Subcutaneous Immunoglobulin Market Size, Share, and Trends 2024 to 2033

Subcutaneous Immunoglobulin Market Size and Manufacturers

The global subcutaneous immunoglobulin market size surpassed USD 15.48 billion in 2023 and is estimated to hit around USD 32.59 billion by 2033 with a CAGR of 7.73% from 2024 to 2033.

Key Takeaways

• North America dominated the market with the largest share in 2023.
• Asia Pacific is observed to grow at the fastest CAGR during the forecast period.
• By product type, the IgG segment held the largest share of the market in 2023.
• By application, the primary immunodeficiency segment dominated the market in 2023. The segment is observed to sustain the position during the forecast period.
• By end-use, the hospital segment dominated the market in 2023.

Subcutaneous Immunoglobulin Market Overview

The global subcutaneous immunoglobulin market offers a method of administering immunoglobulin (Ig) therapy by injecting immunoglobulin beneath the skin (subcutaneously). Immunoglobulins are proteins that play a crucial role in the immune system, helping to fight off infections and providing immunity. SCIg therapy is often used in the treatment of certain immunodeficiency disorders, where the body's immune system is unable to produce enough antibodies to effectively combat infections.

By delivering immunoglobulins subcutaneously, the therapy helps supplement the deficient antibodies, boosting the individual's immune response. Compared to intravenous immunoglobulin (IVIg) administration, which involves injecting immunoglobulins directly into a vein, SCIg allows for a slower and more sustained absorption of the immunoglobulins into the bloodstream.

This method is often preferred by patients because it can be administered at home, reducing the need for frequent hospital visits. The choice between subcutaneous and intravenous administration depends on various factors, including the patient's condition, preferences, and the specific requirements of the immunoglobulin therapy.

Growth Factors

• There is a general trend in healthcare towards more patient-centric and home-based treatments. The shift from intravenous immunoglobulin (IVIg) to SCIg can be driven by the desire to offer patients a more convenient and comfortable treatment option, while promoting the growth of the subcutaneous immunoglobulin market.
• Ongoing advancements in infusion pump technology and the development of more user-friendly devices for administering SCIg can drive market growth. Improved devices may enhance patient experience and ease of use.
• SCIg is commonly used in the treatment of primary immunodeficiency disorders (PIDD), where the immune system is compromised. As the awareness and diagnosis of immunodeficiency disorders increase, the demand for SCIg may also rise. Thus, this is expected to drive the subcutaneous immunoglobulin market during the forecast period.

Subcutaneous Immunoglobulin Market Scope

Subcutaneous Immunoglobulin Market Dynamics

Driver

An increase in immune-related diseases

As immunodeficiency conditions become more prevalent, the subcutaneous immunoglobulin market is growing. The need is being driven by conditions like primary and secondary immunodeficiency diseases. Because patients with compromised immune systems require effective subcutaneous immunoglobulin inoculations for immune system augmentation, the subcutaneous immunoglobulin market is growing. Due to its simplicity as compared to traditional intravenous methods, the market is expanding. As awareness of immune-deficiency diseases and improved diagnostics increase, the market will likely see a rise in demand for affordable and effective immunoglobulin treatments.

Advantages of administration

Ongoing research and development efforts have led to the development of advanced SCIG formulations with improved stability, bioavailability, and pharmacokinetic profiles. Newer SCIG products offer longer dosing intervals, reduced infusion volumes, and enhanced tolerability, which contribute to improved patient compliance and treatment outcomes. SCIG offers several advantages over intravenous immunoglobulin (IVIG) therapy, including convenience, flexibility, and reduced healthcare resource utilization. Patients can self-administer SCIG at home, eliminating the need for frequent hospital visits and intravenous infusions, which enhances patient convenience and quality of life.

Restraint

High cost and limited awareness

The cost of SCIg therapy, including the immunoglobulin product itself and associated administration supplies, can be a significant factor limiting its widespread adoption. Affordability and reimbursement policies may impact patient access to SCIg treatment. Moreover, a lack of awareness among healthcare providers and patients about the benefits of SCIg therapy compared to other forms of immunoglobulin administration, such as intravenous immunoglobulin (IVIg), could be a constraint.

Opportunity

Technological advancements

Significant subcutaneous immunoglobulin market expansion is being driven by technological advancements. Drug delivery innovations, such as the use of autoinjectors and vaccination devices, improve behavior and increase patient comfort and compliance. Production processes yield incredibly complex and sophisticated formulas, optimizing the results of therapy. Advancements in diagnosis and observation methods permit personalized treatment regimens and simultaneous tracking of immunoglobulin levels. The subcutaneous immunoglobulin market is changing as a result of the evolving technical landscape, which promises improved patient outcomes, availability, and productivity in the treatment of immunodeficiency diseases.

Product Type Insights

The IgG segment held the largest share of the subcutaneous immunoglobulin market in 2023. IgG is a type of immunoglobulin, specifically one of the four subclasses of antibodies found in the blood. Immunoglobulin therapy involves the administration of immunoglobulin products, which can include IgG, to individuals with primary immunodeficiency disorders or certain autoimmune conditions. The increasing product launches are expected to propel the segment expansion.

• For instance, In January 2022, Argenx SE announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved VYVGART. For the treatment of individuals with generalized myasthenia gravis (gMG), intravenous infusion of VYVGART is recommended. Besides, the IgM segment is expected to grow at the fastest rate over the forecast period.

