China Monoclonal Antibody (PD-1,CD20,HER2,VEGF,EGFR,TNF-a) Market, 2018-2025: Market is Expected to Grow to RMB262.1 Billion in 2022 at a CAGR of 13.5% From 2017
DUBLIN, Jan. 15, 2019 /PRNewswire/ --
The "China Monoclonal Antibody Market by Targets (PD-1,CD20,HER2,VEGF,EGFR,TNF-a) Research Report, 2018-2025" report has been added to ResearchAndMarkets.com's offering.
China's oncology drug market has grown rapidly in recent years. Revenue of the oncology drugs in China grew from RMB83.4 billion in 2013 to RMB139.4 billion in 2017, representing a CAGR of 13.7%. It is expected to further grow to RMB262.1 billion in 2022 at a CAGR of 13.5% from 2017, and to RMB654.1 billion in 2030 at a CAGR of 12.1% from 2022.
While the majority of the top ten oncology drugs globally in 2017 are either molecularly targeted drugs or immuno-oncology drugs, seven out of the top ten oncology drugs in China are chemotherapy drugs and only three are molecularly targeted drugs. This difference between the global market and the China market suggests significant potential for molecularly targeted drug and immuno-oncology drug market growth in China. Three drugs among the top10 oncology drugs globally were recently approved in China in 2018, indicating China is at its early stage of its paradigm shift to molecularly targeted drugs and immuno-oncology drugs.
Among all types of cancers, lung cancer, liver cancer, stomach cancer, colorectal cancer and breast cancer are the top five cancer types in China by incidence rate, accounting for more than 50% of the annual incidence in the aggregate. The incidences of lung cancer, colorectal cancer and esophageal cancer are expected to grow at higher CAGRs than the others. Such higher CAGR for lung cancer is attributed to the growing smoking population and air pollution. As for colorectal and esophageal cancer, the higher CAGRs are attributable mainly to increasingly prevalence of unhealthy dietary habits.
mAbs (including fusion proteins) only accounted for 5.4% of China's biologics market in 2017, while globally the figure was 43.2% in the same year, representing a sizable market potential. With the inclusion of more mAbs into the NRDL, sales revenue of China's mAbs market is expected to grow to RMB69.6 billion in 2022, representing a CAGR of 42.6% from 2017 to 2022, which will outpace the growth of China's overall biologics market. The diagram below illustrates the size of China's mAb market from 2013 to 2017 and the estimated market size from 2018 to 2022.
In addition to monotherapies, PD-1/L1 inhibitors have shown significant potential in combined therapies. PD-1/PD-L1 inhibitors market is still at an early stage of development but has strong growth potentials. The market size of PD-1 and PD-L1 inhibitors together is estimated to grow to RMB37.4 billion in 2022, representing a CAGR of 534.4% from 2018 to 2022, and further increase to RMB98.4 billion in 2030, representing a CAGR of 12.8% from 2022 to 2030.
In December 2018, the State Drug Administration ( NMPA ) announced that it would conditionally approve the listing of the first domestically produced PD-1 monoclonal antibody, tripril monoclonal antibody injection. Tripril monoclonal antibody was developed by Suzhou Zhonghe Biomedical Co., Ltd. (A subsidiary of Shanghai Junshi Biosciences Co., Ltd.) to treat local progression or metastatic melanoma after previous standard treatment failure.
Currently, there are 6 PD-1/PD-L1 listed in the world, of which 2 PD-1 drugs, namely Opdivo of Bristol - Myers Squibb and Keytruda of Mercadon, have been approved for listing in China in 2018.
Among the domestic R&D companies for PD-1, Innovent Biologics, Inc., Hengrui Medicine and BeiGene, Ltd. have also submitted drug listing applications, but the application indications are all classic Hodgkin lymphoma, and there is no direct competitive relationship with the currently approved indications of Opdivo and Keytruda.
