Immunoglobulin Market - By Product Type (IgG, IgA, IgM), By Route of Administration (Intravenous, Subcutaneous), By Application (Primary Immunodeficiency Disease, Secondary Immunodeficiency Disease) By End-use (Hospitals) & Forecast, 2023 – 2032

Immunoglobulin Industry Analysis

Immunoglobulin Market size was valued at around USD 9.8 billion in 2022 and is estimated to register over 7.4% CAGR between 2023 and 2032. Growing adoption of organic and inorganic strategies by various market players will accelerate the global industry growth.
 

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For instance, in April 2023, Takeda announced that the U.S. Food and Drug Administration approved a supplemental biologics license application (sBLA) to expand the use of HYQVIA. HYQVIA is a subcutaneous immune globulin (ScIG) used to treat primary immunodeficiency (PI) in children 2-16 years old. Thus, increasing number of product approvals will supplement the market growth. Furthermore, growing prevalence of autoimmune diseases such as Guillain-Barre syndrome, primary immunodeficiency disease (PID), and immune thrombocytopenic purpura (ITP), among others will escalate the market demand.
 

Immunoglobulins, also known as antibodies, are specialized proteins produced by the immune system in response to the presence of foreign substances such as bacteria, viruses, and other pathogens. They play a critical role in the body’s defense against infection and diseases by recognizing and binding to specific antigen on the surface of this invaders, thereby making them for disruption by other immune cells or neutralizing their harmful effects. There are several types of immunoglobulins including IgA, IgD, IgE, IgG, and IgM each with unique structures and functions.
 

COVID-19 Impact

The COVID-19 pandemic had a negative impact on the immunoglobulin market. Plasma collection decreased globally because of severe lockdown circumstances and constraints. This caused a storage of plasma and plasma fractionation. For instance, as per the Nigerian Journal of Clinical Practice, a 17.1% decline in numbers of blood donations was observed over the study period, especially in April 2020, a 21.7% decline in numbers of blood transfusions, especially in April 2020. The largest declines in transfusion were noted in surgery department for fresh frozen plasma. As a result, it was challenging for the major players to collect plasma for plasma fractionation. Thus, because of the severe shortage, patients were having trouble getting access to plasma products, particularly immunoglobulin. Such factor hampered the market's expansion.
 

Immunoglobulin Market Trends

The prevalence of immunodeficiency disorders has increased because of sedentary lifestyle patterns, such as consuming saturated fats, salt, and sweets, engaging in fewer physical activities, and consuming large amounts of alcohol. Thus, the increasing incidence of diseases linked to lifestyle, such as obesity and disorders caused by an insufficient supply of antibodies will accelerate the market growth. For instance, according to the National Institute of Health report, there are more than 200 different forms of primary immune deficiency diseases (PIDDs) affecting approximately 500,000 people in the U.S. Thus, the requirement for immunoglobulin therapy is anticipated to rise over the forecast period due to the increasing prevalence of primary and acquired immunodeficiency diseases.
 

Immunoglobulin Market Restraint

The high cost associated with the therapy is expected to hamper the global market growth. For instance, as per the Children's Hospital of Philadelphia Research Institute, lifelong immunoglobulin replacement therapy (IRT) is the standard of care in the U.S. and other high-income nations for the treatment of congenital agammaglobulinemia. It is administered either as a monthly intravenous infusion or a weekly or biweekly subcutaneous infusion. Even while the medication substantially lowers the incidence of infections, not all infections are entirely prevented.
 

Additionally, patients' quality of life is impacted by the requirement for frequent infusions. Furthermore, the treatment with IRT costs between $30,000 and $90,000 in the U.S. Thus, such increased cost of treatment is anticipated to hinder the market growth.
 

 Immunoglobulin Product Type Segmentation

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Based on product type, the market is segmented as IgG, IgA, IgM, IgD, and IgE. The IgG segment accounted around 74% of the market share in 2022 and is projected to witness robust growth over the analysis timeframe. During the projected period, it is anticipated that rising immunoglobulin acceptance, an increase in the frequency of product introductions, and rapid approval from regulatory agencies at all levels of government will boost the market growth. For instance, in January 2022, Argenx SE, a global immunology company announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved VYVGART. VYVGART intravenous infusion (efgartigimod alfa) is used for the treatment of adult patients with generalized myasthenia gravis (gMG) who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). Thus, increasing number of product approvals is expected to foster the market statistics.
 

