Source: Mediligence Blog
Showing posts with label Market Size. Show all posts
Showing posts with label Market Size. Show all posts
Wednesday, January 4, 2012
Friday, October 8, 2010
Thursday, October 7, 2010
Saturday, September 18, 2010
Blood Banking & Blood Products Market to Reach US$36 Billion by 2015
The global market for blood banking and blood products is exhibiting a healthy trend. New infections continue to take a toll on the population across the world, fueling the demand for blood banking and blood products. Regulatory, and healthcare bodies across the world are adopting stringent policies relating to blood safety. As an extension to this, manufacturers are working on developing improved, safer, and advanced blood-banking technologies for the collection, processing and delivery of blood products, further adding fuel to market growth.
The US constitutes the largest regional market for blood banking and blood products, as stated by the new market research report on Blood Banking & Blood Products. In the United States, while 2% of the population receives transfusions annually, another 15% undergo transfusion at least once in their lifetime. On an average, around 50-70 million units of blood, and blood components are transfused in developed countries every year. The developed markets are characterized by increased levels of public awareness, sophistication of blood collection technologies, and governmental support. While developed countries bank blood resources to suffice about 80% of their needs, blood supplies in the developing countries just suffice 40% of the requirements.
Increasing population in developing countries such as India and China, puts pressure on demand for blood on the blood bank segment. Governments of these countries are focused on enhancing healthcare delivery, which includes the blood bank segment. Resultantly, Asia-Pacific is projected to emerge as the fastest growing regional market over the analysis period.
Though blood and blood products provided by blood banks are free from viruses, bacteria, and other disease causing microorganisms, safety has become the main issue the world over. Risks involved in blood transfusion have also become a major issue in the blood banks, and blood products industry. Many companies are now visualizing blood decontamination as a step towards blood safety and availability. Though the process does not do away with the traditional blood screening, and donor exclusion programs, it is expected to prevent infected transmission. New processes are being developed to make blood supply safer. Areas such as blood filtration, and pathogen passivation methods are witnessing development. The need for safe, and suitable blood has been the driving force behind the blood banking, and blood products industry.
The global Blood Banking & Blood Products market is dominated by Blood Components and Plasma Products. The market for blood components and plasma products comprise of whole blood & cellular components, and plasma fractions. Equipment, blood tests, and other consumables are forecast to witness a compounded annual growth rate of more than 4.0% during the analysis period.
Leading blood banks profiled in the report include AABB, America’s Blood Centers, American Red Cross, Canadian Blood Services, Japan Red Cross Society, Lifebank Corp., New England Cord Blood Bank Inc., New York Blood Center, National Blood Foundation, among others. Major players profiled in blood bank technology and supplies space include Beckman Coulter Inc., Becton, Dickinson and Company, CSL Behring LLC, Daxor Corp., Fenwal Inc., Haemonetics Corp., Talecris Biotherapeutics, and ThermoGenesis Corp. Key players in plasma fractionation includes Baxter International, Bio Products Laboratory, CSL Ltd., Grifols, Kedrion, Octapharma, Sanquin, and others.
The report titled “Blood Banking & Blood Products: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the blood banking and blood products market, current market trends, growth drivers, impact of recession on the industry, segment market analysis and potential, new product introductions/innovations, recent industry activity, and focus on major and niche global as well as regional market participants. The study analyzes market data and analytics in terms of value sales for global as well as regional markets including the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Product segments analyzed include Blood Components and Plasma Products (Whole Blood & Cellular Components, and Plasma Fractions), and Whole Blood & Cellular Components.
For more details about this comprehensive market research report, please visit –http://www.strategyr.com/Blood_Banking_and_Blood_Products_Market_Report.asp
Tuesday, September 14, 2010
Global market for surgical hemostats gets bloody!
By showing the pie chart below, with all of its overlapping labels and clutter, we do so not out of any lack of graphing skills but as a blunt reflection of how competitive the global market for surgical hemostats has become.
The number of competitors in this field has rapidly multiplied, driven by the relatively low barriers to market entry and the recent market success of a range of different hemostat product types that are being steadily adopted in clinical practice. Hemostats have become accepted tools in the armamentaria of surgeons, both as stand alone products for stopping bleeding of traumatic and surgical wounds and as adjuncts to other wound sealing and closure technologies.
The natural course of proliferation inevitably leads to market consolidation and this is the short term prospect for products in hemostasis as well established players seek to literally buy greater market share and broaden their product portfolios.
Source: MedMarket Diligence, LLC; Report #S180 (pending publication).
The number of competitors in this field has rapidly multiplied, driven by the relatively low barriers to market entry and the recent market success of a range of different hemostat product types that are being steadily adopted in clinical practice. Hemostats have become accepted tools in the armamentaria of surgeons, both as stand alone products for stopping bleeding of traumatic and surgical wounds and as adjuncts to other wound sealing and closure technologies.
The natural course of proliferation inevitably leads to market consolidation and this is the short term prospect for products in hemostasis as well established players seek to literally buy greater market share and broaden their product portfolios.
Source: MedMarket Diligence, LLC; Report #S180 (pending publication).
Wednesday, September 8, 2010
Vascular Closure Devices’ Sharp Rise in Unit Sales Drives the Overall U.S. Peripheral Vascular Device Market
Vascular closure devices, which include both invasive and non-invasive products, are rapidly being adopted by the medical community. The market for VCDs is expected to exhibit strong growth through to 2016, thus driving the total U.S. market for peripheral vascular devices.
Vascular Closure Devices
VCDs are used in both coronary and peripheral vascular procedures, particularly if a catheter is used during an endovascular treatment. The traditional method for achieving vascular closure is manual compression, where a healthcare worker applies pressure to the site in order to achieve hemostasis. However, manual compression is not only time consuming for healthcare employees, but also requires the patient to remain immobile for an extended period of time.
With the rise of for-profit medical centers and a shortage of available nursing labor, the medical industry has sought a safe and effective alternative to manual compression. Since VCDs were approved for use in the U.S. in the 1990s, two types of devices have been developed: invasive and non-invasive. Invasive VCDs are used percutaneously and achieve hemostasis through the use of sealants, sutures or specialized sponges, while non-invasive VCDs involve the use of a compression pad or inflatable bulb at the surface of the site to mimic the effects of manual compression. In 2009, invasive VCDs represented 85.5% of the total VCD market revenues, while non-invasive devices comprised the remaining 14.2%. While the use of both types of VCDs is expected to rise, growth in non-invasive devices will outpace, but not overtake, invasive devices by 2016.
VCDs Are Cost-Effective and Time-Efficient
VCDs offer healthcare facilities a cost-effective option for vascular closure. While price was a limiter when the devices were launched, the average selling price of the devices has decreased dramatically in recent years, and will continue to decline. Furthermore,
non-invasive VCDs are, on average, four times less expensive than their invasive counterparts, boosting their popularity.
