India Forecast: Use of Medical Procedures Will Double by 2013

Use of Medical Procedures Double by 2015

Almost 17 million surgical procedures were performed in India in 2009, achieving an annual growth rate exceeding 18%, according to TrialMed India. Driven largely by the private sector, the volume of surgical procedures is set to double by 2013.
Indians are facing a life time epidemic in Diabetes, weight gain, metabolic syndrome. The procedures in OB/GYN and ophthalmic interventions accounted for a staggering 87% of the surgical procedures performed in 2009. Ophthalmic procedures are disproportionately high in India because of a large population with reversible blindness: 12 million Indians are estimated to suffer from preventable or reversible blindness. Not-for-profit hospitals specialised in eye care provide treatment to the poor, with an estimated 5.3 million cataract removal surgeries and intraocular lens implantations performed in 2009.

Caesarean section delivery is the main OB/GYN surgery performed. It is estimated that almost two in three births conducted in private hospitals in urban Indian cities are performed using this procedure. The popularity of C-section deliveries is partly because private hospitals encourage patients to choose it as it provides a higher profit margin than vaginal delivery, but also because educated and affluent Indian women are opting for a C-section to avoid pain during delivery.

The increase use of coronary stents. India will become one of the biggest markets to use treatments to curb diabetes in the form of medical device implants like GI Dynamics, VallantX, Onciomed, Allergan, J&J products. Medtronic has an insulin pump, but may not have anthing in the weight loss market which solves the diabetes and weight loss problem-short term or long term.
Estimated over 30 million Indians will be pre diabetic or diabetic by 2015. A third of them will need weight loss treatments like the lapband or other weight loss devices. Assuming 10 million people needing weight loss treatment and each device cost INR 200,000 that is approx $4000 the market size for weight loss  treatment is approx $40B in India alone. China is not too far behind.

Future of Med-Tech Sector in BRIC Countries: 2012-2015

Booming med tech sector will grow at a very aggressive rate. Investments in the sector are increasing. The BRIC countries are trying to bring US innovations the countries, assuming the US regulators are posing a risk to the innovations in the US. If the innovations move to outside US. The health care cost in the US is going to dramatically increase. Yet the US VC investments  in innovative med tech sector has gone up in the 2011 and expected to increase in 2012.  
"Infrastructure in the BRICs has improved notably in recent years, but still remains far behind developed country norms," according to the report. "Infrastructure investment will need to accelerate in the years ahead to prevent it from constraining future growth rates in the BRICs."

BRIC Countries- Individual growth rate predictions were:

• Brazil: 4.5 percent for 2011, 4.0 percent for 2012
• China: 9.4 percent for 2011, 9.2 percent for 2012
• India: 7.5 percent for 2011, 7.8 percent for 2012
• Russia: 5.3 percent for 2011, 5.6 percent for 2012

RUSSIA: This is the first time that Russia has articulated a long-term development strategy for the medical technology and pharmaceutical industries, Tsyb told me. A €4.5 billion investment programme for these two sectors was recently approved by the government, and now it is time to put that money to good use. The pharmaceutical side of the strategy is well underway; the medtech part of the programme took a little longer to implement—a couple of signatures are required from ministries that oversee regulatory approvals—but those are largely pro forma, says Tsyb, and he is here in Düsseldorf to move the project forward. His mission is to lead negotiations with international medtech leaders interested in localisation projects within Russia as well as to support Russian companies in their talks with potential partners. 

The market, which is currently valued at €3.5 billion, is projected to grow six-fold by 2020, according to government forecasts.

CHINA: The government’s 4 trillion RMB stimulus package and policies to boost domestic demand have helped most Chinese companies, but the medical device industry has benefited less than other industries. Because most SMEs manufacture only for the domestic market and medical device demand is determined by domestic institutions, recent medical reforms have not done a great deal to stimulate demand. Some export-oriented companies rely on OEM services and do not benefit from the expansion of domestic demand. If companies can think outside the box and try to expand foreign demand for their products, this might be a way to achieve quick economic gains. The financial crisis has decreased demand for traditional exports, but the decrease in purchasing power of foreign healthcare systems has also decreased the competitiveness of many foreign medical device SMEs. This gives Chinese companies a good opportunity to take advantage of their low manufacturing costs to get a foothold in foreign markets.

For years, companies have been succeeding in the domestic market but have not tried to expand overseas. This can be attributed, in part, to language and cultural barriers and to unfamiliarity with foreign market regulations. In the European Union, Chinese medical device companies only need to obtain CE certification to be eligible to directly enter more than 20 member states. CE certification is much less stringent than SFDA certification. Some small pharmaceutical companies have obtained CE certification while waiting for SFDA certification and marketed their products overseas right away. I suspect such strategies will become more and more popular.

