In 2024, the peripheral interventional market finds itself in an ever-evolving landscape, particularly in a context devoid of safe zones in bulk procurementThis market is classified as one of the three major vascular intervention sectors, encompassing a broad range of procedures aimed at diagnosing and treating peripheral vascular diseases affecting areas like the carotid arteries, femoral arteries, and leg veins.

Within a span of less than a month, this domain has witnessed the implementation of three significant bulk procurement projectsInitially, the fifth national bulk procurement of high-value medical consumables was successfully executed, which specifically includes peripheral vascular stents and vascular devicesShortly after, Gansu province executed a regional procurement covering pivotal products such as interventional microspheres, microcatheters, and guidewiresAdding to this momentum, Hebei’s provincial alliance procurement is on the verge of final results, primarily focused on the acquisition of peripheral vascular guiding sheaths

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Following the implementation of these bulk procurements, Henan province swiftly launched its own follow-up procurement for neurology and peripheral intervention products, incorporating previously excluded items, such as abdominal aortic stents and mechanical thrombectomy catheters, thereby significantly broadening the scope of procurements.

The recent trend in bulk procurement has introduced a remarkable frequency rarely seen in other sectors dealing with high-value medical consumablesAfter several rounds of collective procurement initiatives, the segment pertaining to peripheral intervention products is now saturated with a variety of choices.

Historically, the landscape for peripheral intervention products was characterized by a wide diversity and low penetration ratesDomestic companies had largely focused on quickly following the trends set by international innovationsHowever, the recent surge in bulk procurement activities has squeezed profit margins of established products and expedited the inclusion of novel products into the procurement timelines, with international enterprises actively participating in these initiatives

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This shift underscores an urgent need for domestic firms to transform their long-standing development paradigms.

Bulk procurement is poised to catalyze a market growth of approximately 30%.

The question that arises is how will the consecutive waves of bulk procurement reshape the market dynamics? From a growth perspective, drawing insights from past procurement executions, it’s evident that the drop in product prices generally correlates with an increase in procedural volumesGiven that penetration rates in peripheral interventions have historically been low, this ensuing growth is anticipated to be even more pronouncedAccording to data from IQVIA, there are about 40 million individuals in China suffering from lower limb artery diseases and about 100 million dealing with varicose veins, with symptomatic cases reaching around 5 million and 15 million, respectively

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Despite the substantial base of peripheral vascular disease patients, the total annual procedural volume in this segment has not exceeded one million.

Industry experts commented, “Many diseases within the peripheral intervention space are non-lethal in nature, and the related surgeries often serve preventive purposesIn the past, exorbitant product prices significantly constrained the growth in clinical penetrationDrawing parallels to the postoperative market expansions witnessed following bulk procurements in coronary stents, neuro-interventions, and orthopedic implants, the post-procurement increase in procedural volumes typically hovers around 30%. Furthermore, with an abundance of medical centers and skilled professionals capable of performing peripheral intervention surgeries, it’s reasonable to expect a substantial upward shift in market penetration following these bulk procurements.”

However, whether the peripheral intervention market can fulfill its growth potential remains to be seen and will require market verification

Aside from the bulk procurement policies, other significant industry-impacting regulations, such as the nationwide rollout of the Sanming healthcare reform, will also significantly shape market growth on multiple fronts.

Foreign enterprises adopting defensive strategies and aggressive price reductions.

The dense sequence of bulk procurements prompts one to consider the implications for the existing market landscape in peripheral interventionsThe adjustments in this arena primarily center on the competition between foreign and domestic firms in the battle for market share.

Preceding the bulk procurement shift, the peripheral intervention market was predominantly led by multinational corporationsData from IQVIA indicates that in 2022, foreign enterprises captured approximately 61% of the market, while domestic firms accounted for about 39%. With extensive bulk procurement scheduled for implementation in 2024, what transformations shall we expect in the competitive landscape?

Overall, foreign firms showed a proactive stance in the bulk procurement initiatives, with price reductions exceeding initial expectations, and they continue to hold a competitive advantage post-procurement

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Recent data from bulk procurement offers vividly illustrates that, although local products have begun to emerge, a substantial portion of the market still remains under the dominion of foreign players.

Throughout these bulk procurements, multinational companies exhibited notable price reductionsFor instance, Cordis, during the fifth national procurement initiative, placed their arterial stents at an unprecedented bid of 2,280 yuan, undercutting prices offered by several domestic competitors.

Commenting on the results of the fifth round of national bulk procurement of high-value medical consumables, Zhu Chao, Secretary of the Board at Baitai Medical, reflected on a shared trend observed across the three recent bulk procurements: a conspicuous willingness among foreign firms to reduce prices, driven by their need to maintain existing market sharesAs competition intensifies within the existing market, the dynamics will undoubtedly become fiercer.

While foreign firms have adjusted their pricing strategies downwards, the bid prices for domestic products remain comparatively higher, indicating a significant enhancement in the competitiveness of local products

This reality suggests that domestic firms have begun to receive market recognition for product qualityLeading domestic manufacturers have secured reasonable price agreements, offering them opportunities for both surplus allocation and enhanced market presenceA relatively stable pricing structure equips domestic enterprises with additional profit margins, empowering them to invest back into product quality, research and development, and iterative advancements, fostering a healthy growth cycle for domestic businesses.