With the general shortage of nursing labor, many hospitals are finding it cost-effective and time-efficient to employ VCDs. Non-invasive VCDs remove the need for manual pressure by a healthcare worker and therefore also lessens labor costs. In addition, the use of invasive VCDs further reduces the time necessary to perform vascular closure. Interventional cardiologists are performing peripheral procedures at an increasing rate and are opting to use VCDs in order to reduce operation times and thereby maximize the number of procedures that can be performed per day. Furthermore, the use of VCDs has the potential to allow more procedures to be performed in outpatient settings, significantly increasing patient turnaround times and decreasing costs. The cost savings and reduced times will continue to encourage healthcare facilities to adopt VCDs, especially as hospital budgets become more constrained.
Device Improvements
The relative complexity of VCDs, particularly invasive products, was initially the source of complications due to improper use. However, VCDs have gone through many design configurations since their introduction and different closure methods have been developed. Abbott Laboratories’ StarClose™ and Perclose® invasive VCDs have reduced rates of complications, such as the migration of closure agents through the vascular system. These devices close the arterial hole with a nitinol clip on the exterior of the vessel, meaning that nothing remains in the artery after the procedure.
AccessClosure’s Mynx™ invasive VCD is another device that is designed to reduce procedural complications, such as trauma to the vessel and expansion of the tissue tract. The device applies a bio-inert sealant to the surface of the artery, closing both the arterial opening and the tissue tract. In addition, the Mynx™ can be deployed through an existing procedural sheath, which further eliminates the need for a sheath exchange. The device has increased its adoption rate in recent years and shows great potential.
As manufacturers, continue to address the concerns associated with using VCDs and develop innovative solutions, these devices will account for an ever increasing proportion of vascular closure procedures.
Growth Drivers
The aging population of the U.S. has led to an increase in the number of patients with peripheral arterial disease (PAD), resulting in increasing demand for peripheral vascular procedures. Furthermore, this increase in procedure demand coincides with the rise in the number of for-profit medical centers that have lower staffing levels and a higher preference for VCDs. Between 2005 and 2010, the number of VCDs used has risen more rapidly than the number of peripheral catheterization procedures. Growth of VCD use exceeded that of catheterization procedures due to the continuing shift from manual compression to VCD use. As a result of this growth, by 2016, it is expected that over one million VCDs will be used for peripheral vascular procedures, representing an approximately 50% increase in unit volume from 2009.
Vascular Closure Devices
VCDs are used in both coronary and peripheral vascular procedures, particularly if a catheter is used during an endovascular treatment. The traditional method for achieving vascular closure is manual compression, where a healthcare worker applies pressure to the site in order to achieve hemostasis. However, manual compression is not only time consuming for healthcare employees, but also requires the patient to remain immobile for an extended period of time.
With the rise of for-profit medical centers and a shortage of available nursing labor, the medical industry has sought a safe and effective alternative to manual compression. Since VCDs were approved for use in the U.S. in the 1990s, two types of devices have been developed: invasive and non-invasive. Invasive VCDs are used percutaneously and achieve hemostasis through the use of sealants, sutures or specialized sponges, while non-invasive VCDs involve the use of a compression pad or inflatable bulb at the surface of the site to mimic the effects of manual compression. In 2009, invasive VCDs represented 85.5% of the total VCD market revenues, while non-invasive devices comprised the remaining 14.2%. While the use of both types of VCDs is expected to rise, growth in non-invasive devices will outpace, but not overtake, invasive devices by 2016.
VCDs Are Cost-Effective and Time-Efficient
VCDs offer healthcare facilities a cost-effective option for vascular closure. While price was a limiter when the devices were launched, the average selling price of the devices has decreased dramatically in recent years, and will continue to decline. Furthermore,
non-invasive VCDs are, on average, four times less expensive than their invasive counterparts, boosting their popularity.
With the general shortage of nursing labor, many hospitals are finding it cost-effective and time-efficient to employ VCDs. Non-invasive VCDs remove the need for manual pressure by a healthcare worker and therefore also lessens labor costs. In addition, the use of invasive VCDs further reduces the time necessary to perform vascular closure. Interventional cardiologists are performing peripheral procedures at an increasing rate and are opting to use VCDs in order to reduce operation times and thereby maximize the number of procedures that can be performed per day. Furthermore, the use of VCDs has the potential to allow more procedures to be performed in outpatient settings, significantly increasing patient turnaround times and decreasing costs. The cost savings and reduced times will continue to encourage healthcare facilities to adopt VCDs, especially as hospital budgets become more constrained.
Device Improvements
The relative complexity of VCDs, particularly invasive products, was initially the source of complications due to improper use. However, VCDs have gone through many design configurations since their introduction and different closure methods have been developed. Abbott Laboratories’ StarClose™ and Perclose® invasive VCDs have reduced rates of complications, such as the migration of closure agents through the vascular system. These devices close the arterial hole with a nitinol clip on the exterior of the vessel, meaning that nothing remains in the artery after the procedure.
AccessClosure’s Mynx™ invasive VCD is another device that is designed to reduce procedural complications, such as trauma to the vessel and expansion of the tissue tract. The device applies a bio-inert sealant to the surface of the artery, closing both the arterial opening and the tissue tract. In addition, the Mynx™ can be deployed through an existing procedural sheath, which further eliminates the need for a sheath exchange. The device has increased its adoption rate in recent years and shows great potential.
As manufacturers, continue to address the concerns associated with using VCDs and develop innovative solutions, these devices will account for an ever increasing proportion of vascular closure procedures.
Growth Drivers
The aging population of the U.S. has led to an increase in the number of patients with peripheral arterial disease (PAD), resulting in increasing demand for peripheral vascular procedures. Furthermore, this increase in procedure demand coincides with the rise in the number of for-profit medical centers that have lower staffing levels and a higher preference for VCDs. Between 2005 and 2010, the number of VCDs used has risen more rapidly than the number of peripheral catheterization procedures. Growth of VCD use exceeded that of catheterization procedures due to the continuing shift from manual compression to VCD use. As a result of this growth, by 2016, it is expected that over one million VCDs will be used for peripheral vascular procedures, representing an approximately 50% increase in unit volume from 2009.
Thursday, July 22, 2010
EU Pricing Pressure Sure To Impact Hemostasis Market
"European governments grappling to reduce large budget deficits are focusing their cost-cutting on a large spending item - pharmaceuticals," The Wall Street Journal reports. "Several countries in recent weeks, including Spain, Germany and Italy, have proposed or enacted reductions in what they will pay or taken other cost-control measures for various drugs. ... In Europe, state healthcare systems pay for the bulk of drug purchases. European governments have long been known for their frugality when negotiating prices with drug companies, but the latest cuts are more severe than usual. Europe is the second largest market after the U.S. for many drug companies."The European Federation of Pharmaceutical Industries and Associations, the industry's main lobbying body in Europe, is warning of the economic consequences. In a statement, the group said the cuts would "sharply diminish revenues to manufacturers...with an impact on their R&D investments. This in turn will impact European economic recovery and employment"
The dollar's climbing value threatens to pressure sales in coming quarters for U.S. medical-device and drug makers that are big exporters to Europe.
The greenback's rise--it's up about 15% against the euro this year--compounds worries already brewing that cash-strapped European governments, pressured by a debt crisis on the continent, will cut back on health-care spending.
The greenback's rise--it's up about 15% against the euro this year--compounds worries already brewing that cash-strapped European governments, pressured by a debt crisis on the continent, will cut back on health-care spending.
For device companies, Piper Jaffray analyst Matt Miksic called the currency impact "manageable for most" because of hedging plans. He sees a 1% to 2% earnings impact this year.
The currency effects can be very complex. Many companies routinely give sales estimates that exclude the currency impact so that the business' performance isn't shrouded. Also, they typically employ a mix of natural and financial hedges to protect earnings, even if sales take a big hit.
Natural hedges can include overseas manufacturing capacity, which can put the cost of production in the same currency as sales. For big multinational companies doing business around the globe, currency values in different countries can sometimes have an offsetting effect. Then there are foreign- exchange contracts companies can enter to manage risk.
But the dollar's strength still adds strain. JPMorgan noted a trend over the past decade of device stocks performing better than the broader market when currency rates add to sales, but worse when currency is a negative factor. "In short, MedTech stocks seldom outperform in the face of an FX headwind," analyst Michael Weinstein said.
Some of the dollar's gains have come since companies reported first-quarter results in April; however, device-maker Medtronic's recent report offered some fresh perspective. The company, which posted sales of $15.8 billion for its year ended April 30, said exchange rates at Monday's level would dent sales by $400 million to $500 million in the new fiscal year.
But the company also said its hedging strategy should mostly shield earnings.
The backdrop to currency concerns is the threat European sales also will decline because of government spending cuts. But some big companies have downplayed this risk.
This is "spooking investors," Abbott Laboratories (ABT) Chief Executive Miles White said at a recent conference. He explained that Abbott factored pressure in Europe into its 2010 financial forecasts and that he doesn't plan to change them directly due to European woes.
The currency effects can be very complex. Many companies routinely give sales estimates that exclude the currency impact so that the business' performance isn't shrouded. Also, they typically employ a mix of natural and financial hedges to protect earnings, even if sales take a big hit.
Natural hedges can include overseas manufacturing capacity, which can put the cost of production in the same currency as sales. For big multinational companies doing business around the globe, currency values in different countries can sometimes have an offsetting effect. Then there are foreign- exchange contracts companies can enter to manage risk.
But the dollar's strength still adds strain. JPMorgan noted a trend over the past decade of device stocks performing better than the broader market when currency rates add to sales, but worse when currency is a negative factor. "In short, MedTech stocks seldom outperform in the face of an FX headwind," analyst Michael Weinstein said.
Some of the dollar's gains have come since companies reported first-quarter results in April; however, device-maker Medtronic's recent report offered some fresh perspective. The company, which posted sales of $15.8 billion for its year ended April 30, said exchange rates at Monday's level would dent sales by $400 million to $500 million in the new fiscal year.
But the company also said its hedging strategy should mostly shield earnings.
The backdrop to currency concerns is the threat European sales also will decline because of government spending cuts. But some big companies have downplayed this risk.
This is "spooking investors," Abbott Laboratories (ABT) Chief Executive Miles White said at a recent conference. He explained that Abbott factored pressure in Europe into its 2010 financial forecasts and that he doesn't plan to change them directly due to European woes.
Thursday, April 29, 2010
Hemostat Market Research
- Category I: Important and Enabling
Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood. - Category II: Improved Clinical Outcome
Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery). - Category III: Cost-Effective and Time-Saving
Immediate reduction in surgical treatment time and follow-up treatments. - Category IV: Aesthetic and Perceived Benefits
Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.
Source: MedMarket Diligence, LLC
Sunday, August 16, 2009
Orthovita Powerhouse validates future Hemostasis Growth
Orthovita have released convincing data relaying their belief in the Orthopedic hemostasis market......see below......
Friday, August 14, 2009
Changes ahead in the coagulation factor market by new entrants and technologies
The worldwide market of recombinant and plasma derived coagulation factors grew to more than US$ 7.5 bln in 2008 and will be fundamentally challenged by over 40 projects in the R&D pipeline
Barcelona, Spain | August 14, 2009 | The Business Intelligence firm La Merie S.L. conducted an analysis of the coagulation factor R&D pipeline and benchmarked the over 50 companies active in the field within their peer group. The study revealed that the total market of recombinant and plasma-derived products of more than US$ 7.5 bln in 2008 will be fundamentally challenged by new players with improved next generation molecules as well as with lower priced molecules without being biosimilars. In contrast to other therapeutic proteins, recombinant first generation coagulation factors VIII, IX and VIIa have not been replaced by longer acting successors right in time before patent expiration. Failure of life cycle management efforts further put at risk future growth rates of product sales. This allows new market entrants to position themselves on the same level as the established marketers. New recombinant coagulation factors, e.g von Willebrand factor, fibrinogen, thrombin and F. XIII are challenging plasma derived products, especially in the field of topically used haemostats as an aid to stop bleeding and tissue sealants for wound healing. As the current generation of novel coagulation factors is focused on modifying half-life, there remains room for further improvement by non-invasive delivery or by reducing immunogenicity.These results and more were found in the search conducted by La Merie Business Intelligence. The report can be acquired at La Merie’s online store (www.pipelinereview.com/store ).
The report “Coagulation Factors 2009: Target Pipeline and Corporate Benchmark Analysis” analyzes and assesses the target pipeline for each of the coagulation factors used for systemic and topical administration. Companies active in the therapeutic coagulation business are evaluated and the strengths, weaknesses, opportunities and threats (SWOT) in their R&D pipeline benchmarked in the respective peer group. Technologies used for creation of next generation coagulation factors are discussed and assessed. The report identifies strategies to overcome weaknesses in the portfolio and suggests development strategies.
Barcelona, Spain | August 14, 2009 | The Business Intelligence firm La Merie S.L. conducted an analysis of the coagulation factor R&D pipeline and benchmarked the over 50 companies active in the field within their peer group. The study revealed that the total market of recombinant and plasma-derived products of more than US$ 7.5 bln in 2008 will be fundamentally challenged by new players with improved next generation molecules as well as with lower priced molecules without being biosimilars. In contrast to other therapeutic proteins, recombinant first generation coagulation factors VIII, IX and VIIa have not been replaced by longer acting successors right in time before patent expiration. Failure of life cycle management efforts further put at risk future growth rates of product sales. This allows new market entrants to position themselves on the same level as the established marketers. New recombinant coagulation factors, e.g von Willebrand factor, fibrinogen, thrombin and F. XIII are challenging plasma derived products, especially in the field of topically used haemostats as an aid to stop bleeding and tissue sealants for wound healing. As the current generation of novel coagulation factors is focused on modifying half-life, there remains room for further improvement by non-invasive delivery or by reducing immunogenicity.These results and more were found in the search conducted by La Merie Business Intelligence. The report can be acquired at La Merie’s online store (www.pipelinereview.com/store ).
The report “Coagulation Factors 2009: Target Pipeline and Corporate Benchmark Analysis” analyzes and assesses the target pipeline for each of the coagulation factors used for systemic and topical administration. Companies active in the therapeutic coagulation business are evaluated and the strengths, weaknesses, opportunities and threats (SWOT) in their R&D pipeline benchmarked in the respective peer group. Technologies used for creation of next generation coagulation factors are discussed and assessed. The report identifies strategies to overcome weaknesses in the portfolio and suggests development strategies.
Tuesday, August 11, 2009
.jpg)
Monday, July 20, 2009
Clinical Papers
Dear Reader,
I am inviting submissions for inclusion under the new label of "Clinical Papers" as per the paper below. If you have an article you feel would be useful or of interest please feel free to submit to me directly at hemostatguy@gmail.com
EMS, Surgical, Topical, Sealant, Glue and intravenous articles are all welcomed!
Saturday, July 4, 2009
Analyst predicts - "high-strength, elastic glue without toxicity concerns would revolutionize the market"
Approximately 70 million surgical and procedure-based wounds are created each year in surgeries worldwide that offer potential for adjunctive products for surgical closure and securement. Some 23 million of these wounds are created during surgical procedures in the United States. Although it is possible that healing of all these wounds would be improved through use of adjunctive products for surgical closure and securement, use of the most advanced of these products has been limited to a fraction of these procedures. For example, there are approximately 3 million procedures which receive sealant products around the world, generating $1.6 billion in sales in 2007. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures. New sealant products are also being launched. In addition to improvements in adjunctive treatment of bleeding, new procedure-enabling devices for soft tissue repair and securement have been introduced. These products have expanded the total market for securement and closure of soft tissues with bioresorbable materials.
This field is expanding rapidly as new devices allow the surgeon to perform closure more quickly and with improved outcomes for patients. A significant premium is possible when new products and devices enable complex securement procedures to be performed under minimally invasive protocols with significant time-savings in the operating room. New technologies and new biomaterials allow improved tissue repair, and it is possible to revalue segments of this market based on significant improvements in clinical practice. We expect this market segment to triple in value over the next decade.
The total market potential by 2013, driven by procedure volumes, for hemostats, sealants, and glues, addressable by currently available products, nearly $4.5 billion for hemostats and sealants, and more than $1.3 billion for skin wound closure using high-strength glues. The introduction of a high-strength, elastic glue without toxicity concerns would revolutionize the market further and lead to even higher sales potential.
Source: MedMarket Diligence, LLC
Sunday, June 14, 2009
Hemostasis Market - Review of Gelfoam, Surgicel, Avitene, Floseal, Bovine Thrombin
This post is to provide further commentary to a readily available 2005 article posted early last year from an online source. The source of the original article is linked below*.
So what do we want in a good hemostatic agent? First, the ideal hemostatic agent would of course be such that the agent itself is as well as any of its metabolic breakdown products would be safe to use within the body. Second, you want it to work and you want it to be efficacious.
The definition of efficacy can vary between the different uses, for example a vascular surgeon may want something that polymerizes very quickly in order to stop bleeding, but does not cause clot of the vessel that they spent all this time anastomosing, where as a reconstructive surgeon for example may want something that polymerizes very slowly to give them time to reposition their flaps or grafts.
Third is usability; you want something that is easy to use and that you can use in a variety of different circumstances. Fourth is affordability. This may be more relevant to a hospital administrator or pharmacist who actually does the purchasing, but it impacts the surgeon because that determines what you have available to you in the operating room. And finally, fifth, approvability. Any of these agents need to be approved by the FDA in order to be used in the US. So the different types of hemostatic agents, which I will be addressing in this talk are listed below and I am going to go through each one of these specifically.Gelatin sponge or Gelfoam®, which is also known as commercially as Surgifoam again was first introduced in the 1940s by Dr. Gray in the neurosurgical procedures. What it is is purified pork skin gelatin which you can kind think of like Jello®, as it is the same thing that Jello® is made out of.
It has a very amorphous form and has a lot of air spaces and it stains very eosinophilic on H&E stain. Basically the way it works is that its surface essentially acts in the intrinsic pathway causing contact activation and thus platelets. Since it works very proximally within this cascade, you have to have functioning cofactors or clotting factors in order for this to work in helping create clot. Of note, it does absorb approximately 45 times its weight in blood and can expand to approximately 200% of its initial volume. It is absorbed in approximately four to six weeks and on the nasal mucosa it liquifies within two to five days. In the case presentation, this child was initially packed with Gelfoam® approximately a week prior to the time she was seen in the ER and at that point there was no evidence of any Gelfoam left within her nasal cavity. Now the way Gelfoam® can be used, you can either apply dry, directly to the bleeding surface and hold pressure over it or you can wet it in saline and then squeeze out all the air bubbles and use it that way.
Oxidized regenerated cellulose is also known as Surgicel or Oxycel in its commercial forms. It is derived from alpha-cellulose that is actually plant-based. As you can see on microscopic view, Surgicel comes in knit formwhere as Oxycel comes in a microfibrillar form and on microscopic view Surgicel has these fibers which are knit together and they are solid fibers whereas Oxycel has the hollow fibers but they essentially work the same way. Surgicel is relatively acidic and is thought to cause some small vessel contraction. Like Gelfoam, it works at the same point in the intrinsic pathway of clotting causing contact activation. So again the same thing holds that functional clotting factors are needed in order for this to work. It is thought to berelatively bacteriostatic when compared to other hemostatic agents. The theory behind this is that because of its relatively low pH, it deactivates and denatures some of the bacterial proteins especially those related to antibiotic resistance, thus making them more susceptible to antibiotics. It needs to be applied dry and absorbs within four to eight weeks. Of note, on postop imaging Surgicel sometimes causes a ring-enhancing lesion as you can see here on postop imaging, which can be mistaken for an abscess cavity or tumor recurrence. That is something to keep in mind if you are imaging a patient within two months of having operated on them and Surgicel was used during the procedure. On microscopic view, you can see a giant cell reaction.
Our next agent is microfibrillar collagen commercially known as Avitene ®. It is most commonly used in a light flour form, but it does also come in a non-woven web form. This is collagen, which is derived from bovine skin. Under the microscope it is very eosinophilic and of note, under polarizing light it does have periodicity. It binds tightly to blood surfaces, so you do not actually need to achieve a relatively dry field in order to apply it. It causes minimal swelling especially when compared to Gelfoam ®. T he way it works is slightly different because in addition to being collagen and causing contact activation, it does somehow directly activate platelets. But again, it works very proximally within the intrinsic pathway. It is absorbed in three months and it needs to be applied dry.
Collagen sponges, these come in a wide variety of different commercial forms. Again it is similar to Avitene ® and it is derived from bovine Achilles tendon or bovine skin and it works in basically the exact same way as Avitene works and it absorbs in 8-10 weeks.
The next class of hemostatic agents is slightly different: topical thrombin. The idea of topical thrombin has been around since the early 1900s in order to try to achieve clot and in addition the idea of using topical thrombin plus other hemostatic agents such as Gelfoam ® has been around for quite a longtime. In 1999 a new agent was introduced called Floseal™ which basically consists of bovine thrombin plus cross-linked gelatin granules mixed together. So the way it works is your bovine thrombin directly activates fibrinogen and converts it into fibrin monomers. So you can see that this works in a completely different place within the clotting cascade. It works down here in the common pathway bypassing all of the other necessary clotting factors. You do however have to have functional fibrinogen in order for this to work. The product Floseal™ itself is a little bit different from just using topical thrombin plus Gelfoam ® because the gelatin granules have been cross linked in such a way that they do not swell to nearly the same extent. It is absorbed in approximately 6-8 weeks.
Fibrin sealants are the last class of the hemostatic agents that I am going to address. Commercially it comes in many forms including tisseal and crosseal and there are many variations on the idea of fibrin sealants. One of those basic ideas is that you take pure human fibrinogen and combine it with bovine thrombin and they usually throw in an antifibrinolyticagent into the mix as well. So the way this works is that we take the bovine thrombin, it then converts this exogenous human fibrinogen to fibrin monomers, but you do need intrinsic, you need the patient’s own factor XIII and calcium, which then converts it into fibrin polymer. In addition, they usually add an antifibrinolytic agent to the mix as well in order to stabilize the clot. So this does require functional factor XIII and calcium in order for these fibrin sealants to work. They are absorbed within 10-14 days and need a relatively dry field in order to work.
I am going to briefly mention some of the other classes of agents which are out there, but I am not going to address these in detail. There are some completely autologous fibrin sealants. The patient’s own serum is taken and the fibrinogen and thrombin are purified. This achieves essentially the same effect as the fibrin sealants previously mentioned. There are a target platelet gels where again you purify the platelet with plasma and the patient’s own serum combined with thrombin and you get similar agent to the fibrin sealants only there are some additional benefits: you do have some platelet direct growth factors involved which help with wound healing. There are some completely synthetic agents, which are made from polyethylene glycol gels that when you combine them make a completely synthetic hydrogel. Another product is bovine serum plus albumin plus glutaraldehyde, and poly N-acetyl glucosamine is something that the military is investigating as a hemostatic agent and it is a seaweed-based agent. This is just an idea of what is out there in addition to the agents I addressed previously.
Gelfoam ® and Surgicel, work here very proximally in the intrinsic coagulation pathway via contact activation. Collagen also works via contact activation, but also activates platelets. In a completely separate class we have agents that work in the common pathway, which includes Flowseal™, which is essentially topical thrombin and as well as fibrin glue and its variants.
Safety, three things to remember that Gelfoam® swells and it swells a lot. This has proven to be a problem when used within confined spaces such as the spinal foramina where in it can cause spinal cord nerve compression and brain compression. (Gelfoam adverse events HERE and HERE).
Surgicel, of note, even though it does have an antimicrobial effect relative to the other hemostatic agents, it is still a nidus for infection.( Links of interest HERE and Adverse events HERE and HERE and HERE ). Avitene®, and in fact all of these agents, do cause a certain amount of foreign body reaction and granulation formation. But Avitene® has been found to be the worst offender in this way. You can see in this particular slide, they have the Avitene® cavity here, and then a large amount of surrounding edema and a foreign body reaction with giant cells here surrounding the Avitene®. In this picture you can see the periodic nature of Avitene® under polarized light. In fact, the manufacturers recommend that you apply these agents, then hold pressure and wait a while for a clot to form and then you remove the agent afterwards so that you do not leave it within the cavity in order to try to prevent foreign body reaction as much as possible. In addition, Avitene® because it comes in a light fluffy form, has been known to occasionally cause arterial embolization and it had been reported that it is causing laryngospasm when used in tonsillectomy. Collagen sponge has many of the same side effects as any of the bovine derived agents because there are known allergic reactions to some of these bovine antigens, which are containing these agents. (Avitene adverse events HERE and HERE ).
Floseal™ again as I mentioned before has much less swelling than the Gelfoam so it can be used within some of the more enclosed spaces. Because it is Gelfoam beads it can cause arterial embolization if it is used near a larger vessel. In fact Gelfoam beads themselves have been used in order to embolize arterial malformation. Because it contains bovine antigens, it can have antibody formation, which I am going to talk about a little bit more in detail later. Some of the fibrin sealants use pooled human fibrinogen, in which there is always the potential for transmission of infectious agents. Also again, risks of arterial embolization and antibody formation. ( Floseal, Tisseel, CoSeal and Bioglue discussion HERE and bioglue HERE).
Antithrombin antibodies: These are foreign antigens. A study of 200 patients showed 90% of those exposed to topical thrombin do have a transient elevation in IgG titers. Tadokoro et al in Japan also noted that you can have development of IgE antibodies. This can result in a prolonged thrombin time. Of note, thrombin time is actually a measure of fibrinogen count.
Thrombin time: the way this test was done, you add bovine thrombin to the patient’s fibrinogen and see how long it takes for it to form a monomer. Because you have development of antibodies to bovine thrombin, you can have elevation in your thrombin time. This antibovine thrombin antibody can cross-react with human thrombin, but interestingly enough, this rarely ever causes any sort of clinical bleeding.
