Growth of worldwide cervical artificial disc market

In spine surgery, one of the fastest growing medical technology market segments is cervical artificial discs. On a global basis, sales will grow at a double digit annual rate, but the bulk of the growth will ensue from sales of cervical artificial discs in the U.S., which will be gaining approvals over the coming decade that will result in the U.S. gaining an ever greater share of the global market.  Below is the distribution of the cervical artificial disc market by country from 2010 to 2020.

Source:  MedMarket Diligence Report #M520, "Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities, 2010-2020".

Advanced wound closure: still a growth market

The market for advanced wound closure and securement technologies continues to evolve at a steady pace.  This $10 billion+ market is comprised of sutures, staples, other mechanical wound closure, tapes, hemostats, fibrin and other sealants, high strength medical adhesives, and post-surgical adhesion prevention products.

Source: MedMarket Diligence, LLC; Report #S180.

Despite the fact that this seemingly represents a lot of products operating in the same "space", there are in fact a large number of active companies (we conservatively profiled 104 different companies).  This reflects the fact that this market still has many active growing segments (envision the size of the "sutures, staples" segment in the pie above as representing, literally, a large slice of pie of interest to companies who have yet only taken a few bites out of the other slices).  Traditional wound closure and securement, including sutures, staples and the more recent mechanical closure, still represents a very large (almost $8 billion) market that is being targeted by a growing portfolio of advanced products that have demonstrated much potential to replace, or at least augment, these established wound closure technologies.

During the 1980s, the United States, by virtue of its demonstrated aversion to the risk represented by the many blood-derived advanced wound closure technologies (e.g., fibrin and other sealants and hemostats), fell behind other country markets that were more amenable to these advanced products. But blood-screening methods, purification and other methods addressed this risk to the satisfaction of the markets, such that the current market for these products now represents the more typical global market in which the largest single national market for advanced wound closure and securement products is the U.S.

 

Source: MedMarket Diligence, LLC; Report #S180.

Costs Associated with Spinal Disorders and Treatment

One of the most device-intensive areas of medical technology — one with few effective clinical alternatives — is spine surgery.  This is one medtech arena that, although not immune to pressures for cost containment, is certainly highly resistant to efforts at cost reduction, primarily because of the lack of effective alternatives.  Below is an excerpt from the MedMarket Diligence Report #M520, "Worldwide Spine Surgery: Products, Technologies Markets and Opportunities, 2010-2020".

Methodologies vary; reliability of statistics varies; but there is no question that low back pain and related spine treatment costs are a significant drain on country and global healthcare budgets. These tremendous costs include lost productivity and income from work, the expense of medical, rehabilitation and surgical interventions, and the costs of disabling pain and limited daily function. In the USA alone, estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Examining 1998 statistics (which at the time were the most recent available), Luo and colleagues found total health care expenditures incurred by individuals with back pain in the USA to have reached $90.7 billion; total incremental expenditures attributable to back pain among these persons were approximately $26.3 billion. (Luo X, Pietrobon R, Sun S, Liu G, Hey L. Estimates and Patterns of Direct Health Care Expenditures Among Individuals with Back Pain in the United States. Spine. 2003; vol. 29, no. 1:79-86). On average, individuals with back pain incurred health care expenditures that were about 60% higher than individuals without back pain ($3,498 vs. $2,178). This data points to back pain as one of the most expensive diseases affecting the US population. Rates of spinal surgery in the USA have increased sharply over the last twenty years, and there is documented evidence of enormous geographic variation in the rates of spine surgery.

Indirect costs related to days lost from work are substantial (Ann Intern Med. 2007 Oct 2;147(7):478-91. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Chou R, et al.) Back pain is second only to upper respiratory conditions as the stated cause of work loss. The costs for treatment and compensation for LBP in industry may be greater than the total amount spent on all other industrial injuries combined. In a sense, the 80/20 rule seems to apply here: most of the costs, about 80%, are incurred by about 20% of the LBP patients.

According to a report from the Healthcare Cost and Utilization Project (HCUP Statistical Brief #105, February 2011), inpatient stays for back problems cost more than $9.5 billion in 2008, making it the ninth most expensive condition treated in hospitals. There were about 3.4 million emergency department visits by patients with back problems, and over 663,000 inpatient stays in hospitals for back surgery or other back disorders. The report found that adults ages 18-44 were most likely to require emergency department care for back pain and seniors 65-84 were the least likely.

