Reliable Medical's Clinical Mass Spectrometry Platform Achieves Leading Install Base Within a Year Amid Evolving Market Landscape

As one of the most promising technologies in the IVD field, clinical mass spectrometry has entered a period of rapid growth, maintaining an average annual growth rate of over 35%. The market potential for clinical mass spectrometry in China is expected to exceed RMB 10 billion in the next five years.

In recent years, clinical mass spectrometry has emerged as a significant growth driver in the field of precision diagnosis and treatment. Companies in the industry have continued to invest in technological innovation and product development, attracting unprecedented attention from the capital market. According to data from VCBeat Research Institute, there were 15 financing events in China’s clinical mass spectrometry sector in 2022, with total funding exceeding RMB 640 million. In addition to intensive investment by financial institutions, 51 clinical mass spectrometry products received approval from the National Medical Products Administration (NMPA) in China in 2022, indicating an acceleration in the regulatory compliance of this field.

The founding team of Reliable Med witnessed and participated in the journey of China’s domestically developed, original mass spectrometry industry from “0 to 1.” Leveraging their professional expertise and capitalizing on the historical opportunity of domestic substitution, they decided to focus exclusively on the healthcare sector, achieving the transition from “1”to “10”even “100”the process.

In recent years, the emergence of new theories and technologies in in vitro diagnostics (IVD) has driven rapid advancements in clinical laboratory testing. Clinical mass spectrometry, characterized by its high specificity, high sensitivity, and capability for multi-analyte detection, has become one of the most dynamic emerging technologies in the IVD field. Clinical mass spectrometry is playing an increasingly vital role in a wide range of clinical applications, including newborn screening for inherited metabolic disorders, vitamin testing, therapeutic drug monitoring, hormone assays, microbial identification, pharmacogenomic analysis, and trace element testing.

In recent years, a few leading Grade 3A hospitals in China have purchased mass spectrometers for their clinical laboratories. However, all these devices were registered as scientific instruments rather than medical devices. The optimal performance of such equipment relies heavily on skilled operators proficient in mass spectrometry techniques and capable of performing complex post-acquisition data analysis. These instruments are not only complicated to operate but also tend to exhibit rapidly declining stability when handling the high-volume, batched testing of clinical samples typical in China. As a direct consequence, the turnaround time (TAT) is significantly prolonged compared to other routine tests, often requiring approximately three days for physicians and patients to receive the results.

The founding team of Reliable Med boasts over a decade of experience in the research and development and industrialization of mass spectrometry.“At the beginning of this century, China’s R&D talent pool and supporting industries for mass spectrometry were virtually nonexistent, starting from scratch.’。“There was a severe shortage of talent, hardware and software technologies, and upstream supporting industries within the sector, making the development of mass spectrometry instruments truly challenging over a decade ago. We literally started by painstakingly studying scientific literature, embarking step by step on the long journey of mass spectrometry R&D,” Zheng Yi told VCBeat.

Building on years of deep engagement in the mass spectrometry industry, Zheng Yi, Founder and CEO of Reliable Med, and Li Xiaoxu, Co-Founder and CTO, have become among the earliest professionals in China dedicated to the research, development, and commercialization of mass spectrometers. In June 2019, Zheng Yi and Li Xiaoxu founded Reliable Med, focusing on the field of clinical in vitro diagnostics and striving to create clinically graded mass spectrometry analysis systems that are high-throughput, automated, informatized, highly stable, and equipped with independent intellectual property rights.

But less than half a year after its establishment, Reliable Med faced its first challenge: COVID-19.

Over the past three years, the widespread adoption of COVID-19 testing technologies has heightened public awareness of the in vitro diagnostics (IVD) industry, but it has also overdrawn the capital market’s long-term profitability expectations for the entire sector, thereby squeezing the growth potential of certain companies in niche IVD segments.

After several years of development, Reliable Med has invested over RMB 200 million in research and development. The company currently boasts R&D and production facilities exceeding 10,000 square meters, a team of more than 180 employees, with over 60% of its R&D staff holding master’s or doctoral degrees. It holds more than 100 core patents and software copyrights.

Recently, Reliable Med has launched its flagship high-performance liquid chromatography-tandem mass spectrometry platform (HPLC-MS/MS, INSPEC9000). This platform enables quantitative analysis of small-molecule organic compounds, including vitamins, therapeutic drug concentrations, catecholamines, and other metabolites.

Regarding how to refine clinical mass spectrometry products, Reliable Med has consistently adhered to three principles during its research and development:

When analyzing biological samples, a mass spectrometer must first demonstrate excellent matrix tolerance, stability, and result reproducibility. Second, building on this stable and reliable foundation, the operation of the instrument needs to be concise and efficient to facilitate the broader adoption of mass spectrometry technology. Most importantly, to enable the future integration of mass spectrometry into clinical laboratory automation lines, mass spectrometers must also feature high reliability under ultra-high-throughput conditions and a compact structural design.

Adhering to the aforementioned design philosophy, Reliable Med now boasts the most comprehensive clinical mass spectrometry product pipeline in the industry. It has deployed three high-throughput, fully automated benchtop platforms: Inductively Coupled Plasma Mass Spectrometry (ICP-MS), High-Performance Liquid Chromatography (HPLC), and High-Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS). Additionally, it offers two Point-of-Care Testing (POCT) platforms: a miniaturized Gas Chromatography-Mass Spectrometry (GC-MS) platform for breath analysis, and a Linear Ion Trap Mass Spectrometry (LIT-MS) platform for rapid liquid testing. The company also possesses R&D capabilities and large-scale manufacturing capacity for supporting diagnostic kits used in clinical mass spectrometry.

