Percutaneous Transluminal Angioplasty and Stenting Reconsidered

Originally developed by the Swiss physician Andreas Gruentzig as a less traumatic alternative to CABG, and first performed in the U.S. in 1978, percutaneous transluminal coronary angioplasty (PTCA) has soon emerged as a mainstream revascularization modality, particularly well-suited for singular concentric coronary artery occlusions.

PTCA is a minimally invasive procedure intended to restore normal (or nearly normal) blood circulation in occluded coronary arteries through a radial dilation of atherosclerotic plaque and its compression against arterial wall with transluminally-placed inflatable balloon.

In PTCA procedure, occluding coronary lesion is first crossed with appropriate guidewire, which is typically inserted under fluoroscopic guidance through a puncture in femoral artery and brought to the treatment site via iliac artery and aortic tree. A special balloon-tipped catheter is then deployed over the guidewire across the targeted lesion and repeatedly inflated to provide a required reopening of the arterial lumen. The catheter is then withdrawn and arterial puncture is secured with the use of external pressure aids or special vascular puncture closure device.

Despite some indisputable benefits of “plain old balloon angioplasty,” its ultimate clinical efficacy was seriously compromised by the disappointingly high rate of restenosis that ran as high as 50% at six months and typically required re-intervention. Introduction of coronary bare metal stents (BMS) in the early 1990s allowed to partially alleviate that problem by reducing the average restenosis rate by about one-half. Stents also helped to virtually eliminate many of the complications of conventional angioplasty, such as abrupt and unpredictable collapse and closure of the vessel, which resulted in emergency bypass surgery.

Since the introduction of bare metal coronary stents, the usage of angioplasty expanded considerably, supplanting CABG as the most commonly employed modality of myocardial revascularization.

By the beginning of the past decade, though, growth in PTCA and coronary stenting caseloads started to slow down in the U.S., Europe, and Japan reflecting significant penetration of technically feasible CAD indications and a disappointingly high rate of post-PTCA and in-stent restenosis. The problem of restenosis represented a single major handicap of coronary angioplasty/stenting, which hampered its ultimate clinical outcomes and often forced a revision and eventual conversion to bypass surgery.

In the opinion of many leading clinicians and industry’s analysts, introduction of drug-eluting stents (DES) represented the single most important innovation in endovascular therapy, since the advent of stenting and angioplasty that was bound to have a revolutionary impact on interventional cardiology practices.  In addition to effectively remedying the nagging problem of coronary restenosis (by reducing its rates to mid-low digit figures), the drug-eluting devices also enabled interventional cardiologists to successfully manage coronary indications and patient caseloads that were traditionally deemed unsuited for angioplasty and stenting. The latter include treatment of small diameter vessels, long and bifurcated lesions, left main artery and multivessel disease, as well as expanded coverage of high-risk patient cohorts with advanced diabetes, renal insufficiency/failure and recent major AMI.

Unfortunately, in the middle of the past decade, one could witness a gradually growing concerns about relatively high incidence (compared to BMS) of late and very late stent thrombosis (often leading to AMI and death) and overall safety of DES, that have prompted several warning letters, but were generally ignored due to initial exuberance about superb antirestenotic performance of DES technology. Following a release of disturbing findings from several major studies in 2006, the cited concerns appeared to reach a “critical mass” bringing the safety issues to the forefront of renewed DES debates and ultimately prompting a very significant decline in DES usage and cumulative PCI procedure volumes in the U.S. and Europe.

In the view of many leading clinicians, the higher propensity of drug-eluting stents to late (and very late) thrombosis is stemming from the very nature of current DES technology which is focused primarily on prophylaxis of binary restenosis via distortion and inhibition of natural healing processes involving neointimal outgrowth. The latter, by definition, lead to a significantly delayed epithelialization and protracted stent struts exposure to the blood stream, which have been identified as the main sources of thrombogenicity. According to multiple IVUS and pathology studies, incomplete endothelialization of DES (with associated bare strut exposure and device malapposition) is commonly observed at 3 to 4 years post-implantation, in contrast to full epithelial coverage of BMS occurring at 5 to 6 months after stent placement.

Early termination of dual (aspirin-clopidogrel) antiplatelet regimens due to patient’s non-compliance, serious complications, or other reasons appears to represent another major contributing factor to onset of late thrombotic events. Based on available data, the vast majority of DES-related thrombosis episodes tend to occur at 1.0 to 3.5 years post-implantation, or after the recommended 12-month period of dual antiplatelet therapy. According to clinical literature, other factors implicated in the occurrence of late and very late DES thrombosis include presence of inflammatory polymer on stent, incomplete drug elution, rate of drug elution, cytotoxicity of chosen drug, as well as poor DES patient selection (e.g., utilization of DES in high-risk diabetics, and their off-label uses in small diameter vessels, patients with long and bifurcated lesions, etc.).

