Growth of modalities in tissue ablation

An examination of the future markets for technologies used in therapeutic ablation has support for a general and sustained growth in ablation technology revenues:

Ablation-modality-growth-revenues

Source: Report #A145

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:

Ablation-modality-growth-shares

Source: Report #A145

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.

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Ablation, other energy-based tissue treatment markets, procedures

(Report updated. See 2010 report on Ablation Technologies Worldwide.)

The global market for medical devices is $200 billion opportunity and at least 13% of this market involves products that provide the controlled application of energy to tissue. The segment is dominated by high technology products ranging from devices that can heat and cool tissue over a 600° C temperature range of -200° C to +400° C to those that can vibrate at fifty five thousand cycles per second to denature tissue. While a significant share of the energy-based therapies market is for elective procedures such as refractive eye surgery and cosmetic hair removal, treatments for chronic diseases make up the vast majority of the applications of these technologies.

Underlying the growth of this market will be changes in demographics. The baby boomer generation–those born between 1946 and 1964–represents about one-third of the population in economically-developed countries. Many of these ageing 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 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 have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.
 

Ablation Technologies Markets and Representative Procedures by Modality

ablation-segments-procedures

Source:  Drawn from Report #A125, "Ablation Technologies Worldwide Market, 2008-2017."

Ablation technologies and their variable penetration of clinical applications

Ablation technologies of different types have in common their ability to produce a therapeutic effect on human tissue.  Beyond this common ground, however, there are stark differences in the modalities.  Consequently, ablation technologies have variable penetration of clinical applications, with use of specific modalities for specific clinical applications driven by factors such as the tissue effect produced, likelihood of collateral tissue damage, the designs of manufacturers’ specific systems in meeting clinicians needs, cost, and other considerations. 

Cancer treatment is a good example, with a few modalities having significant shares of their worldwide ablation revenuesin cancer, while other modalities are little used in these areas. 

cancer-ablation

Source: MedMarket Diligence, LLC; Report #A125, "Worldwide Ablation Technologies."

 

 

Ablation technologies prolific in cancer treatment

Energy-based technologies and treatments exist for virtually all clinical specialties.  Given the ability of these technologies, particularly ablation technologies, to very precisely destroy tissue, they have been strongly developed for cancer applications and much success has already been achieved in producing treatments that have low risk, short recovery times and good long term outcomes.  Cost is non insignificant for these technologies, but thus far their clinical benefits have generally supported strong reimbursement.

Energy-based cancer treatment regimens consist of external beam radiation therapy, brachytherapy and a number of newer applications of energy therapies that ablate cancerous tissue. Prostate cancer for example, the most prevalent cancer among U.S. men, can now be treated with a range of energy based therapies that effectively supplement chemotherapy and other targeted therapeutics.
 

prostate-ablation

Souce: MedMarket Diligence, LLC, Report #A125: "Ablation Technologies Worldwide Market, 2008-2017: Products, Technologies, Markets, Companies and Opportunities."  See link for report description, detailed table of contents and list of exhibits.

The range of energy modalities used for ablation in cancer include the following:

  • brachytherapy
  • cryotherapy
  • microwave ablation
  • radiation therapy
  • radiofrequency (RF) ablation
  • stereotactic surgery
  • laser ablation
  • photodynamic therapy
  • ultrasonic ablation

As well, there are combinations of the above, and several of these (e.g., radiation therapy) have many variations in the way they can be delivered (note, for example, the overlap between brachytherapy, radiation therapy and stereotactic surgery).
 


Ablation Technologies Report #A125

Ablation and other energy-based technologies with multiple clinical applications

Manufacturers of ablation and other energy-base therapeutics are both witnessing and driving a steady evolution of multiple technologies with potential to produce therapeutic (or, in some cases, simply cosmetic) tissue effects, with different energy types competing head-on for caseload.  These innovators have continued to improve their understanding of the nature of each energy type’s impact on the target tissue(s) and have optimized the delivery to improve outcome, improve ease of use and minimize adverse collateral tissue effects or other complications.

To illustrate the breadth of applications for energy-based technologies, see the excerpt below from the table of contents to the MedMarket Diligence report #A125, "Ablation Technologies Worldwide Market, 2008-2017: Products, Technologies, Markets, Companies and Opportunities." 

