Technological advancements and Emerging nations propelling the Stents market

Stents are the tubular mesh like devices inserted into the clogged passageways to prop them open, maintain their patency and restore the normal flow of body fluids through them. Highly prevalent vascular and non-vascular stenotic conditions and cerebral aneurysm are in dire need of more efficient and robust therapeutic options that are driving the major global players and research institutes to develop efficacious, economical and value engineered smaller and finely refined stents with minimal complications for their value centric patients.

According to IQ4I analysis, the stents global market is expected to reach $13,522.8 million by 2027 growing at a mid single digit CAGR from 2020 to 2027. Escalating prevalence of various kinds of stenotic diseases and cerebral aneurysm across the globe, increasing demand for highly efficient, minimally invasive therapeutic products from the value centric patient population, the trend of coronary stent price slashing and increasing competitiveness of the domestic players in some of the major APAC countries, favorable reimbursement scenario in developed nations, emergence of technologically advanced stent products, persistently escalating geriatric population and the feasibility of even drug eluting stents (DES) in them and the numerous acquisitions and distribution agreements among the stent companies, developing healthcare infrastructural facilities and increasing demand for better healthcare services in the emerging markets are some of the factors that are boosting the stents market growth.

Most of the major technological advancements in this field are focused on continuously enhancing the overall architecture and efficiency of the stents through the utilization of advanced fabrication technologies, novel stent materials like the shape memory alloy, nitinol; efficient pharmaceutical agents and advanced stent coatings made of organic polymers, inorganic materials or biological components and at overcoming the shortcomings of the currently available stents like stent thrombosis and in-stent restenosis and in stent design breakthroughs through product value engineering to develop finely refined stents with reduced strut thickness, longer lengths, smaller diameters for enabling easy delivery into the tortuous vessels or ducts and ensuring improved traceability and flexibility of the stents.

Drug eluting stents (DES) have been characterized by continuous evolution with the ingenuity observed in the specific anti-proliferative drugs used, their physical design (consisting of strut thickness, strut inter-linkage mechanics, type of metal used) and the drug release characteristics of the polymer (concerned with the rate and amount of drug released). The earliest or first generation of DES made up of stainless steel platforms and sirolimus or paclitaxel eluting Parylene tie-layer and polyethylene-co-vinyl acetate (PEVA), poly-n-butyl methacrylate (PBMA) polymer efficiently reduced the in-stent restenosis and repeat revascularization but were associated with higher rate of late stent thrombosis. To achieve the ideal characteristics of a DES like adequate radial strength, flexibility, biocompatibility, trackability, need of minimal dual antiplatelet therapy (DAPT) duration, earlier stimulation of re-endothelialization, thinner struts, the current second generation DES have been developed. These stents developed on a cobalt chromium or platinum chromium platforms and using fluorinated, thromboresistant, durable, biocompatible polymers like poly(vinylidencefluoride-cohexafluoropropene) (PVDF-HFP) and polylactic acid (PLA) to elute drugs like everolimus, zotarolimus and novolimus for a reduced duration efficiently resolved the issues of very late and late thrombosis, delayed vascular healing, flexibility, trackability and deliverability. To eliminate the risk of long term stent failure, currently the so called third generation DES, polymer free DES (PF-DES) and bioresorbable polymer DES (BP-DES) are being developed. To prevent stent thrombosis, the adverse events associated with the hypersensitivity reactions to the polymer or the cracking issues related with the polymer during stent inflation in the vessel, PF-DES have been developed with the theoretical benefits of significantly reduced long term-stent thrombosis and reduced DAPT duration. To ensure the adequate drug dose and controlled drug elution kinetics in the absence of a polymer, several modifications are made on the stent surface aimed at creating drug localization sites or drug deposition sites leading to the development of drug filled stents (DFS) that will elute the drug from its internal luminal surface. To eliminate the permanent or durable polymer induced vessel inflammation and the subsequent late DES failures, bioabsorbable or bioresorbable polymer DES (BP-DES) have been developed that uses biocompatible, biodegradable polymers coated on a metallic surface for drug elution which will eventually erode or degrade off within a year leaving behind the metallic stent in the vessel. Thus these stents combine the beneficial aspects of bare metal stents (BMS) like late or long term safety with that of DES like high efficiency.

