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With the change of people's eating habits and lifestyle in modern society, the incidence of digestive diseases such as gastroesophageal reflux disease and peptic ulcer disease has increased year by year, and people's attention to the carcinogenesis of helicobacter pylori has increased, and the sales volume of acid suppressants based on proton pump inhibitors (PPI) has topped the list.
Recently, the seventh batch of national catalog was announced, PPI drugs were once again included, of which omeprazole injection has 28 pharmaceutical companies to meet the competition conditions, becoming the most competitive variety, causing hot discussion.
Under the sweeping of collective mining, traditional PPI has entered the era of meager profits, new drugs have appeared, gradually replacing the old drug market, and the tens of billions of acid suppressant market has ushered in a reshuffle.
01
Six PPI: Accelerate domestic substitution
The traditional acid inhibitor proton pump inhibitor (PPI) is a H+/K+ ATPase bound to the surface of the cell membrane. It uses the energy generated by the hydrolysis of ATP to drive the exchange of ions (protons, chloride ions and potassium ions) on both sides of the cell membrane, and inhibits the activity of H+/K+ ATP by competitively binding K+, thus realizing the inhibition of gastric acid secretion. So as to achieve the clinical effect of protecting the digestive tract.
As a first-line drug for the treatment of gastric acid-related diseases, PPI has a wide range of indications, including gastroesophageal reflux disease, gastric and duodenal ulcers, non-steroidal anti-inflammatory drug (NSAID) -associated ulcers, and Helicobacter pylori eradication therapy.
At present, there are two generations of PPI drugs on the market:
The first generation products: omeprazole, Lansoprazole, Pantoprazole;
Second generation products: Rabeprazole, Esomeprazole, Iprrazole.
The first-generation product is metabolized mainly by CYP2C19 in the liver, and CYP2C19 gene polymorphism affects individual differences in its pharmacokinetics, stability of efficacy and drug interactions. As a result, the blood drug concentration of different patients after the use of first-generation PPI is very different.
Therefore, although the first-generation PPI drugs are cheap, they have problems such as slow onset, low bioavailability, short half-life, poor acid inhibition persistence, multiple dosing, and prone to nighttime "acid breakthrough".
The second-generation PPI does not use CYP2C19 as the main metabolic enzyme, and has the characteristics of small individual differences, fast effect of acid inhibition, high level of acid inhibition, small adverse reactions, and less interaction with other drugs, which is more advantageous than the first-generation PPI.
Among the six major PPI drugs, only eprazole is independently developed by Chinese pharmaceutical companies (Lizon Group), and is still an exclusive product. The remaining 5 products due to the expiration of the patent, the domestic layout of generic drug enterprises, especially the first generation of products, domestic generic drug manufacturers are more than 10.
As of March this year, 9 varieties of proton pump inhibitor drugs have passed or deemed to have passed the consistency evaluation, involving 63 enterprises, including Aosaikang, East China Medicine, Stone Pharmaceutical Group, Bate Pharmaceutical, Zhengda Tianqing and so on.
Among them, there were more than 26 enterprises with omeprazole sodium for injection, more than 18 enterprises with esomeprazole sodium for injection and Pantoprazole sodium for injection, and more than 10 enterprises with Lansoprazole for injection.
With the increasing number of overreviews, under the support of the volume procurement policy, domestic generic drugs are accelerating to replace the market position of original drugs. Among them, the first-generation PPI market has been almost completely dominated by domestic generics, and the market share of Aosaikang, Luo Xin Pharmaceutical, Changzhou Siyao, and East China Pharmaceutical ranks top.
PPI sample medicine sales situation
Source: Guosheng Securities Research Institute
With its own advantages, the second generation of PPI gradually seized the market share of the first generation of PPI. From the perspective of sales amount, although the original research drug still occupies the first place, but from the perspective of sales volume, generic drug companies have exceeded the original research drug, with the promotion of volume procurement policy, domestic substitution is inevitable.
Domestic PPI drug market share changes
Source: Guosheng Securities Research Institute
02
Gathering swept: PPI market ushered in a storm of price cuts
Due to factors such as irregular diet and high life pressure, the prevalence of gastrointestinal diseases in China has been increasing in recent years. It is reported that the prevalence of gastroesophageal reflux disease in China has reached 2.5-7.8%, the incidence of peptic ulcer has reached 10%, and more than 700 million people are infected with helicobacter pylori. The number of patients is large and most of them belong to chronic diseases, which makes the clinical demand of PPI drugs in our country huge.
In 2019, the sales of terminal proton pump inhibitor drugs in China's public medical institutions reached a record high of about 35 billion yuan. In the following two years, affected by medical insurance control fees and collection, negative growth occurred for the first time in 2020, and the market size continued to shrink to about 25 billion yuan in 2021, a year-on-year decline of 14.85%.
Due to the huge amount, PPI drugs have always been a key project of collection, and PPI drugs have been included in succession since the third batch of collection in 2020. Up to now, omeprazole oral regular release formulation, esomeprazole oral regular release formulation, Pantoprazole oral regular release formulation, Pantoprazole injection, esomeprazole injection, Lansoprazole injection, and omeprazole injection have entered the collection.
Under the collection rules, drugs that are included in the scope of collection, especially injectables used only in medical institutions, either reduce prices to reduce profits or lose the market. Therefore, the inclusion of collectible mining directly means a sharp drop in prices.
