There is no drug like botulinum toxin, although it is full of controversy, but people do not hesitate to ignore the dangerous side, and they can't stop, and gradually gain the legal status of "wrinkle removal beauty".
The entry threshold for botulinum toxin is very high, and it takes at least 6 years to approve it according to the drug poison and narcotic drugs in China, which is much higher than that of other medical aesthetic products. It is precisely because of the approval problem that this market pattern has been good enough for a long time in the past.
Before the second half of 2020, there were only two regular armies in the domestic botulinum toxin market, Allergan's Botox and Lanzhou Hengli, the former positioned as high-end and the latter in the low-end; In the second half of 2020, Ipsen's Dex of France and Lotibal of Hugel of South Korea were successively approved for marketing, so far, the market competition pattern of approved botulinum toxin products in China has changed from a two-way world to a four-strong competition.
Not in the short term, but 2024 will be a big watershed.
The latest disruptor is the German West Malaysia botulinum toxin, which has been successfully approved as the fifth botulinum toxin product in China. With its past "accumulation" in the parallel market, it may only be a matter of time before it breaks the pattern of the four-strong competition.
More importantly, botulinum toxin is a battleground for domestic medical aesthetic pharmaceutical companies, and after West Malaysia, there are still 9 products in the clinical and marketing stage. Among them, it is expected that 3 more botulinum toxin models will be approved for marketing this year.
Although 90% of them are ** products, the botulinum toxin pattern of "5 (approved) + 3 (coming soon) + 6 (under development)" has been announced, and the era of botulinum toxin involution is coming.
01 The king of "parallel imports" turned positive
On March 1, the "March 1 Drug Approval Certificate Delivery Information" issued by the State Drug Administration showed:
Masssuite Business Management Consulting (Shanghai) was approved for botulinum toxin type A for injection on February 23.
Massservice Business Consulting is a subsidiary of Merz Pharma in Germany. This means that the company's latest botulinum toxin is the well-known brand Xeomin (West Malaysia).
The approval of West Malaysia for marketing in Germany also means the birth of the fifth botulinum toxin product in China. The advantages of its products and the "accumulation" in the parallel market in the past have also made the market have certain expectations for it.
Since 2002, the US FDA has approved a total of six botulinum toxin type A, and West Malaysia is one of them. In addition, it has always been the backbone of the overseas high-end botulinum toxin market, with data showing that as early as 2018, West Malaysia ranked third in the world with a market share of 7%.
Compared with the existing botulinum toxin brands in the market, West Malaysia has its own differentiating advantages. For example, as a pure form of botulinum toxin type A, one of the characteristics of West Malaysia is that it does not contain any complex proteins, which means that patients using West Malaysia** will not theoretically reduce its effectiveness due to the production of antibodies.
For example, West Malaysia is the only botulinum toxin in the world that can be stored at room temperature for 3 years, and can be transported and stored below 40 degrees at room temperature without refrigeration.
This is also the key to its good share in overseas markets. So, can West Malaysia become a disruptor in the domestic botulinum toxin market?
At present, this is a high probability event.
The core is that its popularity in the domestic market is not low. As we all know, the domestic botulinum toxin market has always been rampant with parallel imports, and in 2021, the regular botulinum toxin market accounted for only 38%.
West Malaysia is one of the backbone of the parallel goods market. As shown in the figure below, in 2022, among the types of botulinum toxin selected by Chinese medical aesthetic users, West Malaysia ranked 33The proportion of 5% is second. After the official approval, it will not be too difficult to convert the informal sales of parallel goods into regular sales.
To a certain extent, the logic of parallel import conversion can provide a certain guarantee for the sales of these latecomers. And this may also bring some changes to the entire market that cannot be ignored.
02 2024 watershed
At present, 2024 will be a watershed year for the botulinum toxin market. This seemingly short-term market will usher in more and more regular players.
As a biological agent and one of the most toxic biotoxins, botulinum toxin not only has multiple barriers such as technology and capital, but also is subject to strict administrative control. Due to the toxin, the national approval is strict, and it usually takes about 6-8 years for botulinum toxin to pass the approval.
For example, Aimeike is responsible for the clinical trial and registration application of Hutox product Hutox in China, and the fundraising project shows that the construction period is as long as 65 months. That's five and a half years. It took 6 years from 2014 when Sihuan Pharmaceutical's exclusive ** hugel Letibao was finally approved in October 2020.
It can be said that botulinum toxin is the light medical beauty with the highest barrier. This also makes it possible that for a long time, there are very few products that have passed the approval and listing in China, and the competition pattern is very clear.
Since Botox entered China in 2009, only 4 botulinum toxin models have been approved as of 2023. Before the first half of 2020, there were only two regular armies in the domestic market, Botox and Lanzhou Hengli, the former was positioned as high-end (3000-5000 yuan 100), and the latter was low-end (700-1200 yuan 100);
In the second half of 2020, Ipsen's Lucky and South Korea's HUGEL's Letibao were successively approved for marketing, and the market competition pattern of botulinum toxin products approved in China has changed from a two-way world to a four-strong competition.
At that time, the first-mover company had obvious advantages. Because among the botulinum toxin pipelines under development in China, even if the leader is approved for marketing, it is scheduled after 2024. This is undoubtedly the first time window for the four approved products (Botox, Hengli, Letibao, and Jishi) to seize the market.
