Polymer-based Cardio Vascular Replacement to Boost Structural Heart Devices Market

Structural heart devices technology has seen a paradigm shift with the advent of non-invasive procedures to treat aortic stenosis and mitral regurgitation. From a previously sluggish approach, there seems to be a spate of activity characterized by investor excitement and massive research & development (R&D) initiatives regarding minimally-invasive heart valve technologies. For cardio-thoracic surgeons and interventional cardiologists, this arena offers tremendous scope and potential vis-à-vis traditional open heart surgery that is associated with severe side-effects.

Industry leaders and clinicians are viewing this as the answer to the growing unmet need of treating patients, with lesser hospitalization and a better prognosis. This is fueling the growth of innovations in the structural heart devices market. With the market poised to grow at a CAGR of 7.5% over the forecast period, the global structural heart devices market offers lucrative opportunities to emerging market players who are trying to gain a foothold in an industry that has lush benefits.

Tissue Engineered Heart Valves (TEHV), or biological valves, offer a new and advanced genre of treatment for patients who are in need of complete or partial valve replacement. Heart valves that are tissue engineered are a novel example of a live heart valve that consists of the host’s own tissues and cells. The biologic/tissue valves was the largest sector and accounted for ~55% of the market share in the year 2018. This is likely to reach a valuation of US$ 8 Bn by the end of the year 2027. The large-scale availability of transcatheter tissue valves and their adoption will fuel the growth of the structural heart devices market.

Xeltis is a clinical-stage medical device company that champions restorative solutions in patients needing cardiovascular therapy. Its structural heart devices sector has pioneered a procedure called Endogenous Tissue Restoration (ETR). Through this procedure, the patient is naturally able to restore a damaged heart valve. The latest innovation has been to use a polymer-based technology to restore cardiac function using ETR. With time, these devices can be developed on a large scale, obviating the cumbersome manufacturing processes involved with traditional biologic devices. Similarly, LivaNova’s ‘Perceval’ is the only suture-less, aortic tissue valve that is minimally-invasive, and is designed to be highly versatile in complex cardiomyopathy and acute cases of valvular stenosis. As these new devices are made available globally, the structural devices market will see new innovations and will gain momentum over the forecast period.

structural heart devices market infographic

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Transcatheter Aortic Valve Replacement (TAVR) to Revolutionize Structural Heart Devices Market

Since structural heart diseases pertain to abnormalities in the heart’s anatomy, and these can lead to serious complications such as stroke, cardiac arrest, and heart failure. Traditionally, the only way to treat structural heart diseases was through an open heart surgery. In Aug 2019, the Food and Drug Administration (FDA) approved TAVR as a suitable replacement technology for patients suffering from severe aortic stenosis. This procedure is highly recommended for patients who are younger and lead more active lifestyles.

Experts opine that, the recent FDA approval was in the offing, due to the procedure’s stupendous success in clinical trials. Its approval in low-risk patients paves the way for its proliferation over the next two years, as it will replace surgical valve replacement in a big way. The replacement procedures sector has been gaining significant momentum, and captured ~77% of the market share in the year 2018. The popularity and user-friendliness of TAVR procedures is likely to fuel the growth of the structural devices market over the next decade.

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Winning Imperatives: R&D and Innovation to Fuel Structural Heart Devices Market

North America held a prominent share of the market in the year 2018. The structural devices market in North America is fueled by innovative procedures, research & development, and new product launches. For this reason, North America accounted for 42% of the global market in the year 2018.

Interventional catheter technologies are the new technologies and innovations that are shaping the structural heart devices market, of not only North America, but also the global market space. Hybrid procedures, healthcare reforms, and collaborations amongst surgeons, interventionists, and cardiologists will drive the growth of the structural heart devices landscape.

