The osteoporosis treatment market is stagnating with sales of major products declining in the first half of this year, industry data showed Tuesday. However, combination therapies achieved revenue growth.

According to outpatient prescriptions data from U-BIST, the total sales of osteoporosis treatments went down to 28.5 billion won ($25.5 million) in the first half, declining 9.4 percent from 31.5 billion won a year earlier.

Evista, the No. 1 seller by revenue, suffered more than 20 percent sales decline this year. Its revenue plunged to 5.6 billion won in the first half, down 22.2 percent from 7.3 billion won a year earlier.

Developed by Lilly and sold by Takeda Pharmaceuticals Korea, Evista is a SERM (selective estrogen receptor modulator)-class drug for postmenopausal women’s osteoporosis treatment and prevention.

Sales of MSD’s Fosamax Plus D, treating osteoporosis of both postmenopausal women and men, also fell 15.2 percent to 5.5 billion won from 6.5 billion won over the cited period.

A combo of Fosamax and vitamin D, Fosamax Plus D used to lead the osteoporosis market. However, with its patent expiring and the arrival of general copies, the sales growth of Foxamax Plus D is slowing.

Actonel, a bisphosphonate drug, sold only 3.3 billion won in the first half, 9.6 percent less than 3.7 billion won a year earlier. Sales of Maxmarvil by Yuyu Pharm amounted only to 1.8 billion won in the first half, failing to exceed the previous year’s 1.9 billion won mark.

In contrast, Alvogen’s Bonviva Plus and Hanlim Pharm’s Risenex Plus are performing well.

Bonviva Plus, a combo drug of ibandronate sodium monohydrate and vitamin D, sold 3.58 billion won in the first half, surging 19.6 percent from 3 billion won a year earlier.

Hanlim’s Risenex Plus, which mixed risedronate sodium with vitamin D for the first time in the world, is closely chasing Bonviva Plus with 3.56 billion won outpatient prescriptions, inching up 1.8 percent from a year earlier.

The sales declines of No. 1 and No. 2 osteoporosis treatments reportedly resulted from lost competition against generic copies.

In particular, bisphosphonate-containing remedies suffered the most severe blow, even though they used to account for more than 50 percent of the market.

Bisphosphonate-class drugs require demanding medication conditions such as not lying down for 30 minutes to one hour after emptying stomach or taking medicine. Also, patients must take bisphosphonates with water. The medications have side effects of gastrointestinal disturbances and jawbone necrosis.

However, newly released medicines only require a single injection per month or once every six months with the same therapeutic effect. They are gaining more popularity with fewer side effects.

One of the new treatments is Amgen’s Prolia, which sold 14 million won in the first half, according to U-BIST data. Last year, the annual sales of Prolia reached 3.7 billion won, according to IQVIA data.

Observers said Prolia, an injection for every six months, sold last year might not have been counted as sales this year. Some of the top-selling drugs could have been replaced by Prolia as well, they said.

Prolia has limited insurance coverage because some patients had osteoporotic fractures despite the administration of bisphosphonates for more than one year.

Bisphosphonates and SERM-class drugs will keep competing against each other, industry watchers said.

“If Prolia gets more relaxed criteria for insurance coverage, there will be a change in the market. Suppliers of conventional drugs will have to seek a response measure to deal with generic and new drugs,” said an official at a drugmaker.

sjh@docdocdoc.co.kr

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