Global Intravenous Immunoglobulin Market by Type (IgG, IgM, IgA, IgE, And IgD), by Indication (Primary Immunodeficiency, Chronic Inflammatory, Demyelinating Polyneuropathy (CIDP), Guillain-Barre Syndrome (GBS), and Immune Thrombocytopenic Purpura (ITP)), by Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacies), by Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, and Forecast 2023-2032

Report Overview

In 2022, the Intravenous Immunoglobulin Market Size accounted for USD 13.6 billion and is expected to grow to around USD 24.4 billion in 2032. Between 2023 and 2032, this market is estimated to register the highest CAGR of 7.0%.

Market drivers include an aging population, rising prevalence of immunodeficiency disorders, growing use of intravenous immunoglobulin treatments (IVIGs), and non-label indications. IVIG preparations have been developed largely in response to this increasing incidence of immunodeficiency disorder patients.

The global IVIG market is expanding rapidly due to an escalation in patients suffering from bleeding and chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients. Furthermore, this sector of healthcare has seen increased investment, which in turn is driving demand for IVIG products. Furthermore, this growing patient pool includes those suffering from autoimmune diseases and other conditions as well.

IVIG therapy is becoming more and more commonplace as the best and most efficient treatment option for acquired and primary immunodeficiency diseases. Unfortunately, these diseases have become increasingly common due to sedentary lifestyles such as excessive alcohol consumption, increased consumption of saturated fats, salt, and sugars, along with decreased physical activity due to an increasing prevalence of lifestyle-associated disorders like obesity and antibody deficiencies.

According to the National Institutes of Health (NIH), over 500,000 Americans suffer from at least 200 primary immunodeficiency disorders (PIDDs). With the rising prevalence of primary and acquired immune deficiencies such as X-linked hypogammaglobinaemia and AIDS, analysts anticipate that immunoglobulin therapy will witness significant growth over the forecast period.

The rising cost of IVIG therapy will remain a major obstacle to market expansion. Infusions of immunoglobulin are usually given every 3-4 weeks, and the treatment lasts around 12-16 sessions annually; IVIG costs USD 73.89 per kilogram or up to USD 10,000 depending on disease severity; long-term replacement therapies using IgG typically last six months at rates exceeding 30,000 USD annually according to ABIM Foundation estimates.

Key Takeaways

• The Intravenous Immunoglobulin Market size was USD 12.6 billion in 2022.
• The market is projected to reach USD 24.4 billion by 2032.
• The market will register a CAGR of 7.0% between 2023 and 2032.
• North America held a market share of 49.5% in 2022.
• Over 500,000 Americans suffer from at least 200 primary immunodeficiency disorders (PIDDs).
• IVIG costs USD 73.89 per kilogram.
• Treatment using IVIG can cost up to USD 10,000 depending on disease severity.
• Long-term replacement therapies using IgG can exceed 30,000 USD annually.
• Primary Immunodeficiency held a market share of 31.6% in 2022.
• Hospital pharmacies had a revenue share of over 57.3% in 2022.
• IVIG therapy consists of 12-16 sessions annually on average.
• Grifols S.A. acquired Biotest on April 25, 2022.
• 70% of 100 people with symptomatic primary, secondary, or autoinflammatory diseases and C1 inhibitor deficiencies were infected by SARS-CoV-2.
• 69% of those infected were admitted, and 8% died.

Indication Analysis

One major factor expected to drive the intravenous immunoglobulin (IVG) market growth in 2022 is the growing acceptance of IVIG therapy as a primary treatment for primary immunodeficiency and other rare immunological or neurological diseases.

Primary Immunodeficiency has the highest market share among all indication segments, reaching 31.6% in 2022, and is expected to increase over the forecast period. The primary immunodeficiency segment is driven by an increasing focus on diagnosing primary immunodeficiency (P.I.), followed by tailored treatments based on individual cases and training; unfortunately, many patients lack self-administration skillsets.

Forecasts suggest the chronic inflammatory demyelinating polyneuropathy (CIDP) segment will grow slower due to its relatively low prevalence. The market is currently dominated by primary immunodeficiency (P.I.), an indication for intravenous immunoglobulin, which is expected to boost CAGR over the forecast period.

