It has been almost three years since the coronavirus outbreak. In the post-Covid era, PCR tests and antigen reagents have become part of daily essentials. The increasing demand for PCR tests drives the development of IVD in China. What is IVD? How to explain its popularity in China over the past two or three years? You will find all the answers above in this article.
In vitro diagnostics (IVDs) are tests done on samples such as blood or tissues taken from the human body. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. IVDs may also be used in precision medicine to identify patients likely to benefit from specific treatments or therapies. In vitro diagnostics include next-generation sequencing tests, which scan a person's DNA to detect genomic variations.
IVD can be divided into six parts, immunodiagnosis, biochemical diagnosis, point-of-care testing, molecular diagnosis, microbiological diagnosis and blood diagnosis.
Immunodiagnosis refers to the use of antibody assays, immunocytochemistry, detection of lymphocyte markers, and other strategies to diagnose autoimmune diseases, immunodeficiencies, infections, or malignancies. Biochemical diagnosis is a service that measures biochemical indicators such as enzymes, lipids, sugars, protein and non-protein nitrogen, and inorganic elements in the human body based on various biochemical reactions outside the human body to obtain clinical diagnostic information and determine human diseases. Point-of-care testing entails carrying out a diagnostic test outside of a laboratory that yields a prompt and accurate response, assisting in identifying or managing acute infections and chronic disorders. Molecular diagnosis is the process of identifying a disease by studying molecules, such as proteins, DNA, and RNA, in a tissue or fluid. Molecular diagnosis can also be used for prenatal diagnosis to detect whether the fetus has genetic disorders or not. Microbiological diagnosis focuses on detecting microorganisms in the sample, including bacteria, fungi, chlamydia, mycoplasmas, spirochetes, viruses, etc. Blood diagnosis refers to tests on blood cells, hemostasis, urine, pleural and cerebral fluid to diagnose various diseases of the blood, nervous, digestive and reproductive systems.
According to Frost & Sullivan, China's IVD market size has grown from over CNY 45 billion (USD 6.6 billion) in 2016 to over CNY 124 billion (USD 18.3 billion) in 2021. The market size is expected to attain CNY 195.7 billion (USD 28.9 billion) in 2024. With the rapid growth of the worth’s population and the high incidence of various infectious and chronic diseases, the IVD market size in China will continue to rise rapidly in the future.
Immunodiagnosis is the largest part of IVD in China, representing 38% of the total market size. Biochemical diagnosis ranks second, with 19% of the total market size. With the outbreak of the Covid-19 pandemic, the demand for testing has increased exponentially. Molecular diagnosis has become the sub-sector with the fastest growth rate in IVD in the past two years.
The main techniques of molecular diagnosis include polymerase chain reaction (PCR), gene sequencing, fluorescence in situ hybridization (FISH), DNA blotting, single nucleotide polymorphism (SNP), ligase chain reaction (LCR) and gene chip.
According to public resources, the gene sequencing industry has experienced the fastest growth in Asian countries. China and India are the fastest growing countries in this industry, with a market growth rate of over 20%. Up to now, there are four generations of gene sequencing technologies in the world. The first generation is Sanger sequencing, the second generation is High Throughput Sequencing, the third is Single-molecule fluorescence sequencing, and the fourth is Nanopore gene sequencing. At present, Oxford Nanopore Technologies (Chinese: 牛津纳米孔) and Chinese firm Qitan Technology (Chinese: 齐碳科技) are the only two companies that possess this technology and put it into commercialization in the world. The Nanopore gene sequencing that Qitan Technology focuses on has advantages of long read length, fast speed, real-time sequencing, flexibility and portability.
The application of gene sequencing focuses on cancer diagnosis, Non-invasive prenatal testing (NIPT) and genetic testing. The maturest application of genet sequencing technology in clinical scenarios is NIPT. NIPT is a method of determining the risk that the fetus will be born with specific genetic abnormalities. This testing analyzes small fragments (cell-free DNA or cfDNA) circulating in a pregnant woman's blood.
Celula (Chinese: 赛雷纳), a Chinese company focusing on reproductive health, is dedicated to providing complete and cost-effective IVD products for patients. The company's AssuriT-A technology is the only targeted NIPT technology that has completed clinical trials for product registration in China. Another NIPT technology, AssuriT-One, is suitable for combined screening of chromosomal and monogenic disorders. The company's Sparrow Flow Cytometer, which is easy to operate and popularize, aims to help primary health care solve the barriers to conduct significant disease testing. The founder of Celula, Dr. Zhang Haichuan told EqualOcean why Celula wanted to develop and produce flow cytometers. "At first, our company had the R&D foundation for the products. Secondly, in China, flow cytometers are currently monopolized by foreign brands and sold at a very high price, and the operation is unsuitable for Chinese hospitals. What's more, only the laboratory departments of tertiary hospitals can afford to use foreign products. Lastly, although there are over 10,000 departments of obstetrics and gynecology in China, most of them do not have this kind of product, so the majority of the Chinese infertility population does not get accurate analysis." According to the reasons above, Celula decided to produce China's local flow cytometers to meet the need of Chinese hospitals and patients.
