Exclusive writing: Take your time when the original research of generic drugs replaces the project!

In the stage of generic drug project approval, enterprises will face such a difficult problem: the varieties that enter the centralized procurement catalog have attractive alternatives to the original drug market, but can they really win in the volume-price game in the hospital market? If the target of the project is a variety that is sold in pharmacies in the mainstream market and is basically unaffected by hospital sales, what are the determinants of "explosive models" ?

By 2021, a total of six batches of national centralized drug procurement have been launched
.

Among them, the first three batches have been launched in 2020, and individual products have expired in 2021 and have begun to renew contracts in various provinces

This paper selects the characteristic paclitaxel and ED drugs in the first three batches of centralized procurement, and observes the performance of these two types of products in the hospital market and pharmacy market after the centralized procurement, in order to analyze the consideration for the project establishment of the original research of generic drugs
.

1

Paclitaxel

Representative varieties: paclitaxel for injection (albumin-bound), paclitaxel liposome, paclitaxel injection

Paclitaxel is the chemical drug with the largest market size among the current centralized procurement products
.

According to the data from the Xianda Pharmaceutical Sea database, Paclitaxel for injection (albumin-bound) is the product of the second batch of centralized collection catalogues, and the original manufacturer is Celgene
.

At present, Zhejiang Hisun, Hunan Kelun, Qilu Pharmaceutical (Hainan), Jiangsu Hengrui, and CSPC Ouyi have passed the consistency evaluation

Paclitaxel injection is the fifth batch of products in the centralized collection catalog, and the original manufacturer is BMS
.

At present, the manufacturers that have passed the consistency evaluation include Wuxi Yew, Sichuan Huiyu, Yangzijiang Pharmaceutical and Shanghai Chuangnuo

Luye’s paclitaxel liposome for injection will enter the medical insurance catalogue through medical insurance negotiation in 2020
.

In the start-up season of centralized procurement, the hospital as a whole has reached its peak: the performance of products is differentiated

It can be seen from the rolling annual sales (MAT) of the hospital terminal of Minet that in the first quarter of 2020, the overall scale of paclitaxel products reached a peak value of 7.

84 billion yuan, which is the quarter when the second batch of national volume procurement was launched

Judging from the performance of the hospital market, paclitaxel for injection (albumin-bound) exceeded 3 billion yuan for the first time in the fourth quarter of 2019, and the market size has also stabilized at about 3 billion yuan after entering the centralized procurement.

Annual sales were down just 0.
3% from the first quarter of 2020

  In contrast, the market size of similar products Paclitaxel Injection and Paclitaxel Liposome for Injection has been declining
.

The rolling full-year sales of paclitaxel injection in the second quarter of 2021 decreased by 16.
6% compared with the first quarter of 2020, and the paclitaxel liposome for injection decreased by 25.
3%, the decline was even higher than that of the products entering the centralized procurement

  This means that after the centralized collection of paclitaxel for injection (albumin-bound), the market of paclitaxel injection and paclitaxel liposome for injection has been swallowed; it is not that the market of products that have not entered the centralized collection has outperformed the centralized collection products
.

  From the perspective of manufacturers, Celgene, the original manufacturer of Paclitaxel for injection (albumin-bound), was forced to stop supplying due to quality problems.

In the fourth quarter of 2019, it reached a rolling annual sales peak of 830 million yuan, and by 2021 the second The quarter was only 80 million yuan

  The market size of the original manufacturer Celgene was divided by Jiangsu Hengrui and CSPC Ouyi
.

CSPC Ouyi's rolling full-year sales in the fourth quarter of 2019 were 1.
29 billion yuan, rising to 1.
74 billion yuan in the second quarter of 2021, the highest sales in its market

  Paclitaxel injection is currently the best-selling products of Pfizer subsidiary Heshengrui, Yangzijiang and the original manufacturer BMS
.
In the second quarter of 2021, the rolling annual sales of Heshengrui products were 560 million yuan, the rolling annual sales of Yangtze River products were 240 million yuan, and the rolling annual sales of BMS products were 210 million yuan
.
Wuxi Yew and Sichuan Huiyu, the winning bidders for centralized procurement, shared the market with Yangzijiang in the absence of market accumulation
.