Immunoglobulin Route of Administration Segmentation

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Based on route of administration, the market is segmented as intravenous (IVIG), and subcutaneous (SCIg). The intravenous (IVIG) held a dominant market share of around 67.2% in 2022 and is expected to grow at a significant pace during the analysis period. The rapid absorption rate provided by intravenous mode of delivery and the high immunoglobulin bioavailability are the factors supporting the expansion of the intravenous mode of delivery immunoglobulin market. Furthermore, numerous immunoglobulins are receiving more financing, which is fostering the market's expansion. For instance, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC. The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG. Such factor will accelerate the market growth. Moreover, increasing application of plasma derived therapy for the treatment of rare diseases will further escalate the market growth.
 

Immunoglobulin Application Segmentation

Based on application, the immunoglobulin market is segmented as chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), primary immunodeficiency disease (PID), secondary immunodeficiency disease (SID), Guillain-Barre syndrome, immune thrombocytopenic purpura (ITP) and others. The chronic inflammatory demyelinating polyneuropathy (CIDP) segment held a considerable market share in 2022 and is expected to grow at a steady pace of 7.7% between 2023 to 2032. Increasing prevalence of chronic inflammatory demyelinating polyneuropathy (CIDP) will accelerate the market growth. For instance, the overall prevalence of CIDP is estimated at 4.8 to 8.9 cases per 100,000 persons. The prevalence in children is estimated at 0.5 cases per 100,000 persons. Treatment of CIDP includes the use of immunosuppressants, steroids, and plasmapheresis. Intravenous immunoglobulin (IVIG) is an effective long-term alternative to these methods, thereby driving the market growth.
 

Immunoglobulin End-use Segmentation

Based on end-use, the immunoglobulin market is segmented as hospitals, clinics, and homecare. The hospitals segment held a dominant market share in 2022 and is expected to grow at a significant pace of 7.8% between 2023 to 2032. The presence of advanced medical infrastructure and 24/7 monitoring by medical professionals are some of the main reasons for the segment's dominance. In addition, the number of hospital facilities that consider the health requirements of the population are increasing in developed and emerging countries, leading to an increase in the number of hospitalized patients. For instance, according to the American Hospital Association (AHA), in 2022, the total number of hospitals in U.S. were 6,129 and the total number of admissions in hospitals were 34,011,386. Thus, increasing number of hospitalized patients will supplement the segmental expansion.
 

Immunoglobulin Regional Analysis

U.S. immunoglobulin market exceeded USD 4.9 billion in 2022. This majority market share is attributable to the increasing healthcare expenditure, rising awareness of products used to treat immunodeficiency diseases, and growing inclination of physicians toward immunodeficiencies therapies. In addition, increasing regulatory approval for expansion of immunoglobulin manufacturing process in this region is also expected to drive the market growth. For instance, in April 2021, ADMA Biologics, Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, announced that the U.S. FDA has granted approval for the company’s expanded manufacturing process. This enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of intravenous immune globulin (“IVIG”). Such approval is anticipated to foster the regional market size.
 

Immunoglobulin Industry Leaders

Some of the major market players operating in the Immunoglobulin market are Baxter international Inc., Johnson & Johnson (Omrix Biopharmaceuticals Inc.), Pfizer Inc., Takeda Pharmaceutical Company Limited, Grifols SA, Kedrion S.p.A, and CSL Behring, among others. These players focus on strategic partnerships, new product launch & commercialization for market expansion. Furthermore, these players are heavily investing in research that allows them to introduce innovative products and garner maximum revenue in the market.
 

Immunoglobulin Industry News:

• In March 2022, Grifols, a leading global producer of plasma-derived medicines, announced that its innovative 20% subcutaneous immunoglobulin (SCIG), XEMBIFY has been approved by several European Union member state health authorities as well as the U.K.’s to treat primary and select secondary immunodeficiencies. This strategy helped the company to expand their customer base.
   
• In January 2022, Octapharma announced that the indication for cutaquig, a human immunoglobulin for subcutaneous administration, had been expanded in the European Union (EU). This indication provides flexible treatment options to a far-wider range of patients with acquired immune deficiencies (AID). This strategy helped the company to expand and grow.
   

Immunoglobulin market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032, for the following segments:

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By Product Type

• IgG
• IgA
• IgM
• IgD
• IgE

By Route of Administration

• Intravenous (IVIG)
• Subcutaneous (SCIg)

By Application

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Multifocal Motor Neuropathy (MMN)
• Primary Immunodeficiency Disease (PID)
• Secondary Immunodeficiency Disease (SID)
• Guillain-Barre syndrome
• Immune thrombocytopenic purpura (ITP)
• Other Applications

By End-use

• Hospitals
• Clinics
• Homecare

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Poland
  • Switzerland
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
  • Indonesia
  • Vietnam
  • Rest of Asia Pacific 
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Chile
  • Colombia
  • Peru
  • Rest of Latin America 
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Rest of MEA