Will GC Biopharma's Immune Globulin 'Alyglo' Succeed in the U.S. Market?
Narrow Indications a Weakness, but Supply Shortages Could Be a Positive Factor
The journey to the U.S. for Alyglo has been quite challenging. GC Biopharma applied for approval of a 5% immune globulin product from the U.S. Food and Drug Administration (FDA) at the end of 2015. However, in November 2016, the FDA requested additional information related to the manufacturing process. Even after submitting the required documents, further revisions were requested, causing delays. Eventually, the company decided to pursue approval for a 10% formulation instead of the original 5%.
After completing North American clinical trials for the 10% immune globulin in 2020, GC Biopharma submitted its product approval application in February 2021. However, the approval process was delayed due to COVID-19, which postponed FDA on-site inspections. Following the improvement of the pandemic situation, the company was able to undergo the inspection last year and received the long-awaited approval by the end of the year. This achievement came 8 years after the initial application for approval.
In the U.S., Alyglo has been approved as a 10% intravenous immune globulin product for the treatment of primary immunodeficiency (PI), also known as primary immunodeficiency disease. It is approved for use in adults aged 17 and older. GC Biopharma shipped the first batch of Alyglo to the U.S. on the 8th of this month, and it is expected to be available on the U.S. market later this month.
However, the delay in product approval has led to significant changes in the market landscape. Other approved drugs have expanded their indications and built up their competitive edge during this time.
Blood products available in the U.S. have a wider range of indications compared to Alyglo. CSL Behring's 'Privigen,' which holds the largest market share in immune globulins, has indications for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and immune thrombocytopenia (ITP). Takeda's 'Gammaplex' is prescribed for CIDP as well as for muscle impairment in patients with Multifocal Motor Neuropathy (MMN). Another competitor, Grifols' 'Flebogamma,' is also prescribed for immune thrombocytopenia (ITP). Primary immunodeficiency is a basic indication.
The fact that Alyglo is only approved for patients aged 17 and older is also seen as a challenge. Primary immunodeficiency typically manifests before the age of 20, with over 80% of patients being children. In contrast, Privigen and Gammaplex are approved for use in children as young as 2 years old. GC Biopharma is actively conducting clinical trials to secure pediatric indications.
Moreover, the subcutaneous injection market is expanding. There is a growing preference for subcutaneous formulations that allow for home self-administration without hospital visits. A survey conducted by CSL Behring involving 52 patients and their caregivers who have used both types of formulations revealed that approximately 80% preferred the subcutaneous injection.
As a result, CSL Behring and Takeda are selling subcutaneous formulations, and CSL Behring has also indicated that it may launch a prefilled subcutaneous immune globulin, 'Hyzentra,' in the future. According to Polaris Market Research, the global market for subcutaneous immune globulins was valued at $10.4 billion (approximately 13.7 trillion won) last year and is projected to grow at an annual rate of 13.7%, reaching $33 billion (approximately 43.7 trillion won) by 2032.
In contrast, GC Biopharma is still focused on intravenous formulations. A company representative stated, "We do have plans to develop subcutaneous formulations," but added, "There is no specific timeline or development phase at this point."
GC Biopharma highlights the safety of Alyglo as its competitive advantage. The company has introduced a process called CEX Chromatography (cation-exchange chromatography) to enhance product safety, which has enabled the removal of 99.9% of blood clotting factors known to cause thrombosis. In comparison, competitors' blood clotting factor removal rates are around 85-90%.
Additionally, the shortage of immune globulin supplies in the expanding U.S. market is seen as a positive factor. According to global blood products research organization MPB, the U.S. immune globulin market is approximately $11.6 billion (about 16 trillion won). Even capturing just 1% of the market could result in sales of 160 billion won.
A company official predicted, "The shortage of blood product raw materials and the fact that it is not a drug that can be produced arbitrarily will also positively impact demand."
An analyst from a securities firm commented, "It is true that Alyglo has narrower indications compared to competing products. The company will need to expand indications gradually." However, they also noted that "from the perspective of market growth potential, the outlook is positive."