Bioprosthetics Market

Bioprosthetics Market Outlook (2023 to 2033)

The global bioprosthetics market size is valued at US$ 5.74 Billion in 2023, and is projected to reach US$ 16.30 Billion by 2033, growing at an impressive Compound Annual Growth Rate (CAGR) of 11.0% during the forecast period from 2023 to 2033.

The main types of bioprosthetics are allograft, xenograft, porcine, and bovine. Global demand for xenografts is predicted to increase at a similar CAGR of 11% from 2023 to 2033. Segment growth can be attributed due to the enumerated advantages of these implants, including their long-term stability, ease of availability of raw materials, higher survival rates, low manufacturing costs, and simplicity of implantation procedures. Their broad applicability in fields such as the creation of 3D-based tailored implants and tissue restoration applications makes them a more suitable option among the available bioprosthetics.

Animal tissue is used to create biological valves. They are made from donated human, pig, cow, or horse tissue. A xenograft is a form of animal tissue. The type that comes from a human heart donation is known as an allograft or homograft. To lessen the need for anti-rejection drugs, the valves are treated.

Porcine heart valve replacements have been successfully performed in humans for more than 30 years. It's interesting to note that a pig's heart resembles a human heart in terms of dimensions, mass, and structure.

Pig valve structural degeneration, also known as porcine heart valves, has been discovered to be increased in young to middle-aged individuals. Within four to seven years of the initial procedure, some of these younger patients required second valve replacement surgery. Patients over 60 years old had the highest success rate for porcine valve replacements.

Researchers showed that using a mechanical valve increased survivorship compared to using a porcine bioprosthetic aortic valve placement (76% vs. 66%) in a major randomised experiment, but there was no meaningful difference for patients who had received mitral valve replacement. In a subsequent, 20-year investigation, the survivorship rates showed little to no variation.

Demand for porcine-based devices is also increasing due to the rising R&D activities performed by various researchers due reduce any adverse allergic effects. Animal or human body parts or tissue are employed in bioprosthetics for medical purposes.

In medicine, replacing a missing body part artificially is referred to as a prosthesis. Most people think of prosthetics as devices that replace an absent limb or leg. Prostheses include prosthetic eyes and teeth in addition to the often-used replacements for bones, arteries, and heart valves. The term 'prosthesis' can also refer to devices such as eyeglasses and hearing aids that enhance the functionality of a body part. The medical speciality of prosthetics is the manufacturing of artificial body parts.

Sales of bioprosthetics are increasing rapidly due to the rising incidence of cardiovascular disorders such as rheumatic heart disease, and peripheral artery & coronary diseases, as well as the associated demand for long-term treatment. Furthermore, the growing geriatric population, which is known for having a higher propensity to acquire degenerative cardiac disorders, is expected to boost bioprosthetics market growth over the projected period.

Report Attributes	Details
Bioprosthetics Market Size (2023E)	US$ 5.74 Billion
Forecasted Market Value (2033F)	US$ 16.3 Billion
Global Market Growth Rate (2023 to 2033)	11% CAGR
China Market Growth Rate (2023 to 2033)	16% CAGR
Japan Market Growth Rate (2023 to 2033)	6% CAGR
Germany Market Growth Rate (2023 to 2033)	7.5% CAGR
Key Companies Profiled	Aortech International Plc; Braile Biomedica, Inc.; CryoLife, Inc.; Edwards Lifesciences Corporation; Ethicon, Inc.; Humacyte, Inc.; JenaValve Technology GmbH; Labcor Laboratorios Ltd.; LeMaitre Vascular, Inc.; LifeCell International

Which Market Trends are Driving High Demand for Bioprosthetic Implants?

“Development of Hybrid Tissue-engineered Bioprostheses Valves”

The creation of hybrid tissue-engineered bioprostheses, which use non-biodegradable, cultured tissue scaffolds enclosed in an alloy of nickel and titanium as strong and durable replacements for conventional, biodegradable tissue-engineered prosthetics, is the result of scientific advancements. The usage of completely synthetic artificial heart valves, which have been linked to high thrombogenicity and require the administration of anticoagulants to prevent concurrent embolic events, valve obstruction, and bleeding, is also anticipated to be gradually replaced by these developments.

Demand in bioprosthetics market is increasing rapidly as a result of these revolutionary solutions' ability to significantly lower the mortality and morbidity linked to heart valve replacement procedures. Additionally, the optimised tissue treatment procedures currently in use improve the prostheses' robustness and do away with the requirement for long-term medicines typically associated with prosthetics, both of which are raising sales of this vertical.

Furthermore, these tissue-engineered products' associated advantages, such as quicker recovery times and a generally better patient safety profile, are due to the development of hybrid constructs and improved tissue preservation techniques. These advantages result in better patient outcomes, which are predicted to influence both physician and patient preference for these implantable bioprostheses.

Several potential opportunities are generated in the bioprosthetics market due to the medical community's increasing preference for these alternative prostheses. The overall demand for the various prostheses is also predicted to be influenced by the increasing number of aortic and mitral valve replacements, as well as cases of damaged heart valves.

“Rising Preference for Minimally-Invasive Procedures and Introduction of Advanced Bioprosthetic Valves”

Demand for bioprosthetic heart valves is increasing as a result of a consistent shift toward minimally-invasive procedures among patients who are becoming more knowledgeable about their therapeutic alternatives. The demand for bioprosthetic aortic valves is also likely to be accelerated by the introduction of new implants and technological advancements.

