The global transcatheter mitral valve market is expected to reach a valuation of USD 1.6 billion by the end of 2024 and expand at a CAGR of 10.8%. The market is anticipated to be valued at USD 3.0 billion by 2034.
With increasing ageing population and rising cases of mitral valve regurgitation, transcatheter mitral valve replacement is playing an important role in the field of transcatheter therapeutics. As mitral regurgitation is still considered to be one of the most prevalent forms of valve disease in the world, the market is expected to grow at a rapid pace.
Position of the mitral valve, technique used for anchoring a valve replacement, and considerations revolving around left ventricular outflow tract obstruction have made the transcatheter valve replacement process challenging. Despite the obstacles, both transapical and transseptal devices are being developed at present, with several ongoing feasibility trials across the globe.
Global Transcatheter Mitral Valve Market Assessment
| Attributes | Key Insights |
|---|---|
| Estimated Size, 2024 | USD 1.6 billion |
| Projected Size, 2034 | USD 3.0 billion |
| Value-based CAGR (2024 to 2034) | 10.8% |
Advanced imaging techniques, such as 3D echocardiography and cardiac MRI, are enhancing pre procedural planning and valve deployment accuracy are transforming the market. The development of next generation transcatheter mitral valve devices with increased durability and biocompatibility improves procedure results and patient safety.
Mitral valve abnormalities, such as mitral regurgitation and stenosis, are becoming more common as the population ages and the prevalence of cardiovascular illnesses increases. This spike is driving up demand for less invasive procedures such as transcatheter mitral valve replacement, which provide an alternative to traditional open heart surgery, particularly for high risk patients.
This technique is now being used to treat secondary mitral regurgitation as well as other difficult valvular diseases. Ongoing clinical trials are generating strong evidence on the safety and efficacy of transcatheter mitral valve devices, opening the door for expanded indications and regulatory clearances. This expansion is projected to accelerate market growth in the next ten years.
Key competitors in the market are actively collaborating, partnering, and merging to expand their product portfolios and geographical reach. The agreements facilitate the sharing of expertise, speed up product development, and improve access to innovative this technology in emerging markets.
There is a clear movement toward patient-centered care, with an emphasis on tailored treatment programs and better patient outcomes. This trend is pushing the development of personalized transcatheter mitral valve solutions based on unique patient anatomy and clinical demands, resulting in higher procedural success rates and patient satisfaction.
Evolving regulatory frameworks and advantageous reimbursement policies are also driving market expansion. Streamlined approval processes and acceptable insurance coverage are increasing transcatheter mitral valve usage, making them more accessible to a larger patient group.
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The above table presents the expected CAGR for the global transcatheter mitral valve market over several semi-annual periods spanning from 2024 to 2034. In the first half (H1) of the decade from 2023 to 2033, the market is predicted to surge at a CAGR of 12.5%, followed by a slightly higher growth rate of 12.2% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 12.5% (2023 to 2033) |
| H2 | 12.2% (2023 to 2033) |
| H1 | 10.9% (2024 to 2034) |
| H2 | 10.7% (2024 to 2034) |
Moving into the subsequent period, from H1 2024 to H2 2034, the CAGR is projected to drop to 10.9% in the first half and remain relatively moderate at 10.7% in the second half.
New Product launches to Fuel Demand for Market
The transcatheter mitral valve in valve approach using a balloon expandable valve has become the procedure of choice for high surgical risk patients with degenerated surgical mitral valve bioprostheses. Over 30 transcatheter mitral valve replacement devices are currently being developed and the area is constantly growing.
The majority of the devices are still in the initial phases of safety and feasibility assessment. The following TMVR devices are currently under development and clinical testing: SAPIEN M3 (Edwards Lifesciences Inc.), HighLife Bioprosthesis and Subannular Implant (HighLife SAS), FORTIS (Edwards Lifesciences Inc.), Tiara (Neovasc Inc.), Cardiovalve (Cardiovalve), Tendyne (Abbott Inc.), Intrepid (Medtronic Inc.), NaviGate (NaviGate Cardiac Structures Inc.), CardiAQ/EVOQUE (Edwards Lifesciences Inc.) and Caisson (LivaNova)
Increasing number of expected product launches is projected to drive the demand for market in the upcoming decade. Key players in various parts of the globe are also set to gain fast track approvals from regulatory bodies to distribute and market their in house products, which would aid growth.
Cases of Product Discontinuation and Limitations Associated with are Restraining Market Growth
Mitral valves make a fully percutaneous valve replacement even more complex owing to their position and intricacy. Multiple transcatheter repair procedures have been developed to address the range of etiologies of mitral regurgitation. The procedures typically target only one anatomic feature of the mitral valve apparatus.
