Intravenous Immunoglobulin Market Analysis

Global Intravenous Immunoglobulin Market Overview

The Intravenous Immunoglobulin (IVIg) Market Size was valued at USD 11.35 Billion in 2023. The Global Intravenous Immunoglobulin (IVIg) industry is projected to grow from USD 12.27 Billion in 2024 to USD 22.88 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 8.90% during the forecast period (2024 - 2032).The primary factors driving the market include the expanding elderly population, rising immunodeficiency disease prevalence, rising usage of intravenous immunoglobulin (IVIG) therapies, and rising off-label indications are the key market drivers enhancing the market growth.

Key market drivers enhancing market growth include an aging population, an increase in the prevalence of immunodeficiency diseases, a rise in the use of intravenous immunoglobulin (IVIG) therapies, and an increase in the number of patients treated for off-label indications. The increasing prevalence of autoimmune diseases and other pathologies is also contributing to the growth of the IVIg industry. The fundamental reason for the advancement of IVIG preparations is the increasing number of individuals with immunodeficiency diseases.

Rapid expansion of the global IVIG market is being spurred by an increasing patient population suffering from bleeding disorders and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). With more money being poured into healthcare, the market for IVIG is growing. In addition, there are more people with autoimmune illnesses and other pathological problems, which is driving growth in the IVIG market.

The market is also being propelled by demographic shifts, such as an older population and the growth of immunodeficiency diseases and bleeding disorders treated with immunoglobulin treatment. Autoimmune disorders are on the rise, and no one seems to know why. The rise in this figure is expected to continue throughout the forecast period, which is helping to boost sales of intravenous immunoglobulin.

The demand for IVIG treatments is rising since they are the most effective and the sole therapy option for acquired and primary immunodeficiency illnesses. In addition, the prevalence of these diseases has increased because of sedentary lifestyle patterns, such as eating a lot of saturated fat, salt, and sugar, not getting enough exercise, and drinking a lot of alcohol. The rise is anticipated to be driven by the increasing incidence of lifestyle-related diseases such obesity and antibody deficiency illnesses.

July 2023, GC Biopharma said on Monday that the preliminary review for marketing authorization of its blood product Alyglo (GC5107B, 10% intravenous immunoglobulin) had been completed by the U.S. Food and Drug Administration. The U.S. Food and Drug Administration (FDA) has also begun reviewing GC5107B for final clearance, the firm said. The business submitted a Biologics License Application (BLA) for Alyglo on July 14 (local time), and two weeks later, on August 4, the FDA conducted a preliminary evaluation. Once the BLA has been received, the FDA will perform a preliminary evaluation for 60 days and then commence the complete review procedure if the evidence is sufficient.

Intravenous Immunoglobulin Market Trends

• Expanding Diagnostic Uses of Biomarkers to drive market growth

A rising number of patients with bleeding disorders and patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) are driving the rapid growth of the worldwide IVIG market. The IVIG market is expanding due to increased investment in the healthcare sector. Also, the market for IVIG products is expanding due to the rising number of patients with autoimmune diseases and other pathological disorders.

In addition, the market is being driven by important reasons such as the aging of the population, the increased use of immunoglobulin therapy, and the rise in immunodeficiency illnesses and bleeding disorders. For instance, Amgen received FDA approval for RIABNI (rituximab-Marx), a biosimilar of Rituxan, in June 2022 for people with moderately to severely active rheumatoid arthritis (RA) who have not showed a favourable response to one or more TNF antagonist medicines. In addition, the market is being driven by important reasons such as the aging of the population, the increased use of immunoglobulin therapy, and the rise in immunodeficiency illnesses and bleeding disorders has recently enhanced the intravenous immunoglobulin market CAGR across the globe years.

For instance, Autoimmune disorders are the third most common cause of chronic diseases in the US. The National Institutes of Health anticipates that illnesses impact between 5% and 89% of the U.S. population since many autoimmune conditions are infrequent. For unknown reasons, autoimmune diseases are becoming increasingly prevalent. The number is anticipated to increase throughout the predicted time, which is another factor driving the market growth of the intravenous immunoglobulin revenue.