IgM is one of the five major classes of immunoglobulins, or antibodies, found in the blood. Immunoglobulin therapy typically involves the replacement or supplementation of immunoglobulins, including IgM, for individuals with primary immunodeficiency disorders or certain autoimmune conditions. Immunodeficiency disorders can result in a lack of one or more immunoglobulin classes, including IgM. Replacement therapy aims to provide the deficient antibodies, and the composition of immunoglobulin products may include IgM. Thereby, driving the segment expansion.

Application Insights

The primary immunodeficiency segment dominated the subcutaneous immunoglobulin market. Immunoglobulin surface is used subcutaneously as a patient's primary immunodeficiency treatment, transforming healing gait. The need for subcutaneous immunoglobulin is increasing because of the approval of home spun management, which gives patients self-managing options, reduces reliance on hospital visits, and promotes dependability. Its adaptable treatment plan with customized dosage regimens accommodates various lifestyle choices.

Immunoglobulin administered subcutaneously ensures a constant supply of immunoglobulins, maintaining stable antibody levels and protecting against contaminations. It increases patient satisfaction with the least amount of overall consequences, offering a recommended and feasible solution. Thus, this is expected to drive the global subcutaneous immunoglobulin market growth.

End-use Insights

The hospital segment held the largest share of the subcutaneous immunoglobin market. The segment is observed to sustain the growth during the forecast period. While subcutaneous immunoglobulin therapy is often associated with home-based treatment due to its convenience and self-administration potential, hospitals also play a role in the administration of SCIg. Some patients may receive their SCIg therapy within a hospital setting, particularly if they require medical supervision or if they are newly diagnosed and need initial training.

Hospitals admit patients for immunoglobulin therapy, including SCIg, for various reasons. This could include patients with primary immunodeficiency disorders or other conditions where immunoglobulin replacement is indicated. In such cases, hospitals provide the infrastructure and expertise to administer the therapy.

The homecare segment is expected to grow at the highest CAGR during the forecast period. One of the primary drivers for the growth of the homecare segment in the market is the convenience it offers to patients. Home-based administration allows individuals to self-administer their SCIg therapy, reducing the need for frequent hospital or clinic visits. Additionally, the development of user-friendly and portable infusion devices has facilitated the shift toward home-based SCIg administration. Advances in technology have made it easier for patients to self-administer their treatments. Thereby, driving the segment expansion.

Regional Insights

North America, in 2023, held the largest share of the subcutaneous immunoglobulin market because of advances in technology that have improved productivity in prescription and delivery processes while raising awareness among patients and healthcare donors, boosting the market. Growing healthcare spending is correlated with the recognition of its clinical utility and the approval of the government to expand treatment alternatives. Patient-centered care promotes the ease of SCIG, which promotes wider adoption. The aggressive topography consists of stimulating inventions from both surfacing and entrenched actors. Collaboration drives the gathering of facts, insurance coverage influences strategy, and the COVID-19 effect emphasizes the sector's viability by highlighting its critical role in immune-related scenarios.

Besides, the Asia Pacific is expected to grow at the highest CAGR during the forecast period. Increasing awareness among healthcare professionals and patients about the benefits of SCIg therapy has contributed to its adoption. Education programs and awareness campaigns have played a role in informing the medical community and the public. Moreover, government initiatives and policies supporting the treatment of immunodeficiency disorders may impact the availability and affordability of SCIg in the region. These policies can include reimbursement mechanisms and incentives. Thus, this is expected to drive the subcutaneous immunoglobulin industry in the region.

Recent Developments

• In September 2023, Takeda revealed that CUVITRUTM [Immune Globulin Subcutaneous (Human), 20% Solution] can now be used in patients with agammaglobulinemia or hypogammaglobulinemia1, conditions marked by extremely low or absent antibody levels and a higher risk of serious recurrent infection brought on by either primary (PID) or secondary (SID) immunodeficiency2. With this permission, patients in Japan will get subcutaneous immunoglobulin (SCIG) treatment for the first time.
• In November 2023, Chugai Pharmaceutical Co., Ltd. declared the launch of Phesgo® combination for Subcutaneous Injection MA, IN [generic name: genetically recombinant pertuzumab, trastuzumab, and vorhyaluronidase alfa] (henceforth, Phesgo), an anti-HER2 humanized monoclonal antibody and antineoplastic agent for the treatment of “HER2-positive breast cancer” and “Advanced or recurrent HER2-positive colorectal cancer that has progressed after cancer chemotherapy and is not amenable to curative resection.” On September 25, 2023, Phesgo was authorized by the Ministry of Health, Labour and Welfare (MHLW) and was included in the current national health insurance (NHI) reimbursement price list.
• In April 2023, leading biotechnology company CSL Behring announced that a 50mL/10g prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) has been authorized by the FDA in the United States. To fulfil the specific needs of individuals with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), CSL Behring now provides a full variety of prefilled syringe sizes. The first and only immune globulin (Ig) that comes in an easy-to-use, prefilled syringe that is ready to use is called Hizentra.

Subcutaneous Immunoglobulin Market Companies

• Pfizer Inc.
• Johnson & Johnson (Omrix Biopharmaceuticals Inc.)
• Baxter International Inc.
• Takeda Pharmaceutical Company Limited
• Grifols SA
• CSL Behring
• Kedrion S.p.A
• Biotest AG
• ADMA Biologics, Inc.
• Octapharma AG
• Shanghai RAAS Blood Products Co. Ltd.

Segments Covered in the Report

By Product Type

• IgA
• IgG
• IgM

By Application

• Primary Immunodeficiency Disease
• Secondary Immunodeficiency Disease

By End-use

• Clinics
• Homecare
• Hospitals
• Others

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa