Although it is only 10% of the size of the US biotechnology market, China’s biotech industry has experienced a rapid rise over the past 10 years, and is currently valued at approximately $4.7–$6.2 billion, with agricultural biotechnology worth an estimated $8.1 billion. According to Gryphon Scientific’s recent report for the US-China Economic and Security Review Commission, entitled “China’s Biotechnology Development: The Role of US and Other Foreign Engagement,” China is aiming to decrease the gap between itself and the US through enhancing government strategies, increasing R&D spending in the industry and improving high-tech R&D capabilities. This has been accomplished in part through China’s 11th Five Year Plan, which took place during 2006–2010, when China rose in ranking from the 9th largest biomedical market in the world in 2006 to the 3rd largest by the end of the Plan in 2010. Also in this time period, the value of the country’s biotech industry grew at a CAGR of 23%. As a share of GDP, biotech in China was 4.6% in 2014.
In 2015, China spent nearly $410 billion on biotech R&D, surpassing the EU and landing second to the US in terms of global biotech R&D spending. During the 10-year period between 2007 and 2017, biotech research publications in China also rose year-to-year at an average of 20%. This growth of the biotech industry has been fueled by increasing government investment within the industry, as well as in the life sciences.
The Significance of Biologics
Globally, biologics account for 12% of hospital prescription drug sales, and are continuing to grow as the principal treatment for certain illnesses, such as cancer and autoimmune diseases. China represents approximately 5% of total hospital prescription drug sales, and Chinese companies have created approximately 250 biosimilars to date.
The vast majority of Chinese biotech is concentrated on biologics, with many manufacturers producing biosimilars as opposed to new and innovative biologic materials; however, through the use of CAR-T therapies and CRISPR gene editing, the country’s biotech companies have established a solid foundation for future innovation of biologics. China’s biologics market is largely made up of sales of antibody and protein therapeutics, an expanding category within the biologics market that grew from accounting for 14% of the industry in 2005 to 43% currently. The second largest market is insulin products, which has steadily represented 21%–23% of biologics market since 2005.
Prior to 2013, less than 10 investigational new drug finding applications were filed in China for conducting clinical trials, while in the past few years, filings have increased to 30–40. The large biologics and biopharmaceuticals market in China is largely attributed to factors such as aging populations, pollution issues, increased awareness of health care and issues and rising spending on health care.
Product quality has been an issue within China’s pharmaceutical and biopharmaceutical industry, and to address these concerns, the country joined the International Council for Harmonization in 2017. The Council requires that members adhere to certain regulatory requirements for the manufacturing of pharmaceuticals, the conducting of clinical trials and the stability testing of pharmaceuticals. While the Chinese government has been establishing quality regulations in the recent past, enforcement issues remain.
Increasing Access to Health Care Data
China has acknowledged the significance of health care–related data, making the use of medical data a national priority, and is investing in informatics capabilities to ensure the country is competitive in the field. In 2016, the Chinese State Council released a guidance calling for the creation and establishment of regional health data platforms and one hundred regional clinical medicine data demonstration centers. The guidance also prioritized connecting and combining platforms that contain data on population health, promoted sharing and open resources, and regulating intelligent medical care.
The same year, the National Health and Family Planning Commission publicized a pilot program to create four new national and regional centers, all concentrating on big data in health care. These centers are tasked with amalgamating datasets, such as data from genomic sequences, regional health, local health offices, the Chinese CDC, birth and death registries, and electronic medical records. These programs are part of the Internet Plus initiative, which aims to integrate cloud computing and IoT, and enable their use in a variety of industries.
A key portion of China’s biotech industry will be utilizing health care big data, complementing it with cutting edge applications like genomics and precision medicine that are flourishing in the country.