 

SECTION 1:  ENERGY-BASED THERAPIES BY DISEASE STATE AND TECHNOLOGY
1.1  Cancer
1.1.1  Brachytherapy
1.1.2  Cryotherapy
1.1.3  Microwave Ablation
1.1.4  Radiation Therapy
1.1.5  Radiofrequency Ablation
1.1.6  Stereotactic Surgery
1.1.7  Laser Ablation
1.1.8  Photodynamic Therapy
1.1.9  Ultrasonic Ablation
1.2  Cardiovascular Disease
1.2.1  Angina Pectoris
1.2.2  Atrial arrhythmias
1.2.2.1  Cryoablation
1.2.2.2  Electrical Cardioversion
1.2.2.3  Microwave Ablation
1.2.2.4  RF Ablation
1.2.2.5  Temperature Controlled
1.2.2.6  Fluid Cooled
1.2.3  Bradycardia
1.2.4  Critical Ischemia
1.2.5  Vascular Occlusive Disease
1.2.6  Ventricular Arrhythmias
1.2.6.1  About ICD, CRT and CRT-D
1.2.7  Wolf-Parkinson-White Disease
1.3  Elective Surgery
1.3.1  Cosmetic Surgery
1.3.1.1  Laser Hair Removal
1.3.1.2  Port Wine Stains
1.3.1.3  Psoriasis
1.3.1.4  Varicose Veins
1.4  Ophthalmic Surgery
1.4.1  Capsulotomy Surgery
1.4.2  Laser In-Situ Keratomileusis (LASIK)
1.4.3  Laser Epithelial Keratomileusis (LASEK)
1.5  General Surgery
1.5.1  Fecal Incontinence
1.5.2  Gastroesophageal Reflux Disease (GERD)
1.6  Gynecological Applications
1.6.1  Hysterectomy
1.6.2  Menorrhagia
1.6.3  Fibroids
1.6.4  Bladder Neck Suspension
1.7  Urological Applications
1.7.1  Urinary Tract Stones
1.7.2  Benign Prostatic Hypertrophy
1.7.2.1  TUMT
1.7.2.2  TUNA
1.7.2.3  Photoselective Vaporisation of the prostate (PVP)
1.7.2.4  HoLAP
1.7.2.5  CoreTherm
1.7.2.6  TMX 3000
1.7.2.7  Prolieve
1.7.2.8  Prostiva RF Therapy
1.7.2.9  Water-Induced Thermotherapy
1.8  Tonsillectomy
1.9  Orthopedic Applications
1.9.1  Capsular Shrinkage
1.9.2  Carpal Tunnel Syndrome
1.9.3  Chondroplasty
1.9.4  Debridement
1.9.5  Epicondylitis and Tendinitis
1.9.6  Inflammatory Conditions
1.9.6.1  Nucleoplasty
 
See the report’s complete description, table of contents, and list of exhibits here.

 

Ablation and other energy-based medical technologies worldwide

The world market for energy-based devices was well in excess of $25 billion in 2008. This represents almost 14% of the total medical device market; however, the share varies from country to country, since ablation therapy is high-technology and fairly high-cost; in poorer economies low-cost medical products such as syringes and consumables account for a relatively higher share of the medical market.

Analyses of the medical market by product category typically divide it into a small number of broad product classes such as electromedical equipment; syringes, needles and catheters; medical consumables; etc. The products included in "energy-based therapies" are divided among several of these categories.

Energy-based devices are of nine main categories, and the market share by category.

Worldwide Ablation and Other Energy-based Device Market by Product Category

ablation-segments

Source:  MedMarket Diligence, LLC; Report #A125, "Ablation Technologies Worldwide Market, 2008."
 

Ultrasonic energy offers superior control of energy output. 3D control and directionality of the energy delivered provides the ability to treat a prescribed target volume and shape which is critical for tumor ablation as increased energy penetration into the target tissue enables the treatment of larger tumor volumes and reduces treatment times. Peripheral and coronary vascular occlusive conditions that afflict tens of millions of people worldwide are now being treated with technologies that enable the delivery of ultrasonic energy over the active length of a small diameter guidewire-like device in an occluded blood vessel. The popularity of ultrasonic surgical systems is being driven by their inherent advantages. These systems control bleeding by coaptive coagulation at low temperatures ranging from 50ºC to 100ºC. Coagulation occurs by means of protein denaturation as opposed to thermal welding and the absence of smoke improves the visual field.

