In spite of advancements in treatment, the high morbidity and mortality rate associated with heart failure are driving the global absorbable antibacterial envelope market. Mortality in patients with heart failure is not only caused by hemodynamic failure, but also by ventricular arrhythmias. The adoption of implantable cardioverter defibrillators (ICDs) to reduce arrhythmic sudden deaths is projected to boost the market in the future years. Additionally, cardiac resynchronization therapy (CRT) is a promising treatment option for people with heart failure. Growth in the older population, an increase in the number of people adopting sedentary lifestyles, a rise in the use of tobacco and alcohol, and the adoption of an imbalanced diet are predicted to drive the absorbable antibacterial envelopes market. To increase their market share, manufacturers are working on developing cost-effective and effective heart failure treatments.

A heart-implantable electronic device or an implanted neurostimulator is enclosed in a single-use absorbable antimicrobial envelope. Its purpose is to stabilize the implanted device and deliver antibacterial drugs. This material can be created using multifilament, knitted absorbable mesh, or extracellular matrix (ECM) derived from pig small intestinal submucosa. Within a few weeks of implantation, the envelope is totally absorbed by the body. Arrhythmias or irregular heart rhythms are treated with implantable cardioverter defibrillators, cardiac resynchronization therapy defibrillators, and cardiac resynchronization therapy pacemakers. These devices are surgically implanted into the body to ensure that the individual's heart beats at a consistent rhythm. During the forecast period, the high prevalence of cardiovascular illnesses worldwide and ongoing research & development initiatives for product enhancements are predicted to drive industry expansion.

Cardiovascular diseases (CVDs) are the leading cause of death on a global scale. According to the World Health Organization (WHO), cardiovascular illnesses account for around 17.9 million deaths yearly or 31% of all global deaths. According to the CDC, approximately 6.7% of 20-year-old and older Americans have coronary artery disease (CAD). Two deaths per ten are caused by CAD in adults under the age of 65. Changing lifestyles and a rise in the frequency of diabetes and pre-diabetes have contributed to a rise in the prevalence of cardiovascular diseases in emerging countries. Consequently, the growth in the prevalence of cardiovascular illness promotes demand for cardiovascular monitoring devices. As a result, the presence of a large patient population with cardiovascular problems is predicted to fuel market expansion over the next years.

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According to a study published in the American Journal of Medicine, the U.S. population is rapidly aging. It is expected that increased life expectancy will result in a doubling of the population aged 65 or over (from 40 million people in 2010 to 81 million by 2040). The majority of the increase in the incidence of chronic diseases such as hypertension and excessive cholesterol is related to aging. Unquestionably, this will boost the need for cardiac surgeries to treat heart failure. Mortality rates are higher in Eastern Europe and middle-income countries. Low- and middle-income countries have higher cardiovascular disease mortality rates than developed nations. As a result, the aging of the population is driving up demand for cardiac implantable electronic devices (CIEDs) such as pacemakers and defibrillators. This is anticipated to promote market expansion over the predicted period.

The cardiac resynchronization therapy-defibrillator (CRT-D) application segment dominated the global market for absorbable antibacterial envelopes in 2021, accounting for about 40% of the total market. CRT-D is a customized device used to treat heart failure patients and those at risk of sudden cardiac death. The device can also prevent cardiac arrest brought on by heart rates over 100 beats per minute. If the CRT-D device detects abnormally rapid heartbeats, it delivers an electric shock (defibrillation) to the heart. This electrical impulse stops any aberrant cardiac beats.

The hospital segment is predicted to account for the highest share of the global absorbable antibacterial envelope market by end-user during the period from 2024 to 2032. The hospital market is dominated by the increased usage of absorbable antibacterial envelopes in cardiac implanted devices throughout hospitals. The market for ambulatory surgical centers is anticipated to increase at a quick CAGR between 2024 and 2032. During the forecast period, the segment is predicted to be driven by an increase in demand for ambulatory surgery centers, which provide cardiac patients and cardiovascular procedures with high-quality, cost-effective surroundings.

North America held the largest market share in 2021, surpassing 40%. The regional industry is projected to increase at a CAGR of 5.5% between 2024 and 2032. Only Medtronic plc and Aziyo Biologics, Inc. have reported significant sales of commercially available absorbable antibacterial envelopes.

In 2021, the Asia-Pacific region had the highest growth rate. During the forecast period, the region's business is predicted to increase at a CAGR of 6.5%. This is a result of large populations in countries such as India and China, a large elderly population in Japan, and the enhancement of health care systems. In addition, an increase in cardiovascular disease awareness and the untapped market potential is expected to enhance the market growth in the region throughout the forecast period.

Only two major competitors dominate the market for absorbable antibacterial envelopes. The key strategies utilized by the competitors are product development and mergers and acquisitions. The industry is highly concentrated, with a small number of players. Included among the market leaders are Medtronic plc and Aziyo Biologics, Inc.

Important Market Trends in the Absorbable Antibacterial Envelope Industry

• Aziyo Biologics, Inc. revealed in April 2023 that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for their next-generation biomaterial envelope for use with implantable electronic devices, CanGaroo RM Antibacterial Envelope (IED). The company intends to introduce in the United States a version of its FDA-approved CanGaroo envelope comprising Rifampin and Minocycline in dissolvable polymer rings. The intention of adding antibiotics to the biomaterial envelope is to reduce the chance of bacterial colonization.
• In February 2021, India Medtronic Private Limited announced the release of the TYRX Absorbable Antibacterial Envelope (TYRX Envelope), an absorbable, single-use antibacterial envelope that stabilizes a cardiac implantable electronic device (CIED) or implanted neurostimulator for seven days while releasing antimicrobial agents.
• In January 2021, Aziyo Biologics, Inc. acquired CE Mark authorization for modified CanGaroo Envelope labeling to allow for the addition of gentamicin. The CanGaroo Envelope readings have not been altered. Nonetheless, this approval now permits the envelope to be hydrated in a gentamicin solution prior to implantation as part of the device preparation. In preclinical studies, soaking the CanGaroo Envelope in gentamicin prior to usage suppressed or limited bacterial growth.
• Medtronic plc revealed additional WRAP-IT research findings in September 2020. Statistics show that the TYRX Absorbable Antibacterial Envelope (TYRX Envelope) is cost-effective for receivers of cardiac implantable electronic devices who are at a high risk of infection (CIEDs). The research demonstrates that the envelope is more cost-effective than conventional infection prevention strategies in the American healthcare system.