The market for surgical closure and securement — sealants, glues, sutures, tapes, and 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 expenditures on all medical devices is estimated to have surpassed $173 billion in 2006. In the field of tissue repair and surgical securement, the total market reached almost $7 billion, underpinned by product advances reflecting 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 (see below).
Introduction (through early 2007) of New Securement Technologies to the U.S. Market
Johnson & Johnson
Fabric adhesion prevention
Hyaluronic acid adhesion prevention
Fibrin based sealant/hemostats
Hyaluronic acid adhesion prevention
Autologous blood sealant
Bovine serum albumin-based surgical adhesive
Syneture (US Surgical)
Cyanoacrylate tissue adhesive
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 becoming 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 health care purchasing 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 newer, more advanced technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theater time and costs.
Many new surgical procedures have been established over the last 10 years as products and procedures have been modified to accommodate increased patient awareness and to support practitioner-based competencies. These procedures are often linked to new technologies. For example, minimally invasive procedures that were comparatively rare 10 years ago are now routine; more than 70% of gall bladder surgeries are performed laparoscopically and more than 60% of patients with angina pectoris receive image-guided PTCA (percutaneous transluminal coronary angioplasty) instead of open heart surgery. These procedures depend on new devices and instruments, including improved means of internal and external closures and securement. In addition, aging of the population adds progressively to the surgical caseload. For example, in the United States, Medicare beneficiaries are forecast to increase from 34 million to 70 million between 2000 and 2030. Products targeted at this primarily elderly population would be expected to reflect this trend by compound annual sales growth of 2%–3%. In other regions of the world, this trend is also seen as a major market growth rate determinant.
The market potential for surgical securement products is driven by a combination of new technologies coming to market and expanding caseload for which these technologies are applicable. The potential for these products continues to grow as surgical practices improve and the benefits of new products address the requirement for fast and effective closure.
We forecast that approximately 70 million procedures worldwide might benefit from products in this category and, due to demographic trends and evolving surgical capabilities, this number is forecast to increase at an annualized rate of 3%–5% (see chart, “Potential Procedure Volume for Surgical Sealants, Glues and Wound Closure”).
Of the 70 million surgical and procedure-based wounds created each year in surgeries worldwide, 23 million are created during surgical procedures in the United States. Although it is possible that healing all these wounds could 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 worldwide that receive sealant products, generating $1 billion in sales. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures and as new sealant products are 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.
Driven by procedure volumes, the total market potential for currently available products is in excess of $3 billion for hemostats and sealants, and over $1 billion for skin wound closure using high-strength glues. The introduction of a high-strength, nontoxic elastic glue 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 $500 million in revenues were generated in 2006 in this market segment, and we expect that this market will grow to over $1 billion within the next five years.
Market Consolidation, Competition on the Rise
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, U.S. Surgical (a Tyco company) 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, even though 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 recently partnered with GEM to develop and exploit GEM’s internal high-strength glue product (Glubran) in the United States.
Companies in the sealant market are highly competitive, and acquisitions and mergers have also played a significant role in shaping both this market and the individual companies with their products and underlying strategic focus. For example, Baxter launched fibrin sealant technology (acquired when it bought Immuno) in the United States. In addition, its purchase of Immuno in 1998 forced Baxter to relinquish a monopoly position by forming a partnership with Haemacure, thus allowing it to market fibrin products in the United States. Baxter has also acquired rights to Fusion Inc. technology, giving Baxter a portfolio of sealant products. Separately, CryoLife has demonstrated the potential to compete within the rapidly evolving sealants market in the United States by developing superior products.
MedMarket Diligence is completing the 2008 report, publishing December 2008, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion, 2009-2013." See Report #S175.