The domestic sales of sodium-glucose transport protein-2 (SGLT-2) inhibitors for diabetes treatment expanded about 40 percent to hit nearly 100 billion won ($85.7 million) in 2019, industry data showed.
The growth momentum is expected to continue, as SGLT-2 inhibitors are seeking an additional indication for heart failure and local reimbursement along with dipeptidyl peptidase-4 (DPP-4) inhibitors.
According to data from U-BIST, a pharmaceutical market research firm, outpatient prescriptions of SGLT-2 inhibitors, including monotherapy and combo therapy with metformin, recorded 90.24 billion won ($77.48 million) last year. The figure was up 39 percent, compared to the previous year.
By market size, monotherapies of SGLT-2 inhibitors sold 63.6 billion won, which is larger than the sales of combo therapies.
By the pace of growth, however, combo treatments are expanding more rapidly, with 84.1 percent growth rate, than monotherapies.
By brand name, AstraZeneca’s Forxiga (ingredient: dapagliflozin) ranked first, with 31.14 billion won sales in 2019. However, its annual growth rate stood at only 13.3 percent.
In contrast, prescriptions of Boehringer Ingelheim’s Jardiance (empagliflozin) jumped 37.3 percent to 28.2 billion won last year. While prescriptions of Forxiga increased by 3.6 billion won, those of Jardiance surged by 7.6 billion won during the same period.
In the combo therapy market, AstraZeneca’s Xigduo (dapagliflozin/metformin) showed robust sales growth.
Prescriptions of Xigduo increased to 19.94 billion won in 2019, up 7.8 billion won from 2018. By both the sales and growth rate, Xigduo beat rival drug Jardiance Duo (empagliflozin/metformin) by Boehringer Ingelheim.
The sales of Astellas Pharma Korea’s Suglat (ipragliflozin), which was the only drug to see a prescription decline among SGLT-2 inhibitors, rebounded.
Suglat recorded 2.72 billion won prescriptions last year, up 16.4 percent from a year earlier.
MSD’s Steglatro (ertugliflozin), the latecomer in the SGLT-2 inhibitor market, posted 1.44 billion won prescriptions in 2019.
The SGLT-2 inhibitor market is growing around the world. As SGLT-2 inhibitors offer multiple effects, including cardiovascular and renal benefits and weight control, treatment guidelines recommend them over other oral diabetes treatments. SGLT-2 inhibitors have shown efficacy in heart failure patients in cardiovascular studies, expanding the scope of treatment for heart failure.
Forxiga is leading the widening of SGLT-2 inhibitors’ indication. It obtained the FDA’s approval as a preventive treatment for heart failure in patients with type-2 diabetes last year. Industry officials expect that it could also expand the indication to treat heart failure, regardless of diabetes, this year.
The domestic market offers more room for growth for SGLT-2 inhibitors through reimbursement for a combo of DPP-4 inhibitor and SGLT-2 inhibitor. However, the issue remains controversial.
Although the government and the industry agree that the combo needs reimbursement, the two have different opinions on whether the reimbursement should be based on an agent or drug class.
According to the current approval conditions for SGLT-2 inhibitors, each agent has different combinations with DPP-4 inhibitors. Without changing them, it will be difficult to make all the SGLT-2 inhibitor class drugs reimbursable.
The Ministry of Food and Drug Safety said a change in approval conditions requires a request from a drugmaker.
“The ministry cannot consider clinical benefits and ask pharmaceutical companies to conduct clinical trials to give the nod for reimbursement for a combo of drugs from two different classes,” a ministry official said.
Forxiga is authorized to be used with sitagliptin or saxagliptin, Jardiance with linagliptin, and Suglat and Steglatro, only with sitagliptin.
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