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Medical Technology

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Medical Technology

MEDICAL
TECHNOLOGY

VOL ATILE INDUSTRIES?

A SAFE HAVEN for

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The Benefit of Expansion into Medical Technology financial crisis

2008

2009

2010

2011

Segment comparison at Agilent 2008 - 2011, in US$ M. Source: Agilent annual reports, Novumed Life Science Consulting

In 1999, several business units were spun off from global computer technology provider HewlettPackard to form Agilent, with approx. US$ 8 billion in revenues. This spin-off marked the largest initial public offering in the history of Silicon Valley. Initially, Agilent’s revenues came predominantly from the sales of its electronic test & measurement and semiconductor business units. With its strong ties to the communication industry, specifically the internet, Agilent’s stock was valued highly. Despite this high regard, management decided not to focus solely on its core sectors, by creating a life sciences business unit in 2000. A wise decision in retrospect. The life sciences and chemical analysis units now collectively generate half of the company’s sales, and allowed Agilent to remain profitable despite the collapse of the electronic measurement unit’s profits during the financial crisis.  As one of many examples, this illustrates the growing importance of the medtech segment, which is gaining attention of industry groups from various sectors. What factors make medical technology so attractive? Which industries can benefit from expansion into this segment?

DEFINITION

Segmentation

Medical technology is a widely used term but definitions and segmentations aren’t always consistent. Novumed’s comprehensive segmentation of the medical technology market differentiates between diagnostic and therapeutic products and, on the next level, between devices and consumables. 

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Medical Technology

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Medtech segmentation: 15 broad categories at the 4th level of segmentation. Full segmentation includes 6 levels and a total of 634 segments. Source: Novumed Life Science Consulting

Materials

A very broad range of materials and technologies is used in the medtech field. Even though about 50% of all materials used in medtech are synthetic polymers, other important biocompatible materials also play their part. 

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Biocompatible materials used in medical technology. Source: Novumed Life Science Consulting

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Technologies

In healthcare consulting we observe a multitude of available technologies on diverse levels of complexity. On a low tech level, we see simple syringes, surgical instruments and wound dressings, on a high tech level, new developments encompass microfluidic systems for diagnostics, implantable devices, such as drug-eluting stents, and new biomedical imaging modalities, such as photoacoustic imaging. As a full compilation of applied technologies would be too extensive, selected samples illustrate the diversity. Wound Management

MEMS Ultrasound Probes

Even technologies that have been around for a long time such as ultrasound imaging are being improved constantly, by incorporating new concepts or materials. Currently being developed is a new type of ultrasound probes. These probes are made of silicon wafers with oscillating membranes (microelectromechanical system, MEMS) and potentially enable high resolution 3D images. This technology could be applied in breast cancer screenings and thereby avoid the radiation exposure of mammography.

As a broad field, wound management is applied in many therapeutic areas. While the market for traditional wound care is stagnant, advanced wound care shows a high growth rate of 14.9%. Advanced wound care products comprise moist wound healing, active supplemented wound care, debridement, cleansers and sealants. Also comprised is physical treatment which, as the fastest growing sub-segment, can be performed with a variety of technologies, such as hydrotherapy, electrical or electromagnetic stimulation, UV therapy, ultrasound or lasers.

M A R K E T AT T R A C T I V E N E S S

Global Market

Valued at US$ 273 Bn in 2011, the global market for medtech showed high annual growth rates, around 8%, in recent years with the exception of 2009 when the effects of the financial crisis showed. 

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Global medical technology market by region, in US$ Bn, CAGR = Compound annual growth rate Source: Espicom Medistat Report 2011, Novumed Life Science Consulting

Medical Technology

Robotics

The introduction of robotics into healthcare has been propagated for a long time. Outcomes of procedures performed with the first broadly used surgical robots in the orthopedic field were controversial. The systems never managed to establish themselves in the market. Intuitive Surgical was the first company to successfully introduce a surgical robot into the medical field in 1999. Da Vinci, a minimally invasive four-armed surgical robot with surgical instruments and an endoscopic camera, is controlled from a separate console. With a razor-blade business model (more than 50% of revenues generated by consumables) and around 2,000 units installed globally, the company achieved an astonishing profitability of 27% EAT (Earnings After Tax) in 2010.

