Pinjia Health Files IPO Prospectus to Lead China's At-Home Diagnostics Market

After closely monitoring the home testing market for many years, Ding Wei, a senior expert in in vitro diagnostics (IVD), has observed significant changes in China’s home testing market over the past two years.

Ding Wei previously served as Global Vice President and President of the Asia-Pacific region at bioMérieux, as well as President of Kehua Bio-Engineering, China’s first listed in vitro diagnostics company. Ding has harbored a strong interest in home-based testing for over a decade. “More than ten years ago, I visited Canada to evaluate a point-of-care testing (POCT) technology platform. The testing process was remarkably simple, requiring no involvement from professional medical personnel and allowing patients to perform the tests themselves.” Recognizing the potential applications of this product, Ding was highly impressed, noting that “the foundational accumulation of home-based testing technologies is already in place, promising significant future prospects.”

However, market awareness and maturity always lag behind technology; at the time, Ding Wei believed that the timing for the development of home testing was not yet ripe. It was not until the COVID-19 pandemic sparked a surge in demand for home testing that the market trend began to shift!

In 2022, Ding Wei joined forces with Qingsong Capital and its founder, Dr. Zhang Song, to establish Pinjia Health. Capitalizing on market trends, the company strategically entered core sectors including women’s health, pediatric health, sexual health, and infectious diseases. Pinjia Health is dedicated to building a multi-platform, full-category smart home diagnostics solution to achieve comprehensive home-based health management.

“Affected by the COVID-19 pandemic and other factors, significant changes are taking place in the regulation, market, and technology sectors of China’s home-testing industry.”

Policy-wise,Prior to 2020, policies imposed strict controls on home testing. Currently, regulations governing home testing products have been progressively refined, including provisions on obtaining registration certificates and instructions for guiding non-medical personnel in conducting tests as specified in product labeling. Consequently, home testing products suitable for consumer self-testing have successively received market approval.

On the market side,“The notion that ‘everyone is the primary person responsible for their own health’ has gradually taken root.” The COVID-19 pandemic has popularized concepts such as molecular diagnostics and home-based testing among general consumers. In particular, antigen testing has helped consumers realize that in vitro diagnostics (IVD) are not as complex as commonly perceived, and that they can independently complete a disease test. Furthermore, widely adopted home monitoring of blood pressure, blood glucose, and body temperature also falls under the category of home-based testing, thereby promoting the application of more innovative IVD products in home settings.

On the technical front,In recent years, technologies such as isothermal nucleic acid amplification, immunoassay-based POCT, dry chemistry, and electrochemistry have become increasingly mature and stable. Following the COVID-19 pandemic, the in vitro diagnostic (IVD) raw materials sector has seen a significant surge, with upstream supply chains stabilizing. For instance, the wider selection of membranes for POCT applications is accelerating the trend toward home-use molecular diagnostics.

From the perspective of overall social medical efficiency,Home-based testing enables the at-home completion of screenings for chronic conditions and preventive health measures, facilitating early disease detection and intervention. This approach holds significant importance for conserving medical resources and improving healthcare efficiency.

Home-based testing is a core component of health management, offering substantial value to both society and individuals. In particular, the demand for home health management has always existed; the COVID-19 pandemic merely accelerated the development of the home-based testing market.Home-based testing will be a long-term trend, playing an increasingly important role in the healthcare system., a comprehensive, autonomous, and non-insurance-covered era of health management is poised to begin. Recently, Roche Diagnostics and Jana Care have formed a partnership to enter the home testing market for kidney disease and heart disease. The vast blue ocean of home testing has already attracted the attention of leading multinational corporations, making its future development promising. According to estimates by Pinjia Health,The potential market size of home-based testing in China will reach hundreds of billions of yuan in the next decade.

On the technical front, sample collection and testing are the two major challenges for home-based diagnostic products.

Sample Collection Phase,“There are still significant barriers to the simple, accurate, and painless or minimally painful collection of body fluids such as urine and saliva, as well as the collection of capillary blood from fingersticks and venous blood. For instance, while fingerstick blood collection is convenient, the sample volume is limited; many tests require venous blood draws, which consumers find difficult to perform on their own,” said Ding Wei.

Testing Phase,In home settings, it is difficult to use complex, large-scale diagnostic instruments, nor can they be calibrated daily; therefore, devices need to be compact, simple, accurate, and durable.

Pinjia Health is Tackling the Two Major Challenges of “Sample Collection” and “Testing”, sampling technologies are being developed to address different sample types and collection standards. Solutions for venous blood collection, fingertip blood collection, and collection challenges in specific scenarios such as women's health will soon be unveiled. Meanwhile, the company has specially designed its instruments and reagents for home-use settings, achieving simplicity of operation, low cost, accurate readings, and ambient-temperature transport of reagents.

On the product front, the current home testing market is largely characterized by companies addressing single pain points with standalone products, such as diabetes monitoring or COVID-19 antigen tests. In the future, more enterprises are expected to adopt systematic strategies that integrate with internet-based concepts, thereby creating a closed-loop health management ecosystem. Pinjia Health aims to develop comprehensive, cost-effective home testing product solutions tailored to China’s specific conditions, achieving full-category coverage.

Currently, the key sub-sectors that Pinjia Health is focusing on areWomen's Health, Pediatric Health, Sexual Health, Infectious Diseases.

Within the women’s health segment, women are increasingly accepting emerging solutions such as at-home testing. As key decision-makers in household consumption, women can drive the adoption of at-home testing among all family members. Given the private nature of infectious diseases and sexual health, consumers exhibit a stronger willingness to conduct self-tests at home.These areas are niche segments in home-based testing that are poised to achieve rapid growth first.

The vast potential has made home testing a highly coveted market. However, home testing differs significantly from traditional in vitro diagnostic (IVD) products in terms of product design, market education, and regulatory compliance, making it difficult for traditional IVD companies to easily penetrate this sector. Currently, few companies have achieved substantial success in the home testing market.

Ding Wei believes:“Entering the home-based testing market requires focusing on two key factors: regulatory compliance and market insights.”

First is compliance. During registration, regulatory authorities impose different requirements on product design and clinical data for home-testing products, and the registration approval documents must explicitly state information such as “for consumer self-testing use” to permit use in non-clinical settings. A large number of in vitro diagnostic (IVD) products currently sold on internet platforms carry compliance risks. “In China, IVD products that have truly obtained registration certificates for home testing are exceedingly rare.”

Next is market insight. If enterprises are driven by “opportunism” and blindly push medical-grade products to the home-use segment without considering the actual demands of the home testing market, they are unlikely to achieve tangible results. In short, as an emerging market, home testing requires sustained exploration by enterprises and experts in areas such as product models, marketing strategies, and regulatory policies.

Challenges and opportunities coexist. Amid the growing trend of home-based testing, Pinjia Health is developing a series of products focused on women’s health, pediatric health, sexual health, and infectious diseases. Leveraging its robust technology platforms, upstream and downstream resources in internet healthcare, and strong online and offline distribution channels, Pinjia Health aims to become the leading enterprise in China’s home-testing market.