Cardiovascular Stent : Rising Cost And Localization

 

World's population growth has reached up to 8 billion in numbers, increasing by 0.9% year on growth rate. With this number of humans increasing health and medical challenges are growing exponentially numbers taking the fatality rate to catastrophic levels. Of all of the medical issues, the greatest is increased cardiovascular disease or heart failure. This rate of cardiac disease is becoming high rapidly across the globe because of unhealthy lifestyles, irregular diet routines, and obesity in human beings. The deposition of fat and cholesterol on the artery wall is called atherosclerosis, a disease that narrows the blood vessel reducing the blood flow to the heart, which is the common cause of heart blockage and is the main reason for the rising patient pool for invasive or minimally invasive procedures called angioplasty.

Angioplasty is a procedural permanent placement of a tiny mesh tube called a Stent, to wide open the clogged artery or vein. The stent keeps the artery and vein (based on procedure) side open, compressing the fats, and cholesterol obstructions to reduce the chances of a heart attack. A constant rise in heart procedures around the world due to a sedentary lifestyle by people has increased the demand for coronary and peripheral stents in substantial numbers.

For the last three decades, western countries have worked enormously in research work for cardiovascular disease and its treatments. It has also enhanced stents market growth in the healthcare business between 2018 and 2025.

Stent Manufacturing Process:

Regardless of stent type choices, BMS (Bare Metal Stent) or in advance technology DES (Drug Eluting Stent) the challenges associated with its medical procedures remain the same.

Mechanical Properties & Design:

The mechanical property rules the decision factor of providing the longitudinal and radial behavior and depends on the material, geometry, and medical application of the stent.

Geometry:

Coil:

Most common in non-vascular applications. Coil design allows retrievability after implantation. They are extremely flexible but their strength is limited.

Helical Spiral:

Helical Spirals are usually promoted for their flexible properties, with no. or minimal internal connection points, they have fine flexibility but also lack longitudinal support. Depending upon medical application it can be subject to elongation or compression during delivery and deployment and, consequently, irregular cell size.

Woven:

These designs are often used for self-expanding structures and they offer excellent coverage. But got typically shortened during expansion. Their radial strength also depends on the axial fixation of their ends.

Materials:

Indestructable Alloys:

SS 316 Stainless Steel: 

Its also called marine grade steel and is chromium and molybdenum alloy which have fine strength and corrosion resistant. It is common choice for biogradeable implants.

Nitinol:

It is alloy of nickel and titanium where both elements are present in equal composition. This alloy have two high grade properties shape memory and super elasticity. They are goodchoice for self expandable stents.

Full Degradeable Materials:

Magnesium:

Magnesium is most commonly used structure metal for lightweight materials and alloys. It has tendency to corrode, creep at high temperature.

Poly-l-lactide acid (PLLA) :

It is fully bio degradable thermolastic polyester from renewable material such as corn starch. Degradation is produced by hydrolysis.

Polycaprolactone (PCL):

It is degradable polyester with a low melting point 60 C. Same degradation achieved by hydrolysis.

The manufacturing process of stents involved several biomedical and biological processes including etching, die-casting, electroforming, and laser cutting. These processes depend on the type of material and design on which vascular stents are being made. This operation involves a high-density laser beam targeted on the workpiece surface, absorption of thermal energy transforms the workpiece volume into a molten, vaporized chemically changed state removed by a high-pressure velocity gas jet. Despite all the traditional efforts advancement in laser-cutting technology has made it possible for medical organizations to make it more effective and long-lasting, but this advancement has made a significant effect on the stents manufacturing cost. 

Why is laser cutting making the stent prices higher?

As laser cutting is a thermal process that outcome in thermal damage heat affected zone, striation, recasting layer, microcracks, and tensile residual stress. To rectify these damages, post following techniques are applied to which are pickling techniques, soft etching, annealing, and electropolishing. All these post-application impacts processes cost heavily thus making the final price much higher.

Drug Release Property Addition:

It's the main additional property added as an advanced technology in stent's current clinical procedures. There are no. of steps to include drugs to DES which are Dip-Coating, Electro-treated coating, Plasman-treated coating, and Spray coating.

Multiple variables can be modified to incorporate drug release for cardiovascular stent application, together with biocompatible polymers and antirestenotic drugs. The process chosen can be challenging as most polymers listed as biocompatible and used in medicine can cause vascular inflammation.

Market Fractions:

Rising investments from the key players in the research and development of the coronary stents market have introduced no. of stent types such as bioresorbable stents, bioengineered stents, etc, which are key factors for rising costs in the cardiovascular market.

In coronary stents market is divided into two to three types of stents mainly DES is termed as an advanced stent available for cardiac procedures, in which researches are underway for next-level drugs to be incorporated as DES and to confront venous artery diseases. The annual growth rate for DES is much higher for the period 2018-2025 where the end-user market segment is divided by hospitals, cardio clinics, and catheterization labs.

Regional Localization:

Being dependent on western countries for one to two decades now Asia Pacific stent market is now growing at a markable growth rate because of government participation in deciding the pricing factor for end users by providing effective portions in health and services research budgets.

Price capping and developing active distribution networks are also reasons for significant growth in Asia's market where India is now dominating the race along with China, ability to do continuous growth research has boosted India's accessibility to make future global partners for more clinical trials and approvals. Though currently North America with a revenue generation of US 2344.9 million is leading the stent market because of its continuous advancement in ongoing clinical trials and giving green signals to more especially DES stents and drug approvals, with the Indian market dominating the race will fluctuate, and affect the leading market position of major stent supply companies like Abbot.

Developing the health services sector locally is vital for developing countries to work equally in the health department or to at least be able to fulfill local requirements and avoid spending capital costs on imports. The current vendor landscape in health distribution markets is the key factor of rising costs because of issues in the healthcare innovation business, where investor money circulation is not an easy returnable investment but price capping and continuous focus on healthcare budgets can change the course, and India is the best example also including Pakistan who has become the 18th country to start developing and manufacturing cardiovascular stents locally in 2020, according to government officials prior country was importing approx. $3.5 million stents annually. 

Conclusion:

Present-day advancements in cardiac care have increased the realization of heart disease as a bitter and venous disease reality across the world. Also, these advancement has made the transdermal cardiac procedure more efficient and reduced errors. The procedural incorporation of BMS or DES stent placement has also been owed to well-qualified interventional cardiologists across the globe.

The cardiovascular market has been segmented on basis of operation type, stent type, disease citation, and global regional players. On procedural type, it is divided into coronary and peripheral stents, by disease it is divided into venous and arterial diseases including segregated in hospitals, special clinics, and catheterization labs. By organizational market, structure business is divided into some of the major healthcare manufacturers, i.e. Biotronic SE & Co KG, Cardinal Health, Abbot, Medtronic, MicroPort Scientific Corporation, etc.

Focusing on the localization of stent manufacturing is part of our blog conclusion because, with a great no. of sales of stents in respect of unit sales, high cost and availability is always getting directly proportional to third world population and rising health especially heart issues and equilibrium can be produced by capping price, provision of opportunities to local manufacturers to install facilities and make investments, in this case after China, India is taking the lead by regulating the stent prices and reducing it by 80 to 85 % in cost, this also has increased the local players to enhance their share in local as well as a bit in the international market. China before 2010 wasn't capable to manufacture stents locally but was in between research and development and then afterward revolutionary milestones in manufacturing led them to be capable of not only capturing market share locally but also made the interest of international players to merge their local companies as part of an international drive to capture Asia's market share. Now, Pakistan has become the 18th country to manufacture the stent locally may lead the road to new healthcare business potentials.