Pharmaceutical equipment industry research in pharmaceutical industry: domestic substitution space is broad

1.4 The localization rate of core biological drug equipment is low, and the import substitution space is large

At present, the localization rate of China's biological drug equipment is still very low, and the future import substitution space is huge. In 2020, the biological drug equipment revenue of Aoxing Life Technology, Morimatsu International, Dongfulong and other enterprises is still small, of which Aoxing Life Technology is 900 million (including overseas income), Morimatsu International is 770 million, followed by Dongfulong is 200 million. From the perspective of proportion, the biological drug equipment income of Aoxing Life Technology, Morimatsu International, Dongfulong and other enterprises accounted for the total scale of China's biological drug production equipment and consumables market is still very low, and most of the equipment and consumables have the monopoly of overseas enterprises, and the import substitution space of Chinese enterprises is large in the future.

2 Equipment: Domestic enterprises made breakthroughs in biological medicine equipment

2.1.1 Traditional biological drug pharmaceutical process

The development process of biological products production process generally needs to go through the construction of engineering cell bank, shaker process development, pilot process development, pilot scale up, production purification and preparation steps.

2.1.2 China's biologic drug production equipment and consumables market summary

Overall, the market size of China's biological drug equipment and consumables in 2020 is about 17.5 billion yuan, of which reactor systems, disposable reaction bags, chromatography equipment and consumables account for the main share.

2.2.1 Stainless steel reactor: Low barriers to R & D and production, becoming a breakthrough point for domestic enterprises

Stainless steel reactor has a long history of development, in the 19th century stainless steel reactor development history in the 1950s has come out, the development of now, technology has been very mature, research and development and production barriers are relatively low, China's pharmaceutical equipment enterprises in recent years in this field is also step by step progress, is expected to take the lead in achieving domestic substitution. At present, the main development direction of stainless steel reactor is multi-function, large-scale and intelligent.

2.2.2 One-time reaction system: achieve a substantial reduction in cost and more flexible production

Compared with the traditional stainless steel reaction tank, the cost of the one-time reaction system has been greatly reduced, and the cost has been reduced from the early capital investment to the installation, disinfection, operation manpower, etc., the total cost has been reduced by nearly 50%, and the pre-construction period of the one-time reactor is relatively short. From the specific use scenario, for pre-clinical, clinical stage and relatively small volume of commercial projects, the advantage of disposable reactors is very prominent, enterprises can be more flexible arrangement of production, reduce costs at the same time, production capacity utilization can be improved to a certain extent.

Disposable bioreactor mainly includes shaking type, wave mixing type and stirring type, of which shaking type and wave mixing type have relatively small volume, stirring type reaction volume is larger, and the largest disposable reactor is developed by ABEC with a volume of 6000L. The disposable reaction system is mainly composed of disposable reactors (including reaction bags), disposable liquid storage bags and disposable filter components, etc. From the cost ratio, the proportion of disposable reactors is about 50%, and the proportion of disposable liquid storage bags and reaction bags is about 40%, which is the two items with the highest proportion of one-time reaction system costs. Overall, the technical barrier of the one-time reaction system lies in the design of reaction bags and liquid storage bags.

3 Consumables: Domestic consumables gradually breakthrough, import substitution trend

3.1 Multi-layer co-extruded film and disposable bags: raw materials and processes are the core barriers, and domestic enterprises have gradually broken through

Multi-layer co-extruded film, that is, multi-layer co-extruded composite film, is the resin raw materials with different functions, such as PA/PE/PP/EVOH, respectively melted and extruded, and then combined through their respective flow channels in the same die head after further processing (blow molding cooling method) made of multi-layer composite film. The multi-layer co-extruded film is generally composed of a base layer, a functional layer and a bonding layer. The base layer is used to provide protection and support on the internal and external surfaces, the functional layer plays a barrier role, and the bonding layer is in the middle of the base layer and the functional layer, thus forming an integrated composite film. The larger the volume of disposable bags, the higher the film and process requirements, and the reaction volume of the current disposable reaction system is mainly limited by the performance of disposable bags.