To facilitate the smoother entry of Chinese in vitro diagnostics (IVD) enterprises’ products and services into low- and middle-income countries (LMICs) and accelerate their market access processes, a joint research team from Duke Kunshan University and the Duke-National University of Singapore Medical School launched an in-depth research project in April 2024, entitled *”The CREATInG Initiative”*. This project aims to systematically investigate the opportunities and challenges faced by Chinese IVD manufacturers as they expand into international markets, particularly in meeting the health needs of LMICs.
Following the project’s launch, the research team undertook a series of in-depth interviews. The first round of interviews involved 12 representative Chinese IVD technology innovation companies, including well-known industry leaders such as Wantai BioPharm, BioGerm, and Liferiver. These companies span a spectrum of organizations, from emerging startups brimming with vigor to mature enterprises with prior international market experience. To ensure comprehensiveness and depth in the scope of the research, the interviews were extended to representatives from relevant government agencies, professional investment firms, and overseas contract research organizations (CROs). In total, 13 key stakeholders participated in this stage of the study.
This round of in-depth interviews was guided by clear and vital objectives. The primary goal was to deeply understand the core reasons and strategic motivations behind Chinese IVD manufacturers’ decisions to “go global” and expand internationally, particularly their aspirations to contribute to improving health outcomes and enhancing healthcare accessibility in LMICs through affordable, innovative products. Secondly, the research sought to comprehensively identify the various challenges and obstacles these companies face during their internationalization efforts, spanning from market entry to operational implementation. Thirdly, the project aimed to gather actionable recommendations from a wide range of stakeholders—including industry leaders, government agencies, investors, and international collaborators—on accelerating market access, with a particular focus on overcoming critical hurdles, such as country-specific regulatory approvals. Finally, the research sought to pinpoint the key knowledge and capacity-building needs of IVD companies, enabling them to successfully bring innovative and cost-effective solutions to global markets, especially LMICs.
In terms of research methodology, the team employed a rigorous semi-structured interview approach. Prior to each interview, researchers focused on building strong rapport with participants and conducting thorough preparation. The formal interviews were conducted online via video conferencing, lasting approximately 90 minutes. With the participants’ consent, all interviews were recorded in both audio and video formats. The processing of interview data involved the use of AI-assisted transcription, followed by meticulous manual verification to ensure the accuracy of the transcribed text. For data analysis, a thematic analysis method was applied, enabling the coding and categorization of a substantial volume of interview text to extract key insights. Interviews will continue until the collected information reaches a point of “saturation,” meaning no significant new insights or themes emerge from subsequent interviews.
（图：线上访谈）
The interviews focused on a series of core issues that determine the success or failure of companies’ international expansion. Researchers specifically investigated the enterprises’ overall internationalization strategy, market prioritization decisions, and logic behind resource allocation. From a regulatory perspective, the study explored companies’ registration and application strategies in various target markets, the major regulatory challenges they face, and their perspectives and expectations regarding international regulatory convergence, harmonization, and reliance. Additionally, the interviews examined the diagnostic technology platforms prioritized by the companies and the specific disease areas they target.
To support capacity building within companies, the interviews specifically inquired about the most urgent training needs in their internationalization efforts, as well as their detailed requirements for future executive leadership development programs and specialized training on market access regulations. Furthermore, the researchers gathered input on key topics of interest for stakeholder dialogues to be held in the future.
The in-depth insights gained from the “Leading China’s IVD International Expansion” project will provide significant practical value. These valuable findings from the interviews will directly inform the subsequent design of the project, particularly in the planning and optimization of executive development programs tailored for IVD company leaders, as well as specialized training courses focusing on market access and regulatory affairs, ensuring that the content aligns precisely with the needs of the companies.
More importantly, these core insights will serve as the primary foundation for discussions at the project’s planned international roundtable conference, bringing together global experts to collectively explore innovative solutions. Ultimately, the complete research findings are expected to be consolidated by the end of 2025 and published as a comprehensive 《White Paper on the Internationalization of Chinese IVD Companies》. This white paper aims to provide systematic analysis, practical strategic recommendations, and forward-looking insights to support the international development of China’s IVD industry, becoming an indispensable reference guide for the sector.
Kunshan Duke University and the Duke-National University of Singapore (Duke-NUS) Medical School have jointly launched “The CREATInG Initiative”, an important endeavor to leverage academic research advantages, address real-world industrial needs, and tackle global health challenges. The project team will continue to advance research efforts, aiming to contribute insights and expertise to the globalization journey of China’s in vitro diagnostics (IVD) industry and to improve health outcomes in low- and middle-income countries.
Contact Us
For more information about “The CREATInG Initiative”, please feel free to reach out to us via the following channels:
Email: Liang Yu at liang.yu@dukekunshan.edu.cn
Phone: +86 0512 3665 7095
We look forward to collaborating with you to open a new chapter in global market access for in vitro diagnostic products.
