免疫グロブリンの市場シェア分析、業界動向と統計、成長予測 2025-2030年

本レポートは、世界の免疫グロブリン市場の規模と動向を網羅し、製品（IgG、IgA、IgM、IgE、IgD）、投与方法（静脈内投与および皮下投与）、用途（低ガンマグロブリン血症、慢性炎症性脱髄性多発神経炎（CIDP）、免疫不全疾患、重症筋無力症、その他の用途）、および地域（北米、欧州、アジア太平洋、中東・アフリカ、南米）別にセグメント化しています。本レポートでは、上記セグメントの市場規模（百万米ドル単位）を提供しています。

The Immunoglobulin Market is expected to register a CAGR of 7.31% during the forecast period.

免疫グロブリン市場は、予測期間中に 7.31% の CAGR を記録すると予想されます。

The COVID-19 pandemic has increased demand for immunoglobulin products to help boost the immune response and fight off the infection. For instance, according to an article published by the Frontiers Journal in February 2023, it was found that long-term high-dose immunoglobulin therapy was an effective treatment option for COVID-19 patients. Therefore, the adoption of immunoglobulin therapy surged during the pandemic, thereby burgeoning the market growth. Furthermore, the demand for immunoglobulins is projected to remain high during the post-pandemic period due to the long-term health effects of COVID-19. Post-acute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID, could result in persistent symptoms or conditions that require ongoing treatment, including immunoglobulins. Therefore, looking at the overall scenario, it was observed that the COVID-19 pandemic had a significant impact on the market studied.

The major factors driving the market growth include increased immunodeficiency disease prevalence and a surging number of drug launches by prominent players. Immunoglobulins are crucial in managing immunodeficiency diseases by supplementing deficient antibodies, preventing infections, improving immune function, and managing autoimmune manifestations. Intravenous Immunoglobulins (IVIG) replace the missing antibodies and thereby aid in preventing recurrent infections. Hence, with the rising burden of immunodeficiency disorders, the market is expected to grow significantly during the forecast period. For instance, as per the article published by BioMed Central Ltd in March 2022, the prevalence of Common Variable Immunodeficiency (CVID) in the same population was approximately 16.6% in the United States, 22.5% in Canada, and 34.2% in Australia in 2021. The high prevalence of CVID and improved diagnosis and awareness have increased the demand for immunoglobulin therapies. In addition, immunoglobulin therapy plays a significant role in managing Myasthenia Gravis (MG). Immunoglobulins temporarily improve muscle function and relieve MG symptoms by blocking pathogenic autoantibodies targeting acetylcholine receptors and modulating the immune response. Hence, the rising prevalence of MG is projected to drive market growth during the forecast period. For instance, as per an article published by the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in November 2022, MG is a chronic neuromuscular autoimmune disease that can cause life-threatening muscle weakness, affecting approximately 56,000 to 123,000 people in Europe annually. Therefore, the high prevalence of MG is projected to create high demand for immunoglobulin therapeutics during the forecast period.

Moreover, the active participation of government organisations in the launch of various advanced immunoglobulin therapeutics is also projected to drive market growth during the forecast period. For instance, in August 2022, Argenx received the European (EC) marketing authorisation grant for VYVGART (efgartigimod alfa-fcab), a human IgG1 antibody fragment, as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Thus, the market is expected to project significant growth over the forecast period due to the rising prevalence of immunodeficiency disorders such as Common Variable Immunodeficiency and myasthenia gravis and the number of product launches by prominent players. However, stringent government regulations and the high cost of therapy are expected to impede market growth during the study period.

Immunoglobulin Market Trends

Intravenous Segment is Expected to Hold Major Share Over the Forecast Period

Intravenous immunoglobulin (IVIG) is a therapy where a concentrated solution of immunoglobulins (antibodies) derived from pooled human blood plasma is administered directly into the bloodstream through intravenous infusion. By boosting antibody levels, IVIG helps prevent infections, improves immune function, and enhances overall immune protection. IVIG therapy provides passive immunity and supports the immune system in individuals with immunodeficiency diseases, reducing the frequency and severity of infections, improving quality of life, and potentially preventing complications associated with a weakened immune system. The major factors fueling the segment’s growth are the various advantages related to IVIG therapy, the increase in the launch of IVIG drugs by prominent players, and government organisations recommending the adoption of IVIG therapy for treating immunodeficiency disorders. The expanding number of drug approvals is contributing to segment growth. For instance, in January 2022, Argenx SE revealed that Japan’s Ministry of Health, Labour, and Welfare (MHLW) approved VYVGART (efgartigimod alfa) IgG1 intravenous infusion for the treatment of adult patients with generalised myasthenia gravis (gMG) who do not have a sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