The real problem is with antifactor V antibody, as most commercial form of thrombin is contaminated with a certain amount of other bovine antigens and most importantly bovine factor V. So if you can get these antibovine factor V antibodies, which then cross-react with human factor V this can lead to a very severe coagulopathy and because this antibody can act as an inhibitor of factor V. On laboratory tests you can find a very decreased factor V level, increased PT and PTT, which does not correct when you add FFP and vitamin K. When you mix the patient’s sera with a normal human sera, you do not get correction of the PT and PTT which suggest that it is not a cofactor deficiency, but it is actually an inhibitor causing the problem. So as you can see here the factor V is an activator of the conversion of prothrombin to thrombin and this is where you end up with problems. The same study noted that 50% of the 200 patients that they found that were exposed to topical thrombin did develop human factor V antibodies. The problem usually does not happen on the initial exposure, but it is when they are exposed again in the later point to the topical thrombin is when the potential for coagulopathy is exposed. Fortunately these IgG titers do fall off rapidly three to four weeks after the exposure and the treatment if you do encounter this is steroids, cyclophosphamides, IVIG plasmapheresis and platelet transfusion. Of note, I did not see actually any reports of this in the head and neck literature per se; most of the case reports of these events are in the cardiovascular and vascular literature. (Gelfoam or Thrombin adverse event HERE link of interest HERE . Of course we now have J&J human thrombin HERE and Zymogenetics recombinant HERE).Another requirement of a good hemostatic agent is efficacy. Basically there have been lots of studies both in vitro and in vivo using various animal models as well as human studies comparing these various hemostatic agents. The general gist of them is that fibrin sealant work better than Floseal™ which is better than Avitene® and then the collagen sponge, Surgicel and Gelfoam® are essentially equivocal. They do work better than placebo but can barely differentiate efficacy between any of them. Of note, Floseal™ and Avitene® do cause more inflammatory reactions than the others.
Usability: Gelfoam®, Surgicel, Avitene® and these collagen sponge can be stored at the room temperature and are basically ready to use out of the box. Floseal™ does require two to five minute prep time, you combine the thrombin with calcium and combine that to the gelatin granules. Fibrin sealants on the other hand need to be kept in cold storage and thawed prior to usage; it depends on what company you are using and what type and the prep time can be anywhere up to 20-30 minutes. So it is something to keep in mind if you think you want to use fibrin sealant during your case you should be prepared ahead of time in order to do so.
Affordability: This is an average or sort of an idea of what the cost is for some of these agents. Gelfoam®, Surgicel, collagen sponges are relatively inexpensive in a $10-20 per individual piece, whereas Avitene®, Floseal™ and fibrin sealants are much more expensive.
Approvability: All of these agents are regulated through the FDA as a class III medical device, which means they are subjective to this medical device reporting systems so that the manufacturers are obligated to report to the FDA when an adverse event happens. In fact, in 2004 the FDA released notification to users about Gelfoam® and its swelling and use in neurosurgical procedures because of the potential for paralysis.
*The Full article is available HERE. Links have been added here regarding adverse events and are placed within parentheses.
There is a solution to many of the issues faced with Hemostat requirements with HaemoCer Plus.......read more HERE
Monday, June 8, 2009
Poll Results - Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?
We asked "Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?"
50% said YES
20% said NO
13% said DEPENDS ON THE COUNTRY OF ORIGIN OF PRODUCT
16% said MAYBE
Obviously human and animal sourced products do exhibit some concerns for many.
Thursday, March 26, 2009
Report predicts excess of 100 million procedures
The market potential for the future utilization of surgical sealants, glues, wound closure and anti-adhesion products is based on the progressive adoption of these products for multiple uses (sealing, hemostasis and even anti-adhesion) and their (more) routine use in surgical and other clinical practice, demographic forces influencing potential caseload and with the changing regulatory demands for this diverse set of products. According to the MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013," from 2009 forward, the trends in product adoption and the demographic forces, combined with new product introductions are expected to accelerate market growth. There remains a growing potential for these products to be used in excess of 100 million procedures worldwide. Growth in utilization will exceed double-digit annual rates for new products and for established products in geographic markets that have yet to be fully tapped.
A number of market leaders have consolidated their positions within the surgical closure and securement markets through successful internal development programs and through technology partnerships with innovative vendors of next-generation technologies. For example, Covidien and Ethicon (Johnson & Johnson) are major suppliers of cyanoacrylate products in the United States; with dominant sales resources to sell these products, these companies lead the market, although they face competition from the Canadian company Glustitch, the U.K.-based Medlogic and others. Synovis (formally Biovascular Inc.) has targeted cardiovascular and other procedures, and has a range of closure products; it has partnered with GEM to develop and exploit GEM’s internal high-strength glue product (Glubran) in the United States.
A number of market leaders have consolidated their positions within the surgical closure and securement markets through successful internal development programs and through technology partnerships with innovative vendors of next-generation technologies. For example, Covidien and Ethicon (Johnson & Johnson) are major suppliers of cyanoacrylate products in the United States; with dominant sales resources to sell these products, these companies lead the market, although they face competition from the Canadian company Glustitch, the U.K.-based Medlogic and others. Synovis (formally Biovascular Inc.) has targeted cardiovascular and other procedures, and has a range of closure products; it has partnered with GEM to develop and exploit GEM’s internal high-strength glue product (Glubran) in the United States.
Tuesday, February 3, 2009
Haemonetics Corporation F3Q09 - Edited
Christopher Lindop
The core business remains strong with 12% growth, excluding currency and the TEG acquisition and year-to-date reported revenue growth for the entire business including TEG is 18%. Revenue growth in the quarter came from plasma, diagnostics, and blood banks. Year-to-date all product lines are contributing with solid growth. As we have said many times, we have multiple growth drivers, so let me share more insight.
First I will discuss plasma, our largest business with year-to-date revenues of $150 million. Plasma disposables continue to grow exceptionally well at 30% in the quarter and 31% year-to-date. This growth is driven by market expansion and new contracts. We saw increases in all geographies including Japan as demand for IPIG and albumin outpaced global supplies of plasma. In the US Haemonetics also benefited from a new contract with Octapharma which we announced in Q1 of fiscal ’09. In Japan we saw stronger unit growth combined with a year-over-year price improvement related to a plasma safety enhancement released in Q1 of this year.
It is important to note that plasma-derived drugs are not considered elective treatments and as such are not impacted by current economic trends. Fractionators continue to make investments in their business and industry analysts report that collections are expected to grow about 12% over the next year to meet ongoing drug demands. So as we have shared previously, while we expect plasma growth to moderate from the current extremely high growth rates, we currently expect double-digit revenue growth in the plasma business for the next 24 months.
Blood banks, which are mainly platelet collection disposables, are our second biggest business with $108 million in revenues year-to-date. Blood bank disposables grew 10% in the quarter and 8% year-to-date. The platelet market is growing nominally in developed markets, but we have identified areas for growth in emerging markets, specifically Eastern Europe and parts of Asia. In addition, as you may recall, this year we are benefiting from the market share gains through a contract with Canadian Blood Services. We saw the comparative benefit of the CBS contract through our past quarter. We are pleased that our blood bank business continues to contribute to overall revenue growth as we continue to gain market share in the developed markets and expand markets globally.
Moving to red cells, the red cell disposables business, which has revenues of $37 million year-to-date, grew 5% in the quarter and 7% year-to-date. While more than our original expectations for growth in this product line, our outlook has us growing it between 8% to 10% for the full year.
First I will discuss plasma, our largest business with year-to-date revenues of $150 million. Plasma disposables continue to grow exceptionally well at 30% in the quarter and 31% year-to-date. This growth is driven by market expansion and new contracts. We saw increases in all geographies including Japan as demand for IPIG and albumin outpaced global supplies of plasma. In the US Haemonetics also benefited from a new contract with Octapharma which we announced in Q1 of fiscal ’09. In Japan we saw stronger unit growth combined with a year-over-year price improvement related to a plasma safety enhancement released in Q1 of this year.
