Recently, there is another success in the chemical pharmaceutical ointment market. Fornol Pharmaceutical's Fluocinonide, Hydroquinone, and Tretinoin Cream has been approved for marketing, becoming the first triple-combination cream for melasma treatment to be launched in China.

Since the beginning of this year, six ointments have passed the evaluation, two of which are the first to pass. Eleven have been approved for clinical use, and 28 have applied for marketing authorization.

According to the PharmaOcean database, ointments have exceeded 10 billion yuan in sales for the first three quarters of 2023 in hospital and retail pharmacy channels combined, with several major manufacturers dominating the market. All of the top 20 products have annual sales surpassing 100 million yuan.

Source | PharmaCloud

Market

In terms of total terminal sales, Chongqing Huabang ranks first.

Based on a comprehensive analysis of specific drug names, the top 20 best-selling drugs are as follows:

Desonide Cream:Chongqing Huabang Takes the Lead with a 12.43% Increase; Renfu Pharmaceutical Joins the Race in Q4, Set to Reshape the Landscape.

Mupirocin Ointment:Sino-American SmithKline still leads the way, while Qizheng’s Baomai Ointment and Qingpeng Ointment have carved out their own niche and established a firm foothold.

In the TOP10 of pharmacy retail enterprises in 2023, Johnson & Johnson still ranks first, and Mayinglong ranks second.

Based on a comprehensive analysis of specific drug names, the top 20 in sales volume (TP20) are as follows:

Note: Sales less than 100 million yuan are indicated by *.

Johnson & Johnson Pharmaceutical's Miconazole Nitrate Cream, the famous "Daktarin," still firmly holds the top position with sales exceeding 400 million yuan. Mayinglong Hemorrhoid Cream takes a different path, securing the leading position in the field of cavity drug delivery.

Analyzing the top sales volume at the hospital end and the ranking of pharmacies, it is clear that hospital sales still heavily rely on the high-volume procurement of generic drugs. However, for pharmacies, brand effect remains the best guarantee for sales. As China's volume-based procurement policy continues to advance, multiple provinces are encouraging retail pharmacies to participate in the procurement process, and this brand advantage will gradually begin to disappear.

Battle for

The first choice is still to pass the consistency evaluation.

In 2024, ointments had a total of 6 varieties and 7 specifications approved. The approved varieties are as follows:

Source | PharmaCloud

Currently under review are 28 items:

Source | PharmaCloud (partial)

Qilu, Simai, Huabang, and Renfu all have products applying for market launch.

Is it difficult for ointments to pass the evaluation?

Since 2024, nearly four hundred oral tablets have passed the evaluation, while only six ointments have, indicating the obvious difficulty.

Taking the recently approved Fluocinonide, Hydroquinone, and Tretinoin Cream as an example, this product underwent a lengthy research and development process. Funuo Pharmaceutical's R&D journey lasted over fifteen years, going through three phases of clinical trials before finally being approved for market release.

Funuo Pharmaceuticals also has a compound polymyxin B ointment within the top 20 best-selling products in hospitals. Analyzing the sales rankings reveals that the technology is controlled by just a few companies, creating certain technical barriers for other enterprises looking to enter the market.

Where are the difficulties with ointments?

How to select the appropriate matrix according to clinical needs, adopt different manufacturing processes, and endow ointments with unique characteristics to achieve better efficacy is a current challenge in ointment formulation.

First, it is necessary to select an appropriate matrix. An ideal matrix should be lubricious and non-irritating, with suitable consistency, stable properties, no incompatibility with the main ingredients, water-absorbing ability to absorb wound secretions, no interference with the normal functions of the skin, and good drug-releasing properties, among others.

Secondly, the optimization of the preparation process is crucial. Ointments are complex systems composed of multiple ingredients, where each component relatively combines to form an effective action. The preparation of ointments should follow appropriate dosage and clinical usage.

Finally, the qualitative and quantitative stability of the ointment must be ensured to guarantee the drug-loading capacity and stability within the application period of the ointment.

How to Get Started?

Ointment preparations are a combination of new technologies and traditional manufacturing processes. With the continuous discovery of new drugs and the increasing demand in healthcare and other industries, ointment preparations will have broad application prospects.

On August 15-16, 2024, the "Transdermal Formulation Conference" will be held concurrently with the 2024 CMC (CRO&MAH&CMO) Expo. This event aims to share resources, co-create value, and promote in-depth exchange and cooperation among experts, scholars, and pharmaceutical companies in China’s transdermal formulation field. It seeks to expand the transdermal formulation market and support high-quality development in China's transdermal formulation sector!

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