Data from the European survey on working conditions (http://osha.eu.int) reveal that 30% of European workers suffer from back pain, leading the list of all reported work-related disorders. While in most cases patients make a full recovery from an episode of low back pain (according to the EU OSHA site, 60-70% recover within 6 weeks, 70-90% within 12 weeks), this still adds up to a significant amount of time lost from work. To make matters worse, the recurrence rate for low back disorders is very high. In one year the recurrence rate is estimated to be 20-44%; over a lifetime recurrences of up to 85% are reported.

Although very common across all types of industries and jobs, several studies have demonstrated that low back disorder rates are particularly prevalent in certain types of industries and working groups, including: agricultural workers; construction workers; carpenters; drivers including truck and tractor operators; nurses and nursing assistants; cleaners, orderlies and domestic assistants. It appears that the prevalence of low back disorders in the European Union is similar among men and women.

Estimates from EU Member States of the economic costs of all work-related ill health range from 2.6 to 3.8% of GNP, although precise figures do not exist. However the figures may be higher as the true societal costs are difficult to estimate. A study from the Netherlands estimated the total cost of back pain to society to be 1.7% of the gross national product in 1991 (Work-related Low Back Disorders, Op De Beeck, R. and Hermans, V., European Agency for Safety and Health at Work, 2000, ISBN 92-95007-02-6).

According to Bekkering et al., (Development of an implementation strategy for physiotherapy guidelines on low back pain. Australian Journal of Physiotherapy, 2003, Vol 49), about 85% of people with back pain take less than seven days off, yet this accounts for only half of the number of working days lost by back pain. The rest is accounted for by the 15% who are absent for over one month.

A study by Dagenais et al. (Dagenais S, Caro J, and Haldeman S, A systematic review of low back pain cost of illness studies in the United States and internationally. The Spine Journal, 2008. 8(1): p. 8-20) estimated that the total annual cost of low back pain in Europe was £12.3 billion in 1998 and that 87 per cent of these costs were indirect. A 2001 study in Australia by Walker, Muller et al. (Walker BF, Muller R, Grant WD (2003) Low Back Pain in Australian Adults: The Economic Burden, Asia Pac J Public Health 15:79-87) puts the annual cost of back pain at $9.1 billion, being $1 billion in direct costs and $8.1 billion in indirect costs. This amounts to $474 per person in the total Australian population.

Incidence and Prevalence of Morbid Obesity

Morbid obesity is associated with a substantially increased risk of morbidity and mortality from chronic health conditions, such as diabetes, hypertension, cardiovascular disease, and cancer, and it has been linked to multidimensional impairments in health-related quality of life and psychosocial well-being. The prevalence of morbid obesity, also known as class III or extreme obesity (body mass index (BMI) 40 kg/m2), is rising twice as fast as the prevalence of obesity (BMI 30 kg/m2) in the US. Researchers estimate that at least 5% of the total population, or about 15,350,000 people, are morbidly obese, i.e. these individuals have a BMI > 40 kg/m2. Between 1986 and 2000, the prevalence of severe obesity (BMI ≥ 40 kg/m2) quadrupled from one in two hundred Americans to one in fifty. Extreme obesity (BMI ≥ 50 kg/m2) in adults increased by a factor of five, from one in two thousand to one in four hundred.

From 2000 to 2005, the prevalence of obesity (BMI > 30) increased by 24%. However, the prevalence of a BMI> 40, which equates to about 100 pounds overweight, increased by 50% and the prevalence of a BMI> 50 increased by 75%, two and three times faster, respectively. The heaviest BMI groups have been increasing at the fastest rates for 20 years. In addition, the prevalence of clinically severe obesity is increasing at a much faster rate among adults in the USA than is the prevalence of moderate obesity. This is consistent with the public health idea that the population weight distribution is shifting.

At this time, gastric bypass is the only known effective treatment for morbid obesity, but investment and research into pharmaceutical options remains active, despite the regulatory challenges, and device options are gaining expanded indications.


For comprehensive global market analysis of the products, technologies and companies in the clinical management of obesity, see "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", report #S835.

Latin America: Markets in Advanced Wound Closure

In the Americas, the U.S. dominates all medtech markets, but as manufacturers seek the "low hanging fruit" of readily available market opportunities, Latin America rises to the fore, with its large populations, proximity to existing distribution, lower manufacturing costs and other advantages.  Brazil and Mexico are the biggest opportunities as reflected in the revenues generated there in the sale of medtech products.

The large and growing market for advanced wound closure products — encompassing hemostats, fibrin sealants, high-strength adhesives/glues and post-surgical adhesion prevention — is reflected in Latin America.  Below is the market for these advanced products in Latin America:

Source: Report #S180, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015".

A similar distribution of wound closure revenues across these countries is found for traditional wound closure products (sutures, staples and other mechanical closure), with the dominant category being sutures and staples.

