Continuous blood glucose monitors in diabetes

Continuous blood glucose monitors (CBGMs), which regularly report blood glucose levels and, more importantly, provide alarms for when levels approach critical highs and lows and, even further, advance warning of the trend toward such levels, are a major new area of market opportunity for technologies in diabetes.  On their own, they offer the ability to provide advance intervention for diabetics whose blood glucose is poised to drop to rise to unhealthy levels.  Further, their use in providing patients and their clinicians with data on patterns of blood glucose response to carbohydrate intake, insulin infusion, exercise and other important variables can move diabetics' care toward normalizing glucose levels and avoid the complications of hypo- and hyperglycemia.

Combined in in initially open loop and, eventually, closed loop systems integrated with insulin pumps and CBGMs, these systems represent the potential "artificial pancreas" that is a long sought-after goal in diabetes management.  The only remaining constraints (since open loop systems are already available) is the necessary algorithms and their FDA approval in an integrated device that does not require user input to relate glucose levels to insulin dosage.

The market potential for CBGMs varies by geography according to different local  adoption rates and other variables.  See below for relative growth rates for the market in CBGMs:

Source: MedMarket Diligence, LLC; Report #D510, "Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018."

Diabetes Market, Major Segment Breakouts

It is illustrative to put the individual components of the global diabetes market into context.

Below is illustrated the global diabetes market segmented by geography, with further detail shown for the U.S. markets product segments.

The U.S. represents the single largest share of the global diabetes market, with insulin, glucose meter test strips (not including meters) and anti-diabetic drugs contributing the largest segments to the U.S. total.

Source: MedMarket Diligence, LLC; Report #D510.

European markets for ablation technologies show country-specific rates

The European market for ablation technologies shows considerable variation by modality and country, given the differences in adoption rates for the different modalities, the local practice patterns and other regional variations.

Below is illustrated the distribution of the ablation market by modality across the major markets in Western Europe.

Source: MedMarket DIligence, LLC; Report #A145, "Ablation Technologies Worldwide Market, 2009-2018."

Ablation Technologies Competing for Growing Patient Volume and Penetration of Clinical Practice, According to New MedMarket Diligence Report

Ablation technologies are a growth medtech field driven as much by physicians pursuing larger caseload as manufacturers developing innovative technologies, according to a new global report from MedMarket Diligence.

(PressMethod) – Surgical procedures focus on a wide range of clinical endpoints — the creation of a lesion to block aberrant cardiac rhythms, the destruction of cancerous tissue, the ligation of tissues with associated hemostasis, and many others — which has driven the development of an array of ablation technology types that are now competing aggressively with each other for a growing caseload of procedures. The ablation technologies with some of the most rapidly growing use rates are cryotherapy and radiofrequency ablation, followed by ultrasound, laser and, due to innovations in its implementation, radiotherapy. These are among the findings in a new medical technology report from MedMarket Diligence.

Although the applications of ablation devices include a number of aesthetic treatments, the majority of applications remain chronic disorders in areas which include cancer, cardiovascular, urology, gynecology and orthopedics. Many of these disorders are age-related, and the related device segments are driven by the aging of the global populations. Other market drivers include the Chinese government's push to modernize its healthcare facilities by building 400 hospitals per year, and developed country populations which are demanding anti-aging treatments, to which physicians are responding by purchasing equipment.

"Like the most successful medical technologies, ablation technologies have as their underlying driver for success the ability of physicians to capture greater caseload due to their ability to promote the clinical efficacy of ablation, faster healing times, fewer complications and many other benefits," says Patrick Driscoll, President of MedMarket Diligence. According to Driscoll, the top ablation technologies are growing at nearly 20% annually in manufacturer revenues. These include control systems, instrumentation and probes and other disposables used during the procedures.

The MedMarket Diligence report, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities", describes alternative energy-based technologies and the nature of their effect on soft tissue, the underlying basis of the technology, the requisite systems for their use (including capital equipment, devices and disposables), and their strengths and weaknesses for specific clinical applications. The report details current and anticipated target applications and assesses the current and forecast caseload for each energy-based therapeutic considering competition from any and all alternative energy-based or other therapeutics, with current and worldwide market forecasts (2009-2019) segmented by technology type and specific clinical segment. The report provides segmentation of the worldwide ablation market by both ablation technology and region/country: Americas (USA, Canada, Mexico, Brazil), Europe (Germany, United Kingdom, France, Italy, Spain, BeNeLux), Asia/Pacific (Japan, China, India, Australia) and Rest of World. The report details the current and emerging products, technologies and markets for each energy-based therapy. The report profiles 76 key companies in this industry detailing their current products, current market position and products under development.

