Global Subcutaneous Immunoglobulin Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product Type;
IgG, IgA, and IgM.By Application;
Primary Immunodeficiency Diseases , Secondary Immunodeficiency Diseases, and Others.By End User;
Hospitals, Clinic and Others.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa, and Latin America - Report Timeline (2021 - 2031).Introduction
Global Subcutaneous Immunoglobulin Market (USD Million), 2021 - 2031
In the year 2024, the Global Subcutaneous Immunoglobulin Market was valued at USD 6,389.17 million. The size of this market is expected to increase to USD 15,502.98 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 13.5%.
The market for subcutaneous immunoglobulin is poised for rapid expansion, driven by the growing adoption of both organic and inorganic strategies by various industry participants. In January 2022, Octapharma announced an expanded indication for Cutaquig, a subcutaneously administered human therapy, within the European Union. This expanded indication provides more flexible treatment options for a broader range of patients with acquired deficiencies.
The subcutaneous immunoglobulin market faced significant challenges due to the COVID-19 pandemic. Global plasma collection saw a notable decline because of stringent lockdown measures and difficult circumstances, leading to an accumulation of plasma and delays in plasma fractionation. The most significant decline in transfusion occurred in the surgery department, particularly affecting fresh frozen plasma. This made it difficult for major players to collect plasma for fractionation, resulting in a severe shortage of plasma products, including subcutaneous immunoglobulin, which hindered patient access and impeded market growth.
Additionally, the rising incidence of immunodeficiency disorders can be linked to sedentary lifestyles, characterized by excessive consumption of sugars, saturated fats, high alcohol intake, and reduced physical activity. These factors have contributed to an increase in lifestyle-related disorders, including obesity.
Global Subcutaneous Immunoglobulin Market Recent Developments
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In August 2022, Genentech, a member of the Roche Group announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq (atezolizumab) met its co-primary endpoints.
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In April 2022, Kite Pharma Inc. received product approval from the US Food and Drug Administration (FDA) for its axicabtagene ciloleucel (Yescarta) for adult patients with large B-cell lymphoma (LBCL)
Segment Analysis
The Global Subcutaneous Immunoglobulin Market is segmented by product type into IgG, IgA, IgM, IgE, and IgD immunoglobulins. IgG is the most commonly used product type, as it is primarily used for the treatment of primary immunodeficiencies, autoimmune disorders, and other chronic diseases. IgA, IgM, IgE, and IgD immunoglobulins are less commonly used but are also essential in treating specific immune deficiencies and certain infections. The market is primarily driven by the increased use of IgG-based therapies due to their effectiveness in treating a wide range of immune deficiencies and their ability to provide long-term immunity.
In terms of application, the market is segmented into immunodeficiency, autoimmune diseases, inflammatory diseases, chronic diseases, and others. Immunodeficiencies, both primary and secondary, are the largest application areas for subcutaneous immunoglobulin products. The rising incidence of immunodeficiencies, particularly in both children and adults, is driving the demand for subcutaneous immunoglobulin therapies. Additionally, the growing prevalence of autoimmune and inflammatory diseases, such as rheumatoid arthritis and multiple sclerosis, is fueling market growth, as these conditions often require immunoglobulin-based therapies for disease management and prevention of flare-ups.
The market is also segmented by end-user into hospitals, clinics, and homecare settings. Hospitals and clinics remain the dominant end-users due to their advanced healthcare infrastructure and the ability to provide comprehensive treatment. However, the growing trend of homecare treatments, especially for immunodeficient patients who require long-term management, is contributing to the expansion of the subcutaneous immunoglobulin market. This shift is facilitated by the increasing availability of home administration kits, patient education, and support programs. Geographically, the market is segmented into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. North America, particularly the U.S., leads the market, driven by strong healthcare infrastructure, higher adoption of advanced therapies, and a large patient population. Europe follows closely, while the Asia Pacific region is expected to witness substantial growth due to rising healthcare access and increasing prevalence of immunodeficiencies in countries like India and China.
Global Subcutaneous Immunoglobulin Segment Analysis
In this report, the Global Subcutaneous Immunoglobulin Market has been segmented by Product Type, Application, End User and Geography.
Global Subcutaneous Immunoglobulin Market, Segmentation by Product Type
The Global Subcutaneous Immunoglobulin Market has been segmented by Product Type into IgG, IgA, and IgM.
The Global Subcutaneous Immunoglobulin Market has been segmented by product type into IgG, IgA, and IgM. IgG is the most widely used product type in subcutaneous immunoglobulin therapy, accounting for the largest share of the market. IgG immunoglobulins are primarily used to treat immune deficiencies, autoimmune diseases, and chronic conditions like primary immunodeficiency diseases (PIDD) and certain neurological conditions. The high demand for IgG-based treatments is driven by their effectiveness in providing long-term immunity and reducing the frequency of infections in immunocompromised patients.
