HEMOSTASIS AND TISSUE SEALING AGENTS MARKET ANALYSIS

The global hemostasis and tissue sealing agents market size is valued at US$ 3.39 Billion in 2023 and is expected to reach US$ 4.95 Billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.6% from 2023 to 2030.

Hemostasis and tissue sealing agents are used to stop bleeding during surgery and trauma. There are two main types of products available in the market - mechanical and biological. Mechanical agents work by physically sticking to the tissue and sealing the wound to prevent blood loss. They provide quick hemostasis but are not absorbed by the body over time. The commonly used mechanical agents are surgical staplers, wound closure strips, and sutures.

The hemostasis and tissue sealing agents market is expected to witness steady growth due to the rising number of surgical procedures worldwide. The growing geriatric population, which is more susceptible to chronic diseases will positively influence the demand for effective hemostats and sealants.

Hemostasis and Tissue Sealing Agents Market Regional Insights

In 2023, North America dominated the hemostasis and tissue sealing agents market in terms of revenue share, followed by Europe and Asia Pacific. North America has dominated the global hemostasis and tissue sealing agents market over the past decade. The strong presence of leading medical device companies in the U.S., such as Ethicon (Johnson & Johnson), Baxter, Medtronic, and others, has established the region as a pioneer in developing innovative hemostatic and tissue sealing products. As per U.S. International Trade Commission data published in January 2022, medical devices accounted for over 45% of U.S. exports in 2021, indicating the large export potential of hemostasis products from the region.

Europe is also a significant market for hemostasis and tissue sealing agents market, owing to the high usage of topical hemostats frequently used in surgery to control minor bleeding and seal tissues. Their usage has grown significantly in Europe in recent years as minimally invasive procedures have become more widely adopted.

The Asia Pacific region has emerged as the fastest-growing market for hemostasis and tissue sealing agents over the recent past. According to statistics published by Asia Plastic Surgery in 2020, 22,642 surgical procedures were performed in Japan in 2020, indicating a large patient population requiring hemostasis management in postoperative care. Countries like China and India have also seen tremendous growth in their healthcare sectors, fueled by improving access, rising medical tourism, and increasing investments from both public and private players.

Figure 1. Global Hemostasis And Tissue Sealing Agents Market Share (%), By Region, 2023

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Analyst View

The increasing adoption of minimally invasive surgeries is also driving market growth as such procedures require effective hemostasis to control bleeding. North America currently dominates the market owing to factors such as high healthcare spending and regulatory approvals for advanced products in the region. However, Asia Pacific is poised to be the fastest-growing market in the coming years.

Hemostasis and Tissue Sealing Agents Market Drivers:

• Increasing Number of Surgical Procedures: One of the key drivers fueling the growth of the hemostasis and tissue sealing agents market is the rising volume of surgical procedures performed worldwide. As per recent estimates by the World Health Organization (WHO), over 312 million major surgical procedures are undertaken annually across the world. The surgical volume is steadily increasing on account of factors such as growing global population, notably the aging population segment that is more prone to chronic illnesses and injuries requiring surgical intervention. Several studies indicate that nearly one-third of the world's population is likely to undergo a surgical procedure at some point during their lifetime.
• Rise in Target Disease Incidence Rates: Another key factor stimulating the hemostasis and tissue sealing agents market is the increasing prevalence of target diseases that often require surgical interventions. As per recent estimates by the WHO, cardiovascular diseases remain the leading global cause of death, accounting for over 17.9 million deaths annually. Meanwhile, cancer incidence is also on the rise worldwide, with an estimated 19.3 million new cancer cases and 10 million cancer deaths occurring in 2020 alone. A few common types of cancer surgeries include lung cancer surgery, breast cancer surgery, prostate cancer surgery, and colorectal surgery. A majority of surgeries for heart diseases and cancer conditions involve extensive blood loss that needs to be controlled using hemostats and sealants.
• Technological advancements: Technological advancements are playing a major role in driving the growth of the hemostasis and tissue sealing agents market. With the rapid advancement in medical technology, newer methods and products for achieving hemostasis during surgery are being developed, which require the use of advanced hemostatic and sealing agents. Some of the key technological developments in this area include advanced energy devices for minimally invasive surgery, robot-assisted surgery platforms, and next-generation hemostatic products. Furthermore, technological developments are enabling newer approaches to tissue sealing, like mechanical, chemical, and biologic hemostatic agents. For instance, fibrin sealants are replacing sutures or staples for sealing incisions and are seeing higher adoption rates, especially in cardiovascular and neurosurgeries
• Increasing Awareness about Advanced Treatment Procedures: As medical technology continues to advance, more minimally invasive surgical procedures are becoming available to treat a wide variety of previously complex conditions. This has led to greater awareness among both physicians and patients about options for treatments that can reduce recovery times and trauma to the body compared to open surgeries. Hemostasis and tissue sealing agents play a key role in enabling many of these new procedures by helping to control bleeding and reinforce sutures or staple lines laparoscopically. As awareness grows of how such tools can improve outcomes for orthopedic, cardiovascular and neurological interventions, their demand is rising substantially.

