Nitinol medical devices market

The global nitinol medical devices market was valued at US$ 36,417.2 Mn in 2021 and is forecast to reach a value of US$ 72,516.5 Mn by 2028 at a CAGR of 10.3% between 2022 and 2028. The global nitinol medical devices market is experiencing strong growth due to the growing burden of chronic diseases across the world and increase in clinical application of nitinol based products in the medical industry. Moreover, increase in adoption of nitinol based medical products worldwide is expected to boost the growth of the market. However, availability of alternative metals and high cost of nitinol-based medical devices are expected to hamper growth of market.

Global Nitinol Medical Devices Market: Regional Insights

Based on geography, the global nitinol medical devices market is segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period owing to the growing burden of chronic diseases and rise in adoption of minimally invasive procedures in the region. For instance, according to the Centers for Disease and Prevention (CDC), heart disease is the leading cause of death in the United States. One person dies every 34 seconds in the U.S. from cardiovascular disease (CVDs). Nitinol has been widely used in cardiovascular devices such as stents, guidewires, heart valves, and vena cava filters. This in turn is expected to aid in the growth of the market in the region.

Asia Pacific is also expected to witness robust growth in the global nitinol medical devices market owing to the rise in prevalence of cardiovascular diseases and increase in preference for minimally invasive surgeries in the region, especially in India. For instance, cardiovascular diseases (CVDs) have now become a leading cause of mortality in India. According to the Global Burden of Disease, nearly a quarter (24.8%) of all deaths in India is due to CVDs. India has one of the highest burdens of cardiovascular disease (CVD) worldwide, which in turn is expected to increase the demand for nitinol medical devices, driving the market growth.

Figure 1. Global Nitinol Medical Devices Market Share (%), by Region, 2021

Global Nitinol Medical Devices Market Drivers:

Growing burden of chronic diseases, such as cardiovascular diseases (CVDs), across the world is expected to augment growth of the global nitinol medical devices market over the forecast period. For instance, with the rise in prevalence of cardiovascular diseases, such as coronary and peripheral vascular disease, the adoption of self-expanding nitinol stents is also increasing with a rapid pace. Self-expanding nitinol stents have revolutionized the treatment of peripheral vascular disease. As per the CDC, around 6.5 million people age 40 and older in the U.S. have peripheral artery disease. This in turn is expected to propel growth of the market.

Increased clinical application of nitinol based products in the medical industry is expected to boost the growth of the global nitinol medical devices market during the forecast period. For instance, nitinol is rapidly becoming a metal of choice for the composition of various medical devices in the healthcare industry, and thus, there is an increase in demand for nitinol medical devices across the globe. In April 2022, Endosmart and Chamfr teamed up to provide nitinol components for medical devices. Through the partnership, engineers can order selected nitinol braids, shape-set tubes, and wires and grinder wires from Chamfr’s website.

Global Nitinol Medical Devices Market Opportunities:

Increase in adoption of nitinol based medical products worldwide is expected to provide significant growth opportunities for players in the global nitinol medical devices market. For instance, with the increase in clinical application of nitinol based products in the medical industry, the adoption of nitinol based products is also increasing rapidly. In March 2022, Confluent Medical decided to set up a pilot manufacturing facility for Nitinol products to cater to customers in India and Asia as part of its aggressive expansion plans over the next 12 months. Confluent offers an array of Nitinol contract manufacturing services to medical devices industry.

Formation of regulatory guidelines is expected to offer significant growth opportunities for players in the global nitinol medical devices market. For instance, the formation of regulatory guidelines would offer lucrative opportunities for the players in the market. In April 2019, the United States Food and Drug Administration (FDA) published a draft guidance titled, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, which includes proposed recommendations on what manufacturers should include in their premarket submission of a device containing nitinol, an alloy of nickel and titanium.

Global Nitinol Medical Devices Market Trends:

There is a growing demand for stents for the treatment of diseases affecting the heart and blood vessels in elderly and middle-aged people. Moreover, the growing demand for stents has increased the number of procedures performed every year worldwide. Nitinol is a great choice for medical devices that may be introduced into the body to perform surgical procedures. Thus, with the rise in prevalence of CVDs, demand for nitinol stents is also increasing rapidly. This trend is expected to continue during the forecast period.

