How Far Is Cancer Early Screening? An Emerging Industry at the Crossroads of Technology, Regulation, and Commercialization

Early cancer screening still appears shrouded in mystery, yet its contours become clearer as we draw nearer.

Over the past two years, the early-stage cancer screening market has witnessed alternating surges of substantial primary-market financing and high valuations in the secondary market. As cancer assumes an increasingly prominent position in the spectrum of human diseases, driven by technological leaps and regulatory innovations, the early cancer screening industry has demonstrated strong capital attraction.

Among the 16 cancer early screening companies that secured financing in 2020, 11 raised over RMB 100 million. Of these, five completed Series B financings exceeding RMB 100 million, and two completed Series C financings exceeding RMB 100 million. In July 2020, New Horizon Health completed its final pre-IPO funding round. In December, Genetron Health closed the largest single transaction of the year, securing RMB 1 billion in Series B financing. On the first working day after the Lunar New Year holiday, New Horizon Health, the first publicly listed company specializing in cancer early screening, debuted on the Hong Kong Stock Exchange. Its share price surged by 215% on the first day, bringing its total market capitalization to HKD 35.1 billion, an increase of HKD 24 billion. Within six months, New Horizon Health’s market value grew sixfold. According to its recently released 2020 annual financial report, Burning Rock Biotech’s annual R&D expenditure amounted to RMB 263.9 million, representing a year-on-year increase of 68.2%. Notably, multi-cancer early detection and screening, as one of Burning Rock Biotech’s core R&D focuses, achieved significant research breakthroughs in 2020.

Born in the United States in the 1950s, cancer early screening has witnessed its most rapid development in history in recent years. In a sense, the technical capabilities of Chinese cancer early screening companies have caught up with, and even surpassed, those of leading global enterprises. Based solely on published data, the early screening products from New Horizon Health, Genetron Health, and Huirui Gene have all achieved at least comparable levels of sensitivity and specificity to their overseas counterparts. In terms of biomarker selection, new targets and multi-omics-based cancer early screening products have successively entered clinical trials. In the highly anticipated exploration of pan-cancer early screening, companies such as Singlera Genomics and Burning Rock Biotech are also advancing globally leading prospective clinical studies. Although still in the early stages of commercial implementation, existing cancer early screening products have already become important tools for identifying target patients in multiple clinical scenarios.

On the other side of the coin, early cancer screening companies are also facing growing pains.

In terms of technical pathways, even single-cancer early screening has only just met the requirements for clinical application, while pan-cancer early screening requires more extensive clinical validation. Currently, ctDNA is the most widely adopted and fastest-advancing approach among various tumor early screening technologies; however, only liver cancer and colorectal cancer have achieved true commercial implementation.

In terms of commercialization, only a few companies have initiated market exploration. Even among the leading domestic early-screening enterprises, current revenue scales remain modest. According to the latest annual reports, New Horizon Health generated RMB 80 million in revenue for the full year 2020; Burning Rock Biotech reported RMB 429 million, while Genetron Health’s revenue for the first three quarters of 2020 approached RMB 300 million. At present, these three industry leaders are still in the exploratory phase of developing their profitability models.

As of the data disclosure date, New Horizon Health covered more than 300 hospitals, Genetron Health over 500, and Burning Rock Biotech approximately 600. If variations in hospital penetration rates are taken into account, the actual market penetration of early cancer screening products in hospitals may be even lower. Nevertheless, this does not imply that early cancer screening is a difficult business to pursue. In the United States, for instance, Exact Sciences has achieved remarkable success. In 2020, Cologuard, its flagship colorectal cancer early screening product, generated $1.256 billion in revenue. The commercial success of Cologuard was not achieved overnight; innovation is akin to a relay race. Once market enthusiasm is ignited by technological advancements and promising prospects, companies must focus on cultivating an appropriate commercial ecosystem.

A realistic dilemma is that, compared to other application scenarios of precision medicine, the endgame for early cancer screening appears more difficult to predict. Most novel tests will transition from Laboratory Developed Tests (LDTs) to In Vitro Diagnostics (IVDs). Judging by the product strategies of companies with relatively faster commercialization progress, such as New Horizon Health, Genetron Health, and Kangpu Bio, the ultimate deployment setting for early cancer screening will most likely remain within hospitals. However, given the high dispersion of the broad user base for early-stage tumor detection, settings such as health checkup centers, pharmacies, and even home-based testing may not merely be stopgap measures for early market expansion but could also represent future deployment endpoints. Nevertheless, regardless of whether these endpoints are clear or ambiguous, key questions remain unanswered: When will they materialize? And how will they be implemented?

In fact, from the moment early cancer screening companies make their product technology path choices, many future strategies are already determined. By logically working backward, we find that some approaches have gradually become clear. To summarize, there are three key strategies, distributed by importance as follows:

First, hospital-based strategies that prioritize clinical evidence. This is currently the top priority for companies in the early cancer screening sector, with nearly all market participants actively engaged.

Second, prioritize out-of-hospital strategies focused on expanding capabilities. For companies whose products have already generated substantial data, capturing market share in out-of-hospital channels such as health checkup centers and retail pharmacies serves as a critical source of cash flow. In this process, however, they must compete with consumer-grade products that have long established their presence in these markets.

Third, an online strategy focused on digital capabilities. As an incremental market that transcends the traditional in-hospital and out-of-hospital dichotomy, an increasing number of genetic testing service providers are expanding into the online space; however, clear tactical details have yet to be established in this talent-intensive sector.

A deeper analysis of the R&D expenditure structure of early cancer screening companies reveals that the majority is allocated to acquiring clinical evidence. To a certain extent, the ability to generate clinical evidence has become a key dimension for these companies in building competitive barriers. When promoting their heavily funded research achievements, they often emphasize uniqueness and forward-looking nature. This is because, although not publicly disclosed, most early cancer screening companies have chosen hospital-based deployment, where demand density is higher, and clinical evidence serves as the essential prerequisite for market access into hospitals.

For early cancer screening companies, 2018 was an unavoidable milestone, as most of them launched large-scale prospective clinical studies that year, thereby establishing the fundamental paradigm for early screening products.

Since 2018, Huirui Gene, in collaboration with the National Center for Liver Cancer and Nanfang Hospital of Southern Medical University in Guangzhou, has jointly launched PreCar, the world’s first prospective clinical study on early screening for liver cancer involving a cohort of 10,000 participants. At the 2019 CSCO Annual Meeting, the initial phase results of PreCar were announced, demonstrating that Huirui Gene could detect very early-stage liver cancer 6 to 12 months earlier than the gold standard, thereby achieving clinically significant early screening for liver cancer. At the following year’s CSCO Annual Meeting, Huirui Gene presented findings from the expanded PreCar study with over 10,000 participants, indicating that the enlargement of the cohort and the increase in follow-up visits did not compromise the stability of the screening performance.

Subsequently, Huirui Gene launched its first liver cancer early screening product, Laisining, based on the PreCar study. According to Huirui Gene’s roadmap for early screening and diagnosis of multiple tumor types, the company plans to deliver research findings on early screening and diagnosis for 5 to 8 high-risk, high-incidence cancers in China within the next 3–5 years, and to commercialize these achievements.

For a long time, PreCar has been the most important label for He Rui Gene's early liver cancer screening business.

Also at the 2020 CSCO Annual Meeting, New Horizon Health released the results of China’s first prospective, large-scale, multicenter registrational clinical trial for early cancer screening (Clear-C). The Clear-C trial was officially launched in September 2018 and lasted 16 months, enrolling nearly 6,000 participants, with 4,758 cases ultimately included in the statistical analysis. The resulting clinical data served as a key basis for the National Medical Products Administration’s review and approval of the market launch of “Changweiqing.” According to media reports, New Horizon Health invested over RMB 100 million in research and development for the Clear-C trial.

