Made in China
The world’s most populous state is set for big things in patented (bio) pharmaceutical development, according to a new report
China is the second largest healthcare market in the world and is already a significant player in the manufacture of active pharmaceutical ingredients (APIs) and generics. But over the past 30 years, China has independently developed only 40 chemical drugs – most of which have come out of public sector research (1). With a growing middle class population and increased gentrification in China, healthcare standards and spending are increasing, which is leading to greater demand for higher quality drugs and medical technology. Where will this lead in the next 10 years? According to a survey of 71 Chinese and 223 international companies in the pharma industry, China is upping its game and set to develop significantly larger numbers of new drugs in the future. Here are some of the main findings from the survey.
China’s big pharma
China is a popular player when it comes to exporting excipients and APIs, but 65 percent of international respondents believe that China will be discovering and patenting new chemical and biologic drugs within the next five years.
Chinese firms are expected to discover drug targets for Chinese populations – and these targets will be researched, trialed and manufactured by Chinese CMOs and distributed by Chinese partners. In other words, China will create its own “American Big Pharma model”.
Many Chinese companies are also ambitious about meeting international regulations and exporting their products overseas. In particular, there is huge interest in new biologic drugs. Over 80 percent of foreign respondents predict that China will have the fastest evolving biologics sector over the next decade. Chinese companies are also positive, with 50 percent believing that growth will be faster in biologics and biosimilars than any other pharma supply segment.
In with outsourcing
China’s improving manufacturing quality has led to increased outsourcing activity from western companies (including big pharma) to Chinese CMO’s and other local manufacturing providers. Fifty-one percent of international respondents believe that commercial manufacturing could be completely undertaken within China, with 35 percent stating they would also outsource packaging to China. However, confidence was low in outsourcing analytical testing to China – only 15 percent of respondents believe that this complex area can be competently outsourced.
Regulation overhaul
Seventy-six percent of respondents stated that their investments or progress in China have been hindered by regional regulatory delays, because of the government’s tight control of the pharma market. Seventy-two percent of participants went further, suggesting that a “US-style GDUFA [Generic Drug User Fee Amendments] fee system” is needed, which would deter companies from registering drugs they have no intention of making, thus clearing existing backlogs and speeding up future approvals. Moreover, 94 percent of Chinese companies believe the Chinese FDA needs to quickly grow to a size that is more comparable with US FDA, if it is to properly regulate the Chinese pharma industry.
- I Boutron et al., “Sharing of data from industry-funded registered clinical trials”, JAMA, 315, 2729-2730 (2016). PMID: 27367768.
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