Moreover, nitinol has been used in a wide range of medical devices. Nitinol is used to manufacture catheter tubes, needles, guidewires, filters, stone retrieval baskets, dental files, arch-wire, and other surgical instruments. Moreover, nitinol is a great choice for medical devices that may be introduced into the body to perform surgical procedures. Thus, with the rise in clinical application of nitinol, the demand for nitinol based medical devices is also increasing. This trend is expected to continue over the forecast period, driving the market growth.

Global Nitinol Medical Devices Market Restraints:

Availability of alternative metals is expected to hinder growth of the global nitinol medical devices market. For instance, biomaterials metals, such as cobalt-chromium alloys and stainless steels, are also used for medical devices. Copper-based alloys are also relatively less expensive than nitinol, and thus, are being widely adopted in the medical device industry. Other metal alloys, such as gold, silver, platinum, iridium, tungsten, and tantalum, are also being used in medical devices. Hence, the presence of alternative metals is restraining the market growth.

High cost of nitinol-based medical devices is expected to hamper the growth of the global nitinol medical devices market. For instance, nitinol-based medical devices are expensive and difficult to process. However, the manufacturing costs associated with other materials, such as stainless steel medical devices, are relatively low, and thus, the preference of stainless steel as a bio-material in medical devices is increasing. Even though nitinol medical devices have various advantages, the high cost of manufacturing is expected to hinder market growth.

Figure 2. Global Nitinol Medical Devices Market Share (%), by Product Type, 2021

Global Nitinol Medical Devices Market Segmentation:

The global nitinol medical devices market report is segmented into Product Type, Application, and Geography.

Based on Product Type, the market is segmented into Stents, Stone Retrieval Basket, Guidewires, and Other Product Types. Out of which, Stents Segment is expected to dominate the global nitinol medical devices market over the forecast period and this is attributed to the increase in adoption of self-expanding nitinol stents across the world.

Stone Retrieval Basket Segment is also expected to witness significant growth in the near future and this is due to the increasing prevalence of kidney stone worldwide. Stone retrieval baskets are used to capture and extract kidney stones.

Based on Application, the market is segmented into Cardiovascular, Urology, Dentistry, & Other Applications. Out of which, Cardiovascular Segment is expected to dominate the market during the forecast period and this is attributed to the increase in prevalence of cardiovascular diseases (CVDs) around the world.

Urology Segment is also expected to witness significant growth in the near future and this is owing to the increase in demand for nitinol based urology devices. Nitinol is a choice of material used to manufacture urology devices owing to its super elasticity.

Global Nitinol Medical Devices Market: Key Developments

In February 2019, B. Braun Medical Inc. completed the acquisition of NxStage Medical Inc.’s Streamline Bloodlines Business.

In May 2019, Boston Scientific Corporation received the U.S. FDA approval for Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease.

In March 2019, Becton, Dickinson and Company received the U.S. FDA approval for first venous stent to treat iliofemoral venous occlusive disease.

Global Nitinol Medical Devices Market: Key Companies Insights

The global nitinol medical devices market is highly competitive. This is attributed to the increase in adoption of nitinol medical devices, as a result, players in the market are focusing on launching novel products in the market to meet increasing demand.

Some of the key players in the global nitinol medical devices market are:

Zimmer Biomet, Merck KgaA, EndoSmart GmbH, Cook Medical, Boston Scientific Inc., B. Braun Melsungen AG, Arthrex Inc., W.L. Gore and Associates Inc., Becton, Dickinson & Company, and Terumo Interventional Systems (Terumo Corporation), among others.

*Definition: Nitinol is rapidly becoming a metal of choice for the composition of various medical devices in the healthcare industry. It is ideal for use in internal and external medical applications. Moreover, nitinol differs from other metals, and thus, manufacturers use it in medical devices such as stainless steel or titanium.

Detailed Segmentation:

• Global Nitinol Medical Devices Market, By Product Type:
  • Stents
  • Stone Retrieval Basket
  • Guidewires
  • Other Product Types
• Global Nitinol Medical Devices Market, By Application:
  • Cardiovascular
  • Urology
  • Dentistry
  • Other Applications
• Global Nitinol Medical Devices Market, By Geography:
  • North America
  • Europe
  • Asia-Pacific
  • Middle East and Africa
  • South America