Intravenous immunoglobulin market segments can be divided based on indication, such as primary immunodeficiency, chronic inflammatory demyelinating neuropathy (CIDP), Guillain Barre syndrome (GBS), immune thrombocytopenic purpura (ITP), multifocal motil neuropathy (MMN) and others; in 2022 the primary immunodeficiency segment accounted for 31.6% of global market share. Furthermore, these immunoglobulins come in liquid or lyophilized forms–liquid or lyophilized–as well as end users like home care, hospitals, or clinics.

Distribution Channel Analysis

Hospital pharmacies were the dominant force in 2022, boasting a revenue share of more than 57.3% due to their extensive network of hospitals and diverse product offerings. With the rise in primary immune deficiencies such as hepatitis C and other diseases around the world, hospital pharmacies have seen an uptick in customer preference for quick reimbursement, treatment, and proper care for large numbers of patients, thus leading them to choose these pharmacies over other options for care provision.

Specialty pharmacies offer convenient treatments at home, expanding this segment over the forecast period. The pharmacy business is driven by specialty drugs, with analysts forecasting rapid growth for this sector due to an escalating number of licensed treatments.

Key Market Segments

By Type

• IgG
• IgM
• IgA
• IgE
• IgD

By Indication

• Primary Immunodeficiency
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Guillain-Barre Syndrome (GBS)
• Immune Thrombocytopenic Purpura (ITP)
• Multifocal Motor Neuropathy (MMN)
• Hypogammaglobinemia
• Myasthenia Gravis
• Specific antibody deficiency
• Inflammatory myopathies
• Other Indications

By Distribution Channels

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacies

Drivers

Numerous factors have driven the growth in intravenous immunoglobulin markets such as an increase in the elderly population and hemophilics, improved technologies for immunoglobulin production, and better purification methods (with higher plasma yield) all impact healthcare delivery. Additionally, the rise in the prevalence of diseases such as hypogammaglobinemia, chronic inflammatory demyelinating polyneuropathy (CIDP), and others is anticipated to spur market expansion.

The market’s growth will be restricted by government regulations regarding intravenous immunoglobulin product use and potential side effects. Nonetheless, intravenous immunoglobulins will treat various diseases, offering lucrative business opportunities.

Increased Demand for Hospitals for These Patients

With an increasing number of patients opting for hospital treatment over standalone clinics, the hospital segment dominated this market. IVIG infusions at home have also improved patients’ quality of life; they feel more at ease carrying out daily tasks. Furthermore, having multiple patients seen at once reduces wait times at the doctor’s office.

Restraints

Expensive Treatments

Demyelinating diseases can be costly to diagnose and treat, making IVIG therapy an expensive option. IVIG infusions of immunoglobulin are usually given every 3-4 weeks for 12-16 sessions a year at the cost of USD 73.89 per Gram, with some patients needing up to 10 Grams depending on their severity or condition; therapy lasts around 12-16 sessions annually on average. With prices varying depending on patient severity or condition, there may be an opportunity for those in need of such treatments

Increased Healthcare Expenditure for Immunoglobulins

Immunoglobulins have seen an uptick in funding recently. The National Institute of Allergy & Infectious Diseases funded a Phase III trial entitled Inpatient Treatment with Anti-Coronavirus Immunoglobulin which was later tested as Inpatient Treatment with Anti-Coronavirus Imoglobulin (or IVIG).

Strategic Partnerships and Acquisitions Between Organizations

Market players employ various strategies, such as distribution, mergers and acquisitions, and collaborative agreements, to expand their market penetration and gain a significant share. On April 25, 2022, Grifols S.A. acquired Biotest in an unprecedented deal that will spur growth and innovation by enabling it to expand its product line, provide access to plasma medicine to more patients, manage the largest private European network for plasma facilities, boost revenue growth and margin development – all at once!

Trends

Injectable immunoglobulin therapy (IVIG) has become a major treatment for primary immunodeficiency disease (PID). PIDs with antibody deficiencies are treated through various medical treatments and account for over half of all primary immunodeficiencies; diseases like common variable immunodeficiency (CVID), X-linked agammaglobulinemia, and others all share common features like an impaired antibody function due to the high prevalence of primary immunodeficiencies. This high prevalence has contributed significantly towards driving this segment’s growth over the last few years.

Many pharmaceutical companies are developing immunoglobulin products to treat primary immunodeficiency.

In May 2021, G.C. Pharma announced to the FDA that they had taken their biologics license application for “GC5107” (Immune Globulin Intravenous), which is intended for treating Primary Humoral Immunodeficiency – an inherited genetic condition that causes individuals to have weak or absent immune systems.

