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  • Published In : Nov 2023
  • Code : CMI6295
  • Pages :150
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical

Global Hemostatic Spray Market size is expected to reach US$ 4.69 Bn by 2030, from US$ 2.51 Bn in 2023, at a CAGR of 9.3% during the forecast period.

Hemostatic spray is a topical agent that helps promote hemostasis by facilitating clot formation. It contains active hemostatic ingredients such as thrombin, fibrinogen, or collagen that interact with blood components to form an adhesive matrix over wound. Hemostatic sprays are majorly used in surgical procedures to control bleeding in cases of impaired coagulation. They offer advantages such as ease of application, targeted delivery, and reduced blood loss.  Rising number of surgical procedures and increasing adoption of hemostatic agents are key factors driving the market growth of the global hemostatic spray market.

Global hemostatic spray market is segmented into product type, application, end user, and region. By product type, the market is segmented into gelatin-based, collagen-based, cellulose-based, chitosan-based, combination hemostats, and others. The gelatin-based hemostats segment is expected to account for the largest share during the forecast period owing to their high efficiency in bleeding management.

Global Hemostatic Spray Market Regional Insights:

  • North America is expected to be the largest market for global hemostatic spray market during the forecast period, which accounts for over 33.5% of the market share in 2023. The market growth in North America is due to the high adoption of advanced technologies, developed healthcare infrastructure, and presence of major market players in the region.
  • The Europe market is expected to be the second-largest market for global hemostatic spray market, accounting for over 26.1% of the market share in 2023. The market growth in Europe is due to the rising geriatric population, increasing investments in healthcare, and favorable regulations regarding hemostatic products.
  • The Asia Pacific market is expected to be the fastest-growing market for global hemostatic spray market, with a CAGR of over 20.3% during the forecast period. The market growth in Asia Pacific is due to the expanding patient population, rising healthcare expenditure, and growing awareness about blood loss management.

Figure 1. Global Hemostatic Spray Market Share (%), By Region, 2023

HEMOSTATIC SPRAY MARKET

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Analyst View of the Global Hemostatic Spray Market:

Global hemostatic spray market has significant growth potential over the next decade. Rising number of surgical procedures due to growing geriatric population and injuries that are caused by accidents is expected to drive the demand for effective hemostatic agents. Hemostatic sprays offer distinct advantages over other hemostatic agents as they are easily applied on wound site and help achieve hemostasis quickly. Their usage allows minimal blood loss and shorter procedure time. North America  dominates the market due  to high healthcare expenditure and regulatory approvals for new products. However, Asia Pacific is expected  to witness fastest gains due to rising healthcare investment and expanding patient pool in China and India. The market could face restraint from high costs of advanced hemostatic agents. Alternative wound closure methods like sutures and staplers can also limit adoption.

New product launches focusing on superior attributes like easy application and fast action time will provide key growth opportunities. Companies expanding geographical presence in Asian countries will gain early mover advantage. Partnerships with hospitals and inclusion in medical guidelines will help generate stronger demand. Rising preference for minimally invasive surgeries will benefit hemostatic sprays over traditional hemostats. Innovation in formulations allowing application on internal wounds can further expand applicability.

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.

Hemostatic Spray Market Report Coverage

Report Coverage Details
Base Year: 2022 Market Size in 2023: US$ 2.51 Bn
Historical Data for: 2018 to 2022 Forecast Period: 2023 - 2030
Forecast Period 2023 to 2030 CAGR: 9.3% 2030 Value Projection: US$ 4.69 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East & Africa:  GCC Countries, Israel,  South Africa, North Africa, and Central Africa and Rest of Middle East
Segments covered:
  • By Product Type: Gelatin Based, Collagen Based, Cellulose Based, Chitosan Based, Combination Hemostats, and Others
  • By Application: Trauma Care, General Surgery, Vascular Surgery, Cardiac Surgery, Plastic Surgery, Orthopedic Surgery, and Neurosurgery  
  • By End User: Hospitals, Ambulatory Surgical Centers, Tactical Combat Casualty Care Centers, and Others
Companies covered:

Olympus Corporation, Medtronic plc., Shilpa Medicare Limited, Baxter, BC3 Technologies, Ethicon, Pfizer Inc., HemCon Medical Technologies, Z-Medica, Teleflex Incorporated, Tricol Biomedical, Arch Therapeutics, and Cook

Growth Drivers:
  • Increasing number of surgeries
  • Technological advancements in hemostatic agents
  • Increasing product launch
  • Rising demand in trauma and combat care
Restraints & Challenges:
  • Stringent regulatory policies
  • High costs of hemostatic spray products 
  • Risk of adverse effects

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.

