Transcatheter Heart Valve Replacement (THVR) Market Size, Share & Industry Analysis, By Product Type (Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Replacement (TMVR), and Transcatheter Pulmonary Valve Replacement (TPVR)), By End User (Hospitals, and Specialty Clinics& Others), and Regional Forecast, 2019-2026

The global transcatheter heart valve replacement market size was valued at USD 4.04 billion in 2018 and is projected to reach USD 10.34 billion by 2026, exhibiting a CAGR of 12.5% during the forecast period. North America dominated the global market with a share of 40.1% in 2018.

Valve regurgitation and valve diseases are emerging as one of the leading cause of deaths. According to the American Heart Association, bicuspid aortic valve defects occur in 13.7 per 1,000 people in the U.S. This rising prevalence of cardiac valve disorders coupled with active government interventions has surged the demand for transcatheter heart valve replacement. Furthermore, green signal from the government for the launch of new products and advantages of transcatheter technology over surgical valve are contributing to the demand for transcatheter heart valve replacement. According to the article “The Year in Cardiology 2017 - Valvular Heart Disease,” published in the European Heart Journal, the total number of aortic valve replacement procedure in the world is projected to reach 850,000 by 2020. Apart from this, the rising obese population and growing prevalence of congenital heart diseases are positively impacting the market.

Global Transcatheter Heart Valve Replacement (THVR) Market Overview

Market Size & Forecast:

• 2018 Market Size: USD 4.04 billion
• 2026 Forecast Market Size: USD 10.34 billion
• CAGR: 12.5% from 2019–2026

Market Share:

• North America held the largest share at 40.1% in 2018, supported by high prevalence of valve disorders, active government support, favorable reimbursement policies, and rapid adoption of minimally invasive solutions.
• By Product Type, Transcatheter Aortic Valve Replacement (TAVR) dominated in 2018 due to the large patient base for aortic stenosis treatment, availability of novel devices, and proven clinical outcomes; it is projected to hold an 80.4% share by 2025.

Key Country Highlights:

• Japan: Market expected to reach USD 299.1 million by 2025, driven by aging demographics, early adoption of advanced heart valve technologies, and government-backed approvals.
• United States: CMS reimbursement policy updates in 2019 increased minimum procedure requirements, fostering higher procedure volumes; ~90,000 valve substitutes implanted annually.
• China: Projected CAGR of 13.60% due to rapid adoption of transcatheter procedures, growing elderly population, and expanding cardiac care infrastructure.
• Europe: 12% CAGR expected, with Germany leading in procedure volumes—over 12,900 transcatheter interventions in 2017—boosted by new product launches and strategic collaborations.

MARKET TRENDS

Manufacturers focusing on the Development of Mitral Valve Product will drive the Market

Transcatheter Mitral Valve Replacement (TMVR) in transcatheter heart valve replacement is emerging as a new frontier in the market owing to the increasing research investment by major manufacturers. Unmet treatment needs of patients and limited products available in the market have triggered various manufacturers to develop new TMVR products and enter into strategic collaborations. Many of the TMVR products are currently under investigational stage. 

For example, Shanghai NewMed Medical Co., Ltd. is conducting clinical trials for Mi-thos, transcatheter mitral valve replacement product. Similar researches are projected to further boost the market during 2019-2026.

MARKET DRIVERS

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• North America witnessed a growth from USD 1.44 Billion in 2017 to USD 1.62 Billion in 2018.

Favorable Health Reimbursement to Boost Market

Adequate government as well as private reimbursement policies for transcatheter heart valve replacement is resulting in increasing number of procedures which is fostering the demand for these products. In June 2019, Centers for Medicare & Medicaid Services (CMS) updated the reimbursement policies for THVR. The updated rule increased the procedure volume requirement for reimbursement of transcatheter heart valve replacement. 

Also, according to the new rule, hospitals in the U.S. that want to maintain the existing transcatheter heart valve replacement programs, are required to perform at least 50 aortic valve replacement including 20 TAVR procedures every year. This is projected to drive the transcatheter heart valve replacement market growth.

Launch of Innovative Products to Favor the Market Growth

Introduction of new products for the transcatheter heart valve replacement is expected to provide significant boost to the market. Introduction of transcatheter technology in the era where people are rapidly moving towards minimally invasive treatment options is anticipated to favor the THVR market growth during the forecast period. 

For example, in September 2019, Medtronic announced the launch of Evolut PRO+, a transcatheter aortic valve replacement (TAVR) system in the U.S. In addition to this, proven clinical studies highlighting the safety of transcatheter heart valve when compared to surgical valves, improved clinical outcomes, and less complications are likely to foster the market.

MARKET RESTRAINT

Presence of Alternative Products to Hinder Market

In spite of advantages of minimally invasive transcatheter technology; many regions especially the emerging countries still use the traditional surgical valves. There is a significant demand for the surgical valves among patients. This is mainly because surgical valves are more durable than transcatheter ones and can last lifelong. Established presence of surgical valve is one of the major factors that can hamper the market.