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Current and future global top 5 medtech markets, in US$ Bn. Source: Espicom Medistat Report 2011, Novumed Life Science Consulting

SIZE AND GROWTH

The US market is by far the largest, followed by the Japanese and the German markets.  The Chinese market is small in comparison but will soon reach position four and continue climbing the ladder.

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German medtech market reached EUR 21.4 Bn in 2011 with a CAGR (Compound annual growth rate) of 8%, double growth rate of the German GDP. Revenues in EUR Bn. Source: German Federal Bureau of Statistics, Novumed Life Science Consulting

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Achieving Success through Innovation
US

German Market

Rest of World

IE UK BE MX FR JP DE NL CN

Germany has a unique position in medtech, its market being by far the largest in Europe, and the third largest in the world after the US and Japanese markets. It has been growing significantly in recent years, around 8% annually, with two thirds of sales being generated by exports.  Germany is also the leading European exporter of medical technology, ranking second globally after the US.  One of the reasons for the high acceptance of German medtech products is the high degree of innovation. Currently, 9% of revenues are spent on research and development in the German medtech industry, considerably more than in the German manufacturing industry overall (4%). The general level of innovation in Europe becomes clear when looking at the IP situation. According to the European Patent Office the medical technology sector leads the list of registered inventions with more than 16,700 patents (2008).

Germany: 2ND Largest Exporter of Medtech Products Worldwide
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Global medtech export shares 2010 in %. Source: UN Comtrade database, Novumed Life Science Consulting

Profitability
In general, medical technology companies show good profitability.  The average net profit margin in the industry amounts to 13.7%. A commonly found business model with high profitability is the razor-blade model. Profits are generated not by sales of devices but by sales of consumables to be used with the devices. In the glucose monitoring market 90% of revenues are made with test strips. The same concept can be found with micro arrays, various molecular diagnostic tests and even with surgical robots.

Average Net Profit Margin in the Medtech Industry: 13.7%

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Revenues and EBIT of selected medical technology companies in 2011. Source: Company annual reports, Novumed Life Science Consulting

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Medical Technology

financial crisis

2006/2007

2007/2008

2008/2009

2009/2010

2010/2011

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Revenues of Carl Zeiss AG/Carl Zeiss Meditec AG 2006-2011, in EUR M. Source: Carl Zeiss AG & Carl Zeiss Meditec AG annual reports, Novumed Life Science Consulting Carl Zeiss AG is a manufacturer of optical systems, semiconductor manufacturing technology, metrology systems and medical technology focused on ophthalmic systems and visualization systems for surgery. While the medtech subsidiary, Carl Zeiss Meditec AG, managed to increase its profits during the financial crisis of 08/09, the rest of Carl Zeiss AG suffered losses.

Stability
Even though the effects of the financial crisis were visible in the medtech market, they were less pronounced than in other industries. Agilent and Carl Zeiss AG are companies from outside industries which were able to balance the losses suffered during the crisis with the profits made from medtech.  This stabilizing effect was especially useful for Carl Zeiss AG, as their semiconductor business is very volatile. Especially for high risk devices the approval processes in the US and the EU differ. For CE marking the main objective of trials is to demonstrate safety and performance. Requirements on the criteria to be used in these trials are limited. The majority of trials are non-randomized, single-arm feasibility studies with less than 100 patients. In the US, however, approval for high risk devices (PMA) typically requires randomized controlled studies involving several hundred patients. Thus the time-to-market can be much slower in the US, resulting in devices being available in Europe one to three years earlier than in the US. Often, US-based manufacturers go for an outside US approval first. OsseoFix®, a spinal fracture reduction system by Alphatec Spine, an orthopedics supplier based in California, is available for sale in the EU but not in the US.

Regulatory Environment
In general, regulatory procedures for medical technology are much shorter than for pharmaceuticals. The duration of approval processes differs among countries.  Medical devices are categorized according to the risk associated with use. Approval by the FDA is required for a device to enter the market in the US. In Europe, the so called CE marking is necessary, for which corresponding directives by the European Commission have to be followed.

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US

ClassifiCation of MediCal deviCes by the fda

510k – avg. duration: 4.5 months PMA – avg. duration: 27.1 months CE marking – duration: few months get into reimbursement catalog of health insurers

EU

ClassifiCation of MediCal deviCes

ClassifiCation of in-vitro diagnostiCs (ivd) MediCal deviCes

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Classification of medical devices in the US and EU; Source: Novumed Life Science Consulting In the US, depending on the product class, FDA approval has to be obtained through the 510k or the much longer PMA process. For laboratory based tests regulatory hurdles can be reduced significantly by obtaining a CLIA waiver. Certification in the EU is based on directives by the EP and Council. Necessity of approval by nationally accredited notified bodies depends on product class. Duration of approval processes in the US and EU; Source: Novumed Life Science Consulting Only new, high risk devices (class 3, PMA) in the US require extensive clinical trials. In some European countries, getting into the reimbursement catalogs of health insurances can make or break success.

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Medical Technology

Attaining Stability through Diversification
MARKET DYNAMICS

Interest from Outside
In healthcare consulting we see several outside industries trying to gain a foothold in medical technology for various reasons. L shows the distribution of industries which completed large acquisitions in the medical technology sector in the last 10 years. Aside from buyers within medtech and from the financial sector we see pharmaceutical companies, industrial conglomerates such as Danaher, healthcare distributors, electronics companies and healthcare service providers. Interest within the pharmaceutical industry to expand into the more stable medtech sector arises from their traditional business suffering from patent expiry and the “innovation gap”. As the end of the traditional blockbuster business model approaches, medtech provides a welcome alternative which will lead to the two sectors growing closer together. The only fundamentally different industry seen in the overview is the electronics sector. The high volatility of the electronics industry drives businesses towards expansion into other areas.

Median EV/EBITDA

(Enterprise Value / Earnings before interest, taxes, depreciation and amortization)

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Median EV/EBITDA of the top 100 medtech transactions (2003 - 2012) and corresponding values in all industry sectors (same transaction value range: US$ 0.39 Bn - US$ 29 Bn). Source: Capital IQ, Novumed Life Science Consulting

Medical Technology Companies

Electronics Companies Healthcare Service Providers Others

Financial Investors Pharmaceutical Companies Industrial Conglomerates Healthcare Distributors

The medtech market is a good complement due to its stability, as shown by the example of Agilent.  The overview is not complete as it only accounts for transactions with high values. L We observe other industries looking for ways to enter the medtech market as well. Automotive suppliers, for example, experience high pressure on margins, which is why they are increasingly driven to diversify their business. In 2009, the German engineering company Bosch was present at MEDICA, the world’s largest trade fair for medical technology, for the first time. Furthermore, the plastics industry is looking into applying their technology and capabilities in the medical sector.

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Primary industry / buyers sector in top 100 medtech transactions (US$ 0.39 Bn – US$ 29 Bn) with closing dates 2003–2012, in %. Source: Capital IQ, Novumed Life Science Consulting

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M&A Activity
The EV/EBITDA multiple is one of the measures used by private equity funds to find attractive takeover candidates. The median of the EV/EBITDA of the top 100 medtech transactions with closing dates between 2003 and 2012 is shown in M. Comparing corresponding multiples for transactions in industry sectors with the same value range (US$ 0.39 Bn - US$ 29 Bn), medtech has the highest median, meaning investors are willing to pay comparably high prices (see also N ) which confirms the high potential of the market.

