The global subcutaneous immunoglobulin market size was estimated to be USD 10.35 billion in 2023 and is expected to reach at USD 27.33 billion by 2034 with a CAGR of 9.23% during the forecast period 2024-2034. Rising utilization of subcutaneous immunoglobulin for primary immunodeficiency disorders, growing elderly population, increasing prevalence of immunodeficiency conditions such as HIV, uptake of both organic & inorganic strategies, surge in research & development initiatives, a higher frequency of new drug product introductions, and an escalation in approvals for innovative subcutaneous immunoglobulin products are some of the key factors boosting the market growth.
An escalation in approvals for innovative subcutaneous immunoglobulin products is predicted boost the market growth during the forecast period. The subcutaneous administration of immunoglobulin offers more consistent serum immunoglobulin levels and a reduced occurrence of systemic adverse effects compared to the intravenous route. This approach enhances the patient's quality of life by enabling self-administration or administration by a caregiver in the home setting. For instance, in April 2023, CSL Behring, a leading biotechnology firm, announced that the U.S. Food and Drug Administration (FDA) has given approval for a prefilled syringe of 50mL/10gm for Hizentra (Subcutaneous Human Immunoglobulin 20% Liquid).
By product, IgG was the highest revenue-grossing segment in the global subcutaneous immunoglobulin market in 2023 owing to the growing trend in the acceptance of immunoglobulins, coupled with an upward trajectory in the regulatory approvals of novel products in this category. For instance, in January 2022, Argenx SE declared that the Ministry of Health, Labour and Welfare (MHLW) in Japan has given approval for VYVGART. The treatment involves intravenous infusion and is indicated for individuals diagnosed with generalized myasthenia gravis (gMG). Additionally, IgA is predicted to grow at the fastest CAGR during the forecast period owing to the rising occurrence of product launches and a surge in research and development endeavors.
By application, secondary immunodeficiency diseases was the highest revenue-grossing segment in the global subcutaneous immunoglobulin market in 2023 owing to the increasing prevalence of AIDS, immune system-related cancers such as leukemia, immune-complex diseases such as viral hepatitis, and rising number of approvals for drug candidates targeting secondary immunodeficiency. For instance, in January 2022, Octapharma announced the expansion of the indication for Cutaquig, a human immunoglobulin administered subcutaneously, across the European Union (EU). This extension enhances treatment alternatives, providing increased flexibility and accessibility for a broader range of patients with secondary immunodeficiency. Additionally, primary immunodeficiency diseases is predicted to grow at the fastest CAGR during the forecast period owing to the rising use of interventions to boost the immune system and an increasing emphasis on creating innovative treatment alternatives for primary immunodeficiency diseases are becoming more prominent.
By end-user, hospitals was the highest revenue-grossing segment in the global subcutaneous immunoglobulin market in 2023 owing to the growth of healthcare facilities catering to the requirements of both developed and emerging nations has led to a rise in the number of patients seeking hospital care and an increase in the approval of groundbreaking drugs. For instance, in September 2023, Takeda announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] for individuals aged 2 years and older who have been diagnosed with agammaglobulinemia or hypogammaglobulinemia. These conditions are characterized by significantly low or absent antibody levels, increasing the susceptibility to severe recurring infections related to both primary immunodeficiency (PID) and secondary immunodeficiency (SID). Additionally, home care settings is predicted to grow at the fastest CAGR during the forecast period owing to the subcutaneous route poses minimal risk of severe systemic reactions, increase in patients choosing home administration of subcutaneous immunoglobulin (SCIG) due to its convenient method, straightforward technique, ready availability of programmable pumps, and rising demand among elderly patients.
North America region is anticipated for the highest revenue share during the forecast period owing to the high incidence of immunodeficiency diseases, a rising elderly population, well-established healthcare infrastructure, increasing occurrences of breast cancer and genital cancers, a growing need for immunoglobulin, and numerous notable advancements are taking place in the region. For instance, in January 2023, KORU Medical Systems, Inc., a prominent medical technology firm specializing in drug delivery systems, revealed a collaborative development agreement with a pharmaceutical manufacturer specializing in subcutaneous immunoglobulin therapy (SCIg). The objective is to create and pursue regulatory approval for the Freedom Infusion System, featuring a prefilled syringe for SCIg. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing prevalence of neurological, immunological, & diverse disorders, growing advancements in antibody therapy, a surge in public health awareness, and an escalation in approvals by regulatory authorities. For instance, in April 2023, Takeda disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for a supplemental biologics license application (sBLA) to broaden the application of HYQVIA for the treatment of primary immunodeficiency (PI) in children aged 2-16 years. HYQVIA stands as the exclusive subcutaneous immune globulin (ScIG) infusion designed for monthly administration.
An escalation in approvals for innovative subcutaneous immunoglobulin products is predicted boost the market growth during the forecast period. The subcutaneous administration of immunoglobulin offers more consistent serum immunoglobulin levels and a reduced occurrence of systemic adverse effects compared to the intravenous route. This approach enhances the patient's quality of life by enabling self-administration or administration by a caregiver in the home setting. For instance, in April 2023, CSL Behring, a leading biotechnology firm, announced that the U.S. Food and Drug Administration (FDA) has given approval for a prefilled syringe of 50mL/10gm for Hizentra (Subcutaneous Human Immunoglobulin 20% Liquid).
