NEW YORK – The Chinese in vitro diagnostic market can be difficult to enter for smaller diagnostic firms that do not have an established presence in the country, and a recently expanded program implemented by regional governments in the country may cause further difficulties.

纽约——对于在国内尚未建立业务的小型诊断公司来说，中国体外诊断市场可能难以进入，而该国地区政府最近实施的一项扩大计划可能会带来进一步的困难。

In 2022, China unveiled its centralized volume-based procurement (VBP) program for certain types of diagnostic tests, namely biochemical and chemiluminescence tests for certain conditions, including infectious diseases like human papillomavirus and liver function tests.

2022年，中国推出了针对某些类型诊断测试的集中批量采购（VBP）计划，即针对某些条件的生化和化学发光测试，包括人类乳头瘤病毒和肝功能测试等传染病。

Under the program, diagnostic test manufacturers submit test prices to regional governments, which then select the most favorable price and grant contracts to those companies, sourcing the majority of hospital tests through those firms. Hospitals also provide a volume commitment to ensure companies know exactly how many tests they'll be selling.

根据该计划，诊断测试制造商向地区政府提交测试价格，然后政府选择最优惠的价格并向这些公司授予合同，通过这些公司采购大部分医院测试。医院还提供批量承诺，以确保公司确切知道他们将销售多少测试。

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While the program for diagnostic manufacturers is in its early phases, and its impact is still playing out, experts said that once the dust settles, the VBP program could significantly change China's IVD market.

虽然针对诊断制造商的计划尚处于早期阶段，其影响仍在发挥，但专家表示，一旦尘埃落定，VBP计划可能会大大改变中国的IVD市场。

The country has previously implemented VBP programs for other types of medical products, including pharmaceuticals and medical devices like coronary stents. The key purpose of the VBP programs is to control costs to alleviate the financial burdens on the government's medical fund and improve affordability of healthcare products, said Grace Wang, a partner at LEK Consulting, based in Shanghai.

该国之前已经为其他类型的医疗产品实施了VBP计划，包括药品和冠状动脉支架等医疗设备。总部位于上海的LEK Consulting合伙人Grace Wang表示，VBP计划的主要目的是控制成本，减轻政府医疗基金的财务负担，提高医疗产品的可负担性。

The VBP programs for pharmaceuticals and medical devices, she said, 'is probably so far one of the most successful initiatives implemented by the government in order to control the costs of drugs and devices and reduce excessive channel markup.' .

她说，VBP药品和医疗器械项目“可能是迄今为止政府实施的最成功的举措之一，目的是控制药品和器械的成本，减少过度的渠道加价。”。

Diagnostics, however, has lagged behind other forms of medical devices when it comes to implementation of the VBP schemes. One reason for that, Wang noted, is that there are many different modalities, including immunoassays and molecular PCR tests, for diagnostic testing for many different indications, such as infectious diseases.

然而，在实施VBP计划方面，诊断学落后于其他形式的医疗设备。王指出，其中一个原因是有许多不同的方式，包括免疫测定和分子PCR检测，用于许多不同适应症的诊断检测，例如传染病。

Another barrier to implementing VBP programs for diagnostics is that for certain products there is a closed system[EW1] , meaning that some reagents must be used with a specific instrument instead of being interchangeable. If a hospital does not have the proper equipment to use with the reagents that have been selected through the VBP program, it may be difficult to perform those tests until the new equipment is purchased..

实施VBP诊断程序的另一个障碍是，对于某些产品，存在一个封闭系统[EW1]，这意味着某些试剂必须与特定仪器一起使用，而不能互换。如果医院没有合适的设备与通过VBP程序选择的试剂一起使用，则在购买新设备之前可能很难进行这些测试。。

But there has also been an incentive issue to implementing diagnostics VBP programs, Wang said. In China, patients previously were charged a single test service fee while hospitals paid for the test reagents. In pharmaceuticals and medtech, the procedure fee is charged in addition to the consumable fee.

但是，实施诊断VBP计划也存在一个激励问题，王说。在中国，患者之前只需支付一次检测服务费，而医院则需支付检测试剂。在制药和医疗技术领域，除消耗品费用外，还收取手续费。

Because one of the goals of VBP programs is to control medical spending for patients, implementing the program for diagnostics reagents would have minimal impact if the service cost remains unchanged, since patients didn't pay for reagents in the first place, Wang said. However, the government is now rolling out a program to separate the test reagent cost and the test services fees so that the diagnostic reagents VBP can make an impact..