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The top 10 of all medtech transactions with closing dates between 2003 and 2012. Source: Capital IQ, Novumed Life Science Consulting

Where Is Medtech Going?
OUTLOOK

Geographical Markets
Aside from the US, which is by far the largest medtech market, Germany is positioned well as the leading European country. As long as companies continue innovation at high level, this position can be maintained, but certainly the different roles of countries will change, especially as China’s contribution to the global market increases.

Regulatory Barriers
Growing healthcare expenditures and decreasing hospital budgets exert pressure on payers. They will ask for proof of improved outcomes and increased efficiency of interventions. In the German pharmaceutical market, this became a reality when the Pharmaceutical Market Restructuring Act (AMNOG) was passed. It is only a matter of time until similar legislation is passed for medical technology.
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Medical Technology

Trends

The increasing cost pressure in healthcare systems around the globe is not only a barrier.Medtech products can and will be used in such a way that they help reduce costs.Novumed identified important medtech-trends which mostly focus on both improving healthcare and achieving the much needed reduction of expenditures.

Personalized Medicine

As mentioned before, the pharmaceutical and medical technology sector will grow closer together, as the development of the personalized medicine concept proves. Its idea is to target a therapy to a specific patient group by using a diagnostic test. With the help of genetic or clinical information, the patient’s drug response can be assessed in advance to determine the need of costly treatments involving biologics. Treatment of rheumatoid arthritis with TNFalpha inhibitors such as Remicade®, the 4th bestselling drug in 2010 [see Novumed Pharma Blockbuster 200], costs US$ 7,800 to 15,000 per patient per year. Initial response time amounts to three months. Tests about to be launched will check the gene expression pattern of the most relevant genes implicated in the patient’s response to these biological drugs. Hopes are, the diagnostic test will avoid unnecessary treatment to benefit both patients and healthcare systems by preventing adverse drug reactions and reducing costs.

A prominent POCT device, the Abbott i-STAT blood analyzer, tests for cardiac markers, blood gases, electrolytes, lactate, coagulation, and other hematological markers. Exciting new developments have been made in the field of microfluidics which will allow automated processing of whole-blood samples and even on-chip PCR. This will open up new possibilities such as ambulatory or bedside infectious disease testing, independent from central laboratories.

Telemedicine

Point-of-Care-Testing

Hospitals, especially smaller ones, are outsourcing their laboratory tests to external providers at an increasing rate to save costs. However, due to a lag of a day or more between sample collection and retrieval of results, there are several issues with external testing, like the necessity of quick results in acute care, or the issue of sample quality being affected by transportation. A possible solution is Point-of-care-Testing (POCT), a term used for diagnostic tests being performed in proximity to the patient. Instead of a central laboratory tests can be performed at bedside, in a doctor’s practice, in a pharmacy, or even during patient transport.

Telemedicine is site-to-site exchange of medical information via e-communications to improve patient care. Possible applications can be segmented according to the type of interaction: Doctor-to-doctor interactions include consultations of specific experts that are sent data taken with imaging systems. Doctoral training using telemedical systems also falls into this category. Doctor-to-patient interactions most importantly involve telemonitoring by remotely observing the health status, which is especially useful to monitor patients with chronic diseases such as diabetes or heart insufficiency. As one of the companies recognizing the potential of telemonitoring, Bosch is setting up telehealth kiosks in elderly care centers, residential communities and private homes. The system, ViTelCare, monitors health through attached diagnostic devices. A further application is online consultation, which has yet to become established due to the physicians’ concern about adherence to the required duty of care. Lastly, telemedical technology can open up new possibilities in surgery by allowing expert surgeons not being on site to remotely control a surgical robot. The broader use of telemedicine could shift patient care away from the stationary sector towards the ambulatory sector and thus contribute to the reduction of healthcare expenditures.

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Conclusion
Medical technology is an attractive market with a high level of innovation and good annual growth. The huge US market dominates, but German, Japanese and Chinese markets are important as well. Facing ever increasing volatility, industry groups from various sectors seek stability in the medical technology field which explains the high prices paid in acquisitions. High margins can be achieved, especially with a leading technological position as demonstrated by Intuitive Surgical. In comparison to the pharmaceutical industry, the relatively low regulatory barriers of the medtech industry make it a very attractive segment for expansion. However, when compared to consumer goods the time to market for a medtech product is longer. To successfully enter this market the major trends and developments towards proof of efficacy and cost reduction need to be part of strategic considerations. In conclusion, it can be stated that medical technology is indeed a safe haven for volatile industries. Claudio Silvestrin
Senior Consultant Novumed, 2012

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Dr. Jörn Leewe
Dr. Leewe has been working for over a decade in strategy consulting and in the industry. He has held positions at the Boston Consulting Group, Fresenius Medical Care, and Lufthansa Cargo. Dr. Leewe studied European Business Administration at Madrid, Reutlingen and Loughborough, where he achieved his PhD.

Gordon Ryerson
Prior to joining Novumed, Mr. Ryerson was the Co-Founder and Managing Director of Crosstree Capital Partners. He has also held positions at the Corporate Finance group of William R. Hough & Co., the pharmaceutical drug retailer Eckerd Corporation and Honeywell International. He holds an MBA from the University of South Florida and a BS from Auburn University.

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Among an exclusive circle of leading experts selected by the German government, Novumed participated in the national strategy process “Innovation in medical technology”. Novumed is co-author of a medtech book that serves as a standard reference for students: Medizintechnik – Life Science Engineering
E. Wintermantel, S-W. Ha, Springer, 1774 pgs. ISBN 978-3-540-93936-8

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Orphan Drugs
With its blockbuster strategy challenged the pharmaceutical industry that has historically been spoiled by twodigit annual growth rates faces the end of a trend. The annual growth has decreased steadily from 2002. Can the broken blockbuster strategy now be cured by orphan drugs?

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Licensing
With revenue gaps due to patent expiry and scarcely populated product pipelines, Pharma is facing serious challenges. FDA-approved new molecular entities have been decreasing. Venture capital firms have been reducing their investments in small yet innovative biotechnology companies. Is Licensing a financial alternative in the life sciences industry?

India
A nation of striking diversity, vast ambitions, and large manpower resource, India is on the fast track to becoming a global economic superpower. With a population growth of 17.64% between 2001 and 2011 it is projected to be the world’s most populous country by 2025. How did it rise from global supplier to leading consumer of pharmaceutical drugs?

Efficient Selling in Pharma
Significant regional differences in Pharma sales, prescription patterns, and individual market gain are holding a secret to efficient selling. In a combined approach of a leading pharma data provider and a premium strategy consulting firm, two case studies unlock the exemplary dynamics of a biological and a small molecular drug.

Medical Technology
Facing ever increasing volatility, industry groups from various sectors seek stability in the medical technology market due to its lower regulatory barriers. Analysis of important trends, recent M&A deals, and the challenges involved indicate Medical Technology could really be a safe haven for volatile industries. How can you benefit from expansion into this segment?

Successful Sales in Asia and Latin America
A structured country analysis can apply the most appropriate parameters to identify the most suitable market for your product. Customized databases can be used to close knowledge gaps and provide the necessary market intelligence to weigh the risk and benefits of expansion strategies. How well is your access strategy for AsiaPacific and Latin America prepared?

Next Generation Biomarkers
Biomarkers have become more than an upcoming trend. The use of biomarker-based diagnostics is increasingly required. Looking at examples, background information, and the results of an important bio banks study – What market segments, technologies and prominent market members are involved in its progressive growth?

Novumed has developed a series of Spotlight Publications on issues and topics that impact our clients. These expert forecasts and insights offer valuable information, visualization and case studies on current issues and themes in the life science industry. To receive your free copy today please contact us: info@novumed.com

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