Cardiovascular procedure volumes in the rest of the world

Cardiovascular procedures are high volume, big business in the well developed U.S, European, and Asia/Pacific markets. But much potential procedure volume has been tapped in these markets, with any appreciable growth limited to low volume, emerging procedures.

By comparison, the less-tapped “Rest of World” potential (i.e., non-U.S., non-Europe, non-Asia/Pacific) for growth is significant. Below is illustrated the 2016 size and growth to 2022 for the major cardiovascular procedures in the Rest of World.

Source: “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500 (MedMarket Diligence, LLC)

The global dynamics of cardiovascular surgical and interventional procedures

This is an excerpt from Report #C500, “Cardiovascular Procedures to 2022.”

Cardiovascular Procedures in 2016

• 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;
  • Peripheral atherectomy;
  • Surgical and endovascular aortic aneurysm repair;
  • Vena cava filter placement
  • Endovenous ablation;
  • Mechanical venous thrombectomy;
  • Venous angioplasty and stenting;
  • Carotid endarterectomy;
  • Carotid artery stenting;
  • Cerebral thrombectomy;
  • 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;
  • Pacemaker implantation;
  • Implantable cardioverter defibrillator placement;
  • Cardiac resynchronization therapy device placement;
  • Standard SVT & VT ablation; and
  • Transcatheter AFib ablation

In 2016, the cumulative worldwide volume of the most prevalent cardiac surgeries and other  cardiovascular procedures (at right) is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

  • in coronart artery disease, roughly 4.73 million coronary revascularization procedures via coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) or about 31.4% of the total),
  • close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
  • about 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
  • over 1.65 million  chronic venous insufficiency, deep vein thrombosis, and pulmonary embolism targeting venous interventions (representing 11.0% of the total);
  • more than 992 thousand surgical and transcatheter heart defect repairs and  valve replacement or valve repair  (or 6.6% of the total);
  • close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
  • over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
  • almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

During the period 2016 to 2022, the total worldwide volume of covered cardiovascular procedures is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

http://mediligence.com/c500/

Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.


Report #C500: “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.” Request excerpts.

This report may be purchased for immediate download at link.

Cardiovascular procedure volume growth (interventional and surgical)

Cardiovascular surgical and interventional procedures are performed to treat conditions causing inadequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. These conditions include the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders. Specifically, these procedures are:

  • 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;
  • Peripheral atherectomy;
  • Surgical and endovascular aortic aneurysm repair;
  • Vena cava filter placement
  • Endovenous ablation;
  • Mechanical venous thrombectomy;
  • Venous angioplasty and stenting;
  • Carotid endarterectomy;
  • Carotid artery stenting;
  • Cerebral thrombectomy;
  • 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;
  • Pacemaker implantation;
  • Implantable cardioverter defibrillator placement;
  • Cardiac resynchronization therapy device placement;
  • Standard SVT & VT ablation; and
  • Transcatheter AFib ablation

For 2016 to 2022, the total worldwide volume of these cardiovascular procedures is forecast to expand on average by 3.7% per year to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

Venous indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

Source: MedMarket Diligence, LLC; “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” (Report #C500).

Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.

Source: MedMarket Diligence, LLC; “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” (Report #C500).


Global Cardiovascular Procedures report #C500 details the current and projected surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system.

Interventional and Surgical Cardiovascular Procedure Volumes

Cardiovascular diseases (CVDs) are a variety of acute and chronic medical conditions associated with an inability of the cardiovascular system to sustain an adequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. The CVD conditions may be manifested by the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders.

These diseases are treated via the following surgical and interventional procedures:

  • 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;
  • Peripheral atherectomy;
  • Surgical and endovascular aortic aneurysm repair;
  • Vena cava filter placement
  • Endovenous ablation;
  • Mechanical venous thrombectomy;
  • Venous angioplasty and stenting;
  • Carotid endarterectomy;
  • Carotid artery stenting;
  • Cerebral thrombectomy;
  • 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;
  • Pacemaker implantation;
  • Implantable cardioverter defibrillator placement;
  • Cardiac resynchronization therapy device placement;
  • Standard SVT & VT ablation; and
  • Transcatheter AFib ablation

In 2016, the cumulative worldwide volume of these procedures is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

  • roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),
  • close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
  • about 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
  • over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);
  • more than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);
  • close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
  • over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
  • almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

Below is illustrated the overall global growth for each of the major categories of procedures through 2022.

Source: MedMarket Diligence, LLC; Report #C500.  (Full report available online.)

