The Rise of Domestic Chemiluminescence Platforms in China's Thyroid Function Testing Market: Insights from NCCL EQA Data (2019–2024)
Roche
Oncology Drug Research, Development, and Manufacturing
Author of this article: Red Brick Cheese
During the Spring and Autumn period and the Warring States period in ancient China, the central plains were contested by various powerful states, giving rise to the famous "Five Hegemons" and "Seven Powers." The chemiluminescence testing market, as the main battlefield of China's IVD industry, has also seen remarkable growth in recent years, with a hundred schools of thought contending and invisible smoke spreading — led by the entry of the four major international companies into China, followed by the rise of the five domestic dragons. In the broader field of chemiluminescence testing,Thyroid function is the primary indicator for diagnosing thyroid-related endocrine diseases and also a representative test item using the chemiluminescence method.Its market position and share are pivotal, accounting for approximately 20% of the overall chemiluminescence market. With the recent announcement of the winning prices and grouped brands for the procurement of thyroid function markers in twenty-eight provinces, the landscape of the thyroid function segment in the chemiluminescence market has been largely determined.
As the ancient saying goes, "History is a mirror that reflects the rise and fall." How has today's pattern formed step by step, and what interesting phenomena and inspirations can we discover from it? The author has compiled the data on the number of NCCL EQA users for TSH, a representative project of thyroid function over the past six years (using the data from the second round each year), and provided a brief analysis to share with readers (although there is another parameter, the coefficient of variation CV, it is significantly affected by the number of users in each group and is not suitable for comparison).
Let's first look at the thyroid function data horizontally.
Number of Users for the NCCL EQA TSH Project of Major Luminescence Brands (2019-2024)
1) Six years ago, the undisputed leader in the thyroid function and tumor marker market was the "Big Four" of imported brands, among which Roche stood in a class of its own; meanwhile, the "Five Little Dragons" of Chinese production had yet to gain significant influence, with NCCL EQA participants numbering less than a hundred—only Mindray approached nearly 100.
2) Over time, each year sees over a hundred users of China-produced "Five Little Dragons," while Roche's leading position among the "Big Four" imported brands becomes increasingly solid. Beckman also gradually widens the gap in user numbers with the other two imported brands, forming its own tier.
3) By 2023, domestic brands began to rise, and the number of Mindray users had started to surpass the latter two of the imported "Big Four," ranking third among all brands, with a strong growth momentum;
4) By 2024, the number of Mindray thyroid function users will surpass Beckman again, ranking second. The number of Snibe users will also start to approach Abbott, the last among the imported brands. Meanwhile, although Maccura and YHLO have exceeded 100 users since 2023, their numbers are still more than double behind the other seven companies and ten times less than Roche.
Look at the thyroid function data longitudinally again
1) The number of Roche's thyroid function users has maintained positive growth over the past six years, which is not easy. However, after a significant increase from 2019 to 2020, the growth rate has become increasingly slow.
2) Abbott has also experienced a gradual slowdown in growth since 2021, and even began to show negative growth in 2024.
3) Beckman's growth has also almost stagnated since 2021;
4) The number of Siemens users has been fluctuating and decreasing since 2020, with slight negative growth in 2021 and 2023;
5) The number of users of the five小龙 (小龙 could be a placeholder for specific brands or types, but without more context it's challenging to translate accurately) thyroid function products produced in China has been steadily and rapidly increasing over the past six years, similar to the expansion progress of the five-brand chemiluminescence market. In particular, Mindray achieved a positive growth rate of 35% during 2023-2024, even starting from a high base of over 500 institutions in 2023.
Looking at the changes in market share
1) In 2019, the combined market share of the five major domestic thyroid function testing products accounted for only 10% of the overall market, with YHLO's market share being close to zero.
2) However, by 2024, the combined market share of China's "Top Five" in thyroid function testing reaches 37%, which is still less than half.
3) From the perspective of a single brand, in 2019, the market share of Mindray, the Chinese brand with the highest market share in China, was only one-tenth that of Roche, the brand with the highest imported market share, and one-third that of Abbott, the brand with the lowest imported market share.
4) By 2024, the domestically produced brand with the highest market share will still be Mindray, but at this time, Mindray's market share will reach 15%, nearly half of the leading imported brand Roche, surpassing the market shares of the other three imported brands. At this point, YHLO, which has the smallest market share among the domestic "Five Dragons," will still account for one-tenth of Roche’s market share and one-third of Siemens' and Abbott's. The situation will resemble that of Mindray six years ago.
Summary
1) The revolution has not yet succeeded, comrades still need to work hard: Although mainstream Chinese brands have spent six years securing a place for themselves in China's market for thyroid function testing, their combined market share still does not match that of the top four imported brands.
2) As a representative of imported brands, Roche's ability to maintain its leading position is due to its exceptional strengths. For domestically produced brands in China to achieve full import substitution, they must look beyond price advantages and humbly learn from top imported brands regarding product quality and service quality, striving for continuous improvement.
3）The rise of Chinese brands cannot be separated from the support of end users, so as decision-makers in hospitals, end users should not blindly favor imported products.In China, top hospitals such as Peking Union Medical College Hospital, West China Hospital, Ruijin Hospital, and Tongji Hospital have started to use domestically produced thyroid function testing products. This is not due to a temporary surge of patriotism but rather because these hospitals' laboratories have conducted systematic comparative validations of domestic products and witnessed their progress and maturity.
4) The reason why imported brands had a good reputation a few years ago was that there were no domestically produced products with reliable quality to compete with them at that time. However, as leading domestic brands have fully utilized their late-mover advantages in recent years, they have surpassed imports in the performance of some reagent items. For example, the stability of TRAb reagents in thyroid function tests, the sensitivity of Tg for postoperative monitoring of cancer patients, and the normal rate of FT4 test results in health checkups. Meanwhile, some shortcomings of imported brands have gradually become apparent when compared with domestic products, such as weak anti-biotin interference capability, short shelf life of reagents upon arrival at hospitals, untimely instrument after-sales service, and poor heat dissipation performance, among others.
References
[1] C-07-01-2019 Endocrine Proficiency Testing Report -(2019-2)
[2] C-07-01-2020 Endocrine Proficiency Testing Report-(2020-2)
[3] C-07-01-2021 Endocrinology Proficiency Testing Report-(2021-2)
[4] C-07-01-2022 Endocrinology Proficiency Testing Report-(2022-2)
[5] C-07-01-2023 Endocrinology Proficiency Testing Report -(2023-2)
[6] C-07-01-2024 Endocrinology Proficiency Testing Report-(2024-2)
