China clinical development has experienced robust growth over the past 5-10 years. However, much of drugs developed are caught in homogeneous competition which is expected to be increasingly unsustainable going forward. With more companies starting to tackle the situation, the transformation from extensive growth to quality growth of clinical trials in China is expected.
That was the conclusion L.E.K. Consulting and PharmaDJ, a Chinese business intelligence platform, came to after they partnered to create a comprehensive overview of clinical development trends in China. Supported with feedback gleaned from in-depth interviews with R&D leaders and management executives, and a survey of 101 market participants in China that was completed in October of 2022, they created an in-depth report titled “Pivoting to a High Quality Growth of Clinical Trials in China.”
Though faced with challenges, the foundation for China healthcare market is still strong, which is expected to support the future high-quality growth of China clinical trial. Four strategic trends are anticipated as China clinical trial development pivoting to quality growth:
Development of more innovative and differentiated therapies: Chinese pharmas have surely made some progresses in innovation in the past few years; however, many are concentrated around heated targets (such as PD-1, EGFR), leading to homogeneous competition. With companies starting to focus on new modalities, technology platforms and targets, more innovative and differentiated therapies are expected.
Increasing focus of more commercially attractive development areas: Oncology has become the most heated TA for clinical development in China over the past few years. In the future, companies tend to consider more comprehensively when prioritizing drugs for R&D with commercial attractiveness being more of a key consideration. Other factors considered also include return on investment, company expertise, and feasibility to collaborate.
Adoption of smarter clinical trial tools: As increasing complexity becomes the mega trend of clinical trial, demands for smart and digital tools are rising. Technologies such as EDC, CTMS, eTMF and PVS have already being widely adopted in China clinical trials. It is believed that smart and digital tools will be indispensable for future clinical trial, and revolutionary impact may even be witnessed.
A two-way pursuit – globalization of Chinese biopharma & evolution of MNC China R&D strategy: Globalization is increasingly an imperative for Chinese biopharmas and in order to succeed in oversea trial, careful prioritization of destination, oversea local team setup, and active communication with regulatory agencies are anticipated; With Chinese innovations being validated on the global stage, MNCs also tend to strengthen the cooperation with Chinese counterparts through license-in and incubation.
Clinical development in China has grown extensively in recent years. As the focus shifts to high-quality growth, there are a slew of new issues and questions that pharmaceutical companies will need to address.
To learn more about how this shift will impact both Chinese and multinational pharmaceutical companies alike, please download our analysis.