Healthcare and medical technology ups and downs through 2009/2010

Looking at the course of developments — in the healthcare reform "debate" (as it were) and medical technology — it is not a huge leap of judgment to make the following predictions for the ups and downs of healthcare overall and for specific medical technologies.

Predictions for the healthcare market

  1. A healthcare reform package will pass this year, but it will fall short of what anyone wants or fears (the U.S. will not have a government takeover of healthcare nor become a socialist state despite the outrageous hyperbole flying around and the constrained legislation will do little to address the problems in healthcare).
  2. Through 4Q 2009, startup and early stage medtech company failures will begin to abate, while new company formations will ramp up. 
  3. Investment and manufacturing will pick up in healthcare.  Mid-size and larger companies’ hiring will lag the hiring rate (and relative amounts) of startup and early stage hiring.  By year-end 2009, investment will see a BIG uptick at startups, early stage and later medtech companies. 
  4. Regulatory, liability and other adverse scrutiny of medical device, pharma and biotech will reach a fever pitch into late 2009, early 2010.
  5. Despite the investment and hiring constraints at mid-size and larger medtech companies, stock prices will steadily rise through year-end and into 2010.

In terms of specific technology forecasts…

  1. Stem cell therapy developments and advances will begin to appear at a startling rate in late 2009.
  2. The coronary stent market will become increasingly fragmented as new DES products reach the market.
  3. Traditional general surgical technologies (e.g., "open" procedures") will become rare, eclipsed by single port or incisionless laparoscopy and NOTES procedures.  Robotic surgery will continue to draw more headlines than sales.
  4. Obesity devices and drugs will be one of the most active areas of medical technology developments through 2010 and beyond.
  5. Despite the intuitive appeal of diagnostic technologies (especially imaging technologies) for preventive medicine, there will be considerable pressure to restrict their use due to their contribution to healthcare costs.

More positive data on drug-eluting stents compared to bare metal stents

A meta-analysis by the Cardiovascular Research Foundation, and published in the June 15 edition of Circulation, of 56 studies that covered 190,000 patients revealed unambiguous benefits for use of drug-eluting stents (DES) instead of bare metal stents.

  • DES resulted in a reduction in death from no difference (meta-analysis of 22 randomized trials) to a 22% reduction (34 study observational meta-analysis)
  • DES resulted in a reduction in MI from no difference (meta-analysis of 22 randomized trials) to a 13% reduction  (34 study observational meta-analysis)
  • DES yielded a greater than 50% decrease in subsequent target vessel revascularization procedures

Study authors indicated that these findings are consistent with both on-label and off-label use of DES.


Drug eluting stents represent a $4.7 billion worldwide market, while the bare metal stents market stands at $2.7 billion.  See the MedMarket Diligence Report #C245, "Worldwide Drug-Eluting, Bare Metal and Other Coronary Stents Market, 2008-2017." (Published May 2009.)

Over 50 companies active in drug-eluting stent market development

In spite of arguments contesting whether bare metal or drug-eluting stents perform better, drug-eluting stents are here to stay and are still used in the majority of stent implantations. In fact, a plethora of studies have shown that DES can improve mortality rates and reduce the need for target vessel revascularization (TVR) compared with BMS.

We track no fewer than fifty-two (52) companies active in the drug-eluting coronary stent market, with products on the market or in various stages of development.  Below is a snapshop of the table from our May 2009 report.

 

stent-table-clipped2

Source: Report #C245, "Worldwide Coronary Stent Market."

The global market for drug-eluting coronary stents is approaching $5 billion, creating an enormous incentive for innovative companies to target the revenues and shares of early DES entrants Johnson & Johnson, Boston Scientific and Abbott.

 

SYNTAX: Percutaneous Coronary Intervention (PCI) compared to Coronary Artery Bypass Grafting (CABG)

This is one of the largest clinical trials comparing PCI (with DES) with CABG. Results presented at TCT 2008 found no significant difference in treatment outcomes of patients who were stented compared with those who underwent coronary artery bypass grafting. Also at TCT 2008, Boston Scientific’s next-generation Liberte stent was shown to have high marks for safety and efficacy when used to treat patients with high-risk lesions or preexisting comorbid conditions (e.g., prior stroke, heart attack, or chronic renal disease). After one year, the composite MACE rate for Liberte was 4.4% and in-stent thrombosis was 0.8%.

