100 billion cancer early screening market: just needed, high threshold, difficult compliance

Image source @ Visual China

Text | At the forefront of entrepreneurship, the author | Lan Qi

The world's latest global cancer burden data for 2021 released by the World Health Organization's International Agency for Research on Cancer (IARC). The data shows that in 2021, 19.29 million new cancers fell globally, and 9.96 million cancer deaths fell globally in the whole year.

Professor Chen Wanqing's team from the National Cancer Center of Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences published a paper titled Cancer statistics in China and United States, 2022: profiles, trends, and determinants, predicting that in 2022, China and the United States will have about 4820000 and 2370000 new cancer cases, respectively. and 3,210,000 and 640,000 cancer deaths. This means that the number of new cancer cases in China is about twice that of the United States, but the number of deaths is about 5 times that of the United States.

Another statistic is even more shocking: on average, more than 10,000 people on the mainland are diagnosed with cancer every day, 7.5 people are diagnosed with cancer every minute, and the incidence of malignant tumors continues to rise. But in fact, nearly 80% of these people's cancer can be effectively prevented and treated through early screening.

The great significance of medicine for human beings is to treat diseases and save people. In the prevention and treatment of cancer, early detection, early diagnosis, and early treatment are the key - "early" represents the "vitality" of patients.

In recent years, from the diversified early screening and early detection technology of tumors to the transformation and application of products based on different review technologies, the cancer early screening industry is driving into the fast lane of development and has broad prospects.

01 A promising track

A few years ago, silicon valley company Theranos was notorious for its shocking scam.

The once$9 billion blood testing startup once made Silicon Valley and even the world boil: Founder Elizabeth Holmes dropped out of stanford at the age of 19, and she was going to do something that subverted traditional blood testing — reducing the price of blood testing to $2.99 once, knowing that the price on the market at that time was above $100; since then, she has constantly come out to stand for her company's innovative technology that "will eventually change the world".

Theranos declares that without a needle, just a few drops of blood can be performed in a professional medical laboratory, and up to 240 medical tests can be completed, whether it is simple blood sugar, cholesterol, or complex such as cancer.

Little is known about the beautiful founder, but the endorsement of former US Secretary of State Henry Kissinger, Oracle founder Erikson and others has made the startup one of the "Silicon Valley Star Companies".

Innovation, good stories, celebrity endorsements, high valuations – this seemingly impossible entrepreneurial story was eventually exposed as a leather bag company with fake technology and data, and was characterized by regulators as a fraudulent and embarrassing end.

But does this mean that early cancer screening is meaningless? On the contrary, early screening for cancer is of great significance and the potential of the track is enormous.

Early cancer screening is actually not a new thing, and molybdenum targets, CT, etc. are used in clinical practice for early screening of cancer. Because gastrointestinal endoscopy, biopsy and other methods are not convenient enough, such as want to do gastrointestinal endoscopy, a good top three hospital even has to start an appointment several months in advance, the examination process is not comfortable, and therefore, when it comes to cancer screening, many people's hearts are resistant.

Is there a way to say goodbye to this traditional model and achieve the purpose of early screening?

Taking lung cancer diagnosis and treatment as an example, after decades of development, the mainland has greatly improved in this field, with the continuous emergence of innovative drugs and the development of targeted therapy, lung cancer is gradually transforming into chronic diseases, the five-year survival rate of patients has been greatly improved, and many lung cancer patients have been able to "coexist with cancer" for many years.

Industry insiders introduced to the "forefront of entrepreneurship": "The core of cancer early screening is: 1, can be oriented to high-risk large groups outside the hospital; 2, gene multi-omics technology; 3, the performance of prospective large-scale multi-center clinical verification is effective, the key indicators are NPV negative predictive value (anti-leakage detection), sensitivity." There is also the ability to find precancerous lesions; 4, the early detection of high-incidence cancer, so it has great socioeconomic value; 5, the product compliance is good, the target population is convenient to use, and privacy can be protected; "

However, he also stressed: "The premise of marketing all cancer early screening products is compliance, so as to protect users from missing tests as much as possible after use." ”

From this perspective, the significance of early cancer screening is obvious. As a result, this track also gave birth to listed companies such as Nuohui Health and Burning Stone Medicine. Especially on February 18 this year, after Nuohui Health successfully landed on the Hong Kong stock market and became the "first stock of early screening for cancer in China", the attention of the industry and consumers began to increase.

"If there's an anti-tumor drug that can improve a patient's median survival by eight or ten months, it's a global sensation." However, from the perspective of early cancer screening, if early detection can be achieved, the median survival of patients is calculated in years, and even clinical cure is achieved after a few years. Zhou Jun, CEO of Herui Gene, said the importance of early cancer screening.

So we see the picture of an asymptomatic population at the front end of the cancer screening, which can be treated or prevented for cancer and precancerous lesions that are detected early, and at the back end, innovative drugs that transform cancer from a deadly disease to a chronic disease.