It is important to note that plasma-derived drugs are not considered elective treatments and as such are not impacted by current economic trends. Fractionators continue to make investments in their business and industry analysts report that collections are expected to grow about 12% over the next year to meet ongoing drug demands. So as we have shared previously, while we expect plasma growth to moderate from the current extremely high growth rates, we currently expect double-digit revenue growth in the plasma business for the next 24 months.
Blood banks, which are mainly platelet collection disposables, are our second biggest business with $108 million in revenues year-to-date. Blood bank disposables grew 10% in the quarter and 8% year-to-date. The platelet market is growing nominally in developed markets, but we have identified areas for growth in emerging markets, specifically Eastern Europe and parts of Asia. In addition, as you may recall, this year we are benefiting from the market share gains through a contract with Canadian Blood Services. We saw the comparative benefit of the CBS contract through our past quarter. We are pleased that our blood bank business continues to contribute to overall revenue growth as we continue to gain market share in the developed markets and expand markets globally.
Moving to red cells, the red cell disposables business, which has revenues of $37 million year-to-date, grew 5% in the quarter and 7% year-to-date. While more than our original expectations for growth in this product line, our outlook has us growing it between 8% to 10% for the full year.
Brian Concannon
Thanks Chris and good morning everyone. Chris just mentioned two key points: global economic factors and market extremes. Some of you are asking how Haemonetics will be impacted by the turmoil in the global economy, the predicted downturn in elective surgeries and lower capital spending at hospitals. So, let me try to address these questions, but first, let me give you the bottom line.
We expect any negative impact in fiscal ’10 to be modest. Haemonetics is the global leader in blood management solutions, so at the heart of our business is blood and transfusions are a critical part of every health system around the world. Try to run a hospital without blood. It is impossible. Let me share one example.
Recently a leading hospital network, which accounts for about 5% of inpatient admissions in the US, released some key statistics. The company said that for the nine months ended September 2008 blood costs represented 6% of its total expenses. In this period, while its inpatient census grew at about 2% blood costs were rising at nearly 18% year-over-year. This statistic was compared to pharmaceutical costs, which rose at about 1% per year, and med-surg supplies which grew roughly at 5%.
So we know that there are large for profit organizations incurring significant blood costs affecting their income statements. Inevitably, healthcare providers will have to better manage blood costs and they have only two choices, stop surgeries or control the costs of blood. Which is a better financial decision?
Thanks Chris and good morning everyone. Chris just mentioned two key points: global economic factors and market extremes. Some of you are asking how Haemonetics will be impacted by the turmoil in the global economy, the predicted downturn in elective surgeries and lower capital spending at hospitals. So, let me try to address these questions, but first, let me give you the bottom line.
We expect any negative impact in fiscal ’10 to be modest. Haemonetics is the global leader in blood management solutions, so at the heart of our business is blood and transfusions are a critical part of every health system around the world. Try to run a hospital without blood. It is impossible. Let me share one example.
Recently a leading hospital network, which accounts for about 5% of inpatient admissions in the US, released some key statistics. The company said that for the nine months ended September 2008 blood costs represented 6% of its total expenses. In this period, while its inpatient census grew at about 2% blood costs were rising at nearly 18% year-over-year. This statistic was compared to pharmaceutical costs, which rose at about 1% per year, and med-surg supplies which grew roughly at 5%.
So we know that there are large for profit organizations incurring significant blood costs affecting their income statements. Inevitably, healthcare providers will have to better manage blood costs and they have only two choices, stop surgeries or control the costs of blood. Which is a better financial decision?
Now let me cut this another way. More than 30% of our business is plasma collections and as Chris shared earlier this is a growing market with ongoing demand for plasma derived drugs. Industry analysts see that demand continuing. 35% of our business is platelets and red cell collections and 15% of our business is cardiovascular surgical blood salvage and diagnostics. The fact is, if you need a transfusion as part of you cancer treatment, or if you need heart surgery these are not elective procedures.
The one area where we could have exposure in the changing economic climate is elective surgeries and specifically orthopedic surgical blood salvage. But here our total exposure is just around $35 million annually. Less than 6% of total corporate sales come from our OrthoPAT. The OrthoPAT device can save the hospital costs and the orthopedic surgical blood salvage market is less than 10% penetrated. Downward pressure on large joint procedure reimbursement, a 25% decline in 10 years, combined with increased implant prices is putting pressure on healthcare provider’s profitability. What does all of this mean?
In order for hospitals to make money on a procedure the cost of the surgeon, the nurses, the OR, and yes, the blood products have to be managed. If we can save hospitals money on blood costs in our under penetrated market than some elective surgery issues can be resolved.
Now when you consider that a recent study by the Englewood Hospital in New Jersey estimates the total cost of delivering a unit of blood for transfusion is approximately $1,100.00, the value of avoiding or minimizing transfusion becomes clear. Even in the declining procedure market there is significant opportunity for OrthoPAT growth for market penetration by helping hospitals to control total blood costs.
Let me remind you of Atlantic Health, the health system we spoke about last quarter. Atlantic Health implemented Haemonetics blood management systems and saved about $1 million in blood related costs.
My final point is we place devices and generate revenues from the sale of disposables that save the hospital money every time they are used. With this business model, we avoid the inevitable pressures of tightening capital budgets. We are not in the capital equipment business.
In closing, nearly all of Haemonetics revenue comes from products, systems, and services that healthcare providers need despite a downturn in the economy and pressures on healthcare systems. Our strategy addresses a growing need. We believe we are uniquely positioned in these troubled times as the blood management company. We are the only company which can help customers control blood costs throughout the total blood supply chain from the donor to the patient.
The one area where we could have exposure in the changing economic climate is elective surgeries and specifically orthopedic surgical blood salvage. But here our total exposure is just around $35 million annually. Less than 6% of total corporate sales come from our OrthoPAT. The OrthoPAT device can save the hospital costs and the orthopedic surgical blood salvage market is less than 10% penetrated. Downward pressure on large joint procedure reimbursement, a 25% decline in 10 years, combined with increased implant prices is putting pressure on healthcare provider’s profitability. What does all of this mean?
In order for hospitals to make money on a procedure the cost of the surgeon, the nurses, the OR, and yes, the blood products have to be managed. If we can save hospitals money on blood costs in our under penetrated market than some elective surgery issues can be resolved.
Now when you consider that a recent study by the Englewood Hospital in New Jersey estimates the total cost of delivering a unit of blood for transfusion is approximately $1,100.00, the value of avoiding or minimizing transfusion becomes clear. Even in the declining procedure market there is significant opportunity for OrthoPAT growth for market penetration by helping hospitals to control total blood costs.
