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Recent medtech market insights

It occurred to me that in my position performing, directing and reviewing market research on a global scale that it would be worthwhile to highlight recent insights that have come to me regarding the global medical technology market.  Some of these insights, of course, may only be meaningful to me (and those who have a perspective on medtech markets similar to mine), but I hope that some insights may be useful to some of my niche audiences in medtech.   Keep in mind that some of the insights I have come from proprietary sources, whose identities I am not able to reveal (lest they elect to no longer do business with me!), but I will nonetheless reveal as much non-proprietary information as I can.

  • The global economy is down from two years ago, but is measurably if not significantly up from one year ago.  I gauge this based on the overall level of business we directly receive and the feedback my authors receive from researching medtech companies. This should be no surprise to anyone who reads other business news on a regular basis.
     
  • U.S. markets, for a number of reasons, seem to be lagging markets in the global economy in this period of economic recovery. If I simply use the measure of the number of medtech company inquiries to us originating from U.S. versus OUS companies, I have seen a clear trend that started with a global decline in 2008 followed by a flat 2009 followed by a steady growth in inquiries from OUS companies in 2010 and relative smattering of U.S. company inquiries.  Why this is so may be the subject of countless speculation, but one reason, I believe [insert personal insight here] is that OUS companies (whose pockets weren't so deep as those in the US) felt the hit of the global recession  before the US companies and they sooner ran out of patience waiting for markets to rebound, electing instead to move forward on product development, market development and other initiatives.    
     
  • The trend of OUS emerging from the global recession before the US is one that runs counter to the other truth I see, which is that the U.S. is almost universally a market leader (with the exception of areas like cell therapy, in which academia and business OUS has been more than happy to push forward in research while the U.S. vacillates between right- and left-wing politics).  Almost without fail, I continue to see the most advanced technologies emerging principally from US rather than OUS companies.
     
  • There has been more activity emerging from China and (rogue island) Taiwan in medtech over the past two years than I have ever seen.  This activity — purchase of market research, formation of companies or commercialization in general — has a concentration in academic organizations or institutes apparently seeking to commercialize research discoveries originating from "pure" research.
     
  • Hope springs eternal in the U.S.  Despite two full years of economic woes in the U.S., a surprisingly steady stream of new medtech companies continue to be founded, as entrepreneurs commit to the commercialization of technologies they see warranting the rigorous development, clinical testing, FDA and other hurdles en route to the market.  But to temper the idea that in the US there is a greater abundance of adventurous entrepreneurs, I must note that a remarkable number of new companies in the US recently have been started by serial entrepreneurs, who have so often previously run the gauntlet demanded of startups  that they are fully prepped to make new runs with new technologies. 
     
  • Minimally invasive is minimally invasive (is better).  Lower long term cost is better. With few real "untapped" clinical targets being the subject of new medtech development, the vast majority of activity is clearly centered around improvements in care that lend to the argument of better clinical outcomes and/or reduced cost of patient care.  The thrust of R&D is on yielding advantages that reduce invasiveness, speed the treatment process and/or time to healing or simply provide competitive clinical costs at or lower than alternatives.
     
  • Notwithstanding the prevalence of developments noted above, in reducing cost/invasiveness, there are distinct areas of new technology development that center on providing outcomes where few, if any, effective therapies existed previously.   A good point (perhaps the most salient example) is in cell therapies, deriving from autologous, embryonic or adult stem cell technologies.  Despite ongoing ethical/policy/legal battles regarding embryonic stem cells, cell therapy has moved rapidly to the foreground as one of the most significant drivers of new technologies soon to spawn therapies for previously untreated diseases.  While this field may certainly characterized as simply being en vogue, and is therefore only momentarily benefiting financially from recent attention, there are very real advances in the science and technology of cell therapies that are moving these to clinical and market fruition.

These are some of the insights I have picked up and can reveal from our market research.  It would certainly be intriguing to me to hear what readers have themselves witness that either corroborates, or refutes, what I see.

Recent medtech market insights
Posted 02 September 2010 † P. Driscoll § cell therapy § innovation § investment § medtech § regenerative medicine § stem cell § tissue engineering ‡ View Comments °

Sealants, glues and securement products

Wounds have been closed and secured through the use of suture materials since ancient Egyptian times. In the modern medical age, suture materials have evolved through a succession of stages from non-resorbable, to resorbable, to stapling devices. Since sutures still represent the majority of products used for wound closure and securement, it is important to discuss this class of products and their relationship with adjunctive measures, and with newer products under development.