IgA and IgM immunoglobulins represent smaller segments of the market. IgA is crucial for mucosal immunity, and its use is primarily targeted at conditions that affect mucosal surfaces, such as respiratory and gastrointestinal infections. The use of IgA in subcutaneous immunoglobulin therapy is less widespread compared to IgG, but it holds importance in specific therapeutic areas. IgM, another important immunoglobulin, is used in certain immune deficiency treatments, particularly when there is a deficiency in IgM production or response. Although less commonly used than IgG, IgM has a role in treating specific immune deficiencies and infections.
The increasing demand for IgG is supported by its wide range of applications in treating conditions like Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Hypogammaglobulinemia, and other autoimmune disorders. However, the market for IgA and IgM products is also growing, particularly as awareness increases around the role of these immunoglobulins in managing less common diseases and conditions. The product type segmentation provides a clear view of how different immunoglobulins cater to specific therapeutic needs, with IgG dominating the market while IgA and IgM continue to show niche but essential growth in subcutaneous immunoglobulin therapies.
Global Subcutaneous Immunoglobulin Market, Segmentation by Application
The Global Subcutaneous Immunoglobulin Market has been segmented by Application into Primary Immunodeficiency Diseases, Secondary Immunodeficiency Diseases and Others.
Primary Immunodeficiency Diseases include genetic or congenital conditions that affect the immune system, requiring lifelong management and regular immunoglobulin replacement therapy. Secondary Immunodeficiency Diseases, on the other hand, are acquired conditions resulting from factors such as infections, chemotherapy, or malnutrition, necessitating tailored immunoglobulin treatments to manage the compromised immune function. The "Others" category encompasses a range of additional conditions and off-label uses where subcutaneous immunoglobulin proves beneficial.
This segmentation allows for a detailed understanding of the market dynamics and the specific needs of different patient groups. It highlights the diverse applications of subcutaneous immunoglobulin therapy, addressing both inherited and acquired immune deficiencies. By categorizing the market in this manner, stakeholders can better strategize to meet the varied demands, enhance patient outcomes, and identify growth opportunities within each application segment.
Global Subcutaneous Immunoglobulin Market, Segmentation by End User
The Global Subcutaneous Immunoglobulin Market has been segmented by End User into Hospitals, Clinic and Others.
Hospitals represent a major segment, providing comprehensive care for patients requiring subcutaneous immunoglobulin therapy, particularly for those with severe immunodeficiency conditions that necessitate close monitoring and advanced medical support. Clinics, including specialty and outpatient clinics, cater to patients needing regular immunoglobulin infusions in a more convenient and accessible setting, emphasizing efficiency and patient comfort.
The Others category includes homecare settings and other healthcare facilities that offer subcutaneous immunoglobulin therapy outside traditional hospital and clinic environments. Homecare is increasingly significant as it allows patients to receive treatment in the comfort of their own homes, enhancing their quality of life and adherence to therapy. This segmentation underscores the versatility and adaptability of subcutaneous immunoglobulin therapy across various healthcare settings, highlighting its broad applicability and the market's capacity to address diverse patient needs.
Global Subcutaneous Immunoglobulin Market, Segmentation by Geography
In this report, the Global Subcutaneous Immunoglobulin Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Subcutaneous Immunoglobulin Market Share (%), by Geographical Region, 2024
North America, Europe, Asia Pacific, Middle East and Africa, and Latin America. North America, with its advanced healthcare infrastructure and high prevalence of immunodeficiency disorders, represents a significant market, driven by strong demand and extensive research and development activities. Europe follows closely, benefiting from robust healthcare systems and increasing adoption of innovative therapies like subcutaneous immunoglobulin.
In the Asia Pacific region, rapid economic development and improving healthcare facilities are fueling market growth, with countries like China and India showing substantial potential due to large patient populations and rising awareness of immunodeficiency treatments. The Middle East and Africa region, although still developing in terms of healthcare infrastructure, is gradually adopting these therapies, driven by improving medical access and initiatives to enhance healthcare quality. Latin America also presents growth opportunities, supported by increasing healthcare investments and a growing focus on advanced medical treatments. This geographical segmentation highlights the diverse market dynamics and growth opportunities across different regions, each influenced by unique healthcare landscapes and patient needs.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Subcutaneous Immunoglobulin Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers :
- Rising prevalence of chronic diseases
- Shift towards ScIg
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Growing geriatric population - The Global Subcutaneous Immunoglobulin Market is witnessing significant growth, driven in part by the increasing geriatric population. As people age, their immune systems tend to weaken, making them more susceptible to infections and immunodeficiency disorders. This demographic shift results in a higher demand for immunoglobulin therapies, including subcutaneous options, which offer effective and convenient treatment for managing these conditions. The aging population's preference for treatments that can be administered outside of hospital settings further propels the market, as subcutaneous immunoglobulin can be easily administered at home or in outpatient clinics, ensuring better adherence and quality of life for elderly patients.