SYNTAX results published in 2009 (Lange and Hillis, New England Journal of Medicine, 360:1024-1026, March 5, 2009) found that PCI with stenting did not result in a higher risk of heart attack or dying. In fact, PCI patients were shown to be a decreased risk of stroke even while they were more likely to need additional therapy than bypass patients. In conclusion, while study authors said that CABG remains the gold standard for patients with severe coronary artery disease, PCI proponents also supported use of PCI in some patients, leaving the medical community in debate as to which therapy is preferable. The SYNTAX study results presented a clear picture of the benefits and disadvantages of both PCI and CABG. The study involved 1,800 patients treated at 85 medical centers in the United States and Europe. All patients presented with severe, untreated three-vessel disease or left main coronary artery disease and were randomly assigned to CABG or stenting. Overall, extensive patients had a 17.8% risk of an adverse outcome, compared with 12.4% for bypass patients. The two groups had similar risks for death and heart attack but bypass patients were more likely to suffer stroke (2.2% versus 0.6% of PCI patients). In addition, stunted patients were more likely to require revascularization (13.5% versus 5.9% of bypass patients). Principal Investigator Patrick Serruys reported that a subsequent analysis found bypass surgery to be preferable for rough two-thirds of patients while stenting was preferable for the remaining one-third. The study was sponsored by Boston Scientific.


The MedMarket Diligence report #C245 details fifty (50) different clinical trials and registries covering stents and related technologies and clinical applications.

 

Beyond drug-eluting and bioresorbable stents

In addition to bare metal, drug-eluting and absorbable stents on the market or under development for the treatment of coronary artery diseases, innovative companies have developed other types of stents to treat cardiovascular disease. These include bioactive coatings, antibody coatings, biomimetic coatings, hydrophilic coatings, titanium-nitride-oxide coatings, pericardium-covered stents, radioactive stents, synthetic graft alternatives, tissue engineered coatings, stents with designs that also provide embolic protection and other bioactive coatings that attract the patient’s endothelial cells to speed recovery following stent implantation, or other coatings that improve the biocompatibility of the stents.

As a result of these innovations, new stent (or other anti-restenotic revascularization technologies, as the case may be) will be introduced to the market over the ten-year forecast period that will find varying degrees of success in penetrating existing caseload or tapping new caseload.

The thrust of development beyond drug-eluting or even bioresorbable stents will be to capture and integrate an understanding of atherosclerosis, flow dynamics, inflammatory response, cellular and tissue development and other dynamics within the lumen prior to, during and subsequent to any interventional procedure.  Highlighting a shift in development for clinical field dominated by device technologies, more developments emerging from pharma and, especially, biotech research will impact product development in the treatment of coronary artery disease.  In this trend, it is conceiveable  that pharma and/or biotech solutions to ischemic heart disease will, within 10-15 years advance to the point of relegating device technologies to even a relatively minor market share.

For now, however, device and drug-device hybrid technologies have provided a sufficiently competitive challenge to coronary artery bypass grafting and have set the stage for the coronary stent market to cross $10 billion in annual sales in less than ten years.


Data is drawn from MedMarket Diligence, LLC; Report #C245

Drug-eluting, bare metal and absorbable stents segment growth, 2009 and 2017

stents-by-segmentAngioplasty for the revascularization of blocked coronary arteries gave way in the evolution of clinical practice to the adjunctive use of bare metal coronary stents, but due to a high frequency of restenosis bare metal stents gave way to drug-eluting stents (DESs) in 2003 (J&J/CYPHER, followed in 2004 by Boston Scientific’s TAXUS, and soon followed by DES products from Medtronic, Abbott Vascular and a host of others).  While issues of late stage thrombosis in DESs were a brief setback for their sales in 2005-06, they have only modestly recovered, stimulating the further development of technologies to result in revascularized lumens with a minimum of complications (while also giving bare metal stents a persistent toehold on the coronary stent market). Emerging stent or other anti-restenosis technologies in percutaneous coronary intervention include a range of absorbable stents, as well as drug-eluting balloons.

Needless to say (but we will anyway), the coronary stent market (as well as the broader market for treatment of coronary artery disease, encompassing a variety of coronary artery bypass technologies and procedures) remains a dynamic arena for medtech development.


