Category Archives: urogenital

encompasses urological product/technologies, genital/reproductive medicine

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence has added three previously published, comprehensive analyses of  medtech markets to its Reference Reports listings. The markets covered in the three reports are:

  • Ophthalmology Diagnostics, Devices and Drugs (see link)
  • Coronary Stents: Drug-Eluting, Bare, Bioresorbable and Others (see link)
  • Tissue Engineering, Cell Therapy and Transplantation (see link)

Termed “Reference Reports”, these detailed studies were initially completed typically within the past five years. They now serve as exceptional references to those markets, since fundamental data about each of these markets has remained largely unchanged. Such data includes:

  • Disease prevalence, incidence and trends (including credible forecasts to the present)
  • Clinical practices and trends in the management of the disease(s)
  • Industry structure including competitors (most still active today)
  • Detailed appendices on procedure data, company directories, etc.

Arguably, a least one quarter of every NEW medtech report contains background data encompassing the data listed above.  Therefore, the MedMarket Diligence reports have been priced in the single user editions at $950 each, which is roughly one quarter the price of a full report.

See links above for detailed report descriptions, tables of contents, lists of exhibits and ordering. If you have further questions, feel free to contact Patrick Driscoll at (949) 859-3401 or (toll free US) 1-866-820-1357.

See the comprehensive list of MedMarket Diligence reports at link.

 

Clinical utility of advanced wound closure and securement products

Products for the advanced securement of wounds — stopping bleeding, sealing the wound, tightly closing the wound and preventing post-surgical adhesions — will be accepted by clinicians (and paid for by healthcare systems) to the extent that the provide very specific clinical utility compared to traditional alternatives, many of which (like sutures and tapes) are simple to use, cost little and otherwise are readily accepted in the business of wound management.

Clinicians (and healthcare systems) will accept and adopt for routine use those new products for hemostasis, closure, sealing and anti-adhesion of wounds, whether chronic or acute, based on the level of clinical utility they provide compared to those traditional products, and the extent to which those new products provide utility is based on the types of utility provided (from “critical” to “perceived”), a metric that varies by clinical specialty.  For example, a new product that prevents bleeding and dramatically reduces morbidity is much more likely to be adopted than a product that yields merely aesthetic (e.g., reduced scarring) or perceived benefits that have no impact on morbidity.

Advanced products offer different degrees of utility from, on the high end, the value of enabling procedures otherwise not possible or highly impractical to, on the low end, perceived benefits with no significant positive impact on morbidity.  Further, the impact of advanced products varies by clinical specialty, with some expected differences between, for example, cardiology procedures and cosmetic procedures. The four main categories of benefit from advanced products include:

  • Important and Enabling: Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
  • Improved Clinical Outcome: Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
  • Cost-Effective and Time-Saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • Aesthetic and Perceived Benefits: Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

Below is illustrated the distribution — by clinical category — of the kind of utility provided by advanced wound securement products (fibrin and other sealants, high strength adhesives, hemostatic products and anti-adhesion products):

cardio

 Total: 51.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

cosmetic

Total: 12.7 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 digestive

Total: 20.9 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

general

Total: 27.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

neuro

Total: 16 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

ortho

Total: 10.8 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

 

Current and potential patient caseload for sealants, glues, wound closure and anti-adhesion

The current and potential uses for surgical sealant products (glues, sealants, hemostats, anti-adhesion) varies by the clinical area and the type of benefit these products offer patients. These benefits range from the “important and enabling” in which their use provides potentially life-saving benefits compared to traditional wound sealing/closure products to those “aesthetic and perceived” benefits (e.g., reduced scarring) that are more cosmetic in nature.

We have assessed the potential global patient caseload that would benefit from these wound closure and sealant products along a spectrum from clinically necessary to aesthetically beneficial, in the following four categories:

Category I: Important and Enabling
Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.

Category II: Improved Clinical Outcome
Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).

Category III: Cost-Effective and Time-Saving
Immediate reduction in surgical treatment time and need for follow-up treatments.