It is noteworthy, however, that certain segments such as peripheral guiding sheaths or vascular stents appear ripe for domestic organizations to expand their market share through bulk procurement processesFor example, in the province of Hebei, during the provincial alliance procurement for peripheral guiding sheaths, Cook Medical commanded around 60% of the historical bid volume, while domestic player Baitai Medical claimed approximately 30%, and Huatai Medical accounted for about 15%.

Zhu Chao expressed optimism, stating, “After extensive refinements over recent years, Baitai Medical's guiding sheaths have made substantial inroads in clinical application, achieving widespread recognition

Based on our efforts, we’ve captured around 30% of the market, and following bulk procurement, we aim to secure over 50% of this market share.”

In this competitive environment, whether foreign or domestic, bulk procurement policies present an equitable platform for all players, ultimately testing the strength of product capabilities and supply stabilityPresently, some local manufacturers still face challenges in matching the performance and quality benchmarks of top-tier importsConsequently, domestic firms must prioritize quality assurance, process optimization, and continued innovation in their product offerings.

Wang Yonggang, General Manager of Tianhong Shengjie, remarked, “Bulk procurement levels the playing field for all enterprisesFor domestic firms, it lowers the barriers to access; for foreign enterprises, it mitigates the repercussions of domestic displacement policies

As competition intensifies, the focus will revert to essential attributes, specifically quality system management, supply chain reliability, and service consistency.”

Exploring further opportunities in peripheral interventions

Against the backdrop of widespread bulk procurement coverage, for domestic companies aiming for sustained development, it is imperative to embrace these initiatives and increase shares in existing markets while actively pursuing the introduction of innovative products to unearth growth avenues.

With established products such as stents, balloons, and access devices now heavily procurable, the question arises: what innovative directions lie ahead for peripheral interventions?

First is the emphasis on integrating innovation with clinical realitiesWang Yonggang highlighted that, after two decades of rapid development, peripheral intervention is entering a more mature phase, with evolving treatment philosophies significantly influencing procedural methods

For instance, in the United States, a shift in therapeutic approaches led to a dramatic decrease in the annual implantation volumes of Inferior Vena Cava filters, which plummeted from nearly 130,000 units in 2010 to fewer than 20,000 todayTherefore, product innovation should pivot on clinical needs, utilizing cutting-edge materials, technologies, and techniques for iterative progressThe focus should not be solely on replicating overseas products, as challenges faced by innovations in clinical trials could leave local manufacturers unable to adapt effectively.

Second, peripheral intervention innovations must target larger indications and focus on upgrading widely utilized productsGiven the complexity of the patient demographics and disease categories within this market, the product variety is extensive.

Zhu Chao stated, “With large populations, there’s substantial potential for products targeting vascular stenosis

While balloons and stents are currently under bulk procurement, the very reason for their inclusion into such frameworks is their significant volume of useTherefore, the future innovations within peripheral interventions cannot overlook the potential of these balloon and stent productions.”

Specifically, specialized balloons present a compelling area for developmentDuring ongoing procurements led by Zhengzhou University, the pricing benchmark for constrained peripheral balloons was approximately 7,500 yuanThis price not only surpasses the post-procurement prices of standard balloons, which averaged below a thousand yuan, but also exceeds the prices for prior generations of specialized balloons (like scoring balloons or cutting balloons) that were positioned within the three to four thousand yuan rangeGiven their superior dilation capabilities, specialized balloons are poised to see widespread adoption, potentially replacing conventional balloons.

Another noteworthy developmental direction includes multifunctional drug-coated balloons

The shift towards non-implant interventional treatments featuring drug-coated balloons marks a significant highlight in peripheral interventionsPresently, first-generation drug-coated balloons have already been included in some provincial procurement rounds, thus paving the way for the development of the next generation of multifunctional drug-coated options.

Within the stent category, neck artery stents warrant attentionReports indicate that there are over 150,000 surgical procedures annually related to carotid artery stenosis, yet no domestic products have received approval thus far, while imported offerings have remained stagnant over the past two decades, with some failing to meet current clinical demands.

In addition to addressing broader indications, tackling challenging lesions remains of utmost importance, including tools like the intravascular lithotripsy (IVL) balloon.

Recently, Boston Scientific acquired Bolt Medical, a company specializing in laser-induced shock wave balloons, for a hefty upfront cost of $443 million

IVL balloons, comprising both electrically and laser-induced shock waves, feature representative companies like Shockwave, which was recently acquired by Johnson & Johnson for $13.1 billion in 2024. A challenge faced by IVL products in peripheral interventions lies in their limitation to calcified lesions and larger diametersHowever, laser-induced IVL is anticipated to potentially rectify these limitations.

One industry insider noted, “Theoretically, laser-induced shock wave balloons present greater advantagesShock waves produced by lasers are more stable, while those generated by electrodes may suffer from energy attenuationTypically, the lifespan of an electric shock wave balloon catheter is limited to several dozen uses, whereas laser-induced options might significantly extend usability, thereby lowering IVL operational costsMoreover, the electrode's structural design restricts the catheter size, posing a challenge for access in many narrowing lesions