Can Haprec "Reverse The Wind" When Entering The Heparin API Market In The United States?

Although the capital market reaction continues to be sluggish, the global layout of hipre is ushered in a further step.

On September 21, the domestic heparin industry leading enterprise hipre announced that its wholly-owned subsidiary Shenzhen Tiandao Pharmaceutical Co., Ltd. (hereinafter referred to as Tiandao pharmaceutical) has recently received a notice that the US Food and Drug Administration (FDA) under the US Department of health and human services has approved its registration as a drug and API of enoxaparin sodium preparations in the United States supplier.

The United States is an important market for enoxaparin. According to Frost & Sullivan, total sales of enoxaparin in the United States are expected to increase from $455 million in 2019 to $838 million in 2025, with a compound annual growth rate of 10.7%. Large scale supply and production capacity are the key to grasp the demand of American market.

Enoxaparin sodium of Tiandao medicine is the first generic drug in EU. Enoxaparin sodium injection prevents venous thromboembolic diseases, especially thrombosis related to orthopedics or general surgery. Treatment of deep venous thrombosis with or without pulmonary embolism, clinical symptoms are not serious, excluding pulmonary embolism requiring surgery or thrombolytic therapy. Treatment of unstable angina pectoris and non-Q-wave myocardial infarction, combined with aspirin. It is used in hemodialysis cardiopulmonary bypass to prevent thrombosis. The approved registration is classified as generic drugs with specifications of 100mg / ml and 150mg / ml.

Prior to this, some industry insiders told reporters of the 21st century economic report that it has become one of the important bets for hipray to enter the U.S. market. However, it is worth noting that since the listing of hipray Hong Kong stock, it has been in a state of downturn, once falling below 23% of the issue price, and a shares also showed a similar trend.

Oligopoly competition continues

Although the capital market is cold, the situation of oligopoly competition in heparin market is gradually formed.

In recent years, with the rapid expansion of patients, cardiovascular and cerebrovascular diseases have become one of the main diseases threatening human health. In the process of treatment, heparin and other antithrombotic drugs play a key role. It is worth mentioning that heparin is the only effective and specific drug with irreplaceable effect in hemodialysis treatment.

According to relevant data, in 2015, the global heparin drug market was about 12.58 billion US dollars. The sales volume of sanofixacin (enoxaparin sodium injection) reached 1.719 billion euro in 2015, which is one of the best-selling antithrombotic and anticoagulant drugs in the world. In 2015, the market scale of low molecular weight heparin sodium preparations in China was 2.556 billion yuan, which rose to 3.374 billion yuan in 2018. According to the prediction, the market scale of low molecular heparin sodium preparations is expected to reach 6.017 billion yuan in 2025.

At present, China is the largest pig breeding country in the world and the largest exporter of heparin API in the world. There is a huge demand for heparin in the international market, so the export of heparin API has become the main source of income for some enterprises in China. HPR, Jianyou, Qianhong pharmaceutical, Changshan pharmaceutical, Jiulong biological are the main export enterprises of heparin API in China.

In recent years, the number of heparin sodium enterprises increased first and then decreased. The number of heparin related enterprises in the whole country increased from 2015 to 2020, which was 54, which was higher than that in 2015-2020.

However, the heparin market is not competitive with the domestic market. There are not many heparin enterprises left in China. The market demand is great and the added value of API is high, so the price of heparin on the market is relatively high. " Shi lichen, founder of Beijing Dingchen Management Consulting Co., Ltd., said in an interview with 21st century economic reporter.

The Chinese market is developing rapidly

Looking around the world, the EU is the largest enoxaparin market in the world, and China is the fastest growing enoxaparin market in the world.

According to Frost & Sullivan's data, the global sales of enoxaparin in 2019 will be 782 million, including 489 million in the European Union. In 2019, the total sales of enoxaparin (including original drug brands and bio generics) in the EU will be US $1.665 billion, which is expected to reach US $2.705 billion in 2025; while the total sales of enoxaparin in China will reach US $308 million in 2019 and US $698 million in 2025 with a compound annual growth rate of 24.5% since 2014.

Despite the variety of heparin products, there is no doubt that there is a large demand for heparin preparations, and the heparin market prospect is broad. According to the data of the National Bureau of statistics, the number of inpatients in medical and health institutions continued to increase from 2011 to 2019, reaching 61.7158 million in 2018, an increase of 10% over the same period last year. It is preliminarily estimated that the number will increase to 67.59 million in 2019. However, heparin preparation with anticoagulant effect is needed in hemodialysis and various surgical operations.

In addition, the sales price of heparin preparations fluctuated due to market influence. According to the analysis on the supply and demand market situation and development trend of China's heparin sodium industry in 2020 released by the prospective industry research institute, with the epidemic spreading around the world, the price of heparin sodium will rise substantially in 2020. From 2017 to 2019, the export amount of heparin and its salt increased significantly, reaching 7613.28 million yuan in 2019, and the export volume reached 2.01 million tons; according to the export quantity and amount of heparin and its salt, the average price of heparin sodium from January to may 2020 was 58.17 million yuan / ton, which increased by 54% compared with the average price in 2019.

For the future development trend of heparin industry, Shi lichen told the 21st century economic report: "the industry as a whole will still develop very well. With the enhancement of R & D capacity of domestic generic pharmaceutical enterprises, the market demand is also higher and higher, and the market will be bigger and bigger."

As the industry leader, the market of hipre is mainly concentrated in overseas.

According to the semi annual report of 2020 released by hipray at the end of June, the export revenue of hipray accounted for 87.27% of the total revenue in the first half of June. The core business of the company is mainly export, and some countries exceed the market share of the original research institute. The revenue of heparin sodium and low molecular weight heparin sodium API accounted for 55.03% of the total revenue, preparations accounted for 24.07% of the total revenue, and cdmo business accounted for 14.54%.

As the European market is the main sales market of enoxaparin, the epidemic factors to a certain extent form a disturbance to hypri. However, under the continuous effect of prescription spillover effect from hospital to drugstore, the average sales price of preparations still increased significantly, which also promoted the sales of preparations.

In addition, heparin is the raw material of pig slaughtering, which has a great impact on the production of pig raw materials and pig industry. Due to the impact of African swine fever, the price of raw materials rose or there was a shortage, which had a great impact on the production and sales of preparations to a certain extent.

The domestic pharmaceutical industry rebounded in the second quarter, and entering the U.S. market to further strengthen the international market layout may be a "reversal of the wind" opportunity. In this regard, Shi lichen, the founder of Beijing Dingchen Management Consulting Co., Ltd., analyzed to the 21st century economic reporter that "the possibility of counter attack is still very large after the business scope of hipre is further expanded."