Wang说，由于VBP计划的目标之一是控制患者的医疗支出，因此如果服务成本保持不变，实施诊断试剂计划的影响将微乎其微，因为患者首先不支付试剂费用。然而，政府目前正在推出一项计划，将测试试剂成本和测试服务费用分开，以便诊断试剂VBP能够产生影响。。

Compared to other VBP programs, which were implemented either nationally or in multi-region alliances, diagnostics VBP programs have only been implemented in certain regions, including one large alliance led by the Anhui province that includes 25 provinces, and only applies to diagnostic reagents, not instruments..

与全国或多地区联盟实施的其他VBP计划相比，诊断VBP计划仅在某些地区实施，包括由安徽省领导的一个大型联盟，其中包括25个省，仅适用于诊断试剂，而不适用于仪器。。

While there have been temporary provincial alliances for short-term tenders focused on one type of test, such as a liver function test that includes 26 analytes, the newly centralized VBP program will include more provinces and more types of tests.

虽然有临时省级联盟进行短期招标，重点是一种类型的测试，例如包括26种分析物的肝功能测试，但新集中的VBP计划将包括更多省份和更多类型的测试。

The Anhui-led alliance's procurement program involves five categories: PCR-based typing tests for human papillomavirus, human chorionic gonadotropin chemiluminescence tests, chemiluminescence assays for six sex hormones, ELISA and chemiluminescence tests for eight infectious diseases, and chemiluminescence assays for two glucose metabolisms.

安徽领导的联盟的采购计划涉及五类：基于PCR的人乳头瘤病毒分型检测，人绒毛膜促性腺激素化学发光检测，六种性激素的化学发光检测，八种传染病的ELISA和化学发光检测，以及两种葡萄糖代谢的化学发光检测。

The program will initially last for two years but can be extended. .

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Roche Diagnostics, Siemens Healthcare Diagnostics, Beckman Coulter Diagnostics, Abbott, Sysmex, DiaSorin, Maccura Biotechnology, and Danaher's Radiometer received contracts under that VBP program.

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Anhui has been a leader in procurement, previously starting the centralized procurement for routine chemiluminescence reagents for tumor markers, thyroid tests, and infectious diseases in 2021 and procuring coagulation clinical testing reagents in 2023, according to a report from the China Association of Clinical Laboratory Practice.

根据中国临床实验室实践协会的报告，安徽省在采购方面一直处于领先地位，之前于2021年开始集中采购用于肿瘤标志物，甲状腺检测和传染病的常规化学发光试剂，并于2023年采购凝血临床检测试剂。

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An immediate impact of the diagnostics VBP is that hospitals will see cost benefits as the prices of their reagents drop, Wang said. However, the larger impact will be felt by test manufacturers and distributors, who will have to lower their reagent prices, which, in turn, will lead to lower profit margins that they will then have to make up.

Wang说，诊断VBP的直接影响是，随着试剂价格的下降，医院将看到成本效益。然而，测试制造商和分销商将感受到更大的影响，他们将不得不降低试剂价格，这反过来将导致利润率下降，然后他们将不得不弥补。

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'The manufacturers … have to think about how to plan their distribution strategy in order to squeeze that channel margin as a result of the lowered price after VBP,' Wang said.

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Firms may reconfigure their distribution, sales, and marketing channels to avoid significant reductions in the base manufacturing price, she added. However, if a company wins a VBP contract, there is already a set volume commitment from each participating hospital, so the firm may be able to reduce its sales and marketing efforts and staff.

她补充道，企业可能会重新配置其分销、销售和营销渠道，以避免基本制造价格大幅下降。然而，如果一家公司赢得了VBP合同，那么每个参与的医院都已经有了一个固定的数量承诺，因此该公司可能能够减少其销售和营销工作以及员工。

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Manufacturers and distributors will also have their market share affected in the provinces that implement VBP programs, Wang said. In those provinces, typically between 80 percent and 90 percent of market share will go to the companies that were awarded VBP contracts.

王说，制造商和分销商在实施VBP计划的省份的市场份额也将受到影响。在这些省份，通常80%至90%的市场份额将流向获得VBP合同的公司。

'Historically, we've seen the multinational players typically have a higher price than the local Chinese companies, so we would expect that local Chinese companies will continue to have that price advantage in VBP, and we'll expect them to continue to take share from multinational companies,' Wang said..