Drawn from Report #C245:  "Worldwide Coronary Stents Market, 2008-2017."

Cardiovascular Disorders Applicable for Stent Implantation

Cardiovascular disease includes high blood pressure, coronary heart disease (myocardial infarction, angina pectoris), heart failure, stroke, and congenital cardiovascular defects. Roughly 80 million Americans have one or more of these types of heart disease. Of those, more than 38 million are greater than 60 years of age.

Cardiovascular disease is the leading cause of death worldwide and is responsible for 35% (864,480) of all deaths in the United States and 30% (17.5 million) of all deaths globally. The exhibit shows the rates of death attributed to cardiovascular disease and coronary heart disease. For men ages 35–74, the United States ranks sixteenth in cardiovascular deaths; for women ages 35–74, the United States ranks thirteenth. 

 

International Death Rates Per 100,000 Population
for Total Cardiovascular Disease and Coronary Heart Disease for the Top 20 Countries
 
Men, ages 35–74
 
Country

CVD Deaths

CHD Deaths

Russian Federation (2002)

1,555.2

835.0

Bulgaria (2004)

915.6

273.3

Romania (2004)

770.0

314.3

Hungary (2005)

709.7

384.7

Poland (2005)

517.3

201.3

Czech Republic (2005)

454.7

224.8

China, Rural (1999)

413.4

64.3

Argentina (2001)

405.9

119.8

China, Urban (1999)

389.0

105.7

Colombia (1999)

331.3

168.2

Scotland (2004)

327.3

220.6

Finland (2005)

311.2

193.9

Greece (2004)

306.7

164.8

Belgium (1997)

289.3

143.0

Denmark (2001)

285.7

141.8

United States (2005)

283.3

169.4

Northern Ireland (2004)

281.7

194.4

New Zealand (2001)

273.6

181.2

Germany (2004)

270.8

142.2

England/Wales (2004)

262.8

168.9
 
Women, ages 35–74
 
Country

CVD Deaths

CHD Deaths

Russian Federation (2002)

659.2

288.1

Bulgaria (2004)

434.6

100.4

Romania (2004)

403.1

134.3

Hungary (2005)

291.1

118.1

China, Rural (1999)

279.3

40.9

China, Urban (1999)

273.4

71.1

Colombia (1999)

229.9

94.7

Poland (2005)

201.8

59.6

Czech Republic (2005)

200.0

82.3

Argentina (2001)

174.2

35.2

Mexico (2001)

166.0

69.0

Scotland (2004)

153.9

80.6

United States (2005)

145.3

69.6

New Zealand (2001)

135.2

74.9

Northern Ireland (2004)

129.2

66.0

Denmark (2001)

127.3

51.0

Belgium (1997)

126.4

44.0

Greece (2004)

125.5

43.1

Portugal (2003)

123.2

35.0

England/Wales (2004)

117.0

55.4
 
Note: Data shown is most recent year available, revised 2008
 
Sources: The World Health Organization, NCHS, and NHLBI
 

The above is an excerpt from MedMarket Diligence report #C245, "Worldwide Market for Drug-Eluting, Bare and Other Coronary Stents, 2008-2017." April 2009

 

Worldwide coronary stents market

The global market for drug-eluting, bare and bioresorbable stents for the treatment of coronary artery disease is in a "growth and proliferation" phase, as the market for these devices is growing steadily through application to growing patient caseload, and as the number of companies with approved products or products in development multiplies.

The bulk of interest in this market continues to reside in drug-eluting stents for their ability to prevent the high rates of restenosis seen with initially marketed stent designs.  And with the "late stage thrombosis" concern of these stents an apparently temporary blip in the technologies’ prospects, the market is on a very strong growth track.

