Research firm Kalorama Information has released the latest edition of its annual report, The Global Market for Medical Devices, containing detailed market sizing, projections, and profiles of major companies.
Below is a sampling of the findings included in the report:
Trump Administration and Medical Device User Fee Amendments: The medical device industry advocates for legislation on a bipartisan basis, and medical device issues enjoy more bipartisan support than most industries. This is because of their geographically diverse base and supportive senators from both parties. That being said, it is logical for medtech to expect a sympathetic hearing from the incoming administration, especially as it opposed President Obama’s signature healthcare reform legislation.
Still, it is too early if the abstract political change of the election will lead to concrete action. One test of the new admin’s stance toward the device industry will be the Medical Device User Fee agreement fee negotiations. It cost over $200,000 for a standard business to launch a new device with the FDA and $4,700 for a “shortcut” or 510(k) application off a previously approved device.
There are also inspection fees for facilities that manufacture some devices. These fees are substantially reduced for a small business. Fees were down more than 10% from 2016. A further reduction or limited/no increase are goals of the industry
Trump Administration, the Affordable Care Act, and FDA: Likewise, improving the FDA regulatory process, and an outright repeal versus suspension of the medical device tax, are other trends for which the industry will be advocating. While the industry through its lobby group AdvaMed will seek ACA repeal, they also signaled they’d like to see coverage of newly insured not disrupted, as they said “ensuring that the coverage process allows patient access to the latest innovations.”
Revenue Growth Slow, but Steady: The 390+ billion-dollar medical device market will experience growth this year, according to Kalorama Information’s estimates. But the firm said it anticipates lower growth than expected if the firm was making the prediction 5 years ago. Looking forward to 2017 and the following 5 years, expect 2.8% average growth. While the user base for medical devices is growing, cost-cutting mechanisms have impacted price increases and this should continue near-term.
No Slowdown in M&A: In a sluggish growth environment, medical device leaders have looked to acquisitions to boost growth, gain share and take advantage of buying opportunities while present. We expect trend that to continue in 2017. There were 153 significant device market mergers and acquisitions in 2015 and early 2016. Notable was Canon’s purchase of Toshiba Medical Systems, Becton Dickinson’s purchase of Care Fusion, and Abbott’s proposed buy of St. Jude Medical.
To read the full report, visit Kalorama Information.