According to the World Health Organization report, there are approximately 50 million epilepsy patients worldwide, 40 million of whom are in developing countries. In China, epilepsy has become the second most common neurological disease after headaches. Data shows that the overall prevalence of epilepsy in China is 7.0‰, the annual incidence rate is 28.8/100,000, and the prevalence of active epilepsy with seizures within one year is 4.6‰.

So, what is the current state of the anti-epileptic drug market in China? What impact has the centralized drug volume-based procurement had on this field? This article analyzes the changes in the hospital terminal market for anti-epileptic chemical drugs in recent years, as well as the sales situation of levetiracetam in sample hospitals before and after centralized procurement.

　　01、Overall Overview:Domestic Enterprises Awaiting to Catch Up

According to PDB data, in 2021, the sales value of anti-epileptic drugs in sample hospitals was 1.498 billion yuan, with the total drug purchase amount in public hospitals nationwide being approximately 5.003 billion yuan. Data from the past five years shows a double-digit growth trend from 2017 to 2019, with sample hospital sales value reaching a peak of 1.570 billion yuan in 2019, a 13.3% increase compared to 2018. In 2020, both sales value and sales volume decreased slightly.

　　Gradual Price Decline and Volume Increase

Looking at the data for 2021 and the first quarter of 2022, sales value decreased slightly while sales volume increased slightly. This is mainly due to the full implementation of levetiracetam, included in centralized procurement, at lower winning bid prices, achieving the effect of price decline and volume increase. From the average unit price, it can be seen that prices increased slightly from 2017 to 2019, with the highest unit price being 2.94 yuan in 2018 and 2.95 yuan in 2019. Starting from 2020, the average unit price has shown a downward trend, which is also the result of the implementation of centralized procurement and increased competition from more generic drugs.

　　High Market Concentration

In terms of drugs, there were 18 anti-epileptic drugs sold in sample hospitals in the first quarter of 2022. The top five were sodium valproate, levetiracetam, oxcarbazepine, pregabalin, and lamotrigine. The sales value of these five drugs in sample hospitals exceeded 326 million yuan, accounting for 86.4% of the sales value and 61.2% of the sales volume of anti-epileptic drugs, indicating high concentration and higher average unit prices. Among the 18 drugs, the highest unit price was 10.2 yuan for lacosamide preparations, and the lowest was 0.14 yuan for phenytoin sodium preparations.

　　Foreign Enterprises Still Dominant

In terms of manufacturers, there were 62 manufacturers selling anti-epileptic drugs in sample hospitals in the first quarter of 2022. The sales value of the TOP 10 manufacturers in sample hospitals accounted for 75.3% of the total anti-epileptic drug sales. Among the 62 manufacturers, 49 were local pharmaceutical companies and 13 were foreign-invested pharmaceutical companies. The sales value of local pharmaceutical companies in sample hospitals for anti-epileptic drugs accounted for 37.9%, while foreign-invested companies accounted for 62.1%. In terms of sales volume, local pharmaceutical companies accounted for 56.5%, and foreign-invested companies accounted for 43.5%. It can be seen that the average unit price of foreign-invested pharmaceutical companies exceeds that of local companies, leaving significant room for local companies to catch up.

　　02. Representative Drug: Levetiracetam's Centralized Procurement Shake-up

Up to the seventh round of national centralized procurement, the anti-epileptic chemical drug levetiracetam has seen its tablet 250mg specification, oral solution 10% (150mL:15mg) specification, and concentrated solution for injection 5mL:500mg specification become centralized procurement items.

　　Tablet 250mg:Winning Bidders Essentially Dominate the Market

Levetiracetam tablets 250mg were included in the first round (4+7 expansion) of national centralized procurement, with two companies winning bids. Zhejiang Jingxin Pharmaceutical's winning bid price was 2.393 yuan/tablet, and Zhejiang Apeloa Kangyu's winning bid price was 2.397 yuan/tablet. The results were announced in September 2019, implementation began in December 2019, and the contracts with the original winning bidders were renewed in both 2020 and 2021.

In 2018, the sales value of levetiracetam tablets in sample hospitals was 318 million yuan, the highest in the past four years. After the implementation of the winning bid prices in the first round of national centralized procurement in 2019, the average price decreased by 23.7% that year, sales volume increased by 30.1%, while sales value decreased by 0.8%. After the full implementation of the winning bid prices in 2020, the average price decreased by another 36.4%. Compared to 2019, sales volume increased by 30.3%, while sales value decreased by 17.1%.

