Global Immunoglobulin Market - 2023-2030

Overview

Immunoglobulins (Ig) which are also known as antibodies are the glycoproteins produced by plasma cells. B cells are instructed by specific immunogens, such as bacterial proteins, to differentiate into plasma cells, which are protein-making cells that participate in humoral immune responses against bacteria, viruses, fungi, parasites, cellular antigens, chemicals, and synthetic substances. The immunogen or antigen reacts with a B-cell receptor on the cell surface of B lymphocytes. A signal is produced that directs the activation of transcription factors to stimulate the synthesis of antibodies, which are highly specific for the immunogen that stimulated the B cell.

Moreover, the various immunoglobulins produced by plasma cells are classified by isotype, each differs in function and antigen responses primarily due to structure variability. The five major antibody classes that have been identified in placental mammals, they are IgA, IgD, IgE, IgG, and IgM. This classification is based on differences in amino acid sequence in the constant region of the antibody heavy chains. IgG and IgA are further grouped into subclasses based on additional small differences in the amino acid heavy chain sequences. These are used to treat many autoimmune and other chronic disorders.

Market Dynamics: Drivers

Increasing demand for innovative immunoglobulins

The increasing demand for innovative immunoglobulins is expected to drive the market over the forecast period. The innovative immunoglobulins are mainly designed to treat various types of diseases and they aim to address the unmet needs associated with the management and treatment of various disorders by providing alternative or complementary treatment options. Regulatory approvals such as FDA approvals are also increasing, which further increases the adoption of immunoglobulins.

For instance, on May 19, 2023, AbbVie, cleared that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapies. EPKINLY is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology.

Moreover, immunoglobulins have traditionally been used for conditions such as primary immunodeficiency disorders and autoimmune diseases. However, researchers and pharmaceutical companies are focussing on exploring their potential for treating and diagnosing a broader range of conditions by using immunoglobulins.

For instance, on August 24, 2023, Thermo Fisher Scientific, the world leader in serving science, launched the EXENT Solution, after receiving IVDR certification. The EXENT solution is a fully integrated and automated mass spectrometry system designed to transform diagnosis and assessment for patients with monoclonal gammopathies, including multiple myeloma. The analyzer is combined with the EXENT Immunoglobulin Isotypes (GAM) immunoassay, a highly sensitive and specific immunoassay for measuring and quantifying IgG, IgA, and IgM.

Additionally, on March 29, 2022, Sanofi partnered with IGM Biosciences to create, develop, manufacture and commercialize six immunoglobulin M (IgM) antibody agonists, three against oncology targets and the other three against immunology/inflammation targets.

Further, the increasing prevalence of immunodeficiency and other immune-related disorders, rising FDA approvals, increasing clinical trials, increasing awareness and advancements in the development of novel products are the factors expected to drive the market over the forecast period.

Restraints

Factors such as severe and rare side effects of immunoglobulins like transfusion-related acute lung injury (TRALI), acute renal failure, anaphylaxis to IgE or IgG antibodies to IgA, arrhythmias, aseptic meningitis, arthritis, hepatitis, pleural effusion and other dermatological manifestations are expected to hamper the market.

Segment Analysis

The global immunoglobulin market is segmented based on type, form, application, route of administration, end-user and region.

The immunoglobulin G (IgG) segment accounted for approximately 52.1% of the immunoglobulin market share

The immunoglobulin G (IgG) segment is expected to hold the largest market share over the forecast period. Immunoglobulin G is further subdivided into four types, they are IgG1, IgG2, IgG3 and IgG4. IgG is the most commonly abundant class of antibodies in the human body, constituting about 75-80% of the total immunoglobulin pool. It is found in the blood and tissues and is crucial for long-term immunity. IgG can neutralize toxins and viruses, preventing them from infecting cells.

Furthermore, intravenous immunoglobulins involve the administration of IgG antibodies extracted from the plasma of thousands of donors. These intravenous immunoglobulins are used to boost the immune system in patients with immunodeficiency disorders and to modulate immune responses in certain autoimmune conditions.

For instance, on September 21, 2023, Biotest AG launched its intravenous immunoglobulin Yimmugo (IgG Next Generation) and got approval in the United Kingdom for the treatment of patients with congenital and acquired immunodeficiencies and for immunomodulation, following approvals in Germany and Austria.