The report is described in detail, including table of contents and list of exhibits, at link. The report may purchased for immediate download at link.

 

New Technologies in Type 1 and Type 2 Diabetes Management

(See PRLog press release at link.)

As well established as the practices are for the management of types 1 and 2 diabetes, a raft of new technologies, from modest to radical, are steadily entering clinical practice and the industry, according to a new report from MedMarket Diligence.

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Aug 16, 2010 – The diagnosis, monitoring and management of both insulin-dependent diabetes mellitus (also known as Type 1) and non-insulin dependent diabetes mellitus (aka Type 2) is a well established practice of regulating blood glucose levels. Nonetheless, manufacturers have steadily developed new technologies that continue to improve the management of the disease by reducing burden on patients, reducing the incidence of diabetes-related complications and reducing the overall cost of the disease on healthcare systems.

“Without a doubt, the 10-year study known as Diabetes Control and Complications Trial, or DCCT, played an enormous role in validating the technologies that now routinely serve to improve the quality of life for diabetics,” says Patrick Driscoll, President of the medical technology business research firm MedMarket Diligence. “But the steady growth in diabetes prevalence worldwide, driven by increased prevalence of obesity, demographic trends and other forces, combined with persistent demand for ever less intrusive monitoring technologies and better long-term blood glucose management, creates an enormous opportunity for new technology development by diabetes product manufacturers.”

According to Driscoll, and detailed in the MedMarket Diligence report (see link), products in diabetes management represent an enormous $36 billion global market annually, encompassing insulin, blood glucose meters, lancets, test strips, insulin pumps, syringes (and other delivery devices), continuous blood glucose meters and a broad range of anti-diabetic drugs (oral hypoglycemic agents). Each of these product areas has many competitors offering and developing new products (even the area of insulin has a dozen competing companies), with a steady stream of innovations being introduced to the market and clinical practice. Moreover, aggressive research has continued to push for more advanced solutions to diabetes, including novel insulin delivery methods, pancreas transplants, islet cell transplants, stem cell approaches, antibody treatment, vaccines, novel drugs, new continuous blood glucose monitoring systems and the “holy grail” of diabetes management, a closed-loop blood glucose monitoring and insulin pump system (sometimes referred to as an “artificial pancreas”), which may be approved for marketing in the very near future.

Growth in the market for diabetes management products ranges globally from a low of about 11% annually in Europe to nearly 24% annually in Asia. Overall, the U.S. and Europe, with their advanced healthcare markets and payment systems, still represent an aggregate 68% of the global market. By product area, the segments driving the largest annual revenues are insulins and anti-diabetic drugs, comprising almost two thirds of the global sales of diabetes management products.

The MedMarket Diligence report #D510, “Products, Technologies, Markets and Opportunities in Diabetes Management Worldwide, 2009-2018,” details the worldwide incidence and prevalence by country/region of Type 1 and Type 2 diabetes and details the current and projected market for diagnostic and therapeutic products in the management of diabetes, including anti-diabetic drugs, alternative insulin types, blood glucose monitoring (including continuous monitoring devices), insulin pumps, and other established and emerging products in diabetes management. The report provides an emphasis of detail on the status of development of novel products including noninvasive monitoring, oral/inhaled/other insulin delivery. The report details the clinical and technology developments underlying this huge and evolving worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. Separate size, growth and competitor share data are presented for the U.S., European, Asia/Pacific and Rest of World. The report profiles active companies including detailed profile information on major competitors, brief profiles of companies with less sizeable current or potential positions in the market, plus additional profiles of companies with novel or advanced research activities in the market.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

The report is described, with complete table of contents and list of exhibits at http://mediligence.com/rpt/rpt-d510.htm and may be accessed for immediate download via http://mediligence.com/store/page34.html.

Segmentation of global ablation market by geography and modality

The global market for ablation technologies is characterized, like many medtech markets, by a dominance of revenues in western economies.  There are nonetheless distinct patterns in the share of ablation by modality from one geography to the next.

