Automated laboratories are an effective solution that can greatly improve the efficiency of modern laboratories, reduce processes, and enhance accuracy. Looking back at early 2020, when the COVID-19 pandemic raged, facing the surge in the number of test samples, extremely high demands were placed on both sample testing efficiency and accuracy. This has led to the production of a large number of automated and highly integrated instruments and equipment, such asFully automatic pipetting workstationFully automatic nucleic acid testing instruments, etc., have also accumulated practical experience for a large number of high-throughput tests. It is foreseeable that in the future, automated experiments will become a hot technology area of concern for major domestic scientific research institutions, medical instrument manufacturing industries, and other sectors.
forAutomated LaboratorySo far, there is no universally accepted definition. It usually refers to an integrated device that uses various automatic detection instruments, equipment, computers, and other means to achieve experimental processes such as measurement, sample preparation, pretreatment, and data processing.
The simplest and most widely applied scenario for automated laboratories is currently in hospital laboratories. Generally speaking, to meet the needs of patients for medical tests such as blood routine, a large number of laboratory staff are required to participate throughout the process, from sampling, bottling, opening caps, centrifugation, extraction, repackaging to sending samples for testing. At present, it is possible to automate all the pre-treatment, testing, result reporting, and subsequent sample storage through biochemical and immunological assembly lines after blood collection. This article will focus on analyzing the application of this part in China.
China's medical laboratory equipment industry chain
Source: Frost & Sullivan
Looking at the medical laboratory equipment industry chain, upstream consists of instrument component suppliers. Due to reasons such as production processes and component stability, core components of medical laboratory equipment are still mainly imported, including Shimadzu gratings from Japan and sample loading needles from Yiteng in Japan. Midstream manufacturers of medical laboratory instruments sell in various modes such as standalone machines, MA (multi-axle) machines, and TLA (tandem linkage) machines. The downstream of the industry is at the end-user application sites, such as hospitals, disease control centers, third-party testing centers, research institutions, and health check-up facilities.
Single-machine sales are mostly in the form of bundled sales, which means that profits are obtained by deploying free medical testing instruments at target locations and relying on long-term sales of biochemical diagnostic reagents. A considerable number of domestic manufacturers have gained recognition in this field.
With the improvement of detection throughput and automation levels, there has emerged single-module automation, which refers to the automated and intelligent integration of a specific laboratory operation or step, such as automated liquid preparation, automated weighing, automated centrifugation, etc., known as the MA model. Above this level, manufacturers integrate multiple modules to achieve a series of continuous automations, obtaining TTA automation modules. Common examples include the automation of chemical pretreatment processes, microbial pretreatment processes, and nucleic acid testing processes.
Source: Frost & Sullivan
The field with the highest integration is undoubtedly TLA, which refers to fully automated assembly lines. It is an integrated facility that encompasses modules such as biochemical diagnosis and immunodiagnosis, capable of fully automating the entire process from sample loading to result output.
TLA belongs to high-precision and advanced equipment, with the complete set of TLA costing a high price, mainly concentrated in large tertiary hospitals. The TLA sector has long been monopolized by multinational in vitro diagnostic giants such as Abbott, Beckman, Johnson & Johnson, and Roche. Local enterprises are generally in their initial stages, with some leading domestic in vitro diagnostic companies such as Transgene Life,Antu BiologyDomestic TLA products have been launched through independent research and development, joint development, and other forms.
On the one hand, affected by the pandemic, downstream inspection demand has continued to grow rapidly in recent years; on the other hand, along with hospital hierarchical diagnosis and treatment, procurement and salestwo-ticket systemWith the successive introduction of policies such as medical insurance control, the demand terminal has continuously strengthened its requirements for cost control while increasing its demand for biochemical diagnostic products. This has provided development opportunities for domestic products with high cost performance.
TLA mode
The full name of TLA is Total Laboratory Automation, also known as a fully automated laboratory. It is an integrated facility that intelligently completes a series of operational steps such as sample loading and sorting, data detection, batch analysis, and sample storage. It usually includes fully automated biochemical analysis modules and fully automated non-analytical modules, capable of conducting both types of in vitro diagnostic technology tests simultaneously.
