April 20, 2010 04:38 PM Eastern Daylight Time  Newest version of the company’s Internet-based Document Management and Document Sharing Software

NEW YORK–(BUSINESS WIRE)–Target Health Inc., an industry-leading eCRO, has announced the release of Target Document® version 1.5. Target Document® is a cost-effective, distributable, secure, user-friendly, 21 CFR Part 11 compliant, Internet-based, document sharing, distribution, and management system that allows users in any industry, depending on their roles and permissions, to post, share, electronically sign, and archive any electronic document within a Web browser. New features include advanced user management, access to recycle bin, parallel sign off of documents, manual backup of any folder, configuration of e-Signature text, document expiration dating, email alerts to all users, etc. According to Jules Mitchel, MBA, Ph.D., President of Target Health, “Target Document® eliminates the need to manage and distribute documents via email, saves paper and is ideal for vendors, CROs, clinical research sites, and Sponsors who want to transparently communicate among themselves in a secure environment. Dr. Mitchel added that in pharmaceuticals, “Target Document® allows for a paperless Trial Master File (TMF) and is part of the paperless eClinical toolbox of products available from Target Health.” The Target Health toolbox includes: Target e*CRF®, Target Health’s flagship EDC software, which has been used in over 200 clinical trials, including 18 regulatory approvals; Target Encoder® – which links directly into the Target e*CRF® database to encode MedDRA and WHODRUG terms; Target e*CTMS™ (Clinical Trial Management System)- which allows for Internet-based project management, across studies at one website ; and Target Newsletter® – which allows for a clinical trial newsletter with real time enrollment data and comments.

About Target Health Inc.

Established in 1993, Target Health Inc. has been providing advanced clinical trial technology for more than a decade. As a full service CRO, the company is dedicated to all aspects of regulatory affairs, clinical research, biostatistics, data management, strategic planning, and drug device development. The company’s client list is comprised of some of the most highly respected pharmaceutical companies as well as smaller biotechnology firms. Target Health is based in New York, NY.

For more information about Target Health and Target Document, go to www.targethealth.com.

Contacts

Target Health Inc.
Jules T. Mitchel, MBA, Ph.D.
President
212-681-2100 begin_of_the_skype_highlighting              212-681-2100      end_of_the_skype_highlighting
julesmitchel@targethealth.com

Permalink: http://www.businesswire.com/news/home/20100420007353/en/Target-Health-Unveils-Target-Document%C2%AE-Version-1.5%C2%A0%C2%A0

Device Designed to Mimic Natural Mechanism of Blood Sugar Control

GoogleNews.com, April 19, 2010, by Julie Steenhuysen  –  A test run of an “artificial pancreas” that monitors blood sugar and delivers both insulin and regulatory hormone called glucagon helped patients achieve near-normal blood sugar levels for more than 24 hours, U.S. researchers said on Wednesday.

The system — made up of a glucose monitor, two pumps and a laptop — is designed to better mimic the body’s natural mechanism of controlling both high and low blood sugar.

In previous tests of artificial pancreas systems that deliver only insulin, some patients have developed dangerously low blood sugar, known as hypoglycemia.

Adding small doses of glucagon, a hormone released by the pancreas to raise blood sugar levels, helped overcome this, according to the study published in the journal Science Translational Medicine.

After some adjustments to a sophisticated computer program that acts as the brain of the system, all 11 adults in the study had good blood sugar control without experiencing hypoglycemia, even after eating three high-carbohydrate meals.

“This is the first artificial pancreas device that has used both insulin and glucagon,” said Dr. Steven Russell of Massachusetts General Hospital in Boston, who helped lead the study.

The finding is the latest in what has become a race to develop a fully functioning artificial pancreas that can give patients with type 1 diabetes an automated way to control their blood sugar.

Type 1 diabetes is an autoimmune disease in which the body destroys its own ability to make insulin, rendering sufferers unable to properly break down sugar. People with the condition must frequently monitor and take insulin to regulate blood sugar and prevent diabetic complications such as eye damage, kidney failure and heart disease.

Devices like continuous glucose monitors, such as those made by Medtronic or Abbott Laboratories, that constantly track blood sugar and pumps that inject insulin help, but patients still risk hypoglycemia.

That is where glucagon comes in, Russell said. In people with type 1 diabetes, glucagon does not work properly. Building this into the system helps balance out both the highs and the lows of blood sugar control.

SURPRISE FINDINGS

The system was developed in the lab of Edward Damiano, a biomedical engineer at Boston University whose son David developed type 1 diabetes when he was a year old.

Damiano’s team developed the brains of the device, the computer program that constantly analyzes blood sugar and calculates when diabetics need a dose of insulin or glucagon.

Initial tests of the system revealed a surprise. While the computer program was based on recommended doses of the fast-acting insulin Humalog, made by Eli Lilly and Co, they discovered that many diabetics in their study process insulin much more slowly than expected.

Tweaks to the computer program fixed the problem but the issue demonstrates the complexities of treating diabetes.

In February, British researchers tested a similar system on 17 children and found it kept their blood sugar levels within the normal range for 60 percent of the time.

The Juvenile Diabetes Research Foundation has teamed up with Johnson & Johnson’s unit Animas, which makes insulin pumps, and DexCom Inc, which makes continuous glucose monitoring devices, to develop and test an artificial pancreas system.

GoogleNews.com, WebMD.com, by Lisa Nainggolan, April 20, 2010 (Washington, DC) — As widely expected, the US Institute of Medicine (IOM) is advising the FDA that it should set new federal standards for the amount of salt that food manufacturers, restaurants, and food-service companies can add to their products [1]. In its new report, issued today, the IOM explains that such a strategy would make it easier for American consumers to consume less sodium, because the vast majority of salt intake comes from prepared meals and processed foods.

As discussed in detail in a recent heartwire feature, a number of other countries have instituted policies to try to reduce the amount of salt in the diet of their whole populations, and many experts have been calling for the US to institute similar initiatives.

The report says the FDA has the authority to regulate salt as a food additive and is recommending that the agency should gradually reduce the maximum amount of salt that can be added to foods, drinks, and meals, so that consumers are unlikely to notice the change in taste.  Previously, salt has been treated as “generally recognized as safe,” and there have been no regulatory limits on its use as an additive, the report explains.

“For 40 years we have known about the relationship between sodium and the development of hypertension and other life-threatening diseases, but we have had virtually no success in cutting back the salt in our diets,” says the chair of the committee that compiled the report, Dr Jane E Henney (University of Cincinnati College of Medicine, OH).  “This report outlines strategies that will enable all of us to effectively lower our sodium consumption to healthy levels,” she notes in a statement [2]. 

Henney says the best way to accomplish this is to provide companies with “the level playing field they need so they are able to work across the board to reduce salt in the food supply.” But the committee appreciates that the FDA will need time to gather and assess sufficient data to determine what limits to set and what the incremental decreases should be. 

Taking this into account, the committee is recommending that restaurants, food-service firms, and food and beverage manufacturers should pursue voluntary sodium-reduction efforts in the meantime.

The IOM report was requested by Congress and sponsored by the US Centers for Disease Control and Prevention; the FDA; the National Heart, Lung, and Blood Institute; and the Office of Disease Prevention and Health Promotion of the US Department of Health and Human Services. 

References

  1. Henney JE, Taylor CL, and Boon CS, eds. Institute of Medicine. Strategies to Reduce Sodium Intake in the United States; Washington, DC: National Academies Press, 2010. Available here.
  2. National Academies. Press. FDA should set standards for salt added to processed foods, prepared meals [press release]. April 20, 2010. Available here.

American Academy of Neurology (AAN) 62nd Annual Meeting

April 20, 2010, by Caroline Cassels, (Toronto, Ontario) — Combining moderate physical exercise with computer use, even in late life, may help reduce the risk of mild cognitive impairment (MCI), new research suggests.

Presented here at the American Academy of Neurology 62nd Annual Meeting, the latest findings from the Mayo Clinic Study of Aging show the combination of these 2 activities had a benefit that was over and above the beneficial effect of either activity alone.

“Moderate physical exercise, such as brisk walking, biking, and swimming, may be beneficial in terms of reducing the risk of MCI, and we also know that mentally stimulating activities also reduce the risk of dementia or cognitive impairment. What our study showed is that when you combine moderate physical exercise and computer use there is an additive beneficial effect,” principal investigator Yonas E. Geda, MD, MSc, a neuropsychiatrist and an associate professor of psychiatry and neurology at the Mayo Clinic in Rochester, Minnesota, told Medscape Psychiatry.

A number of studies have shown that exercise reduces the risk for Alzheimer’s disease, and a recent study by Dr. Geda and colleagues published in the January 2010 issue of Archives of Neurology (2010;67:80-86) also demonstrated that any frequency of moderate exercise — which includes activities such as brisk walking, swimming, and cycling — performed in middle or late life also reduces the odds of developing MCI.

Another study also conducted by Dr. Geda and colleagues from the Mayo Clinic Study of Aging (MCSA) suggests mentally stimulating activities, such as craft activities (eg, quilting, knitting), reading books, playing games, and participating in computer activities, are associated with up to 50% decreased risk of developing MCI. These data were presented at the 61st annual conference of the American Academy of Neurology in Seattle, Washington, in April 2009.

In addition, the same team in the same study sample observed that increased caloric intake may increase the odds of developing MCI.

However, said Dr. Geda, it is not clear whether there is an added benefit when physical activity and mentally stimulating activities are combined after controlling for caloric intake and other relevant covariates.

Additive Interaction

To examine the joint effects of physical exercise and mental activity on the odds of developing MCI after adjusting for caloric intake, medical comorbidity, and other traditional confounders, the researchers conducted a case-control study derived from the population-based Mayo Clinic Study of Aging.

The study population included a sample of 926 elderly participants aged 70 to 90 years. Of these individuals, 817 were cognitively normal and 109 had MCI. Surveys gathering data on physical exercise cognitive activities and caloric intake for the previous year were administered.

Multivariable-adjusted analysis revealed that any frequency of moderate physical exercise in late life vs none and any computer use in late life vs none was associated with an odds ratio (OR) of 0.64 (95% confidence interval [CI], 0.42 – 0.98; P = .04) and 0.56 (95% CI, 0.36 – 0.89; P = .01), respectively.

In addition, the investigators found that compared with subjects who consumed 600 to 1526 calories per day, those who consumed 1526 to 2143 calories per day had a 7% increased risk of developing MCI (OR, 1.07; 95% CI, 0.61 – 1.88; P = .80), whereas those who consumed between 2143 and 6000 calories per day more than doubled their MCI risk (OR, 2.03; 95% CI, 1.21 – 3.41; P = .007).

The investigators also observed an additive interaction between moderate physical exercise and computer use (P = .01).

“This combined benefit of physical exercise and computer use is over and above the expected arithmetic sum of the two. This means you get a benefit from physical exercise and a benefit from mentally stimulating activities. Each of these is independently beneficial, but when you do them in combination the effect is even better,” said Dr. Geda.

Although researchers did not examine the type and duration of computer use, Dr. Geda said that unfortunately we did not collect the type and duration of the computer use.

Potential Mechanism

At this point the mechanism is unclear, he added. However, some researchers have suggested that mentally stimulating activities may enhance synaptic activity, whereas physical exercise may increase blood flow to the brain and the 2 in combination may have a synergistic effect. However, added Dr. Geda, at this point the mechanism remains speculative.

A major limitation of the study is its cross-sectional design, and therefore, said Dr. Geda, the findings need to be replicated in a prospective cohort study.

Although no clinical recommendations can be derived from this study alone, these results, in combination with the results of a growing body of literature, support the premise that there is value in “advising patients — even elderly adults — to be more physically and mentally active and to be mindful of their caloric intake,” he said.

Dr. Geda has disclosed no relevant financial relationships. The study was funded by the National Institutes of Health.

American Academy of Neurology (AAN) 62nd Annual Meeting: Abstract S44.004

April 20, 2010, by Robert Lowes — The US Food and Drug Administration (FDA) today launched a new Web site allowing people to track how the agency has regulated a catheter or a computed tomography (CT) scanner — from the approval process, to reports of errors or adverse events once the device is on the market, to a product recall.

The new Center for Devices and Radiological Health Transparency Web site, part of the agency’s transparency initiative, comes at a time when the FDA is crusading against excessive medical radiation, as well as responding to charges that device manufacturers have wielded excessive, behind-the-scenes influence in the regulatory process.

It is not as if the FDA has always maintained a closed set of books, however. The new Web site incorporates databases on such subjects as premarket approvals and 510(k) premarket notifications — the 2 means by which devices get a green light to go on the market — that the agency had already made public. New features now on the Web site include the Total Product Life Cycle database, which chronicles a device’s FDA history before and after it hits the market. Other new treasure troves of information are review memos on design changes of products that have already received premarket approval and a database for premarket approval clinical trials.