Key Topics Covered:
1. Policy Snapshot
1.1 Snapshot of Policies
1.2 Basic Data Requirements for Reporting and Listing of Anti - PD-1/PD-L1 Monoclonal Antibody
1.3 Opinions on Reform of the Drug and Medical Device Review and Approval
1.4 The State Organized Pilot Program for Centralized Drug Procurement
1.4.1 Characteristics and Significance of Drugs Procurement with Target Quantity
1.4.2 Impact on Foreign Enterprises and Local Enterprises
1.4.3 Development Trend of Drugs Procurement with Target Quantity
2. Overview of Chinese Monoclonal Antibody Market
2.1 China's Oncology Drug Market
2.2 Market Outlook of China's Monoclonal Antibody
3. Chinese Monoclonal Antibody Market by Target Species
3.1 PD-1/PD-L1
3.1.1 Indication and usage
3.1.2 Primary drug resistance and acquired drug-resistance of PD-1/PD-L1 makes combo therapy a inevitable trend
3.1.3 PD-L1 expression quantity, MSI, TMB-core predictive markers of most immunotherapies
3.1.4 Immune checkpoint inhibitors combo and oncolytic virus combo-the new R&D direction
3.1.5 Market cap outlook of PD-1/PD-L1 drugs
3.1.6 Competitive landscape
3.2 CD20
3.2.1 First generation CD20- Rituximab
3.2.2 Second generation CD20- Ofatumumab & Ocrevus
3.2.3 Third generation CD20- Obinutuzumab: FC portions glycosylation modification, better therapeutic effect on lymphoma
3.2.4 Market cap outlook of CD20 drugs
3.3 HER2
3.3.1 Trastuzumab-initial therapy for HER2 positive breast cancer and gastric cancer
3.3.2 Continuous emerging of new HER2 target point drugs
3.3.3 Market cap outlook of HER2 drugs
3.4 VEGF
3.4.1 New direction of anti VEGF - multi target inhibiting of angiogenesis and immunotherapy combined therapy
3.4.2 PDGF - significant target for accessory angiogenesis
3.4.3 Typical anti VEGF drug - Bevacizumab
3.4.4 Applications of anti VEGF drugs in ophthalmology
3.4.5 Market cap outlook of VEGF drugs
3.5 EGFR
3.5.1 Major biological target for colorectal cancer and NSCLC, expanding therapy for other tumours
3.5.2 EGFR small molecule targeting - breakthrough treatments of positive NSCLC, fierce competition of TKIs
3.5.3 Market cap outlook of EGFR monoclonal antibody
3.5.4 Market cap outlook of EGFR TKI
3.6 TNF-a
3.6.1 Essential target for autoimmune diseases, facing competition from new target drugs
3.6.2 Troublesome original drug in China market, Etanercept dominates the market
3.6.3 Market cap outlook of TNF-a drugs
3.6.4 Competitive landscape
3.6.5 CD22-brandly new target from SinoMab BioScience
4 Leading Chinese Monoclonal Antibody Players
4.1 Jiangsu Hengrui Medicine Co., Ltd.
4.2 Shanghai Junshi Biosciences Co., Ltd.
4.3 BeiGene, Ltd.
4.4 Innovent Biologics, Inc.
4.5 Beijing Mabworks Biotech Co., Ltd.
4.6 ZHEJIANG HISUN PHARMACEUTICAL Co., LTD.
4.7 Genor Biopharma Co. Ltd.
4.8 Shanghai Henlius Biotech, Inc.
4.9 CStone Pharmaceuticals
5 Technical Development Trends of Monoclonal Antibody
5.1 Immunogenicity is essential for the safety and effectiveness of antibody drugs, humanized antibody and fully human antibody hit the mainstream
5.2 Fc portions glycosylation modification significantly enhanced the cytotoxic effect of monoclonal drugs
5.3 Antibody-Drug Conjugates (ADC) can reduce the toxicity of chemical medicines, but preparation technology is still a challenge
5.4 Bispecific antibody - 1+1>2'
6 Appendix
6.1 PDB Sample Hospitals Medicine Sales Data, 2017Q1-2018Q2
6.2 PDB Sample Hospitals Sales Data of Medicines in Medical Insurance Negotiation Directory, 2017Q3-2018Q2 (unit: RMB million)
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