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Navigating the Immunoglobulin Therapy Landscape: An Overview

The Immunoglobulin Replacement Therapy (IG) market is growing, as these treatments are essential for thousands of patients with rare diseases, especially immunodeficiency and autoimmune disorders. 

This article provides the latest advances in the Immunoglobulin treatments landscape and presents the pharma companies that have emerged as key players in the space.

Immunoglobulin therapy treatments (IG) are human pooled plasma-derived products, currently available as intravenous IG (IVIG) and subcutaneous IG (SCIG) formulations, with the patients being the ones who decide about the formulation of their therapy considering their lifestyle and their disease. 

Immunoglobulin Therapy for chronic diseases and advancements in rare disorders diagnoses drive IG growth.

According to a report from Transparency Market Research and Rare Revolution Magazine, the demand for Immunoglobulin Therapy treatments continues to grow worldwide at a rate of 6-8% due to expanding its use in chronic diseases and the advancements in diagnosing rare disorders. 

Globally, Primary Immunodeficiency Disorders (PIDD), Secondary Immunodeficiency disorders (SIDD), and chronic inflammatory demyelinating polyneuropathy account for more than 60% of Immunoglobulin Therapy (IG) use.

The increased use of targeted immune therapies for autoimmune, inflammatory, and malignant diseases is the reason behind the expected continuous increase in the incidence of SIDDs.

At this point, it is essential to highlight that PIDDs is an umbrella term used for a group of more than 400 genetic disorders that cause an increased risk of recurrent or severe infections while various reasons, including medications, infections, and metabolic disorders, cause SIDDs.

3 players in Immunoglobulin Therapy treatment dominate the market with a higher than 65% market share.

Interestingly, Immunoglobulin Therapy is one of the few therapies not subject to patent cliffs. Due to high entry barriers associated with supply chain and production costs, only a few players currently operate in this market. Takeda, CSL, and Grifols dominate and hold more than 65% of the overall market share.

Plasma-derived therapies lead Takeda’s future growth.

Takeda, one of the largest players in the Immunoglobulin Treatments segment company, is dedicated to its commitment to plasma-derived therapies, considering them its key growth driver for the future. 

In March 2023, Takeda announced an investment of > $764.6 million to build a new world-class manufacturing facility for plasma-derived therapies in Japan. Last year, the company also announced an investment of €300 million for a new plant and warehouse at an existing facility in Belgium.

Immunoglobulin Therapy’s future lies in subcutaneous IG formulations (SCIG).

The future is bright for SCIG. CSL, Takeda, and Octapharma AG are already active in SCIG drug development.

CSL was the first company to launch a SCIG product in the US in 2006; it is considered a pioneer in the field and derives most of its revenue from its plasma portfolio. More recently, CSL launched a SCIG prefilled syringe product in the US called HIZENTRA.

Takeda also recently scored a pediatric PID USFDA approval for its SCIG HYQVIA.

In 2021, CUTAQUIG (Octapharma AG), a SCIG product, gained approval in the US for use as a replacement therapy in PIDD for children (2 years and older) and adults. 

SCIG prefilled syringe systems are expected to become the preferred treatment format as they enable at-home, accurate administration without a need to visit hospitals, allowing for better patient adherence and lower cost.

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