[Below is an excerpt from Report #S145, "Worldwide Surgical Sealants, Glues & Wound Closure", published Feb. 2007. This report is the subject of a new analysis, Report #S175, to be published December 2008.]
Introduction
The market for surgical closure and securement 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 surpassed $173 billion in 2006, and in the field of tissue repair and surgical securement, the total market reached almost $7 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 healthcare system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the USA) 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 out-patient 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.
Demographic trends
Many new surgical procedures have been established over the last ten years as products and procedures are modified to accommodate increased consumer (i.e. 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, ageing of the population adds progressively to the surgical caseload. For example in the USA, Medicare beneficiaries (disabled and elderly patients) are forecast to increase from 34 million to 70 million between 2000 and 2030. Products that are targeted at this elderly population – and reimbursed – 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.
Consumer Driven Product Selection
Other important driving factors are accelerating public healthcare awareness and education, improved communication techniques and media, rises in gross domestic product in many countries around the world, and awareness of patient rights (including litigation potential). All lead to increased uptake for the best new products, technologies, and techniques, once these have been proven safe and effective. For example, it might now be viewed as negligent for a gynaecological surgeon to not use an adhesion prevention product on a female patient of child-bearing age. Patient access to clinical trial records and regulatory approval information is now becoming more universal, and this contributes powerfully to consumer-driven product selection.
Mechanisms of Tissue Repair
As recently as ten years ago, the biochemical mechanisms underlying tissue repair were still incompletely understood. For example, during the early 1990s as many as a hundred companies were actively engaged in clinical trials evaluating efforts to accelerate repair based on applying higher than physiological levels of growth factor to non-healing tissue. By 2003, many companies had abandoned this approach due to disappointing results. A better understanding of the underlying mechanisms of tissue repair has led to the evaluation of more complex approaches, combining structural repair materials with active pharmacological agents, biologically-derived and cellular components. This improved knowledge of physiological healing processes has led to formulation and adoption of new securement and adjunctive surgical devices, resulting in improved hemostasis, reduction in post-surgical adhesion (PSA) formation, and stronger and quicker biological repair.
Commercial Imperatives
MedMarket Diligence carried out a survey of the companies exploiting medical devices targeted at the surgical securement market, to examine the products they market and the timelines associated with their approvals. A greater awareness of regulatory approval mechanisms and requirements around the world has become apparent in this market sector, and we believe this indicates a growing trend in the medical device industry overall. In the USA, a new medical device is usually marketed after the FDA approves a pre-market application, or clears a 510K pre-market notification submission. The time required for the FDA to carry out this approval has been steadily reducing (around 3 months now for a 510k and 13 months for a PMA). The FDA has improved to accelerate this process and make the approval process less arbitrary.
Regulatory bodies in Europe and Japan have also made marked advances in the last ten years to streamline their approval processes, so that clear guidelines are given for approval and for reimbursement categories. In addition, companies making submissions have become more aware of the need to identify the key factors for approval (KFA), and to engage with the regulatory bodies early in the process to clarify the routes forward for any exceptional aspects of product development.
We also found that all medical devices businesses (from small biotechnology companies to large capital conglomerates) are becoming more efficient at managing their new product pipelines, and focusing on a mixture of short-term product concepts and longer term, more risky breakthrough opportunities.
Industry Consolidation
In the last few years there has been a significant consolidation of the securement industry, as venture-based companies are incorporated into larger market-based corporations with critical mass in their sales effort. This represents a welcome development for investors in leading-edge technologies, which are now being developed into marketable ventures. Examples exist covering the full range of deal structures from exclusive distribution deals and joint development agreements with exclusive marketing licenses through to full acquisitions of companies.
In addition, regulatory progress in the securement field has led to a continued stream of new approvals around the world offering real value to the patient, and demonstrating improved awareness of regulatory needs, understanding of the biochemical mechanisms of repair, and offering real potential to build market value.
Clinical Caseload
The market potential for products in the surgical securement field 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 around the world might benefit from products in this category in the future, and due to demographic trends and evolving surgical capabilities, this number is forecast to increase at an annualized rate of 3-5%.
In the forthcoming decade we will see strong penetration of new therapies into new procedure areas, and some new introductory techniques for treatment of orthopedic, cardiovascular and neurological procedures.
Market Segmentation and Dynamics
This market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products. The total securement market is forecast to grow from almost $7 billion in 2004 to reach $10 billion in 2011 at a CAGR of 7.5%.
Aggregate growth rates worldwide per segment are shown for illustrative purposes below:
The 2007 report #S145 on worldwide sealants, glues and wound closure is available for purchase and immediate download. The December 2008 report may also be purchased with pre-paid advance discount (price noted below is $1,500 off the publication price).
Report #S175, “Worldwide Surgical Sealants, Glues and Wound Closure 2009-2013.” Purchase in advance at this link or purchase via Google Checkout, below.
Report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure 2009-2013.” Purchase for immediate download at this link or purchase via Google Checkout, below.
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