The bispecific antibody market is expanding rapidly, and the domestic scale will exceed 10 billion yuan in 2030

【Pharmaceutical Network Market Analysis】Bispecific antibody drug is the abbreviation of bispecific antibody, which is an artificial antibody
that can specifically bind two antigens or epitopes at the same time.
Following PD-L/1 monoclonal antibody, CAR-T cell therapy, and ADC (antibody conjugate drug), bispecific antibody drugs have become another major outlet
in the pharmaceutical market in recent years.
According to data, the global biresist market size will be close to $4 billion
in 2021.
As the approval process of bispecific antibody drugs continues to accelerate, the global bispecific antibody market is expected to reach $80.
7 billion
in 2030.
In recent years, the hot trend of bispecific antibody research and development has gradually grown, and in addition to the continuous expansion of the market, the huge market potential is also attracting more and more enterprises to increase their layout
.
It is reported that there are currently more than 700 bispecific antibody drugs under development worldwide, of which nearly 300 have entered the clinical stage
.
This year, four bispecific antibodies have been approved for marketing, including Roche Faricimab, which was approved for marketing in the United States in January, Mosunetuzumab, which was conditionally approved for marketing in Europe in June, Akeso's Cardonilimab approved for marketing in China, and Johnson & Johnson Teclistamab
, which was approved for marketing in Europe in August.
In contrast, although the development of bispecific antibody drugs in China started late, China's antibody drug industry is facing a good opportunity, including national policy support, reform of the Food and Drug Administration, and huge market potential
.
It is understood that there are currently more than 300 bispecific antibody drugs under research in China, of which nearly 100 have entered the clinical stage
.
In terms of indications, among the drugs on the market and under development, tumor indications account for the majority, accounting for about 86.
7% of the total number of bispecific antibody drugs, and the second indication is blood diseases, accounting for about 20.
89%.

In terms of domestic enterprises, in addition to Akeso, Hengrui Pharmaceutical, Corning Jereh, BeiGene, Innovent Biologics, Zai Lab, CSPC Group, Henlius, Zejing Pharmaceutical, Junshi Biologics, Kelun Pharmaceutical, Bio-Thera and more than 30 other companies have layouts
.
On June 29, 2022, Akeso's AK104 was approved for marketing as the world's first PD1 bispecific antibody, and cardonilimab was approved (single-agent) for second-line/third-line treatment of relapsed or metastatic cervical cancer
.
The clinical trial of the drug was initiated in March 2020 and patient enrollment was completed in 8 months
.
The interim analysis of ENREACH-LUNG-01, a Phase III trial of Alpha PD-L1/CTLA-4 bispecific antibody KN046 in combination with chemotherapy in the treatment of first-line advanced squamous non-small cell lung cancer, reached the preset endpoint
in March this year.
On January 6, Henlius also announced that the company's clinical trial application for PD-L1/TIGIT bispecific antibody HLX301 has been accepted by the NMPA for the treatment of a variety of advanced solid tumors, which is the third PD-L1/TIGIT bispecific antibody
to be applied for clinical trial in China.
On the whole, with the establishment of relatively mature bispecific antibody technology platforms by domestic pharmaceutical companies in recent years, local bispecific antibody drugs have taken advantage of the momentum and are entering a stage
of rapid development.
The industry expects that with the maturity of the bispecific antibody technology platform in the future and the increase in the types of approved drugs, the scale of China's bispecific antibody market will expand rapidly, and the scale of China's bispecific antibody market is expected to reach 10.
8 billion US dollars in 2030, with a compound growth rate of 81.
7%
from 2022 to 2030.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.