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:
Electrosurgical/radiofrequency
Cardiac
Surgical
Microwave
Oncologic
Urologic
Laser
Aesthetic
Ophthalmic
Surgical
External Beam Radiation Therapy (EBRT)
LINAC Systems
Cobalt-60
Cryoablation
Cardiac & Vascular
Oncologic Surgery
GYN Surgery
Dermal/Cutaneous Surgical
Ultrasound
Ophthalmic (Cataract) Surgical
Multipurpose Surgical
Urologic Surgical
Multipurpose High Intensity Focused Ultrasound (HIFU)
Geographic Areas:
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
An examination of the future markets for technologies used in therapeutic ablation has support for a general and sustained growth in ablation technology revenues:
However, when considering the relative growth of each of the modalities in tissue ablation, it is clear that some modalities are growing more aggressively than others:
The “traditional” types of tissue ablation — electrosurgery and radiation therapy — are losing relative share as new modalities are able to penetrate caseload of other modalities, or even tap previously untreated patients and increase the aggregate caseload. In particular, radiofrequency and cryotherapy will demonstrate the highest growth over the 2011 to 2019 period.
Ablation technologies are used to destroy ("ablate") diseased or traumatized tissue for therapeutic benefit. This includes destruction of cancerous tumors, ablation of endometrial tissue associated with endometriosis or abnormal uterine bleeding, creation of myocardial lesions to block the errant electrical signals in arrhythmia, and numerous others.
The largest share of the market for energy-based ablation devices is used in cancer therapy, primarily using the radiation therapy modality. Following that is general surgery with its use of electrocautery and electrosurgical devices, RF ablation, cryotherapy, etc. Cardiovascular applications are growing, particularly for cryoablation and radiofrequency ablation for arrhythmia, and now represent hold the third largest clinical area of ablation. The remaining applications are relatively small and fall in line behind the three leading sectors.
In the aggregate (i.e., for each modality worldwide), the largest segment is radiation-based ablation technologies, based to a large degree on the cost of the systems and their well-established use in clinical practice.
Below is a chart of the 2011 markets for ablation technologies by modality, with their projected compound annual growth rates (CAGRs) from 2011 to 2019.
Surgical management of soft tissues via "ablation" therapies, in which alternative energy types (radiation, electrosurgcal, ultrasound, etc.) are applied to excise, destroy, or otherwise produce a therapeutic effect at the tissue level has undergone a proliferation in development with all of these alternatives vying for caseload in clinical applications as diverse as tumor ablation, arrhythmia ablation, endometrial ablation for treatment of endometriosis, ophthalmic procedures for vision and disease treatment, cosmetic, and many others.
The alternatives run the gamut from well established, high volume, low growth procedures like conventional x-ray to emerging, relatively low volume, high growth procedures like microwave ablation in cancer and arrhythmia ablation, and every other type of procedure in between.
Below illustrates the growth versus market size distribution of ablation technology alternatives.
Select technologies in ablation are among the most dynamic growth markets in the entire medtech sector. The therapeutic and other benefits with these technologies included that they are typically less invasive than traditional surgery and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities therefore have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.
A cursory review of data in the recent MedMarket Dilgence report #A125 reveals the countries with the highest expected growth rates in markets for ablation technologies.
Based on the growth in the ablation modality segments (e.g., radiofrequency, microwave, cryosurgery, thermal, ultrasound, etc.) that comprise each country’s total ablation market, the countries with the highest ablation market growth are India and China. The high growth in these countries ensues from how nascent these markets are, since potential application of ablation in these countires have yet to be tapped to any significant extent (the current market for ablation in India is $190 million compared to the U.S. market at $12.9 billion).
Ablation Technologies Market by Country Compound Growth Rate 2008 to 2017
[Insight: One of the more fascinating aspects of medical technology development is the penchant in the industry for finding different ways to accomplish traditional tasks in medical and surgical care. While certainly some technologies can be oversold for their putative clinical benefits — driving up healthcare costs and giving the industry a bad rap — some medtech advances indeed provide clinically better outcomes that few can legitimately argue, IMHO, as not being cost effective. These include major technology paradigm shifts like laparoscopic surgery. Another area that has shown a progressive set of changes to medical and, especially, surgical care, has been ablation technologies, the use of energy-based and other technologies to accomplish the dissection of tissue, the destruction of cancerous and other lesions and other functional alternation of tissue (e.g., in arrhythmia ablation) that was in most cases previously accomplished by, for the most part, a scalpel only (OK, a little simplified, but you get the idea). These ablation technologies now represent a pretty strong market or collection of market segments that are changing the way surgeons manipulate tissue. Below are some highlights of how the market breaks down by different modality. We also present some of the recent M&A activity in this industry. For additional details on ablation technologies, see the tag or category of "ablation" (or any of the separate modalities) in this blog. – Patrick Driscoll, Founder, MedMarket Diligence]
The worldwide high energy therapies market represents a $25 billion opportunity in 2008. The category consists of therapeutic devices and equipment that deliver the controlled application of one or more modalities of energy to tissue.
