Revenues for medical technology industry in US and Europe grew by 11% in 2008

Revenues for the US and European medical technology industry grew 11% in 2008 despite the global recession. Revenue growth flattened out in the first half of 2009 and the industry will face significant challenges as it seeks to maintain long-term momentum, including a stubborn funding drought for early-stage companies and a changing global regulatory and reimbursement environment. These and other findings are highlighted in Pulse of the industry: medical technology report 2009, Ernst & Young's annual report on the industry's performance, released today from AdvaMed 2009, the medtech conference.

"While the medtech industry has not been immune to the effects of the global economic crisis, it has fared better than most industries and the fundamental drivers for long-term growth in the sector remain intact," said Scott Sarazen, Markets Leader, Ernst & Young's Global Life Sciences Center. "We expect that the industry's long-term prospects will be bolstered by fundamental trends, including an aging global population, an expanded pool of patients in both emerging markets and traditional geographic strongholds, and new product innovations."

Key industry findings described in the report include:

• Financial performance. Revenues for publicly traded medtech companies in the US and Europe grew 11% in 2008 to US$289 billion, driven by a combination of organic growth, acquisitions and favorable exchange-rate related gains of US companies. Revenues through the first half of 2009 have remained flat compared to the same period in 2008. Net income decreased by 11% in 2008 to US$11.4 billion, primarily because of special charges associated with major acquisitions and asset impairments at a few large companies. Absent these expenses, global net income would have increased instead of falling.
• Financing. Capital raised by US and European companies in 2008 totaled US$9.2 billion, a 38% decline from the previous year. This trend has continued into the first half of 2009, with the amount of financing raised in this period down 59% from the same period in 2008.
• Venture capital (VC). While medtech public financing was down sharply in 2008, venture capital flowing to the sector held relatively steady. In the US, total VC funding reached US$3.6 billion in 2008, 10% shy of the US$4 billion record set in 2007. European medtechs received US$772 million in VC financing in 2008, a decrease of 20% as compared to 2007. For the first six months of 2009, VC investment in the sector for both the US and Europe totaled US$1.6 billion -- a decrease of 38% from the comparable period in the prior year.
• IPO performance. The US medtech industry has not had an IPO since the first quarter of 2008, the longest dry spell since 2003. In Europe, there were only two IPOs in 2008.
• Deal space. The total value of mergers and acquisitions (M&As) in the industry in 2008 was US$41 billion, a 33% decline compared to 2007. Through the first half of 2009, only 44 deals with an aggregate value of US$6.7 billion have been announced.

New challenges loom

The Pulse of the industry report also identifies emerging challenges that could create new sources of opportunity and uncertainty for companies and investors:

A changing reimbursement environment: Healthcare reform in the US --the world's largest healthcare market -- and elsewhere could have a profound impact on the global medtech industry. It is likely that reimbursement for devices will change significantly in the years ahead, as payors adopt some form of comparative effectiveness in making reimbursement decisions.

Product approval uncertainty: The US Food and Drug Administration (FDA) is currently considering restricting the types of medtech products eligible for 510(k) marketing clearance, which requires that a product be substantially equivalent to a device cleared by the FDA or marketed before 1976. Changes to the approval process could increase the time and expense of bringing new products to market.

Medtech business model under strain: Financial and regulatory developments are placing increased strain on the traditional medtech emerging company business model, which is based on a streamlined regulatory pathway that allows for rapid innovation cycles and relatively quick exits for investors. In addition to potentially longer product approval timelines and increased reimbursement uncertainty, reduced levels of capital across the global financial markets will result in less capital invested in medtech and likely a drop off in M&A exits in the sector. This will create new challenges for companies to fund their innovation and provide adequate returns for their investors.

"While the industry faces financing and other challenges, it has successfully used its ingenuity to overcome similar issues in the past," remarked Heinrich Christen, Ernst & Young's Medtech Leader for Europe, Middle East, India and Africa. "Within this challenging environment, companies will need to be nimble and creative in tackling a host of challenges simultaneously, including: using capital more efficiently, adapting business strategies for a changing regulatory environment, finding new methods to demonstrate product value, and embracing innovation in their business models as much as they do with their products."