There is considerable variation in the growth of cardiovascular procedures globally, but most growth is coming out of Asia/Pacific. For example, within the area of venous interventions, the growth in the use of endovenous ablation for chronic venous insufficiency is markedly higher in Asia/Pacific than in other regions, though the U.S. will remain the largest volume of these procedures.

Source: MedMarket Diligence, LLC; Report #C500.  (Full report available online.)


“Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022” (Report #C500), published August 2016. See description, table of contents, list of exhibits at link. Available for purchase and download from link.

Cardiovascular Surgical and Interventional Procedures Worldwide, 2015-2022

In 2016, the cumulative worldwide volume of the the following CVD procedures is projected to approach 15.05 million surgical and transcatheter interventions:

  • roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),
  • close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
  • about 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
  • over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);
  • more than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);
  • close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
  • over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
  • almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

screen-shot-2016-11-07-at-7-26-38-am

CABG: Coronary artery bypass graft; PCI: Percutaneous coronary intervention; AAA: Abdominal aortic aneurysm; TAA: Thoracic abdominal aneurysm; CVI: Chronic venous insufficiency; DVT: Deep vein thrombosis; PE: Pulmonary embolectomy.

Source: MedMarket Diligence, LLC; Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.” (To request report excerpts, click here.)

Coronary and venous interventions show inevitable Asia/Pacific dominance

Coronary revascularization, whether by bypass graft or percutaneous coronary intervention, drives an enormous amount of medtech business. Angioplasty catheters, guidewires, and the plethora of devices in cardiothoracic surgery represent many millions in sales annually. Manufacturers pursuing growth in these areas will see big, but slowing growth rates in the U.S., while markets in Asia/Pacific reflect the growing demand for cardio technologies. Already, these markets are surpassing western markets:

screen-shot-2016-10-03-at-2-20-47-pm

Source: Report #C500.

While coronary applications have a long history, venous interventions have less, and procedure data shows that patient populations have not been fully tapped in any geographic region. Already, Asia/Pacific markets would appear to be on course to eclipse western markets, but not until after 2022, and will eclipse Western Europe markets before challenging the U.S.

screen-shot-2016-10-03-at-2-20-38-pm

Source: Report #C500.

Global and Regional Cardiovascular Surgical and Interventional Procedures Forecast; Reveals Cardio Tech Outlook

With few exceptions, cardiovascular technologies no longer command big premiums (like many other medtech sectors) and mature Western markets for cardio devices have already captured most of the readily available patient caseloads. The lines between different markets (device, drugs, materials) are blurring, while surgical specialists seek to slow the caseload migration to interventionalists. The epicenter of growth in utilization of advanced cardiovascular technologies and techniques is gradually shifting to emerging Asia-Pacific markets away from the increasingly stagnant U.S. and Western European marketplace. The latter reflects the sheer size of underserved patient caseloads, availability of funding, and increasing reliance on economical domestically reproduced sophisticated endovascular devices.

“In order to be successful, manufacturers, investors, healthcare providers, advisors, and others in cardiac surgery and endovascular fields need to understand the real dynamics and asymmetrical development pattern of different cardiovascular device markets in different geographies,” says Patrick Driscoll of MedMarket Diligence. “At the root of understanding the market is accurately and realistically gauging the current and future demand for, and likely usage of, specific medical and surgical technologies and procedures.”

MedMarket Diligence has published a comprehensive resource available to manufacturers, investors, and others with interest in cardiovascular technologies. “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” is a worldwide competitive analysis and forecast of existing and emerging cardiovascular technologies and procedures coupled with identification and assessment of the most promising and sizable device markets.

The report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting the 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 epidemiology and mortality data for the major cardiovascular conditions along with 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.

Methodology. The MedMarket Diligence procedural assessments and forecasts are based on the systematic analysis of a multiplicity of sources including (but not limited to):

  • Latest and historic company SEC filings, corporate presentations, and interviews with product management and marketing staffers;

  • Data released by authoritative international institutions (such as OECD and WHO), and national healthcare authorities;

  • Statistical updates and clinical practice guidelines from professional medical associations (like AHA, ACC, European Society of Cardiology, Chinese, Indian, and Japanese Societies of Cardiology, etc.);

  • Specialty presentations at major professional conferences (e.g., TCT, AHA Scientific Sessions, EuroPCR, etc.);

  • Publications in major medical journals (JAMA, NEJM, British Medical Journal, Lancet, etc.) and specialty magazines (CathLab Digest, Endovascular Today, EPLab Digest, etc.);

  • Findings from relevant clinical trials;

  • Feedback from leading clinicians (end-users) in the field on device/procedure utilization trends and preferences; and

  • Policy papers by major medical insurance carriers on uses of particular surgical and interventional tools and techniques, their medical necessity and reimbursement.