The growing geriatric population also places a greater burden on healthcare systems globally, emphasizing the need for efficient and scalable treatment solutions. Subcutaneous immunoglobulin therapies cater to this need by reducing hospital visits and enabling more flexible treatment schedules. As the elderly population continues to grow, the demand for accessible and reliable immunoglobulin therapies is expected to rise, driving innovation and expansion in the subcutaneous immunoglobulin market. This trend underscores the market's crucial role in addressing the healthcare needs of an aging global population.
Restraints :
- High cost
- Limited reimbursement
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Need for specialized training - The Global Subcutaneous Immunoglobulin Market necessitates specialized training for healthcare providers and caregivers to ensure safe and effective administration of therapy. Subcutaneous immunoglobulin administration requires precise techniques to avoid complications such as infections or improper dosing. Healthcare professionals, including nurses and clinicians, need comprehensive training on infusion procedures, patient monitoring, and managing potential side effects. Additionally, caregivers and patients themselves must be educated on how to administer the therapy at home, recognize adverse reactions, and maintain sterile conditions during the process.
This need for specialized training underscores the importance of developing robust training programs and resources to support the growing adoption of subcutaneous immunoglobulin therapy. Proper training not only enhances the efficacy of treatment but also improves patient outcomes and adherence. By investing in specialized training, healthcare systems can better equip providers and patients, ultimately expanding access to this vital therapy and addressing the increasing demand driven by rising incidences of immunodeficiency disorders.
Opportunities :
- Technological advancements
- Increased awareness
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Biosimilars - The Global Subcutaneous Immunoglobulin Market is witnessing the emergence of biosimilars, which are poised to play a significant role in the market's growth and development. Biosimilars are biologic medical products highly similar to already approved reference products, offering comparable safety, efficacy, and quality at a lower cost. The introduction of subcutaneous immunoglobulin biosimilars provides a more affordable treatment option for patients, potentially increasing accessibility and reducing the financial burden on healthcare systems. As patents for original biologic drugs expire, the market for biosimilars is expected to expand, driving competition and innovation.
The development and approval of biosimilars in the subcutaneous immunoglobulin market face rigorous regulatory scrutiny to ensure they meet stringent standards. However, once approved, these biosimilars can significantly enhance patient access to essential therapies, particularly in regions with limited healthcare resources. The increasing acceptance and adoption of biosimilars among healthcare providers and patients will likely stimulate market growth, offering new opportunities for manufacturers and contributing to the overall expansion of the Global Subcutaneous Immunoglobulin Market.
Competitive Landscape Analysis
Key players in Global Subcutaneous Immunoglobulin Market include
- Biotest AG
- CSL Limited (CSL Behring)
- Grifols, S.A
- Kedrion S.p.A
- Octapharma AG
- Takeda Pharmaceutical Company Limited
- Bio Products Laboratory Ltd
- LFB S.A
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
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Market Snapshot, By Product Type
- Market Snapshot, By Application
- Market Snapshot, By End User
- Market Snapshot, By Region
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- Global Subcutaneous Immunoglobulin Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Rising prevalence of chronic diseases
- Shift towards ScIg
- Growing geriatric population
- Restraints
- High cost
- Limited reimbursement
- Need for specialized training
- Opportunities
- Technological advancements
- Increased awareness
- Biosimilars
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
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Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Subcutaneous Immunoglobulin Market, By Product Type, 2021 - 2031 (USD Million)
- IgG
- IgA
- IgM
- Global Subcutaneous Immunoglobulin Market, By Application, 2021 - 2031 (USD Million)
- Primary Immunodeficiency Diseases
- Secondary Immunodeficiency Diseases
- Others
- Global Subcutaneous Immunoglobulin Market, By End User, 2021 - 2031 (USD Million)
- Hospitals
- Clinic
- Others
- Global Subcutaneous Immunoglobulin Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Subcutaneous Immunoglobulin Market, By Product Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Biotest AG
- CSL Limited (CSL Behring)
- Grifols, S.A.
- Kedrion S.p.A
- Octapharma AG
- Takeda Pharmaceutical Company Limited
- Bio Products Laboratory Ltd
- LFB S.A.
- Company Profiles
- Analyst Views
- Future Outlook of the Market