The Dilemma of Early Cancer Screening

Healthcare Author: Siren Chen Editor: Luke Jul 21, 2022 11:23 AM (GMT+8)

Looking through the industry report on forms of early cancer screening available on the market, you will find that the NGS is a technology that cannot be bypassed. Is it really the best choice for an early cancer screening company?

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1. Definition of early screening

According to the WHO, early cancer screening refers to detecting warning signs in apparently healthy individuals before symptoms appear. However, how to define a ‘healthy’ population and the meaning of the word ‘early’ both need to be further clarified. According to our interview with an industry-related expert, we can clarify that early screening is a service provided for healthy high-risk populations and that ‘early’ means testing for Stage 0, Stage I cancer and pre-cancer changes in the body.

2. Meaning of early cancer screening

Cancer has become one of the most common diseases in China and is the leading cause of death. As stressed in the Healthy China Action Plan (2019-2030) issued by National Health Commission, there are huge unmet needs among cancer patients, and they are bearing a heavy and disproportionate burden. According to the Union for International Cancer Control (UICC), cancer continues to bring significant losses to patients and health systems. It is estimated that the annual economic cost of cancer may exceed USD 1.2 trillion. This means that the healthcare costs attributed to cancer are higher than all 15 leading causes of death in the world, putting great pressure on the health system. The investment in cancer control could reduce the global economic burden of cancer.

However, in some low- and middle-income countries (LMICs), there are misconceptions about cancer control. The investments are always labelled ‘expensive and complicated’, which reduces the willingness of LMICs’ government to invest in prevention. High-income countries spend 5 to 10 times more than LMICs on cancer control per capita. It is predicted that the implementation of cancer control services such as early cancer detection could yield an economic benefit of over USD 400 billion and save 2.4 million to 3.7 million lives every year, particularly for LMICs. China has entered the fast track of innovative drug research and development since 2015, especially in the R&D of anti-cancer drugs. However, there is still a certain gap in the investment in cancer detection between China and developed countries. Only improved treatment, together with early detection, can better reduce the burden of cancer and protect people's health.

3. Market size and trends

China is one of the countries with the fastest aging population growth in the world. In the foreseeable future, population aging will continue to be a major social characteristic of China. The National Bureau of statistics released China's economic data for 2021, by the end of 2021, the population aged 60 and above exceeded 267 million, accounting for 18.9% of the national population and the number will expand to 300 million by 2025. If the population size remains stable or decreases, but the population aging continues to increase, the trend of a rising cancer burden in China is likely to remain in place. In the meantime, China is undergoing a transition of the cancer profile, with an increased incidence of lung, colorectal, breast and prostate cancer. Progress in cancer prevention and active response to population aging in the US spawned many listed companies specializing in the detection of early-stage cancers such as Exact Science and Grail. The same wind has blown over China and brought a massive explosion of investment.

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*Exact Science launched the first stool DNA test for colorectal cancer in 2014 and the Grail was listed on NASDAQ in 2020.

4. The reality and the comparison of main technologies

4.1 Industrial chain of early cancer screening

Early cancer screening belongs to the subdivision of molecular diagnosis. Its upstream is the sequencing equipment manufacturers represented by Illumina, Thermo Fisher, MGI and so on. The midstream is the early screening service provider including Anpac Bio (Chinese: 安派科生物), Ammunition Life Technology (Chinese: 艾米森生物科技), Exact Science, Grial and New Horizon Health (Chinese: 诺辉健康). Downstream are end-users like laboratory-developed test (LDT), which is also the service provider, hospitals, physical examination centers and independent clinical laboratories (ICL).

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4.2 Challenges early cancer screening faces

Even though early cancer screening has attracted a lot of attention and investment, most of the popular early screening products in China are essentially the application of companion diagnostics. EqualOcean was told by the stakeholders in this area: “Even the so-called ‘first certificate’ of cancer screening, ColoClear, produced by New Horizon Health (Chinese: 诺辉健康), was not a purely prospective research study. The study involved more than 4000 samples in total and about 400 of them were detected with colon cancer, however, the incidence rate per 100,000 of colorectal cancer in both sexes is 19.7, which means its data have been condensed and the result is not objective”. One of the reasons is that a prospective research study is time-consuming and costly compared with a case-control study.

Despite the above challenges, promoting activities are needed. Education and community outreach are not enough. “It is obvious most people in China are not aware of the importance of cancer screening.” said one of the investors focusing on the healthcare industry.

4.3 The comparison of different approaches

Most cancer screening products are based on next-generation sequencing (NGS) and polymerase chain reaction (PCR) platforms, as also some other niche approaches like using biophysical properties to screen for cancer.

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The market believes that NGS will replace PCR in the future. However, considering the cost, convenience of operation and coverage of the equipment, we hold the view that PCR will be the mainstream screening approach.

At present, the coverage of imported or domestic sequencers in hospitals is relatively low. The screening approach relying on these platforms will be limited by their distribution and cannot be widely used. And the usage of the NGS platform will be restrained by the upstream manufacturers, which will lead to a high cost. Due to the difficulty in entering the hospital, the profit model of most NGS technology is LDT. The high cost makes it impossible for IVD products to be centralized in procurement. In the meantime, the LDT model will not be covered by national health insurance. Therefore, according to the current situation, at least in the Chinese Mainland, early cancer screening based on the NGS platform has basically proved to be unworkable.

It goes without saying that the price of NGS will be reduced and the platform will be more popular in the future. However, there are two conditions NGS need to achieve if NGS wants to substitute for PCR. First is cost control, which is on the same order of magnitude as PCR. Second, NGS’s platform coverage can be as much as PCR. Up to now, PCR is available in more than 20000 hospitals. It would be seen that NGS still has a long way to go.

Ammunition, an early cancer screening company that focuses on PCR technology, believes that using a simple technique to make high-end products is bound to make more technological improvements and breakthroughs.

Zhang Lianglu, the CEO of Ammunition, introduced that ‘early, accuracy, convenience and affordable’ constitute the competitive elements of their products.

Not come singly but in pairs, Anpac Bio (Chinese: 安派科生物), a company that developed Cancer Differentiation Analysis (CDA) technology summary its technology advantages as ’early, multiple, accuracy and quickly’. They also emphasize that their cost is very competitive as their technology is self-owned. Anpac is positive about the application for a registration certificate and has already established a sales network, including cooperation with some local governments, and large purchase orders will increase to a certain extent in the future.

Up to now, the benefits and prospects of early cancer screening are significant. However, problems in the real-world like user education, health insurance coverage and the difficulty of entering a hospital are faced by all players. We believe that enterprises with strong access to hospitals and competitive prices will occupy the market fast.