Published on March 13, 2014
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 1 TISSUE SEALANTS MARKET SIZE Scope of the Study Tissue Sealants report covers the sources of Sealants and the various applications of tissue sealants in the market. The Sources of Tissue Sealants covered include Homologous Sealants, Synthetic Sealants and Autologous Sealants. The applications of Tissue Sealants in Odontology, Cardiology, Neurology, Orthopedics and Other (such as Urology, Hepatic, Dermatology, etc). The report provides an in depth analysis of each of the Sources and Applications by their respective categories. The study includes estimates and projections for the total global Tissue Sealants market and also key regional markets that include North America, Japan, Europe, Asia-Pacific, Latin America and Rest of World. Estimations and predictions are illustrated graphically. Business profiles of 27 major companies are discussed in the report. The report serves as a guide to global Tissue Sealants industry, covering more than 127 companies that are engaged in tissue sealants R&D and supply of products and services. Information related to recent product releases, product developments, partnerships, collaborations, and mergers and acquisitions is also covered in the report. Tissue Sealants report is an ideal research tool providing strategic business intelligence to the corporate sector. This report may help strategists, investors, laboratories, pharmaceutical companies, contract research organizations, and biotechnology companies in – Gauging Competitive Intelligence Identifying Key Growth Areas and Opportunities Understanding Geographic Relevance to Product Knowing Regional Market Sizes and Growth Opportunities and Restraints Keeping Tab on Emerging Technologies Equity Analysis Tapping New Markets Analytics and data presented in this report pertain to several parameters such as – Global and Regional Market Sizes, Market Shares, Market Trends Product (Global and Regional) Market Sizes, Market Shares, Market Trends Technology Trends Corporate Intelligence Key Companies By Sales, Brands, Products Consumer Behavioral Patterns Other Strategic Business Affecting Data
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 2 Research Methodology RI Technologies publishes business intelligence reports by going through a cycle of diligent research and analysis activity. Research is done using both online and offline resources. The study outline of this report is sketched on the following lines – Global Value Market Estimations & Predictions (2005 -2015), regional market analysis, product segmentation, global and regional market analysis by product segment, market trends, M&A, R&D, competitive landscape, technology trends, and other key drivers. Current data helps in analyzing the future of the industry and is also helpful for doing market evaluations, and estimating the market size for the future. This report is uniquely researched and the methodology includes: Need and Scope of Study Product Definitions Segmental Analysis Regional Analysis Exclusive Data Analytics Corporate Intelligence Feedback Right from concept to final compilation of this report, both primary and secondary research methods are applied. We have provided exclusive feedback forms/pre-release questionnaires for this report to use the information for authentication of our own findings. Secondary research includes government publications, investment research reports, web based surveys, website information of both companies and markets, and other offline resources such as print publications and CDs. Our compilation of easy to navigate PDF reports are essential value addition resources for leading and growing companies.
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 3 II. REPORT SYNOPSIS The sealing of the wounds and skin openings after surgery can be done in a compact manner with the help of tapes and sutures which reduce the rate of contamination of the injured regions by waste materials and infectious organisms. The other important advantage is that the use of tapes and sutures will reduce the scar formations to some extent. The major risk with these techniques is the improper application of tapes and sutures causing complications such as infections, longer time periods of healing of wounds and in some rare cases even death of the patient because of infections in the tissue resulting in septicemia. Currently, as an alternative to the above mentioned age old techniques of sealing the wounds and skin openings due to invasive surgical procedures, hemostats, sealants and glues are being used. Morbidity associated with infection rates, post‐surgical adhesions, and other specific procedures is reduced to a considerable extent by the use of hemostats, sealants and glues. Critical surgeries, such as knee replacement surgery, require the application of tourniquet to control the bleeding. The use of the tourniquet sometimes results in deep vein thrombosis during the surgery which can be controlled by the application of hemostats, sealants and glues. The use of hemostats and sealants during surgeries is both cost effective and time saving. The application of these substances to the wounds helps the patient to recover faster than the normal methods of suturing and stapling, thus saving both money and time. The whole surgical process becomes safer and faster. Mainly, these products are applied to the external wounds. The application and the working of these products in treating the internal injuries have to be explored extensively. Application of cyanoacrylate glues for closure of surgical wounds is approved worldwide. The usual process of closing a small bleeding trauma laceration by suturing includes use of local anesthesia, antibiotic cream and suture removal kit. The total cost of these products excluding the labor and time is approximately $75. In contrast, cyanoacrylate products can be applied without anesthetic and without sutures. There is no need for a removal as cyanoacrylate sloughs off the skin surface. Experiments proved that cyanoacrylate products have an anti‐microbial property which gave the product an approval by the FDA. This property also aids in the reduction of the costs to approximately 30% of using sutures. The cost further reduces to 5% of suture cost on inclusion of labor and time to the application of product. Many of the critical surgeries take longer time as they are to be performed carefully avoiding heavy bleeding during the surgery. Application of hemostats considerably reduces the time and in turn the cost (estimated to be $2000 to $10000 per hour) of the surgery as the operation can be done faster than the expected time because of less hemorrhage during surgery. For example, a $115 hemostat shaves off nearly 4 minutes off the operating time to be cost effective and was proved it could. Based upon the surgical process hemostats save five to two hours of surgery time. Use of sealants is not only a cost effective but also an attractive health economic attribute. This was proved in cases of air leaks occurring after lung resection. Use of normal sutures and staples sometimes result in air leaks in lung resection patients. Due to this, the patient has to stay for longer periods of time in the hospital for nearly a month after surgery in the intensive care unit and in some rare cases has to endure another surgery. Use of sealants completely eliminates air leaks and thus the extra burden in the form of mental stress, time and expenses on the patient can be reduced effectively. Neurological and spine injuries sometimes result in leakage of cerebrospinal fluid due to infections like meningitis, severe headaches and
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 4 other miscellaneous reasons. In order to avoid the cerebrospinal fluid leaks, the normal process is to close the dura which is time consuming. Application of proper sealants by efficient surgeons can tackle the problem of cerebrospinal fluid leakage. Segmentation of Tissue Sealants Market Exhibit 1. Segmentation of Tissue Sealants Market by Source and Application Source Application Homologous Sealants Odontology Synthetic Sealants Cardiology Autologous Sealants Neurology Orthopedics *Other *Other Includes Urology, Hepatic,, Dermatology etc © RIT, 2013
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 5 Global Market Analysis Global Tissue Sealants market was estimated at US$XX.XX billion in 2012, and is projected to reach US$ XX.XX billion by 2020, growing at a compounded annual growth rate (CAGR) of XX.XX %. Exhibit 2. Tissue Sealants – Global Value Market Estimations & Predictions (2005 -2020) in US$ Million Year Value 2005 XX.XX 2006 XX.XX 2007 XX.XX 2008 XX.XX 2009 XX.XX 2010 XX.XX 2011 XX.XX 2012 XX.XX 2013 XX.XX 2014 XX.XX 2015 XX.XX 2016 XX.XX 2017 XX.XX 2018 XX.XX 2019 XX.XX 2020 XX.XX CAGR% XX.XX © RIT Figures, 2013 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 US$ Million
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 6 Synthetic Sealants Registering a CAGR of XX.XX % during the analysis period, the global market for Synthetic sealants is projected to be worth US$ XX.XX billion by 2020. The market was estimated at US$ XX.XX million in 2012. With an estimated market share of about XX.XX % in 2012, North America represents the largest market for Synthetic sealants with a market of worth US$ XX.XX million. North America is projected to reach US$ XX.XX million by 2020 by growing at a CAGR of XX.XX % during 2005-2020 to retain the leadership. Asia-Pacific is expected to be the fastest growing market (CAGR is XX.XX %). while Japan represents second largest market with a share of XX.XX % in 2010. Exhibit 3. Synthetic Sealants – Global Value Market Estimations & Predictions (2005 -2020) by Geographic Regions for North America, Japan, Europe, Asia-Pacific, Latin America and Rest of World in US$ Million Year/Region North America Japan Europe Asia-Pacific Latin America RoW Total 2005 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2006 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2007 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2008 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2009 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2010 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2011 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2012 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2013 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2014 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2015 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2016 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2017 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2018 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2019 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX 2020 XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX CAGR% XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX XX.XX © RIT Figures, 2013 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 US$ Million North America Japan Europe Asia-Pacific Latin America RoW
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 7 III. MARKET DYNAMICS Market Overview Due to the cost advantage and rapid increase in population, Asia-Pacific is the fastest market for Tissue Sealants. Asia-Pacific and Rest of World are expected to gain market shares while the US may lose market dominance. The medical organizations all over the world have been persistently making efforts to manage wounds. Medical practitioners have been trying to find an impeccable remedy substance that would seal and heal human tissues and which would also be an ideal alternative to stick the tissue exteriors so that bleeding can be prevented and also provide a supportive healing platform. The latest arrivals in periodical development of wound management devices are the Fibrin sealants. They are grouped differently as medical devices or pharmaceutical products as their distinctive characteristics are to seal and heal tissues by blocking air and fluids from tissues and to render a strong basis for the tissues to start healing. Fibrin sealants can be used in post surgical methods for sealing the tissues which will help in the gain of speedy recovery. They have such an in-built capacity to even eliminate the customary methods. Now days, these Fibrin sealants are being used as supplements to wound closing procedures like sutures and staples. Fibrin sealants may be autologous, i.e., developed from plasma of patient’s blood or pooled i.e., from many donors. The risk of blood contamination and viral transmission scares imposes a decline in the growth of such products . Research and Development are given least priority as they are cost intensive and risk areas, as a result the market is still in its infancy with least rates of product development and technological advancements.