“从历史上看，我们看到跨国公司通常比中国本土公司的价格更高，因此我们预计中国本土公司在VBP方面将继续拥有这种价格优势，我们预计他们将继续从跨国公司那里获得份额，”王说。。

Cannacord Genuity analyst Kyle Mikson echoed Wang's comments about bias toward local companies within China's diagnostics industry. Over the past few years, China has particularly tried to favor local companies, which has served as a headwind for many US-based firms looking to enter the Chinese market, he said.

Cannacord Genuity分析师凯尔·米克森（KyleMikson）回应了王的评论，即中国诊断行业对本土公司的偏见。。

It's also difficult to sell products directly in China, and the need for a distributor based in Asia can be a deterrent for companies that may want to sell their diagnostics products to Chinese customers but don't have access to an Asian distributor. .

直接在中国销售产品也很困难，对于那些可能想向中国客户销售诊断产品但无法获得亚洲经销商的公司来说，需要在亚洲建立经销商可能会产生威慑作用。

'Even though China is this big growth driver, big market … it's harder to penetrate and expand quickly in China,' Mikson said. In recent years, China has also seen flatness in growth due to fewer investments in biotechnology from the government, and that flatness in combination with VBP programs that put caps on prices may put its position as a large growth market in question.

米克森说，尽管中国是这个巨大的增长驱动力、巨大的市场……但在中国很难迅速渗透和扩张。近年来，由于政府对生物技术的投资减少，中国的增长也出现了平缓，这种平缓加上对价格设定上限的VBP计划，可能会使其作为一个大型增长市场的地位受到质疑。

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'These sorts of programs really limit or handicap the growth that we once thought was so robust,' Mikson said.

米克森说：“这些项目确实限制或阻碍了我们曾经认为如此强劲的增长。”。

While the VBP programs tend to be biased toward larger companies that can afford to cut their prices, smaller firms may not be completely shut out. Under the diagnostics VBP program, there is a specific price cut level listed, meaning if a company is willing to cut their prices by that amount, they can participate in the market.

虽然VBP计划往往偏向于有能力降价的大公司，但小公司可能不会被完全排除在外。在诊断VBP计划下，列出了一个特定的降价水平，这意味着如果一家公司愿意降价那么多，他们就可以参与市场。

However, the largest market share will still go to the firm or firms with the largest price cuts, and those price cuts can be significant: some VBP programs have set the minimum at a cut of 50 percent, Wang said..

然而，最大的市场份额仍将留给降价幅度最大的一家或多家公司，这些降价幅度可能很大：一些VBP项目已将最低降价幅度设定为50%，王说。。

'As long as they are willing to meet that minimum threshold of price cuts, [smaller firms] can stay in the game,' Wang added. For smaller companies with high cost of goods, however, the price cuts may be prohibitive enough to shut them out of the competition entirely.

王补充说，只要他们愿意达到最低降价门槛，规模较小的公司就可以留在游戏中。然而，对于商品成本较高的小公司来说，降价可能会让他们望而却步，完全被排除在竞争之外。

The VBP program's impact on a company depends largely on its existing position within the Chinese diagnostics market, Wang noted. For firms already with a leading position in China's IVD market in certain test categories, such as infectious diseases, the program is unlikely to seriously affect its market position in the country if they bid to win.

王指出，VBP计划对公司的影响很大程度上取决于其在中国诊断市场中的现有地位。对于在某些测试类别（如传染病）中已经在中国IVD市场处于领先地位的公司来说，如果他们投标获胜，该计划不太可能严重影响其在中国的市场地位。

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Based on previous VBP programs in the medical technology sectors, 'those with a very major presence in China in specific product categories would typically choose to stay in the game,' Wang said. However, 'for some companies with just a minor presence, it's going to be very painful for them to make such large price cuts.' .

王说，根据之前在医疗技术领域的VBP项目，“那些在中国特定产品类别中占有重要地位的人通常会选择留在游戏中。”。然而，“对于一些规模较小的公司来说，大幅降价将是非常痛苦的。”。

The VBP program may also serve as a deterrent for companies without a presence in China already that may be considering expanding to the country. Before the existence of the programs, China was typically seen as a 'premium pricing market,' with prices that were generally higher than other international markets, excluding the US, making the difficulties of selling in China worth the effort, Wang said.

VBP计划也可能对尚未在华业务的公司起到威慑作用，这些公司可能正在考虑向中国扩张。Wang说，在这些计划存在之前，中国通常被视为“溢价定价市场”，价格普遍高于除美国以外的其他国际市场，因此在中国销售的困难值得努力。

But post-VBP, some of that pricing has dropped dramatically, which may give pause to firms aiming to enter the market. .

