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Global Nitinol Medical Devices Market $5.1 Billion by 2027

The global market for Nitinol medical devices expected to reach nearly $5.1 billion by 2027, expanding at a CAGR of 9.0% over the forecast period, driven by increasing demand for less invasive medical procedures, and new medical applications requiring the advances of materials technology with improved mechanical and physical properties.

Global Nitinol Medical Devices Market
  • Nitinol’s superelastic properties enable it to maintain shape memory characteristics while performing under fatigue and stress. Those properties have led companies to develop medical devices including stents and heart valves that would be impossible to create using conventional materials.
    • However, on the downside, Nitinol biomaterial used to make medical devices has been known to trigger allergies and metal sensitivities in a handful of patients.
      • Nitinol, a nickel-titanium alloy ubiquitous in medical devices, is getting more scrutiny from US FDA in a recently released draft guidance.
        • As safety concerns have arisen in the past few years over biocompatibility of certain materials in implanted products, the agency is asking device makers to provide additional information on nitinol in their device submissions.
          • The US FDA draft guidance proposed premarket applications for devices containing the material should include testing to evaluate susceptibility to corrosion, overall biocompatibility and performance under various stress and temperature conditions.

Nickel-titanium (Nitinol or NiTi) is in the unique class of shape memory alloys. Nitinol alloys are rapidly becoming the materials of choice for self-expanding stents, graft support systems, filters, baskets and various other devices for minimally-invasive interventional and endoscopic procedures.

  • The use of the flexible metal Nitinol in medical devices has benefited both manufacturers and patients. Nitinol-based stents, guidewires, surgical instruments, coliosis rods, embolic protection filters are used in a host of medical applications.
    • In the past decade, the Nitinol medical device marketplace has been dominated by peripheral vascular products, such as stents and guidewires. In recent years, endovascular aneurysm repair devices, inferior vena cava filters and embolic protection devices have also developed into significant commercially successful products.
  • The success of Nitinol in the peripheral vascular space has spurred development in a number of other areas, including general surgery, structural heart disease and orthopedics.
    • Most self-expandable bare-metal stents use nitinol, because they retain its initial shape after implementation. The self expanding nitinol stent are indicated for improving blood-flow in patients with symptomatic peripheral artery disease.
  • The growth of Nitinol in the medical industries has exploded in the past ten years. Patients and care providers have encouraged the transition from traditional open-surgical procedures, which require long hospital stays, to less-invasive techniques, which are often performed in out-patient clinics.

The global Nitinol medical devices market report provides market size ($million 2017 to 2027), market share, growth trends and forecast (CAGR%, 2021 to 2027).

The global Nitinol medical devices market segmented by raw material (Nitinol wires, Nitinol tubing, others), finished product (Nitinol stents, Nitinol guidewires, others), geography.

  • This demand for minimally invasive procedures has allowed novel instrumentation and implants to be designed. An increasing number of these devices use Nitinol as the critical component. Examples of medical applications range from orthodontic archwires and endoscopic instruments to endovascular stents.
    • Super-elastic Nitinol is now a common and well-known engineering material in the medical industry. While the greater flexibility of the alloy drives many of its applications, there are also a large number of lesser- known advantages of Nitinol in medical devices.
      • Similarly, Nitinol medical devices also provide a perfect solution for the problems caused by minimally invasive surgical procedures such as infections, injury to other organs, risks of anesthesia and bleeding with its unique biomechanical properties such as super elasticity, shape memory effect and superior biocompatibility properties.
  • Nitinol wires are gaining importance in the medical device industry and currently being used in various clinical applications such as orthopedics, endoscopy, laparoscopy, catheter wall supports, custom springs and ablation catheter.

The global market for Nitinol medical devices research report is divided by geography (regional and country based) into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA), and Rest of the World.

  • In terms of geography, the North America region accounted for the largest share of total Nitinol devices market, followed by the Europe region and also expected to maintain its leadership position during the forecast period, primarily due to higher demand for minimally invasive surgeries using Nitinol devices and rising geriatric population and associated diseases.
    • Demand for biological Nitinol-based devices is high in North America, as technological developments in the medical industry and rising number of peripheral and coronary stent procedures and growing usage of Nitinol for the manufacturing of stents.
      • The U.S. is expected to continue to dominate the market, as most companies are domiciled there and consider North America as their primary market for product launch and market penetration, eventually leading to huge revenue generation.

The global Nitinol-based medical devices market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments.

Major competitors operating in the global market for Nitinol-based medical devices and included in this report are Abbott Laboratories, Inc., Becton, Dickinson and Company (C. R. Brad, Inc.), Boston Scientific Corporation, Cook Medical, Inc., Cordis Corporation, Custom Wire Technologies, Inc., Gore Medical, Endosmart GmbH, Medtronic plc (Covidien plc), Nitinol Devices and Components, Inc., Terumo Corporation., and W. L. Gore & Associates, Inc.

  • Raw Material
    • Nitinol Wires
    • Nitinol Tubing
    • Others
  • Finished Product
    • Nitinol Stents
    • Nitinol Guidewires
    • Others
  • Geography 
    • North America (U.S., Canada)
    • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
    • Asia Pacific (Japan, China, India, Rest of APAC)
    • Latin America (Brazil, Mexico, Rest of LA)
    • Rest of the World
  • Company Profiles
    • Abbott Laboratories, Inc.
    • Becton, Dickinson and Company (C. R. Brad, Inc.)
    • Boston Scientific Corporation
    • Cook Medical, Inc.
    • Cordis Corporation
    • Custom Wire Technologies, Inc.
    • Endosmart GmbH
    • Medtronic plc (Covidien plc)
    • Nitinol Devices & Components, Inc.
    • Terumo Corporation
    • W. L. Gore & Associates, Inc.

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