Use human resources to accelerate the pace of product commercialization. Medical device development in China lacks the support of national research institutions, which are often out of sync with practical needs. This leaves technology and product development in the hands of medical device companies. Unfortunately most medical device companies use their limited investment funds to expand production and sales rather than to develop new products or technologies. China’s so-called new products are often imitations of foreign products, which limit the impact they might have on foreign markets.

Medical devices, especially small products, can be developed and manufactured in a relatively short time-frame, and human resources can be harnessed to drive innovation. Over the past 30 years of opening and reform, a significant portion of the 200,000+ Chinese students who have studied abroad have gone to work for major medical device manufactures. Domestic companies should find ways to put these intangible assets and technological assets to use. 

BRAZIL: Brazil has the largest economy and medical device market in Latin America, but per capita medical expenditure is still very low. The market fell in 2009 but recovered in 2010. The highest expenditure is in the large cities, such as Sao Paulo or Rio de Janeiro, but producers are moving into regional markets outside the major state capitals. Diagnostic imaging apparatus, followed by obesity weight loss, diabetes, orthopaedics, spine and consumables are the largest market sectors.
Dilma Roussef took office as President on January 1^st 2011, she has not decided whether herself or her predecessor Lula will run for the next elections in 2014.
Brazil, and Latin America in general, have emerged more quickly from the global downturn than more developed nations. Additionally the region is projected to grow at a faster rate in the near future. Brazil’s GDP is set to expand by a healthy 4.3% in 2011 and growth will be between 4% and 5% over the medium term. With a growing economy, if inflation is kept in check, there will be more money available to spend on healthcare both in the public and private sectors.
The shape of the medical device and diagnostic imaging sector is expected to change following recently announced manufacturing investments. In June 2010, GE Healthcare opened its first South American plant in Brazil, focusing around “healthymagination”. The factory represents an investment of US$50 million over 10 years. Philips Healthcare inaugurated the first Latin American plant for the production of MRI equipment in Brazil in October 2008.
Imports hold a relatively small share of the market, totalling US$1.8 billion in 2009. The economic slowdown and a more “realistic” exchange rate in 2009 have contained medical imports as imports increased just 1.7% in 2009 compared to a CAGR 2005-09 of 21.1%. Imports tend to be high-tech medical equipment not produced locally. In 2009, 68% of imports were supplied by Europe and the USA.
Medical exports reached US$442.3 million in 2009, reflecting a less favourable exchange rate. The country has a well-established medical industry, comprising local and multinational companies. Domestic production, however, is geared towards the local market. Exports are small in comparison with total production and the country consistently runs a negative balance of trade in medical equipment and supplies

INDIA: India’s medical device and equipment market is expected to reach US$6.41 million by 2014, growing 15.5% annually. The market has opened up for importers, MNCs as well as indigenous manufacturers. Driving this growth is increased awareness and affordability coupled with an expanding patient pool and ever-growing export demands from Western and emerging markets. The Indian medical device market is booming, writes emerging markets according to Sonali Deshpande of TrialMed Life Sciences in India. Currently valued at approximately US$3 billion, India’s medtech market is expected to grow 12% to 16% during the next five years (2016)

Canadian Med Tech Sector Hot 2012-2015

Canadian Med Tech Sector Hot 2012-2015

The health care industry in Canada has experienced steady growth in the past decade, driven by universal access to health care, an aging population, rise of lifestyle disease rates, and advances in the pharmaceutical and medical technologies. Key challenges facing the Canadian health care sector include extended wait times leading to limited access to services and a rising health care financing deficit. Part of the complex solution for solving both challenges includes the adoption of advanced medical technologies, which can have a long term result of lower per-treatment cost and duration, as well as better health outcomes.

 

The outlook for medical technology sector looks very bullish. The med tech sector is trending the same way as the Israel, Ireland, China, India, Brazil and US medtech sectors.

US med tech sector is going to be in demand as innovation is all time high across the sectors. The impact of obesity and obesity related problems has created new opportunities in the weight loss, cardiovascular, spine and orthopedic market.

Also, following the US regulatory system may do more harm to the Canadian med tech sector. Following the EU system is the most ideal system.

The United States remains overwhelmingly the primary market for Canadian medical device exports and the destination for approximately 71% of all medical device exports in 2010.

Many of the large international medical device manufacturers are represented in the market, though relatively few have set up manufacturing plants locally, preferring to maintain only their sales team in Canada. The Canadian medical device market is estimated at $6 B in 2010, is primarily an import market; with 52% of all imports destined for the US.

“Growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies. Companies have seen a vast difference in the approval processes in Europe vs. the U.S

By: The Advanced Medical Technology Association (“AdvaMed”), prepared by Josh Makower, M.D., consulting Professor of Medicine, Stanford University 
A medical device meeting recently reported that “Growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies.  Companies have seen a vast difference in the approval processes in Europe vs. the U.S.  A study released by Stanford University indicated that the cost of bringing a technology to market is dramatically lower in Europe.”
The Advanced Medical Technology Association (“AdvaMed”) recently released the report, prepared by Josh Makower, M.D., consulting Professor of Medicine, Stanford University and Founder, President & Chief Executive Officer of ExploraMed Development, LLC; et al, “FDA Impact on U.S. Medical Technology Innovation,” which garnered responses from more than 200 companies concerning their experiences in working with the FDA.  Participants were also asked about their experiences working with European regulatory authorities in order to offer a comparison between aspects of the two dominant regulatory systems.
“In general, survey respondents viewed current U.S. regulatory processes for making products available to patients as unpredictable and characterized by disruptions and delays,” the results summary states.  Forty-four percent (44%) indicated that part way through the premarket regulatory process they experienced untimely changes in key personnel, including the lead reviewer and/or branch chief responsible for the product’s evaluation.  Thirty-four percent (34%) of respondents also reported that appropriate FDA staff and/or physician advisors to the FDA were not present at key meetings between the FDA and the company.”
The report goes on to highlight that those factors contribute to significant delays in navigating FDA regulatory processes, with premarket process for 510(k) pathway devices (of low-to moderate risk) taking an average of 10 months from first filing to clearance.  Devices requiring a clinical study for low- to moderate-risk devices before making a regulatory submission, the premarket process took an average of 31 months from first communication to being cleared to market while, in comparison, it took an average of 7 months in Europe.
For higher risk devices seeking premarket approvals, responding companies indicated that it took an average of 54 months to work with the FDA from first communication to being approved to market the device.  In Europe, it took an average of 11 months.”
Beyond the time gap comparing FDA and Europe approval processes, the survey also showed that the average total cost for a low- to moderate-risk 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities.  For a higher-risk PMA product, the average total cost from concept to approval was approximately $94 million, with $75 million spent on stages linked to the FDA.
According to the report, these statistics result in a “significant, measurable cost to U.S. patients in the form of a device lag.  Respondents reported that their devices were available to U.S. citizens, on average, nearly 2 full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country.”

Stephen J. Ubl, President & Chief Executive Officer of AdvaMed, says, “This report is a wake-up call for those who want to promote medical innovation and preserve American jobs.  A regulatory environment that is marked by needless delays and inefficiencies makes it harder for medical innovation to thrive and companies to survive.  These delays particularly hurt small companies and their ability to produce next generation technologies.”
To read the full report go to: http://www.advamed.org/NR/rdonlyres/040E6C33-380B-4F6B-AB58-9AB1C0A7A3CF/0/makowerreportfinal.pdf
Ultimately, growth within the life sciences will continue at a quick pace during the next few years, with development of R&D pipelines, alliances, and partnerships being a key factor for success.
As the economy continues to chug back to full force, the only obstacle appears to be the differing of opinions between the medical device manufacturers and the FDA.  Perhaps if they come to a meeting of the minds, these growth projections will not just be projections, but will be the reality of a growing field that is quickly, and effectively, delivering what the U.S. healthcare system requires.”

“FDA Impact on U.S. Medical Technology Innovation,”

“FDA Impact on U.S. Medical Technology Innovation,”

Obesity Devices And The FDA Review Process: Enormous & Unmet Need

Obesity Devices And The FDA Review Process: An Interview With Lee Kaplan, MD

With increasing concerns about the US Food & Drug Administration (FDA) review process and its impact on innovation in the obesity arena, members of academia and industry are working with the FDA to identify best practices for clinical trials and help standardize the clinical investigation and review process. As part of this initiative, the FDA, Massachusetts General Hospital (MGH), and Dartmouth College are sponsoring a much anticipated public meeting and workshop in October 2011 that will focus on delineating best practices for clinical trials in the field of bariatrics. To find out more, Medtech Insight interviewed one of the meeting co-directors, Lee Kaplan, MD, director of the Obesity, Metabolism and Nutrition Institute at MGH, in Boston. According to Kaplan, patient need in the obesity field is "enormous and generally unmet," so it is important for the field to "adopt strategies that will facilitate bringing new, effective therapies to market."

Q: Medtech Insight: How has academia been working with the FDA in terms of improving the FDA review process for weight loss devices?