Global Ablation and Other Energy-Based Therapies Market Share and Compound Annual Growth Rate by Modality
The field of energy-based companies is well populated, partly because there are several different categories of energy application in clincial medicine, and because companies tend to be focused on single or tightly-focused energy applications. Thus there are companies specialising in cryoablation, thermal ablation, electrosurgery, brachytherapy and so on. Many companies have entered this field offering a new technology in one particular form of energy application.
A growing tendency in recent years has been the acquisition by larger, multifunctional medical device companies of smaller and often newer energy-based companies, as a means of adding a new technology to their portfolio. The past five years have seen many mergers and acquisitions of this kind involving energy-based companies. Exhibit 4-1 shows some examples of M&A activity from the past three years.
The major national markets in Western Europe for ablation technologies account for almost 12% of the global ablation market. Their share of the total medical device market is around 30%. Healthcare spending per capita is broadly similar across all the countries for which an example forecast (France) is provided below, ranging from approximately one-quarter to half of the equivalent expenditure in the USA. Apart from this variance, the inter-country differences in ablation market size are mainly a factor of different population sizes.
Source: MedMarket Diligence Report #A125
Below is a description of the MedMarket Diligence report #A125:
This report is a detailed market and technology assessment and forecast of the products and technologies in the ablation market for treatment of soft tissues via energy-based modalities, including electrosurgery, radiosurgery, gamma knife, brachytherapy, cryogenic therapy, fluidjet therapy (hydrotherapy), microwave ablation, radiofrequency ablation, laser, thermal ablation, and ultrasonic ablation.
The report describes alternative energy-based technologies and the nature of their effect on soft tissue, the underlying basis of the technology, the requisite systems for their use (including capital equipment, devices and disposables), and their strengths and weaknesses for specific clinical applications. The report details current and anticipated target applications and assesses the current and forecast caseload for each energy-based therapeutic considering competition from any and all alternative energy-based or other therapeutics, with current and worldwide market forecasts (2008-2017) segmented by technology type and specific clinical segment. The report provides segmentation of the worldwide ablation market by both ablation technology and region/country: Americas (USA, Canada, Mexico, Brazil), Europe (Germany, United Kingdom, France, Italy, Spain, BeNeLux), Asia/Pacific (Japan, China, India, Australia) and Rest of World. The report details the current and emerging products, technologies and markets for each energy-based therapy. The report profiles over 60 key companies in this industry detailing their current products, current market position and products under development.
The Report #A125, “Ablation Technologies Worldwide Market, 2008-2017: Products, Technologies, Markets, Companies and Opportunities,” is described in full at link. The report may be order for immediate download online or my be purchased via Google Checkout below.
Technologies for ablation and other energy-based treatments in medical/surgical markets are currently dominated by electrosurgical-type therapies, but a growing array of other modalities are creating new applications or penetrating existing ones.
At right is shown the forecast, by modality type, of ablation and other energy-based therapies through 2017. The most significant growth is expected to come from microwave, thermal, hydromechanical and cryotherapy, each of which will demonstrate compound growth rates in excess of 15% annually.
Excerpt from report #A125, “Ablation Technologies Worldwide Market,” (August 2008). See link. Report #A125, “Ablation Technologies Worldwide”, may be purchased online.
Energy-based therapies generate sales of $13 billion in the United States alone, with probably another $12 billion in other developed markets worldwide. This represents around 13% of the total medical device market, and it is growing at 11% per annum—twice the growth rate for medical devices overall.