The study segment is expected to grow with the availability of IVIG therapies and advances in intravenous immunoglobulin products to treat primary immunodeficiency disease, which is highly probable.

Regional Analysis

North America Was the Leading Market in 2022.

North America held a dominant market share of 49.5% in 2022 due to increased awareness about products for treating immunodeficiency disorders, rising interest among clinicians, and rising healthcare spending. Furthermore, IVIG treatments are becoming more commonly prescribed due to advances in healthcare infrastructure and rapid approvals from U.S. FDA. The market outlook looks promising going forward due to these factors and other anticipated growth drivers, such as product approvals from international bodies like WHO or WHOIDS

This industry is growing due to changing lifestyles and increased chronic illnesses among the elderly. Forecasts indicate this market will experience strong growth over the coming years due to increasing rates of PID (autoimmune diseases). Autoimmune diseases are currently the third leading cause of chronic illness in America; NIOSH estimates that between 5%-8% of U.S. residents will be affected by these illnesses by 2050. For unknown reasons, autoimmune diseases are becoming more frequent; therefore, this number is expected to increase during the forecast period.

Due to increasing awareness of immunoglobulin-based therapies for treating primary immune deficiencies and an aging population, the Asia Pacific region is expected to experience significant growth during the forecast period. Emerging economies, rising healthcare spending, and a rapidly expanding immunoglobulin market have all contributed to its expansion. With rising incidences and awareness about immune disorders along with improved healthcare facilities, further growth can be expected in this business sector.

Key Regions

North America

• The US
• Canada
• Mexico

Eastern Europe

• Russia
• Poland
• The Czech Republic
• Greece
• Rest of Eastern Europe

Western Europe

• Germany
• France
• The UK
• Spain
• Italy
• Portugal
• Ireland
• Austria
• Switzerland
• Benelux
• Nordic
• Rest of Western Europe

APAC

• China
• Japan
• South Korea
• India
• Australia & New Zealand
• Indonesia
• Malaysia
• Philippines
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Colombia
• Chile
• Argentina
• Costa Rica
• Rest of Latin America

Middle East & Africa

• Algeria
• Egypt
• Israel
• Kuwait
• Nigeria
• Saudi Arabia
• South Africa
• Turkey
• United Arab Emirates
• Rest of MEA

Key Players Analysis

The number of FDA approvals is rising rapidly, propelling this industry. Many international and local players have started investing in IVIG. Pfizer was approved by the FDA in February 2021 for their supplemental Biologics Lien Application (BLA) with PANZYGA intravenous immunoglobulin, used to treat adults suffering from Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Market players employ various strategies to expand their market presence, such as mergers and acquisitions, distribution, and collaborative agreements. On April 25, 2022, Grifols S.A. acquired Biotest AG in a major deal to spur growth and innovation within the sector. Grifols’ acquisition of Biotest AG will enable it to expand its product line, provide more patient access to plasma medicines, and run the largest private European network (87 sites) of plasma facilities.

Furthermore, this acquisition helps boost revenue growth and develop margins. Argenx SE recently confirmed to the Japanese Ministry of Health, Labour and Welfare that VYVGART intravenous injection is now approved as a treatment option for severe adult patients suffering from generalized myasthenia Gravis. Unlike steroids or other non-steroidal immunosuppressive therapies, this therapy does not necessitate steroids or other steroids.

The Intravenous Immunoglobulin Market is highly fragmented, featuring numerous local and regional players. Companies facing intense competition from top market participants – particularly those with strong brand recognition and extensive distribution networks – must employ various expansion strategies, such as partnerships and product launches, to remain competitive.

These are some of the major players in the global Intravenous Immunoglobulin Market:

Market Key Players

• CSL Behring
• Shire (Takeda Pharmaceutical Company Limited)
• Grifols, S.A.
• Kedrion S.p.A
• Octapharma
• Bio Products Laboratory Ltd.
• Biotest AG
• China Biologic Products Holdings, Inc.
• LFB SA
• Shanghai RAAS Blood Products Co., Ltd.
• Other Key Players

Recent Development

• In May 2019, the FDA granted ADMA Biologics, Inc.’s product offering of BIVIGAM. Subsequently, ADMA announced that they would commence commercial sales.
• In April 2019, ADMA Biologics, Inc.’s novel intravenous immunoglobulin Asceniv (Immune) will be approved for treating primary immunodeficiency.

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