Lee Kaplan: We've been working with the FDA to help identify best practices for clinical trials of devices for obesity and metabolic disorders and how to assess the effectiveness of medical devices in this area in a more standardized and predictable way. It has been a stepwise process. Because of the importance of this effort, representatives of the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American Society for Gastrointestinal Endoscopy (ASGE) met with the FDA in the summer of 2010 and recently presented a white paper outlining the perspective of these two societies regarding what should be done in this area. In follow-up to that, we are putting together a public meeting in October, sponsored by the FDA, MGH, and Dartmouth, to take it to the next level. The meeting will be a workshop on clinical trials and GI devices for the treatment of obesity and related metabolic disorders. The conference is being formulated right now, and over the next couple of weeks we will distribute the details.

 

Life sciences dollars jump 37% from first quarter 2011 Internet-specific investments at 10-year high level

Venture capitalists invested $7.5 billion in 966 deals in the second quarter of 2011, investment activity increased 19 percent in terms of both dollars and the number of deals compared to the first quarter of 2011 when $6.3 billion was invested in 814 deals.

The Life Sciences sector (biotechnology and medical device industries combined) saw an increase in VC dollars invested during the second quarter, rising 37 percent in dollars and 12 percent in deal volume from the prior quarter to $2.1 billion going into 206 deals. Investments in Internet-specific companies also rose considerably to the highest quarterly level since 2001.

"The rise in venture capital investments going into the Life Sciences and Internet sectors can be attributed to the increase in exit activity in the Life Sciences sector and attractive valuations for Internet companies," noted Tracy T. Lefteroff, global managing partner of the venture capital practice at PwC US. "The exit market for both biotech and medical device companies has been active over the past year, and this has encouraged VCs to put more money back to work in this space.
At the current pace of venture capital investing, 2011 is on track to exceed $26 billion, which would put it as the sixth most active year in VC investing history."

India has largest pool of patients for clinical trials

By: Trialmed editor

Aug 20, 2011

India these days has the largest pool of patients suffering from cancer, obesity, diabetes and metabolic syndrome is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials. India with its booming economy has both the diseases of the west and the diseases of the east.

Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities, especially Pune, Mumbai, Hydearbad and Ahmedabad and Bangalore. This is because India offers western trained doctors and english speaking patients for the most parts in the above mentioned cities.

Global consultancy McKinsey & Co estimated that by 2011, global pharma majors would spend around $1-1.5 billion just for drug trials in the country.

Data from the US government’s global trials registry, clinicaltrial.gov, show only 246 clinical trials were held in India in 2009. That was 9.6 per cent lower than the number of trials a year before. On the other hand, the number in China (316) and Korea (397) grew 15.3 per cent and 20.7 per cent, respectively, in 2009 as against the previous year.

If India has the patient population, as much of Latin America and EU combined. Why have the number of clinical trials dipped. The answer is the time lag in the regulatory approvals, once an easy approval process has become extremely bureaucratic process, by the time the study is approved, the investigators have lost interest in the study.

Investigators who are mostly key opinion leaders have very little time to follow the process laid out by the protocol, leading to protocol deviations and paucity of time to complete the documents.

CROs have played a big role in combating the above problems, but in doing so the competitive pricing is not available.

We still believe that the smaller CROs have more potential and time to offer to companies that can spend the time to work with the approval process, training of the doctors and the CRA with the protocol and study requirements. Helping CROs develop study information packets enables patient recruitment per protocol and keeps the enthusiasm of the study high.

CROs like TrialMed India www.trialmed.com are providing clinical trial support and marketing support to the early start ups who want to do clinical trials in India. They are also available for large medical device firms to market their medical devices in India.

FDA to relax regulations

By: Trialmed editor

Aug 19, 2011

Medical device companies operating in the in vitro diagnostic and radiology sectors of the industry received some surprising news this past month when it was revealed that the FDA had decided to relax certain regulatory requirements pertaining to these products. Specifically, a number of device types will now be exempt from pre- market notification requirements. The FDA move, which affects approximately 30 medical device types ranging from radiology film processors to blood testing, was prompted by the long track record of safety and effectiveness of each respective product. CDRH Director Jeffrey Shuren stated that “the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers,” without risking the health of the public in the process. The FDA has also stated that this is the first step in what will be a gradual loosening of 510(k) requirements across the board for low-risk radiology and in vitro diagnostic devices. Until this occurs, the FDA will exercise what it calls “enforcement discretion” in handling pre-market notification submissions for the 30 medical device types described within the document. There is as of yet no timetable for the adoption of this dramatic shift in medical device regulatory approval standards, but a 90-day comment period on the proposal is currently in effect.