There are six main categories of closure and securement devices as discussed below:

  • Sutures, Staples, and Other Mechanical Closure Devices
  • Tapes
  • Hemostats
  • Fibrin and Other Sealants
  • High-Strength Medical Adhesives
  • Post-Surgical Adhesion Prevention

This market may be subdivided into the following product categories: sutures, staples and other mechanical closure devices; tapes; hemostats; fibrin and other sealants; high-strength medical adhesives; and post-surgical adhesion prevention. The total securement market is growing at an aggregate of almost 10% annually. 

Definition of Surgical Closure and Securement Products

ProductDescription
SutureSutures are medical devices made out of woven or single filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.
StapleStaples are rigid or semi-rigid suture-like materials delivered through a closure device and consisting of single- or multi-filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.
TapeTapes are fabric and polymer-based medical devices that are used to secure cuts, lacerations, and incisions in the surface of the skin as an adjunct to wound closure.
HemostatA hemostat reacts in the presence of blood to establish the normal cascade of factors that arrest bleeding. These products can be added to a bleeding field during surgery to prevent further bleeding, and are mostly dependent on a full complement of normal factors in the patient’s blood.
SealantA sealant will prevent leakage of fluid and/or gas from a surgical incision (such as pulmonary gases or spinal fluids). These products will often hold back pressurized fluids from normal vascular activity. Although their efficiency does not normally require the full complement of active clotting factors in blood to be within normal levels, these products (e.g., fibrin sealants) normally also have some hemostatic activity.
Glue/adhesiveGlues and adhesives (e.g., cyanoacrylate glues) are used to attach organs, structures, or tissues to each other or to effect repair. These materials can be enhanced by incorporating additional hemostatic or sealant properties, such as Angiotech’s Vitagel (a combination of collagen and thrombin) and Nycomed’s Tachocomb (a combination of thrombin, collagen and fibrin).
AdhesionAbnormal joining of two organs or tissues occurring after inflammation, especially post-surgery. Adhesion-prevention products are medical devices or substances made from synthetic polymer or natural biomaterials that are manufactured into gels, fabrics, films, and dried solids that are used to avoid the formation of post-surgical adhesions (PSA).

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

Sealants, glues and securement products
Posted 01 September 2010 † P. Driscoll § surgical glue § surgical sealant § wound management ‡ View Comments °

Pressure Ulcers and Wound Management

A key driving force in the market for wound management is the reduction of costs associated with managing chronic wounds.  Central to this is clinical challenge of dealing with pressure ulcers.  Below is an excerpt on pressure ulcers from the MedMarket Diligence report #S247, "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World."

Pressure ulcers, or bedsores, are areas of local necrosis resulting from vascular insufficiency due to the prolonged application of pressure to the tissues. There is an important relationship between the magnitude of pressure applied to the capillary bed and the duration that pressure is applied. Pressure ulcers are more likely to occur under relatively low pressures over long periods of time rather than under short episodes of high pressure. A healthy adult can develop a pressure ulcer if pressure sufficient to close capillaries (25-32 mm Hg) is applied for sufficient time, such as when undergoing a lengthy surgical procedure. In the compromised or elderly patient, significantly lower pressures may lead to pressure ulcer formation.

Pressure ulcer formation is enhanced through the additional application of shearing forces, friction, and moisture. Shearing occurs when the skin is anchored to a surface, such as a bed or chair, and restrained from sliding over the surface while the underlying tissues are forced to move. The shearing force contributes to the destruction of deep tissue through the angulation and obstruction of blood vessels and excessive stretching of tissue. Shear occurs when a patient left sitting in a bed is pulled down into a slouch by gravity. The skin will adhere to the bed linen, while the coccyx will gradually drag the underlying tissue downward. Shearing forces may result in a disruption of the dermal-epidermal junction and produce blisters. Proper and frequent repositioning of a patient can reduce both pressure and shearing forces.

Friction occurs when the adhesion to the surface is not quite sufficient to prevent sliding, but sufficient to impart resistance to motion, that results in heat and wearing away of the outer layers of the skin. A patient who has slid down toward the bottom of the bed and is dragged back to the top will experience friction on the heels and other bony prominences. For this reason patients should be lifted back into position, and sliding over the bed surface should be avoided. Dressings that protect against friction and mattress covers with a low friction coefficient are helpful.

Moisture that is in prolonged contact with the skin produces maceration and reduction in the skin’s ability to tolerate additional stress. Macerated skin has a higher friction coefficient, increasing the likelihood of damage from friction and shear. Several sources of moisture are common in hospital and nursing home situations, including perspiration and urinary and fecal incontinence. Moisture may lead to fungal infections, and fecal incontinence can generate infections by E. coli. Thus, moisture may contribute to wound formation and present complications to wound healing.