Additionally, on January 6, 2023, Eisai Co., Ltd. And Biogen Inc. released the approval from U.S. Food and Drug Administration (FDA) for lecanemab-irmb (LEQEMBI) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (AB) for the treatment of Alzheimer's disease (AD).

Geographical Analysis

North America accounted for approximately 41.1% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing adoption of immunoglobulins. North America especially the United States is known for its strong presence of major players such as pharmaceutical companies and biotechnology companies. The presence of major players actively performing research activities to develop immunoglobulin products for the treatment of various diseases.

For instance, on April 11, 2023, Takeda cleared that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application to expand the use of HYQVIA to treat primary immunodeficiency (PI) in children 2-16 years old. HYQVIA is the only subcutaneous immune globulin infusion that can be administered once a month, every three or four weeks and was first approved in the U.S. for the treatment of PI in adults.

Furthermore, the increasing adoption of immunoglobulins in the region is also driving the market in the region. There is a continuously increasing prevalence of immunodeficiency disorders in the region, further increasing the adoption of immunoglobulins for the treatment and management of these disorders. For instance, according to the Journal of Allergy and Clinical Immunology (JACI), 2020, the prevalence of primary immunodeficiency disorders in the United States is estimated at 1 in 2000 individuals.

Competitive Landscape

The major global players in the immunoglobulin market include: Takeda Pharmaceuticals Inc., CSL Limited, Octapharma AG, Kedrion Biopharma Inc., Grifols, S.A., ADMA Biologics, Inc., Pfizer Inc., Kamada Pharmaceuticals, Cygnus Technologies and Emergent BioSolutions Canada Inc. among others.

Key Developments

• On September 26, 2023, Takeda released that the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in patients aged 2 years and older with agammaglobulinemia or hypogammaglobulinemia1, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency or secondary immunodeficiency.
• On February 18, 2021, Agilent Technologies Inc. launched the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit intended for the qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma. The kit, which marks Agilent's entrance into SARS-CoV-2 testing in the US, has completed the notification process to the FDA in accordance with Section IV.D of FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency".
• On November 10, 2020, Beckman Coulter, a clinical diagnostics leader, launched its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries accepting the CE Mark. The new IgM antibody test demonstrated 99.9% specificity with 1,400 negative samples and 100% sensitivity at >18 days post-symptom onset and positive PCR. Beckman Coulter's antibody assays and its other planned SARS-CoV-2 offerings run on the organization's award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, which is capable of processing 200 samples per hour.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global immunoglobulin market. When infected with COVID-19, patients produce antibodies to fight off the infection. These antibodies are known as immunoglobulins and are key players in the response to COVID-19. The demand for immunoglobulins has increased due to the pandemic.

For instance, on May 21, 2021, the Defence Institute of Physiology and Allied Sciences (DIPAS), a laboratory of the Defence Research and Development Organisation (DRDO), developed an antibody detection-based kit 'DIPCOVAN', the DIPAS-VDx COVID-19 IgG Antibody Microwell ELISA for sero-surveillance. The DIPCOVAN kit can detect both spikes as well as nucleocapsid (S&N) proteins of SARS-CoV-2 virus with a high sensitivity of 97 percent and specificity of 99 percent.

Market Segmentation

By Type

• Immunoglobulin G (IgG)
  • IgG1
  • IgG2
  • IgG3
  • IgG4
• Immunoglobulin M (IgM)
• Immunoglobulin A (IgA)
  • IgA1
  • IgA2
• Immunoglobulin D (IgD)
• Immunoglobulin E (IgE)

By Form

• Soluble Immunoglobulins
• Membrane-Bound Immunoglobulins

By Application

• Hypogammaglobulinemia
• Chronic Inflammatory Demyelinating Polyneuropathy
• Immunodeficiency Disorders
• Myasthenia Gravis
• Idiopathic Thrombocytopenic Purpura
• Inflammatory Myopathies
• Others

By Route of Administration

• Intravenous
• Subcutaneous
• Others

By End-User

• Hospitals
• Specialty Clinics
• Diagnostic Centers
• Research and Academic Centers
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Why Purchase the Report?

• To visualize the global immunoglobulin market segmentation based on type, form, application, route of administration, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of immunoglobulin market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global immunoglobulin market report would provide approximately 77 tables, 84 figures, and 187 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies