HEMOSTATIC SPRAY MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

Market Challenges And Opportunities

• Stringent regulatory policies
• High costs of hemostatic spray products 
• Risk of adverse effects

Restraints & Challenges:

• Stringent regulatory policies: The stringent regulatory policies surrounding approval of hemostatic spray products are a major restraint for the market growth. Hemostatic agents need to undergo extensive preclinical and clinical evaluations to prove product safety and efficacy. Companies need to establish sterility, lack of adverse events, biosafety, and performance consistency before regulator bodies like U.S. FDA. The overall stringent approval processes are leading to increased R&D costs and longer timelines from development to commercialization. This makes it challenging for manufacturers to launch new products and expand their market share.
• High costs of hemostatic spray products: The high costs of hemostatic spray products limit their adoption across healthcare facilities with budget constraints. Since these products utilize biological components like fibrinogen, thrombin, collagen, their production costs are higher than synthetic agents. The need for cold storage and transportation further increases expenses. Limited reimbursement in developing regions also increases out-of-pocket expenditure for patients. Healthcare facilities need to consider costs versus benefits before integrating such products into their protocols. This acts as a key challenge for market growth.
• Risk of adverse effects: The potential adverse effects associated with hemostatic spray components pose a major restraint for market growth. For example, thrombin derived from bovine origins carries risks of anaphylaxis. Fibrin sealants also increase chances of post-operative complications like infections at application sites, fluid buildup, and nerve compression. Lack of awareness regarding proper product usage can amplify risks. Concerns regarding patient safety necessitate strict staff training before adoption. This may discourage use among resource-constrained healthcare settings. For instance, in August 2021, according to data published, by RxList Inc., side effects associated with hemostatics includes anaphylaxis, blurred vision, chest pain, slurred speech, trouble breathing, and others.

Global Hemostatic Spray Market Drivers:

• Increasing number of surgeries: The increasing number of surgical procedures across the globe is a major factor driving the growth of global the hemostatic spray market. Surgeries like cardiovascular, orthopedic, plastic surgeries are increasing rapidly due to various factors like growing geriatric population, rising prevalence of chronic diseases, expanding healthcare infrastructure, and medical tourism. For instance, in July 2020, according to data published, by National Library of Medicine, a staggering 310 Mn major surgeries are performed each year globally.
• Technological advancements in hemostatic agents: Continuous advancements in hemostatic spray technologies are expected to boost the market growth during the forecast period. Companies are developing novel spray devices and applicators to improve delivery and enhance efficiency of hemostatic spray products. For example, innovative electrospray techniques are being leveraged to produce ultrafine hemostatic particles for precision targeting of bleeding spots. Companies are also using plant-based polysaccharides and integrating antifibrinolytics to develop novel spray formulations. Further, intelligent delivery systems are being designed to optimize spray dose and minimize product wastage. These advancements are improving patient outcomes in major surgeries, trauma and combat injuries, thereby driving adoption.
• Increasing product launch: Increasing product launch by the key market players is expected to drive the growth of the market over the forecast period. For instance, on April 20, 2023, Olympus Corporation, a medical device company, launched EndoClot Adhesive (ECA), EndoClot Polysaccharide Hemostatic Spray (PHS) and EndoClot Submucosal Injection Solution (SIS) in the Europe, Middle East and Africa (EMEA) region.
• Rising demand in trauma and combat care: Growing use of hemostatic sprays in trauma injuries and combat care is expected to boost product demand. Uncontrolled bleeding remains a major cause of preventable deaths in traumatic injuries. Hemostatic sprays allow quick hemorrhage control in severe trauma from accidents, sports injuries or natural disasters. Their ease of use makes them suitable for first responders and emergency care. Rising cases of civilian shootings have also augmented their adoption in law enforcement and tactical combat casualty care. Hemostatic sprays are vital tools for militaries worldwide. This rising demand is anticipated to accelerate market growth during the forecast period.

Global Hemostatic Spray Market Opportunities:

• Increasing use in minimally invasive surgeries: The rising adoption of minimally invasive surgeries across healthcare facilities provides significant growth opportunities for hemostatic spray manufacturers. Compared to open surgeries, minimally invasive procedures like laparoscopy offer benefits like smaller incisions, shorter hospital stays, and reduced complications. Hemostatic sprays allow easy bleeding control in such surgeries via catheter delivery systems. Their ability to rapidly reach target sites through small ports is increasing their demand. This trend of transition from open to minimally invasive techniques provides huge scope for hemostatic sprays. For instance, in 2020, according to Plastic Surgery Statistics Report 2020, 13.2 Mn cosmetic minimally-invasive procedures were performed in U.S
• Growing potential in emerging economies: Emerging economies worldwide present lucrative growth opportunities for the hemostatic spray market due to improving healthcare infrastructure and rising surgical procedures. Countries like India, China, Brazil, and Mexico have a large population base and increasing healthcare expenditure. Government initiatives to expand healthcare access are also on the rise. This is projected to significantly increase patient volume and the number of surgeries. The rising cases of chronic diseases due to changing lifestyles also add to the demand. As awareness regarding the benefits of hemostatic sprays increases, their adoption is expected to see robust increase in these regions. 
• Rising surgical procedures in ambulatory care settings: The shift of surgeries from hospitals to ambulatory surgical centers (ASC) provides growth opportunities for hemostatic spray manufacturers. ASCs provide same-day surgical care services at lower costs. Minimally invasive procedures like endoscopies, ophthalmic, and cosmetic surgeries are increasingly being performed at ASCs. Hemostatic sprays allow smooth patient recovery and discharge in such outpatient procedures. Their ability to reduce post-surgical complications also lowers re-admission rates. This rising volume of surgeries in cost-effective ASCs is projected to push product demand.
• Increasing product approval: Increasing product approval by the regulatory bodies is expected to drive the market growth over the forecast period. For instance, in September 2022, Medtronic plc. a medical device company, announced U.S. Food and Drug Administration (FDA) clearance of the Nexpowder endoscopic hemostasis system. Nexpowder uses a noncontact, nonthermal and nontraumatic hemostatic powder sprayed through a catheter that has a propriety powder-coating technology for minimized clogging which provides improved visibility and control for treating upper gastrointestinal nonvariceal bleeding.