Industry perspective
Cervical cancer has a heavy burden in the world, and HPV vaccine can effectively prevent the incidence. More than 80% of women have had HPV infection at least once in their life. High risk HPV persistent infection is a necessary factor for the occurrence of high-grade intraepithelial lesions and cancer in the lower reproductive tract, and has become a public health problem seriously threatening women’s health. According to the data of global cancer statistics 2020 and who, in 2020, there were Shanghai Pudong Development Bank Co.Ltd(600000) confirmed cases and 340000 deaths of cervical cancer in the world, 110000 confirmed cases and 60000 deaths in China. HPV vaccination is a primary preventive measure to prevent HPV infection related diseases, which can effectively block the occurrence and development of cervical precancerous lesions.
HPV vaccine has become the best-selling conventional vaccine in the world. There is a large gap between global supply and demand, and there is broad room for China to improve its penetration. The global demand for HPV vaccine is high. In 2021, the global sales of MSD Gardasil series reached US $5.673 billion, becoming the world’s best-selling non covid-19 vaccine product for the first time. Based on the estimated output value of batch issuance in 2020, the batch issuance output value of MSD’s four / nine valent HPV vaccine in the Chinese market is estimated to reach 12.3 billion yuan, which is also the first vaccine variety in China. In 2020, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) of the first domestic bivalent HPV vaccine has been in high volume since its listing. With the late stage of clinical research and development of domestic nine price HPV vaccine and the synchronous promotion of production capacity construction, the industry penetration of HPV vaccine is expected to increase rapidly in the future, driving the accelerated excavation of stock market space. We estimate that the potential stock market space of HPV vaccine in China exceeds 100 billion.
The clinical research of male indications is gradually promoted, which is expected to further broaden the ceiling of the industry. HPV virus can also infect men and is at risk of causing serious diseases in men, such as condyloma acuminatum, penile cancer, anal cancer and head and neck cancer. The CDC of the United States has recommended that all boys aged 11-12 should be vaccinated against HPV. At present, there is no relevant policy proposal in China. Since 2021, MSD has launched two phase III clinical trials of nine valent HPV vaccine for Chinese men aged 9-45. Assuming that the male indications are approved in the future, the industry space is expected to be further expanded. In 2020, the national male population aged 9-45 will be about 350 million. Based on this calculation, assuming that the male indications are approved in the future, the market space for new male indications of HPV vaccine in China is expected to reach about 100 billion.
The overseas market demand is broad, and the domestic HPV vaccine has considerable potential to go to sea. There is still a large supply gap in the overseas HPV vaccine market. Even in countries and regions carrying out immunization planning, the average coverage rate of the first dose of HPV vaccine is only 67%, and the coverage rate of complete vaccination is 53%. There are great differences in different countries and regions, which is far from reaching the WHO target of 90% coverage rate for girls aged 9-14. According to WHO estimates, the global potential demand for HPV vaccine (regardless of supply constraints) will exceed 100 million doses in 2021. In 2021, Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) completed the WHO PQ on-site inspection and preliminarily passed it. In the future, domestic enterprises are expected to move towards a broader international market with the advantages of cost performance and cost.
Investment advice
Industry strategy: we are optimistic about the broad stock market space of HPV vaccine and the consumption upgrading driven by the iteration of multi price product upgrading in the future. At the same time, we benefit from the improvement of people’s vaccination awareness at the policy end and the gradual expansion of industry production capacity in the future. The industry penetration rate is expected to accelerate, which is recommended to focus on.
Recommended combination: recommend comprehensive leading companies with strong sales ability and innovative product development technology ability, Chongqing Zhifei Biological Products Co.Ltd(300122) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Walvax Biotechnology Co.Ltd(300142) ; As well as R & D companies with leading clinical progress in pipeline research, such as Kangle guard, Ruike biology, etc.
Risk tips
Changes in immunization procedures, and the progress of R & D and listing is less than expected; Intensified market competition; Some HPV vaccine varieties have been included in the national immunization plan; International market development did not meet expectations, etc.