Upstream companies in IVD industry provide IVD raw materials, including raw materials for biological products, fine chemicals, and precision electronic components. The main raw materials for in vitro diagnostics are enzymes, antigens and antibodies.
The production of raw materials remains a significant difficulty for the IVD industry in China. The quality of raw materials plays an essential role in the capacity and precision of diagnostic reagents. Chinese companies prefer to buy raw materials from foreign companies rather than local ones because the upper provides raw materials with higher and more durable quality. What's more, foreign companies represent 90% of China's market share in this field. But when the Covid-19 pandemic arrived, the price of imported raw materials increased rapidly and it took more time to transport these materials into the country. Besides, as diagnostics reagents were a high-profit sector in the past, the manufacturers didn't pay much attention to the cost. But now, under the context of coronavirus, as Chinese companies can provide these materials at lower cost and transport is more convenient in the country, Chinese IVD companies captured more attention than foreign enterprises in the past two or three years.
According to the website Vbdata, in 2021, 12 companies in the sector of IVD raw materials completed 15 financing rounds, with a total amount of over CNY 3.4 billion (USD 501 million), including 10 financing events worth over CNY 100 million (USD 14.7 million).
Midstream companies in IVD industry are those which provide IVD equipment and reagents. The leading Chinese companies in this sector are such as Mindray (Chinese: 迈瑞医疗), Autobio (Chinese: 安图生物), Maccura Biotechnology (Chinese: 迈克生物), KHB (Chinese: 科华生物) and Wondfo Biotech (Chinese: 万孚生物).
Founded in 1991, Mindray is a global medical instrumentation developer, manufacturer, and marketer. It designs and produces medical equipment and accessories for human and veterinary use. The company is organized into three key business lines: Patient Monitoring & Life Support, In-Vitro Diagnostic Products, and Medical Imaging Systems. The company's IVD business line represents 33.43% of its total business, with CNY 8.4 billion (USD 1.2 billion) in 2021.
Founded in 1998, Autobio specializes in R & D, production, marketing and service of clinical diagnostic products, mainly covering immunoassay, microbiology and biochemistry. Meanwhile, Autobio is also actively planning developments in molecular diagnostics and provides comprehensive solutions for medical laboratories. The company's total revenue accounted for CNY 3.8 billion (USD 559 million) in 2021, an increase of 26.45% than in the previous year.
Founded in 1994, Maccura Biotechnology focuses on the research, manufacture, marketing, and services of IVD products. The company's products have covered platforms of biochemistry, immunoassay, POCT, hematology, molecular diagnosis and pathology and could meet more than 90% requirements of medical labs with the product integration. Maccura became the first Chinese enterprise member of IFCC in 2010, and was certified by CNAS in 2013. The company's revenue accounted for nearly CNY 4 billion (USD 589 million) in 2021.
Founded in 1981, KHB is a company that boasts a full line of medical diagnostic products. Focusing on immune diagnosis, biochemical diagnosis, molecular diagnosis and POCT, KHB has built two R&D technology platforms for clinical IVD reagents and whole automatic analyzers to progressively promote the serial development and integration of reagents and instruments. The company's total revenue worth nearly CNY 4.3 billion (USD 634 million) in 2021, 2.71% higher than in the previous year.
Founded in 1992, Wondfo is a fast-growing biotechnology company in China and mainly focuses on rapid diagnostics in China. Based on the above technology platforms, Wondfo has extended the product lines to the rapid identification of cardiovascular diseases, inflammation, tumor, infectious diseases, drug abuse, pregnancy, etc. The company's revenue accounted for nearly CNY 3.4 billion (USD 501 million) in 2021, an increase of 19.57% than in the previous year.
The downstream IVD industry includes hospitals, Medical Examination Centers, Centers for Disease Control and Prevention (CDC), independent third-party laboratories, blood banks and other health facilities. Hospitals are the largest demand side of the downstream IVD industry, representing 89% of the total market size. Independent third-party laboratories account for around 1%, Medical Examination Centers account for 4%, and other medical institutions represent 6%.
Although China's IVD industry has grown rapidly in the past five years, the equipment in the upstream supply chains have been monopolized by foreign manufacturers. For example, Illumina and Thermo Fisher have a high market share and have formed a particular monopoly position in China's gene sequencing industry. Qitan Technology told EqualOcean that local Chinese companies in gene sequencing should make efforts in the following areas to enhance their competitiveness and break this foreign monopoly situation. Firstly, continue to invest in R&D. Build a multidisciplinary R&D team to maintain the research and innovation capability. Secondly, insist on independent intellectual property rights. Thirdly, confirm that upstream supply chains are autonomous and controllable. "China's gene sequencing era has opened. Currently, biological data security has risen to the level of national strategy, and domestic sequencers are more capable of guaranteeing the information security of genetic data", an industry insider added.
There is no doubt that IVD is a high-growth industry in China. But in order to maintain the industry's competitiveness and vitality, Chinese companies should continuously improve their R&D capacities to produce more domestic equipment and to break the foreign monopoly in the future.