Hemostasis and Tissue Sealing Agents Market Opportunities:

• Expansion into Emerging Economies: Emerging markets like Asia Pacific, Latin America, and Africa could present a great opportunity for growth in the hemostasis and tissue sealing agents market in the coming years. These regions are witnessing rapid economic development and a rise in disposable incomes. As a result, healthcare Infrastructure and facilities in these nations are strengthening significantly. This provides better access to advanced medical technologies and surgical procedures that utilize hemostasis and tissue sealing products. Furthermore, governments of many developing nations have implemented reforms to expand health insurance coverage and make healthcare more affordable to citizens. For instance, the Ayushman Bharat scheme launched by the Indian government in 2018 aims to cover over 500 million poor and vulnerable individuals with health insurance.
•  Development of Bio-Absorbable Hemostatic and Tissue Sealing Agents: The development of bio-absorbable hemostatic and tissue sealing agents can provide a great opportunity in the hemostasis and tissue sealing agents market. Bio-absorbable agents offer significant advantages over traditional agents as they get absorbed in the body over time and do not require removal. This reduces the procedural time and complications associated with product removal. As such, bio-absorbable agents improve patient outcomes and experiences. Several clinical studies indicate bio-absorbable agents are as effective as traditional agents in controlling bleeding and sealing tissues during surgeries. Additionally, they pose a minimal risk of post-procedure infections since the body safely absorbs these agents within days or weeks.
• Combination product offerings: Combination product offerings in hemostasis and tissue sealing agents could unlock significant opportunities in the market. With modern surgery becoming more complex, there is an increasing need for products that can efficiently and effectively achieve hemostasis as well as tissue sealing. Combination offerings that integrate these complementary capabilities into a single product will appeal greatly to surgeons and providers. By providing a more straightforward and streamlined surgical workflow, combination products allow for shorter procedure times and reduced costs. Surgeons can focus on the nuances of the surgery itself rather than toggling between separate hemostatic and sealing steps. This leads to better patient outcomes.

Hemostasis and Tissue Sealing Agents Market Trends:

• Adoption of non-invasive procedures: The healthcare industry has witnessed a significant rise in the adoption of minimally invasive and non-invasive surgical procedures over the past decade. Procedures like laparoscopy and endoscopy allow for smaller incisions and faster recovery times for patients compared to traditional open surgeries. This shift towards non-invasive options is positively impacting the hemostasis and tissue sealing agents market. As complex surgeries are increasingly performed using minimally invasive techniques, the need for effective hemostasis and tissue sealing agents to control bleeding through narrow access ports becomes even more important. Agents that can quickly seal tissues and blood vessels during such procedures help surgeons perform safer surgeries in less time.
• Shift towards Single-Use Hemostats and Glues: The shift towards single-use hemostats and glues is having a significant impact on the hemostasis and tissue sealing agents market. Hemostats and glues that are meant for single use are more convenient and help reduce the risk of infection by eliminating the need for reprocessing instruments. Many newer products entering the market are designed specifically for single use, which is becoming the preferred option, especially in minimal access surgeries. The shift has incentivized companies to innovate novel hemostats made from advanced materials as well as adopt sophisticated glues capable of rapid sealing within minutes. For instance, Ethicon (Johnson and Johnson), a medical technology company launched a new Surgicel Ultra hemostatic device in 2022 specifically formulated to aid bleed control during laparoscopic and robotic operations.
• Strategic collaborations: Strategic collaborations between companies in the hemostasis and tissue sealing agents market has become a major trend in recent years that is positively influencing market growth and dynamics. Through collaborations, companies are able to leverage each other's strengths and core competencies to develop innovative new products. This allows them to stay competitive and address the increasing complexity in medical needs. For instance, in March 2023, Siemens Healthineers, a multinational technology corporation signed a global Original equipment manufacturer (OEM) agreement on hemostasis products with Sysmex Corporation, a Japan based healthcare company under which each company will supply the other with their products in the diagnostic field of hemostasis on an OEM basis.

