In the field of pharmaceutical preparations, create a new blue ocean

Formulation definition

Preparation refers to a drug that is prepared in accordance with the requirements of a certain dosage form to meet the needs of treatment or prevention and can be finally provided to the drug object. The so-called drug preparation, in a narrow sense, is a specific drug product prepared in accordance with a certain form, such as amoxicillin capsules.

Pharmaceutical preparation industry analysis

Pharmaceutical preparation is an important branch of pharmaceutical manufacturing industry, and the demand for pharmaceutical preparation products has a certain rigidity, which is related to national health, social stability and economic development. Pharmaceutical preparation is the first pillar industry in the domestic pharmaceutical industry. With the obvious aging trend of the population, the improvement of residents' living standards, the strengthening of health awareness, the continuous improvement of the social security system and the continuous development of medical science and technology, the human demand for pharmaceutical preparations will continue to increase, and the market size of the pharmaceutical preparations industry will continue to grow.

The long-term development model of "heavy apis, light preparations" in China's pharmaceutical industry has led to the strong position of apis, while the preparation industry is very weak. At present, the market of new preparations, new excipients and new preparations technology in China is almost monopolized by foreign companies, which directly leads to the abnormal development of China's pharmaceutical industry.

The varieties of preparations in China do not match the varieties of raw materials. China is already a major producer of raw material drugs in the world, but it is difficult to enter the international market because of insufficient research and development of drug preparation technology, low level of preparation, and low quality of most preparation products. On average, a raw material in China can only be made into three preparations, while a foreign raw material can be made into a dozen or even dozens of preparations. The preparation technology is backward and the quality stability of the preparation products is not high.

The continuous development of the pharmaceutical industry is mainly driven by technological innovation and capital investment. In the international pharmaceutical market, large multinational pharmaceutical enterprises rely on their strong capital strength and strong research and development force, constantly improve the development of innovative drugs, and through the continuous launch of innovative drugs and market expansion, so as to obtain monopoly income of patented drugs. This model requires a lot of research and development investment, high resource investment, is currently mainly used by pharmaceutical companies in developed countries. At present, most domestic enterprises adopt the generic drug model, that is, pharmaceutical enterprises obtain market development space through imitation patent protection expired patent drugs. In order to improve market competitiveness, some enterprises have gradually increased investment in new drug research and development, gradually converted to the new drug innovation model, and introduced new drugs with independent intellectual property rights to the market.

The global pharmaceutical technology development in the past 70 years and the future prospects of the pharmaceutical pharmaceutical market

In 1952, Smith Kline Beecham successfully developed the first oral sustained-release formulation of D-amphetamine 12h, which greatly improved patient compliance. In the 1970s, the theory of basic slow release transport system was gradually established. At the same time, the first transdermal patch, Scop®, was marketed in 1979.

Into the 1980s, liposomes, nanoparticles, and microspheres were locked as research and development hotspots, and drug precision delivery was required to be higher. In the 21st century, with the development of computer technology, 3D printing, digital drugs, chip insertion drugs and other preparation technology will be further refined.

As of 2019, the FDA has approved 38,117 drugs (9820 new drugs and 28,297 generic drugs), including 112 new routes of delivery and 172 new dosage forms.

In recent years, with the in-depth exploration of diseases and the progress and development of related basic disciplines, the research level of new preparations has been continuously improved. Over the past decade, the global compound annual growth rate of new formulations has reached more than 10%, which is ahead of the average growth level of the pharmaceutical industry. At present, the utilization rate of new preparations in China is less than 5%, which is far lower than the global average level, and the development prospects of the industry are broad. With the upgrading of pharmaceutical consumption, the use of new preparations is an inevitable trend, and China's new preparations market will show explosive development.

China's pharmaceutical preparation industry currently presents the following characteristics