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IVD In China and Asia – Challenges And Opportunities


IVD companies from worldwide are working hard to enter and expand in the fast-growing China and other Asian markets. This includes some novel approaches. We have seen product development, market entrance, commercialization to meet unique demand and different needs from these markets.

China and the rest of Asia together, are looking at the fastest growing in per-capita income and living standards. As well as the most populous region in the world. No double China and Asia have become a place of importance that no IVD companies can ignore. Here is comparative data points: worldwide, the IVD industry were growing at the pace of 5% in 2016, wheas the IVD growth number went up to 14% in the Asia Pacific area during the same time. China is no double our champion, with an expected growth CAGR at around 20% YOY till 2020.

For IVD manufacturers, it will take time, strategy and execution to meet demands in China and Asia. Here are top factors affecting IVD companies growth in these region:

Regulatory challenges. Compared to US FDA and peers in developed countries, the regulatory agencies and policies relatively new. They are inexperienced, and often are short of resources and funds needed to get the job done. We have found that the best bet for IVD companies entering into China and Asia is to find a partner who possess proven experience and know-how in local registration, country by country and region by region.
Region’s heterogeneity. Very different from North America or European Union (EU) where population, culture, language, living standard, social structure are more or less homogeneous, you will find in China and the rest of Asia, each country and region is very different from another. Global IVD companies must make adequate effort to understand each market there and devote to complete localization in each market they are in. Understand the special requirements of the customer base in China and each Asian regions you are in, then develop or modify your product that truly meets the needs from each market.
Lack of funding and growth support. Often international IVD manufacturers found themselves stuck in an Asian region without desired speed for growth and expansion, due to lack of local funding and growth support. Again, call for connecting up with a local partner who are IN THE LOCAL NETWORK within the country or region and can provide with needed local funding and growth support.
Infrastructure and workforce issues. Unliked in developed countries, areas in China and Asia haven’t build the adequate infrastructure for reach out all population for IVD testing and often IVD company find it is hard to find and recruit staff with needed training and skill set.

China and the rest of Asia demand solutions to overcome these difficulties and meanwhile challenge IVD companies to be creative and innovative about localizing their IVD products and related services, throughout this vast and diversified region.

Some global IVD companies are adopting new technologies and business approaches to bring to life some of these innovations. For example, automation in testing and diagnosis could cover well in places where skilled personnel are hard to find. Point-of-care testing and diagnostics may be a great option to consider when reaching out the target population in remote areas. Internet and network connectivity, as being improved in developing areas, are ensuring that the test data can be collected and processed in a secure fashion.

In fact, we won’t be surprised that the next generation of innovations in IVD products and services may right be coming from those creative efforts in overcoming these localization challenges, leveraging advancement in technology such as internet of things (IoT) and remote management.

In addition to overseas players, local IVD product and service companies across China and the rest of Asia are also taking part in this wave of IVD innovation, especially to the diagnostics areas that most matter to the locals. Furthermore, we are also witnessing elevated IVD investment and M&A activities across China and Asian, involving local investors and partners with overseas IVD product and service companies. For example, earlier this year a Chinese investment firm participated a US $900 million round of financing in an overseas IVD company developing early cancer detection from blood testing.


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at

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