Most of the cited problems were effectively addressed by the next-generation DES devices that combine sophisticated cobalt and platinum alloy stenting platforms and biodegradable drug coatings with super-low-profile delivery and minimally traumatic deployment systems.

It is assumed that clinical efficacy and utility of DES technology would be significantly enhanced with the advent of specialty bifurcation-targeting devices, vascular healing-focused biopharmaceutical coatings, and in increased adoption of fully biodegradable stenting systems.


For forecasts of off-pump CABG, on-pump CABG, primary PCI with stenting, and drug-eluting stent-based PCI procedures (separately for U.S. Western Europe, Asia/Pacific and Rest of World), as well as all major cardiovascular surgical and interventional procedures, see Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

Medtech fundings for August 2016

The top fundings for medical technology companies in August 2015 totaled a modest $335.1 million.


See the 2016 global reports:

Surgical Sealants, Glues, Hemostats, 2015-2022. details

Global Dynamics of Cardiovascular Surgical and Interventional Procedures, 2015–2022. details


Fundings for August 2016 were led by the $93 million funding of CVRx, followed by the $49 million funding of Auris Surgical Robots, and the $30 million funding of VytronUS. See link for the complete list.

IMG_2020

For a comprehensive list of medtech fundings since 2009, see link.

 

New Global Cardiovascular Procedures Report Reveals Medtech Outlook

MedMarket Diligence has published, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

See link for report description, sources, table of contents, and list of exhibits. The report may be purchased for download.

The report details the therapeutic procedures that address acute and chronic conditions affecting myocardium and vascular system, with relevant prevalences, incidence rates, separate procedure counts for surgical versus interventional and other key splits of the procedure volume.

Screen Shot 2016-08-12 at 9.48.46 AMThe 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.

Each set of forecasts is accompanied by discussion per condition of the changing clinical practice and technology adoption rates, procedural limitations or drivers competitively, the surgical-interventional balance, and the resulting market outlook for cardio manufacturers.

Excerpts available on request.

Surgical and interventional cardiovascular procedures, worldwide

In August 2016, MedMarket Diligence will be releasing Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”. The report details prevalence, incidence, and caseload for the following procedures, forecast to 2022, and examines the clinical practice trends, technologies emerging on the market, and the dynamics leading to trends in procedures utilization and technology adoption.

Surgical and interventional procedures included:

  • 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
  • Transcatheter AFib ablation

In very general terms, the category “cardiovascular diseases” (CVD) refers to a variety of acute and chronic medical conditions resulting in the inability of cardiovascular system to sustain an adequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. The CVD conditions could 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

The scope of 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.

The cited procedural assessments and forecasts are based on the systematic analysis of 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, 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, etc.) and specialty magazines (CathLab Digest, EP Digest, Endovascular Today, etc.);
  • findings from relevant clinical trials;
  • feedbacks 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.

Surgical and Interventional Procedures Covered in the report include:

  • 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, cumulative worldwide volume of the aforementioned CVD 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).

During the forecast period, 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).

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.

Screen Shot 2016-08-12 at 9.48.46 AM

Source: MedMarket Diligence, LLC; Report #C500.

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.

See “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500 (publishing August 2016).

List of high growth medtech products

Below is a table with a list of the market segments demonstrating greater than 10% compound annual growth rate for the associated region through 2022, drawn from our reports on tissue engineering & cell therapy, wound management, ablation technologies, stroke, peripheral stents, and sealants/glues/hemostats. Products with over 10% CAGR in sales are shown in descending order of CAGR.

RankProductTopicRegion
1General, gastrointestinal, ob/gyn, othertissue/cellWW
2Ophthalmologytissue/cellWW
3Organ Replacement/ Repairtissue/cellWW
4Urologicaltissue/cellWW
5Neurologicaltissue/cellWW
6Autoimmune Diseasestissue/cellWW
7CV/ Vasculartissue/cellWW
8Bioengineered skin and skin substituteswoundRest of A/P
9Peripheral drug-eluting stents (A/P)peripheral interventionalA/P
10Peripheral drug eluting stentsperipheral interventionalRoW
11Peripheral drug-eluting stents (US)peripheral interventionalUS
12Negative pressure wound therapywoundGermany
13Hydrocolloid dressingswoundRest of A/P
14Cancertissue/cellWW
15Foam dressingswoundRest of A/P
16Growth factorswoundRest of A/P
17Alginate dressingswoundRest of A/P
18Dentaltissue/cellWW
19Bioengineered skin and skin substituteswoundJapan
20Hemostatssealants, glues, hemostatsA/P
21Skin/ Integumentarytissue/cellWW
22Bioengineered skin and skin substitutessealants, glues, hemostatsUS
23Bioengineered skin and skin substitutessealants, glues, hemostatsWW
24Film dressingswoundRest of A/P
25Surgical sealantssealants, glues, hemostatsA/P
26Hydrogel dressingswoundRest of A/P
27TAA Stent graftsperipheral interventionalA/P
28Negative pressure wound therapywoundRoW
29Biological gluessealants, glues, hemostatsA/P
30FoamwoundRoW
31HydrocolloidwoundGermany
32AAA Stent graftsperipheral interventionalA/P
33Cerebral thrombectomy systemsstrokeA/P
34High-strength medical gluessealants, glues, hemostatsA/P
35Carotid artery stenting systemsstrokeA/P
36Cardiac RF ablation productsablationA/P
37Alginate dressingswoundGermany
38Peripheral venous stentsperipheral interventionalA/P
39Cerebral thrombectomy systemsstrokeUS
40Left atrial appendage closure systemsstrokeA/P
41Cyanoacrylate gluessealants, glues, hemostatsA/P
42Foam dressingswoundRest of EU
43Foam dressingswoundKorea
44Cryoablation cardiac & vascular productsablationA/P
45Bioengineered skin and skin substituteswoundGermany
46Thrombin, collagen & gelatin-based sealantssealants, glues, hemostatsA/P
47Cardiac RF ablation productsablationRoW
48Bioengineered skin and skin substituteswoundRoW
49Microwave oncologic ablation productsablationA/P