Category IV: Aesthetic and Perceived Benefits
Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

Most importantly, we have assessed the sizes of the patient populations that are the targets of these different classes of clinical benefits by major clinical area.  Below are illustrated, by both Clinical Area/Benefit and Benefit/Clinical Area, to illustrate the current and future volume of patient caseload for these novel wound closure and sealant products:

Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide (Millions), 2011

sealant-categories-A

Source: Report #S190

Sealant-categories-B

Source: Report #S190

Opportunities for med/surg sealants, glues, hemostats driven by type of clinical benefit, competition

Advanced products for the closure, sealing, hemostasis and other endpoints for medical and surgical wounds generate varying degrees of clinical benefit based on the manner and extent to which they enable management of different wound types.  Degrees range from the acute need end of “important and enabling” to the less clinically necessary “aesthetic and perceived benefits”:

  • Important and enabling: Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
  • Improved clinical outcome: Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
  • Cost-effective and time-saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • Aesthetic and perceived benefits: Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

These benefits are clearly different on a clinical specialty-by-specialty basis.  The numbers of targeted or prospective procedures also vary considerably by specialty. As a result, wound closure and securement products have the following categorized potential use worldwide:

Source: “Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide “; Report #S190.


Tissue engineering & cell therapy markets, 2012 and 2018

The varied technologies underpinning the market for “tissue engineering & cell therapy” are diverse — even more so than people in the industry often recognize.  Frequently, both tissue engineering and cell therapy are presumed to be purely developmental in current “markets”, a far cry from when such technologies will be so advanced as to make organ replacement a retail market.  The truth is that, on the one hand, tissue engineering has become a very routine part of clinical practice (as in skin grafts and orthopedic tissue grafts) and, on the other hand, while cell therapy still has vastly more clinical (and commercial) potential than it has as yet demonstrated, it has nonetheless demonstrated sufficient advance that several obstacles to cell therapy benefits have been greatly diminished: (1) the issue of the Bush-era ban on federally-funded embryonic stem cell research was promptly lifted by the Obama administration and (2) advances in the use of adult stem cells and the reversion of cells from a differentiated to undifferentiated state (i.e., creation of pluripotent cells) have made limitations on embryonic stem cells largely moot.

Consequently, the great struggle for anyone seeking to assess the “commercial potential” in tissue engineering and stem cell therapy is overcoming the presumption that these technologies are still a long way off from attaining any level near their potential commercial success.

The solution has been to track actual company revenues especially, but not limited to, readily verified SEC 10(K) company reports on revenues generated from these technologies.  This has been our experience in characterizing worldwide markets for tissue engineering and cell therapy in our Report #S520.

The aggregate worldwide market for tissue engineering and cell therapies, representing an already stunning range of clinical applications, stands at roughly $12 billion in 2012.  This market, through commercial introduction of new products and expanded applications of approved products, will reach almost $32 billion by 2018. See our 2012 and 2018 estimates, below.

Source: “Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018″, Report #S520.

Potential for medical and surgical sealants, glues, hemostasis and other wound products

Advanced products for the closure, sealing, hemostasis and other endpoints for medical and surgical wounds generate varying degrees of clinical benefit based on the manner and extent to which they enable management of different wound types.  Degrees range from the acute need end of “important and enabling” to the less clinically necessary “aesthetic and perceived benefits”:

  • Important and enabling: Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
  • Improved clinical outcome: Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
  • Cost-effective and time-saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • Aesthetic and perceived benefits: Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

These benefits are clearly different on a clinical specialty-by-specialty basis.  The numbers of targeted or prospective procedures also vary considerably by specialty. As a result, wound closure and securement products have the following categorized potential use worldwide:

Source: “Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide “; Report #S190.


Ablation technology regional growth to 2019

In our analysis of the global market for the spectrum of ablation technologies – Electrical, Radiation, Light, Radiofrequency, Ultrasound, Cryotherapy, Thermal (other than cryo), Microwave, and Hydromechanical — we assessed the size and growth of sales of these technologies with specificity to a large number of regions and countries:

  • U.S.A.
  • Canada
  • Brazil
  • Mexico
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
  • BeNeLux
  • Japan
  • China
  • India
  • Australia
  • Rest of World

Below, we illustrate, ranked from low to high, the compound annual growth rates of each geography/technology combination.  This data reflects the strong trends that exist for clinical adoption and sales growth of specific technologies, driven by the unique combination of country-specific and technology-specific forces.

Source: Report #A145, MedMarket Diligence, LLC.