The Turbulence of the IVD Market: The Road of Transformation and Breakthrough
At that time, a famous top - tier hospital in Shanghai selected a domestic semi - automatic chemiluminescence device. The agent not only provided equipment and reagents but also equipped the hospital with professional operators.
These operators could grasp the department's dynamics in real - time, including relevant information about competitors. Once they found problems with competitors, they could quickly formulate response strategies and even give away instruments for free to seize market opportunities.
However, there were also some unethical phenomena in the industry, such as data tampering. Conducting experiments in the morning, tampering with data at noon, and issuing reports in the afternoon. Such behavior seriously violated professional ethics and had a negative impact on the entire industry.
The chemiluminescence industry was a highly profitable industry at that time. There were not only cases of smuggling of imported reagents. In some underdeveloped areas, the fees for certain chemiluminescence detection technologies were even higher than those of other imported products. Due to the lower cost of domestic reagents, the profit margin was relatively large. For some marginal projects, hospitals were more inclined to choose domestic reagents considering cost and other factors. However, in mainstream projects such as tumor markers, glycated hemoglobin detection related to diabetes, thyroid function, and the detection of infectious diseases such as hepatitis B, hepatitis C, and AIDS, foreign companies, with their advanced technology and mature brands, still firmly dominated the market.
Taking the data of 2012 as an example, in the reagent market for these mainstream projects, the market share of imported brands was as high as 90%, while domestic reagents only accounted for 10%.
Take Mindray as an example. It initially started as an agent and gradually developed its own products. In the early days, the quality of its products was average. However, when developing the hematology analyzer project, it hired professional experts from Miami. One of them put forward a quality concept different from the conventional one. This concept, like a key, opened the door to the domestic and international markets for this hematology analyzer, enabling it to achieve great success.
Now, in the hematology analyzer market, Mindray can compete on an equal footing with Sysmex. Data shows that in 2012, the market share of Mindray's hematology analyzer in the domestic market was about 20%. By 2023, this figure had increased to over 50%, and it also accounted for about 20% of the global market share.
There are also some enterprises with unique development paths.
A company that entered the IVD industry more than ten years ago had a hundred salespeople but only one R & D personnel. They occupied the market by diluting biochemical products and "borrowing" other products.
At that time, the Chinese market was vast, and supervision was not yet perfect. All kinds of situations emerged in an endless stream, such as diluted products, shoddy products, and even unbranded products. However, with the passage of time, product iteration, the improvement of quality control systems, and the wide application of big - data monitoring technology, these improper means have become difficult to continue.
Another company started with large - package biochemical reagents. Through continuous technological R & D and extensive international exchanges, it has accumulated strong technical advantages in the field of specific protein detection. It cooperated with Beckman, Siemens, and other enterprises to supplement its product menu and can now compete with The Binding Site.
This company has a unique model. It has a hundred R & D personnel but only one salesperson. It adopts a "top - down" market strategy, gradually expanding its business territory from top - tier hospitals.
In the field of specific protein reagents, the company's market share was less than 3% in 2019. By 2023, it had increased to 12%, and its market share in domestic top - tier hospitals had even reached over 30%.
There is also a listed company. More than ten years ago, its products were neglected in big - city hospitals. However, surprisingly, more than 3,000 small hospitals across the country were its customers.
In the chemiluminescence track, it knew that reagents were the core of profits, so it chose to cooperate with foreign manufacturers to introduce instrument hardware, greatly shortening the product launch cycle. In the chemiluminescence market, the company's market share was almost zero in 2012. By 2023, with its unique development strategy, its market share had been successfully increased to 6%.
Competition in the Chinese market is extremely brutal, treating domestic and foreign enterprises equally. Enterprises that can take the lead in the Chinese market can step onto the world stage.
However, currently, many domestic enterprises, due to fierce competition in the domestic market, have no choice but to go overseas for development, which is regrettable. Taking the chemiluminescence market and the biochemical market as examples, in mature international markets, there may be only a few or a dozen companies competing, while in China, there are hundreds of companies competing fiercely on this battlefield, and elimination is inevitable.
Previously, China's home appliance, mobile phone, and automotive markets have also experienced similar competition and elimination processes. It is precisely these baptisms that have ultimately promoted the continuous development and progress of the industry.
Appendix Reference:
ByteDance was officially established in March 2012.
The development of Roche Diagnostics in China in 2012 is as follows:
Technology and Products: The first set of cobas?connection modules (ccm) laboratory automation system was launched in China, marking the beginning of the era of laboratory automation in China.
Market Size and Growth: In 2012, the size of the IVD market in China was approximately 19 billion yuan, with an average annual growth rate of 15% - 20%. The market showed a rapid growth trend and had huge potential. It was expected that the market size would exceed 30 billion yuan by 2015.
Enterprise Development
Leading Enterprises: Established companies such as Mindray, Deerui, and Kehua were in a leading position in terms of technology research and development and market share. After the partial unlocking of employees' stocks following Mindray's listing on NASDAQ, it trained talents for the industry and provided technical conditions. Deerui adopted a flexible sales model for its biochemical analyzers, and its products were in short supply, making it a preferred partner for many reagent manufacturers.
Small and Medium-sized Enterprises: A large number of small and medium-sized enterprises continuously entered the market, but they were generally small in scale, with a single product line, and relatively weak in terms of technology research and development and market competitiveness.