The overall trend of pharmacy terminals, hospital terminals may not be able to "fill the gap"

  In terms of pharmacies, in 2019, the scale of paclitaxel reached a peak of 1.
48 billion yuan.
The market mainly came from 1.
4 billion yuan of paclitaxel for injection (albumin-bound), including 910 million yuan of Hengrui products that could only be linked to hospitals without opening bids.
The products of CSPC Ouyi are 320 million yuan, and the products of the original manufacturer Celgene are 150 million yuan
.
In 2020, possibly due to centralized procurement and the epidemic, the market size of the pharmacy market for paclitaxel for injection (albumin-bound) will gradually decline.
Yuan, Qilu 40 million yuan
.
If the market of hospitals and pharmacies is considered, the increase in Hengrui's scale in the hospital market is still not equal to the amount lost in the pharmacy market; however, the overall market of CSPC Ouyi has increased slightly
.

  Before 2019, paclitaxel liposomes for injection maintained a scale of 70 million yuan in pharmacies, and continued to decline in 2020 and 2021
.
Even though medical insurance negotiation products have been launched into "dual-channel" sales in 2021, the pharmacy market size of paclitaxel liposomes for injection in 2021 will still drop to 30 million yuan
.

Taxol injection rose against the trend, and the growth was mainly from Heshengrui

  Although the market size of paclitaxel for injection (albumin-bound) and liposome for injection in pharmacies will both decline in 2020 and 2021, paclitaxel injection has bucked the trend
.
The market size of paclitaxel injection drugstores has nearly doubled year after year, reaching 50 million yuan in 2021.
The growth momentum is mainly from Heshengrui's products
.

2

ED medication

Representative varieties: Tadalafil, Sildenafil

  The oral normal-release dosage form of tadalafil has entered the second batch of centralized collection
.
The original manufacturer of Tadalafil is Eli Lilly.
There are currently 17 companies that have passed the consistency evaluation, namely Chengdu Shengdi (Hengrui), Guangdong Dongguang Sunshine, Guangzhou Langsheng, Hunan Dino, Hunan Qianjin Xiangjiang, and Jiangsu Tasliti.
Yi, Nanjing Zhengda Tianqing, Nanjing Zhengke, Qilu Pharmaceutical (Hainan), Shandong Lukangset, Shandong Luoxin, Suzhou Hongsen, Wuhan Renfu, Yuanda Pharmaceutical (China), Changchun Haiyue, Zhejiang Yongning, Chongqing Hua state
.
The second batch of centralized procurement won two bids, namely Jiangsu Tasly Diyi and Changchun Haiyue
.

  Sildenafil oral normal-release dosage form has entered the third batch of centralized collection
.
The original manufacturer is Pfizer, and there are currently 10 companies that have passed the consistency evaluation, namely Aurobindo, an Indian generic drug company, and domestic companies such as Fujian Guangshengtang, Guangdong Dongyangguang, Guangzhou Baiyunshan, Guangzhou Langsheng, China Resources Secco, and Jiangsu Asia.
Bon Epson, Qilu Pharmaceutical, Shenzhen Haiwang and Yangzijiang Nanjing Hailing
.
For the second batch of centralized procurement, only Qilu Pharmaceutical won the bid
.

Hospital terminal: the overall market has not reached the record of the original research single drug

  It can be seen from the rolling annual sales (MAT) of the Minet hospital terminal that in the first quarter of 2020, the overall scale of tadalafil tablets reached a peak of 135 million yuan, and the sales were basically provided by the original researcher, Lilly
.
Since then, the overall size of tadalafil tablets has been declining
.
The second batch of centralized procurement will be launched in early 2020
.

