Glycorex has been active in the global transplant market since the first kidney transplant was carried out using the company’s unique product Glycosorb® ABO in 2001. Since then, this technology, which allows transplants across the blood group barrier, has been used in more than 5,000 organ transplants.
Kidney disease is a global problem with more than 850 million people having some form of chronic kidney disease. This is about twice as many people suffering from diabetes making it one of the most common diseases. By 2040, kidney disease is expected to be the 5th leading cause of death.
The need for kidney therapy, either dialysis or transplantation, is therefore very big and growing. By 2030, 14.5 million people are expected to need dialysis or transplantation, but only 5.4 million are estimated to be able to receive therapy. Glycorex’s role in the kidney transplant market is to make more organs available for transplants through its blood group incompatible transplant technology.
In addition to the kidney transplants, the company’s products are also used in the transplantation of stem cells, heart, liver and lung.
Significant drivers of growth
Glycorex sees significant growth opportunities in the coming years. The need for kidney transplants is expected to grow strongly by 2030 as the number of patients with chronic kidney diseases increases.
There are also strong health economic reasons to increase the number of kidney transplants. Continuous dialysis treatment, which is the alternative to transplantation, is over time very costly. Besides the potential significant savings with transplants, it means large positive effects on patients’ quality of life. The argument for transplantation is therefore very strong and Glycorex can help to increase the total number of organs available.
Since 2020, Glycorex is also active in the market for universal blood plasma and is currently also developing a product for the treatment of the autoimmune disease rheumatoid arthritis (RA). Both of these products are expected to make positive contributions to the company’s development in the coming years.
The global transplant market
Organ transplantation is a well-proven treatment method. There are an estimated 300 transplant clinics in Europe and just over 250 in the US. In Europe, which is currently Glycorex’s largest market, nearly 60 transplant clinics used Glycosorb® ABO in 2020. For some patient categories, a transplant is the only way to survive and for most people a transplant means a better and healthier life, while for society it is a much more cost-effective treatment compared to alternative treatments.
Globally, more than 150,000 organ transplants were performed in 2019, according to the Global Observatory on Donation and Transplantation (GODT). This corresponds to an increase rate of approximately 4 percent, compared to an increase rate for the dialysis population of 6-8 percent. Transplants from living donors in kidney and liver transplants represent a slightly smaller proportion of the total number of transplants but give significantly better results for the transplanted as the organ is taken from a completely healthy person and the transplant can take place at the desired time and under optimal conditions.
The number of patients waiting for a transplant has doubled in the last ten years and is expected to continue to grow at the same rate. Waiting times for kidney transplants amount to several years in most countries, with significant differences in waiting times between different blood groups.
Glycorex enables more transplants
By enabling transplants between donors and recipients from different blood groups, waiting times are reduced as more transplants become possible between family members. The company estimates that the potential for blood group incompatible kidney transplants from living donors alone is at least 10,000 transplants globally a year. This presupposes that transplant activities are allocated increased resources. Thus, there is good potential to increase the number of transplants using Glycosorb® ABO provided that the transplant activities are allocated more resources.
Common to most markets where Glycorex is not present is that transplants from living donors occur almost exclusively between compatible blood groups. In other words, there is great potential here to increase the number of possible transplants and thereby significantly increase sales of Glycosorb® ABO.
For patients with chronic renal failure, transplantation is the preferred treatment. Dialysis acts as a life supporting method but requires several treatments per week for the rest of the life if the patient is not transplanted. A transplant results in a higher quality of life, longer patient survival and great savings for society.
Globally, just under 100,000 kidney transplants are performed annually, both from living and deceased donors. Kidney transplants from living donors make up a slightly smaller proportion of the total number of transplants but produce significantly better results. Thanks to Glycosorb® ABO, this type of transplant has been increased in several countries and in some of our markets by over 20 percent.
Glycorex estimates the global market potential for blood group incompatible kidney transplants from living donors to 420-630 million Swedish Kronor per year.
