| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 12.99 Billion |
| Market Size (2030) | USD 21.88 Billion |
| CAGR (2025 - 2030) | 11.00 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Subcutaneous Immunoglobulin Market Analysis
The Subcutaneous Immunoglobulin Market size is estimated at USD 12.99 billion in 2025, and is expected to reach USD 21.88 billion by 2030, at a CAGR of 11% during the forecast period (2025-2030).
The COVID-19 pandemic had a significant impact on the market. Some biopharmaceutical companies, such as Merck & Co. Inc. and Eli Lilly and Company, announced clinical trial delays due to the pandemic. For instance, data from ClinicalTrials.gov published in November 2022 indicated that more than 200 interventional oncology studies were suspended due to the COVID-19 pandemic. In addition, 60% of institutions in the United States and 86% in Europe enroll new patients at a lower rate. Therefore, it was observed that the pandemic significantly affected the market growth. However, the market has reached its pandemic nature in terms of research and is expected to witness strong growth.
The major factors attributing to the growth of the market include the increasing use of subcutaneous immunoglobulin for primary immunodeficiency disorders, the increasing geriatric population, and the patient pool.
The increasing burden of immuno-deficiency diseases such as HIV is propelling market growth. For instance, as per the data from NACO published in August 2022, there were around 2.4 million HIV cases in India in 2022. Similarly, the data further stated that the number of HIV patients is still high across various countries such as South Africa and Nigeria, which is believed to contribute significantly to the market growth in the coming years.
Also, as per the Wiley Online Library article published in April 2022, it was indicated that up to 1 in 25,000 people worldwide are born with common variable immunodeficiency (CVID), a genetic disorder that can cripple patients' immune defenses. The data also stated that the overall burden of CVID has been rising in recent years, which is the leading factor responsible for the market growth.
The market players are heavily invested in drug development and approval due to the increasing burden of targeted diseases. For instance, in January 2024, Takeda Pharmaceutical received the United States approval from the US FDA for its HYQVIA to treat a rare, acquired, immune-mediated neuromuscular disorder. Also, in April 2022, Kite Pharma Inc. received product approval from the US FDA for its axicabtagene ciloleucel (Yescarta) for adult patients with large B-cell lymphoma (LBCL). Hence, such approvals and launches of new therapies are expected to propel the market growth.
However, stringent government regulations and the high risk of side effects from the treatment are some factors restraining market growth.
Subcutaneous Immunoglobulin Market Trends
Secondary Immunodeficiency Diseases are Expected to Witness a Strong Growth During the Forecast Period
AIDS, cancers of the immune system like leukemia, and immune-complex diseases like viral hepatitis are some of the most common examples of secondary immunodeficiency diseases. With the growing burden of the above-mentioned diseases, the segment is believed to witness strong growth in the coming years.
According to the data updated by WHO in 2023, it was observed that there were around 39.0 million people around the globe with AIDS in 2022. Also, there were approximately 1.3 million new AIDS cases were identified globally in 2022. Among the infected people, 1.5 million were children, which is creating a significant burden on the global healthcare industry. Hence, with the high prevalence of secondary immunodeficiency diseases such as AIDS, the segment is expected to grow significantly during the forecast period.
Also, the increasing approvals of drug candidates for secondary immunodeficiency are boosting segment growth. For instance, in January 2022, Octapharma announced that the indication for cutaquig, a human immunoglobulin for subcutaneous administration, was expanded in the European Union (EU), providing more flexible treatment options to a far wider range of patients with secondary immunodeficiency.
The new Global Health Sector Strategies (GHSS) on HIV, viral hepatitis, and sexually transmitted infections, 2022-2030, are seen as an opportunity to refocus global efforts, speed up the response, and recommit to the elimination of viral hepatitis by 2030, according to participants in the third World Hepatitis Summit. Hence, with the increasing focus of various countries on eliminating such diseases, there is expected to be a growing demand for immunoglobulin, which is believed to propel the segment growth during the forecast period.
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North America is Expected to Dominate the Market During the Forecast Period
North America is expected to dominate the overall subcutaneous immunoglobulin market during the forecast period. The market growth is due to factors such as the presence of key players, the high prevalence of immunodeficiency disease patients, the increasing geriatric population in the region, and the established healthcare infrastructure.