Spinal disease and trauma map

Diseases and disorders of the spine are numerous and complex.  The spine itself is a complex anatomy with structure and function that are susceptible to a wide range of conditions, whether by trauma or disease, that have been the focus of continued development of medical technology with the purpose of restoring (or approximating) as much of that structure and function as possible.

For the sake of illustration, below is a map of the diseases and disorders (including trauma) of the spine:

Source: Pending MedMarket Diligence Report #M520, "Worldwide Spine Surgery 2011: Products, Technologies, Markets & Opportunities, Worldwide, 2010-2020." (Publishing May/June 2011)

Radiofrequency ablation market continued growth strong globally

As mentioned earlier, the radiofrequency (RF) market is one of the largest in the ablation device market sector. Its clinically proven uses are many: general surgery, cardiovascular (frequently off-label), orthopedics, cancer therapy and aesthetics. From electrosurgery and small joint repair, to treatment of BPH, and from treatment of cardiac arrhythmias, to body contouring, RF is one of the strongest markets in ablation.

In 2009 the market for RF ablation technologies was worth about $1.4 billion. By 2019 it is forecast to increase to five times as large. The market is expected to experience such high growth due in large part to its clinically-proven efficacy. The aging population will also be a driver in the use of RF, as more people experience cardiovascular irregularities which can be treated with RF ablation.

Electrophysiology (EP) is one specialty which helps to drive this market in the area of cardiovascular usage. EPs consistently cite procedure time as the most significant barrier to increased use of ablation therapy to treat cardiac arrhythmias. Hence, they are very interested in any ablation systems or procedures which can streamline the workflow in the EP lab.

There are several very large companies vying for position in this market. Covidien is the market leader, followed by Medtronic and Boston Scientific. St. Jude Medical and Smith & Nephew are also strong in the market.

The Americas accounted for a little over half of the revenues in 2009, followed by the EU. Asia-Pacific and ROW account for the remaining share of the market less than a quarter of the total.

The Americas are expected to show strong growth in the RF market. Much of the enthusiasm for RF, especially for cardiovascular use, now stems from the US. The EU has been using RF to treat atrial fibrillation (AF) and other arrhythmias longer than the US in part because it is easier to obtain the CE mark and to then market devices in the EU, than it is to get FDA clearance to market in the US, especially for a new indication. Now, with the approval of Biosense Webster’s RF catheter for AF for the US market, other devices will be following, and the segment in the Americas will grow. The other uses of RF, such as for treating certain cancers and BPH, will increase as well, as all of the RF boats rise with the cardiovascular tide.

The EU market, although smaller in 2010, will demonstrate aggressive market growth to quadruple, reaching nearly $2.1 billion annually.

The Asia-Pacific market, although smaller than either the Americas or the EU in 2010, will be growing more rapidly than either. RF in Asia-Pacific is forecast to grow at a better than 20%, driven by the Japanese market’s aging populations, supplemented by purchasing by Indian and Chinese hospitals and specialists.

The "Rest of World" market for RF ablation technologies will also see strong growth in revenues, again to the modality’s proven efficacy in treating a wide array of disorders. Although adoption of RF in these markets will not be as aggressive as in the developed markets, the double-digit annual growth will demand attention to RF manufacturers seeking additional revenue streams.


See "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities", report #A145.

Obesity Devices Breaking Ground in an Emerging Landscape

The landscape for obesity treatments is largely characterized by a smattering of drugs, bariatric surgery and an emerging array of device options.  The landscape itself is also changing steadily with surging numbers of patients globally fitting the diagnosis of "obese", regardless of the shifting definition of what constitutes obesity.  Over the next few years, the emergence of newly approved clinical options will produce a distribution of growing revenue streams for drug, device and other manufacturers and clinicians.

Considering only the device side of obesity, which is proving to be much less susceptible to the whimsy of the FDA than are drugs for obesity, the next few years will indeed see the emergence and market growth of many new products. Moreover, the dynamics in the regulation and reimbursement (and other dynamics) across different geographies will further produce differences in market dynamics.

Below is illustrated the 2011 and the 2019 landscape for obesity devices globally by major geographic region.

Source: Report #S835: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019." 

Tissue engineering and cell therapy: applications, technologies and global markets

The market for tissue engineering and cell therapy products is set to grow from a respectable $8.3 billion in 2010 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.

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, industry investments (or lack thereof), and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. Changes in the U.S. government’s federal funding of embryonic stem cell research has given a potentially critical mass of researchers increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

regional-forecast

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

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, stricter regulations in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a very robust 20% annually.


MedMarket Diligence’s Report #S520 remains the most comprehensive and credible study of the current and project market for products and technologies in cell therapy and tissue engineering.