The Web site is the latest achievement of the agency’s transparency initiative, which grew out of a task force formed last year by FDA Commissioner Margaret Hamburg, MD. The task force has recommended various ways in which the agency can make information on FDA activities and decision-making “more transparent, useful, and understandable to the public,” as the task force phrased it.

Diana Zuckerman, PhD, president of the nonpartisan National Research Center for Women and Families, which specializes in health issues, said that transparency efforts such as the new FDA Web site contrast with the agency’s past reputation for making decisions “behind closed doors” in concert with manufacturers.

“People wondered how they made their decisions, and on what basis,” Dr. Zuckerman said.

FDA Regulation of Radiation-Emitting Devices Under Close Scrutiny

The new Web site will allow physicians, manufacturers, and agency critics to take a closer look at how the Center for Devices and Radiological Health regulates radiation-emitting devices, which have come under increased scrutiny in recent months. In February, the FDA unveiled a campaign to reduce unnecessary radiation exposure from CT scans, nuclear medicine studies, and fluoroscopy. The National Council on Radiation Protection and Measurements states that these 3 modalities are mostly responsible for nearly a 2-fold increase in nationwide exposure to ionizing radiation during the past 20 years.

The FDA solicited ideas for making CT and fluoroscopic equipment safer at a 2-day meeting in March, and in the process, it got an earful from Julian Nicholas, MD, a former FDA consulting scientist. Dr. Nicholas said his superiors decided not to renew his contract last fall after he blew the whistle on the radiation risks of a CT scanner that a manufacturer wanted to market for virtual colonoscopies. His remarks called to mind a series of letters that dissident FDA physicians and scientists wrote last year to the White House and Congress, depicting the agency as a “corrupt” institution full of managers who broke the law and suppressed scientific data to benefit private industry.

The campaign against excessive radiation continued earlier this month when the agency announced it was tightening its approval process for radiotherapy devices.

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 12th World Congress of Endoscopic Surgery

April 20, 2010, by Jennifer Monti — World renowned experts on robotics and virtual reality shared their perspectives on how advancements in technology are transforming the operating room from an environment dominated by human interactions to a space where the surgeon is a steward of robotic and virtual technologies that will improve surgical planning and outcomes.

In a symposium presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 12th World Congress of Endoscopic Surgery, hosted by SAGES and the Canadian Association of General Surgeons, National Harbor, Maryland, Mehran Anvari, MD, professor of surgery at McMaster University in Hamilton, Ontario, Canada, and Jacques Marescaux, MD, chairman, Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg, France, led a panel of experts in discussing innovations that are likely to affect surgical practice in the near future. Dr Anvari emphasized that “new technologies from information age discoveries are driving basic approaches in virtually all aspects of healthcare innovation.”

Virtual Imaging

Luc Stoler, MD, of the Research Institute Against Cancer of the Digestive System at the University of Strasbourg, emphasized that the fusion of virtual and real-time imaging will drive surgical planning in the near future and will play an active role during surgical cases. He explained that “virtual imaging of the patient is important because it offers great detail on where key structures are located in the actual patient. Through a visualization scope this map can be superimposed on the active surgical field, so it is evident where, for example, a blood vessel lies or how far out of the viewing field a tumor extends.”

The key challenge limiting this technology is its inability to adapt to patient movements, such as breathing and repositioning, that occur during surgery. Despite that, current systems have 2-mm accuracy in the liver, and 1- to 3-mm accuracy of virtual systems has been recorded in kidney surgery. Dr. Stoler compared use of this technology to the use of similar tools in flight planning and execution. “Flight patterns correct for wind,” he notes. “Why shouldn’t these planning and execution tools be able to correct for movements of the body?”

When Can Robotics Eliminate Surgery?

Rick Satava, MD, professor, Department of Surgery, University of Washington, Seattle, and expert on next-generation robotic systems, noted that these technologies are being developed to guide surgical planning and execution such that a surgeon may become more of a “general, guiding multiple robotic and virtual systems, rather than a soldier, executing each individual cut.” He reported that increasing attention is being given to technologies that can diagnose and treat injuries in the field. He reported on the development of an ultrasonography system that can detect internal bleeding with Doppler flow and deliver high-intensity frequency ultrasound powerful enough to coagulate bleeding vessels and remove the need for surgery in some cases.

