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. Available online.

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.

The Demand for Sealants, Glues, and Hemostats in 2016

The following is drawn from “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” Report #S290.

The need for surgical sealants, glues and hemostats is directly related to the clinical caseload and procedure volumes, as well as to the adoption of these products for multiple uses, such as the use of one product for sealing, hemostasis and anti-adhesion. It is fair to say that use of these products has become routine in the surgical suite and in other clinical locations. Procedure volumes are in turn driven by demographic forces, including global aging populations, while regulatory changes will continue to influence uptake of these products.

wound-prevalance

Source: MedMarket Diligence, LLC; Report #S290.

Medical Sealants

Fibrin sealants are made of a combination of thrombin and fibrinogen. These sealants may be sprayed on the bleeding surface, or applied using a patch. Surgical sealants might be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates.

Sealants are most often used to stop bleeding over a large area. If the surgeon wishes to fasten down a flap without using sutures, or in addition to using sutures, then the product used is usually a medical glue.

Hemostatic Products

The surgeon and the perioperative nurse have a variety of hemostats from which to choose, as they are not all alike in their applications and efficacy. Selection of the most appropriate hemostat requires training and experience, and can affect the clinical outcome, as well as decrease treatment costs. Some of the factors that enter into the decision-making process include the size of the wound, the amount of hemorrhaging, potential adverse effects, whether the procedure is MIS or open surgery, and others.

Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a flowable putty that may be applied to the bleeding area.

Medical Glues

Sealants and glues are terms which are often used interchangeably, which can be confusing. In this report, a medical glue is defined as a product used to bond two surfaces together securely. Surgeons are increasingly reaching for medical glues to either help secure a suture line, or to replace sutures entirely in the repair of soft tissues. Medical glues are also utilized in repairing bone fractures, especially for highly comminuted fractures that often involve many small fragments. This helps to spread out the force-bearing surface, rather than focusing weight-bearing on spots where a pin has been inserted.

Thus, the surgeon has a fairly wide array of products from which to choose. The choice of which surgical hemostat or sealant to use depends on several factors, including the procedure being conducted, the type of bleeding, severity of the hemorrhage, the surgeon’s experience with the products, the surgeon’s preference, the price of the product and availability at the time of surgery. For example, a product which has a long shelf life and does not require refrigeration or other special storage, and which requires no special preparation, usually holds advantages over a product which must be mixed before use, or held in a refrigerator during storage, then allowed to warm up to room temperature before use.

 

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.

output_dYHN2K

Source: MedMarket Diligence, LLC; Report #S290.

Top Cardiovascular Surgical and Interventional Procedures, Projected to 2022

Below, after the categories of cardiovascular procedures, are the comprehensive listings of the surgical and interventional procedures in the management of cardiovascular disease represented in the MedMarket Diligence Report #C500, which also analyzes the clinical practice patterns, trends, and the impact on medical device sales and the impact of new medical device introductions during the forecast period, addressing each major area of surgical and interventional cardiovascular medicine:

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
  • Transcatheter AFib ablation

We have sorted procedures first by growth (CAGR) to 2022, then by volume in 2022.

CV Procedures by Growth

Source: MedMarket Diligence, LLC; Report #C500.

CV Procedures by Volume

Source: MedMarket Diligence, LLC; Report #C500.

Cardiovascular Surgical Procedures, Technologies Trended Globally to 2022

cardiovascular procedures

Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022. See Report #C500.

Publishing July 2016

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.

See the complete table of contents at Report C500.

 

 

Growth in Advance Wound Care Product Revenues, 2014 to 2024

Even excluding the three traditional wound care dressing segments, the advanced wound care market is enormous — over the next ten years, it will grow at a compound annual growth rate of at least 7.7%, and is forecast to reach nearly $16 billion by 2024. This market is being driven by several inter-related factors: the increasing percentage of the aged (65years old and over) in country populations, the fact that people are living longer, obesity, the virtually epidemic rise of Type 2 diabetes, government policies intended to curb healthcare spending, and an increasingly sedentary population. The latter trend is seen especially in developed countries, but is also on the rise in less-developed countries as their economic standing improves and the middle class grows in numbers.

