Korea faces immunoglobulin, albumin shortage as demand rises

GC Biopharma Corp.’s albumin. [Courtesy of GC Biopharma]

Fractionated plasma products such as immunoglobulin and albumin are running short in hospitals across South Korea, sparking an emergency in the treatment of immune diseases and critical illnesses. According to the pharmaceutical and medical industry on Wednesday, immunoglobulin and albumin stock levels are dwindling, with only small amounts currently available at large hospitals.

Immunoglobulins are widely used to treat Kawasaki disease, autoimmune diseases, infertility, and hematopoietic stem cell transplant recipients. Kawasaki disease causes acute vasculitis and mainly affects children under the age of five, with an estimated 4,000 to 5,000 patients diagnosed annually in Korea. “Many patients with Kawasaki disease come to see us, but it’s worrying that we will run out of immunoglobulin soon,” Jung Seong-gwan, board chair at Woorisoa Children’s Hospital, said. “I know that supplies are also low at nearby university hospitals.”

Supplies are also low for albumin, a protein in the blood that is commonly used to treat hemorrhagic shock, cirrhosis, and hemodialysis patients. Varicella-zoster immune globulin, which is used to treat immunodeficient children exposed to chickenpox, has been unavailable for at least a year due to disrupted imports at local blood banks. GC Biopharma Corp. is currently the sole supplier of varicella-zoster immune globulin in Korea.

Fractionated plasma products are made from plasma components excluding red blood cells, white blood cells, and platelets in blood. They are classified as an essential drug to treat diseases that can be critical to human life. As blood selling is prohibited in Korea under the World Health Organization (WHO), raw plasma is supplied through blood donations and the shortage is entirely imported from the United States.

However, competition for plasma supply has intensified globally and domestic blood donations have declined significantly since the Covid-19 pandemic. According to the pharmaceutical industry, Korea’s plasma self-sufficiency rate has plummeted to 43.1 percent last year from 95.4 percent in 2015. Currently, only GC Biopharma and SK plasma Co. are capable of producing blood products in Korea.

Plasma and material costs account for about 60 percent of total costs for fractionated plasma products. The price of raw plasma imported from the United States jumped 45 percent to 245,000 won ($184.5) per liter last year from 169,000 won in 2017, according to GC Biopharma. At double the price of domestic plasma supplied by the Korean Red Cross, the price hike makes it difficult for local pharmaceutical companies to meet their profit margins when using imported plasma.

The medical and pharmaceutical industries say that the government should consider diversifying sources of plasma imports, including encouraging blood donations, and compensating for the rising cost of raw materials.

“Blood products for export can be made with raw plasma that is imported from any country, but those for domestic use can only be imported from the United States, where blood selling is allowed, so the supply of domestic products is more limited,” an official from the medical industry said. “We should actively consider diversifying plasma import sources and measures for cost compensation.”

The pharmaceutical industry also maintains that cost compensation is a matter of urgency, as fractionated plasma products have been designated and managed as one of the nation’s shortage prevention drugs since October 2010. Shortage prevention drugs are those essential for patient care but are not economically feasible for pharmaceutical companies to produce or import, and their prices are adjusted when production costs require compensation.

“As the competition for securing plasma intensifies globally and the cost of imported plasma continues to rise, we incurred irrecoverable losses of more than 40 billion won in fractionated plasma products annually due to lack of cost compensation over the past five years,” an official from GC Biopharma said. “Until now, we have increased the amount of plasma imports to respond to the domestic plasma shortage, but we have reached our limits.”

In response, “we are working to ensure smooth supply by, among others, prioritizing certification to diversify plasma import sources,” an official from the Ministry of Food and Drug Safety said.

“We are consulting with relevant ministries and plan to come up with measures to improve the supply.”