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【Pharmaceutical Network Market Analysis】Complex preparations have the characteristics of obvious clinical value, good safety and long product life cycle, but they also face challenges
such as high technical barriers, original research patent protection, and key excipients and equipment constraints.
How to promote the development of the complex formulation industry has become a difficult problem
.
In 2020, the National Pharmacopoeia Commission proposed at the third clinical drug treatment conference that "two paths can be considered to solve the clinical accessibility of complex preparations in the future: one is improved new drugs, and the other is generic drugs
.
" Due to the great difficulty of imitation of complex preparations, it is recommended to give priority to encouraging the development of improved new drugs, allowing improved new drugs of complex preparations to be approved for marketing if they achieve biological equivalent or non-inferior efficacy with the original drug, so as to increase drug selection and meet the accessibility of
clinical drugs.
In 5 years, the market size of the liquid dispensing system will approach 2.
2 billion yuan! (Image source: Pharma.
com) The market for improved new drugs is growing rapidly Compared with Class 1 new drugs, improved new drugs have the characteristics of low R&D investment, low R&D risk, short R&D cycle, and can quickly seize market opportunities, and the market presents great potential
.
With favorable support, domestic pharmaceutical companies are enthusiastic
about the research and development of improved new drugs.
Relevant statistics show that from January 2016 to March 2022, the registration acceptance of improved new drugs in China showed a gradual increasing trend, especially the number of registrations accepted in 2021 grew rapidly, doubling
that of 2020.
At present, China's improved new drug industry has gradually entered a rapid development channel, and the overall market has shown rapid growth
.
Data show that the market size of improved new drugs in China has increased from 261.
39 billion yuan in 2016 to 323.
99 billion yuan in 2020, with a CAGR of 5.
5%.
It is estimated that the market size will reach 561.
29 billion yuan by 2025, reach 795.
17 billion yuan by 2030, and the CAGR of 2020-2025 and 2025-2030 is 11.
6% and 7.
2%, respectively, with rapid
overall growth.
Complex preparations bring new growth points to the pharmaceutical machinery industry With the rapid development of complex preparation industries such as improved new drugs and the continuous update of process needs of pharmaceutical companies, upstream equipment such as liquid dispensing systems are also expected to usher in new growth points
.
Zhongtai Securities mentioned in a recent research report that the liquid dispensing system, as an important equipment for the production process of complex preparations, is expected to have an industry scale of 2.
194 billion yuan in 25 years and a CAGR of 18.
70%
in 2020-25.
At present, the domestic liquid dispensing system market is mainly occupied by imported high-end complex preparation pharmaceutical equipment manufacturers, local manufacturers mainly include Dongfulong, Chutian Technology, etc.
, and the industry is expected to have powerful head enterprises are expected to obtain domestic substitution opportunities
.
Among them, Dongfulong's high-end complex preparation system has entered the stage of accelerated volume, through years of accumulated lyophilization, filling and other technologies, cut into all aspects of the production and preparation process of high-end complex preparations, focus on the development of high-end complex preparation process equipment, and break through the monopoly position
of foreign high-end complex preparation pharmaceutical equipment.
The orders in hand in 2020, 2021 and 2022Q1 were 282 million, 429 million and 480 million
respectively.
At the same time, Dongfulong is also accelerating its overseas expansion, and the company has begun to enter the supply chain
of developed countries since 2020 with strong product competitiveness.
In February 2022, the company supplied a series of equipment
including liquid dispensing systems to the French plant of Recipharm, a large CDMO company.
In order to increase production capacity, Dongfulong recently announced that it intends to raise no more than 3.
2 billion yuan, of which 530 million yuan is planned to be used for the biopharmaceutical equipment industry trial production center project, which involves the expansion of the production line of complex preparation liquid dispensing system, with a planned production capacity of 157 sets of liquid dispensing systems per year, an increase of 68.
82%
compared with the company's 2021 liquid dispensing system output of 93 units 。 Recently, in the prospectus (registration draft) for the issuance of A shares to specific targets in 2022, Dongfulong said for the production line of complex formulation dispensing system that its expected operating income for the production year is about 616.
9802 million yuan, the net profit is about 144.
8723 million yuan, and the gross profit margin is 42.
37%.
However, if the development speed of the complex formulation industry is not as fast as expected, the company's complex formulation dispensing system cannot meet the continuous update of customer process needs, or the price of raw materials rises significantly, etc.
, it will lead to the actual indicators of the fundraising and investment project cannot reach the level of benefit measurement
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.