Taking omeprazole enteric-coated capsules as an example, two enterprises won the bid in the third batch of collection, the winning price of Luoxin Pharmaceutical 10mg specification was 0.12 yuan/capsule, and the winning price of Hainan Hailing 20mg specification was 0.15 yuan/capsule. Directly resulting in the average price of omeprazole enteric-dissolved capsules dropped from 2.49 yuan in 2019 to 1.88 yuan in 2020, and after the execution of the winning price in 2021, the average price dropped sharply to 0.38 yuan.
In 2021, sales of omeprazole enteric-coated capsules decreased by about 65% compared to the same period last year, while sales volume increased.
In addition, as innovative drugs are not included in the collection, in the context of the other five PPI drugs have entered the collection, Lizon Group's second-generation PPI drug, iprrazole, has been rapidly released, and the sales revenue growth rate has far exceeded expectations.
From 2018 to 2020, the sales revenue of iprrazole series (oral enteric-coated tablets + injection) reached 504 million yuan, 975 million yuan and 1.77 billion yuan, respectively, an increase of 76.45%, 65.65% and 81.2% year-on-year. In 2021, there is no revenue data published in its annual report, and it is estimated that the sales revenue of iprrazole series in 2021 will exceed 2.5 billion yuan from a 50% increase in the field of its digestive tract.
From the perspective of terminal sales data of public medical institutions, in 2021, sales of iprrazole sodium for injection increased by 100%, ranking from 12th in 2020 to 5th; Iprrazole enteric-coated tablets saw a 40% increase in sales, moving up to 8th place from 11th place in 2020.
eprazole
Source: Official website
Under the promotion of the collection policy, the prices of the five major PPI drugs have dropped significantly, the market position of generic drugs and original drugs has been reshuffled, and the market share of innovative drugs Iprrazole has increased significantly while the overall market size has shrunk.
03
New drugs arrive: P-CAB emerges
At the same time as the internal transformation of the PPI drug market, the innovative drug P-CAB from the outside is bringing greater market reshaping.
Although PPI has been used as a first-line treatment for acid-related diseases for more than 30 years, and occupies a leading share in the field of acid inhibition, it still has pain points such as short half-life and insufficient acid inhibition.
Studies have shown that more than half of patients with GERD receiving standard dose PPI treatment for 4 weeks, the proportion of complete relief of heartburn is 50%-72%, and the proportion of reflux symptom control is only 26%-64%.
In February 2015, a new generation of acid suppressant drugs, Takeda's Vonorasang tablets, were listed in Japan, and at the end of 2019, the drug was approved for listing in China.
Vonorazine tablet is a potassium competitive acid blocker (P-CAB). Unlike PPI drugs, P-CAB can directly compete with K+ for binding sites on H+/K+ -ATPase through ionic form, and inhibit H+/K+ -ATPase in both static and active states, thus effectively inhibiting gastric acid secretion.
Compared with PPI drugs, P-CAB drugs have the characteristics of rapid onset, full effect of the first dose, strong acid inhibition, and long half-life (only one dose per day), etc. The latest Chinese GERD guidelines have regarded P-CAB as one of the preferred drugs for reflux esophagitis.
After entering China, Vonora raw tablets will enter the medical insurance catalog at the end of 2020. In 2021, the sales of Vonora tablets in China's public medical institutions and retail channels totaled about 300 million yuan, and the trend of rapid growth.
On April 13, 2022, Roxin Pharmaceutical's Tigora tablet was approved for listing, becoming the second P-CAB drug listed in China and the first in China.
Roxin Pharmaceutical has high hopes for Tigorazan, which is expected to participate in medical insurance negotiations in 2022, when it is expected to achieve volume, the outside world predicts that the market size of Tigorazan is conservatively estimated at 2-3 billion yuan, and optimistic estimates are expected to reach 4-5 billion yuan.
Tigora tablets
Source: Luo Xin Pharmaceutical
In the research pipeline, the Konolazan developed by Copipin Pharmaceutical was accepted on September 30, 2021, and is expected to become the second P-CAB drug in China; Fesurazan, introduced by Yangzijiang for 2.2 billion yuan, also started Phase III clinical trials in October 2021.
In addition, Vonorosen's patent in China will expire in 2026, and a number of domestic companies have begun to compete to lay out generic drugs at this stage. Among them, Kelun Pharmaceutical, Sichuan Haihui Pharmaceutical and Shandong New Times have submitted four generic drug listing applications.
P-CAB drugs have significant advantages compared with PPI drugs in terms of efficacy, and with more and more P-CAB innovative drugs and generic drugs coming to market, and more indications being approved, the PPI drug market will be impacted.
04
peroration
Any glorious past will pass with time, only change is permanent. When the industry ushered in changes, only adapt to The Times, take the initiative to change, can be invincible.
Reference materials:
1. The proton pump inhibitor (PPI) industry interpretation 】 【 products overview "https://mp.weixin.qq.com/s/ausE1lwo7HEbDelhDftLxg
2. The "six big big varieties named (attached list) https://new.qq.com/omn/20220310/20220310A09ZCY00.html
3. PPI Volume and Price Game Outbreak https://www.baidu.com/link?url=qOhThX5uXMjLlZMe89ky0f68OLG_7T6KfOHXX1vMoK3Fht-0Ur01cvwkbcfpJiiDgI5pSrVvCpl-xTpso2zXw7evk VOiV_eAm3KOXU-MsEy&wd=&eqid=9278a4ff000136dd0000000562b98788
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