The growth in sales of a medical technology is dictated by a unique combination of a specific technology in a specific clinical application in a specific geographic market.
In the Smithers Apex report, “The Future of Tissue Ablation Products to 2020“, the markets for the different ablation technology types were assessed per application in each of the major world geographies. See the groupings, below:
Ablation Types and Clinical Applications:
External Beam Radiation Therapy (EBRT)
Cardiac & Vascular
Ophthalmic (Cataract) Surgical
Multipurpose High Intensity Focused Ultrasound (HIFU)
United States & Other Americas
Largest Western & European States
Major Asian States
Rest of World
The Smithers Apex report contains the detailed assessment of ablation technology sales in each combination of technology, geography and clinical application. Below is illustrated graphically, sorted by compound annual growth rate in sales, each of the combinations.
Growth of Ablation Technologies by Clinical Application and Geography, 2014-2020
The global interventional cardiology technologies market reached an estimated $12,179 million in 2014. By 2021 it is predicted that this market will have further increased in value to $22,472 million with a compounded annual growth rate of 9.1%. Despite the issues and challenges confronting healthcare providers and players globally, this market remains buoyant and continues to provide improved quality of life for patients suffering from coronary artery disease.
The Future of Coronary Heart Disease Medical Devices to 2021 examines the management of this disease and takes a close look at the technological developments that are driving this market, including detailed geographical analysis and key company profiles.
See details on this report from Smithers Apex at link.
Excerpt from Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure 2013-2018”.
Biologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly.
Selected Biologically Active Sealants, Glues, and Hemostats
Asahi Kasei Medical
CryoSeal FS System
Fibrin sealant system comprising an automated device and sterile blood processing disposables that enable autologous fibrin sealant to be prepared from a patient's own blood plasma in about an hour.
Fibrin sealant spray
Biodegradable fibrin sealant made of human fibrinogen and human thrombin. For oozing and diffuse bleeding.
Hemostatic bioresorbable sealant/glue containing human thrombin and bovine-derived, glutaraldehyde-crosslinked proprietary gelatin matrix. For moderate to severe bleeding.
Hemostatic sponge comprising Pfizer's Gelfoam hemostatic sponge, made of porcine skin and gelatin, packaged with human plasma-derived thrombin powder.
Fleece-type collagen hemostat coated with fibrin glue components.
Bristol-Myers Squibb/ZymoGenetics (Sold by The Medicines Company in the US and Canada)
First recombinant, plasma-free thrombin hemostat.
Beriplast P/Beriplast P Combi-Set
Freeze dried fibrin sealant. Comprised of human fibrinogen-factor XIII and thrombin in aprotinin and calcium chloride solution.
Haemocomplettan P, RiaSTAP
Freeze-dried human fibrinogen concentrate. Haemocomplettan (US) and RiaSTAP (Europe).
Evicel is a new formulation of the previously available fibrin sealant Quixil (EU)/Crosseal (US). Does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, nor does it contain synthetic or bovine aprotinin, which reduces potential for hypersensitivity reactions.
Absorbable fibrin sealant patch comprised of flexible matrix of oxidized, regenerated cellulose backing under a layer of polyglactin 910 non-woven fibers and coated on one side with human fibrinogen and thrombin.
BIOSEAL Fibrin Sealant
Low-cost porcine-derived surgical sealant manufactured in China by J&J company Bioseal Biotechnology and targeted to emerging markets.
Human thrombin for topical use as hemostat. Made of pooled human blood.
Bovine-derived topical thrombin hemostat.
Bovine collagen and thrombin hemostat.
Absorbable surgical patch made of collagen sponge matrix combined with human fibrinogen and thrombin.
Teijin Pharma Ltd/Teijin Group (Tokyo, Japan)
Company is working with Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) to develop a sheet-type surgical fibrin sealant. Product combines KAKETSUKEN's recombinant thrombin and fibrinogen technology with Teijin's high-performance fiber technology to create the world's first recombinant fibrin sealant on a bioabsorbable, flexible, nonwoven electrospun fiber sheet.
The Medicines Company (TMC)
Raplixa (formerly Fibrocaps)
Sprayable dry-powder formulation of fibrinogen and thrombin to aid in hemostasis during surgery to control mild or moderate bleeding.
The Medicines Company (TMC)
In development: Fibropad patch
FDA accepted company's BLA application for Fibrocaps in April 2014 and set an action date (PDUFA) in 2015. In November 2013, the European Medicines Agency agreed to review the firm's EU marketing authorization application. Status update in report #S192.
Thick, but flowable, thrombin-based mixture to prevent bleeding in the subcutaneous pectoral pockets created during pacemaker and ICD implantations.
Advanced technologies are frequently developed in well developed economies, then migrate to other economies over time. Consequently, relatively new technologies tend to be more dominant in the well developed economies while relatively old technologies tend to be more dominant in the developing economies.
Case in point, surgical sealants for wound management versus surgical tapes, the former relatively new (and advanced) and the latter relatively old.
Tissue Engineering. Tissue engineering is a young, emerging, very promising area of medicine that combines engineering principles and processes to human tissues, resulting in the modification and ideally the regeneration of tissues which are able to fully function like the original tissues. The resulting engineered, living tissues may be delivered to the body at places of injury, trauma or disease, thus stimulating the body’s natural healing processes. It does this by activating the body’s innate ability to regrow and regenerate. At this time, scientists still have a great deal to learn about the body’s ability to regenerate tissues, but there are already innovative therapies that are intended to heal or reconstruct diseased tissues, and to support further regeneration and repair. Such therapies are helping to speed up healing and to help heal tissues that cannot heal on their own. Researchers feel that, in the future, tissue engineering will likely help to heal fractures, severe burns, chronic wounds, heart and nerve damage and likely many other diseases as well. While it is true that most of the industry and its benefits lie in the future, the promise of tissue engineering is materializing virtually on a daily basis.
Cell Therapy. Patient-specific cell therapies are either autologous or allogeneic. Off-the-shelf cell therapies involve donor cells which are expanded in tissue cultures, allowing the growth of large banks of cells. These cells, which originally came from a single individual, can then be frozen or otherwise preserved for use as treatments for potentially thousands of patients. By definition, off-the-shelf cell therapies are always allogeneic. Formally speaking, cell therapy covers a wide area, touching as it does on gene therapy, cancer vaccines, and even on delivery of drugs to tumour bodies. Cells might be delivered by injection directly to the site of disease, or by using a medical device. Some areas of cell therapy have shown distinct promise in early clinical trials, but only Phase 2 and 3 clinical trials will show whether the therapies will work in the clinic. Safety is of leading importance whenever cell therapies are involved. The areas of greatest interest for cell therapy at this time are cancer, cardiovascular and neurological, as well as for treatment of diabetes.
Source: Smithers Apex
Tissue engineering and cell therapy markets are the subject of a pending global study by Smithers Apex.
The global market for products used in wound closure encompasses sutures/staples, tapes, specialized vascular closure devices, hemostats, and surgical sealants. Some well known companies dominate some segments, but the market remains open to innovations by others. As a result, the balance of control of each segment has continued to shift. Below is illustrated the overall market shares of companies in this market.
In 2013, energy-based tissue ablation tools and techniques were used in hundreds of millions of procedures required, generating an estimated $12.4 billion in cumulative global sales. These total sales are projected to register a healthy growth over the forecast to the year 2020, reaching $16.8 billion by that time.
A new report published by Smithers Apex covers the global market for energy-based tissue ablation products. See link.