02 "Compliance" starts, and there is still a long way to go

The industry generally believes that China's cancer early screening market will soon reach a scale of 100 billion. A research report by Industrial Securities in 2020 predicts that the market size of China's pan-cancer early screening market will reach 52.2 billion yuan in 2035; for the detection of specific cancer species, the market space for liver cancer as an example is about 7.9 billion yuan.

A research report of Guoyuan Securities mentioned that the potential market space for liquid biopsy and early screening for cancers with high incidence of liver cancer and colorectal cancer and the rapid progress of early screening products is estimated, and it is expected that the potential market space for liver cancer and colorectal cancer early screening in 2030 is 10.65 billion yuan and 9.6 billion yuan, respectively.

Although the cancer screening track has always been optimistic, it is undeniable that if the industry wants to achieve long-term healthy and sustainable development, compliance is a problem that must be solved in front of it.

In the development process of cancer early screening, the support of national policies has pushed the industry forward rapidly.

For example, the "Cancer Prevention and Control Implementation Plan (2019-2022)" issued in 2019 mentioned that by 2022, the cancer prevention and control system will be further improved, the comprehensive prevention and control of risk factors will make phased progress, and the level of cancer screening, early diagnosis and treatment, and standardized diagnosis and treatment will be significantly improved.

Since the opening of the two sessions this year, many deputies and members have suggested early screening for cancer. The 2022 policy work report also clearly pointed out that it is necessary to "adhere to the principle of prevention and further promote the healthy China action." Gradually improve the insurance level of cardiovascular and cerebrovascular diseases, cancer and other disease prevention and treatment services. ”

As one of the important actions of healthy China, cancer prevention and treatment has always been a hot topic of concern to the two sessions. According to the latest data from the National Cancer Center, malignant tumor death has become the largest cause of death for mainland residents, and the annual medical cost of malignant tumors exceeds 220 billion.

Gu Jin, a deputy to the National People's Congress, and Wang Guiyi, a member of the National Committee of the Chinese People's Political Consultative Conference, suggested that early screening at home for cancer should be included in the certification system of medical institutions, and the people should be encouraged and guided to take the initiative to screen at home early. The results of early screening at home are recognized by medical institutions, first of all, we must strengthen the compliance and qualification certification of early screening for cancer, in order to truly play the role of the "funnel" of early screening at home.

Zhu Yeqing, CEO of Nuohui Health, a representative enterprise of the early screening industry, holds the same view on this, he believes: "Only by standardizing standards, the results of home testing have authoritative and clinical value, and ultimately have medical value, home screening can truly ensure the fundamental rights and interests of users, play the role of "funnel", and concentrate high-risk groups." ”

In fact, the State Food and Drug Administration has begun relevant compliance work as early as 2020. On November 9, 2020, China's first cancer early screening product "Chang Weiqing" was approved for marketing by the State Food and Drug Administration, and the intended use of the product is clear, which is suitable for "screening of people at high risk of colorectal cancer aged 40-74 years".

As the first cancer early screening product in China, its registration certificate clearly states the intended use of "screening". This also means that the product can be sold to hospitals or directly to C-end users through THE IVD form (in vitro diagnostic industry) compliantly, and the large-scale commercialization of cancer early screening products is about to become a reality. Prior to this, all similar companies in China provided laboratory self-test services (LDTs), whose functions were limited to auxiliary diagnosis and could not be used for early screening.

The news that Nuohui obtained the three types of certificates has also become a milestone event in this industry. At this time, the outside world also learned that prospective clinical research can provide data support for the declaration of registration certificates, which is the only way for early screening products to go from technology to commercialization.

But at the same time, due to the long time of prospective research, the large size of the subject group, and the need for at least 3-5 years of follow-up, the scale of investment is huge, which undoubtedly raises the threshold of the industry.

At this year's two sessions, Yu Jinming, a deputy to the National People's Congress, an academician of the Chinese Academy of Engineering, and president of the Shandong Provincial Cancer Hospital, also put forward suggestions for standardizing tumor diagnosis and treatment through early screening and other means. This year, he remains committed to continuing to promote the implementation of early cancer screening so that patients can obtain more standardized and effective diagnosis and treatment.

"I often say that cancer patients only have one chance to be treated, and the first time they seize it, standardize treatment, and the patient may be cured." If the first opportunity is not seized, it is difficult to succeed in developing into the middle and late stages, and then patching treatment. Therefore, grasping the standardized diagnosis and treatment is the soul of cancer treatment, in order to truly improve the efficacy of patient treatment. ”

03 Write at the end

Although only two cancer early screening products on the market have been approved for registration, it can be seen that the spring of cancer early screening has arrived. On the road of commercialization, although the first comers have invested a lot because of "opening up the wasteland", they have also enjoyed the first-mover advantage of being the first to enter the game.

In the future, as more and more high-tech joins the field of cancer early screening, this track may usher in a better stage of development, at that time, the situation of "talking about cancer" in China may be significantly improved.