Intravenous Immunoglobulin Market Segment Insights

Intravenous Immunoglobulin Type Insights

Based on type, the intravenous immunoglobulin (IVIg) segmentation includes IgD, IgG, IgE, IgA, and IgM. The IgG segment is currently the largest and most widely used IVIG type, accounting for most IVIG sales. This is due to its broad spectrum of indications and effectiveness in treating many autoimmune and inflammatory diseases. However, the market share of each segment may vary depending on factors such as regional differences in disease prevalence and treatment practices. It is important to note that the market for IVIG is constantly evolving, and new types of IVIG may emerge in the future that could shift the market landscape

For instance, a research released in the August 2020 issue of Frontiers in Immunology and titled "Systematic Evaluation of Primary Immunodeficiency Disorders in Malaysia: 1979-2020," only 27,000–60,000 of the six million persons estimated to have PIDs had been detected. According to the source above, the incidence of PIDs in Singapore was reported to be 2.65 per 100,000 live births, with an estimated occurrence rate of one in 37,000.

The IgA or immunoglobulin A segment holds the second-largest intravenous immunoglobulin (IVIg) revenue share. IgA, or immunoglobulin A, is one of several types of antibodies found in IVIg. IgA is important for immune defense in the respiratory, gastrointestinal, and genitourinary tract's mucous membranes. It is also found in saliva, tears, and breast milk. IVIg has been increasing in recent years due in part to the growing number of indications for its use.

August 2021:The phase III clinical trial for the investigational SARS-CoV-2 Immune Globulin Intravenous (COVID-HIG) plasma-derived therapy has begun, according to Emergent BioSolutions, Inc., a specialty biopharmaceutical company with U.S. headquarters. This trial will assess the efficacy of this therapy as an effective outpatient treatment for patients with coronavirus (COVID-19) who are at high risk of developing severe disease.

February 2021:Pfizer received US FDA approval for PANZYGA, an intravenous immunoglobulin used to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Intravenous Immunoglobulin Application Insights

Based on application, the intravenous immunoglobulin (IVIg) industry has been segmented into Guillain–Barré Syndrome, Hypogammaglobulinemia, Specific Antibody Deficiency, Chronic Inflammatory Polyneuropathy, Inflammatory Myopathies, Myasthenia Gravis, Idiopathic Thrombocytopenic Purpura, and Multifocal Motor Neuropathy. A revenue share of over 20% is anticipated for Inflammatory Myopathies in 2022 due to the rising prevalence of primary and acquired immunodeficiency diseases (PID & AID).

In 2022, the chronic inflammatory demyelinating polyneuropathy sector was anticipated to have the second-largest share. Diabetes mellitus patients typically have it: Steroids, plasmapheresis, and immunosuppressive medications are all used to treat CIDP. An efficient and long-lasting substitute for these techniques is IVIG. The accompanying advantages of safety, minimal invasiveness, and user-friendliness foster the industry's expansion.

In 2022, hypogammaglobulinemia was anticipated to contribute the third-largest revenue share in the intravenous immunoglobulin (IVIg) industry. This is explained by the rise of primary immunodeficiency disorders (PID) cases worldwide. It is the most prevalent chronic immunological deficiency (LPD) among individuals with lymphoproliferative diseases.

Figure 1: INTRAVENOUS IMMUNOGLOBULIN (IVIg) MARKET SHARE BY APPLICATION 2022-2030 (USD BILLION) 

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

January 2023, Lecanemab-irmb (LEQEMBI) 100 mg/mL injection for intravenous use is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid beta (A) for the treatment of Alzheimer's disease (AD), its manufacturers Eisai Co., Ltd. and Biogen Inc. announced in January 2023. The clearance was based on Phase 2 evidence showing that LEQEMBI decreased the buildup of A plaque in the brain, a hallmark of AD. Data from the massive global confirmatory Phase 3 clinical study, Clarity AD, were just released, and Eisai plans to use them to promptly submit a Supplemental Biologics License Application (sBLA) to the FDA for approval via the standard process.

Intravenous Immunoglobulin Regional Insights

By Region, the study provides market insights into North America, Europe, Asia-Pacific and Rest of the World. North America held the largest market share, with 45.80%. The primary drivers of market expansion include expanding clinician propensity for these medicines, rising knowledge of items used in treating immunodeficiency illnesses, and rising healthcare spending.

Diseases, growing consumer knowledge of biomarkers, encouraging government programs, technical breakthroughs, and improvements in the healthcare system. A significant element anticipated to fuel the region's growth is the presence of prominent firms in this area and the many organic and inorganic projects they have undertaken. For Instance, Akoya Biosciences, Inc. declared the release of PhenoCode signature panels for high-throughput spatial biomarker identification in November 2022.