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 8 Analysis by Source The global market for homologous Sealants is the largest with a market of US$ XX.XX million in 2020.. In terms of market value, Homologous Sealants was estimated at US$ XX.XX billion in 2012. Autologous Sealants grew at a faster rate with a CAGR of XX.XX %. Exhibit 4. Tissue Sealants – Global Value Market Estimations & Predictions (2005 -2020) by Source for Homologous Sealants, Synthetic Sealants and Autologous Sealants in US$ Million Year/Source Homologous Sealants Synthetic Sealants Autologous Sealants Total 2005 XX.XX XX.XX XX.XX XX.XX 2006 XX.XX XX.XX XX.XX XX.XX 2007 XX.XX XX.XX XX.XX XX.XX 2008 XX.XX XX.XX XX.XX XX.XX 2009 XX.XX XX.XX XX.XX XX.XX 2010 XX.XX XX.XX XX.XX XX.XX 2011 XX.XX XX.XX XX.XX XX.XX 2012 XX.XX XX.XX XX.XX XX.XX 2013 XX.XX XX.XX XX.XX XX.XX 2014 XX.XX XX.XX XX.XX XX.XX 2015 XX.XX XX.XX XX.XX XX.XX 2016 XX.XX XX.XX XX.XX XX.XX 2017 XX.XX XX.XX XX.XX XX.XX 2018 XX.XX XX.XX XX.XX XX.XX 2019 XX.XX XX.XX XX.XX XX.XX 2020 XX.XX XX.XX XX.XX XX.XX CAGR% XX.XX XX.XX XX.XX XX.XX © RIT Figures, 2013 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 US$ Million HomologousSealants SyntheticSealants AutologousSealants
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 9 Exhibit 5. List of Major Companies in North America S. No Company Name Country Website 1 3M Company USA www.3m.com 2 Abbott Laboratories USA www.abbott.com 6 Angiotech Pharmaceuticals, Inc. Canada www.angiotech.com 7 Baxter International, Inc. USA www.baxter.com 8 C.R. Bard, Inc. USA www.crbard.com 9 CryoLife, Inc. USA www.cryolife.com 10 CSL Behring USA www.cslbehring.com 11 Ethicon, Inc. USA www.ethiconinc.com 12 Kensey Nash Corporation USA www.kenseynash.com 13 King Pharmaceuticals, Inc. USA www.kingpharm.com 14 Medafor, Inc. USA www.medafor.com 15 Pfizer, Inc. USA www.pfizer.com 16 Protein Polymer Technologies, Inc. USA www.ppti.com 17 ThermoGenesis Corporation USA www.thermogenesis.com © RIT, 2013
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 10 IV. PRODUCT TECHNOLOGY/ RESEARCH At times, during surgery or other medical emergencies, major blood vessels are ruptured. Surgical methods such as staples and sutures become essential for controlling such bleeding. In the meanwhile, however, there is a possibility of losing substantial blood through unchecked bleeding. To mitigate such loss of blood, a hemostat is used. Hemostat stops the bleeding, and this process of checking bleeding is known as hemostasis. In natural course, hemostasis starts almost immediately after a tissue is damaged. The process is completed in phases. The first phase involves restricting the blood to the region through vasoconstriction. In other words, there is constriction of blood vascular system, which controls the blood supply to this region. This is the reason this phase is known as vascular phase. The broken endothelium of the vascular system at the site exposes collagen, which attracts platelets. The platelets start the clotting as soon as they come in contact with blood. This is the second phase. A clot retraction and clot destruction phase follows the second phase. In the clot destruction phase, plasminogen is transformed into plasmin. This plasmin is responsible for clot lysis. Amicar is a chemical agent that restricts the transformation of plasminogen into plasmin. Therefore, when Amicar is administered, clots do not lyse and thereby become stable. Clotting process or clotting cascade is made of two different pathways eventually joining together to form a common pathway. One of these pathways is intrinsic and the other is the extrinsic. The process of clotting is started by collagen, which when exposed, binds factor XII. Simultaneously collagen also grabs platelets that are then activated by many other cofactors. As a result, platelets also release different factors. Collectively, this pathway is known as intrinsic pathway. The extrinsic pathway of clotting process is started by a tissue factor. This factor is exposed because of tissue injury. This results in factor VII activation that starts this pathway. Both intrinsic and extrinsic pathways of clotting combine to form a common route in which thrombin transforms fibrinogen into fibrin monomers. These fibrin monomers are cross‐linked with calcium and factor XIII, forming fiber polymer, which is the clot. Because hemostats play such a crucial role in human life, they are indispensable in any first aid gear of paramedics and combat doctors. Conventionally, a hemostatic clamp is used for stopping profuse bleeding at outdoor locations. Hemostatic clamp restricts the bleeding by a mechanical action. This clamp is very effective when a major artery is ruptured and blood starts gushing out. During surgery, however, doctors use another type of hemostat. This hemostat is known as microfibrillar collagen hemostat or MCH. MCH is made from resorbable microfibrillar collagen. This hemostat is generally used when the bleeding is not from a major blood vessel. For controlling bleeding from major vessels, hemostatic clamp is the best option even today. MCH has a very specific mechanism in stopping the bleeding. Platelets are drawn towards MCH by chemical interaction. This results in a blood clot as soon as the blood nears the MCH. There is no mechanical action
RITMIR025: Tissue Sealants – A Market Insight Report, July 2013 © RI Technologies - www.researchimpact.com Sample Page - 11 involved here. Surgeons apply MCH at the bleeding point and collagen does the rest. The haemostatic effect of fibrin was first illustrated by Bergel in the 20th century. He explained the hypothesis of employing clotting constituents from human blood for handling wounds and to arrive at haemostatis in bleeding parenchymatous organs. Surgical Sealants and their Significance Hemostasis or clotting of blood is a natural physiological phenomenon of the body that prevents blood loss. It involves a cascade of reaction steps. When the tissues are damaged by a cut, the blood platelets are activated. These platelets convert inactive prothrombin of blood into active thrombin. The latter transforms soluble blood protein fibrinogen into insoluble fibrin. The fibrin threads are viscous polymers, which crosslink with activated blood factor XIII to form a mesh at the site of wound that prevents oozing of blood. This mesh in which the erythrocytes get entangled is the clot. This clot is later on dissolved by the enzyme fibrinolysin. Fibrinolysis involves the release of fibrinopeptides initiating angiogenesis [formation of blood vessels] and tissue repair. The surgical sealants accelerate this process of hemostasis. TISSUE SEALANTS – MARKET OUTLOOK The market is already occupied by biological glues and adhesives which are strong synthetic and biological materials that glue the surfaces together, preventing the wide spread use of fibrin sealants. Product substitution and off label use are the areas challenging the wide spread use of fibrin sealants. Although the market is aware about the advantages of fibrin sealants in cardiothoracic and pulmonary applications, their utility in surgical applications is challenged because of insufficient clinical proof. There will be an increasing market if there is enough documentation on the evidences collected for the use of fibrin sealants in other areas of surgical applications The policy of companies to improve the market is to invest more in new product development and new areas of application which expands the market opportunities. In order to increase consumption of tissue sealants, the consumer can be exposed to events imparting knowledge on the strengths, deviations and commercial benefits of tissue sealants as compared to the other synthetic sealing devices. It will also help subdue the issues of interchange owing to ill-defined differentiation amongst the diverse range of wound care brands. Scope for maximum tissue sealant applications (licensed indications) exist in Dental, Cardiac surgery, pulmonary surgery and vascular surgery. There is an ascending perception in the use of tissue sealants in hepatic surgery. Even though the needs for sealants in burn applications are bent to multiply, more investigations are being done in orthopedic indications. The current Pharmaco economic data is efficient in convincing the medical practitioners about versatility, superiority and cost advantage of tissue sealants over challenging alternatives…………….. About RI Technologies
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