Increasing demand for outsourced manufacturing due to changing Chinese market conditions, CPHI Worldwide conference told

Rise of innovative companies with high-risk portfolios will necessitate need for CDMOs, says Thermo Fisher senior executive

In the session ‘China: Opportunities and high growth potential for global and domestic pharma,’ Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, Thermo Fisher Scientific said there would be an increase in high-risk R&D portfolios such as biologics, cell and gene therapy, steriles drug product development and vaccines.

“There will be the emergence of new biotech start-up companies in China as well as more global players interested in accessing the Chinese market due to the country’s significant growth potential,” he said.

Kane said that among the strengths of the Chinese market were strong private hospital sector growth and plans to increase the pharmaceutical manufacturing industry “so there are significant opportunities for pharma companies to have growth in their innovative drug pipelines.”

He added that Chinese regulatory agencies are moving very quickly to support faster drug review processes and approvals and changing the rules to bring in more innovative medicines and attract both local and international pharmaceutical manufacturers.

He also cited significant regulatory changes that have transformed the healthcare system in China, not least legislation that was introduced in 2015 which effectively enabled drug manufacturing outsourcing by removing the obligation of Marketing Authorisation holders to manufacture their drug products themselves.

“This has enabled the business model of outsourcing, allowing for different companies to manufacture products while the MA holder can continue to have the rights of registering and bringing these products to the domestic market,” he told the conference. “This regulation will attract CDMOs both globally and locally to bring innovative products into the Chinese market.”

Last year, Thermo Fisher announced it had signed a joint venture agreement with China’s Innoforce to build a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing. The new facility is scheduled to be completed in 2022.