In the wake of drug price regulator NPPAs move to cap stent prices, various major healthcare companies have requested the NPPA to allow them to withdraw their latest stents from the Indian market stating commercial unsustainability.

The introduction of percutaneous coronary intervention (PCI) in the late 1970s revolutionized the management of stable and unstable coronary artery disease, providing an effective, quick, safe, and increasingly widely available method for coronary revascularization for many patients. Over the last four decades PCI has come of age with enormous forays in technology and drugs which have greatly enhanced its capability. Rapid development in this field led to the introduction of a number of new technologies, including coronary stents that have resulted in improved efficacy and long-term safety.

The development of stents has drastically reduced target-lesion restenosis rates associated with percutaneous coronary angioplasty. Contemporary coronary stent technology continues to seek to improve on the outcomes of the preceding generation of devices by refining their design, structure, and component materials. These technologies include new generations of drug-eluting stents (DES), nonpolymeric stents, bioresorbable polymer-coated stents, and fully bioresorbable scaffolds.

The dreamlike remarkable reduction in in-stent restenosis (ISR) with DES was enthusiastically welcomed. The noninvasive procedure offered by DES is gaining popularity. Currently, PCI with DES is the most commonly employed modality in the treatment of patients with coronary artery disease. The rising demand of minimally invasive procedures and increasing number of PCI are driving the coronary stent market worldwide.

Indian Market

The Indian coronary stent market was valued at 3557.7 crore in 2016 and is expected to expand at a CAGR of 14 percent from 2016 to 2026, predicts Future Market Insights. Demand for coronary stents is currently witnessing robust growth in India, mainly due to FDA approval for new stents and increasing number of PCI procedures in hospitals.

The market is mainly dominated by MNCs, accounting for the largest share of 70 percent. Rising health consciousness and increased healthcare expenditure are expected to drive the market in the near future. Macroeconomic factors such as favorable government reimbursement policies and increase in FDI in healthcare sector are further projected to drive the growth of the market. Other prominent growth drivers include rapidly growing medical technology industry and rising affordability of CHD treatment. However, lack of a well-established distribution channel associated with increased overall cost associated with it, will in turn negatively impact the overall adoption of stents in the country.

The drug-eluting stent product type segment is expected to exhibit the highest growth over the next 10 years. The bare metal stent (BMS) segment is expected to exhibit stable growth till 2026 and is mainly attributed to emergence of new and effective stents in the market.

Pricing Policy

On February 13, 2017, India's National Pharmaceutical and Pricing Authority (NPPA) made a landmark decision to fix price ceilings for coronary stents, which had been placed on the National List of Essential Medications (NLEM) in July 2016 by the health ministry. The recent decision by the NPPA precipitated immediate price cuts of up to 85 percent in some cases. According to a notification on NPPA's website, the ceiling price of bare metal stents has been fixed at 7260 and 29,600 for DES(USD 108 and USD 444, respectively). The order was brought into effect immediately, which meant that distributors and hospitals that had stents on their inventory would make a significant loss, as they would have bought these at the previous higher prices.

The medical device industry has opposed the NPPA notification, claiming it will kill innovation and slow down development of advanced stents. The Association of Indian Medical Device Industry also criticized the move, saying that the notification will rob local device manufacturers of opportunities.

According to industry experts, higher-end and sophisticated models will disappear from the market, and consumers will be left with only those models that can be profitably sold at the capped price. Furthermore, experts believe that such a regulation might lead to flooding of substandard products. Companies will chose to focus on other markets and will withhold launching newer and more sophisticated products in India. It will also stifle any form of innovation by domestic producers.

Right on cue, three major companies, Abbott, Medtronic, and Boston Scientific, have requested the NPPA to allow them to withdraw their latest premium stents from the country stating commercial unsustainability. The companies are disappointed that the government has not fixed prices of old and new technology of stents separately. Such withdrawal from the MNCs will create severe shortages for advanced stents.

Global Market

The global coronary stent market is expected to reach USD 10.31 billion by 2021 from USD 7.16 billion in 2016, reflecting a CAGR of 7.6 percent, predicts MarketsandMarkets. The growth of this market is mainly driven by technological advancements, increasing number of PCI procedures, rising burden of CAD, increasing demand for minimally invasive procedures, and rising geriatric population.

