U.S. Immunoglobulin Market Size, Share & COVID-19 Impact Analysis, By Route of Administration (Intravenous, and Subcutaneous), By Indication (Primary Immunodeficiency, Secondary Immunodeficiency, Chronic Inflammatory Demyelinating Polyneuropathy, Syndrome, Immune Thrombocytopenic Purpura, Multifocal Motor Neuropathy, and Others), By Form (Liquid and Lyophilized), By End-user (Hospitals, Clinics, and Homecare), and Country Forecast, 2023-2030

The U.S. immunoglobulin market size was worth USD 8.14 billion in 2022 and is projected to grow at a CAGR of 8.7% during the forecast period. 

There has been a significant rise in the patient population suffering from auto-immune conditions, including primary immunodeficiency, secondary immunodeficiency, Guillain-Barré syndrome, among several others, in the U.S. in the past few years. The increasing clinical trials showing positive results in using immunoglobulins for these disorders are expected to drive the demand in the market.

Major players operating in the market are focused on the development and introduction of novel therapies using immunoglobulins to treat several conditions among the population, which is considered one of the major factors contributing to the U.S. immunoglobulin market growth. The market experienced slower growth due to the impact of the COVID-19 pandemic. The hindrance in the plasma collection among the key manufacturers owing to COVID-19 lockdown restrictions and guidelines resulted in the shortage of plasma products, including immunoglobulins.

LATEST TRENDS

Subcutaneous Route of Administration Gaining Popularity Among the Healthcare Providers 

There are several clinical benefits of the subcutaneous route of administration of immunoglobulin products, including fewer systemic adverse effects and shorter administration time, among others. The treatment mode has also shown economic advantages to the patients by reducing the overall cost, the number of hospital visits, and improving the quality of life.

Key players are focusing on more SCIg product approvals and launches to cater to the gaining popularity among healthcare providers. 

• For instance, in June 2023, argenx received the U.S. FDA approval for its SCIg injection, VYVGART Hytrulo, for administration in myasthenia gravis patients.

DRIVING FACTORS

Growing Prevalence of Auto-immune Disorders Among the Population to Foster the Demand in the Market

The prevalence of autoimmune conditions, inflammatory disorders, and other infectious diseases has grown in the U.S. in the past few years among the adult and geriatric population. According to the National Institutes of Health (NIH), the third most common cause of chronic illness in the U.S. is considered to be autoimmune disorders.

• According to the 2022 report published by GBS-CIDP Foundation International, the prevalence of CIDP in the U.S. is around 60,000, with a prevalence rate of 0.8-10.3 per 100,000 individuals.

The major market players are focused on developing novel therapies for these chronic conditions for the rising number of patients in the country. These are a few of the prominent factors driving the U.S. market growth.

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RESTRAINING FACTORS

High Cost Associated with the Treatment to Limit the Market Development

The costs associated with intravenous immunoglobulin therapy, including medication, hospital administration, and other costs, are higher than other alternative treatment options in the U.S. for the patients. 

• According to a 2022 article published by the National Institutes of Health, the average cost of IVIg in the U.S. is around USD 9,270 per infusion. Patients typically administer 4-5 infusions per month. The total monthly cost is around USD 41,000 for a patient.

SEGMENTATION

By Route of Administration Analysis

On the basis of route of administration, the market is bifurcated into intravenous, and subcutaneous.

The intravenous segment dominated the market in 2022. The increased number of product approvals and launches by the key players to cater to the rising demand of the patient population is one of the major factors driving the segment's growth.

• In February 2021, Pfizer Inc. received U.S. FDA approval for its PANZYGA, IVIg, to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.  

By Indication Analysis

On the basis of indication, the market is segmented into Guillain Barré syndrome, primary immunodefiency, chronic inflammatory demyelinating polyneuropathy, secondary immunodeficiency, multifocal motor neuropathy, immune thrombocytopenic purpura, and others.

The Primary Immunodeficiency (PI) segment accounted for the largest U.S. immunoglobulin market share in 2022 and is expected to register the highest CAGR during the forecast period. The increasing number of patients suffering from the condition in the country and the higher penetration of Ig therapies are major factors contributing to the segment growth.

By Form Analysis

On the basis of form, the market is bifurcated into liquid, and lyophilized.

The liquid segment held the highest share in 2022 and is expected to grow at a significant CAGR during the forecast period. The higher number of liquid immunoglobulin products available for administering various chronic conditions in the country, with increased adoption among healthcare providers, are prominent factors contributing to the segment’s growth. Moreover, the robust efforts of market players to introduce liquid solutions for the treatment of various conditions is another prominent factor expected to augment the adoption of these products in the U.S.

• For instance, the U.S. FDA accepted the resubmission of GC Biopharma’s Biologics License Application (BLA) for its GC5107B (IVIg) for the treatment of primary humoral immunodeficiency (PI).

By End User Analysis

On the basis of end user, the market is segmented into hospitals, clinics, and homecare.

Clinics dominated the market in 2022 and is expected to grow at the highest CAGR during the forecast period. The preference shift toward specialty clinics among patients for treatment owing to the better services and quality of care is one of the significant reasons for the segment's dominance.

KEY INDUSTRY PLAYERS

The market is consolidated with a few key players accounting for the major proportion of the U.S. market. Some of the major players operating in the market are Takeda Pharmaceutical Company Limited, CSL Limited, among others. The robust efforts of these players to invest in research and development activities to introduce novel therapies for the growing patient population in the country is one of the prominent factors supporting the growth of the market shares of these players.

Grifols, S.A., ADMA Biologics, Pfizer, Inc., and Bio Products Laboratory Ltd., with other players, are focusing on expanding their product portfolio in the country to increase the penetration and adoption of the products among the patient population. The focus of these players to expand its manufacturing capacities of the Ig products to favor the increasing adoption among the healthcare providers is another contributing factor to the growing shares of these players.

• According to a 2023 press release by ADMA Biologics, Inc. The company initiated the manufacturing of ASCENIV, 10% liquid IVIg, at a production scale of 4,400 liters. The facility is expected to increase the production yield of immunoglobulin in the country.

LIST OF KEY COMPANIES PROFILED:

• Takeda Pharmaceutical Company Limited (Japan)


• CSL (U.S.)


• Grifols, S.A. (Spain)


• Octapharma AG (Switzerland)


• Kedrion S.P.A (Italy)


• Pfizer, Inc. (U.S.)


• ADMA Biologics, Inc. (U.S.)


• Bio Products Laboratory Ltd. (U.K.)


• LFB Group (France)

KEY INDUSTRY DEVELOPMENTS: 

• April 2023 – Takeda Pharmaceutical Company Limited received the U.S. FDA approval to expand the use of HYQVIA to treat primary immunodeficiency in children.


• March 2023 – The U.S. FDA approved LEQEMBI by Eisai Co., Ltd., and Biogen Inc. under the accelerated approval pathway for treating Alzheimer’s disease.


• March 2022 - The United States Patent and Trademark Office granted a new patent (US Patent number: 11,149,079) to BPL for its E+I process. The patent is related to the extraction process of immunoglobulin IgG, an overall increase in the total yield of IgG from blood plasma.

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The report provides U.S. market analysis, and key aspects such as prevalence of key autoimmune disorders, technological advancements, and various products available in the market. Additionally, it includes the latest trends in the market, new product launches, key industry developments such as mergers, partnerships, & acquisitions and the impact of COVID-19 on the market. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market over recent years.

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