ARAKNES Project

In addition, Sir Alfred Cuschieri, MD, director, Institute of Medical Science and Technology, University of Dundee, Scotland, focused on the ARAKNES (Array of Robots Augmenting the KINematics of Endoluminal Surgery) project of several European Union countries. The project aims at bringing inside the patient’s stomach a set of advanced biorobotic and microsystem technologies for therapy and surgery.

Future of Robotic Surgery: Pros and Cons

Meeting attendee Courtney Spear, MD, University of Colorado School of Medicine, Denver, noted that “these advancements are exciting, but really require people to think about surgery in a completely different way, and these systems are likely to be very expensive and limited to large centers.”

On the other hand, Bernard Dallemagne, MD, University of Strasbourg, discussed the flexibility of robotic platforms to perform different types of robotic surgery using the same core technologies. It is likely that some of these advancements will diffuse into tertiary care operating rooms in the next 1 to 5 years.

Dr. Rick Satava reported a consulting relationship with Karl Storz Endoscopy. Dr. Stole, Dr. Cuschieri, Dr. Dallemagne, and Dr. Spear have disclosed no relevant financial relationships.

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 12th World Congress of Endoscopic Surgery. Presented April 15, 2010.

European Association for the Study of the Liver (EASL) 45th Annual Meeting

This coverage is not sanctioned by, nor a part of, the European Association for the Study of the Liver.

April 20, 2010, by Thomas R. Collins,  (Vienna, Austria) — Dark chocolate helps to keep down blood pressure after meals in the liver of cirrhosis patients, according to research unveiled here at the European Association for the Study of the Liver (EASL) 45th Annual Meeting by Swiss and Spanish researchers.

In a small study of 22 patients who received a meal that included either white chocolate or dark chocolate, there was a significant increase in the hepatic venous portal gradient (HVPG) in the overall population.

However, the 11 patients in the white chocolate group had an average change in HVPG of almost 4 mm Hg compared with their premeal level, whereas the dark chocolate group saw a change of just over 1 mm Hg in HVPG (P = .02).

“The postprandial increase in HVPG was significantly lower in the dark chocolate group, while hepatic blood flow and portal vein blood flow increased similarly in both dark and white groups,” Andrea De Gottardi, MD, PhD, a junior faculty member at the Institute of Clinical Pharmacology and Visceral Research in Bern, Switzerland, told audience members in discussing the results.

“Dark chocolate attenuated the postprandial increase in HVPG by allowing intrahepatic vasorelaxation in response to the increase in portal blood flow,” Dr. Gottardi explained.

Eating brings about vasodilation, which, in cirrhotic patients, can cause a dangerous increase of the HVPG, caused by an impaired intrahepatic vasodilatory adaptive response to rapid increases in blood flow. The dysfunction is accompanied by a decreased availability of nitric oxide in the liver.

Antioxidants have been shown to blunt the postmeal increases of HVPG. Cocoa has high levels of flavonoids that have potent antioxidant properties. But flavonol-rich dark chocolate had not been tested for its effects on HVPG in cirrhotic patients.

In the study, patients were randomly split into 2 groups of 11. At baseline, there were no significant differences in HVPG, portal vein blood flow, or hepatic blood flow.

The liquid chocolate meal included 0.55 g of Lindt Excellence dark chocolate for one group and 0.63 g of Lindt Excellence white chocolate for the other group. Those amounts contained virtually the same levels of energy content, proteins, fat, and carbohydrates and had similar volumes.

All patients were also given 200 mL of Ensure Plus to complete their meals.

Portal vein blood flow, hepatic blood flow, and HVPG all increased significantly from baseline for the whole patient population.

There were no significant differences between the white and dark chocolate groups in the increase in portal vein blood flow and hepatic blood flow, but there was a significant difference in the increase in HVPG between the 2 groups.

The white chocolate group’s HVPG increased from a little more than 15 mm Hg before the meal to about 20 mm Hg after the meal (P = .003). The dark chocolate group’s HVPG was 15 mm Hg before the meal and increased only about 1 mm Hg, not a significant increase (P = .07).

Researchers also found there was a significant difference between the white and dark chocolate groups in the mean change in arterial pressure. There was a jump of about 7% in arterial pressure in the dark chocolate group, whereas there was no increase in the white chocolate group.

“Since dark chocolate also increased mean arterial pressure, it also may exert beneficial system effects,” Dr. Gottardi said.

Heiner Wedemeyer, MD, senior physician and assistant professor in the Department of Gastroenterology, Hepatology, and Endocrinology at Hanover Medical School in Germany and the secretary general of EASL, cautioned that the data, so far, are limited.