In the USA, MitraClip edge to edge repair is the only transcatheter therapy which has been approved by regulatory bodies for commercial application. Despite being beneficial for many patients living with primary mitral regurgitation, subsequent mitral regurgitation, and prohibitive surgical risks, this has limits.
The limitations include immobile leaflets, calcified leaflets due to past radiation therapy or rheumatic disease, healed endocarditis, clefts, and numerous jets, which are not suited for MitraClip repair.
FORTIS valve, which was developed by Edwards Lifesciences and was initially implanted in 2014, is a self expanding bovine pericardial valve set on a nitinol stent frame. In depth research into the device has been discontinued due to early reports of high incidence of valve thrombosis.
Similar cases of product discontinuation and limitations associated with transcatheter mitral valve replacement procedures may hamper the global transcatheter mitral valve market during the forecast period.
Principal Consultant
The market exhibited a CAGR of 10.2%. Advancements in transcatheter technologies have transformed the treatment procedures of aortic valve disease, thereby resulting in the approval of transcatheter aortic valve replacement for patients of all risk categories.
In various parts of the globe, mitral regurgitation is the most common type of valve illness. This becomes more common as people become older, with a prevalence rate of 0.5% in young adults (18 to 44 years) and about 10% in seniors (aged 75 years and older).
Owing to the rapid advancements of heart failure therapies, incidence rate of ischemic heart disease is expected to surge. This is further set to result in the growing number of functional mitral regurgitation cases.
Rising life expectancy of people in developed countries has also resulted in increasing prevalence of mitral valve disease among the geriatric population. Conventional surgical therapy methods may not be suitable for older adults because of anatomic restrictions or greater surgical risks.
As a result, both physician investigators and the transcatheter therapeutics industry are expanding at a rapid pace to develop a new transcatheter approach to mitral valve replacement. Usual dangers of surgery can also be avoided due to the less invasive nature of transcatheter treatment, allowing for symptomatic relief without higher early perioperative risk.
Majority of the symptomatic severe mitral regurgitation patients are not recommended for standard surgery due to their high risk profiles, as well as absence of proof of a surgery impact on difficult outcomes.
Although treating severe secondary mitral regurgitation may not improve mortality, this is likely to enhance its symptoms. In such scenarios, a transcatheter approach to mitral valve regurgitation treatment is considered to be a viable option.
Owing to the aforementioned factors, the global industry is expected to grow at a CAGR of 10.8% during the forecast period from 2024 to 2034.
The transcatheter mitral valve market, with a total value of USD 1044.1 million, is highly concentrated among its top competitors. Tier 1 players dominate this industry, accounting for 49% of the total. To preserve their industry positions, the prominent corporations rely on considerable research and development skills, cutting edge technology, and powerful distribution networks.
Their supremacy is further strengthened by considerable investments in innovation, which enable them to provide cutting edge transcatheter mitral valve solutions and improve patient results.
Tier 2 players control 38% of the industry. Tier 2 players, while not as large as Tier 1 firms, are important to driving industry growth through competitive pricing tactics and specialty product offers. Tier 2 players frequently target specific segments or regions, capitalizing on developing possibilities and filling gaps created by larger firms. Their speed and specific concentration allow them to react rapidly to industry needs and technical changes.
The market concentration depicts a competitive landscape in which Tier 1 and Tier 2 players have substantial impact over industry trends and growth. Their collaborative efforts in discovery, strategic alliances, and industry growth are critical to determining the future this therapy. This specialization emphasizes the need of ongoing innovation and strategic maneuvers in maintaining and improving industry positions in this changing industry.
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The section below covers the industry analysis for the industry for different countries. Industry demand analysis on key countries in several regions of the globe, including North America, Asia Pacific, Europe, and others, is provided. The United States is anticipated to ascend at a CAGR of 12.8% through 2034. In Asia Pacific, China is projected to witness a CAGR of 11.7% by 2034.
| Countries | Value CAGR (2024 to 2034) |
|---|---|
| The United States | 12.8% |
| China | 11.7% |
| Germany | 10% |
| France | 9.6% |
| Italy | 9.2% |
The United States is likely to ascend at a CAGR of 12.8% over the projected period. The Centers for Medicare & Medicaid Services (CMS) has expanded coverage for transcatheter edge to edge treatments for patients with secondary mitral regurgitation.
This has currently doubled the number of patients eligible under previous coverage guidelines in the U.S. Such initiatives are anticipated to surge the focus of several companies on venturing into the mitral space. The aforementioned factors are likely to propel the industry growth in the country throughout the forecast period.