For Letibao and Jishi, the three-year window period is extremely critical. However, at present, three years have passed, and the market pattern has not fundamentally changed. Despite the pandemic, tighter regulations and other factors, the opponents below the table are not slowing down.
Due to the high barriers to the industry, domestic pharmaceutical companies mostly enter by means of first-class and equity investment, mainly by signing cooperation agreements with botulinum toxin manufacturers in South Korea, the United States and Germany, with the aim of shortening the listing process.
As mentioned above, after West Malaysia, Germany, it is expected that 3 more botulinum toxins will be approved for marketing this year, namely Orange Poison of Aimeike**, RT002 of Fosun Pharma** and Blue Poison of Huadong Pharmaceutical**.
These three are all veteran players in medical aesthetics, and they are more experienced in both channels and marketing. This also means that after 2024, the entire botulinum toxin market will also usher in more fierce competition.
03 Born to the roll
Before this year, there were only 4 regular players in the domestic botulinum toxin market, but now it has become 5, and it may become 8 by the end of the year, and then there are at least 6 products waiting to be listed.
This is destined to be the Botulinum toxin market will be born in a volume. In the end, it remains to be seen what impact the involution will have on the market size, and at present, the botulinum toxin market has great room for imagination.
Botulinum toxin needs to be injected multiple times when used for wrinkle removal, which has the characteristics of repeated consumption, and needs to be re-injected every 3-4 months on average, and it is versatile, and can be used with hyaluronic acid and other medical aesthetic items, which is regarded as a "miracle weapon" by medical aesthetic institutions.
Globally, 43% of the aesthetic market is occupied by botulinum toxin, while hyaluronic acid is only 28%. On the contrary, the market share of hyaluronic acid in China is twice that of botulinum toxin.
In contrast, the penetration rate of botulinum toxin in China is also much lower than that of other mature markets. In 2019, the penetration rate of botulinum toxin in the United States was 43%, the penetration rate of botulinum toxin in China is 02%。
The above data shows that botulinum toxin is an underestimated track in the domestic market, and if it develops according to the global trend, the growth rate of botulinum toxin in the future will be higher than that of hyaluronic acid.
In addition, we also have to mention the domestic botulinum toxin "parallel import" market. According to the data of the China Plastic Surgery Association, the sales volume of regular botulinum toxin products accounted for only 30% in 2019, and after the approval of Jishi and Letibao in 2020, the proportion of regular products increased to 38% in 2021.
With the continuous involvement of regulators, botulinum toxin has ushered in the era of compliance. Next, the increase in market penetration and the logic of replacing parallel imports under the trend of compliance will support the growth of the botulinum toxin market. According to Frost & Sullivan, the market size of botulinum toxin products in Chinese mainland will be about 3.9 billion yuan in 2020, and it is expected to reach 11.4 billion yuan and 29.6 billion yuan in 2025 and 2030, respectively.
In this fast-growing botulinum toxin market, the preemptive scene that has been staged in South Korea is also very likely to happen in China.
Referring to South Korea, a major plastic surgery country, the entire market has already been swept up before the second largest manufacturer, Medytox, overturned due to product or compliance issues.
In 1996, Botox was approved to enter South Korea, and the botulinum toxin market was officially opened, and until 2006, Korean local brand botulinum toxin products were launched one after another, and the competition gradually became fierce.
In 2006, Medytox's first botulinum toxin product was launched in South Korea, and it quickly seized the market with low price + high quality, and surpassed Botox to become the No. 1 market share in 2009. Then, in 2010 and 2014, HUGEL Baiwei and Daxiong Pharmaceutical's Green Poison were launched respectively, while Meditox launched new products in 2013 and 2016 respectively in an attempt to stabilize market share.
With the fierce competition, in 2017, companies such as Medytox began to expand production capacity and cut prices in order to seize market share, and the war intensified. Since 2016, HUGEL has ranked first in South Korea's market share for 8 consecutive years.
At the same time, Medytox and Daxiong Pharmaceutical have been caught in legal disputes, with Medytox itself being removed from the shelves due to non-compliant products such as the production process, while other companies such as Jugl are also involved in compliance issues, and the market supervision has become stricter.
Before the Medytox rollover, the South Korean botulinum toxin market was relatively fixed. According to the statistics of HUGEL's annual report, the size of the Korean botulinum toxin market reached 1$1.2 billion, the top three manufacturers are HUGEL, Meditox and Allergan, with a sales share of 88% and CR3 sales accounting for 88%.
Through the development of the botulinum toxin market in South Korea, it is not difficult to find two points. First, with low price and high quality, local brands can seize the market of imported brands; Second, although the first mover has a first-mover advantage, it is still necessary to be vigilant against the first mover at all times.
Back to China, although the domestic brand Hengli has been on the market for many years, in the past, due to the huge differences between the two products in terms of excipients, dispersion, production process, application scenarios, marketing and doctor training, it is impossible to talk about seizing the market.
Nowadays, the situation has long been different, and more and more domestic pharmaceutical companies** botulinum toxin are gearing up. Although Botox and Hengli have a first-mover advantage, with reference to the Korean experience, the first-mover advantage may also be subverted by the higher cost performance of the latecomer.
Growth and involution are coming at the same time, how will the market evolve next?