Note source links: Tissue/Cell, Wound, Sealants/Glues/Hemostats, Peripheral Stents, Stroke, Ablation.

Source: MedMarket Diligence Reports

Components used in surgical sealants

While fibrin is a biological sealant that has been harnessed by several companies to provide tissue sealing, a wide variety of other components and component combinations have been developed for sealant use.

Below are sealant formulations from selected participants in the market for surgical sealants:

Sealant Components by Manufacturer

CompanySealant component(s)
AdhesysPolyurethane
CoheraUrethane & lysine
EndomedixDextran and chitosan biopolymers
Gecko BiomedicalProprietary, light-activated, synthetic elastomer
GrifolsFibrin sealant
BaxterHuman fibrinogen and thrombin
EthiconFibrin sealant
BardHydrogel
TakedaFibrin sealant
The Medicines CompanyFibrin sealant, and synthetic sealant
CryoLifeBovine serum albumin and glutaraldehyde adhesive
HyperbranchActivated polyethylene glycol polyethlyeneimine
Integra LifesciencePolyethylene glycol hydrogel
LifeBondPolymer hydrogel matrix
Ocular TherapeutixPolyethylene glycol and trilysine
SealantisAlga-mimetic tissue adhesives

Source: MedMarket Diligence, LLC; Report #S290.

Peripheral Vascular Stents

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:

U.S.:  9.5%
Western Europe: 5%
Asia/Pacific: 21.3%
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

Screen Shot 2016-08-08 at 12.49.53 PM

Source: MedMarket Diligence, LLC; Report #V201.

Where will medicine be in 2035?

An important determinant of “where medicine will be” in 2035 is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries) and the demands they put on healthcare delivery work directly against quality of care. So, in the U.S., whether Obamacare persists (most likely) or is replaced with a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective. 

From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:

  • Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it. 
  • Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.

Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics.

  • Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.

Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines.

  • Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.

    Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions.
  • Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.

    As the human genome is the engineering plans for the human body, it is a potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based conditions.
  • Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.
  • Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.

    By 2035, technologies such as these will measurably reduce inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating collateral damage.

Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.

  • Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
  • Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).

The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development. 


See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”

Hemostats Development, Sales Growth By Region

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

CompanyProduct
BaxterFloSeal Flowable Hemostat
BaxterHemopatch Sealing Hemostat
BaxterTachoSil¨
BaxterGelfoam Plus Hemostasis Kit
B BraunSanguStop Collagen Hemostat
Covalon Technologies LtdCovaStatª
Covidien (Medtronic)Veriset¨
CryoLifePerClot¨ Powdered Hemostatic Agent
Ethicon (JNJ)Evithrom¨
Ethicon (JNJ)Surgifoam¨ Family of Products,
Ethicon (JNJ)Surgicel¨ Family of Absorbable Hemostats,
Ethicon (JNJ)Surgiflo¨ Hemostatic Matrix
MallinckrodtRecothrom
PfizerThrombin-JMI

(Note: Status on these products provided in Report #S290.)

Source: MedMarket Diligence, LLC; 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.

hemostat-sales-region-s290

Source: MedMarket Diligence, LLC; Report #S290.

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.

USA and Asia/Pacific Size Versus Growth in Sealants, Glues, Hemostats

The market dynamics in Asia/Pacific stand apart from those in the U.S. In the case of surgical sealants, glues, and hemostats, what stands out is the Size versus Growth metric.

Much of the potential in China, in particular, remains untapped (low volume, high growth), while in the U.S., these markets are more well established and, therefore, more penetrated.

Below are the size/growth “bubbles” for, alternating, the U.S. and Asia/Pacific.

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Source: MedMarket Diligence, LLC; Report #S290.