Below is a simple representation of the global ablation market by major region and modality (aggregated from the detail by country in MMD report #S520):

Source: MedMarket Diligence, LLC; Report #S520, "Ablation Technologies Worldwide Market."

Market Drivers: U.S. and European Cell Therapy, Tissue Engineering

Tissue engineering and cell therapy comprise a market for regenerative products that is expected to grow worldwide from $6.9 billion in 2009 to almost $32 billion by 2018. This market spans many specialties, the biggest of which is therapies for degenerative and traumatic orthopedic and spine applications. Other disorders that will benefit from cell therapies include cardiac and vascular disease, a wide range of neurological disorders, diabetes, inflammatory diseases, and dental decay and/or injury. Key factors expected to influence the market for regenerative medicine are continued political actions, government funding, clinical trials results, industry investments, and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications.

There are key market drivers affecting the relative growth of cell therapy and tissue engineering in specific regions or countries. One historical driver has been the dynamics of stem cell research in the United States. The unavailability of additional stem cells due to President Bush’s Presidential Executive Order in 2001 (since rescinded in 2009 by President Obama) had the affect of decelerating the number of new embryonic stem cell research projects launched, thus postponing the optimistic timeline anticipated by some researchers. This directly delayed the commercialization of products based on embryonic stem cell research, which had the effect of dampening the overall U.S. market.  Simultaneously, this also drove increased research and development of the science (if not technologies as well) in areas outside the U.S., especially in the EU. While this distinction between the U.S. and Europe does not account for all the market size and growth differences, it is a distinct, identifiable cause.  (The U.S. also has in many respects a more mature — or at least more penetrated cell/tissue market — and the EU is simply catching up.)

Below for comparison is the relative U.S. and European share of the cell therapy and tissue engineering market in 2009 and 2019.

Source: MedMarket Diligence, LLC; Report #S520.

Ablation Technologies Market to Reach $10 Billion in 2010, According to a New MedMarket Diligence Report

PRLog (Press Release) – Jun 09, 2010 – The practice of surgery has long employed energy-based technologies to excise, cut, ablate, cauterize, destroy or otherwise manipulate tissue to produce therapeutic results. Various energy modalities — from cryotherapy to microwave to radiofrequency to ultrasound to radiation and others — have proven their ability to effect healthy or diseased tissue with more effective outcomes than other physical methods (e.g., the scalpel) can allow. These effects and outcomes include: 

  • destruction of diseased (e.g., cancerous) tissue preferentially over healthy tissue
  • simultaneous cutting and hemostasis of the surgical wound
  • creating lesions, as in treatment of atrial fibrillation, that block aberrant electrical pathways
  • sculpting of tissue as in laser vision correction
  • a wide range of other applications

The number and diversity of clinical applications in ablation is driven by the diversity of the different energy modalities: 

  • Microwave
  • Ultrasound
  • Electrical
  • Radiation
  • Radiofrequency
  • Hydromechanical
  • Cryotherapy
  • Thermal
  • Light

Products and technologies in ablation include capital equipment, instruments and disposable probes and other products. It is a robust area in which manufacturers aggressively develop and release new product configurations that improve upon patient outcomes and capture growing share of caseload. 

While there is a concentration of some ablation modalities for specific types of treatment (e.g., radiation has long been a predominant treatment in cancer), the modalities that compete with one another for caseload varies considerably from one clinical application to the next.  Therefore, a consideration of the market for any one of these modalities is not complete without also examining the competition presented by other modalities on a case-by-case basis. 

MedMarket Diligence's report (described at http://mediligence.com/rpt/rpt-a145.htm) on the Ablation Technologies Worldwide Market details the global market for ablation technologies, encompassing discussion of the specific tissue effects of each modality, the current and emerging surgical procedures, the products and technologies under development, the growing list of active manufacturers and developers and the worldwide market, by country/region for ablation technologies by modality. 

This 488 page report, with 123 tabular and graphic exhibits, is a detailed market and technology assessment and forecast of the products and technologies in the ablation market for treatment of soft tissues via energy-based modalities, including electrosurgery, radiosurgery, gamma knife, brachytherapy, cryogenic therapy, fluidjet therapy (hydrotherapy), microwave ablation, radiofrequency ablation, laser, thermal ablation, and ultrasonic ablation. 