In January 2021, Changweiqing was included in China’s first national-level cancer screening guideline. The Chinese Journal of Oncology published the “Guidelines for Colorectal Cancer Screening and Early Diagnosis and Treatment in China (2020, Beijing),” which explicitly recommends multi-target stool FIT-DNA combined testing as one of the important methods for early screening of colorectal cancer.

Furthermore, Burning Rock Dx launched a prospective clinical study on early lung cancer screening, named the “Bell Project,” in 2018, and has since enrolled nearly 10,000 participants.

From large-scale prospective studies to product registration certificates, and further to clinical guidelines, Zhu Yeqing, CEO of New Horizon Health, stated that the phased construction plan for the commercial ecosystem of Colotect is just getting started. This path, which has already revealed some promising prospects, has at least instilled confidence in peers and formed a trend: an increasing number of companies are launching various forms of large-cohort population validations in China, covering a broader range of cancer types. For instance, Geneseeq has initiated the Jinling Cohort Study Special Project, offering 100,000 free early cancer screening tests, while Juhua Biotechnology is conducting a multicenter prospective study on gene methylation for gynecological tumors.

In March 2019, a prospective cohort study conducted jointly by Genetron Health and the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences, involving 331 asymptomatic HBV carriers, was published in the Proceedings of the National Academy of Sciences (PNAS). This remains the only prospective study published in China in the field of early liver cancer screening. In February 2021, Genetron Health announced that its findings on early liver cancer screening had been cited in the “Guidelines for Patients with Primary Liver Cancer” issued by the China Anti-Cancer Association. Furthermore, Genetron Health is currently conducting a multicenter prospective study involving 4,500 individuals who are positive for hepatitis B surface antigen (HBsAg).

Burning Rock Biotech began its strategic deployment in early cancer screening in 2016, gradually expanding from lung cancer to pan-cancer screening. A significant milestone in this transition was the initiation of a large-scale prospective cohort study. In May 2020, Burning Rock Biotech announced a collaboration with multiple clinical research institutions to officially launch “PREDICT,” China’s first prospective pan-cancer early screening study involving more than 10,000 participants. The study is expected to enroll over 14,000 subjects and cover nine cancer types (with the addition of gastric cancer, cholangiocarcinoma, and head and neck cancer), marking the formal entry of Burning Rock Biotech’s pan-cancer early screening program into the clinical validation phase.

In July of the same year, Kunyuan Genomics published the results of a large-scale natural population cohort study on its product, PanSeer®, in the prestigious international journal Nature Communications. This made Kunyuan Genomics the third company globally, following GRAIL and Thrive Earlier Detection, to release large-scale clinical data on pan-cancer early screening. The data demonstrated that the PanSeer® assay can detect trace ctDNA methylation signals associated with five types of cancer—lung, liver, gastric, esophageal, and colorectal cancers—up to four years earlier than clinical diagnosis.

Although many details of clinical trials for early cancer screening still need to be refined under current conditions, the unprecedented emphasis placed on clinical evidence itself represents a disruption of past practices and is sufficient to redefine the future of early cancer screening.

Many people believe that health checkup institutions serve as a springboard for early cancer screening products to enter the market. First, the concept of early cancer screening aligns closely with the core mission of health management in checkup institutions, creating synergies that offer more options for both parties. Second, compared with the multiple barriers faced when entering medical institutions—ranging from regulatory approvals and catalog inclusion to procurement processes—the threshold for checkup institutions is relatively low, allowing most early cancer screening products to gain access with minimal effort. Third, compared with highly fragmented retail channels, checkup institutions concentrate a higher density of potential users for early cancer screening.