Further, the major countries studied in the market report are: The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: INTRAVENOUS IMMUNOGLOBULIN (IVIg) MARKET SHARE BY REGION 2022 (%) 

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe intravenous immunoglobulin (IVIg) accounts for the second-largest market share. IVIg is in high demand in Europe as it is used to treat a variety of ailments, such as primary immunodeficiencies, autoimmune illnesses, and neurological disorders. Europe has a well-established healthcare system and a high level of awareness about the benefits of IVIg, which also contributes to the market's growth in this region. . Further, UK intravenous immunoglobulin (IVIg) held the largest market share, and Germany intravenous immunoglobulin (IVIg) was the fastest-growing market.

The Asia Pacific Intravenous Immunoglobulin (IVIg) Market is expected to grow at the highest CAGR from 2024 to 2032 due to growing awareness and potential opportunities for adopting immunoglobulin-based therapies to treat primary immune deficiencies, combined with a growing senior population. Emerging countries, rising healthcare spending, and the quickly expanding immunoglobulin market are other reasons boosting the development of this industry. Further, China's intravenous immunoglobulin (IVIg) held the largest market share, and India's intravenous immunoglobulin (IVIg) was the fastest-growing market in Asia.

Intravenous Immunoglobulin Market Key Market Players & Competitive Insights

Major market players spend a lot of money on research and development to expand their product offerings, which will spur further growth in intravenous immunoglobulin (IVIg). With significant market developments like introducing new products, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations, market participants are also undertaking various strategic initiatives to expand their footprint. To grow and thrive in a market that is ever more competitive and growing, competitors in the biomarker testing industry must provide affordable products.

One of the most common business methods firms use in the intravenous immunoglobulin (IVIg) industry to benefit clients and expand the market sector is manufacturing locally to reduce operating costs. In recent years, the intravenous immunoglobulin (IVIg) industry has provided medicine with some of the most significant benefits. The intravenous immunoglobulin (IVIg) major players include Kedrion S.p.A, Baxter International Inc, OMRIX Biopharmaceuticals Ltd, Biotest AG, Hualan Biological Engineering Inc, and others working on expanding the market demand by investing in research and development activities.

Grifols is a healthcare company headquartered in Barcelona, Spain, specializing in developing, producing, and distributing plasma-derived medicines, diagnostic systems, and medical devices. For instance, in April 2022, Grifols S.A. finalized Biotest's substantial and game-changing acquisition, which will foster development and innovation. The acquisition of Biotest AG by Grifols enables it to expand and accelerate its product line, increase patient access to plasma medications, run the largest private European network of plasma facilities (87 locations), and increase revenue growth and margin expansion.

Also, Baxter operates in over 100 countries worldwide and has a diversified product portfolio that includes pharmaceuticals, medical devices, and biotechnology products. The company's core business focuses on developing and producing renal and hospital products, such as dialysis machines, intravenous (IV) solutions, and anesthesia products.

Key Companies in the intravenous immunoglobulin Market includes

• Kedrion S.p.A


• Baxter International Inc


• OMRIX Biopharmaceuticals Ltd


• Biotest AG


• Hualan Biological Engineering Inc


• Shanghai RAAS Blood Products Co


• CSL Limited


• Grifols


• Guizhou Taibang Biological Products Co, among others

Intravenous Immunoglobulin Industry Developments

November 2023: Grifols, S.A. received approval from the U.S. Food and Drug Administration (FDA) for its new immunoglobulin (Ig) purification and filling facility at its Clayton, North Carolina. The FDA approval was specifically for Gamunex-C (immunoglobulin G brand). The approval enabled the company to manufacture an additional 16 million grams of the therapy annually, bringing total global capacity to 60 million grams. 

March 2022:Sanofi and Seagen Inc. reached an exclusive partnership deal to create, develop, and market antibody-drug conjugates (ADCs) targeting up to three cancer targets. The cooperation will use the exclusive monoclonal antibody (mAb) technology from Sanofi and the exclusive ADC technology from Seagen.

Intravenous Immunoglobulin Market Segmentation

Intravenous Immunoglobulin Type Outlook

• IgD


• IgG


• IgE


• IgA


• IgM

Intravenous Immunoglobulin Application Outlook

• Guillain–Barré Syndrome


• Hypogammaglobulinemia


• Specific Antibody Deficiency


• Chronic Inflammatory Polyneuropathy


• Inflammatory Myopathies


• Myasthenia Gravis


• Idiopathic Thrombocytopenic Purpura


• Multifocal Motor Neuropathy

Intravenous Immunoglobulin Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America