The basic components of TLA include a sample sorting system, a sample processing system, various automatic analyzers, a sample delivery system, and network workstations. Its goal is to improve efficiency and reduce labor costs by enhancing quality and safety, increasing the number of tests, and simplifying processes. It can perform measurements and reports accurately and timely, achieve comprehensive network management, and provide better services for scientific research and patients. In addition, operators do not come into contact with specimens, reducing the risk of biological infection.
The industry believes that laboratory automation will lay a solid foundation for the construction of clinical laboratory standardization and quality certification, especially for major international standards and certifications such as CAP (American Association for Clinical Pathologists) clinical laboratory quality certification, ISO (International Organization for Standardization) medical laboratory quality certification, global clinical laboratory quality control service system.SOPStandardized operation procedures, etc.
In terms of application scenarios, the construction cost of fully automated production lines is high, mainly targeting large tertiary hospitals with an average daily diagnostic demand of over a thousand patients and research institutions with strong financial resources. Under normal circumstances, if the sample size is less than 500 tubes per day, there is no need to introduce TLA equipment. Single machines with fast speeds can also complete testing within a short period, making it more cost-effective in terms of benefit-cost ratio. However, when the sample size continues to increase, it is necessary to consider introducing production lines to save human resources while meeting the sample testing turnaround time (TAT) requirements.
Source: Frost & Sullivan
According to the distribution of turnaround times for medical test samples, the most time-consuming stages during testing are the preliminary preprocessing and post-processing of diagnosis.
In fact, rechecking problematic results only accounts for 30% of the time spent by laboratory staff reviewing results. Automated laboratories replace traditional manual operations with automated mechanical operations, reducing diagnostic sample preprocessing and post-processing time. Ultimately, they can save 60-70% of testing time overall and improve the overall turnaround rate within the laboratory.
At the same time, in terms of inspection quality, automated laboratories can avoid manual contact with diagnostic samples during processes such as lid removal, sample loading, and sample storage, significantly reducing the risk of cross-contamination and preventing errors in manual specimen handling.
In addition, considering the application scenarios of automated laboratories, fully automatic high-throughput measurement and reporting can be carried out accurately and in a timely manner, achieving comprehensive traceability management. This is particularly suitable for situations with high testing volume requirements such as epidemic prevention and control.
Source: Frost & Sullivan
Compared with traditional testing methods, the advantages of TLA are mainly reflected in (1) reducing the amount of blood drawn from patients and the number of blood collection tubes; (2) shortening sample turnaround time (TAT); (3) improving work efficiency and reducing personnel numbers; (4) reducing manual intervention and lowering error rates; (5) reducing laboratory biocontamination and protecting the health of operators, etc., playing a positive role in improving the entire laboratory process.
Current Market Situation of Automation Laboratories
Regarding the automation laboratory market in China, referring to data from 300 sample hospitals, more than 70% of hospitals use imported TLA products.
Although the Chinese automation laboratory market is monopolized by multinational in vitro diagnostic giants such as Roche, Siemens, Abbott, and Beckman, local in vitro diagnostic enterprises are striving to break through this monopoly through independent research and development and cooperative development. For example, Mindray Medical and Antu Biotech have independently developed fully automated production lines that include biochemical and immunodiagnostic tests. Most of their immunological instruments use their own brands, while high-end biochemical instruments are a scarce resource in the market. Therefore, the biochemical instrument sector has more or less cooperated with well-known Japanese manufacturers.
In comparison to the characteristics of various TLA systems, multinational giants and domestic leading enterprises that entered the field earlier often adopt a closed system design, highly binding biochemical diagnostic reagents with instruments, ensuring unique matching for the same brand. This forms an automated solution centered around the brand as the product core. Therefore, for some hospitals, this limits their ability to expand testing programs and their cost control capabilities.
