The market for stents used in peripheral vascular indications — inclusive of stent grafts, and arterial and venous stents — is growing at an aggregate 6.2% CAGR from 2016 to 2020, which belies much stronger growth in specific subsets, especially in emerging markets like Asia/Pacific.
The aggregate compound growth rates for peripheral stent markets in each global region is shown below, with growth rates weighted by individual segment sales:
Western Europe: 5%
Rest of World: 13.9%
Peripheral stent products include the following, each of which is growing in sales at varying rates above and below the aggregregate regional sales growth:
Peripheral Arterial Stenting
– Bare Metal Stent Devices
– Drug Eluting Stent Devices
Aortic Aneurysm Repair
– Abdominal AA Stent-Grafts
– Thoracic AA Stent-Grafts
Peripheral Venous Stents
Worldwide Peripheral Stent Market by Product Category, 2015 and 2020
Hemostats are normally used in surgical procedures only when conventional bleeding control methods are ineffective or impractical. The hemostat market offers opportunities as customers seek products that better meet their needs. Above and beyond having hemostats that are effective and reliable, additional improvements that they wish to see in hemostat products include: laparoscopy-friendly; work regardless of whether the patient is on anticoagulants or not; easy to prepare and store, with a long shelf life; antimicrobial; transparent so that the surgeon continues to have a clear field of view; and non-toxic, i.e. preferably not made from human or animal materials.
Hemostat sales are being driven by several factors. These include the growth in the volume of inpatient and of ambulatory same-day surgeries, as well as the growth in minimally-invasive surgical procedure volumes. Effective hemostats may also reduce the time spent in the operating suite, which directly saves both surgeons and hospitals time and money. If the products can also reduce the risk of adhesions, then the patient may be able to avoid a second surgery sometime down the road.
Selected Manufacturers of Hemostats
FloSeal Flowable Hemostat
Hemopatch Sealing Hemostat
Gelfoam Plus Hemostasis Kit
SanguStop Collagen Hemostat
Covalon Technologies Ltd
PerClot¨ Powdered Hemostatic Agent
Surgifoam¨ Family of Products,
Surgicel¨ Family of Absorbable Hemostats,
Surgiflo¨ Hemostatic Matrix
(Note: Status on these products provided in Report #S290.)
Most markets for hemostats (as well as for sealants and glues) are experiencing very strong competition, and the US market, although the largest, is also saturated for many medical devices and products. Price controls are high priority in the European Union in order to control healthcare budgets. Japan, despite recent legislation making entry slightly easier, remains a tough market to crack. The easier-entry markets tend to be outside of the EU and Japan.
However, emerging markets are often characterized by fragile or unsteady economies, and healthcare markets that may not be ready to receive the more advanced sealant, glue and hemostat products. These hurdles must be overcome using shrewd market strategies and local offices in order to gain a foothold. Not all companies have the funds required to get into these markets directly, in which case a joint venture may be the best route.
The following is drawn from “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” Report #S290.
The need for surgical sealants, glues and hemostats is directly related to the clinical caseload and procedure volumes, as well as to the adoption of these products for multiple uses, such as the use of one product for sealing, hemostasis and anti-adhesion. It is fair to say that use of these products has become routine in the surgical suite and in other clinical locations. Procedure volumes are in turn driven by demographic forces, including global aging populations, while regulatory changes will continue to influence uptake of these products.
Fibrin sealants are made of a combination of thrombin and fibrinogen. These sealants may be sprayed on the bleeding surface, or applied using a patch. Surgical sealants might be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates.
Sealants are most often used to stop bleeding over a large area. If the surgeon wishes to fasten down a flap without using sutures, or in addition to using sutures, then the product used is usually a medical glue.
The surgeon and the perioperative nurse have a variety of hemostats from which to choose, as they are not all alike in their applications and efficacy. Selection of the most appropriate hemostat requires training and experience, and can affect the clinical outcome, as well as decrease treatment costs. Some of the factors that enter into the decision-making process include the size of the wound, the amount of hemorrhaging, potential adverse effects, whether the procedure is MIS or open surgery, and others.
Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a flowable putty that may be applied to the bleeding area.
Sealants and glues are terms which are often used interchangeably, which can be confusing. In this report, a medical glue is defined as a product used to bond two surfaces together securely. Surgeons are increasingly reaching for medical glues to either help secure a suture line, or to replace sutures entirely in the repair of soft tissues. Medical glues are also utilized in repairing bone fractures, especially for highly comminuted fractures that often involve many small fragments. This helps to spread out the force-bearing surface, rather than focusing weight-bearing on spots where a pin has been inserted.
Thus, the surgeon has a fairly wide array of products from which to choose. The choice of which surgical hemostat or sealant to use depends on several factors, including the procedure being conducted, the type of bleeding, severity of the hemorrhage, the surgeon’s experience with the products, the surgeon’s preference, the price of the product and availability at the time of surgery. For example, a product which has a long shelf life and does not require refrigeration or other special storage, and which requires no special preparation, usually holds advantages over a product which must be mixed before use, or held in a refrigerator during storage, then allowed to warm up to room temperature before use.
Below, after the categories of cardiovascular procedures, are the comprehensive listings of the surgical and interventional procedures in the management of cardiovascular disease represented in the MedMarket Diligence Report #C500, which also analyzes the clinical practice patterns, trends, and the impact on medical device sales and the impact of new medical device introductions during the forecast period, addressing each major area of surgical and interventional cardiovascular medicine:
Surgical and Interventional Procedures Covered:
Coronary artery bypass graft (CABG) surgery
Coronary angioplasty and stenting
Lower extremity arterial bypass surgery
Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting
Peripheral drug-coated balloon angioplasty
Surgical and endovascular aortic aneurysm repair
Vena cava filter placement
Mechanical venous thrombectomy
Venous angioplasty and stenting
Carotid artery stenting
Cerebral aneurysm and AVM surgical clipping
Cerebral aneurysm and AVM coiling & flow diversion
Left Atrial Appendage closure
Heart valve repair and replacement surgery
Transcatheter valve repair and replacement
Congenital heart defect repair
Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices
Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022. See Report #C500.
Publishing July 2016
This report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).
The report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.
Even excluding the three traditional wound care dressing segments, the advanced wound care market is enormous — over the next ten years, it will grow at a compound annual growth rate of at least 7.7%, and is forecast to reach nearly $16 billion by 2024. This market is being driven by several inter-related factors: the increasing percentage of the aged (65years old and over) in country populations, the fact that people are living longer, obesity, the virtually epidemic rise of Type 2 diabetes, government policies intended to curb healthcare spending, and an increasingly sedentary population. The latter trend is seen especially in developed countries, but is also on the rise in less-developed countries as their economic standing improves and the middle class grows in numbers.
Certain product segments are forecast to have stronger growth than others. Sales of bioengineered skin & skin substitutes for wound care will increase at a CAGR of at least 15%, while sales of foam and hydrocolloid dressings will be growing at high single-digit rates, respectively.