Cryogenic energy or the extreme absence of heat is very attractive as it is highly containable and thus localized. Cryoablation can be safely employed adjacent to delicate tissue and structures such as certain vasculature. Cryoablation may eliminate many of the problems seen in treating complex arrhythmias such as pulmonary vein stenosis. Cooling freezes tissue and does not seem to cause extracellular matrix changes or damage to the endocardium, which may lower clot-related complications. Thanks largely to advances in ultrasound, which allows physicians to target diseased tissue with pinpoint accuracy, and temperature control, which allows physicians to destroy the diseased tissue without harming the surrounding healthy tissue, cryoablation has become the fastest growing minimally invasive option for prostate cancer patients.

Microwave energy offers the inherent advantage of accommodating parallel delivery points. An increased treatment area can be treated with microwave energy very efficiently. Microwave probes are ideally suited for a full spectrum of cardiac ablation procedure from simple pulmonary vein isolation in paroxysmal AF to a full Maze for permanent AF. Energy delivery times are short, on the order of 25 to 60 seconds, and the unidirectionality of the microwave ensures the protection of surrounding tissues during epicardial application–a significant requirement for beating-heart application. Microwave energy is also being used as a transurethral therapy to treat BPH.

Light energy is being harnessed and focused for a variety of therapeutic applications. CO2 lasers are being used to revascularize injured myocardial tissue while excimer lasers are being adapted to atherectomy catheters that can clear thrombosis and reperfuse vessels. Over 2 million individuals seek the therapeutic benefits of laser vision correction each year; low level “cold” lasers are being employed to treat chronic pain relief for debilitating conditions like carpal tunnel syndrome–a leading cause of lost workdays. Intense pulsed light (IPL) that affects subtle changes in collagen is being used to treat vascular and pigmentation irregularities.

Hydromechanical energy systems that jet streams of saline only five one-thousandths of an inch in diameter — about the thickness of a human hair–can precisely dissect tissue, sparing vessels and nerves, and are being employed for hepatic resection and nerve-sparing retropubic radical prostatectomy. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.

Radiation energy using focused arrays of intersecting beams of gamma radiation is being used to treat lesions within the brain. Radiosurgery devices that can ablate otherwise untreatable tumors and malformations when directed by computers are finding otherwise untreatable lesions.

Thermal energy is employed successfully to treat menorrhagia due to benign causes in premenopausal women. When tissue is heated above 46°C, cellular protein denatures and the cell dies. Thermal uterine balloon therapy offers a less-invasive option that allows women to preserve their uterus. Thermal therapy is also being employed for breast and prostate cancer. Implants made of ferromagnetic material that can be “turned-on” when placed within an electromagnetic field and heated in situ offer a high degree of specificity with respect to the treated tissue area.

Electrical energy delivered by small implants can deliver a life saving jolt of electricity to shock a patient’s heart back to normal when rhythmic disturbances of the lower heart chambers that can cause sudden cardiac death are detected. Similar devices deliver electrical energy to speed up a heart beating too slowly. Image-guided radiofrequency ablation which uses heat to destroy diseased tissue can preserve kidney function and avoid kidney dialysis for patients with solid renal tumors who are not surgical candidates.

Radiofrequency energy is gaining widespread use in the field of sports medicine surgery for the thermal modification of soft tissue structures within the joint. The use of radiofrequency energy for thermal chondroplasty has gained tremendous popularity because of the quality of the therapy. Radiofrequency surgical systems have the inherent ability to seal large vessels as a result of the tremendous temperatures the energy can generate.
 

Energy modalities and market growth in ablation technology

The global market for medical devices is currently a $185 billion opportunity and at least 13% of this market involves products that provide the controlled application of energy to tissue. The segment is dominated by high technology products ranging from devices that can heat and cool tissue over a 600° C temperature range of -200° C to +400° C to those that can vibrate at fifty five thousand cycles per second to denature tissue. While a significant share of the energy-based therapies market is for elective procedures such as refractive eye surgery and cosmetic hair removal, treatments for chronic diseases make up the vast majority of the applications of these technologies.

Underlying the growth of this market will be changes in demographics. The baby boomer generation–those born between 1946 and 1964–represents about one-third of the population in economically-developed countries. Many of these ageing 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 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 have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.