但在VBP之后，其中一些定价大幅下降，这可能会让那些试图进入市场的公司停滞不前。

Yun-Fu Hu, chief medical officer at Chinese diagnostics firm Genetron, noted via email that a prerequisite for joining a VBP program is regulatory clearance from Chinese authorities, which may also be a deterrent for some companies, particularly those outside of China. 'Considering that regulatory science is still evolving in China, [the] regulatory pathway could be especially challenging for the 'first person to eat the crabs,' as we say in Chinese.' .

中国诊断公司Genetron的首席医疗官胡云福（Yun Fu Hu）通过电子邮件指出，加入VBP计划的先决条件是获得中国当局的监管许可，这也可能对一些公司，尤其是中国境外的公司产生威慑作用考虑到监管科学在中国仍在不断发展，正如我们在中文中所说的那样，对于“第一个吃螃蟹的人”，监管途径可能尤其具有挑战性。

Diagnostics companies who want to join the VBP programs 'would have to adjust their product strategies to ensure whatever products they develop must have a reasonable chance to receive regulatory approvals,' Hu added.

胡补充说，想要加入VBP计划的诊断公司“必须调整产品策略，以确保他们开发的任何产品都有合理的机会获得监管部门的批准”。

In addition, to join the VBP programs diagnostics companies must work with local hospitals to establish their tests' clinical utility and health economics before they can enlist their approved products with a regional authority and become eligible for VBP, Hu said. This could be challenging for companies without expertise in government affairs, especially firms that are based abroad.

此外，胡说，要加入VBP计划，诊断公司必须与当地医院合作，建立其测试的临床实用性和健康经济学，然后才能向地区当局征集其批准的产品并获得VBP资格。对于没有政府事务专业知识的公司来说，这可能是一个挑战，尤其是总部位于海外的公司。

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However, Tycho Peterson, an analyst at Jefferies, noted that thus far the impact of VBP is 'fairly limited' and focused on companies with 'more traditional diagnostic exposure,' since the tests included in current VBP programs are routine, and those markets are mature. It's a headwind, but one that has so far been manageable for large companies like Danaher, Revvity, and Bio-Rad Laboratories, he added..

然而，杰弗里斯（Jefferies）分析师蒂乔·彼得森（TychoPeterson）指出，迄今为止，VBP的影响“相当有限”，主要集中在“更传统的诊断风险”的公司，因为当前VBP计划中包含的测试是常规的，而且这些市场已经成熟。他补充道，这是一个逆风，但对于Danaher、Revivity和Bio-Rad Laboratories等大公司来说，迄今为止还是可以控制的。。

'These are markets that … have largely consolidated,' he said. 'I'd say for the kind of high volume, more mature assays, it's largely in the hands of the bigger companies.'

他说，这些市场……已经基本巩固我想说的是，对于这种高容量、更成熟的检测方法，它主要掌握在大公司手中。”

In a conference call to discuss Revvity's Q1 2024 financial results earlier this year, CEO Prahlad Singh said that the firm assumes and has seen mid-single-digit price declines on an annual basis related to VBP. He added that the firm will 'continue to have some volatility related to VBP' in its diagnostics business..

今年早些时候，Revivity首席执行官普拉德·辛格（PrahladSingh）在一次电话会议上讨论了Revivity 2024年第一季度的财务业绩，他表示，该公司假设并且已经看到与VBP相关的年度价格下降了中个位数。他补充说，该公司的诊断业务将“继续存在与VBP相关的一些波动”。。

Peterson added that the impact of VBP will largely be felt in Revvity's reproductive health business, and that 1 percent of its revenues have already been affected by VBP.

彼得森补充说，VBP的影响将主要体现在Revivity的生殖健康业务中，其收入的1%已经受到VBP的影响。

Danaher CFO Matt McGrew, meantime, said in a conference call to discuss the firm's Q3 2023 financial results last year that the company expects a headwind of about $50 million per year related to VBP, largely from its subsidiary Beckman Coulter Diagnostics. Peterson noted that even with the VBP headwind, Danaher is still above pre-COVID-19 pricing trends.