Upcoming technologies like development of smart stents integrated with micro- electromechanical systems (MEMS) for remote monitoring of the implanted stent and providing real-time prognostic information associated with the stent to assist in the early diagnosis and prevention of potential adverse events, development of 3D printed customized or patient specific stents, 4D printed personalized shape memory microstents for treating uretheral strictures in foetus or new born babies, Polyzene-F (PzF) nanocoated anti-inflammatory and thrombo-resistant non-drug eluting coronary stent, bioengineered stents coated with human antibodies to accelerate natural healing mechanism of the stented vessel, to camouflage the stent and avoid triggering of patient’s immune response, gene eluting stents (GES) for prolonged elution of therapeutic genes to mitigate the problems of late stent thrombosis and restenosis and to aid and accelerate tissue regeneration capacity are expected to drive the stents market in the coming years. Thus the current technological advancements and upcoming technologies that help in overcoming the limitations of the present stent innovations will help in reversing the scattered adoption and implementation rate of the highly efficient stent interventions.

Another trend exhibited by the stents industry currently is deviation from the usual medical device market trend of North American or European countries dominating the market. Stents market is currently dominated by the developing nations of the Asia-Pacific (APAC) region and its futuristic growth is largely dependent on the emerging nations from the Rest of World (ROW) region. Emergence of local companies in the region, their increasing competitiveness, adoption of product innovation according to the local needs or demands as their major business strategy, development of novel, next-generation stent products of international quality standards and efficiency from the domestic players of these regions and the various government measures to curb the highly inflated prices of these life saving devices from MNC’s and thereby increase accessibility of these devices to their ever escalating patient pool have contributed largely to the butterfly effect or reversal of the usual medical device market trend in the stents industry. The year on year high growth rate of the stents market in this region is further fuelled by the growing middle class population in the region, persistently elevating geriatric population in the region, increasing healthcare awareness, developing healthcare infrastructural facilities in the region, increasing government support, overseas sales expansion, preference for indigenous products and the improving reimbursement scenario in the region. The domestic players in these regions are using the price capping and stepping back of the reputed MNC’s from the stent market in the region as an opportunity to increase their market share and proving the equivalency or non-inferiority of their indigenously manufactured products with the quality stamped stents of the stent manufacturing giants like Abbott, Boston, Medtronic and others through various clinical research studies and is gaining the regulatory approvals of the national as well as global regulatory authorities. For instance, in July 2019, the Indian Stents manufacturer, Sahajanand Medical Technologies Ltd’s Supraflex Cruz, a Sirolimus-eluting coronary stent system, received CE mark approval by proving its efficacy and safety in comparison to a market-leading drug-eluting stent. In August 2019, the indigenously designed and developed bioresorbable scaffold (BRS), MeRes100 BRS of Meril Life Sciences (India) received CE approval by proving its long-term sustained and positive efficacy safety outcomes through various clinical trials. In July 2020, the Indian firm, SMT had clinched Italian government’s order for 40,000 Supraflex stent systems, further substantiating that these domestic players are not only increasing their domestic market share but also their overseas share.

The stents global market is consolidated with few companies dominating and occupying major share of the market. Some of the leading players in stents market are Boston Scientific Corporation (U.S.), Abbott Laboratories (U.S.), Medtronic PLC (Ireland), Terumo Corporation (Japan), Cook Medical LLC (U.S.), Cardinal Health Inc. (U.S.), Becton, Dickinson and company (U.S.), B. Braun Melsungen AG (Germany), Biotronik SE & Co.KG (Germany), Blue Sail Medical Co. Ltd (Biosensors International Pte Ltd) (China) and others.




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