See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”
In the field of surgical sealants, glues, wound closure and anti-adhesion, the most significant opportunity for products is the area of high strength glues. Currently, there is no standout biologically or chemically based product that has the performance necessary to displace the very large and established market for traditional wound closure — sutures, staples and clips. Fibrin-based surgical sealants, glues, hemostats and other products are at best adjuncts to traditional wound closure, providing a complementary role of helping to seal wounds or hasten the healing process. The real opportunity of fibrin or other surgical sealants and glues lies in their ability to provide the tensile strength of sutures with rapid hemostasis and tissue adhesion and with no toxicity or other biocompatibility effects beyond what sutures might produce. Secondly, such future sealant/glue products must also be able to achieve this performance at lower cost and/or improved outcomes.
So, this is no small challenge.
Having said this, there are quite a number of companies active in the development of these products and it is eminently reasonable that the companies involved will be making significant inroads to this challenge over the coming decade.
Even at existing levels of performance, biological and other sealants/glues/hemostats are progressively gaining caseload and market share from traditional wound management products. The forecast below, which illustrates shares for the market in 2009, imputes a modest level of penetration of traditional products. Any significant advance in improved tensile strength, with reduced toxicity, of emerging sealants/glues/hemostats would result in the market growth rate eclipsing the modest 11.5% CAGR in the data below.
(Note: This was posted initially in August 2011. The data in the table is drawn from the 2012 updated, published report #S190.)
In light of the recent development in which Stanford researchers invented a method for a sutureless attachment of blood vessels (i.e., vascular anastomosis) using a surgical glue (Dermabond), it is worth highlighting that the applications of surgical sealants and glues in medical/surgical applications are remarkably numerous, with a potential already begun to be realized in reshaping many medical and surgical procedures.
Below is an excerpt of the clinical applications by major field for surgical sealants and glues (drawn from Report #S190):
* Adhesive agent in CNS tissue surgery. CNS tissue cannot be sutured. Fibrin glue is almost equivalent to microsurgical suture. Fibrin glue works as a sealant but not a nerve barrier.
* Repair of dural defects.
* Conjunctival closure in strabismus.
* Wound closure in glaucoma.
* Lower blepharoplasties (for lower eyelids).
* Myringoplasty in large persistent tympanic membrane perforation.
* Repair of laryngotracheal separation with cricoidectomy.
* Narrowing of nasal fossa in atrophic rhinitis.
Oral and dental surgery:
* Local hemostatic measures in patients with bleeding disorders and patients on anticoagulants.
* Sealing of oro-antral fistula.
Head and neck:
* Parotidectomy closure.
* Axillary dissection in carcinoma of the breast. Reduces adhesion, bleeding and serous drainage with earlier drain.
* Prevention of mastectomy seroma.
Cardiovascular thoracic surgery:
* Reduced postoperative bleeding and intrapericardial adhesion.
* In cardiothoracic surgery using fibrin glue significantly reduced postoperative bleeding.
* Sealing of prolonged air leak after thoracotomy in lung cancer.
* Bronchopleural fistula.
* Percutaneous lung biopsy.
* Microvascular anastomosis: Suture may induce vascular narrowing, foreign body reaction, intravascular thrombosis but are less common in those with fibrin glue application.
Sutures and staples are at an aging stage in their product life cycle; there are numerous predicate devices, and the materials are well established and cover most of the spectrum of clinical need for suturing. However, a great number of procedure-enhancing devices have been developed in the last seven years, particularly as minimally invasive surgery and robotics have created a need for new instrumentation to secure tissue. Good examples of this are the development of stapling devices for pneumostasis and securement devices for arthroscopy. This illustrates the fact that once clinical evaluation of a new product has been completed to the satisfaction of regulatory authorities for launch of the new product, incremental developments and clinical evaluations are usually continued throughout the lifetime of the product.
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Similarly, a number of hemostats and devices for preparation of autologous fibrin sealant have also been available for some time for prevention of blood loss (e.g., from Harvest Technologies). These materials and devices are generally approved for hemostasis, and companies have attempted to develop new physical forms, mixes, and delivery systems to speed up and improve the usefulness of these products.
Commercial forms of pooled human fibrin have been used clinically outside of the United States for many years, for reasons of preventing infection; however these products did not reach this stage of clinical evaluation in the United States for many years. In 1996, the FDA approved the clinical investigation of fibrin sealants and a number of trials commenced. These resulted in a cascade of approvals for specific indications and claims, and considerable off-label use and clinical evaluation. Fibrin sealants have been employed and reported to prevent bleeding in many types of procedures including cardiovascular (e.g., restiotomy), neurological (e.g., craniotomy), orthopedic (e.g., knee replacement), spinal (e.g., vertebral fusion), cosmetic (e.g., breast augmentation) and digestive (e.g., closure of temporary colostomy).
Alternatives to fibrin sealant have been developed and launched with specific claims and targeted at specific indications. Cyanoacrylates have been employed as external suture replacements since 1997 in the United States. These materials started life as off-label sports injury products; they were approved with limited claims, which were then expanded to include “reduced injection risk,” and general use of these products for topical application is well established; reports from major suppliers suggest that approximately 20% of the accident and emergency opportunity for treating lacerations in the United States is penetrated by cyanoacrylate glue products.
Variables Associated With Clinical Evaluation of Closure and Securement and Related Products
Low cost if short follow-up, (e.g., cuts and grazes) and low-cost procedure
High cost if long-term follow-up required, (e.g., ligament repair) and high cost procedure
Some procedures require short follow-up periods (e.g., hemostasis endpoints and use of cyanoacrylate on cuts)
Some procedures require at least two years follow-up (e.g., musculoskeletal sports injuries)
Community care (lacerations)
Doctor’s surgery (accidents)
Critical care (e.g., burns)
Some devices and developments have predicate devices which allow more rapid approval. Autologous products are also relatively quick to develop
New biologicals, complex mixtures of biomaterials, and new chemical entities require extensive validation and testing
Device for delivery
Can accelerate clinical approval and improve clinical efficacy
Can complicate clinical development if both device and product are new
The market for surgical closure and securement (sealants, glues, sutures, staples, tapes, hemostasis, anti-adhesion) has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate circumstances. There is now a continuum between simple closure using sutures and the use of specially designed devices and delivery systems with new bioresorbable securement materials either as supplements to conventional closure methodology or as stand-alone replacements.
Worldwide expenditure on all medical devices is estimated to have surpassed $180 billion in 2007, and in the field of tissue repair and surgical securement, the total market reached $7.3 billion, underpinned by product advances reflecting our improved understanding of the underlying mechanisms of tissue repair, patient demographic pressures creating an increasing caseload of procedures, and a rapidly expanding number of new products available.
The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are growing to be components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.
Overall industry spending in the health care system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the United States) creates a pressure for cost-effectiveness arguments and supporting clinical efficacy data, and may also limit pricing potential, often when the overall cost in a category appears to be growing uncontrollably. The shift to outpatient and community-based treatment sites and practices affects the way that products are designed, marketed and distributed. In the securement segment, hospital administrators are involved in purchasing more routine and generic surgical securement and closure products, with surgeons selecting more advanced and new technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theatre time and costs.
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.
In the field of postoperative adhesion control, newly developed products improve on early prototypes and have substantial clinical efficacy data to allow for a significant premium cost. Over $700 million revenues were generated in 2007 in this market segment, and we expect that this market will grow to nearly $1.5 billion dollars in the next five years.