与此同时，Danaher首席财务官马特·麦克格鲁（MattMcGrew）在讨论该公司去年2023年第三季度财务业绩的电话会议上表示，该公司预计每年与VBP相关的阻力约为5000万美元，主要来自其子公司贝克曼·库尔特诊断公司（Beckman Coulter Diagnostics）。彼得森指出，即使有VBP的逆风，达纳赫的定价趋势仍高于新型冠状病毒肺炎之前的水平。

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Positive outlook

积极的前景

Many large diagnostic companies either did not respond to requests for comment or declined to speak on the record, but among those that agreed to comment, some expressed optimism that the impact from VBP programs and government pricing aren't necessarily negative. A spokesperson from Siemens Healthineers said via email that the pricing impacts from the VBP initiative are expected to continue and accelerate, 'turning from a case-by-case provincial approach into a national program.' .

许多大型诊断公司要么没有回应置评请求，要么拒绝公开发表评论，但在同意置评的公司中，一些公司表示乐观，认为VBP计划和政府定价的影响不一定是负面的。西门子Healthineers的一位发言人通过电子邮件表示，预计VBP计划对定价的影响将继续并加速，“从逐案的省级方法转变为国家计划”。

The spokesperson added that Siemens sees this 'as an opportunity in the long run, as VBP prompts customers to redirect their focus from cost considerations to product quality and service excellence.'

这位发言人补充说，西门子认为这“从长远来看是一个机会，因为VBP促使客户将重点从成本考虑转移到产品质量和卓越服务。”

In a conference call discussing the firm's fiscal first quarter 2024 results in February, Siemens CEO Bernd Montag said that China makes up about 10 percent of the firm's global business in its diagnostics division, and that VBP affects about 20 percent of that business. He added that VBP 'gives you a more direct access to customers' because it is intended to 'cut out the middlemen and all the margin stacking, which is currently still happening within the Chinese healthcare system.' It also 'gives you the opportunity to get to firm volume commitments.' .

西门子首席执行官伯纳德·蒙塔格（Bernd Montag）在2月份召开的一次电话会议上讨论了公司2024年第一季度的财报，他表示，中国占公司诊断部门全球业务的约10%，而VBP影响了该部门约20%的业务。他补充说，VBP“让你更直接地接触客户”，因为它旨在“切断中间商和所有利润堆积，而目前这种情况仍在中国医疗体系中发生。”它还“为您提供了实现固定数量承诺的机会”。

'While we are a market leader in the US in diagnostics, we are not in such a strong position in China, so … we have potentially more to gain than to lose,' Montag said.

蒙塔格说，虽然我们是美国诊断领域的市场领导者，但我们在中国的地位并不那么稳固，因此……我们可能会获得比损失更多的收益。

Abbott, another beneficiary of the Anhui alliance's VBP program, has also mentioned the benefits of the initiative, although it has largely seen those benefits in its medtech business. In a conference call to discuss the company's fourth quarter 2023 financial results in January, CEO Robert Ford said that, while there were price challenges throughout the year with VBP in the firm's electrophysiology segment, the volume and market share the company picked up 'more than offset' the pricing concerns..

安徽联盟VBP计划的另一位受益人雅培（Abbott）也提到了该计划的好处，尽管它在其医疗技术业务中基本上看到了这些好处。首席执行官罗伯特·福特（RobertFord）在1月份召开的一次电话会议上讨论了公司2023年第四季度的财务业绩，他表示，虽然VBP在公司的电生理领域全年都面临价格挑战，但公司的销量和市场份额“大大抵消了”了价格方面的担忧。。

Ford previously said he expected the diagnostics VBP to impact about 20 percent of Abbott's core laboratory business.

福特此前表示，他预计诊断VBP将影响雅培约20%的核心实验室业务。

Haibo Song, chairman of the China Association of In Vitro Diagnostics and founder of the China Association of Clinical Laboratory Practice, said via email that 'the transparent price positioning from the government to control the overall selling price of the manufacturer from China' is a 'healthier way to make the market more reasonable in price positioning.'.

中国体外诊断协会主席、中国临床实验室实践协会创始人宋海波通过电子邮件表示，“政府透明的价格定位，以控制中国制造商的整体售价”，是一种“更健康的方式，使市场在价格定位上更合理”。

The Chinese IVD market is 'far from mature,' he added, and in addition to new hospitals that are being built, existing hospitals will soon need to upgrade their instruments and consumables, so there is 'space for new markets, and also for the existing market.'

他补充说，中国IVD市场“远未成熟”，除了正在建设的新医院外，现有医院很快将需要升级其仪器和耗材，因此“既有市场也有新市场的空间”