Let me remind you of Atlantic Health, the health system we spoke about last quarter. Atlantic Health implemented Haemonetics blood management systems and saved about $1 million in blood related costs.
My final point is we place devices and generate revenues from the sale of disposables that save the hospital money every time they are used. With this business model, we avoid the inevitable pressures of tightening capital budgets. We are not in the capital equipment business.
In closing, nearly all of Haemonetics revenue comes from products, systems, and services that healthcare providers need despite a downturn in the economy and pressures on healthcare systems. Our strategy addresses a growing need. We believe we are uniquely positioned in these troubled times as the blood management company. We are the only company which can help customers control blood costs throughout the total blood supply chain from the donor to the patient.
Brad Nutter
I would also mention Dan, that we have seen great balanced growth in all geographies. North America is up 21%, Asia is up 21%, Europe is up 17%, Japan 11%, although we, as Chris indicated, some of that currency. The fact is, this is the first time in a long time that we have seen all of our geographies all growing double digits, so that is a tremendously strong aspect of our business when you consider that more than 50% of our sales are outside of the United States. We like that balanced growth. North America has done that for four years in a row, but it is nice to see both Asia and Europe do it two years in a row.
I would also mention Dan, that we have seen great balanced growth in all geographies. North America is up 21%, Asia is up 21%, Europe is up 17%, Japan 11%, although we, as Chris indicated, some of that currency. The fact is, this is the first time in a long time that we have seen all of our geographies all growing double digits, so that is a tremendously strong aspect of our business when you consider that more than 50% of our sales are outside of the United States. We like that balanced growth. North America has done that for four years in a row, but it is nice to see both Asia and Europe do it two years in a row.
Source: seekingalpha
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013
WALTHAM, Mass., Feb 02, 2009 /PRNewswire via COMTEX/ -- Growing interest and innovation will drive adhesion barrier market, according to Millennium Research Group
According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report, growing surgeon interest in adhesion barriers, combined with numerous upcoming product launches, will fuel revenues in the US adhesion barrier market. Exceeding $550 million by 2013, the adhesion barrier market will experience a compound annual growth rate of almost 25% over the next five years.
It is estimated that the cost of treating adhesiolysis (the surgical removal of adhesions) in the US is over $2 billion annually. Due in part to the narrow range of approved indications for currently available products, the US adhesion barrier market remains underpenetrated; however, interest in these products is expanding rapidly as hospitals and surgeons realize the many benefits of using an adhesion barrier in surgical procedures. This interest will prompt a growing number of competitors to enter the US adhesion barrier market in the coming years.
The arrival of new adhesion barriers will expand indications, and the associated favorable clinical data that supplement product approvals, will boost surgeon awareness and drive adoption. Improved awareness will further be bolstered by continuing innovation and intensifying competition from market competitors, contributing to unit growth and adhesion barrier market expansion over the next five years.
"Following the removal of Gliatech's ADCON-L, FzioMed's Oxiplex/SP adhesion barrier was slated to be the first such product approved for spinal applications in the US," says Kevin Flewwelling, Manager of Orthopedics at MRG. "But, due to the product's unfavorable approval vote from the FDA's Orthopaedic & Rehabilitative Devices Panel in July of 2008, several companies have demonstrated renewed interest in developing an adhesion barrier approved for use in the lucrative US spine market."
MRG's US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report provides in-depth coverage of the surgical hemostat, internal tissue sealant, and adhesion barrier markets. Competitors covered include Baxter BioSurgery, Covidien, CryoLife, Davol (a subsidiary of C.R. Bard), Ethicon (a Johnson & Johnson company), Genzyme Biosurgery, King Pharmaceuticals, MAST Biosurgery, Orthovita, Pfizer, and many more.
According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report, growing surgeon interest in adhesion barriers, combined with numerous upcoming product launches, will fuel revenues in the US adhesion barrier market. Exceeding $550 million by 2013, the adhesion barrier market will experience a compound annual growth rate of almost 25% over the next five years.
It is estimated that the cost of treating adhesiolysis (the surgical removal of adhesions) in the US is over $2 billion annually. Due in part to the narrow range of approved indications for currently available products, the US adhesion barrier market remains underpenetrated; however, interest in these products is expanding rapidly as hospitals and surgeons realize the many benefits of using an adhesion barrier in surgical procedures. This interest will prompt a growing number of competitors to enter the US adhesion barrier market in the coming years.
The arrival of new adhesion barriers will expand indications, and the associated favorable clinical data that supplement product approvals, will boost surgeon awareness and drive adoption. Improved awareness will further be bolstered by continuing innovation and intensifying competition from market competitors, contributing to unit growth and adhesion barrier market expansion over the next five years.
"Following the removal of Gliatech's ADCON-L, FzioMed's Oxiplex/SP adhesion barrier was slated to be the first such product approved for spinal applications in the US," says Kevin Flewwelling, Manager of Orthopedics at MRG. "But, due to the product's unfavorable approval vote from the FDA's Orthopaedic & Rehabilitative Devices Panel in July of 2008, several companies have demonstrated renewed interest in developing an adhesion barrier approved for use in the lucrative US spine market."
MRG's US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report provides in-depth coverage of the surgical hemostat, internal tissue sealant, and adhesion barrier markets. Competitors covered include Baxter BioSurgery, Covidien, CryoLife, Davol (a subsidiary of C.R. Bard), Ethicon (a Johnson & Johnson company), Genzyme Biosurgery, King Pharmaceuticals, MAST Biosurgery, Orthovita, Pfizer, and many more.
Wednesday, July 16, 2008
J & J report Q2 Double Digit Growth in Market
J & J have released their Q2 2008 financials and present a positive result for the hemostasis market.
Regarding the Ethicon division report "... Ethicon worldwide sales grew operationally by 6% with the U.S. up 7% and sales outside the U.S. growing operationally by 5%. Solid growth in sutures and double-digit growth in homeostasis and mesh products were the major contributors to growth in the quarter."
Commenting on the offer for the Ethicon Woundcare segment by One Equity Partners, Dominic Caruso (CFO) remained tight-lipped saying "If the offer is accepted and the closing conditions are satisfied, the proposed transaction would be expected to close later in 2008. It would be premature to say anything more about this pending transaction at this time. "
Regarding the Ethicon division report "... Ethicon worldwide sales grew operationally by 6% with the U.S. up 7% and sales outside the U.S. growing operationally by 5%. Solid growth in sutures and double-digit growth in homeostasis and mesh products were the major contributors to growth in the quarter."
Commenting on the offer for the Ethicon Woundcare segment by One Equity Partners, Dominic Caruso (CFO) remained tight-lipped saying "If the offer is accepted and the closing conditions are satisfied, the proposed transaction would be expected to close later in 2008. It would be premature to say anything more about this pending transaction at this time. "
Subscribe to:
Posts (Atom)