• To enhance its use in the treatment of aortic stenosis patients who are at a lower risk for open heart procedures, Edward Lifesciences, for example, received the CE mark for Edwards SAPIEN 3 in November 2019.

Manufacturers have recently developed cutting-edge technologies that are efficient, long-lasting, less intrusive, and hemodynamically improved. These medical implants have several advantages and are surgically inserted into the body to replace defective or badly performing heart valves.

What May Prevent Sales of Bioprosthetics from Rising Faster?

“Risk of Several Infections after Surgeries”

People currently lead far more complex and sophisticated lives as a result of the tremendous evolution of lifestyles. Also connected to improper food and lifestyle choices are developing several heart problems.

An untidy lifestyle causes tissue damage and heart issues which increases the demand in bioprosthetics market. Thus, the market further may be constrained by issues such as the possibility of infections, the need for numerous procedures, incompatibility (tissue rejection), and the risk of uneven skin tone and scarring following operations, among others.

Country-wise Analysis

How are Bioprosthetic Sales Unfolding in the U.S.?

“Increasing Cases of Cardiovascular Diseases”

The demand for bioprosthetic valves in the United States is being driven by the rising prevalence of diseases including diabetes and obesity, rising investments in medical research and development, and the existence of favourable reimbursement schemes.

The prevalence of valvular heart disorders has been steadily increasing in the United States over time, necessitating the use of cardiac treatments such as transcatheter aortic valve replacement (TAVR). This trend is anticipated to continue throughout the forecast period.

• Heart disease is the top cause of death in the United States, according to the Centers for Disease Control and Prevention (CDC). Cardiovascular disease claims one life in the United States every 34 seconds.

Thus, as a result, the demand for bioprosthetic heart valves in the nation is increasing rapidly. Additionally, the market for bioprosthetics is rising as a result of ongoing technological developments in the healthcare industry and the rising acceptance of minimally-invasive procedures mainly due to the reduced demand for open-heart surgeries.

What is the Demand Outlook for Bioprosthetics in European Countries?

“Rapidly Rising Number of Minimally-Invasive Surgeries”

Germany, the U.K., and Italy are some of the major marketplaces for the medical sector in the European region due to rising medical tourism in these nations.

The demand for heart bio-implants in Germany is expanding as a result of factors including increased cardiac valve disease prevalence and rising demand for minimally-invasive surgeries such as transcatheter aortic valve replacement (TAVR).

The treatment for valvular heart problems known as transcatheter aortic valve replacement (TAVR) has developed over time into an alternate, minimally-invasive option. Around 18,000 TAVR procedures are carried out each year in 97 facilities in Germany employing around 7 different types of valves and better reimbursement guidelines.

How are Sales of Bioprosthetics Shaping Up in Asian Countries?

“Rapidly Developing Healthcare Systems in Asia”

Longer life is guaranteed by bioprosthetic implants. Due to a higher prevalence of cardiovascular disease in the region, several key manufacturers of bioprosthetic heart valve devices are investigating the untapped growth potential in Asian nations such as China, Japan, India, and South Korea.

Asia is home to many developing nations, and their healthcare systems are rapidly evolving. To give its inhabitants better care, respective governmental organisations are concentrating on developing their healthcare infrastructure. The Asia Pacific bioprosthetics market will expand more quickly as a result of the above-mentioned reasons.

The average lifespan of the Japanese is higher than that of the global population, and the rapidly growing number of the senior population is fueling the sales of bioprosthetic valves in the nation. Also, the working population of the nation is living a very stressful lifestyle, and the overburden of stress is leading to several heart-related disorders, which is again boosting sales growth.

Category-wise Analysis

Why are Cases of Cardiovascular Diseases Increasing Rapidly?

“Poor Dietary Habits and High Consumption of Alcohol & Tobacco”

According to the World Health Organization, cardiovascular disease is the leading cause of mortality globally. The main causes of the rise in cardiovascular disease instances include high salt intake, rising tobacco usage, rising cigarette use, and excessive alcohol use.

Cardiovascular problems are more prevalent because of depression, sedentary behaviour, and poor dietary habits. Thus, the demand for bio-implants is increasing rapidly due to the aforementioned reasons.

Competitive Landscape

Some of the key players in the bioprosthetics market are Aortech International Plc, Braile Biomedica, Inc., CryoLife, Inc., Edwards Lifesciences Corporation, Ethicon, Inc., Humacyte, Inc., JenaValve Technology GmbH, and Labcor Laboratorios Ltd.

Leading companies in the bioprosthetics market are strongly investing in R&D and producing advanced bio-implants as well as they are adopting various organic and inorganic strategies to earn more income.

• Aortic disease-focused cardiac and vascular surgery company CryoLife, Inc. announced in January 2022 that it would change its name and brand to Artivion, Inc. with immediate effect. The company's new name and brand, which are derived from the words "aorta," "innovation," and "vision," reflect its evolution to focus on offering cutting-edge solutions to surgeons who treat patients with aortic diseases.

Key Segments Covered in Bioprosthetics Industry Research

• By Type :

  • Allograft
  • Xenograft
  • Porcine
  • Bovine

• By Application :

  • Cardiovascular
  • Plastic Surgeries
  • Wound Healing

• By Region :

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia & Oceania
  • MEA