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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;

  • Peripheral atherectomy;

  • Surgical and endovascular aortic aneurysm repair;

  • Vena cava filter placement;

  • Endovenous ablation;

  • Mechanical venous thrombectomy;

  • Venous angioplasty and stenting;

  • Carotid endarterectomy;

  • Carotid artery stenting;

  • Cerebral thrombectomy;

  • 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;

  • Pacemaker implantation;

  • Implantable cardioverter defibrillator placement;

  • Cardiac resynchronization therapy device placement;

  • Standard SVT/VT ablation; and

  • Transcatheter AFib ablation

Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, is described in full at link. The report may be purchased for download at link.

For information, contact Patrick Driscoll, +1.949.891.1753 or reports@mediligence.com.

 

Medtech Fundings for September 2016

Fundings in medical technology stand at $900 million for the month, led by the $345 million private placement by Insulet Corp., followed by the $168 million funding of Intarcia Therapeutics, the $86 million IPO of iRhythm Technologies, and the $75 million IPO of Obalon Therapeutics.

Below are the top fundings for the month thus far. Revisit this post (and refresh your browser) through September to see updates.

For the complete list of September 2016 fundings, see link.

screen-shot-2016-09-26-at-10-54-28-am

Source: Compiled by MedMarket Diligence, LLC.

For a historical list of medtech fundings by month since 2009, see link.

Eight Sectors of Cardiovascular Surgery Reveal Growth, Volume to 2022

The global market for cardiovascular devices is in the billions. Its size and association with life-saving clinical utility ensures that investors will support a surprisingly strong range of innovations in an otherwise very well-established medtech market. There is stable growth in many cardio technologies that have attained “gold standard”; aggressive growth in China, India, and Japan; and select new cardio technologies expected to rapidly seize caseload. 

Report #C500, excerpted below, provides forecasts and analysis of cardiovascular surgical and interventional procedures to illustrate the volume and growth by clinical area, caseload trend, practice trend, technology introduction or regional dynamic impact.


During the forecast period 2016 to 2022, the total worldwide volume of cardiovascular surgical and interventional procedures, tracked by MedMarket Diligence, is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).

The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).

Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.

However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.

screen-shot-2016-09-09-at-1-11-05-pm

Source: MedMarket Diligence, LLC; Report #C500.

Report #C500 is a worldwide and regional cardiovascular surgical and interventional procedure forecast and analysis of device market impacts.

Growth of Lower Extremity Angioplasty with Drug-Coated Balloons

The rationale for the development of drug-coated angioplasty balloons (DCBs) derives mainly from the limitations of drug-eluting stents (DES). Nonstent-based localized drug delivery using a DCB maintains the antiproliferative properties of a DES, but without the immunogenic and hemodynamic drawbacks of a permanently implanted endovascular device. Moreover, DCBs may be used in subsets of lesions where DES cannot be delivered or where DES do not perform well. Examples include torturous vessels, small vessels or long diffuse calcified lesions, which can result in stent fracture; when scaffolding obstructs major side branches; or in bifurcated lesions.

Additional potential advantages of DCBs include:

  • homogenous drug transfer to the entire vessel wall;
  • rapid release of high concentrations of drug sustained in vessel wall no longer than a week, with little impact on long-term healing;
  • absence of polymer, which reduces the risk of chronic inflammation and late thrombosis;
  • absence of a stent, preserving the artery’s original anatomy, very important in bifurcations or small vessels to diminish abnormal flow patterns; and
  • avoided need for lengthy antiplatelet therapy.

Currently, paclitaxel is primarily used by DCB manufacturers. Its high lipophilic property allows for passive absorption through the cell membrane and sustained effect within the treated vessel wall.

Below we illustrate the rise of drug-coated balloons for peripheral angioplasty procedures in lower extremities.

Screen Shot 2016-09-06 at 3.11.12 PM

Source: Report #C500.

 

The usage of peripheral DCB in clinical practices can be expected to experience explosive growth in superficial femoral artery and femoro-popliteal below-the-knee indications to over half a million procedures annually by the year 2022. Anticipated rapid adoption of peripheral DCB technologies in the U.S. and major Asia-Pacific States (especially in China and India accounting for 95% of the covered region’s population) should work as a primary locomotive of growth of projected global procedural expansion.
IMG_2631

Source: Report #C500.