The bowel preparation market valued at 50 billion won is fluctuating noticeably. New products flooding in just a few years time have overly crowded the market.

These products are jumping into the market with improved drug compliance for examinees and patients, but the market has not been easy for them to survive.

Three types of bowel preparations approved in Korea

In Korea, only three types of bowel preparations are approved by the health authority. Two types of polyethylene glycol (PEG) are most popular aside from oral sulfate solution (OSS).

Iso-osmotic and non-absorbable PEG products are considered as the safest to use with lower risk of adverse change in electrolytes and metabolism. These are the reasons why Korea uses PEG the most.

High-dose PEG, such as Colyte Powder and Colonlyte Powder, is usually supplied in 4 liter. Low-dose PEG, such as Coolprep Powder and Clicool Powder, is in 2-liter unit. Recently, many of PEG products are designed to be administered at minimum dose for better drug compliance.

In fact, the majority of PEG products were in 4-liter unit when the U.S. Food and Drug Administration (FDA) first approved it in 1992, but now the market trend is leaning towards 2-liter dose after FDA approved the lower-dose product in 2006.

OSS in tablet form was released to the market to enhance drug compliance with small amount. The world’s first incrementally modified OSS, Orafang by Pharmbio Korea is a well-known OSS tablet.

While PEG still dominates the market, Orafang struggles to settle down

Currently, Taejoon Pharmaceutical owns the biggest pie in the bowel prep market. The company generates over 10 billion won, easily topping the market valued at 50 billion won.

In 1990s, Taejoon Pharmaceutical imported Colyte Powder and Colyte F Powder, and continued to dominate the market over a decade with FDA-approved Coolprep and other various doses of PEGs. The Korean company has the fullest line up in the market.

Joining the race late, Pharmbio Korea seems to have avoided PEG by launching the world’s first incrementally modified OSS Orafang in May last year.

To snatch a chance to compete in the bowel prep market, the company had to find a key product besides PEG. Pharmbio actually has tried the market with PEG before, but the performance was underwhelming.

Although it was dropped during clinical stage in 2013 due to unforeseen renal issues, the conveniently administered Orafang came back in tablet form with most of the problematic part sorted out.

Phase III trials conducted in eight hospitals like Seoul National University Hospital and Korea University Medical Center have confirmed Orafang’s bowel cleansing efficacy at 95.5 percent non-inferior against other OSS in liquid form at 98.2 percent.

But apparently, the OSS was faced with limitation in the PEG-dominated market. The biggest difficulty was entering university hospitals.

A head of general medical checkup center at one of Big Five hospitals hinted, “We are aware of Orafang, but the hospital does not use it or have a plan to consider using,” and “checking at conferences and seminars, majority of university hospitals were not interested in entering the product’s prescription code.”

New products flooding in, the latecomer competition also unavoidable

Regardless of the world’s first incrementally modified drug struggling to expand in the market, new products are released one after another in the Korean bowel prep market.

The latecomers’ competition would inevitably heat up high as the market is already crowded with firstcomers.

Korea Pharma has signed an exclusive deal with Norgine, a Dutch company specializing in bowel prep, for supplying PLENVU in the Korean market.

Kolmar Korea is readying for the launch of Easyprep 1.38 Power that reduced the regimen amount down to 1.38 liter. The company has received Ministry of Food and Drug Safety’s (MFDS) approval on the incrementally modified drug.

Dong Seok Ho, a President of the Korean Society of Health Screening and Promotion, stated “The board of directors is also reviewing newly released bowel preps through product presentation,” but “as all of them have clear advantages and differentiate themselves by improved drug compliance, products with high level of safety and bowel cleansing efficacy would ultimately win the market.”