Several kinds of energy are used for medical purposes, including electrical energy, radiation, thermal and light (see chart, “Energy-Based Therapies by Modality”). When the market is analyzed by function, it emerges that the fastest-growing area within this dynamic sector is ablation therapies: a segment that includes devices using electrical, radiofrequency, thermal and other forms of energy. A Market of $25 Bln and Growing The total market for energy-based therapies is estimated at $25 billion, of which 60% is in the United States and the rest mainly concentrated in developed economies around the world. Ablation therapies consist of several market segments. Arrhythmia ablation generates sales estimated at $60 million in the United States and $50 million internationally; ablation products for cancer therapy are valued at $225 million, of which $125 million are generated in the United States. Thus ablation therapies for these two leading indications—almost all consisting of RF devices and consumables—generated sales around $335 million in 2007. In fact, total RF ablation therapy sales are estimated at $1.5 billion worldwide. Also, this sector is growing much faster than the energy sector overall—annual rates are in the range 25%–30%. Demographic Factors—Growth of the market for ablation therapies is based partly on dynamic changes in demographics. The baby boomer generation (i.e., the 78 million Americans born between 1946 and 1964) represents about one-third of the U.S. population and a similar proportion of the population of other developed countries. These maturing citizens have both the economic means and the demand for therapies that can extend their active lives and delay the visible signs of aging. Pushing the growth of energy therapies beyond basic changes in demographics are the unique benefits that they offer. They are typically less invasive and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve. Technological Change—The ablation market is also driven by technological innovation. First-generation ablation devices and catheters have been supplanted by more sophisticated newcomers. Some of the improvements are incremental, other represent more fundamental innovation. Typical is the recent introduction by VNUS Medical Technologies of the ClosureFAST catheter, an endovenous radio frequency (RF) ablation catheter that is designed to heat, shrink and close diseased saphenous veins (large leg veins) in three to five minutes. VNUS claims treatment is as fast as laser ablation devices and causes minimal pain and bruising. The entire procedure, from insertion of the catheter to removal, can be completed in approximately 16 minutes—less than half the time required for previous RF-based procedures. The ClosureFAST catheter received FDA clearance in August 2006, and is now in general distribution.
A Handful of Companies Dominate
The energy-based medical device industry is led by a small group of companies: Medtronic, which has 30% share; St. Jude Medical, with 12%, and Varian Medical Systems, with 10%. A fourth strong presence was, until a few months ago, Boston Scientific, which had acquired Guidant, one of the pioneers in the field. However, Boston’s cardiac and vascular surgery business has been absorbed by the Swedish group Getinge (see MedMarkets, January 2008, “MedTech Companies Refine Therapies for Cardiac Ablation“) and is being marketed under the Maquet Cardiovascular name. Boston Scientific has retained its Blazer, Chilli, Steerocath and Maestro ablation systems for cardiac applications. In terms of ablation therapies, different market contenders make their appearance. Valleylab, a division of Covidien, is a leader in the field of RF ablation for general surgery. In the arrhythmia ablation segment, the Johnson & Johnson company Biosense Webster has a significant share, competing with CryoCath Technologies, AtriCure, Getinge and St. Jude Medical.
Ablation Therapy in Cardiology
Ablation therapy using RF waves is used to cure or treat a variety of cardiac arrhythmias such as supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia and especially atrial fibrillation. The term laser ablation is a process by which the molecular bonds of a material are dissolved by a laser; the technique is used as a part of percutaneous transluminal coronary angioplasty (PTCA) to dissolve plaque and restore patency in stenosed coronary vessels. Rotoablation, also used in PTCA, consists of inserting a tiny, diamond-tipped, drill-like device into the affected artery to remove fatty deposits or plaque. The major and fastest-growing use of ablation in cardiology is in the management of atrial fibrillation. Fibrillation is a disorder in which the orderly sequential propagation of an electrical impulse throughout the heart (which controls the heartbeat), is disrupted by multiple impulses so that the heart’s rhythm is disrupted. Atrial fibrillation involves ablating select areas of the heart’s upper chambers, which receive blood from the systemic and pulmonary circulations and pass it on to the ventricles. Before the development of ablation therapy, treatment of atrial fibrillation consisted of drugs to control the heart rhythm, and surgery in selected cases. The object of surgery was to cut away tissues in the heart that were transmitting the errant electrical impulses. This was an open-heart procedure with all the attendant risks, and recovery usually took eight weeks or more. Ablation therapy, like PTCA, is essentially noninvasive; a special ablation catheter is inserted into a peripheral vein and threaded up to the heart, where it is carefully positioned. RF pulses are then generated at the catheter tip to destroy tissue in the immediate vicinity. A series of such pulses is required to disrupt the abnormal electrical pathways.