“It’s a small study. It’s the first to think that there might be an effect,” said Heiner Wedemeyer. “Just look at it about coffee — the coffee story. Coffee is good for the liver. And the more, the better. So there’s a dose effect. So we know already that certain things that we are taking on a daily basis might be beneficial.”

This study is probably going in the same direction but more needs to be learned, he said.

“I want to see more data, I want to see mechanistic data, what is actually the effect on specific cell types explaining this,” Dr. Wedemeyer commented.

The study received no commercial financial support. Dr. Gottardi and Dr. Wedemeyer have disclosed no relevant financial relationships.

European Association for the Study of the Liver (EASL) 45th Annual Meeting. Presented April 15, 2010.

FiercePharma.com, April 20, 2010, by Tracy Staton  –  Drug sales growth will slow this year, but the industry is still set to top $1 trillion by 2014. Burgeoning markets in the developing world will help make up the losses to generic competition elsewhere, IMS Health says. And that’s not what everyone was expecting a few years ago when the patent cliff loomed large in every pharma executive’s mind. 

“What’s a little surprising is how robust we expect the growth to be notwithstanding we’re going to be passing through the peak years of loss of exclusivity,” Murray Aitken, SVP at IMS Healthcare Insight, tells Reuters. “That really is a reflection of how much the global market has moved away from dependence on five or six major developed markets.”

Here are the numbers: IMS is expecting a 5 percent to 8 percent compound annual growth rate over the next five years, amounting to a $300 billion increase in the size of the global drugs market. Major emerging markets such as India and China are expected to fuel a big chunk of that rise, with up to 17 percent growth per year. China is expected to become the world’s third-largest drugs market next year, surpassed only by the U.S. and Japan.

So, the main question for Big Pharma is whether individual companies can take advantage of the emerging-markets growth to offset generic competition and pricing pressures in mature markets such as the U.S. and Europe. Which companies will do the best job of riding the emerging-markets wave?

Posted April 20, 2010

Contacts:               
Gary Gatyas
+ 1.610.834.5338 begin_of_the_skype_highlighting              + 1.610.834.5338      end_of_the_skype_highlighting
ggatyas@us.imshealth.com

Clive Savage
+44 20 3075 5311 begin_of_the_skype_highlighting              +44 20 3075 5311      end_of_the_skype_highlighting
csavage@uk.imshealth.com

Peak years of patent expiries shift growth toward generics
Publicly funded markets face slower growth, added uncertainty
China on path to become world’s third-largest market in 2011

NORWALK, CT, April 20, 2010 – IMS Health reported today that the size of the global market for pharmaceuticals is expected to grow nearly $300 billion over the next five years, reaching $1.1 trillion in 2014. The 5 – 8 percent compound annual growth rate during this period reflects the impact of leading products losing patent protection in developed markets, as well as strong overall growth in the world’s emerging countries. These conclusions are included in the latest release of IMS Market PrognosisTM, the company’s series of strategic market forecasting publications.

Global pharmaceutical sales growth of 4 – 6 percent is expected this year, consistent with IMS’s prior forecast. In 2009, the market grew 7.0 percent to $837 billion, compared with a 4.8 percent growth rate in 2008.

“Patient demand for pharmaceuticals will remain robust, despite the ongoing effects of the economic downturn being felt in many parts of the world,” said IMS’s Murray Aitken, senior vice president, Healthcare Insight. “In developed markets with publicly funded healthcare plans, pressure by payers to curb drug spending growth will only intensify, but that will be more than offset by the ongoing, rapid expansion of demand in the pharmerging markets. Net growth over the next five years is expected to be strong – even as the industry faces the peak years of patent expiries for innovative drugs introduced 10 – 15 years ago and subsequent entry of lower-cost generic alternatives.”