SEGMENTATION

By Product Type Analysis

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Unmet Patient Needs to Provide High Growth to the TMVR Segment

Based on product type, the market is segmented into Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral Valve Replacement (TMVR), and Transcatheter Pulmonary Valve Replacement (TPVR). The TAVR segment is estimated to account for a major portion of the market in 2018 owing to the increasing number of transcatheter aortic valve replacement and availability of novel products. For instance, in November 2019, Edward Lifesciences received CE mark for Edwards SAPIEN 3 for the treatment of patients with aortic stenosis having lower risk for open heart surgery.

• The Transcatheter Aortic Valve Replacement segment is expected to hold a 80.2% share in 2018.

Huge unmet needs of patient population requiring mitral valve treatment are anticipated to render remarkable business opportunities for the Transcatheter Mitral Valve Replacement (TMVR) segment. According to a report by Edwards Lifesciences, less than 2% of the patients with mitral valve disease receive interventions, leaving millions of patients in need of treatment. This represents the potential growth opportunities present in the TMVR segment in the forecoming years. Increasing number of births with congenital heart defects and rising need for interventional pulmonary valve products are anticipated to foster the expansion of Transcatheter Pulmonary Valve Replacement (TPVR) during the forecast period. The transcatheter aortic valve replacement (TAVR) segment is expected to hold a 80.4% share in 2025.

In March 2017, Medtronic received FDA approval for Melody, a transcatheter pulmonary valve for patients with congenital heart diseases. This is expected to augment the TPVR segment.

By End User Analysis

Improving Government Guidelines for Valve Disease to Drive Hospital Segment

In terms of end user, the transcatheter heart valve replacement market is segmented into hospitals and specialty clinics & others. The hospital segment dominated the market owing to the favorable health reimbursement and rising number of procedures in hospitals. Furthermore, improving government guidelines for the management for vulvar diseases is another factor contributing to the expansion of the hospital segment. The specialty clinics & others segment for THVR procedures is projected to grow during the projected period owing to the significant increase in the number of private cardiologists and unmet needs of patient population. The hospitals segment is projected to generate USD 7,336.7 million in revenue by 2025.

REGIONAL ANALYSIS

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The transcatheter heart valve replacement market size in North America stood at USD 1.62 billion in 2018.Active government support through product approvals and favorable health reimbursement are the major factors attributed to the increasing demand for transcatheter heart valve replacement products. According to the American Heart Association, 90,000 valve substitutes are implanted in the U.S. every year which is likely to augment the market in North America. The increasing prevalence for cardiac valve diseases and the rising demand for minimally invasive products are estimated to augment the transcatheter heart valve replacement procedures in Europe. 

• Europe is anticipated to grow at a CAGR of 12.0% during the forecast period.

According to the German Heart Surgery Report, a total of 34,394 heart valve procedures were conducted in Germany in 2017, among which, 12,965 were performed through transcatheter interventions. This, coupled with new product launches and strategic collaborations are likely to boost the market in Europe. In Asia Pacific, the market is projected to grow significantly, which can be attributed to the rapid adoption of transcatheter valves, rising geriatric and obese population, and strong government support. Primary reasons for the growth of the market in Latin America and the Middle East & Africa are the rising cases of heart valve leakage and improving health infrastructure. 

• The transcatheter heart valve replacement market in Japan is expected to reach USD 299.1 million by 2025.
• China is projected to witness a strong CAGR of 13.60% during the forecast period.

According to Innovus, a technology transfer company owned by Stellenbosch University, approximately 1,400 aortic valve replacements are done annually in South Africa, which in turn is boosting the market in the Middle East and Africa.

KEY INDUSTRY PLAYERS

Edwards Lifesciences and Abbott to Lead the transcatheter heart valve replacement Market

In terms of the market revenue, Edwards Lifesciences accounted for the maximum portion of the market, mainly due to the higher sales of SAPIEN, new product approvals, and diverse product portfolio of the company. Increased focus of the company on developing products to best match the requirements of the patients is expected to strengthen the company’s position in the overall market. On the other side, the acquisition of St. Jude Medical, Inc. rendered second position to Abbott owing to the increasing investments on the development of new products to maintain its market position.

LIST OF KEY COMPANIES PROFILED:

• Edwards Lifesciences Corporation
• Abbott
• Medtronic
• LivaNova PLC
• Boston Scientific Corporation
• CryoLife, Inc.
• Micro Interventional Devices, Inc.
• Others

KEY INDUSTRY DEVELOPMENTS:

• September 2019 - Medtronic announced the launch of Evolut PRO+, a transcatheter aortic valve replacement (TAVR) system in the U.S.
• November 2019 - Edward Lifesciences received CE mark for Edwards SAPIEN 3 to expand its use for the treatment of patients with aortic stenosis having lower risk for open heart surgery.
• March 2017 - In March 2017, Medtronic received FDA approval for Melody, a transcatheter pulmonary valve for patients with congenital heart diseases.

REPORT COVERAGE

An Infographic Representation of Transcatheter Heart Valve Replacement Market

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The transcatheter heart valve replacement (THVR) market report offers an elaborative analysis of numerous factors affecting the market. These include opportunities, growth drivers, threats, key developments, and restraints. In addition to this, the THVR market report further helps in analyzing, segmenting, and defining the transcatheter heart valve replacement based on different segments such as product type and end user. It strategically analyzes several strategies such as product innovations, mergers, alliances, joint ventures, and acquisitions adopted by players in the industry.

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