Pheonix Research - Editorial Index
Editorial analysis anchored to industries, segments, and the market intelligence behind them.
Twenty-three of the FDA's 46 novel approvals in 2025 carried orphan designation — half the year's approvals on 19.2 per cent of its pivotal evidence. The median orphan programme enrolled 114 patients, nine ran on a hundred or fewer, and the whole cohort's evidence base is smaller than three non-orphan programmes enrolled in the same year.
Nine of the 46 methods Brazil recognises as alternatives are animal tests, and the register is deep at the skin and empty inside the body. That gap, not the ban, is what decides which ingredient classes can be served in vitro — and why the growth curve is a step in 2027, a plateau, and a second step in 2031.
A pill is eligible for Medicare price negotiation at seven years, a biologic at eleven. With the negotiated price taking effect two years later, that is nine protected years against thirteen — a four-year subsidy for injectables written into a price-control statute, and the reason a 10 per cent market can grow on flat approval counts.
Epic ended 2025 with 43.7 per cent of the US acute care EMR market, up 1.4 points, in a year when hospital purchase activity fell sharply. That combination — rising share, falling installations — tells you the 7.9 per cent category growth is annuity, not demand, and the EU health data space will entrench it further.
When the OECD amended two skin test guidelines in June 2025, it deleted a validated method because the reconstructed tissue behind it had left the market. That supply-chain fragility, not the science, is what constrains in vitro toxicology — and it explains why the value is migrating from assays to platforms and reference data.
Eliquis faces three clocks: a patent date of 1 April 2028, a Medicare negotiated price effective 1 January 2026, and a clinical shift toward mechanical thrombectomy. Only the first is already in every model.
Eylea's US franchise fell 27% in 2025 and revenue per geographic-atrophy injection is down roughly a fifth, yet ophthalmology still compounds at 5.98% to 2033. Alcon's segment split shows where the growth went: consumables and equipment grew 5-6% while the intraocular lens did not grow at all.