Over 75 companies are active in this field, encompassing not only drug-eluting stents but also bare metal stents and bioresorbable stents.  While bare metal stents have been eclipsed by drug-eluting stents, the use of different metals, shapes and other innovations are being pursued to minimize the tendency of bare stents to induce an inflammatory or other response leading to restenosis.  Similarly, bioresobable stents represent another alternative to drug-coating in minimizing restenosis, or offer other benefits, by degrading over time to leave, ideally, a recanalized lumen that free of not only restenosis but stent as well.

c245-cvrThe worldwide coronary stent market is the subject of the May 2009 report by MedMarket Diligence, described below:

This report details the worldwide market for the use of coronary stents in the treatment of coronary artery disease. The report assesses the treatment of coronary artery disease by alternative treatment methodologies (percutaneous intervention with or without stenting, coronary artery bypass grafting alternatives and other medical/surgical treatment options), with estimated current/forecast caseload across treatment types. The report details currently approved coronary stents, providing data on current and forecast impact on the market. The report also details the current state of product development in bare stents, drug-coated or drug-eluting stents and bioabsorbable stents in coronary applications and details the products under development, the anticipated timeline and impact of their market introduction. The report assesses the current and ten-year forecast global market for coronary stents, with segmentation by U.S., Europe, Asia/Pacific and Rest of World. The report provides competitor market shares by these geographic regions. The leading and key emerging coronary stent manufacturers are profiled with current product offerings, development status and market strengths/advantages.

The report is described in detail, with table of contents and list of exhibits here.

 

Bare metal coronary stents: still active worldwide

Lest anyone believe that drug-eluting coronary stents have taken over the acute myocardial infarction world, a good number of companies are active in the development and marketing of bare metal stents.

See a list of manufacturers below, drawn from the MedMarket Diligence Report #C245, "Worldwide Market for Drug-Eluting, Bare and Other Coronary Stents, 2008-2017."

Aachen Resonance GmbH
Abbott Vascular
amg International GmbH
Atrium Medical Corp.
Balton
Blue Medical Devices
Cappella Inc.
CID (Carbostent & Implantable Devices) SRL (Formerly Sorin Vascular Therapy)
CorNova
eucatech AG
EuroCor (owned by Opto Circuits)
Global Therapeutics (Cook Medical)
Hexacath
ICON Interventional
InTek
Invatec
Medinol
Medlogics Device Corporation (MDC)
Medtronic Vascular
Minvasys
MIV Therapeutics (genX formerly made by Biosync Scientific)
Neovasc
OrbusNeich
Sahajanand Medical Technologies
TriReme Medical
Tryton Medical
 

Clinical trials on coronary stents (drug-eluting, bare, resorbable)

There is a wide range of clinical trials evaluating drug-eluting, bare, and resorbable coronary stents for their safety, efficacy and performance.  Below are many of the key trials in process or completed.

 

ABSORB
HORIZONS-AMI
ARRIVE II Registry
ISAR, ISAR-TEST-2
ARTS
LONG DES
AXXESS PLUS
NOBLESS
BASKET
NOBORI
BBC ONE
NORDIC
CARE
OLYMPIA Registry
COREL
PASSION
COSTAR
PREPARE
COURAGE
PROGRESS
CUSTOM
RESOLUTE
DEScover Registry
RESORB
DIRECT
REWARD Registries
DIVERGE
SERIES
e-HEALING
SIMPLE Registries
EASTER Registry
SIRIUS, E-SIRIUS, C-SIRIUS
ENDEAVOR
SORT-OUT III
ETHOS
SPIRIT
EuroSTAR
STEALTH
EVENT Registry
STEMI
FAME
STENT Registry
GENESIS
SVELT
FOCUS
TAXUS
HEALING
TYPHOON

Source: Report #C245, "Worldwide Coronary Stents, 2009-2018."


These trials are described in the business market analysis from MedMarket Diligence, LLC, Report #C245, "Worldwide Market for Drug-Eluting, Bare and Other Coronary Stents, 2008-2017," publishing March/April 2009.

This report details the worldwide market for the use of coronary stents in the treatment of coronary artery disease. The report assesses the treatment of coronary artery disease by alternative treatment methodologies (percutaneous intervention with or without stenting, coronary artery bypass grafting alternatives and other medical/surgical treatment options), with estimated current/forecast caseload across treatment types. The report details currently approved coronary stents, providing data on current and forecast impact on the market. The report also details the current state of product development in bare stents, drug-coated or drug-eluting stents and bioabsorbable stents in coronary applications and details the products under development, the anticipated timeline and impact of their market introduction. The report assesses the current and ten-year forecast global market for coronary stents, with segmentation by U.S., Europe, Asia/Pacific and Rest of World. The report provides competitor market shares by these geographic regions. The leading and key emerging coronary stent manufacturers are profiled with current product offerings, development status and market strengths/advantages.