The Wave of Home Testing

After closely monitoring the home testing market for many years, Ding Wei noticed that the Chinese home testing market has undergone significant changes in the past two years.

Ding Wei is a senior expert in in in vitro diagnosis. He has served as the global vice president and Asia Pacific president of BioMerier, as well as the president of Kehua Biotechnology, the first domestic listed company in vitro diagnosis. Ding Wei's complex of home testing has been around for more than 10 years. "More than 10 years ago, I visited a POCT platform in Canada. The platform does not need professional medical personnel to intervene, and patients can complete the testing themselves." This model made Ding Wei see clearly, "Home testing must be a trend in the future."

However, market awareness always lags behind technology, and Ding Wei believed that the time for the development of home testing was not yet right. Until the COVID-19 triggered the demand for home testing, Ding Wei realized that the time had come!

In June 2022, Ding Wei took advantage of the situation and established SanteFam Healthcare, targeting core markets such as women's and children's health, sexual health, and infectious diseases. He created a multi-platform and comprehensive smart home diagnosis solution, achieving comprehensive home health management.

The scale of China's home testing market will reach 500 billion yuan

"Influenced by the COVID-19 and other factors, the supervision, market and technology of China's home testing market are changing significantly."

On the policy side, before 2020, the policy had strict control over home testing. Now, the relevant regulations for home testing products have been gradually improved, including how to obtain a registration certificate, how to guide non medical personnel to conduct testing on the manual, and other regulations. There are also gradually approved home testing products suitable for consumer self testing in the market.

On the market side, "everyone is the first responsible person for their own health" has gradually become popular. The COVID-19 epidemic has popularized the concepts of molecular diagnosis, home testing and other concepts to ordinary consumer groups, especially antigen testing, so that consumers realize that in vitro diagnosis is not as complex as they think, and they can also complete a disease detection independently. In addition, blood pressure, blood sugar, and body temperature tests, which have already been widely used, are also part of home testing and have a driving effect on the application of more innovative in vitro diagnostic projects at home.

On the technical side, technologies such as isothermal amplification of nucleic acids have become increasingly mature and stable in recent years, and after the COVID-19 epidemic, the plate of in vitro diagnostic raw materials has caught fire, and the supply of upstream raw materials tends to be stable. For example, the selection of POCT membranes has become more diversified, driving the acceleration of the domestic trend of molecular diagnosis.

From the perspective of overall medical efficiency in society, home testing enables basic diseases and prevention projects to be completed at home, achieving early disease detection and intervention, which is of great significance for saving medical resources and improving medical efficiency.

Home testing is the core link of health management and has great value for society and individuals. In particular, the demand for family health management has always existed, and COVID-19 has only accelerated the process of home testing market. Home testing will be a long-term trend and play an increasingly important role in the healthcare system. The era of comprehensive, autonomous, and non medically insured health management is expected to begin. Recently, Roche Diagnostics and Jana Care have reached a partnership to enter the home testing track for kidney disease and heart disease. The vast blue ocean of home testing has attracted the attention of leading foreign companies, and future development is worth looking forward to. According to SanteFam Healthcare's calculation, the size of China's home testing market will reach as high as 500 billion yuan by 2030.

Solve the two key challenges of "procurement" and "inspection"

On the technical side, collection and testing are two major challenges for home testing products.

There is still a large threshold for how to collect urine, saliva, and other bodily fluids, as well as fingertip blood and venous blood, in a simple, accurate, painless or slightly painful manner during the sample collection process. For example, fingertip blood collection is convenient, but the collection volume is limited; many projects require venous blood collection, but consumers find it difficult to complete venous blood collection on their own, "Ding Wei said.

In the detection process, it is difficult to use complex and large diagnostic instruments in the home environment, and daily calibration cannot be carried out. The instruments need to be small, simple, accurate, and durable.

SanteFam Healthcare is addressing the two major challenges of "sampling" and "testing", developing sampling techniques for different sample types and collection standards. For specific scenarios such as venous blood collection, fingertip blood collection, and female health, corresponding solutions will soon be available. At the same time, the company has also specially designed instruments and reagents for household scenarios, achieving simple instruments, low costs, accurate readings, and transportation of reagents at room temperature.

On the product side, most of the current home testing market starts from a single pain point and distributes a single product, such as diabetes testing and COVID-19 antigen testing. In the future, more enterprises will carry out systematic layout, connect with the Internet concept, and form a closed-loop health management. The purpose of SanteFam Healthcare is to form a comprehensive home testing product solution that is suitable for China's national conditions, with high cost-effectiveness, and achieves full category coverage.

At present, SanteFam Healthcare focuses on the sub areas of female health, early childhood health, sexual health, and infectious diseases.

Among them, in the female health sector, women's acceptance of emerging things such as home testing is increasing, and women are the leaders of household consumption, which can drive all members of the family to undergo home testing. Infectious diseases and sexual health have privacy, and consumers have a higher willingness to self test at home. These fields are the first to achieve rapid growth in home detection segmentation scenarios.

Market insight and compliance are core elements of home testing

The huge imagination space has always made home testing a coveted market. However, home testing differs greatly from traditional in vitro diagnostic products in terms of product design, market education, compliance, and other aspects. Traditional in vitro diagnostic enterprises cannot easily conquer this market. Currently, no companies have achieved significant results in the home testing market.

Ding Wei believes: "To layout the home testing market, we need to pay attention to two factors: compliance and market insight

The first is compliance. At the time of registration, regulatory authorities have different requirements for the product design and clinical data of home testing products, and the registration approval documents clearly reflect information such as "consumer self testing use" before they can be used in non medical scenarios. The large number of in vitro diagnostic products sold on internet platforms now pose compliance risks. At present, there are very few in vitro diagnostic products in China that have truly obtained a registration certificate for home testing

Secondly, there is market insight. If enterprises are driven by "opportunism" and do not consider the actual needs of the home testing market, blindly pushing medical products towards the home end will be difficult to achieve practical results. In short, home testing is an emerging market that requires enterprises and experts to persistently explore product models, market promotion, regulatory policies, and other aspects.

Challenges and opportunities coexist. Under the trend of home testing, Pinjia Health is developing a series of products focusing on women's health, early childhood health, sexual health, and infectious diseases. In the future, relying on rich technology platforms, internet medical upstream and downstream resources, and strong online and offline channel resources, SanteFam Healthcare will build the first brand of home testing in China.