  • The evolution of hybrid procedures that include a mix of surgical and interventional procedures will give rise to the catheter lab or the hybrid operating room. These will be built to facilitate both the procedures by using a mix of modern equipment, sterility, high quality imaging systems, and ventilation. With multi-disciplinary capability, this will be a time-saving and cost-effective strategy, lowering healthcare costs and boosting the growth of the structural heart devices market.
  • Advancements in Computed Tomography (CT) scans will have an impact on catheter technologies in the structural heart devices market. Non-Invasive readings will be available to cardiologists and surgeons, which will help them map out the entire coronary tree in one CT scan. It will also enable the implantation of virtual stents and a visual depiction of how it will impact flow. This tool will reduce time and procedural costs, and will act as a fuel for the growth of the structural devices market.
  • 3D rotational angiography will see complete integration into other imaging solutions. This will create enhanced visualization of transcatheter procedures inside the body. A high level of 3D integration will be a very effective remedial step towards the treatment of chronic total occlusions (CTO). The structural heart devices market will gain traction with the incorporation of modern 3D rotational angiography.
structural heart devices market segmentation

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New Product Launches and Acquisitions Define the Competitive Landscape

The competitive landscape of the structural heart devices market is highly consolidated with four major players, Edward Lifesciences Corporation, Abbott, Medtronic, and Boston Scientific Corporation account for ~92% of the total market share. Their growth strategy is centered around product innovations, patient care, and transformative catheter procedures.

Edward Lifesciences and Medtronic are the dominant leaders in the structural heart devices market landscape, and their rapid rise can be attributed to acquisitions, collaborations, product innovations, and sophisticated distribution channels that have allowed them to grow globally.

Edward Lifesciences has pioneered TAVR, which was approved by the FDA in Aug 2019. This innovative solution has further consolidated its position as a global leader in transformative healthcare, and has aided it in propelling ahead in the structural heart devices market. Its other product offerings are the SAPIEN 3 and SAPIEN XT. SAPIEN 3 is a trans-catheter heart valve that is artificial, and there are several accessories used to implant the valve without an open heart surgery. In Feb 2019, Edward Lifesciences entered into a merger agreement to acquire CAS Medical Systems, a medical technology company that deals with non-invasive monitoring of oxygen in the brain. This will strengthen Edward’s leadership in smart monitoring capabilities.

In Aug 2019, Medtronic announced the U.S FDA approval of its Evolut TAVR system for patients suffering from native stenosis. Evolut offers an excellent safety solution for low-risk patients with minimum hospital stay and excellent quality of life. In May 2019, Medtronic announced its decision to acquire Titan Spine, a privately-held titanium spine inter-body implant and surface technology company. With this merger, Medtronic will acquire Titan Spine’s entire range of innovative spinal titanium fusion devices. This will have a dramatic impact on both, the cardiac and spine market, and will fuel Medtronic’s growth in the structural heart devices market.

Micro Interventional Devices, Inc is an emerging player that designs and manufactures disruptive technologies for usage in structural heart repair procedures. Its products like the permavalve is a new-found catheter-based solution, and is said to drive the structural heart devices market.

In Mar 2019, Micro Interventional Devices Inc entered into a strategic alliance with OSCAR Inc. With this, both companies will be able to spearhead innovative solutions for structural heart diseases, and leverage their place in the market. Under this agreement, Micro Interventional Devices Inc acquires a global license to OSCAR’s patented catheter technology. This will give Micro Interventional Devices the technical prowess to ramp up production and enhance its revenue portfolio.

Analysts’ Perspective

A comprehensive view of the structural heart devices market has led our analysts to conclude that, the market is growing at a high CAGR, with North America holding a large chunk of the global demand for structural heart devices and their applications. The rising demand for structural heart device technology and its versatile applications in the treatment of cardiac diseases is spurring its demand. The impact of new innovations and product launches in the field of valve replacement will remain high on the structural heart devices market, globally. Strong financial position, acquisition strategies, and technological innovations of key market players will also give impetus to the structural heart devices market.

Technological breakthroughs such as TAVR and Hybrid therapy could provide timely relief as a cost-effective and time-saving strategy, thereby increasing profit margins for market players. Companies with research & development capabilities and technological prowess will gather momentum and profitability in the structural heart devices market. Leading players who are leveraging technology will continue to grow exponentially and have a vast market revenue share. However, stringent government regulations and high cost of minimally-invasive procedures could restrain the growth of the structural heart devices market.