As per the data from the American Cancer Society Report 2022, there were an estimated 1.9 million new cancer cases in the United States in 2022. Among those, breast cancer and cancers of the genitals were expected to witness the highest numbers. The report further stated that the burden of cancer in the United States is increasing rapidly, which is providing opportunities to healthcare companies operating in the therapeutics business. Hence, with the high burden of cancer in the United States, the market for subcutaneous immunoglobulin is expected to witness strong growth in the coming years.
Additionally, Canada has been facing a huge burden of cancer in recent years. As per the data from the Government of Canada published in June 2022, it was projected that the number of people living with cancer would reach 233,900 in 2022. Diagnosis for lung, breast, colorectal, and prostate cancers was anticipated to continue being the highest in Canada.
Several key developments are occurring in the United States that are fueling market growth. For instance, in January 2023, KORU Medical Systems Inc., one of the leading medical technology companies operating in the drug delivery systems business, announced a development agreement with a pharmaceutical manufacturer of subcutaneous immunoglobulin therapy (SCIg) to develop and seek regulatory approval of the Freedom Infusion System with a SCIg prefilled syringe.
Therefore, the above statistics indicate that with the rising burden of cancers in North American countries, there will be a growing demand for immunoglobulin, which is expected to boost the market growth in the coming years.
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Subcutaneous Immunoglobulin Industry Overview
The subcutaneous immunoglobulin market is moderately competitive and consists of several major players. Takeda Pharmaceutical Company Limited, Biotest AG, CSL Behring, Grifols SA, Octapharma AG, Kedrion SpA, and Bio Products Laboratory dominate the market.
Subcutaneous Immunoglobulin Market Leaders
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Takeda Pharmaceutical Company Limited
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Biotest AG
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CSL Behring
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Grifols, S.A.
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Octapharma AG
- *Disclaimer: Major Players sorted in no particular order
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Subcutaneous Immunoglobulin Market News
- September 2023: Takeda Pharmaceutical Company received approval from the Japanese Ministry of Health, Labour, and Welfare, CUVITRU (Immune Globulin Subcutaneous (Human), 20% Solution) to treat hypogammaglobulinemia or agammaglobulinemia. With this approval, Takeda entered the Japanese subcutaneous immunoglobin market.
- 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.
Subcutaneous Immunoglobulin Industry Segmentation
As per the scope of the report, subcutaneous immunoglobulin infusions are given by gradually injecting purified immunoglobulin into the fatty tissue beneath the skin. The subcutaneous immunoglobulin market is segmented by application, end user, and geography. By application, the market is segmented into primary immunodeficiency diseases, secondary immunodeficiency diseases, and other applications. The subcutaneous immunoglobulin market is segmented by end users in hospitals, home care settings, and other end users. The market has been geographically segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report offers the value in USD for the above segments.
| By Application | Primary Immunodeficiency Diseases | ||
| Secondary Immunodeficiency Diseases | |||
| Other Applications | |||
| By End User | Hospitals | ||
| Homecare Settings | |||
| Other End Users | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Subcutaneous Immunoglobulin Market Research FAQs
How big is the Subcutaneous Immunoglobulin Market?
The Subcutaneous Immunoglobulin Market size is expected to reach USD 12.99 billion in 2025 and grow at a CAGR of 11% to reach USD 21.88 billion by 2030.
What is the current Subcutaneous Immunoglobulin Market size?
In 2025, the Subcutaneous Immunoglobulin Market size is expected to reach USD 12.99 billion.
Who are the key players in Subcutaneous Immunoglobulin Market?
Takeda Pharmaceutical Company Limited, Biotest AG, CSL Behring, Grifols, S.A. and Octapharma AG are the major companies operating in the Subcutaneous Immunoglobulin Market.
Which is the fastest growing region in Subcutaneous Immunoglobulin Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Subcutaneous Immunoglobulin Market?
In 2025, the North America accounts for the largest market share in Subcutaneous Immunoglobulin Market.
What years does this Subcutaneous Immunoglobulin Market cover, and what was the market size in 2024?
In 2024, the Subcutaneous Immunoglobulin Market size was estimated at USD 11.56 billion. The report covers the Subcutaneous Immunoglobulin Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Subcutaneous Immunoglobulin Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Subcutaneous Immunoglobulin Industry Report
Statistics for the 2025 Subcutaneous Immunoglobulin market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Subcutaneous Immunoglobulin analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