Certain product segments are forecast to have stronger growth than others. Sales of bioengineered skin & skin substitutes for wound care will increase at a CAGR of at least 15%, while sales of foam and hydrocolloid dressings will be growing at high single-digit rates, respectively.

Advance Wound Care Product Revenues, 2014 to 2024

Wound 2014 and 2024

Source: MedMarket Diligence, LLC; Report #S251.

Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022

Publishing June 2016:
Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022

This is a global report from MedMarket Diligence detailing from 2015 to 2022 the volume of interventional and surgical cardiovascular procedures, including open heart, peripheral vascular, cerebrovascular and all associated endovascular interventions.

Table of Contents

Executive Summary

Section 1: Common Acute and Chronic Cardiovascular Conditions Targeted by Surgical and Transcatheter Interventions

1.1     Ischemic Heart Disease

1.1.1     Angina Pectoris
1.1.2     Acute Myocardial Infarction
1.1.3     Incidence, Prevalence, Established Treatment Modalities

1.2     Heart Failure

1.2.1     Incidence, Prevalence, Established Treatment Modalities

1.3     Peripheral Artery Disease

1.3.1     Critical Limb Ischemia
1.3.2     Incidence, Prevalence, Established Treatment Modalities
1.3.3     Aortic Aneurysm
1.3.4     Incidence, Prevalence, Established Treatment Modalities

1.4     Peripheral Venous Disorders

1.4.1     Deep Venous Thrombosis and Pulmonary Embolism
1.4.2     Chronic Venous Insufficiency and Varicose Veins
1.4.3     Incidence, Prevalence, Established Treatment Modalities

1.5     Cerebrovascular Disorders

1.5.1     Cerebrovascular Occlusions and Acute Ischemic Stroke
1.5.2     Cerebral Aneurysm & AVM and Hemorrhagic Stroke
1.5.3     Incidence, Prevalence, Established Treatment Modalities

1.6     Structural Heart Disorders

1.6.1     Congenital Heart Defects

1.6.1.1     Incidence, Prevalence, Established Treatment Modalities

1.6.2     Valvular Disorders

1.6.2.1     Incidence, Prevalence, Established Treatment Modalities

1.7     Cardiac Rhythm Disorders

1.7.1     Bradycardia
1.7.2     Tachycardia

1.7.2.1     Atrial Fibrillation

1.7.3     Incidence, Prevalence, Established Treatment Modalities

Section 2: Current and Projected Volumes of Therapeutic Interventional and Surgical Cardiovascular Procedures

2.1    Coronary Artery Revascularization

2.1.1    Coronary Artery Bypass Graft Surgery

2.1.1.1    Utilization Trends and Procedure Volumes

2.1.2    Percutaneous Coronary Interventions

2.1.2.1    Coronary Angioplasty and Stenting

2.1.2.1.1 Utilization Trends and Procedure Volumes

2.1.2.2    CoronaryMechanical and Laser Atherectomy

2.1.2.2.1 Utilization Trends and Procedure Volumes

2.1.2.3    Mechanical Thrombectomy

2.1.2.3.1 Utilization Trends and Procedure Volumes

2.2    Acute and Chronic Heart Failure Management

2.2.1    Ventricular Assist Device Placement

2.2.1.1    Utilization Trends and Procedure Volumes

2.2.2    Total Artificial Heart Implantation

2.2.2.1    Utilization Trends and Procedure Volumes

2.2.3    Donor Heart Transplantation

2.2.3.1    Utilization Trends and Procedure Volumes

2.3    Peripheral Artery Revascularization

2.3.1    Lower Extremity Arterial Bypass Surgery

2.3.1.1    Utilization Trends and Procedure Volumes

2.3.2     Percutaneous Transcatheter Interventions

2.3.2.1    Angioplasty and Stenting

2.3.2.1.1 PTA and Bare Metal Stenting
2.3.2.1.2 PTA and Drug-Eluting Stenting
2.3.2.1.3 PTA with Drug-Coated Balloons
2.3.2.1.4 Utilization Trends and Procedure Volumes