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  • According to Transparency Market Research’s latest report on the global structural heart devices market for the historical (2017–2018) and forecast period (2019–2027), rise in the number of transcatheter aortic valve replacement procedures across the globe, new product launches by key players, surge in diagnostic rates, and increase in awareness about structural heart diseases are the major drivers of the global structural heart devices market.
  • The global structural heart devices market is estimated to reach ~US$ 13 Bn by 2027, growing at a CAGR of 7.5% from 2019 to 2027.

Surge in Minimally-invasive Procedures: A Key Driver

  • Minimally-invasive procedures are non-surgical procedures that enable minimal incision, shorter hospital stay, lesser complications, and faster recovery.
  • There has been an increase in the use of structural heart devices that can be implanted through a minimally-invasive approach. Transcatheter aortic valve replacement (TAVR) is a procedure that allows insertion of heart valves without the need of an open heart surgery.
  • According to the National Institute for Cardiovascular Outcomes Research (NICOR) U.K. TAVI and Adult Cardiac Surgery databases, 13,295 TAVR procedures were performed in the U.K. from 2007 to 2016.
  • Hence, increase in the awareness about the advantages of minimally-invasive surgery has led to a surge in the adoption of these procedures in cardiology.

Increase in Awareness about Structural Heart Devices and Favorable Reimbursement Policies Drive Market

  • The global structural heart devices market is expanding at a rapid pace, owing to a surge in the awareness about structural heart diseases and favorable reimbursement policies for structural heart devices and procedures.
  • Awareness about structural heart diseases is increasing among the general population. A number of public and privately-held organizations are conducting awareness programs highlighting the risk factors, symptoms, diagnosis, and treatment options for valvular heart disease and other heart defects. These awareness programs are likely to contribute to the growth of the global structural heart devices market.
  • In 2017, Alliance for Aging Research (a non-profit organization) conducted the National Heart Valve Disease Awareness Day program. The primary objective of the program was to ensure that more people are aware about the risks and symptoms of heart valve diseases.
  • The European Heart Valve Disease Awareness Day program was conducted in September 2018 to improve the diagnosis, treatment, and management of heart valve disease in Europe.
  • Favorable reimbursement policies is another major factor anticipated to boost the growth of the global structural heart devices market during the forecast period. In March 2018, Abbott Laboratories announced that MitraClip was granted national reimbursement in Japan, which enables greater access for patients to this life-altering therapy.
  • However, stringent government approval processes and the high cost of minimally-invasive procedures are anticipated to hamper the growth of the global structural heart devices market.

Global Structural Heart Devices Market: Key Segments

  • In terms of procedure, the global structural heart devices market has been categorized into biological/tissue valves, mechanical heart valves, annuloplasty rings, occluders, and accessories. The biological/tissue valves segment has been bifurcated into transcatheter heart valves and surgical heart valves.
  • The biological/tissue valves segment accounted for a leading share of the global structural heart devices market in 2018. The segment is likely to dominate the global market during the forecast period.
  • Based on procedure, the global structural heart devices market has been segregated into replacement procedures and repair procedures. The replacement procedures segment is projected to account for a significant share of the global market during the forecast period.
  • In terms of indication, the global structural heart devices market has been classified into valve stenosis, valve regurgitation, cardiomyopathy, congenital heart defects, and others. In terms of market share, the valve stenosis segment is expected to dominate the global structural heart devices market during the forecast period.
  • The market size and forecast for each of these segments has been provided from 2017 to 2027. The CAGRs of respective segments are also provided for the forecast period from 2019 to 2027, considering 2018 as the base year.

Structural Heart Devices Market: Competitive Landscape

  • Prominent players in the global structural heart devices market have been profiled based on attributes, such as company overview, product portfolio, financial overview, recent developments, and competitive business strategies.
  • The global structural heart devices market is consolidated, with the top three players accounting for ~80% share in 2018.
  • New product development for unmet needs such as mitral valve repair and replacement is a key strategy adopted by key players to be competitive in the global structural heart devices market. These players are also adopting inorganic growth strategies by acquiring small-scale manufacturers to expand market reach. These players strive to provide access to technologically-advanced devices for the treatment of structural heart diseases.
  • Major companies profiled in the global structural heart devices market report are
    • Medtronic
    • Abbott Laboratories
    • Boston Scientific Corporation
    • Edwards Lifesciences Corporation
    • LivaNova plc
    • Lepu Medical
    • Micro Interventional Devices, Inc.
    • Lifetech Scientific
    • NeovasCryoLife, Inc.

