Is the World Ready for China-Made Vaccines and Biologics?
China-made vaccines will soon enter the market. China has long proved they are the “world’s factory” for toys, consumer electronics, clothing, and plastic, but will the world trust a China-manufactured biological product?
The pharmaceutical industry in the country will grow to $625 billion in 2026, and vaccines are not the only products expected to rise. Monoclonal products (MAb), used to treat cancer, make up the largest percentage of biologic product growth in China. The biopharmaceutical industry may have lagged since 1989, but, because of the government’s aggressive efforts and focus on biopharmaceutical manufacturing and biotechnology, the world’s factory will become a large pharmaceutical production center.
Today, China accounts for less than 10% of the world’s biopharma trade, but with a 23% growth every year, it’s expected to eclipse many emerging markets and western developed industries.
So How Does China Do It?
The growth of the biopharmaceutical industry in China can be credited to many factors. Chief among them is China’s explosive economic growth. The country was richer than ever, outranking Japan and Europe. China is now the second-largest economy in terms of gross domestic product (GDP), thanks to its manufacturing environment and a huge workforce.
Speaking of their population, the growth of China’s economy has prompted the expansion of healthcare insurance programs, covering more than a billion Chinese citizens. All basic medical insurance and cooperative medical systems now cover everyone in China. Because of their efforts to cover everyone in health insurance, total healthcare expenditures have increased from $150 billion to $4.8 trillion in a decade, at the same time that the country’s GDP grew by 4.5% to 6.2%.
The double-digit annual economic growth of the country is the reason for the development of the biological therapeutics industry. Also, as some 300 million people age, they are turning to this industry for solutions to growing health problems.
Which Biopharma Sectors Will Grow Rapidly?
Most subsectors of the biopharmaceutical industry are expected to rise in the next years. These include recombinant products, biosimilars, growth factors, and vaccines. Among these, long range opportunity awaits these three sectors: therapeutic antibodies, contract biomanufacturing, and clinical trial contract research.
MAb Therapeutics and Biosimilars
Monoclonal antibodies (MAb) and biosimilars products make up a large percentage of the global biologics. At the moment, China’s industry falls behind with only 7 percent of the market. When it comes to sales of individual MAbs, the difference is even more noticeable. Only 12 out of 70 USA FDA-approved MAb therapeutics have been approved by the Chinese Food and Drug Administration (CFDA) and made available in circulation in the mainland.
Even though China developed therapeutic MAbs relatively late compared to other countries, this particular industry in the Chinese market is catching up quickly. By 2021, the country’s total market will increase to 27.6 billion yuan ($4.1 billion). The country’s healthcare insurance system will cover these emerging products. Many domestic drug makers are also gaining interest in launching biosimilar MAbs.
Fast-track Drug Approvals
Speedy drug approvals contribute to the growth of China’s biologics. The Chinese Food and Drug Administration (CFDA) has approved 1,653 biologics manufacturers, of which 95 percent have brought therapeutic biologics to the market. In 2018, 288 of the 401 pipeline antibodies in China were in active development. 77 of them were initiated outside China, while the remaining 211 were produced by domestic pharma manufacturers.
Chinese companies also started clinical trials abroad. For instance, Genor Biopharma conducted a phase 1 clinical study of its anti-Her2 MAb in Australia.
Since the majority of biosimilar products are likely to be put on the National Reimbursement Drug List (NRDL), the industry has strong potential for growth in the coming decade.
China may have entered the mammalian bioprocessing late, but with expansion plans and new facility construction news coming out almost weekly, the country expects a biomanufacturing capacity of approximately 85,000 liters of biological products.
Several expanded facilities will adopt the most cutting-edge technologies, such as single-use technologies (SUTs) and modular strategies. For example, Pfizer China and JHL Biotech have used GE Healthcare’s KUBio modular factory to build their facilities in China.
International Outsourcing of Biomanufacturing
The majority of industry leaders in China believe that bioprocessing outsourcing is the future. They predict that outsourcing of bioprocessing to Chinese Contract Manufacturing Organizations will become a mainstream activity. 21% of the global manufacturers will consider China to be a possible outsourcing destination by 2023. For now, China attracts local demand for contract manufacturing. Hundreds of start-up companies flocked to the Yangtze Region, to begin developing innovative biologics. This research claims that more than 50 domestic companies in China have begun Monoclonal antibodies (MAb) development projects.
Development of Clinical Trials
Aside from CMOs, Contract Research Organizations (CRO) are also expected to be a long-term industry in China. Clinical trials in China have their unique benefits and limitations. The country has the largest patient pool for most common diseases. Patient recruitment and retention are the most time-consuming factors of clinical research and a major cause of missed trial deadlines. China’s high rate of recruitment and retention of trial subjects makes the country the best option for this industry. According to Advances in Biopharmaceuticals China study, less than 80% of trials fall behind schedule and 90% of those were the result of a slow-moving recruiting of sample patients.
High patient-recruitment rates are the best catch for international clients. Many patients from rural areas seek medical attention from tertiary hospitals in the big cities of China, making up a huge percentage of medical services and higher recruitment rates than any other country. Follow-up risk is also low, as Chinese people tend to comply with physicians’ orders.
Costs also play a vital factor in choosing China as a CRO. Choosing a study site in China at the drug discovery stage costs about a third to one-half less than doing so in developed countries such as the USA. At the clinical trial stage, cost-savings seem to be even more evident. The cost per patient of all therapeutic areas could be three times less in China, because of these factors: investigator and site fees; the cost of trial-related medications; laboratory tests; hospital stays; financial compensation for the patients; CRO service fees; and other supporting fees. Almost everything is less expensive in China than anywhere else. Plus, because of quick patient enrollment and high retention rates, infrastructure, and personnel costs are greatly reduced.
Challenges to China’s Biologics
Biological processing in China still has a lot of roadblocks that hold it back from accelerating. Chief among them is the lack of qualified investigators and expertise in clinical research, limited funding to support these researches, substandard adherence to good clinical practices (GCPs), and regulation blocks.
But the opportunities in front of China’s biopharma industry overshadows these challenges. The country has been establishing regulatory bodies. Its ascension to the International Council on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) proved beneficial when most of their problems are being addressed in this organization. Regulation authorities are asking for self-examination of the drug makers’ clinical data. This stringent process prompted a lot of low-quality researchers to withdrew from several studies, leaving only those with competitive and higher clinical-trial data standards. As a result, the reputation of Chinese CROs has improved in the global scene. The country will soon be a favourable clinical trial hub.
China’s economic growth, on top of the accelerating biotechnology industry, will usher in a new era of growth to the country. Not only will China be seen as the world’s factory where toys and consumer products flood the market, but they will also be visible in the pharma biologics field. Chinese products will join the ranks of western products flooding the biologics market. The citizens themselves, increasingly older and increasingly affluent, will drive this growth even further. In the next few years, China’s growth in the biologics industry will attract the rest of the world’s biologics developers, manufacturers, suppliers, distributors, and regulators.