By product, IgG was the highest revenue-grossing segment in the global subcutaneous immunoglobulin market in 2023 owing to the growing trend in the acceptance of immunoglobulins, coupled with an upward trajectory in the regulatory approvals of novel products in this category. For instance, in January 2022, Argenx SE declared that the Ministry of Health, Labour and Welfare (MHLW) in Japan has given approval for VYVGART. The treatment involves intravenous infusion and is indicated for individuals diagnosed with generalized myasthenia gravis (gMG). Additionally, IgA is predicted to grow at the fastest CAGR during the forecast period owing to the rising occurrence of product launches and a surge in research and development endeavors.
By application, secondary immunodeficiency diseases was the highest revenue-grossing segment in the global subcutaneous immunoglobulin market in 2023 owing to the increasing prevalence of AIDS, immune system-related cancers such as leukemia, immune-complex diseases such as viral hepatitis, and rising number of approvals for drug candidates targeting secondary immunodeficiency. For instance, in January 2022, Octapharma announced the expansion of the indication for Cutaquig, a human immunoglobulin administered subcutaneously, across the European Union (EU). This extension enhances treatment alternatives, providing increased flexibility and accessibility for a broader range of patients with secondary immunodeficiency. Additionally, primary immunodeficiency diseases is predicted to grow at the fastest CAGR during the forecast period owing to the rising use of interventions to boost the immune system and an increasing emphasis on creating innovative treatment alternatives for primary immunodeficiency diseases are becoming more prominent.
By end-user, hospitals was the highest revenue-grossing segment in the global subcutaneous immunoglobulin market in 2023 owing to the growth of healthcare facilities catering to the requirements of both developed and emerging nations has led to a rise in the number of patients seeking hospital care and an increase in the approval of groundbreaking drugs. For instance, in September 2023, Takeda announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] for individuals aged 2 years and older who have been diagnosed with agammaglobulinemia or hypogammaglobulinemia. These conditions are characterized by significantly low or absent antibody levels, increasing the susceptibility to severe recurring infections related to both primary immunodeficiency (PID) and secondary immunodeficiency (SID). Additionally, home care settings is predicted to grow at the fastest CAGR during the forecast period owing to the subcutaneous route poses minimal risk of severe systemic reactions, increase in patients choosing home administration of subcutaneous immunoglobulin (SCIG) due to its convenient method, straightforward technique, ready availability of programmable pumps, and rising demand among elderly patients.
North America region is anticipated for the highest revenue share during the forecast period owing to the high incidence of immunodeficiency diseases, a rising elderly population, well-established healthcare infrastructure, increasing occurrences of breast cancer and genital cancers, a growing need for immunoglobulin, and numerous notable advancements are taking place in the region. For instance, in January 2023, KORU Medical Systems, Inc., a prominent medical technology firm specializing in drug delivery systems, revealed a collaborative development agreement with a pharmaceutical manufacturer specializing in subcutaneous immunoglobulin therapy (SCIg). The objective is to create and pursue regulatory approval for the Freedom Infusion System, featuring a prefilled syringe for SCIg. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing prevalence of neurological, immunological, & diverse disorders, growing advancements in antibody therapy, a surge in public health awareness, and an escalation in approvals by regulatory authorities. For instance, in April 2023, Takeda disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for a supplemental biologics license application (sBLA) to broaden the application of HYQVIA for the treatment of primary immunodeficiency (PI) in children aged 2-16 years. HYQVIA stands as the exclusive subcutaneous immune globulin (ScIG) infusion designed for monthly administration.
Segmentation: Subcutaneous Immunoglobulin Market Report 2023 - 2034
Subcutaneous Immunoglobulin Market Analysis & Forecast by Product 2023 - 2034 (Revenue USD Bn)
- IgA
- IgG
- IgM
Subcutaneous Immunoglobulin Market Analysis & Forecast by Application 2023 - 2034 (Revenue USD Bn)
- Secondary Immunodeficiency Diseases
- Primary Immunodeficiency Diseases
- Others
Subcutaneous Immunoglobulin Market Analysis & Forecast by End-user 2023 - 2034 (Revenue USD Bn)
- Hospitals
- Homecare Settings
- Others
Subcutaneous Immunoglobulin Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Subcutaneous Immunoglobulin Market: Product Estimates & Trend Analysis
8. Subcutaneous Immunoglobulin Market: Application Estimates & Trend Analysis
9. Subcutaneous Immunoglobulin Market: End-user Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Subcutaneous Immunoglobulin Market
12. Europe Global Subcutaneous Immunoglobulin Market
13. Asia Pacific Global Subcutaneous Immunoglobulin Market
14. Latin America Global Subcutaneous Immunoglobulin Market
15. MEA Global Subcutaneous Immunoglobulin Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Takeda Pharmaceutical Company Limited
- CSL Behring
- Johnson & Johnson (Omrix Biopharmaceuticals Inc.)
- Grifols SA
- ADMA Biologics Inc.
- Kedrion S.p.A
- Pfizer Inc.
- Baxter International Inc.
- Octapharma AG S.A.ghai RAAS Blood Products Co. Ltd.
- Biotest AG
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | March 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 10.35 Billion |
| Forecasted Market Value ( USD | $ 27.33 Billion |
| Compound Annual Growth Rate | 9.2% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