Staging of Pressure Ulcers

  • Stage I ulcers are indicated by damaged friable surface skin with considerable hidden cell death caused by continuous pressure damage usually from immobilization in a single position. Identification of signs of pain and early indications of visible damage is a significant event in that it alerts caregivers of the need for interventions to prevent more serious damage. 
     
  • Stage II ulcers present as partial thickness wounds, which may heal with early intervention by regeneration under advanced wound care techniques. 
     
  • Stage III ulcers are usually full-thickness pressure sores. These are often difficult to classify due to the presence of eschar that obscures visualization of the wound bed. The presence of eschar does indicate a full thickness wound but the eschar must be removed (debrided) before classification can be established. 

    Early Stage III or Stage IV pressure ulcers may superficially resemble Stage I ulcers. A wound initially classified as Stage I may, therefore subsequently appear to progress to higher stages as the already damaged deeper tissues slough off or as auto-debridement occurs with moist wound healing therapy. 
     

  • Stage IV pressure ulcers are characterized by full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining of healthy surrounding skin and sinus tracts may also be associated with Stage IV pressure ulcers.

The success of the four-stage system of pressure ulcer classification has led to attempts to utilize it for other wound types, with varying degrees of success. The four-stage system was developed for the initial assessment of the wound by determining the depth of injury and tissues involved. As full thickness wounds heal by granulation and scar formation it is inappropriate to use the system to describe the process of healing. Stage IV wounds do not become Stage III wounds during the course of healing. Tissues destroyed during the wounding process are not regenerated in full thickness wounds.

Pressure ulcers occur most frequently over bony prominences where the padding effect provided by adipose tissue and muscle is least present. Pressure ulcers may also occur under casts, orthopedic devices and under compression bandages and stockings. The majority of pressure sores occur in the following regions:- lower spine (40%), feet (21%), trochanters 20%), scapula (5%), with upper spine, elbows, ribs, head, knees, and lower limbs making up most of the remainder.

(See further coverage of pressure ulcers and the associated products in wound management on the market and under development in MedMarket Diligence report #S247.)

Pressure Ulcers and Wound Management
Posted 31 August 2010 † P. Driscoll § clinical practice § market data § medtech § wound management ‡ View Comments °

Medtech financing at $2.57 billion through August 2010

Medtech financings year to date (through August 2010) now stand at $2.57 billion, about 17% ahead of financings by this date in 2009. 

August 2010 financing came in at a modest $267 million, following the year-high month of July which had financings of $518 million.

If the remainder of 2010 follows a typical course, total medtech financings will hit just shy of $4 billion, compared to a total $3.2 billion in 2009.  However, variability (and uncertainty) in the market (healthcare and the general economy) is considerable, so predictions are a somewhat academic exercise.

2010 Medtech Financings by Month

Month Financings
($millions)		 Detail
January $514 link
February $160 link
March $241 link
April $125 link
May $432 link
June $312 link
July $518 link
August $267 link

 

Compiled by MedMarket Diligence, LLC

 

 

 

Source: MedMarket Diligence, LLC

Medtech financing at $2.57 billion through August 2010
Posted 31 August 2010 † P. Driscoll § innovation § investment § market data § medtech ‡ View Comments °

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.

Diabetes Market, Major Segment Breakouts
Posted 30 August 2010 † P. Driscoll § Asia/Pacific § Europe § diabetes § market data § medtech ‡ View Comments °

Type 1 diabetes, insulin types

Type 1 diabetes is still treated with insulin injections. Insulin is supplied in a variety of long, intermediate and short-acting preparations. The duration of action of insulin preparations required to give optimal control varies from patient to patient. This means that individual patients are established on particular regimens which are not changed unless they are not working.

In the early days of insulin treatment, animal insulin was used—bovine and porcine, of which porcine became the favorite as the molecule differed from human insulin by only a single amino acid. Bovine insulin was phased out as the purification and supply of porcine insulin was scaled up. This helps to explain why the Danish company Novo Nordisk became the leading insulin manufacturer in Europe, given the strength of the Danish pig industry.

Ultimately, it became possible to make "humanized" insulin from pig insulin by replacing the pig-specific amino acid with the human-specific amino acid. Human insulin is now manufactured from cloned human insulin genes. Genentech and Eli Lilly devised a means of achieving this for the U.S. market and Novo Nordisk followed suit in Europe. The bulk of the market is now converted to human insulin.

The second major innovation in insulin has been the development of ultra fast-acting insulin derivatives. The introduction of recombinant production methods of human insulins made it possible to alter the insulin molecule in order to tailor the pharmacokinetics. Thus, insulin analogues such as insulin lispro (Humalog, Eli Lilly) and insulin aspart (NovoRapid, Novo Nordisk) are absorbed very rapidly and the variability of their effect is minimized.

