle East and Africa represent an emerging market with untapped potential. The availability of advanced healthcare facilities, government reimbursement policies, and increasing awareness about immunodeficiency and autoimmune diseases contribute to regional market growth. Understanding these regional dynamics helps manufacturers develop targeted strategies to enhance market penetration and address local healthcare needs.

North America

North America accounted for over 40% of the global IVIg market revenue in 2024, valued at approximately USD 5.6 billion. The high prevalence of primary and secondary immunodeficiency disorders and autoimmune diseases, along with strong healthcare infrastructure and favorable reimbursement policies, drive market growth. The United States is the largest contributor, with over 60% of the regional market share. Increasing awareness about immunoglobulin therapies and the presence of leading manufacturers such as CSL Behring and Grifols further strengthen the market. The growing elderly population and rising incidence of chronic diseases are expected to sustain demand for IVIg in North America.

Europe

Europe held around 30% of the global IVIg market in 2024, valued at approximately USD 4.2 billion. Germany, France, and the United Kingdom are the major markets in the region, accounting for over 70% of the total European market share. The rising incidence of autoimmune diseases and immunodeficiency disorders, coupled with government support for immunoglobulin therapies, has driven market growth. The European Medicines Agency (EMA) has approved several new IVIg products, enhancing treatment options for patients. Increased healthcare spending and improved diagnostic capabilities are expected to further drive market expansion in Europe.

Asia-Pacific

Asia-Pacific represented around 20% of the global IVIg market in 2024, valued at approximately USD 2.8 billion. Japan, China, and South Korea are the key contributors to regional growth. Increasing healthcare expenditure, improving access to advanced treatments, and a rising prevalence of immunodeficiency and autoimmune diseases are fueling demand for IVIg. China has seen rapid growth in the market due to government initiatives to improve healthcare infrastructure and increase domestic production of immunoglobulin products. Japan’s well-established healthcare system and reimbursement policies also contribute to the steady growth of the IVIg market in the region.

Middle East & Africa

The Middle East & Africa market accounted for approximately 10% of the global IVIg market in 2024, valued at around USD 1.4 billion. The growing prevalence of infectious diseases and rising cases of immunodeficiency disorders, particularly in Saudi Arabia, the UAE, and South Africa, are driving market growth. Limited healthcare infrastructure and high treatment costs remain key challenges, but increasing government investments in healthcare and expanding access to immunoglobulin therapies are creating growth opportunities. The introduction of new IVIg products and improving awareness among healthcare providers are expected to support future market growth in the region.

LIST OF KEY INTRAVENOUS IMMUNOGLOBULIN (IVIG) MARKET COMPANIES PROFILED

• Baxter
• Grifols
• CSL
• Octapharma
• Biotest
• Kedrion
• Hualan Bio
• CNBG
• Shanghai RAAS
• CBPO
• LFB Group
• BPL
• Sichuan Yuanda Shuyang

Top Two Companies with Highest Market Share:

• CSL – Approximately 25% market share
• Grifols – Approximately 21% market share

INVESTMENT ANALYSIS AND OPPORTUNITIES

The Intravenous Immunoglobulin (IVIg) market has witnessed significant investment inflows, driven by rising demand for immunodeficiency treatments and expanding therapeutic applications. Major pharmaceutical companies are focusing on enhancing production capacity and improving the supply chain to meet growing market demand. For instance, CSL announced an investment of over $1 billion to expand its production facility in Bern, Switzerland, which is expected to increase the output of immunoglobulin products by over 30% by 2025.

Grifols, another key player, has allocated more than $400 million toward building a new fractionation plant in North Carolina, USA. This plant is anticipated to process more than 6 million liters of plasma annually, boosting the company’s ability to supply IVIg globally. Furthermore, Octapharma invested approximately $300 million in expanding its manufacturing capacity in Vienna, Austria, aimed at increasing the production of plasma-derived therapies, including IVIg products.

Emerging markets such as Asia-Pacific and Latin America are becoming hotspots for IVIg investment due to the growing incidence of immune-related diseases and increasing patient awareness. Government support and favorable reimbursement policies are further encouraging investments in these regions. Additionally, strategic collaborations and joint ventures among key market players are driving technological advancements, facilitating market expansion, and enhancing overall product accessibility.

NEW PRODUCTS DEVELOPMENT

The Intravenous Immunoglobulin (IVIg) market has seen notable product development activities aimed at improving efficacy, reducing side effects, and enhancing patient convenience. CSL launched a new subcutaneous immunoglobulin product, Hizentra®, with an improved formulation to reduce infusion time by up to 30%. The product has already gained regulatory approval in Europe and the United States, contributing to increased adoption in homecare settings.

Grifols introduced Xembify®, a 20% subcutaneous immunoglobulin solution designed for primary immunodeficiency (PI) patients. The product's enhanced bioavailability and lower infusion volume have made it a preferred choice among healthcare providers and patients. Additionally, Octapharma’s new product, Cutaquig®, a 16.5% immunoglobulin solution, has shown positive results in clinical trials for treating chronic inflammatory demyelinating polyneuropathy (CIDP).

Biotest introduced a high-concentration immunoglobulin solution specifically targeted at patients with compromised immune systems, demonstrating a 15% reduction in adverse reactions during clinical testing. Kedrion also developed a new intravenous immunoglobulin product with an extended half-life, reducing the frequency of infusions required by up to 20% compared to conventional products. These advancements are expected to improve patient outcomes and increase market penetration.

FIVE RECENT DEVELOPMENTS BY MANUFACTURERS IN INTRAVENOUS IMMUNOGLOBULIN (IVIG) MARKET

• CSL completed the expansion of its Bern, Switzerland facility in Q3 2023, increasing its immunoglobulin production capacity by approximately 35%.
• Grifols signed a strategic agreement with the American Red Cross in 2023 to secure a long-term plasma supply, ensuring stability in IVIg production.
• Octapharma launched an upgraded version of Cutaquig® in 2024, which has demonstrated a 20% improvement in bioavailability in clinical trials.
• Biotest received regulatory approval in Europe for its new immunoglobulin product targeting CIDP in Q2 2024, positioning it as a competitor in the segment.
• Kedrion entered a joint venture with Shanghai RAAS in 2023 to enhance plasma collection capabilities in China, aiming to increase supply by over 1 million liters annually.

REPORT COVERAGE OF INTRAVENOUS IMMUNOGLOBULIN (IVIG) MARKET

The report on the Intravenous Immunoglobulin (IVIg) market provides a comprehensive analysis of key market trends, drivers, restraints, and opportunities. It covers detailed market segmentation based on type (IgG, IgA, IgM, IgE, and IgD) and application (Primary Immunodeficiency, Secondary Immunodeficiency, Autoimmune Diseases, and Others). Regional analysis includes market performance in North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa, with detailed insights into demand patterns, competitive landscape, and growth drivers.

The report includes a competitive landscape analysis featuring key players such as CSL, Grifols, Octapharma, Biotest, Kedrion, and others. Market share analysis highlights CSL and Grifols as dominant players, with a combined market share exceeding 46%. Investment trends, product pipeline analysis, and technological advancements are also covered in detail. The report evaluates recent regulatory changes impacting product approvals and market access, providing strategic recommendations for stakeholders. Additionally, it features a section on market dynamics, including the impact of supply chain disruptions and changing healthcare policies on the IVIg market.

The report offers detailed case studies of successful product launches and strategic partnerships, along with insights into patient preferences and shifting treatment trends. Forecasts include anticipated product launches and market penetration strategies through 2030, helping stakeholders identify high-growth opportunities and plan long-term investments effectively.