Germany is likely to ascend at a CAGR of 10% over the projected period. The country is rapidly gaining importance as a crucial hub for medical tourism. Availability of various low cost procedures with the ongoing development of technologically advanced equipment, as well as presence of favorable reimbursements for both national citizens and immigrants is set to propel industry growth in the country.
China is likely to ascend at a CAGR of 11.7% over the projected period. Mechanical heart valves are immensely popular in China, despite the fact of being less common in developed markets. Increasing prevalence of rheumatic fever that causes valve damage in early childhood, particularly to the mitral valve, is anticipated to boost growth.
Mechanical heart valves are preferred for circumstances when durability is a major concern, despite downsides such as higher cost and more complicated procedures. Growing concerns regarding cardiac health and increasing prevalence of rheumatic diseases in the country are set to open new opportunities for established players to expand their presence in China.
The section contains information about the leading segments in the industry By product, the transcatheter mitral valve repair segment held a industry share of 82.4% in 2023. The hospitals segment held the largest transcatheter mitral valve market share of 36.7% in 2023.
| Product | Transcatheter Mitral Valve Repair |
|---|---|
| Value Share (2023) | 82.4% |
By product, the transcatheter mitral valve repair segment held an industry share of 82.4% in 2023. Transcatheter mitral valve repair can improve left ventricular function preservation with lower operative mortality. This can provide higher independence from prosthetic valve related complications such as thrombosis, anticoagulant related bleeding, and endocarditis.
| End User | Hospitals |
|---|---|
| Value Share (2023) | 36.7% |
In terms of end user, the hospitals segment held the largest industry share of 36.7% in 2023. Increasing number of cardiac procedures in various countries on the back of surging development in the field of mitral valves is anticipated to drive the segment.
Government investments in the improvement of healthcare infrastructure are estimated to push the adoption of technologically advanced tools in hospitals. Increasing number of mitral valve repair and replacement procedures in hospital settings is another vital factor that would fuel the segment in future.
The global transcatheter mitral valve market is dominated by two industry players, namely, Abbott and Edwards. Both companies are mainly focusing on the development of ground breaking technologies to serve and support patients suffering from mitral and tricuspid regurgitation.
The companies have licensed and patented their technologies within the domain, wherein, expiration of licenses and patent protection can affect future revenues and operating income of key players.
Recent Developments:
In terms of product, the industry is divided into transcatheter mitral valve replacement and transcatheter mitral valve repair.
In terms of indication, the industry is segregated into mitral stenosis and mitral regurgitation.
The industry is classified by end user as hospitals, ambulatory surgical centers and cardiac catheterization laboratories
Key countries of North America, Latin America, Western Europe, South Asia, East Asia, Eastern Europe and Middle East & Africa have been covered in the report.
The global industry is projected to witness CAGR of 10.8% between 2024 and 2034.
The global transcatheter mitral valve industry stood at USD 1.2 billion in 2023.
The global transcatheter mitral valve market is anticipated to reach USD 3.0 billion by 2034 end.
Canada is set to record the highest CAGR of 13.4% in the assessment period.
The key players operating in the industry include HLT Inc, Coramaze Technologies, Medtronic, Biotronik and NeoChord, Inc.
1. Executive Summary 2. Industry Introduction, including Taxonomy and Market Definition 3. Market Trends and Success Factors, including Macro-economic Factors, Market Dynamics, and Recent Industry Developments 4. Global Market Demand Analysis 2019 to 2023 and Forecast 2024 to 2034, including Historical Analysis and Future Projections 5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034 5.1. Product 5.2. Indication 5.3. End User 6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Product 6.1. Replacement 6.2. Repair 7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Indication 7.1. Mitral Stenosis 7.2. Mitral Regurgitation 8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By End User 8.1. Hospitals 8.2. Ambulatory Surgical Centers 8.3. Cardiac Catheterization Laboratories 9. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Region 9.1. North America 9.2. Latin America 9.3. Western Europe 9.4. South Asia 9.5. East Asia 9.6. Eastern Europe 9.7. Middle East & Africa 10. North America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 11. Latin America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 12. Western Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 13. South Asia Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 14. East Asia Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 15. Eastern Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 16. Middle East & Africa Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 17. Sales Forecast 2024 to 2034 by Product, Indication, and End User for 30 Countries 18. Competition Outlook, including Market Structure Analysis, Company Share Analysis by Key Players, and Competition Dashboard 19. Company Profile 19.1. HLT Inc 19.2. Coramaze Technologies 19.3. Medtronic 19.4. Biotronik 19.5. NeoChord, Inc. 19.6. Colibri Heart Valve LLC 19.7. Neovasc 19.8. Edwards Lifesciences Corporation 19.9. Abbott Laboratories 19.10. LIVANOVA PLC
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Transcatheter Mitral Valve Market