Metabolic syndrome and obesity

Below is an excerpt from "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019" (Report #S835, MedMarket Diligence, LLC).

Metabolic syndrome (MetS) is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. It affects one in five people, and prevalence increases with age. Some studies estimate the prevalence in the USA to be up to 25% of the population. MetS is composed of an array of factors including insulin resistance, obesity, dyslipidemia, hypertension, and greater risk for diabetes, heart disease and stroke. These are all related to obesity, although recent research indicates that these may be related to the body’s attempts to protect organs from excess fat.

In a review in the March 9th, 2010 issue of Trends in Endocrinology and Metabolism, Roger Unger, MD, University of Texas Southwestern at Dallas, suggested that obesity may not be all bad: it may be the body’s way of storing lipids in a less harmful manner, i.e. in fat tissue, in order to protect the body’s organs from the toxic effects of excess lipids. When the lipids become too numerous for the fat tissue to handle, then those fats spill over into places where they can produce toxic effects. These effects trigger the cascade of symptoms known as metabolic syndrome.

The body’s resistance to leptin, known for its appetite-suppressing abilities, is at the center of the shift from protective obesity to metabolic syndrome. Leptin is also responsible for partitioning fat in the body; but as fat stores grow, this partitioning can only go so far before resistance sets in, and the fat starts being stored in and harming other organs. The researchers found that most humans develop leptin resistance as they pass their reproductive years, meaning that everyone needs to watch their diet and exercise, or start on the path to MetS.

Definitions of MetS differ. There are no well-accepted criteria for diagnosing the metabolic syndrome. The WHO criteria (1999) require the presence of diabetes mellitus, impaired glucose tolerance, and impaired fasting glucose or insulin resistance, in addition to at least two of the following:

  • Blood pressure: ≥ 140/90 mmHg
  • Dyslipidemia: triglycerides (TG): ≥ 1.695 mmol/L and high-density lipoprotein cholesterol (HDL-C) ≤ 0.9 mmol/L (male), ≤ 1.0 mmol/L (female)
  • Central obesity: waist:hip ratio > 0.90 (male); > 0.85 (female), or body mass index > 30 kg/m2
  • Microalbuminuria: urinary albumin excretion ratio ≥ 20 µg/min or an albumin:creatinine ratio ≥ 30 mg/g

The criteria proposed by the American Heart Association’s National Cholesterol Education Program (NCEP) are widely used. The American Heart Association and the National Heart, Lung, and Blood Institute recommend that the metabolic syndrome be identified as the presence of three or more of these components:

  • Elevated waist circumference:
    • Men — Equal to or greater than 40 inches (102 cm)
    • Women — Equal to or greater than 35 inches (88 cm)
  • Elevated triglycerides: Equal to or greater than 150 mg/dL (1.7 mmol/L)
  • Reduced HDL (“good”) cholesterol:
    • Men — Less than 40 mg/dL (1.03 mmol/L)
    • Women — Less than 50 mg/dL (1.29 mmol/L)
  • Elevated blood pressure: Equal to or greater than 130/85 mm Hg or use of medication for hypertension
  • Elevated fasting glucose: Equal to or greater than 100 mg/dL (5.6 mmol/L) or use of medication for hyperglycemia

Report #S835 on the worldwide market for obesity drugs and devices is described below and a link:

This report is a detailed market and technology assessment and forecast of the products and technologies in the clinical management of obesity (bariatrics). The report describes the current and projected patient population in obesity, detailing their incidence worldwide, with available incidence by country for the U.S., major European countries, major countries in Asia/Pacific (including Japan, China, India and Australia), the clinical practices in their management to encompass surgical approaches, medical supervised severely restricted diets, drug therapies, OTC treatments, biopharmaceuticals, non-pharmacologic approaches and weight maintenance approaches. The report describes clinical trends in the management of the obese. The report details the products on the market and the status of those in development for bariatric surgery, drug therapy, gastric stimulation devices, brain stimulation devices, combination therapies and genetic therapy and other therapies under development, and will provide current and worldwide market forecasts (2009-2019) separately for pharmaceuticals (with separate segment forecast data for satiety, malabsorption, appetite suppression and combination drugs) and devices (with separate segment forecast data for stomach restriction artificial fullness, malabsorption, gastric emptying and appetite suppression), with current (2009) market shares of the leading competitors in each segment. (The report addresses the challenges to obesity drug approval, such as the FDA's February 2011 rejection of Orexigen's Contrave, and considers the realistic prospects for obesity drugs and their changing opportunities to succeed in the U.S. and international markets.) The report profiles the 45 leading competitors, detailing current and potential position in the market, their products and their market strengths and likelihood of future success.