New Horizon Health, a veteran in the field, began partnering with health checkup providers in 2015 to promote its colorectal cancer screening products. By the end of June 2020, the company had reached 233 health checkup centers and branches, establishing a strong relationship with its key partner, iKang Healthcare Group. According to New Horizon Health’s prospectus, revenue from the health checkup channel accounted for more than half of its total revenue in the years leading up to its IPO. Similarly, Genetron Health has partnered with iKang Healthcare Group to promote and provide early liver cancer screening services across China.

However, an industry practitioner told VCBeat that because product pricing significantly exceeds the average transaction value of routine health checkups, early cancer screening companies are in a highly disadvantaged position when collaborating with health checkup channels, and kickback-driven sales practices are not uncommon. “In reality, there are many early cancer screening products seeking entry into health checkup institutions, with serious homogenization; brand competition in this channel has become extremely intense.”

It is estimated that from 2011 to 2018, the average transaction value per customer for health checkups in China increased from RMB 104.36 to RMB 267.93, representing a compound annual growth rate (CAGR) of 14.42%. Among these, private health examination institutions had slightly higher average transaction values than hospital-based health management centers. Taking Meinian Onehealth as an example, its average transaction value per customer was approximately RMB 606 for individual checkups and RMB 499 for group checkups in 2019. In contrast, Changweiqing is priced at RMB 1,996, while liver cancer screening products are even more expensive. For instance, Genetron Health’s GanYu is sold on internet healthcare platforms at RMB 5,000. Huirui Gene’s early liver cancer screening product is not sold directly to consumers; VCBeat has learned that its pricing ranges from RMB 3,000 to RMB 5,000.

The high pricing of early cancer screening products has long been an acknowledged Achilles’ heel in their commercialization. In response, Huirui Gene previously stated its aim to reduce the cost of early liver cancer screening to under RMB 1,000 within ten years. Zhang Jiangli of Genron Diagnostics also told the media that the company’s R&D and market strategy is focused on developing the most cost-effective early cancer screening products. “We neither blindly pursue optimal performance at high costs nor indiscriminately compromise performance for the sake of cost control. Instead, we strive to simultaneously develop top-tier multi-cancer screening products and single-cancer screening tests priced at the hundred-yuan level. This would make them affordable for the general public and, from a health economics perspective, potentially eligible for reimbursement by national medical insurance.”

However, the pain points are immediate. In China, health checkups are out-of-pocket expenses not covered by basic medical insurance, and they are rarely included in commercial health insurance plans. Even though the cost of early cancer screening is significantly lower than that of cancer treatment, checkup packages priced far above traditional examinations such as colonoscopy, CT scans, and tumor marker tests are difficult for target consumers to accept. Under market dynamics, early cancer screening products have become a dilemma for health checkup providers. Including them results in poor sales of high-priced checkup packages; excluding them raises concerns about diminished competitiveness due to a lack of distinctive individualized testing options.

How far the health screening model for early cancer detection can go, much like its endgame, remains unclear.

An increasing number of early cancer screening companies have realized that relying solely on health checkup institutions is insufficient. Leveraging the marketing networks of large pharmaceutical companies has become a frequently discussed strategy in recent times. For instance, Genetron Health has partnered with Chia Tai Tianqing to explore the liver cancer early screening market, while New Horizon Health has collaborated with AstraZeneca to promote its product Changweiqing® in public hospitals, pharmacies, and internet hospitals across mainland China, both making significant efforts to penetrate the in-hospital market. According to officially disclosed details, the AstraZeneca business unit collaborating with New Horizon Health covers a large number of gastroenterologists in China but does not have any self-marketed gastrointestinal tumor drugs. This move by New Horizon Health appears to target the extensive lower-tier in-hospital market.

However, for collaborations that are still in the signing phase, any interpretation is merely speculative. All we can do is hope that these companies, by leveraging external resources, will gradually build stable internal sales capabilities while achieving rapid growth and overtaking competitors.