Ultrasonic energy offers superior control of energy output. 3D control and directionality of the energy delivered provides the ability to treat a prescribed target volume and shape which is critical for tumor ablation as increased energy penetration into the target tissue enables the treatment of larger tumor volumes and reduces treatment times. Peripheral and coronary vascular occlusive conditions that afflict tens of millions of people worldwide are now being treated with technologies that enable the delivery of ultrasonic energy over the active length of a small diameter guidewire-like device in an occluded blood vessel. The popularity of ultrasonic surgical systems is being driven by their inherent advantages. These systems control bleeding by coaptive coagulation at low temperatures ranging from 50ºC to 100ºC. Coagulation occurs by means of protein denaturation as opposed to thermal welding and the absence of smoke improves the visual field.

Cryogenic energy or the extreme absence of heat is very attractive as it is highly containable and thus localized. Cryoablation can be safely employed adjacent to delicate tissue and structures such as certain vasculature. Cryoablation may eliminate many of the problems seen in treating complex arrhythmias such as pulmonary vein stenosis. Cooling freezes tissue and does not seem to cause extracellular matrix changes or damage to the endocardium, which may lower clot-related complications. Thanks largely to advances in ultrasound, which allows physicians to target diseased tissue with pinpoint accuracy, and temperature control, which allows physicians to destroy the diseased tissue without harming the surrounding healthy tissue, cryoablation has become the fastest growing minimally invasive option for prostate cancer patients.

Microwave energy offers the inherent advantage of accommodating parallel delivery points. An increased treatment area can be treated with microwave energy very efficiently. Microwave probes are ideally suited for a full spectrum of cardiac ablation procedure from simple pulmonary vein isolation in paroxysmal AF to a full Maze for permanent AF. Energy delivery times are short, on the order of 25 to 60 seconds, and the unidirectionality of the microwave ensures the protection of surrounding tissues during epicardial application–a significant requirement for beating-heart application. Microwave energy is also being used as a transurethral therapy to treat BPH.

Light energy is being harnessed and focused for a variety of therapeutic applications. CO2 lasers are being used to revascularize injured myocardial tissue while excimer lasers are being adapted to atherectomy catheters that can clear thrombosis and reperfuse vessels. Over 2 million individuals seek the therapeutic benefits of laser vision correction each year; low level “cold” lasers are being employed to treat chronic pain relief for debilitating conditions like carpal tunnel syndrome–a leading cause of lost workdays. Intense pulsed light (IPL) that affects subtle changes in collagen is being used to treat vascular and pigmentation irregularities.

Hydromechanical energy systems that jet streams of saline only five one-thousandths of an inch in diameter — about the thickness of a human hair–can precisely dissect tissue, sparing vessels and nerves, and are being employed for hepatic resection and nerve-sparing retropubic radical prostatectomy. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.

Radiation energy using focused arrays of intersecting beams of gamma radiation is being used to treat lesions within the brain. Radiosurgery devices that can ablate otherwise untreatable tumors and malformations when directed by computers are finding otherwise untreatable lesions.

Thermal energy is employed successfully to treat menorrhagia due to benign causes in premenopausal women. When tissue is heated above 46°C, cellular protein denatures and the cell dies. Thermal uterine balloon therapy offers a less-invasive option that allows women to preserve their uterus. Thermal therapy is also being employed for breast and prostate cancer. Implants made of ferromagnetic material that can be “turned-on” when placed within an electromagnetic field and heated in situ offer a high degree of specificity with respect to the treated tissue area.

Electrical energy delivered by small implants can deliver a life saving jolt of electricity to shock a patient’s heart back to normal when rhythmic disturbances of the lower heart chambers that can cause sudden cardiac death are detected. Similar devices deliver electrical energy to speed up a heart beating too slowly. Image-guided radiofrequency ablation which uses heat to destroy diseased tissue can preserve kidney function and avoid kidney dialysis for patients with solid renal tumors who are not surgical candidates.

Radiofrequency energy is gaining widespread use in the field of sports medicine surgery for the thermal modification of soft tissue structures within the joint. The use of radiofrequency energy for thermal chondroplasty has gained tremendous popularity because of the quality of the therapy. Radiofrequency surgical systems have the inherent ability to seal large vessels as a result of the tremendous temperatures the energy can generate.

Given the varying clinical utilities of the different energy modalities and the correspondingly different current and potential caseload, the growth in the market for ablation technologies varies by modality, as shown below.

ablation-modality-growth

 Source:  MedMarket Diligence, LLC; "Ablation Technologies Worldwide Market, 2008-2017." Report #A125.