PharmaSources/XuanyaoFebruary 25, 2019
Tag: biological drugs , global , therapeutic area
There were 355 biological drugs marketed in the decade from 2009 to 2018. More than 2,000 biological drugs are in development in the world, wherein, over 1,700 have entered clinical trials. According to the latest forecast report of the U.S. market research institution: EvaluatePharma, all the top 10 pharmaceutical products that were best-selling or had the largest sales growth would be biological drugs in 2018, wherein, 8 might be monoclonal antibody drugs. Among the 12 blockbuster new drugs in 2017, 3 were monoclonal antibodies, and others were enzyme inhibitors and CAR T-cell therapies. Among the top 10 pharmaceutical products by global sales in 2016, 8 were biological drugs, including 6 monoclonal antibodies.
Sales of global biological drugs have grown at an annual average of more than 30% since 1990s, which is far higher than the annual average growth of less than 10% of the global pharmaceutical industry. And from the perspective of the development trends of the global biomedicine industry, it is now at the beginning of large-scale industrialization of biomedical technology, and it is expected to enter the fast development period in 2020 and gradually become the leading industry of the world economy. Biological drugs marketed in the recent decade will be analyzed from region, type, and therapeutic area below.
Firstly, the distribution of the top 10 regions of biological drugs marketed in recent decade is shown in Fig. 1.
近10年全球上市生物药地域TOP10分布 | Distribution of Top 10 Regions of Global Biological Drugs Marketed in Recent Decade |
数量 | Quantity |
美国 | U.S. |
欧盟 | EU |
中国 | China |
日本 | Japan |
印度 | India |
韩国 | South Korea |
俄国 | Russia |
埃及 | Egypt |
中国台湾 | Taiwan, China, China |
英国 | UK |
Taken together, the U.S. was far ahead in the world, followed by the EU.
The U.S. dominates in the global market in terms of biomedical products, and its total biomedical output value accounts for about 17% of its GDP, being one of the most promising industries. 90% biological drugs in the global sales market are from well-known U.S. enterprises and wholesale medical supply companies, such as Pfizer, Merck, J & J, and Roche.
While, in Europe, Germany’s total biomedical output value accounts for about 12% of its GDP, and the industry is fast growing owing to the government’s attention; in the UK, Cambridge Biomedical Campus is one of the global parks engaging in the state-of-the-art biological R&D, which is in the area with dense universities and research institutions and has laid a solid foundation for the biomedicine industry.
China’s biological drug market exceeds the global market in terms of growth rate, and is in the fast development stage. The market size of biological drugs in China is expected to reach RMB326.9 billion in 2021, which brings unprecedented opportunities for China’s biological drug industry. There are many biological drugs marketed in China, however, Chinese-produced global blockbuster products, such as the king of monoclonal antibodies: Humira (adalimumab) with sales exceeding USD20 billion, remain to be seen.
Japan’s biomedicine industry was clearly behind the western countries in the 20th century, however, in the 21st century with the support from the business world and introduction of important policies by the Japanese government to utilize the biotech revolution, Japan’s biomedical field has become increasingly competitive and vigorous. Policies such as introduction of the "bioindustry for building the country" strategy, amendment of the Pharmaceutical Affairs Act to accelerate biological drug approval, and amendment of the Commercial Code of Japan to promote enterprise M&A have enabled Japan’s biotech development to gradually rank among the global leaders.
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