2.3.2.2    Mechanical and Laser Atherectomy

2.3.2.2.1 Utilization Trends and Procedure Volumes

2.3.2.3    Catheter-Directed Thrombolysis and Thrombectomy

2.3.2.3.1 Utilization Trends and Procedure Volumes

2.4    Aortic Aneurysm Repair

2.4.1    Surgical AAA and TAA Repair
2.4.2    Endovascular AAA and TAA Repaire
2.4.3    Utilization Trends and Procedure Volumes

2.5    DVT and CVI Management

2.5.1    Vena Cava Filter Placement

2.5.1.1    Utilization Trends and Procedure Volumes

2.5.2    Endovenous Ablation

2.5.2.1    Utilization Trends and Procedure Volumes

2.5.3    Venous Revascularization

2.5.3.1    Mechanical Thrombectomy
2.5.3.2    Venous Angioplasty and Stenting
2.5.3.2     Utilization Trends and Procedure Volumes

2.6    Acute Stroke Prophylaxis and Treatment

2.6.1    Carotid Artery Stenosis Management

2.6.1.1    Carotid Endarterectomy
2.6.1.2    Carotid Artery Stenting
2.6.1.3    Utilization Trends and Procedure Volumes

2.6.2    Cerebral Thrombectomy

2.6.2.1    Utilization Trends and Procedure Volumes

2.6.3    Cerebral Aneurysm and AVM Repair

2.6.3.1    Cerebral Aneurysm and AVM Surgical Clipping
2.6.3.2    Cerebral Aneurysm and AVM Coiling & Flow Diversion
2.6.3.3    Utilization Trends and Procedure Volumes

2.7    Treatment of Structural Heart Disorders

2.7.1     Congenital Heart Defect Repair

2.7.1.1    Utilization Trends and Procedure Volumes

2.7.2    Heart Valve Repair and Replacement

2.7.2.1    Heart Valve Repair and Replacement Surgery
2.7.2.2    Utilization Trends and Procedure Volumes
2.7.2.3    Transcatheter Valve Repair and Replacement
2.7.2.4    Utilization Trends and Procedure Volumes

2.8    Cardiac Rhythm Management

2.8.1    Implantable Pulse Generator-Based Therapy

2.8.1.1    Pacemaker Implantation
2.8.1.2    Implantable Cardioverter Defibrillator Placement
2.8.1.3    Cardiac Resynchronization Therapy Device Placement
2.8.1.4    Utilization Trends and Procedure Volumes

2.8.2    Arrhythmia Ablation Therapy

2.8.2.1    Standard SVT Ablation
2.8.2.2    Utilization Trends and Procedure Volumes
2.8.2.3    AFib Ablation

2.8.2.3.1 Surgical AFib Ablation
2.8.2.3.2 Transcatheter AFib Ablation
2.8.2.3.3 Utilization Trends and Procedure Volumes

Section 3: Country Healthcare Profiles

3.1    United States and Other Americas

3.1.1    United States
3.1.2    Brazil
3.1.3    Canada
3.1.4    Mexico

3.2    Largest West European States

3.2.1    France
3.2.2    Germany
3.2.3    Italy
3.2.4    Spain
3.2.5    United Kingdom

3.3    Major Asian States

3.3.1    China
3.3.2    India
3.3.3    Japan


Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022
June 2016
Price:  $3,950 (print or PDF; add $200 for both).  Site/Global License also available.
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