Subcutaneous Immunoglobulin Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Subcutaneous Immunoglobulin Market Report is Segmented by Application (Primary Immunodeficiency Diseases, Secondary Immunodeficiency Diseases, and Other Applications), End User (Hospitals, Home Care Settings, and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The Report Offers the Value in USD for the Above Segments.

Subcutaneous Immunoglobulin Market Size

Subcutaneous Immunoglobulin Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 11.70 Billion
Market Size (2029) USD 19.70 Billion
CAGR (2024 - 2029) 11.00 %
Fastest Growing Market Asia Pacific
Largest Market North America
Market Concentration Medium

Major Players

Subcutaneous Immunoglobulin Market Major Players

*Disclaimer: Major Players sorted in no particular order

Compare market size and growth of Subcutaneous Immunoglobulin Market with other markets in Healthcare Industry

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Subcutaneous Immunoglobulin Market Analysis

The Subcutaneous Immunoglobulin Market size is estimated at USD 11.70 billion in 2024, and is expected to reach USD 19.70 billion by 2029, growing at a CAGR of 11% during the forecast period (2024-2029).

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.

Subcutaneous Immunoglobulin Market: Number of People Living With AIDS, (in Million), Global, 2022

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.

Subcutaneous Immunoglobulin Market - Growth Rate by Region

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

  1. Takeda Pharmaceutical Company Limited

  2. Biotest AG

  3. CSL Behring

  4. Grifols, S.A.

  5. Octapharma AG

*Disclaimer: Major Players sorted in no particular order

Subcutaneous Immunoglobulin Market Concentration
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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 Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Use of Subcutaneous Immunoglobulin For Primary Immunodeficiency Disorders

      2. 4.2.2 Increasing Geriatric Population and Patient Pool

      3. 4.2.3 Rise in Government Funding

    3. 4.3 Market Restraints

      1. 4.3.1 Stringent Government Regulations

      2. 4.3.2 High Risk of Side Effects

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION - (Market Size by Value - USD)

    1. 5.1 By Application

      1. 5.1.1 Primary Immunodeficiency Diseases

      2. 5.1.2 Secondary Immunodeficiency Diseases

      3. 5.1.3 Other Applications

    2. 5.2 By End User

      1. 5.2.1 Hospitals

      2. 5.2.2 Homecare Settings

      3. 5.2.3 Other End Users

    3. 5.3 Geography

      1. 5.3.1 North America

        1. 5.3.1.1 United States

        2. 5.3.1.2 Canada

        3. 5.3.1.3 Mexico

      2. 5.3.2 Europe

        1. 5.3.2.1 Germany

        2. 5.3.2.2 United Kingdom

        3. 5.3.2.3 France

        4. 5.3.2.4 Italy

        5. 5.3.2.5 Spain

        6. 5.3.2.6 Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. 5.3.3.1 China

        2. 5.3.3.2 Japan

        3. 5.3.3.3 India

        4. 5.3.3.4 Australia

        5. 5.3.3.5 South Korea

        6. 5.3.3.6 Rest of Asia-Pacific

      4. 5.3.4 Middle East and Africa

        1. 5.3.4.1 GCC

        2. 5.3.4.2 South Africa

        3. 5.3.4.3 Rest of Middle East and Africa

      5. 5.3.5 South America

        1. 5.3.5.1 Brazil

        2. 5.3.5.2 Argentina

        3. 5.3.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Takeda Pharmaceutical Company Limited

      2. 6.1.2 Biotest AG

      3. 6.1.3 CSL Behring

      4. 6.1.4 Grifols SA

      5. 6.1.5 Octapharma AG

      6. 6.1.6 Kedrion SpA

      7. 6.1.7 Bio Products Laboratory

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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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

The Subcutaneous Immunoglobulin Market size is expected to reach USD 11.70 billion in 2024 and grow at a CAGR of 11% to reach USD 19.70 billion by 2029.

In 2024, the Subcutaneous Immunoglobulin Market size is expected to reach USD 11.70 billion.

Takeda Pharmaceutical Company Limited, Biotest AG, CSL Behring, Grifols, S.A. and Octapharma AG are the major companies operating in the Subcutaneous Immunoglobulin Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Subcutaneous Immunoglobulin Market.

In 2023, the Subcutaneous Immunoglobulin Market size was estimated at USD 10.41 billion. The report covers the Subcutaneous Immunoglobulin Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Subcutaneous Immunoglobulin Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Subcutaneous Immunoglobulin Industry Report

Statistics for the 2023 Subcutaneous Immunoglobulin market share, size and revenue growth rate, created by Mordor Intelligenceā„¢ Industry Reports. Subcutaneous Immunoglobulin analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Subcutaneous Immunoglobulin Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)