In its latest analysis, IMS identifies the following key market dynamics:

Geographic balance of the pharmaceutical market continues to shift toward pharmerging countries. Pharmerging markets are expected to grow at a 14 – 17 percent pace through 2014, while major developed markets will grow 3 – 6 percent. As a result, the aggregate growth through 2014 from pharmerging markets will be similar to the growth experienced in developed markets – about $120 – $140 billion. This compares to aggregate growth over the past five years of $69 billion in pharmerging markets and $126 billion in developed markets. The U.S. will remain the single largest market, with 3 – 6 percent growth expected annually in the next five years and reaching $360 – $390 billion in 2014, up from $300 billion in 2009.
Therapy area growth dynamics driven by innovation cycle and areas of unmet need. As the pharmaceutical industry’s research and development programs adjust to the broad availability of low-cost generic options in many chronic therapy areas, higher growth will occur in those therapy areas where there is significant unmet clinical need, high-cost burden of disease, and innovative science that can bring new treatment options to patients. In the areas of oncology, diabetes, multiple sclerosis and HIV, annual growth is expected to exceed 10 percent through 2014 as new drugs are brought to market, patient access is expanded and funding is redirected from other areas where lower-cost generics will be available.
Broad cuts in spending applied by public payers to reduce growth in drug budgets. Publicly funded health systems are under increased pressure to reduce growth in drug budgets following the global economic downturn. Countries including Turkey, Spain, Germany and France already have announced plans to apply across-the-board restrictions on access or reductions in reimbursements to reduce drug spending growth. Governments in other countries seeking to restore fiscal balance may take similar actions, or shift more costs to patients.
Peak years of patent expiries shift major therapies to generic dominance. Over the next five years, products with sales of more than $142 billion are expected to face generic competition in major developed markets. Collectively, the impact of patients shifting to lower-cost generics in major therapy areas such as cholesterol regulators, antipsychotics and anti-ulcerants will reduce total drug spending by about $80 – $100 billion worldwide through 2014. This impact particularly will be felt in the U.S., where nearly two-thirds of the total value of patent expiries will occur. Patent expiries in the U.S. will peak in 2011 and 2012 when six of today’s ten largest products are expected to face generic competition.
Closer scrutiny of new products contributes to lower initial spending by payers. The number of new molecular entities launched annually over the next five years is expected to remain in the range of 30 to 35 products. However, these will be subject to more rigorous and complex assessments by payers before being accepted into clinical practice and reimbursed. In many countries – including China, Spain, Italy and Canada – funding and implementation of healthcare at regional or local levels is becoming more significant. This is expected to extend the time it takes for new medicines to become available to patients, and contribute to lower initial spending by payers.
Said Aitken, “The expected global economic recovery removes an element of uncertainty for the industry over the next five years, although the way payers address lingering budget deficits will remain an issue in many markets. Health system reforms, such as those to be implemented in the U.S., can spur fundamental change in the market – but the full impact may not be felt until the latter half of this decade. Leading up to 2020, IMS expects to see a continuing shift toward biopharmaceuticals, specialty-driven products, and changes in the mix of disease areas of interest.”

For more information about the global pharmaceutical market, go to http://www.imshealth.com/media.

About IMS Market Prognosis
IMS Market Prognosis offerings are subscription-based, strategic market forecasting publications that provide unparalleled insights into the economic and political issues affecting the pharmaceutical and healthcare industries. Based on a rigorous evaluation of the key events affecting the marketplace, IMS Market Prognosis provides a five-year forecast at the country, regional and global level. The scope of coverage includes 42 in-depth country analyses and more than 220 top-line country forecasts in 11 regions worldwide.

The forecasts take full account of key issues impacting the pharmaceutical and healthcare industries. Additional factors that may affect overall growth include major safety events resulting in product withdrawal or prescribing restrictions; shifts in regulatory approval standards from their current levels; the application of sudden cuts to drug spending levels; public health crises; and a deterioration in economic conditions. Growth is measured in constant dollars to avoid the influence of currency exchange rates; sales are calculated at the ex-manufacturer level. IMS Market Prognosis forecasts use an econometric model that includes forecasts for economic indicators such as Gross Domestic Product, Consumer Expenditure, and the Consumer Price Index from the Economist Intelligence Unit. As the basis for the forecast model, changes in these indicators will impact forecasted pharmaceutical performance.

About IMS
Operating in more than 100 countries, IMS Health is the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries. With more than 55 years of industry experience, IMS Health offers leading-edge market intelligence products and services that are integral to clients’ day-to-day operations, including product and portfolio management capabilities; commercial effectiveness innovations; managed care and consumer health offerings; and consulting and services solutions that improve productivity and the delivery of quality healthcare worldwide. Additional information is available at http://www.imshealth.com.

Read more: http://www.fiercepharma.com/press_releases/ims-forecasts-global-pharmaceutical-market-growth-5-8-annually-through-2014-maintai-0?utm_medium=nl&utm_source=internal#ixzz0lg8ME57H