  The obvious decline in the market size of the original research drug after losing the bid began in the third quarter of 2020, and the MAT dropped to only 35 million yuan in the second quarter of 2021
.
The winning bidders, Jiangsu Tasly Diyi and Changchun Haiyue, have divided the market for the original drug, but the overall market size has not surpassed the historical record created by the original drug
.

  In the third quarter of 2019, the overall scale of sildenafil citrate tablets reached a peak of 125 million yuan, and the original research pharmaceutical company Pfizer accounted for 96% of the share
.
Since then, the overall scale of sildenafil citrate tablets has been declining, and by the second quarter of 2021, MAT is only 61 million yuan
.
In August 2020, the third batch of centralized procurement was launched.
After the original research drug lost its bid, the market size began to decline significantly in the fourth quarter of 2020.
In the second quarter of 2021, MAT dropped to only 49 million yuan
.
Qilu Pharmaceutical has not yet opened the hospital market in the second quarter of 2021, and the MAT in the second quarter of 2021 is only 90 million yuan
.

Pharmacy burst strength: brand power > curative effect strength

  ED drugs get together for imitation, mainly because the mainstream market is in pharmacies and is basically not affected by hospital sales
.
With the swarms of generic drugs, how are the pharmacies of this variety performing?

  In 2020, tadalafil reached the peak of the pharmacy market at 770 million yuan; in 2021, it will drop to 740 million yuan
.
The main reason for the decline is that the original research company Eli Lilly has dropped from 720 million yuan in 2020 to 630 million yuan in 2021
.
The best generic drugs in pharmacies are the products of Jiangsu Tasly Diyi Pharmaceutical and Qilu Pharmaceutical (Hainan), with a market size of more than 40 million yuan
.
Except for Chengdu Shengdi and the above-mentioned manufacturers, the market size of the products of other generic drug manufacturers in pharmacies will not exceed 10 million yuan in 2021
.
According to the performance of general hospitals and pharmacies, only 5 companies have a market scale of over 10 million yuan in 2021, and the market returns of most generic drugs in 2021 failed to recover their investment in the consistency evaluation of tadalafil
.

  The drugstore market of sildenafil will continue to grow in 2021.
The market size will be 2.
57 billion yuan in 2020 and 2.
91 billion yuan in 2021.
The driving force for market growth is mainly from Baiyunshan and the products of the original manufacturer Pfizer
.
Baiyunshan's products will have a pharmacy market size of 1.
32 billion yuan in 2020 and 1.
50 billion yuan in 2021; Pfizer's products will have a pharmacy market size of 1.
13 billion yuan in 2020 and 1.
27 billion yuan in 2021
.
The market size of Jiangsu Yabang Epson's product pharmacy market has also increased from 70 million yuan in 2020 to 80 million yuan in 2021.
Jilin Jinheng's products will reach a historical peak of 50 million yuan in 2021, while the Qilu products that won the bid for centralized procurement are in The size of the pharmacy is only 0.
05 billion yuan
.

  The onset and duration of tadalafil is more advantageous than that of sildenafil, but in terms of market size, a company's strong brand power is more rewarding in pharmacies
.
If the generic drugs that get together have no brand power, it is difficult to capture the market in the competition of pharmacy terminals
.

  Enterprises must clearly understand their comprehensive strength in the stage of generic drug project approval
.
If you want to rely on centralized procurement to break through, you must overcome the cost barrier and ensure that your products can win the first batch of bids in centralized procurement
.
If you want to deploy a pharmacy, you must consider your brand power and whether it can win the competition in pharmacies
.
The most important thing is that for the medicines that get together, the fifth place just got a bowl of soup, and no more than three can eat meat
.
If you don’t market it yourself, you will not be able to fully eat the market of the original research drug if you only rely on the share of the original research drug
.