The report describes alternative energy-based technologies and the nature of their effect on soft tissue, the underlying basis of the technology, the requisite systems for their use (including capital equipment, devices and disposables), and their strengths and weaknesses for specific clinical applications. The report details current and anticipated target applications and assesses the current and forecast caseload for each energy-based therapeutic considering competition from any and all alternative energy-based or other therapeutics, with current and worldwide market forecasts (2009-2019) segmented by technology type and specific clinical segment. The report provides segmentation of the worldwide ablation market by both ablation technology and region/country:Americas (USA, Canada, Mexico, Brazil), Europe (Germany, United Kingdom, France, Italy, Spain, BeNeLux), Asia/Pacific (Japan, China, India, Australia) and Rest of World. The report details the current and emerging products, technologies and markets for each energy-based therapy. The report profiles over 76 key companies in this industry detailing their current products, current market position and products under development.

The report is described in detail at link.  The report may be purchased for immediate download online or may be purchased by order form.


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MedMarket Diligence provides data and insight to the medical products, investment and other industries on © 2018, MedMarket Diligence, LLC -- advanced medical technologies through focused medical technology market and assessment Reports and the Medtech Startups Database.

 

 

 

 

 

 

 

 

Patents, Cell Therapy and the European Union

Before President Barack Obama’s 2009 Executive Order that reversed the ethics-driven ban on U.S. Federal funding for human embryonic stem cell research, the European Union had a clear advantage in stem cell research. However, now that the way is clear in the United States to accelerate embryonic stem cell research there, some worry that current regulations in Europe might undermine investor confidence and thus hamper funding for research in Europe.

The ethical debate surrounding the use of embryonic stem cells impacted not only the United States, but Europe as well. In the European Union, the debate has affected patent processes there, thus affecting funding and commercialization of the technologies in question.

The Legal Protection of Biotechnological Inventions (EU Directive 98/44/EC), which governs embryonic stem cell patents among other technologies, was intended to create a consistent approach across member states that would allow Europe to fully exploit opportunities in biotechnology. According to the directive, patents may not be granted for the human body at various stages of development, including the embryo stage. Therefore, cells that can develop into a human being cannot be patented, but adult cells and those that can be developed into body parts may be patented. While the European Patent Office grants most patents in Europe, the same patents must also be enforced in individual member states, where national courts may interpret the directive differently. In some cases, resistance has mounted to granting patents on any inventions using stem cells, leading some countries to resist implementing the directive into national law.

While the EU Directive bans patents for products that use embryos for industrial or commercial purposes, a European Patent Office board of appeal ruled that stem cells cannot be patented if they are obtained only by destruction of a human embryo. Until recently, this was the only way stem cells could be obtained. As such, the patent office’s ruling effectively created a ban on patents that involve any stem cells.

However, now that stem cells can be obtained without destruction of the embryo (e.g., adult stem cells or umbilical cord blood stem cells), the way is likely cleared for patents to be granted for embryonic stem cell inventions where a stem cell bank is listed as the source.

Needless to say, the uncertainty created by the directive and subsequent rulings has made some investors wary of investing in a market where the resulting technology may remain unprotected.

In the aggregate market of cell therapy and tissue engineering (recognizing the less strict regulatory environment of tissue engineering compared to cell therapy), the European Union generates less than half the revenues of the U.S. market, but this is expected to change (see below) as Europe expands its adoption of both tissue engineering and cell therapy in clinical practice.

Source: MedMarket Diligence, LLC; Report #S520.

Technology migration in medtech markets

Western markets, including the U.S. and Europe, tend to drive the formation of new medical technology markets, which then evolve and migrate to Asia/Pacific and the rest of the world.  While this is not always the case (a notable exception is the technology and market development of fibrin and other blood-based tissue sealants technologies, which substantially took hold in Japan first), it is often the case due to the level of innovation in these markets, available capital for investment and, in no small part (and to the ire of the cost conscious) the high percent of gross domestic product spent on healthcare, especially in the U.S.

One of the most well established markets for cell therapy and tissue engineering products, and second only to orthopedics, is in the area of skin or integumentary applications — treatment of burns, diabetic and venous ulcers and plastic and reconstructive surgery.  As an example of the trend of U.S. markets driving innovation, the market for cell/tissue products in skin applications has been dominated by the U.S., and the recent past trend in reported revenues geographically, which is certainly going to continue, is that the U.S. will represent a progressively smaller share of this global market.

Source: MedMarket Diligence, LLC; Report #S520.