Commercialization of the EPO drugs to propel its growth in the future

Ever since the first erythropoietin (EPO) drug was introduced for end consumers in the healthcare market segment, these ‘wonder drugs’ have been a blockbuster. Given the lifesaving application it has in critical anemic conditions, it went on to be a great hit among medical practitioners and in their prescriptions. Successful l placement of the EPO drugs in commercial market platforms initiated a growth chart that has not seen a slug till current date. In fact, industry inputs indicate substantial expansion at a global scale based upon the revenue generated within the segment during recent past. 

Driving forces for the industry
The exponentially growing demand for EPO drugs in global markets can be attributed to the rising cases of diseases such as HIV, Cancer, and End Stage Renal Disorder (ESRD). Around 70% of the population suffering from ESRD, and 20% of patients diagnosed with HIV/Cancer respectively, undergo chemotherapy; thus, calling for this therapeutic class of drugs. However, extremely high pricing keeps a huge population refrained from availing the benefits and thus, impedes overall market growth. This issue can probably be addressed with cost optimization of development techniques for erythropoietin drugs. Typical isolation technique of developing a DNA in a cost effective manner, should add commercial viability to production processes for manufacturers. 

The first EPO drug, Epogen (Erythropoietin alfa), launched by Amgen, witnessed a patent expiry in 2014. This opened up new product launch opportunities for existing market competitors, plus the new entrants. The trend of switching to biosimilar drugs also influences the businesses in this segment. Subsequently, different biosimilar to Erythropoietin alfa that have been introduced by key firms such as Ranbaxy, Biocon and Emcure Pharmaceuticals captures market shares from existing market players. 

Natural occurrence versus laboratory recombination
Erythropoietin is a protein signaling hormone secreted by fibroblasts in kidney and within perisinusoidal spaces in liver. Post synthesis in the bone marrow, these hormones act as precursor to erythropoiesis, or the process of producing red blood cells. A dynamic balance between the secretion of EPO and hemoglobin levels is maintained inside a normally functioning body. However, the process is slightly hindered when an ailment prevails. In severe cases of anemia, resulting from one among the many factors such as chronic or short-term renal dysfunction, chemotherapy, and/or insufficient RBC production by the bone marrow. The first resort to get such situations fixed is through appropriate blood transfusion. A variety of options, or the absence of any, could possibly eliminate the possibility of blood transfusion though. That is when the need for exogenous recombinant human erythropoietin (rhEPO) arrives. 

Recombinant DNA modeling technique is used to produce synthetic EPO in laboratories. The recombinant DNA (rDNA) molecules generated in this manner are chemical imitation of human DNA, their genetic material sourced from random species. Remarkably, the consequent nucleotide sequence achieved in such molecules are unique to the genome. Synthetically obtained EPO drugs are thus prepared for its critical therapeutic applications in healthcare segment.

Challenges of market expansion
Even when administered intravenously under medical supervision, the EPO drugs could inhibit some serious risks of myocardial infarction, strokes, tumors, and deep vein clotting. Therefore, it is unimaginable to predict side-effects when consumed un-administered as a performance enhancement drug by athletes. Ethical regards with misuse of EPO drugs in market taps attention from dope critics. Proper inspection and monitoring within distribution channel is what helps EPO drugs to fall into the rightful hands. In both cases, blood and urine assays are performed to study normalcy of EPO levels in a body. Drug inspection agencies actively try to protect the channels of product flow from any illegal access.

Government organizations and regulating bodies that grant patents, development rights, and approval certifications have a huge role to play in the EPO drugs market. For example, there exists a very fine line between protecting original approaches to rDNA modeling and limiting companies from bringing improved drugs to the consumer markets. The Genetics Institute-Amgen patent conflict over rights to isolating active EPO from human urine and through transformation of Chinese hamster ovary (CHO) cells is one such instance. The process patent which was earlier denied to Amgen due to the ‘obviousness’ of the isolation procedure, was later granted to it after a long legal battle. However, during the course of entire conflict, both their products were placed in the market. The court itself, found it unreasonable to place an injunction on the lifesaving drug. 

Market leads for EPO drugs

The research firm Allied Market Research (AMR), in a recently published report titled “Global Erythropoietin (EPO) Drugs Market (Type, Application and Geography) - Size, Share, Global Trends, Company Profiles, Demand, Insights, Analysis, Research, Report, Opportunities, Segmentation and Forecast, 2013-2020,” forecasts the global erythropoietin market to attain overall market size of $11.9 billion by 2020, registering a CAGR of 9.7% through 2014 to 2020.

The EPO drugs market is led by Anemia therapeutics; however, by the year 2020, kidney therapeutic market would emerge as the dominant segment. At present, developed countries account for about 70% of the overall erythropoietin market share due to supporting reimbursement policies by the government that makes the production of the drug cost effective. The Asia-Pacific region would grow significantly with 13.3% CAGR during the forecast period due to commercialization of EPO biosimilar drugs.

To view the report, visit the website at: https://www.alliedmarketresearch.com/erythropoietin-market

 

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