There is a great variety of insulin formulations on the market; as summarized in the following tables.

Rapid acting (onset less than 15 minutes)

TypeCompanySource
Humalog, Insulin lisproEli LillyAnalogue
Humalog CartridgesEli Lilly and CompanyAnalogue
NovoLog, Insulin aspartNovo NordiskAnalogue
ApidraTM, insulin glulisineAventis PharmaceuticalsAnalogue

Short acting (onset 1⁄2-2 hours)

TypeCompanySource
Humulin R (Regular)Eli Lilly and CompanyHuman
Iletin II RegularTMEli Lilly and CompanyPorcine
Humulin R Cartridges (1.5 ml)Eli Lilly and CompanyHuman
Novolin R (Regular)Novo NordiskHuman
Velosulin Human (Regular) (Buffered)Novo NordiskHuman

Intermediate acting (onset 2-4 hours)

TypeCompanySource
Humulin L (Lente)Eli Lilly and CompanyHuman
Humulin N (NPH)Eli Lilly and CompanyHuman
Iletin II LenteEli Lilly and CompanyPorcine
Iletin II NPHTMEli Lilly and CompanyPorcine
Humulin N Cartridges (1.5 ml)Eli Lilly and CompanyHuman
Novolin N (NPH)Novo NordiskHuman

Long acting (onset 4-6 hours)

TypeCompanySource
Humulin U (Ultralente)Eli Lilly and CompanyHuman

Very long acting (24+ hours)

TypeCompanySource
Lantus (formerly HOE901), Insulin glargineAventis PharmaceuticalsAnalog
Levemir (formerly NN304), insulin detemirNovo NordiskAnalog

Mixtures

TypeCompanySource
Humalog, Insulin lisproEli LillyAnalogue
Humalog CartridgesEli Lilly and CompanyAnalogue
NovoLog, Insulin aspartNovo NordiskAnalogue
ApidraTM, insulin glulisineAventis PharmaceuticalsAnalogue

Source: MedMarket DIligence, LLC; Report #D510, "Diabetes Management Worldwide, 2009-2018".

Type 1 diabetes, insulin types
Posted 26 August 2010 † P. Driscoll § diabetes § drug § market data § medtech § pharmaceutical ‡ View Comments °

August 2010 medtech financings

(Bookmark this page to check recent changes in individual financings and totals.)

Below is the spreadsheet listing of medtech financings for August 2010.  This blog post will reflect in the spreadsheet below the current listing of financings as we identify them.

Source: MedMarket Diligence, LLC

August 2010 medtech financings
Posted 26 August 2010 † P. Driscoll § medtech ‡ View Comments °

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."

European markets for ablation technologies show country-specific rates
Posted 25 August 2010 † P. Driscoll § Europe § France § Germany § Italy § Spain § United Kingdom § ablation § cryosurgery § cryotherapy § electrosurgery § hydromechanical ablation § laser § market data § medtech § microwave ablation § radiofrequency ablation § ultrasound ‡ View Comments °

Clinical applications of tissue engineering and cell therapy

The market for tissue engineering and cell therapy products is set to grow to nearly $32 billion by 2018. This figure includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies. The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

An overview (map) of the spectrum of clinical applications in tissue engineering and cell therapy is shown below:

Source: Report #S520

Clinical applications of tissue engineering and cell therapy
Posted 24 August 2010 † P. Driscoll § Cosmetic/aesthetic § biomaterials § biopharmaceutical § biotech § cancer § cardiology § cell therapy § clinical practice § diabetes § digestive § gastroenterology § gynecology § market data § medtech § neurology § obesity § ophthalmology § regenerative medicine § spine § tissue engineering § wound management ‡ View Comments °

Diabetes market by segment size and growth, U.S. and worldwide

The U.S. market for products in the management of diabetes represents roughly 38% of a $41 billion global annual market. Products in the market are currently comprised of blood glucose monitors, lancets and test strips, continuous blood glucose monitors, insulin, insulin pumps, syringes and other insulin delivery devices and anti-diabetic drugs.  The most significant growth in this market (U.S. and worldwide) is in continuous blood glucose meters, insulin pumps and anti-diabetic drugs.

 

Source: MedMarket Diligence, LLC; Report #D510, "Worldwide Diabetes Management Market, 2009-2010."  Available for download at link.

Diabetes market by segment size and growth, U.S. and worldwide
Posted 20 August 2010 † P. Driscoll § diabetes § market data § medtech ‡ View Comments °