Structural Heart Devices Market: Key Developments

  • In January 2019, Abbott acquired Cephea Valve Technologies, Inc., which strengthened Abbott’s position in the global structural heart devices market.
  • In March 2019, Abbott received the FDA approval for its MitraClip for the treatment of heart failure patients and mitral regurgitation.
  • In December 2018, Boston Scientific Corporation acquired transcatheter mitral valve repair system developer - Millipede, Inc.
  • In July 2017, Medtronic received CE mark for its CoreValve Evolut PRO valve for aortic stenosis. This enabled the company to enhance its customer reach and strengthen its product platform in the structural heart devices market in Europe.

In the global structural heart devices market report, we have discussed individual strategies, followed by company profiles of the manufacturers of structural heart devices. The competitive landscape section is included in the report to provide readers with a dashboard view and a company market share analysis of the key players operating in the global structural heart devices market.

Structural Heart Devices Market - Scope of the Report

[230 Pages Report] TMR’s recent publication on the structural heart devices market for the forecast period of 2019-2027 is the result of detailed and comprehensive analysis provided by its top-rated analysts. The report provides projections in terms of both, value (US$ Mn) and volume (million units) for statistical evaluation of the structural heart devices market. Objective insights of the structural heart devices market provided herein will equip stakeholders in making impactful business decisions. So much so, the analysis provided is deemed to be game-changing for competitive dynamics in the structural heart devices market.

The report studies the past and current growth trends to provide reliable insights for the structural heart devices market for the 2019-2027 forecast period. Market indices including demand drivers, restraints, threats, and opportunities have been studied at length for their impact on the structural heart devices market for the forecast period. Analysis of SWOTs of the entire structural heart devices market over the forecast period is a highlight of this report.

The report on the structural heart devices market is prepared using industry-centric tools and proven research methodologies. Porter’s Five Forces analysis and SWOT analysis are some tools employed in an attempt to gather information on industry strongholds as well as areas for scope of improvement.

Apart from this, the competitive analysis of players in the structural heart devices market is a key feature of this report. This entails insights into mergers, acquisitions, partnerships, R&D, and technological innovations of key players to accelerate growth in the structural heart devices landscape.

Structural Heart Devices Market – Key Questions Answered in the Report

Adopting a holistic approach to analyze the structural heart devices market, authors of this report have provided answers to some critical questions pertinent to the said market;

  1. What are the key factors influencing growth in key regions of the structural heart devices market?
  2. What are prevalent trends and how are they likely to impact the scope of the structural heart devices market over the forecast period?
  3. What is the stance of players for growth in the structural heart devices market?
  4. What are revenue shares of key segments under various criteria in the structural heart devices market?
  5. What are the key developments likely to come to the fore in the structural heart devices market at the end of forecast period in 2027?

Structural Heart Devices Market – Research Objectives and Research Methodology

The making of the report involved extensive primary and secondary research carried out by seasoned analysts. They referred to proprietary databases and annual reports of companies for data collection. Secondary research involved reaching out to company websites, government websites, industrial publications, journals, trade associations, and government statistics. Face-to-face interviews carried out with industry leaders and opinion makers close the gaps between primary and secondary research.

Comprising a total of 14 sections, the entire compilation is presented in a chapter-wise layout for reading comprehensibility. The report contains an exhaustive collection of tables and graphs that are interspersed appropriately. Growth behaviour of key segments in the past as well as future projections are presented pictorially for ease of comparison.

Structural Heart Devices Market – Segmentation

In order to understand the finer details of the market, the report segments the structural heart devices market on the basis of product, procedure, indication, and region. This allows market stakeholders to assess incremental opportunities in this market landscape.

Product

Biological/Tissue Valves

  • Transcatheter Heart Valves
  • Surgical Heart Valves

Mechanical Heart Valves

Annuloplasty Rings

Occluders

Accessories

Procedure

Replacement Procedures

Repair Procedures

Indication

Valve Stenosis

Valve Regurgitation

Cardiomyopathy

Congenital Heart Defects

Others

Region

North America

Europe

Asia Pacific

Middle East and Africa

Latin America