Stem cells transplants
Every year, more than 90,000 stem cell transplants are performed globally, of which about 45 percent are allogeneic, i.e. the stem cells come from another person. Of these, about 20 percent have a blood group incompatibility which can cause serious complications and thus increase the risk of morbidity and mortality in the early phase after transplantation. Therefore, it is an advantage to use Glycosorb® ABO which is developed to specifically remove anti-A/B antibodies without any impact on the immune system. The results of Glycosorb® ABO in stem cell transplants are good, but experience is so far limited. If the long-term results are found to be in the same class as in blood group incompatible organ transplants, the potential for this product application is large and Glycorex values the global application to at least 230 million Swedish Kronor per year.
In acute liver failure, quick access to a compatible liver is life changing. Glycosorb® ABO increases the possibility of transplantation for these patients. More than 35,000 liver transplants are performed annually globally, and the number may increase if more transplants are performed across blood group boundaries. Today, Glycosorb® ABO is mainly used in acute situations, but Glycorex has the ambition to broaden the use of Glycosorb® ABO to include blood group incompatible transplants in non-acute situations.
Transplants of the heart, lung and pancreas are also performed, but these transplants represent significantly smaller markets. Today, relatively few blood group incompatible transplants of this type are carried out. However, Glycosorb® ABO has so far been used in a small number of heart and lung transplants and with good results. The simultaneous treatment with heart-lung machine and Glycosorb® ABO facilitates the use of Glycosorb® ABO in these settings.
The market for universal blood plasma
Glycorex’s new product to produce universal blood plasma is based on the same technology as Glycosorb® ABO for transplants but targets another customer segment: transfusion clinics and blood centers.
In blood transfusions, compatibility of blood groups is important. Transfusion of blood plasma that is ABO incompatible can lead to severe and fatal reactions. AB blood plasma does not contain anti-A or anti-B antibodies. The AB plasma is therefore often used in acute situations where the patient’s blood type is unknown or when there is a lack of plasma of the recipient’s blood group.
However, AB plasma represents only about 5 percent of available blood plasma and thus the supply of compatible plasma is very limited. In addition, AB-plasma contains soluble AB antigens, which can react with blood group-specific antibodies and cause side effects. For this reason, there is a great need for universal plasma to solve these problems.
Glycorex offers transfusion clinics and blood banks a very smooth and easy solution to produce universal blood plasma themselves. The process does not require any investments of additional equipment and by using the UBP product, the blood bank and clinic can ensure that there is always adequate access to blood plasma.
The market for blood donor plasma is large and the UBP product is a high-volume product unlike Glycosorb® ABO for transplants, which has more character of special product.
It is estimated that approximately 30 million units of blood plasma are produced globally annually. The plasma is used not only in transfusions, but also to produce other blood products, proteins and immunoglobulins. In the EU, approximately four million units of plasma are transfused into patients annually. The demand for universal blood plasma amounts to around one million units every year in the EU alone. The pricing in the German market for standardized plasma today is around 1,200 Swedish Kronor per unit, which applied to the EU market would correspond to a market size of more than 1 billion Swedish Kronor annually.
Market for the treatment of Rheumatoid Arthritis
Glycorex has a unique technology platform in extracorporeal blood therapy which also is well suited to effectively eliminate the specific antibodies, autoantibodies, formed by patients with autoimmune diseases. In this area, the priority is Rheumatoid Arthritis (RA).
The potential market is very large and, in the EU, alone there are five million patients suffering from RA. Current medical treatments aim to ease the pain and delay the course of the disease. Unfortunately, up to 10 percent of the patients do not respond to medical treatments and end up in a therapeutic dead end with a worse prognosis. We value the potential market for the RA product to at least 5 billion Swedish Kronor.
Within the RA-project, biocompatibility studies have been conducted with good results, which means that we can start planning for a clinical study in RA patients. The development work is carried out in collaboration with a leading European research institute.