Looking at corporate sales, in the first quarter of 2022, the two winning bidders, Zhejiang Jingxin Pharmaceutical and Zhejiang Apeloa Kangyu, together accounted for 92.9% of the sales volume and 91.8% of the sales value of the 250mg specification in sample hospitals. It can be said that the market for levetiracetam tablets 250mg in public hospitals is essentially monopolized by the two winning bidders. In the sample hospital market for both the 250mg and 500mg specifications of levetiracetam tablets, the sales value and sales volume share of these two winning bidders increased from 13.1% and 31.7% in 2018 to 48.7% and 70.0% in the first quarter of 2022, respectively.

The original manufacturer, UCB Pharma SA, holds a dominant position in the sales of the 500mg specification, with a 96.6% share, allowing it to remain ranked first in the sample hospital market for both specifications. Meanwhile, Zhejiang Huahai Pharmaceutical experienced a situation in the first quarter of 2022 where the return volume was greater than the sales volume.

　　Oral Solution 10% (150mL/15mg): Reduced Market Share for Original Manufacturer

Levetiracetam oral solution 10% (150mL:15mg) specification was included in the third round of national centralized procurement, with two winning bidders. Chongqing Shenghuaxi Pharmaceutical's winning bid price was 38 yuan/bottle, and Jianmin Group Yekaitai Pharmaceutical (Suizhou)'s winning bid price was 77 yuan/bottle.

In 2019, the sales value of levetiracetam oral solution in sample hospitals was 41 million yuan, the highest in the past four years. The winning bid prices for the third round of centralized procurement began implementation in October 2020, with no significant decrease in the average price that year. After full implementation in 2021, the average price decreased by 36.4% year-on-year, sales volume decreased by 16.6%, while sales value decreased by 67.0%. The average price dropped from 223.1 yuan in 2020 to 88.2 yuan in 2021 and 63.8 yuan in the first quarter of 2022.

Looking at corporate sales, in the first quarter of 2022, the two winning bidders, Chongqing Shenghuaxi Pharmaceutical and Jianmin Group Yekaitai Pharmaceutical (Suizhou), together accounted for 94.6% of the sales volume and 83.9% of the sales value in sample hospitals (increasing from 1.37% and 1.44% in 2020 to 31.8% and 52.1% in the first quarter of 2022, respectively). It can be said that UCB Pharma SA has little market space left, and Zhejiang Jingxin Pharmaceutical has gradually withdrawn from the sales of levetiracetam oral solution in sample hospitals.

　　Concentrated Solution for Injection 5mL/500mg:Four Companies Share 90% of the Market

Levetiracetam concentrated solution for injection 5mL:500mg specification was included in the third round of national centralized procurement, with four companies winning bids. Chongqing Shenghuaxi Pharmaceutical's winning bid price was 28 yuan/vial, Hainan Poly Pharm's was 65.888 yuan/vial, UCB Pharma SA's was 85 yuan/vial, and Hebei Renheyikang Pharmaceutical's was 98.5 yuan/vial.

In 2021, the sales value of levetiracetam concentrated solution for injection in sample hospitals was 32 million yuan, the highest in the past four years. The third round of centralized procurement began implementation in October 2020. In 2020, its average price decreased by 19.0%, and in 2021, it decreased by another 76.3%. Compared to 2020, sales volume increased significantly by 4.6 times, while sales value also rose by 33.0%. The average price dropped from 265.1 yuan in 2020 to 62.9 yuan in 2021 and 60.6 yuan in the first quarter of 2022.

Looking at corporate sales, in the first quarter of 2022, the four winning bidders together accounted for 94.2% of the sales volume and 90.1% of the sales value in sample hospitals, holding an absolutely dominant position. During the third round of centralized procurement in 2020, Jumpcan Pharmaceutical was qualified but did not win a bid, and its sales have struggled to improve. Chengdu Tiantai Mount Pharmaceutical, which ranked first with a 60.7% sales value share in 2020, only passed the consistency evaluation for levetiracetam concentrated solution for injection in March 2022, was not eligible to participate in the 2020 centralized procurement, and its sales value share dropped to 8.8% in the first quarter of 2022.

Looking at the market development of levetiracetam formulations, the sales of the concentrated solution for injection are showing a trend of rapid growth. Epilepsy is a common complication after neurosurgery, and the rational use of anti-epileptic drugs during the perioperative period in neurosurgery is crucial, leading to significant growth in the use of injectable anti-epileptic drugs.

　　Summary <<<

According to the "2021-2025 Global Anti-epileptic Drug Industry In-depth Market Research and Key Regional Report" released by Xinjie Industry Research Center, due to China's large population, the number of new epilepsy patients exceeds 400,000 per year, indicating broad prospects for the anti-epileptic drug market. However, looking at the overall sales situation in sample hospitals in recent years, local pharmaceutical companies in China face considerable challenges. Currently, Chinese pharmaceutical companies primarily focus on producing generic anti-epileptic drugs, with the market share of domestically produced anti-epileptic drugs accounting for less than 40%. There is significant room for improvement in the future, and it is a time for local pharmaceutical companies to strive.