Some domestic systems, considering the level and economic strength of their target hospitals, attempt to break the link through open systems, forming automated solutions centered around customer needs. This enables biochemical diagnostic reagents and instruments from different brands to operate independently without affecting the biochemical diagnostic testing procedure.
TLA Brand Distribution in Chinese Sample Hospitals in 2020
Source: Frost & Sullivan
Observing the TLA assembly time of sample hospitals, most are equipped with Beckman, Roche, and Siemens TLA systems registered in China between 2013-2015. Calculated based on the typical lifespan of TLA systems of 8-10 years, it is anticipated that there will be a huge demand for replacing imported production lines between 2022-2025. According to literature reports, the TLA assembly rate in Japanese public hospitals reached 72% in 1998.
In comparison, the penetration rate of TLA in domestic hospitals is extremely low. According to a research report by Pacific Securities, about 2,000 units were assembled nationwide in 2020. In the same year, China had 2,996 tertiary hospitals and 10,404 secondary hospitals. Considering that the TLA system is more suitable for high-volume scenarios and can only generate economic benefits when there is an adequate sample size, including the vast majority of tertiary hospitals and some secondary hospitals with particularly high diagnostic and treatment volumes as the main sales targets, it is roughly estimated that the demand for hospital TLA alone will exceed more than 3,000 units.
Due to the high concentration of medical resources, there is a mismatch in diagnostic and treatment needs. In some large tertiary hospitals with concentrated patient populations, there may also be multiple TLA system requirements. Considering the increasing number of third-party testing centers and health check-up centers, China's actual TLA demand far exceeds expectations.
The future development of automated laboratories
TLA is a multi-disciplinary, multi-technical complex systems engineering project, different from stand-alone products. It emphasizes a balanced integration of multiple disciplines, reliable, and stable comprehensive technology. Practitioners of various types will optimize from various aspects such as software and hardware equipment:
(1) Automation laboratories are developing towards high throughput
With the rapid development of the life sciences industry, the laboratory field is constantly innovating while also facing numerous challenges. For example, there is an increasing demand for massive real-time data and advanced technical methods in areas such as drug research and development and screening, gene sequencing; clinical diagnosis requires faster and more accurate test results; and laboratories are paying increasing attention to personnel safety.
In the future, fully automated sample processing and testing platforms with high intelligence and high throughput are expected to gradually replace traditional automated pipetting platforms, nucleic acid purifiers, amplifiers, and other standardized and integrated automation equipment that have limited capabilities. Laboratories are rapidly developing towards high throughput, large-scale, and comprehensive overall automation.
(2) Laboratory automation and informatization will drive laboratory solutions towards intelligent development
Laboratory automation and informatization include technologies and products related to laboratory equipment IoT management, laboratory automation workflows, automated testing and analysis, laboratory data management, and automated laboratory report processing. The related applications of laboratory automation and informatization will provide practical and effective solutions for industry users in fields such as life sciences, gene sequencing, clinical diagnosis, biomedicine, cell and molecular biology, drug screening, food, environment, chemical engineering, healthcare and inspection quarantine, education and research.
To meet the ever-growing needs of laboratory scientific research, the laboratory information management platform will continuously provide innovative application products and one-stop solutions for laboratory users. It promotes the intelligent development of laboratories in the future and aids in laboratory technology and R&D innovation.
(3) Automation laboratories will develop into more application domains
With the continuous development of testing technologies and processes in laboratories in recent years, especially the rapid popularization of a series of application scenarios centered on nucleic acid testing, such as non-invasive prenatal testing, tumor gene mutation testing, early tumor screening, precision medicine, and pathogen detection, large-scale testing demands have driven the rapid development of laboratory automation in the field of nucleic acid testing. However, since precision medicine requires multi-omics coordination, a large number of individual precision medicine needs will give rise to more automation in the field of multi-omics testing.
As research and clinical institutions increasingly recognize the advantages of multi-omics laboratory automation, it is expected that in the future, genomic sequencing will be integrated with transcriptomics, proteomics, metabolomics, and other fields for large-scale automation.
