Hyperimmune immunoglobulins Market Size, Share, and Industry Analysis, By Type (Hepatitis B Immunoglobulin, Rabies Immunoglobulin, Tetanus Immunoglobulin, and Others), By Dosage Form (Liquid and Powder), By Route of Administration (Intravenous, Intramuscular, and Others), By End User (Hospital Pharmacies, Retail Pharmacies, and Others), and Regional Forecast, 2026-2034

The global hyperimmune immunoglobulin market is anticipated to observe growth in the upcoming years. This growth is driven by the rising burden of infectious diseases such as hepatitis B, rabies, and tetanus, where immediate passive immunity is essential for effective prophylaxis and treatment. Increasing improvements in plasma collection and fractionation technologies have further expanded the availability and reliability of these life-saving therapies. Growing government immunization programs, wider adoption in both developed and emerging markets, and advancements in product formulations with enhanced safety profiles are also accelerating market uptake. 

Furthermore, various key companies are focusing on expanding their product offerings through novel product launches and ensuring availability across different geographical locations. 

• For instance, in January 2024, CSL announced the availability of a 10g prefilled syringe for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid), indicated for people living with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). 

Hyperimmune Immunoglobulins Market Driver

Growing Awareness and Adoption of Post-Exposure Prophylaxis to Drive Market Growth

Increasing awareness about the risks of infectious diseases such as rabies, hepatitis B, and tetanus has led healthcare providers to emphasize the importance of timely post-exposure prophylaxis. As a result, demand for hyperimmune immunoglobulins has surged since they provide immediate passive immunity when vaccines alone are insufficient. This growing adoption is further supported by government immunization programs and procurement contracts that expand patient access. Consequently, wider use of PEP has become a significant driver of the hyperimmune immunoglobulin market’s growth. 

• For instance, in January 2025, Kamada Ltd. signed a contract with an international organization for the supply of KAMRAB and VARIZIG in Latin America for 2025-2027. The valuation of the three-year contract was at USD. 25.0 million. VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for post-exposure prophylaxis in high-risk individuals.

Share of total and early childhood HBV infections by the World Bank Group, 2023

In 2023, NIH published an article titled ‘Global HBV disease burden and current care gaps’ that estimated that there were 253 million people living with HBV globally, representing a prevalence of 3.2%. 

Hyperimmune Immunoglobulins Market Restraint

Resistance to Organizational Change and Limited User Adoption may Hamper Its Adoption in Market 

The hyperimmune immunoglobulin market faces constraints due to the finite availability of human plasma, which is the essential raw material for production, and increased demand. Plasma collection is, highly regulated process and requires repeat donors, making it difficult to scale supply rapidly. The fractionation, purification, and pathogen inactivation processes add further complexity and cost. Manufacturers also face rising operational expenses in maintaining donor networks, quality control, and cold-chain logistics. As a result, limited plasma availability coupled with high production costs acts as a major restraint on market growth.

• For instance, in March 2023, the European Hematology Association discussed shortages of immunoglobulins, which were reported to the European Commission in an ‘EMA multistakeholder workshop on Shortages’.

Hyperimmune Immunoglobulins Market Opportunity

Research and Development for Novel Formulations to Offer Lucrative Market Growth Opportunities

The development of novel formulations and broader clinical applications presents a strong opportunity for the hyperimmune immunoglobulin market growth. Advances in product innovation, such as more stable liquid formulations, subcutaneous options, or next-generation delivery systems, are enhancing ease of use and improving patient compliance. At the same time, expanding research is uncovering new therapeutic areas beyond traditional post-exposure prophylaxis, including applications in transplant medicine, immunodeficiency management, and autoimmune conditions. By broadening the clinical utility of hyperimmune immunoglobulins and offering more convenient formulations, manufacturers can tap into wider patient populations and strengthen long-term market demand.

• For instance, in July 2024, Grifols SA received an expanded label for XEMBIFY from the U.S. FDA. The novel drug contains 20% subcutaneous immunoglobulin (SCIg) to include treatment-naïve patients with primary humoral immunodeficiencies (PI).

Key Insights

The report covers the following key insights:

• Prevalence of Key Disease Indication, By Key Counties, 2024
• Pipeline Analysis, Key Players
• New Product Launches
• Key Industry Development- Mergers, Acquisitions, Partnerships, Others

Segmentation

Analysis by Type

By type, the market is divided into hepatitis B immunoglobulin, rabies immunoglobulin, tetanus immunoglobulin, and others.

The Hepatitis B immunoglobulin (HBIG) segment is expected to hold a substantial market share in the global hyperimmune immunoglobulins market. The dominance of the segment is due to the high global burden of hepatitis B infection and the critical role of HBIG in both prevention and post-exposure prophylaxis. It is also widely used in healthcare settings for accidental exposure to infected blood or body fluids, as well as in liver transplant patients to prevent reinfection. The combination of its broad clinical use and strong demand across both developed and emerging markets ensures the strong foothold of the segment.

