COX-2 inhibitors recover and grow 56% in 5 years

Original still making KRW 40 billion a year, but Acelex and Arcoxia underperform

Over 100 generics released, but volume leaps from KRW 32 billion in 2016 to KRW 65 billion in 202

The prescription volume of cyclooxygenase-2 (COX-2) inhibiting nonsteroidal anti-inflammatory drugs (NSAIDs) seems to be increasing rapidly.

 

A major product Celebrex (celecoxib) had its pricing cut by half after its patent was expired in 2015, but the prescription volume soared by 56 percent in five years until last year.

 

The industry experts say the increased prescription frequency canceled out the decreased pricing.

 

While the original Celebrex is still going dominating the market by annually making 40 billion won, 100 or so generics have doubled the prescription volume in five years and made a 65-billion-won market.

 

However, other follow-on originals like Acelex (polmacoxib) and Arcoxia (etoricoxib) are making disappointing performance with narrow indication.

 

◆Half-priced COX-2 inhibitor prescription volume soars by 56% On Jan.

 

28, a pharmaceutical market research firm UBIST reported the COX-2 inhibitor NSAID market reached the volume of 112.9 billion won as of last year.

 

Compared to 113.5 billion won recorded in 2019, the market shrunk by 1 percent, but considering the last six years, the market has been growing at a remarkable rate.

 

The market size marked 72.3 billion won in 2015 grew by 11 percent, 7 percent, 19 percent and 11 percent in 2016 at 80.2 billion won, 2017 at 85.8 billion won, 2018 at 102.2 billion won and 2019 at 113.5 billion won, respectively.

 

Except for 2017, the market has been making a two-digit growth annually until 2019.

 

Considering the star product of the market Celebrex got its pricing halved to 53.55 percent since the patent expiration in June 2015 and a series of generic launched at similar pricing, the prescription volume itself has almost tripled.

 

◆20 years in South Korean market, Celebrex still generated 40 billion won The market is predominantly filled with celecoxibs.

 

As of last year, the original Celebrex and celecoxib generics took up 36 percent and 57 percent of the market, respectively.

 

In fact, Celebrex’ market presence is still substantial as it made 40.6 billion won last year, regardless of the patent expired five years ago.

 

Although compared to the previous year (44.3 billion won), the prescription volume dropped 8 percent, but the market experts analyze it was due to the drug’s temporary shortage.

 

Celebrex was out of stock for about two months last year due to delayed manufacturing schedule from February.

 

Launched for the South Korean market in 2000, Celebrex prescription volume peaked in 2014 with 70 billion won.

 

But the volume plummeted to 58.8 billion won the following year as the patent expired, and it continued to drop to 40.2 billion won and 36.5 billion won in 2016 and 2017, respectively.

 

Mainly the generics entering the market and pricing cut caused the steep drop in the volume.

 

Since 2018, however, the drug gained back the prescription volume up to 40 billion won.

 

Releasing higher dose, expanding indication and healthcare providers’ high demand for the original seem to have affected the recovery.

 

As the generic pricings were leveled with the off-patent original, the healthcare providers are firmly demanding for the original.

 

◆Over 100 generics released, the prescription volume doubles in five years Celebrex generic prescription volume was doubled in just five years.

 

As soon as the patent expired in June 2015, 60 companies released their celecoxib generics.

 

And as of late last year, over 100 companies are apparently supplying generics.

 

The total prescription volume of the generics was at 64.9 billion won.

 

Compared to 32.1 billion won in 2016, it is more than twice as much.

 

While the COX-2 inhibitor market volume shrunk by 1 percent last year, the generic prescription was increased by 7 percent.

 

The top selling generics were as follows; Samjin Pharm’s Klicox (4.2 billion won), Hanmi Pharmaceutical’s Coxib (4.2 billion won), Korea Arlico Pharm’s Celcobrex (3.5 billion won), Chong Kun Dang’s Coxbito (3.1 billion won), and Hutecs Korea Pharmaceutical’s Cybrex (2.5 billion won).

 

◆Original Acelex and Arcoxia generate below 5 billion won each Other original COX-2 inhibitors—Acelex and Arcoxia—are showing rather underwhelming performances.

 

Acelex is a domestically developed new drug by Crystal Genomics.

 

It emerged to the market in August 2015 and Dong-A ST handles the local sales.

 

The two companies have signed a 8.5-billion-won exclusive local sales deal.

 

But from 2018, Daewoong Pharmaceutical joined the force to accelerate the Acelex sales.

 

The company was in charge of small and medium hospitals with 300 and less beds, whereas Dong-A ST marked general hospitals.

 

Acelex’ prescription volume was at 4.2 billion won, 5.8 billion won, 4.9 billion won and 5.5 billion won in 2016 through 2019, respectively.

 

The volume plummeted by 24 percent last year and made only 4.2 billion won.

 

MSD’s Arcoxia is also underperforming.

 

Ever since an older version of COX-2 inhibitor Vioxx was delisted from the market due to adverse reaction reports, MSD ambitiously launched Arcoxia as a follow-up.

 

To avoid concerns on safety, the multinational company also conducted a clinical trial in South Korea as well.

 

But its prescription generated 3.7 billion won, 5.7 billion won, 5.6 billion won, 3.4 billion won and 3.3 billion won in 2016 through 2020.

 

The industry says the two originals’ limited indications are widening the prescription volume gap between Celebrex, and Acelex and Arcoxia.

 

Currently, Acelex and Arcoxia are only indicated to treat osteoarthritis, when Celebrex is indicated to treat rheumatoid arthritis, ankylsoing spondylitis, primary dysmenorrheal and acute pain.