Technology and Products
Instrument R&D: The focus was mainly on the research and development and production of traditional instruments such as biochemical analyzers, hematology analyzers, and urine analyzers. Deerui was one of the few domestic manufacturers that launched an 800-speed biochemical analyzer at that time.
Reagent Sales: The sales model of reagents underwent changes, and the role of instruments in sales became increasingly prominent. The model of reagent manufacturers driving reagent sales through the sale of instruments gradually took shape.
Industry Competition
Domestic Competition: Competition among enterprises gradually intensified, with enterprises competing in terms of technology, product quality, and sales channels to capture market share.
International Competition: Imported products still occupied a large share of the domestic market. Chinese IVD enterprises had a gap compared with international enterprises in terms of high-end products and technologies, but they had already gained a certain competitive edge in the mid-to-low-end market. Moreover, some enterprises began to actively expand into overseas markets.
IVD 市场风云：变革与突破之路
当年，上海一家著名三甲医院选用了国产半自动发光设备。代理商不仅提供设备和试剂，还为医院配置了专业操作人员，这些操作人员能够实时掌握科室动态，包括竞争对手的相关信息。一旦发现对手出现问题，便能迅速制定应对策略，甚至不惜免费赠送仪器以抢占市场先机。
然而，行业中也存在一些不良现象，如篡改数据等，早上进行实验，中午擅自篡改数据，下午出具报告，这种行为严重违背职业操守，给整个行业带来了负面影响。
发光行业在当时堪称暴利行业，不仅存在进口试剂走私的情况，在一些经济欠发达地区，某些发光检测技术的收费甚至高于其他进口产品。国产试剂由于成本较低，利润空间相对也大，在一些边缘项目上，医院出于成本等因素的考量，更倾向于选择国产试剂。
但在肿瘤标记物、糖尿病相关的糖化血红蛋白检测、甲状腺功能以及传染病如乙肝、丙肝、艾滋病等的检测等主流项目上，外企凭借其先进的技术和成熟的品牌，仍牢牢占据着主导地位。以 2012 年的数据为例，在这些主流项目的试剂市场中，进口品牌的占有率高达 90%，国产试剂仅占 10%。
以迈瑞为例，它最初从代理业务起步，逐步发展自主产品。早期其产品质量一般，但在开发血球分析仪项目时，从迈阿密聘请了专业专家，其中一位提出了不同于常规的质量理念，这一理念犹如一把钥匙，为这款血球分析仪打开了国内外市场的大门，使其获得了巨大成功。如今在血球分析仪市场，迈瑞已能与 sysmex 平分秋色。数据显示，2012 年，迈瑞血球分析仪在国内市场的占有率约为 20%，到了 2023 年，这一数字已增长至 50% 以上，在全球市场也占据了约 20% 的份额。
还有一些企业，发展路径独具特色。
有一家企业十多年前刚进入 IVD 行业时，拥有一百个销售人员，却仅有一位研发人员，他们通过稀释生化产品、“借鉴” 其他产品等方式来占领市场。
当时中国市场广阔，监管尚不完善，各种情况层出不穷，有稀释产品的，有以次充好的，甚至还有白牌产品。但随着时间的推移，产品不断迭代升级，质量控制系统日益完善，大数据监控技术广泛应用，这些不正当手段已难以继续施展。
另一家企业从生化大包装试剂业务起步，通过持续的技术研发和广泛的国际交流，在特定蛋白检测领域积累了强大的技术优势，与贝克曼、西门子等企业合作补充产品菜单，如今已能与 The Binding Site 分庭抗礼。
这家企业模式别具一格，拥有一百位研发人员，却仅配备一个销售人员，采用 “自上而下” 的市场策略，从顶级三甲医院逐步拓展业务版图。在特定蛋白试剂领域，该企业在 2019 年的市场份额不足 3%，到 2023 年，已增长至 12%，在国内顶级医院的市场份额更是达到 30% 以上。
还有一家上市公司，十多年前其产品在大城市医院备受冷落，但令人意想不到的是，全国却有三千多家小医院是其客户。在化学发光赛道上，它深知试剂是利润的核心所在，故而选择与国外厂家合作引进仪器硬件，大大缩短了产品上市周期。在化学发光市场，该公司在 2012 年的市场份额近乎为零，到 2023 年，凭借其独特的发展策略，市场份额已成功提升至 6%。
中国市场的竞争异常残酷，对国内外企业一视同仁。能够在中国市场占据领先地位的企业，便有机会走向世界舞台。但目前许多国内企业因在本土市场竞争激烈，无奈选择出海发展，这着实令人惋惜。以发光市场和生化市场为例，在成熟的国际市场中，可能仅有几家或十几家公司参与竞争，而国内却有上百家公司在这片战场上激烈角逐，淘汰在所难免。
此前中国的家电、手机、汽车市场，也都经历过类似的竞争与淘汰过程，而正是这些洗礼，最终推动了行业的持续发展与进步。
附录参考：
2012 年 3 月，字节跳动正式成立。
2012 年罗氏诊断在中国的发展情况如下：
市场规模与增长
2012 年中国 IVD 市场规模约为 190 亿元，年均增长率达到 15%-20%，市场呈现快速增长态势，且潜力巨大，预计 2015 年市场规模将超过 300 亿元.
企业发展
技术与产品
行业竞争