In accordance with these advantages, many key players are focusing on strategic collaboration for research and development to formulate novel immunotherapies.

• For instance, in June 2021, Grifols, S.A., started commercialization of HyperHEP B, a new formulation of its hepatitis B immune globulin [human] for hepatitis B postexposure prophylaxis.

The new formulation significantly reduces procoagulant activity and IgG aggregates. Such developments are expected to drive the segmental growth.

Analysis by Dosage Form

By dosage form, the market is divided into liquid and powder.

The liquid form segment dominated the market in terms of dosage form in 2024. The liquid formulation segment dominates the hyperimmune immunoglobulin market as it offers greater convenience, faster preparation, and reduced risk of handling errors compared to lyophilized or powder forms. These ready-to-use solutions eliminate the need for reconstitution, which not only saves time in emergency settings such as rabies or hepatitis B exposure but also minimizes the chance of contamination during preparation. 

• For instance, in June 2024, Takeda Pharmaceutical Company Limited. Received approval from the U.S. FDA for GAMMAGARD LIQUID ERC, the liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). The immunoglobulin is administered either intravenously or intramuscularly. 

Analysis by Route of Administration

By route of administration, the market is divided into intravenous, intramuscular, and others.

The intravenous segment is expected to hold a considerable market share in the global hyperimmune immunoglobulins market. The intravenous administration delivers antibodies directly into the bloodstream, ensuring rapid and complete systemic availability. It also enables the administration of larger doses, which is critical in severe infections or immunocompromised patients. Additionally, growing adoption of IV therapies in advanced healthcare settings and new product launches incorporating liquid immunoglobulins strengthen the segment dominance.

• For instance, in February 2021, Pfizer Inc. received approval from the U.S. FDA for a supplemental Biologics License Application (sBLA) for PANZYGA, an intravenously administered immunoglobulin to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP). 

Analysis by End User

By end user, the market is divided into hospital pharmacies, retail pharmacies, and others.

Hospital pharmacies are projected to dominate the market. These products are most often administered in acute care or post-exposure emergency settings, such as after rabies or tetanus exposure, during childbirth for Rho (D) prevention, or in immunocompromised patients requiring immediate protection. They require specialized care and specialized staff to deliver these biologics safely. This central role in both specialized care and urgent interventions positions hospital pharmacies as the leading distribution channel in the global market.

Regional Analysis

By region, the market is divided into North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America.

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North America accounted for the largest global hyperimmune immunoglobulins market share in 2024. The dominance of the region is due to its well-established plasma collection network and advanced plasma fractionation infrastructure, which provide a relatively reliable supply chain for critical therapies. Also, increasing demand for immunoglobulin replacement therapies due to rising prevalence to drive the market growth. Along with these factors, the key companies are ensuring availability in key markets to cater to the increasing demand and capitalize on growth.

• For instance, in October 2023, Kamada Ltd. showcased multiple achievements related to CYTOGAM (Cytomegalovirus Immune Globulin Intravenous [Human]), indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart. It also reported the availability of CYTOGAM for commercial sales in the U.S.

Europe is the second-largest market based on the demand for hyperimmune immunoglobulins. The hyperimmune immunoglobulins market growth in Europe is supported by numerous factors such as strong healthcare infrastructure, favorable policies, and evolving patient needs. Also, rising awareness of infectious diseases and the importance of post-exposure prophylaxis has fueled demand, with governments actively incorporating immunoglobulins into national immunization and emergency care guidelines. These factors augment the demand for hyperimmune immunoglobulins.

• For instance, in February 2025, Octapharma AG was appointed sole fractionator for the UK's plasma for medicines programme by the UK government-appointed National Health Service (NHS) England. This development aimed to cater to the increasing demand for immunoglobulins.

Asia Pacific is also expected to grow with a significant CAGR in the global hyperimmune immunoglobulins market. The region is poised for growth due to rising healthcare spending, expanding access to advanced diagnostics, and growing awareness of immunodeficiency and autoimmune disorders. Additionally, increasing income levels and growing insurance/reimbursement coverage are making expensive treatments such as immunoglobulins more affordable to larger parts of the population. Together, these factors create favorable conditions for the immunoglobulin market’s sustained growth in the region.

Key Players Covered

The global hyperimmune immunoglobulins market is consolidated, with a select number of companies present in the market. The report includes the profiles of the following key players:

• Octapharma AG (U.S.)
• CSL (U.S.)
• Grifols, S.A. (U.S.)
• Kamada Ltd. (U.S.)

Key Industry Developments

• In May 2025, Grifols, S.A. received clearance from the U.S. FDA for an Investigational New Drug (IND) application to initiate a Phase 2 trial evaluating its immunoglobulin (IG) drops – GRF312 Ophthalmic Solution. 
• In June 2024, Amgen Inc. showcased positive results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial (NCT04540497) evaluating the efficacy and safety of UPLIZNA (inebilizumab-cdon) for the treatment of Immunoglobulin G4-related disease (IgG4-RD).