Industry News

A framework now taking shape among institutional investors and biotech strategy teams argues that the way the industry values innovative medicines is fundamentally broken — and that the fix is not more science, but a better map. The problem is familiar. Drug research is repeatedly seduced by three stories: a large patient pool, a headline global total addressable market (TAM), and a mechanism that happens to be in fashion. All three can be true at once, and a drug can still fail commercially. What actually determines value is narrower and harder: how many patients can be diagnosed, how many of those reach treatment, how many get paid for, and how long they stay on therapy — and critically, how much differentiation the product still retains against the standard of care on the day it finally launches. The framework proposes that global innovative-drug research be run in ten layers, from total market size and disease structure through mechanism, commercial model, lifecycle, competition, payment, geography, pipeline and future standard of care. Every layer, in the end, has to be converted into the same five variables: patient-time, unit net revenue, probability of success, cash flow and cost of capital. That conversion is what turns scattered knowledge into a reusable judgment system.   Layer One: Whether the market narrative is even true The starting point is deliberately boring. Before asking whether a drug is good, ask how big the thing is it sells into. That means establishing the baseline: how much the world spends annually on prescription medicines, and how that spend splits across oncology, autoimmune, metabolic, cardiovascular, neuroscience, infectious disease, vaccines, ophthalmology, rare disease, respiratory, hematology and nephrology. Only against that baseline do the adjectives mean anything. Is a $10 billion product exceptional or merely respectable? Where in the distribution does $5 billion sit? Is a $30 billion category large or small? And why does the United States — a single country — carry disproportionate weight in the valuation of every global medicine? The therapy-area map applies the same six questions to each field: global market size, patient count, annual cost of therapy, the top ten products, growth rate, and the pipeline over the next five to ten years. The output is a taxonomy that is more useful than "hot" or "cold": large market and low growth; small market and high growth; and the relatively rare fields that are genuinely expanding.   Layer Two: Disease economics — why equal science is not equal value Two diseases with identical biological elegance can have radically different commercial value. The differentiators are structural: prevalence, age of onset, survival, whether the condition is chronic, whether treatment is lifelong, whether a clear biomarker exists, how easily it is diagnosed, whether payers are willing to pay, and the economic cost of not treating it. This is the layer that explains the industry's puzzles. Why obesity can support products of unprecedented scale. Why lung cancer reliably produces multi-billion-dollar medicines. Why pancreatic cancer, even with genuinely good efficacy, struggles to produce a global blockbuster. Why ATTR amyloidosis, with a modest patient population, still sustains multi-billion-dollar franchises. And why Alzheimer's disease, with an enormous patient pool, remains one of the hardest commercial propositions in medicine.   Layer Three: Lifecycle — the money is in knowing where on the curve you are Studying a medicine from zero through peak sales to the patent cliff remains one of the highest-return exercises in pharmaceutical investing. The reference set is well known — Keytruda, Humira, Ozempic, Dupixent, Tagrisso, Eliquis — and the questions are consistent: what happened in years one to three; how indications expanded; when guidelines shifted; how payer coverage was won; how quickly geography expanded; what line extensions delivered; how strong the patent estate proved; how biosimilars or generics entered; and how fast sales decayed after loss of exclusivity. The insight is blunt: the profitable skill is not knowing that a drug is good. It is knowing which segment of its lifecycle it currently occupies.   Layer Four: Indication expansion — big drugs are expanding patient pools Growth rarely comes from the original indication simply getting bigger. It comes from a ladder of expansion: later line to earlier line, advanced to adjuvant, single tumor to multiple tumors, single disease to multiple diseases, adult to pediatric, infusion to oral, hospital to home. Studied across Keytruda, Dupixent, Skyrizi, Jardiance, Enhertu and Vyvgart, the pattern converges on a single rule: a genuinely large medicine is, in essence, a patient pool that keeps getting larger.   Layer Five: Mechanism and its commercial ceiling Mechanisms can be analyzed the same way. PD-1/PD-L1, GLP-1, IL-23, IL-17, TNF, JAK, SGLT2, BTK, CDK4/6, EGFR, FcRn, C5, TTR, VEGF, ADCs — each can be assessed on biological position, the current leading product, validated indications, plausible future indications, competitive intensity, the next-generation successor, addressable capacity, and whether the space has already turned red.   Layer Six: The price-times-patients matrix Plot annual cost of therapy against patient numbers and the market sorts itself into four familiar quadrants: large patient pool at low price, as in hypertension and diabetes; large pool at mid-to-high price, as in GLP-1s and immunology; small pool at high price, as in rare disease; and very small pool at extremely high price, as in gene therapy. Add treatment duration as a third dimension, and the chart begins to answer the question investors most often get wrong: why a therapy with high scientific value can still have limited commercial value.   Layer Seven: Payers, not prescribers, decide For much of the global innovative-drug market, commercialization is determined neither by the manufacturer nor the physician, but by the payer. Comparing US Medicare and commercial insurance, European HTA bodies, the UK's NICE, Germany's AMNOG, Japan's pricing system and China's national reimbursement negotiation reveals a consistent hierarchy of evidence. Overall survival, reduced hospitalization, quality-adjusted life years, weight reduction, progression-free survival and overall response rate are not interchangeable — and payers price them very differently.   Layer Eight: Why the United States still crowns global champions Many medicines address large global populations, yet few become super-blockbusters without succeeding in the US. The determining mechanics are list price versus net price, pharmacy benefit managers, Medicare, Medicaid, the 340B program, rebates, and price negotiation under the Inflation Reduction Act. The comparison is instructive: a product reaching RMB 10 billion in China is a genuine achievement. The same product in the US may be merely mid-sized. Comparative market structure work across the US, China, Japan, Germany, France, the UK, Italy and Spain — on market size, speed of new-drug uptake, pricing, reimbursement, hospital access, patient ability to pay and local competition — explains how the same molecule produces very different cash flows in different hands.   Layer Nine: Reading a launch curve Launch trajectory is the layer most directly tradable. A first-year result of $100 million, $500 million or $2 billion each means something specific, and calibrating those reference points in advance is what lets an observer see a drug post $500 million in its first six months and immediately judge whether that is slow, normal or explosive.   The common denominator Across all ten layers, the discipline is the same: reduce every qualitative argument to patient-time, unit net revenue, probability, cash flow and cost of capital. That reduction also guards against the most common analytical failure in the sector — valuing a medicine against today's standard of care rather than the one that will be in place on its launch day.