Ablation Therapy in Cancer
A major and growing use of ablation is in the treatment of solid tumors, especially in the liver, lung, kidney and prostate. RF ablation is a minimally invasive, FDA-approved treatment for cancer. Physicians worldwide have used RF ablation to treat thousands of patients for liver/kidney tumors, and bone cancer pain. RF ablation is an image-guided technique that kills cancer cells by heating and destroying them. It is an alternative when surgery is not likely to be successful or has failed, or when other medical conditions increase the risk of surgery. In these cases, RF ablation can offer an effective treatment for small cancers; it is minimally invasive with no skin incision and there is minimal risk to the patient (who typically suffers little or no pain). The technique is cost-effective, with minimal hospital stay, and the procedure can be repeated if a new cancer appears. Liver—RF ablation has achieved excellent results in treating primary liver tumors such as hepatoma or hepatocellular carcinoma. These tumors tend to grow slowly and are usually encapsulated. The technique is especially useful for patients who are not ideal surgical candidates, who cannot undergo surgery, who have recurrent tumors or who do not respond to conventional therapies. Liver cancers most likely to be good candidates for RF ablation include tumors 4 cm diameter or smaller; cases with no more than three tumors per patient; and patients waiting for a liver transplantation who have a hepatoma. The most common metastatic disease in the liver treated by RF ablation has been colon cancer. As with primary liver cancers, results are good if the tumors are small and few, and if there is no evidence of metastatic disease elsewhere, RF ablation can also be combined with surgery to treat patients who have several tumors in different locations. Reports indicate that RF ablation results in complete cell death in the majority of hepatomas 3 cm–4 cm in size. Patients who have residual tumors can be re-treated if necessary. In patients who have metastatic colon cancer, re-treatment results are similar. Lung Cancer—Lung cancers are among the most intractable of malignancies and the mortality rate remains high. Any incremental improvement in therapy is therefore to be welcomed. RF ablation may be an alternative nonsurgical treatment for selected patients who have cancers that are limited in size (less than 3 cm in diameter) and few in number (one or two). Tumors should be separate from vital structures in the body. RF ablation may also help lung cancer patients who are not candidates for traditional surgery due to advanced disease in the lungs, poor cardiac function and/or poor pulmonary function. Kidney Cancer—Experience of RF ablation in kidney tumors is considerably less than with liver tumors. However, early results at the Mayo Clinic indicate that RF ablation is very effective for small tumors. In the Clinic’s experience with more than 70 patients, the tumor was destroyed in more than 95% of patients treated. Surgery is the treatment of choice for most kidney tumors; however, RF ablation might be considered for patients who have only one kidney, or who have other medical conditions that might prevent surgery; also for elderly patients who might have difficulty with surgery or postsurgical recovery, and in cases where the tumor is less than 4 cm in size.
Diverse Factors Drive Market Growth
The ablation device market is a buoyant one supported by a number of significant growth drivers, and its annual growth is almost certain to be in the range of 15%–25% over the next few years. The industry landscape is changing with the introduction of new technologies and the development of new indications for ablation-based therapy. This market will be strongly influenced by a new graying population who knows what it wants in terms of health care and who are intensely cost-conscious.
Company
Product
Energy Modality
Primary Application
Market Segment
Accuray
Cyberknife
Radiation
Tumor ablation
Cancer
Atricure
Coolrail Pen
RF
Arrhythmias
Cardiovascular
Biosense Webster (Johnson & Johnson)
Thermocool
RF
Atrial arrhythmias
Cardiovascular
Cryocath Technologies
Freezor Cryoablation System
Thermal
AV tachycardia
Cardiovascular
Elekta
Gamma Knife
Radiation
Tumor ablation
Cancer
EndoCare
Cryocare CS
Cryogenic
Prostate cancer
Cancer
ERBE
Erbokryo CA
Cryogenic
Pulmonary
Cardiovascular
ErbeJet 2
Hydro
Soft tissue ablation
General surgery
Ethicon EndoSurgery (Johnson & Johnson)
Harmonic Scalpel
Ultrasonic
Soft tissue ablation
General surgery
Focus Surgery
Sonablate 500
Ultrasonic
Prostate cancer
Cancer
Galil Medical
Presice
Cryogenic
Prostate, kidney cancer
Cancer
Gynecare (Johnson & Johnson)
ThermaChoice
Thermal
Gynecological
General surgery
Gyrus (Olympus)
PK Tissue Management System
RF
Gynecological
General surgery, urology, gynecology
Healthtronics
Ossatron
Ultrasonic
Chronic proximal plantar fasciitis
Orthopedic
Hologic
MammoSite
Radiation
Breast cancer
Cancer
Imagyn
isoStar
Radiation
Prostate cancer
Cancer
Insightec
ExAblate 2000
Ultrasonic
Uterine fibroids
Cancer
Integra LifeSciences
Sonotom
Ultrasonic
Soft tissue ablation
General surgery
Irvine Biomedical (St. Jude Medical)
Therapy
RF
Atrial arrhythmias
Cardiovascular
Maquet Critical Care (Medical Systems division of Getinge)
Several kinds of energy are used for medical purposes, including electrical energy, radiation, thermal and light (see chart, “Energy-Based Therapies by Modality”). When the market is analyzed by function, it emerges that the fastest-growing area within this dynamic sector is ablation therapies: a segment that includes devices using electrical, radiofrequency, thermal and other forms of energy.