Hemostasis and Tissue Sealing Agents Market Restraints:

• High cost of hemostasis and tissue sealing devices: High cost of hemostasis and tissue sealing devices is significantly restraining the growth of the hemostasis and tissue sealing agents market. These advanced medical devices that help control bleeding during surgeries come at a very high price, which most hospitals and healthcare facilities in developing nations are unable to afford. According to data from the World Bank, about 1.53 billion people globally still lack access to even basic surgical care due to resource constraints within their healthcare systems. To overcome this restraint, the companies should focus on manufacturing cost effective products.
• Availability of Alternative Wound Closure Materials: The availability of alternative wound closure materials is providing strong competition to the hemostasis and tissue sealing agents market, thereby restraining its growth prospects. Various alternative options available for wound closure, such as surgical staplers, sutures, and adhesive bonding agents, are able to effectively manage hemorrhage and seal tissues. Staplers allow for precise apposition of tissues and edges with uniform compression across the wound. Different types of sutures, including absorbable and non-absorbable sutures, are favored by medical practitioners due to their long-lasting and secure closure of wounds without requiring removal. Furthermore, advanced tissue adhesives based on cyanoacrylate chemistry exhibit superior adhesive strength, bactericidal properties, and cause less pain compared to hemostats.
• Risks associated with hemostasis and tissue sealing products: One of the key risks restraining the growth of the hemostasis and tissue sealing agents market is the possibility of adverse effects and complications arising from the use of these products. All medical procedures and devices carry some risks; however, hemostasis and tissue sealing can potentially lead to issues like infection, scarring, bleeding, and damage to surrounding tissues if not used correctly. This poses regulatory hurdles for approvals and also increases liability concerns for manufacturers. Patients may hesitate to opt for procedures relying on these products due to the risks involved.

Recent Developments

New product launches/approvals

• In July 2023, Baxter International Inc., a company focused on advancing surgical innovation, announced the launch of PERCLOT Absorbable Hemostatic Powder in the U.S. PERCLOT is a passive, absorbable hemostatic powder that is ready to use and designed for patients with intact coagulation to address mild bleeding.
• In January 2023, Medcura, Inc., a medical device company, announced that the U.S. Food and Drug Administration (FDA) had granted the coveted breakthrough device designation for its LifeGel Absorbable Surgical Hemostat. LifeGel is the first and only hemostatic agent to receive breakthrough device designation seeking a new and highly differentiated indication: in surgical procedures (except in ophthalmic and urological) as an adjunctive hemostatic device.
• In April 2022, Ethicon, part of Johnson & Johnson MedTech, announced the launch of the ENSEAL X1 Straight Jaw Tissue Sealer, a new advanced bipolar energy device that cuts and transects, enables stronger sealing, and captures more tissue per bite than the LigaSure Blunt Tip, a tissue sealing device from Medtronic.

Acquisitions

• In 2021, BD, a global medical technology company, announced it had acquired Tissuemed, Ltd., a privately held firm headquartered in Leeds, England, that is an industry leader in developing self-adhesive surgical sealant films.
• In 2021, Baxter International Inc. announced its Baxter Healthcare Corporation subsidiary had completed the acquisition of certain assets related to the PerClot Polysaccharide Hemostatic System from CryoLife, Inc., cardiac and vascular surgery company.
• In February 2023, Advanced Medical Solutions Group plc, a global specialist in tissue-healing technologies, announced it had acquired Connexicon Medical Limited, a tissue adhesive technology specialist. The acquisition further strengthens AMS’s position in the US$ 300 million global tissue adhesive market, expands its product portfolio, and significantly enhances its technical and research and development capabilities in cyanoacrylate technology.

Figure 2. Global Hemostasis and Tissue Sealing Agents Market Share (%), By Product Type, 2023

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Top Companies in the Hemostasis and Tissue Sealing Agents Market

• Ethicon (a subsidiary of Johnson & Johnson)
• Baxter International
• CryoLife
• B. Braun Melsungen AG
• Covidien (now part of Medtronic)
• Integra LifeSciences
• Pfizer
• BD
• Teleflex
• Arch Therapeutics

Definition: Hemostats, also known as hemostatic agents or hemostatic products, are medical devices or substances that help stop bleeding, primarily during surgical procedures or to manage wounds. Tissue sealing agents, also known as tissue adhesives or surgical sealants, are medical products used to close or seal tissues in surgical and medical procedures. They serve to achieve hemostasis, prevent leaks, and enhance tissue repair and healing.