The market is highly fragmented with several big and emerging players. The market players are focusing on product innovation and geographical expansion to augment market share in emerging markets such as Asia-Pacific and are expanding their manufacturing facilities and distribution network to gain a larger share of the global market.

Abbott Laboratories, Medtronic, and Boston Scientific Corporation emerged as the global market leaders and are estimated to hold more than 70 percent revenue share of the global market in 2016. Other key players include Biosensors International Group, Biotronik SE & Co. KG, B. Braun Melsungen, Terumo Corporation, Stentys SA, MicroPort Scientific Corporation, Meril Life Sciences, Vascular Concepts, and Translumina GmbH.

Technological innovation, new product launches, collaborations, mergers, and acquisitions are other key strategic initiatives undertaken by the companies. For instance, in July 2016, Abbott Vascular launched one of the world's first biodegradable stents Absorb GT1 BVS. This initiative is anticipated to increase market penetration in this vertical.

Technology Trends

New stent technology is evolving at a dizzying pace. Even cardiologists may have trouble keeping it all straight. Since the first implantation of a coronary stent in 1986 and the first US Food and Drug Administration (FDA) approval for a coronary stent in 1994, medical and technological advances have brought pioneering transformations. These include the establishment of newer stent designs and the development of a variety of coronary stents, including BMS, DES, and fully bioabsorbable stents.

Bare-metal coronary stents made of stainless steel, cobalt, chromium, or other metals were the first introduced to the market. Although bare-metal stents are still used in some centers, significant concerns remain regarding the high risk of restenosis and stent thrombosis. The big advances came with the development of DES that reduced the risk of arteries re-narrowing to 10 percent and revolutionized the treatment of PCI.

DES. Although, all DES have the same general components, they differ with respect to the stent design, polymer coating, and the drug. Currently available DES, with reduced strut thickness, enhanced biocompatibility of durable polymers or biodegradable polymers, and newer anti-proliferative agents have better efficacy and safety compared to early DES and BMS. DES are now available using updated polymer technology. These new polymers appear to cause less inflammation, and allow better tissue healing at the site of treatment. It is believed that they substantially reduce the risk of late thrombosis. These stents – which are generally referred to as second-generation stents –now find widespread use around the world.

Nevertheless, once thought to be the solution for restenosis, DES are now faced with their own challenges of late stent thrombosis. This has renewed interest in designing a better coronary stent. Newer third-generation stents, including stents with biodegradable polymers, polymer-free stents, and biodegradable stents, are the novel frontiers.

Bioresorbable stents. One of the big advancements in DES technology has been the development of bioresorbable polymers that disappear and leave behind a bare metal stent. This engineering was done to solve ongoing issues in some patients, whose vessels do not tolerate the anti-proliferative drug-carrying polymers well, resulting in chronic inflammation.

BVS. These fully BVSs or biodegradable stents present a promising alternative in the future to overcome the problems of metallic DES. The development of completely biodegradable stents where the entire stent is reabsorbed and eventually disappears altogether, is a major breakthrough in coronary stent technology. Several versions of these stents have been developed, and are in active clinical trials. In July 2016, the U.S. FDA approved the first absorbable stent for arterial disorder. BVS has added advantages of restoring vasomotor function, expanding future treatment options, and helping avoid future complications with permanent devices.

Road Ahead

The coronary stents are technologically driven medical devices undergoing continuous upgradations and advancements. Many permutations and combinations of technological factors differentiate coronary stents amongst each other. Currently drug eluting stents (DES) have reached a high degree of sophistication where there seems very little scope of improvement. Even so every year or so there is some advancement in technology and a new generation is released.

However, despite all advances made in stent technology, it has been found that there are still complications arising from arteries' re-narrowing, and those complications can be abrupt, leading to sudden and potentially fatal heart attacks. The pursuit for an ideal DES system is still ongoing. As stent technology is evolving, newer stents are being developed with the intent to have better efficacy, safety, and performance; and it seems likely that sooner or later stents will be available that come close to eliminating both restenosis and thrombosis.


 

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