Global Hemostatic Spray Market Trends:

  • Increasing adoption of inorganic growth strategies such as acquisition: Increasing adoption of inorganic growth strategies such as acquisition by the key market players is expected to drive the market growth over the forecast period. For instance, in July 2021, Baxter International Inc., a medical products company, announced acquisition of certain assets related to PerClot Polysaccharide Hemostatic System from CryoLife, Inc., a global medical device company.
  • Increasing use of plant-based polysaccharides: The growing adoption of plant-based polysaccharides like chitosan as key components in hemostatic spray formulations is a significant trend. Chitosan demonstrates wound-healing, antimicrobial and hemostatic properties. Its cationic nature allows rapid electrostatic interactions with blood components for stable clot formation. Spray products using chitosan demonstrate higher biocompatibility, thus making them safer as compared to animal-derived agents. Manufacturers are increasingly utilizing plant polysaccharides due to their sustainability, affordability, and efficacy advantages.
  • Technology advancement: Technological innovations in hemostatic agents are transforming trauma care and are significantly contributing to the expansion of the hemostatic spray market. New formulations that can quickly stop life-threatening hemorrhages at the site of injury have greatly improved clinical outcomes for casualties on the battlefield and in emergency rooms. For instance, on March 22, 2023, BC3 Technologies, a medical device company, announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its seal hemostatic wound spray, an aerosolized chitosan for the rapid management of serious arterial bleeding. When sprayed on a bleeding wound, seal quickly forms a strong barrier that helps stop bleeding within seconds and without pain.
  • Growing investments in research and development: The hemostatic spray market is witnessing increasing research and development (R&D) investments by companies to develop novel products and thereby enhance existing Efforts are underway to improve spray consistency, increase shelf-life of formulations, and achieve stronger adhesion. Nanotechnology and bioengineering are being leveraged to create superior biocompatible agents. Companies are collaborating with academia and research institutes to accelerate product development through extensive trials. The growing R&D investments are resulting in new product launches, thereby expanding the market scope.

Global Hemostatic Spray Market Restraints:

  • 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.

Counterbalance: The key market players should create more awareness among the people in providing staff trainings for adoption of the hemastatic sprays.

Recent Developments:

New product launches/approval:

  • In September 2022, Medtronic a medical device company, announced that the company received U.S. Food and Drug Administration (FDA) approval for its powder-to-gel bloodstopping spray for upper gastrointestinal bleeding.
  • In February 2021, EndoClot Plus, Inc., a medical device company, announced the U.S. Food and Drug Administration (FDA) approval of EndoClot Polysaccharide Hemostatic System (EndoClot PHS), an innovative product that assists Gastroenterologists to stop bleeding rapidly and reliably.

Acquisition and partnerships:

  • In October 2022, Teleflex acquired Z-Medica to enhance its product portfolio with innovative hemostatic technologies for surgical applications.
  • On May 16, 2023, Olympus Corporation, a medical device company, announced partnering with EndoClot Plus, Inc., a medical device company, to launch hemostatic agents in Europe, Middle East and Africa region.

Figure 2. Global Hemostatic Spray Market Share (%), By Product Type, 2023

HEMOSTATIC SPRAY MARKET

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Top Companies in Global Hemostatic Spray Market:

  • Olympus Corporation
  • Medtronic plc.
  • Shilpa Medicare Limited
  • Baxter
  • BC3 Technologies
  • Ethicon
  • Pfizer Inc.
  • HemCon Medical Technologies
  • Z-Medica
  • Teleflex Incorporated
  • Tricol Biomedical
  • Arch Therapeutics
  • Cook

Definition: The hemostatic spray was originally developed in the military to stop bleeding in the field and has since been applied to bleeding in the upper and lower gastrointestinal tract

Frequently Asked Questions

Stringent regulatory policies, high costs of hemostatic spray products and risk of adverse effects are the major factors hampering the growth of the global hemostatic spray market.

Increasing number of surgeries, technological advancements in hemostatic agents, increasing product launch, and rising demand in trauma and combat care are the major factors driving the growth of the market over the forecast period.

The gelatin based segment is the leading product type segment in the market.

The major players operating in the market includes Olympus Corporation, Medtronic plc. Shilpa Medicare Limited, Baxter, BC3 Technologies, Ethicon, Pfizer Inc., HemCon Medical Technologies, Z-Medica, Teleflex Incorporated, Tricol Biomedical, Arch Therapeutics, and Cook.

North America leads the market.

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