Additionally, in February 2021, Pfizer Inc. received United States Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) for PANZYGA (Immune Globulin Intravenous [Human] – is 10% liquid preparation) to treat adult patients with a rare neurological disease of the peripheral nerves called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Panzyga is the intravenous immunoglobulin (IVIg) with two FDA-approved maintenance dosing options for CIDP, helping to meet the clinical needs of patients. Moreover, as per the article released by the NIH in December 2022, The COVID-19 Treatment Guidelines Panel (the Panel) recommended using IVIG in combination with low to moderate dose glucocorticoids in hospitalised patients for the treatment of multisystem inflammatory syndrome in children (MIS-C).

Therefore, the rising number of product launches by prominent players and government recommendations for using IVIG for treating immunodeficiency disorders are also projected to impact segment growth during the forecast period positively.

North America is Expected to Dominate the Immunoglobulin Market Over the Forecast Period

The geographical analysis of the Immunoglobulin market shows that North America holds a significant market share in the global market. The major factors driving the market growth in North America include the rising prevalence of various immunodeficiency disorders and an increasing inclination of clinicians toward immunodeficiency therapies.

The rising prevalence of HIV in the region is projected to drive the demand for immunoglobulin therapy during the forecast period. For instance, as per the article published by the United States Department of Health and Human Services (HHS) in October 2022, around 1.2 million people currently have HIV. Similarly, as per the data released by the Government of Canada in June 2023, there were about 1,472 newly diagnosed cases of HIV in Canada in 2021. Therefore, the rising prevalence of HIV in the region is projected to drive the demand for immunoglobulin therapeutics during the forecast period.

In addition, the presence of various prominent players in the region, their active participation in R&D activities, and the presence of different immunoglobulin drugs under clinical trials are projected to impact the market growth during the forecast period significantly. For instance, according to the National Clinical Trial (NCT) Registry, as of June 2023, in North America, there were around 12,327 immunoglobulin-based ongoing clinical trials across different phases of development. In addition, in January 2023, the United States FDA approved the Biologics License Application (BLA) for nirsevimab, an IgG1 antibody provided by Sanofi and AstraZeneca for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. Similarly, in July 2021, the United States FDA approved Octapharma’s Octogam 10% IVIg for treating adult dermatomyositis, a rare immune-mediated inflammatory disease. Thus, the abovementioned factors are expected to drive regional market growth over the forecast period.

Immunoglobulin Industry Overview

The immunoglobulin market is competitive due to the presence of several players developing immunoglobulin drugs. Some global immunoglobulin market players are Baxter International Inc., CSL Ltd., Octapharma AG, Kedrion Biopharma Inc., and Grifols SA (Biotest AG).

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Prevalence of Immunodeficiency Disorders
4.2.2 Rising Advancements in Antibody-based Therapies
4.2.3 Growing Research and Development Activities
4.3 Market Restraints
4.3.1 Stringent Government Regulations
4.3.2 High Cost of Therapy
4.4 Porter’s Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Value by Size – USD million)
5.1 By Product
5.1.1 IgG
5.1.2 IgA
5.1.3 IgM
5.1.4 IgE
5.1.5 IgD
5.2 By Mode of Delivery
5.2.1 Intravenous
5.2.2 Subcutaneous
5.3 By Application
5.3.1 Hypogammaglobulinemia
5.3.2 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
5.3.3 Immunodeficiency Disease
5.3.4 Myasthenia Gravis
5.3.5 Other Applications
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Baxter international Inc.
6.1.2 CSL Ltd
6.1.3 Grifols SA (Biotest AG)
6.1.4 Octapharma AG
6.1.5 Kedrion Biopharma Inc.
6.1.6 LFB group
6.1.7 China Biologics Products Inc.
6.1.8 Sichuan Yuanda Shuyang Pharmaceutical Co. Ltd
6.1.9 Eli Lilly
6.1.10 Takeda Pharmaceutical Company Limited
6.1.11 Bio Products Laboratory Ltd.
6.1.12 Pfizer Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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