Furthermore, the surge in internet-based healthcare has quietly extended to the cancer early screening industry. Among the players, Genetron Health is one of the earliest and most deeply engaged in online operations. According to its prospectus, Genetron Health established a dedicated direct sales team for early screening services, focusing on promotion to health checkup centers and corporate clients. Leveraging the extensive experience of this e-commerce team, a significant proportion of Genetron Health’s individual customers for cancer early screening services were acquired through online platforms.

In January 2021, Genetron Health Co., Ltd. signed an agreement to establish the headquarters of its internet hospital project in the Binhai-Zhongguancun Science and Technology Park within the Tianjin Economic-Technological Development Area (TEDA). Reportedly, this project will handle the operational functions of online early cancer screening services. Additionally, New Horizon Health has been directly providing its products to end consumers through internet healthcare platforms (such as Penguin Almond and Ping An Good Doctor), thereby expanding its large base of health-conscious customers.

However, when VCBeat inquired about the specific details of their internet healthcare initiatives, both FanShengZi and New Horizon Health stated that further information would be disclosed at a later date. In fact, online strategies for early cancer screening extend beyond internet hospitals to include digital marketing, an area where companies previously engaged in consumer-grade genetic testing may have greater expertise. For instance, YiGene has leveraged various online platforms to conduct patient education and consistently enhance its brand influence.

Other early cancer screening companies have chosen to meet public livelihood needs.

For a long time, the state has attached great importance to cancer screening. The Healthy China Initiative has further clarified the goals of increasing the early screening rate for key cancer types to 55% and raising the five-year cancer survival rate by 10%. On the other hand, as more than 50% of national medical expenses are reimbursed through the basic medical insurance fund, early diagnosis and treatment of cancer will significantly alleviate the payment pressure on the insurance system. Consequently, local governments have their own incentives to fund comprehensive early cancer screening programs covering high-risk populations.

Furthermore, cancer early screening products, which are still in the early stages of development, require extensive clinical data for validation. Government-funded procurement can facilitate the acquisition of a sufficiently large sample size in the short term.

On November 27, 2020, Genetron Health announced a strategic partnership with the Wuxi Municipal Government and launched the “Comprehensive Prevention and Control Project for Early Screening of Liver Cancer,” a public health initiative guided by the National Cancer Center and led by the Wuxi Municipal Government. Under this project, Genetron Health’s HCCscreen will provide testing and comprehensive prevention and control services to 150,000 individuals at high risk for liver cancer in the local area over a three-year period.

On January 8, 2021, the launch ceremony for the Colorectal Cancer and Other Major Diseases Screening Program in Hanjiang District, Yangzhou City, was held. The program will provide free screening for colorectal cancer and other major diseases to 120,000 eligible registered residents aged 40–74 across the district over a three-year period, with the first batch in 2021 targeting 40,000 individuals. Led by the Hanjiang District Government and spearheaded by the District Health Commission, the project features Genetron Health as the technical support provider, utilizing its proprietary patented methylation detection technology.

However, participating in government-led early cancer screening programs is not a foolproof strategy. First, epidemiological characteristics vary across regions; whether products optimized using sample data from one locality are applicable to other areas remains to be verified. Second, the market infrastructure required for government projects differs substantially from that of purely commercial channels, necessitating upfront capital investment in establishing sampling sites, sample processing centers, and operational teams. Third, these initiatives are highly influenced by policy directives; once phased targets are achieved, the pace of government project channels may slow down, thereby impacting corporate development.

From health checkups to clinical settings, from out-of-hospital to in-hospital environments, and from partnerships with pharmaceutical companies to integration with the internet, early cancer screening appears to be following the same trajectory as cancer genetic testing. However, it is still premature to discuss the endgame of the early cancer screening market. For companies in this sector, only by enduring the substantial capital investment required for clinical studies and the prolonged drain of low-profit commercial channels can they truly establish a business model for early cancer screening that generates positive cash flow. It will not be too late to discuss business models suitable for scaling and strengthening the early cancer screening industry at that point.