The aforementioned mass spectrometry products are primarily used for qualitative and quantitative detection of small molecules. Their applications span three major areas: maternal and child health management, early screening for cardiovascular diseases, and drug metabolism and chronic disease management. These products enable precise analysis in specialized fields, including various trace elements, vitamins and metabolic profiles, catecholamine profiles, homocysteine and its metabolite profiles, drug concentrations, and other small-molecule hormones.

As mass spectrometry enters the mainstream as a novel diagnostic technology, it must address the critical pain points of hospital clinical laboratories by upgrading research-grade mass spectrometers into high-throughput, automated, and highly stable clinical-grade instruments. Furthermore, the development of point-of-care testing (POCT) mass spectrometry will facilitate the deployment of this technology to secondary hospitals and below, extending even to community clinics and other healthcare facilities. Zheng Yi stated, “We need to make concerted efforts in this area. Not only must we preserve the inherent advantages of mass spectrometry—such as its intelligence, stability, and accuracy—but we must also enhance the overall convenience and accessibility of the integrated systems.”

A significant portion of Reliable Med’s core team hails from the biochemistry and chemiluminescence industries. Consequently, the company brings a unique perspective to the emerging field of clinical mass spectrometry, maintaining that “the intrinsic logic driving industrial development in the biochemistry and immunoassay sectors is equally applicable to clinical mass spectrometry.”

The clinical chemistry and immunodiagnostics industry has evolved from early manual testing to semi-automated and fully automated systems, and now to integrated laboratory automation lines.Driven by upgrades in detection technologies and significant advances in automation, achieving fully automated clinical mass spectrometry and enhancing “throughput” are key factors propelling industry progress. Technological advancements in clinical mass spectrometry will lead the industry’s evolution and leap from today’s fully manual workflows to future ultra-high-throughput assembly-line models. Consequently, companies worldwide in this field face substantial responsibilities and a long, challenging road ahead.

Driven by a deep understanding of clinical users’ needs and adhering to the philosophy of “keeping complexity in-house while delivering simplicity to users,” Reliable Med’s first clinical-grade mass spectrometer, the ICP-MS InspectorSQ60 (Inductively Coupled Plasma Mass Spectrometry Platform; Zhejiang Medical Device Registration No. 20212220150), has been widely favored by users since its market launch. Within one year of its release, it has achieved a commanding lead in total clinical installations.

When domestic IVD companies reach a certain scale, they inevitably face two topics: import substitution and global expansion.

China has over 3,000 tertiary hospitals, but only slightly more than 500 of them are truly equipped with clinical mass spectrometry instruments, with the total number of installed units approaching 1,000 (covering all types of mass spectrometers). Compared to the installation base of traditional biochemistry and immunoassay IVD equipment, there is still substantial market potential in this field.

Most of the research-grade mass spectrometers currently installed in China are imported, and the instruments have manyBottlenecks Urgently Needing Improvement: such as the difficulty in standardization due to excessive reliance on manual operations, high barriers for user learning and maintenance, and compatibility issues between instruments and reagent kits. Taking the imported HPLC-MS/MS systems procured by hospitals in the early stages as an example, most of them could only perform mass spectrometry testing through Laboratory Developed Tests (LDTs) within the hospital. With the increasing number of domestic clinical mass spectrometry companies year by year, the industry is now able to provide comprehensive solutions covering instruments, reagents, and technical services, leading to greater acceptance of domestic brands by hospitals.

To secure a foothold in this field, domestic enterprises must not only master core mass spectrometry technologies but also gain a deep understanding of clinical needs, thereby developing high-throughput, highly stable total solutions that align with customer usage habits and offer significant differentiation and cost-effectiveness.thereby establishing significant advantages over imported brands in both technical and commercial dimensions.This is also a key reason why Reliable Med’s ICP-MS (Inductively Coupled Plasma Mass Spectrometry Platform, Zhejiang Medical Device Registration No. 20212220150), as an emerging force in China’s clinical mass spectrometry sector, has rapidly earned user acclaim within just two years of its launch.

Furthermore, Reliable Med is actively establishing collaborations with major hospitals, universities and research institutes, as well as upstream and downstream enterprises, to develop forward-looking reagent kits with strong diagnostic significance.

In addition to cultivating the domestic clinical market, global expansion is an inevitable path for Chinese clinical mass spectrometry companies. Since its inception, Reliable Med has been conducting research and strategic planning on how to enter overseas markets.User profiles differ significantly between China and other countries: the domestic market is primarily hospital-based, whereas in Europe and the United States, third-party clinical laboratories dominate.In addition to proactively securing overseas market access for its products and establishing international marketing channels, Reliable Med has also made in-depth investments in core patents for mass spectrometry technology, thereby building a competitive moat.

In this era of rapid advancement in multi-omics, Reliable Med is poised to leverage the advantages of its integrated mass spectrometry R&D and manufacturing platform in terms of technology, talent, and cost efficiency. By benchmarking against international best practices and accelerating collaboration with upstream and downstream partners across the industry chain, the company aims to facilitate the translation of novel technologies from research to clinical practice, thereby making advanced mass spectrometry-based diagnostic techniques accessible to the general public.