The definition and scope of Taiwan’s biologics refers to products types that is made or derived from living creature, such as sera, antitoxins, vaccines, toxoids, and bacterial solutions. Based on Taiwan’s “Regulations for Registration of Medicinal Products”, biologics could be further classified into six categories: genetically engineered drugs, biosimilar drugs, vaccine drugs, human plasma drugs, allergen drugs, and others. Additionally, based on the incorporation of genetic engineering, biologics are divided into two main types: genetically engineered products (or “biopharmaceuticals”) and non-genetically engineered products. The former includes recombinant protein products (including antibody products), subunit vaccines, nucleic acid products, gene therapy and cell therapy products (elaborated in Section 4 of this chapter under “Cell and Gene Therapy Industry in Taiwan”). The latter comprises traditional human vaccines, blood products, antitoxins, toxoids, allergens, and more.
I、Definition and Scope of the Industry
II、Production and Sales Status
III、Product/ Technology Status
IV、Status of Companies
V、Summary
Figure 1 Production values of biologics in Taiwan from 2018 to 2022
Figure 2 Clinical trial phases of biologics developed by Taiwan companies
Figure 3 Clinical trial phases of biologics developed by Taiwan companies by therapeutic area
Table 1 Import and export volumes of biologics in Taiwan from 2021 to 2022
Table 2 Top ten best-selling biologics in Taiwan in 2022
Table 3 Top ten best-selling human vaccines in Taiwan in 2022
Table 4 Biosimilars on the Market in Taiwan as of 2022
Table 5 Main manufacturers of biologics in Taiwan
Table 6 Business trends of major biologics companies in Taiwan in 2022