2024年制药研发年度回顾补充：2023年推出新的活性物质

New Active SubstancesLaunched During 2023 Following on from our 2024 review oftrends in the current pharmaceuticalR&D pipeline (visithereto download thereport for free), this supplement looksat the industry’s success stories of 2023— the drugs launched onto the marketfor the first time during the year. Oursurvey focuses exclusively on newactive substances (NASs): new chemicalor biological entities for which theactive ingredient had received no priorapproval for human use. This would alsoinclude vaccines with novel antigeniccomponents. As such, this list represents a subset ofall the first launches that Pharmaprojectsreported during 2023 and excludesan additional 68 first drug launchesof reformulated or non-NAS moieties,biosimilars, and imaging agents. So, tocontinue with our meteorological themefor the Pharma R&D Report this year, thissupplement will focus on the drugs thatweathered the storm of clinical trials andregulatory approval to emerge, blinkinginto the sunlight, onto the market duringthe year just passed. Nordisk’s Ozempic (semaglutide) with $6.7billion, the latter being supercharged by itssecond life as the weight loss product Wegovy.Not every launch results in such a heatwave,though. Consider the fate of the high-profileAlzheimer’s drug Aduhelm (aducanumab),whose initial approval was controversial to saythe least. After not finding favor with US payersand being quickly superseded by the similar butmarginally superior Leqembi (lecanemab-irmb),Aduhelm was withdrawn from the market atthe start of 2024, having only produced a lightdrizzle of sales. It seems that this drug’s houseof cards was rapidly blown over by a few gustsof wind. Weather forecasters have similar issuesto pharma industry analysts in terms ofsuccessfully predicting the future beyond whatis immediately apparent. Once a drug has beenapproved, in most (but not all) cases, it will moveonto the market as sure as a predicted warmfront will move through. But, much like entirelyaccurate weather forecasts cannot really beguaranteed beyond about five days ahead inmany parts of the world, as one moves furtheraway chronologically from a projected launchdate, the predictability of a positive outcomebecomes shrouded by clouds. Not all drugs thatare filed for approval will pass muster. Many willfail in Phase III, and by the time you get back toPhase I, the probability of successful marketingdiminishes to around 1% — about as likely assuccessfully forecasting the weather conditionsfor this day next year. So, let’s collectively lookout of the window and celebrate the rays ofsunshine that bathed the pharma industryduring 2023. For every fine day, there wereplenty which turned unsettled. What pharma is looking for are not just high-selling drugs enjoying their moment in thesun, but those that will address longer-termissues and actually improve lives. Just as it isscientific innovation that will (hopefully) solvethe climate change issue, it is drugs with novelways of treating disease that are the pot ofgold at the end of the rainbow for the industry.Thus, as usual, in this report we’ll look not justat statistical trends in the numbers of NASs, butalso zero in on the molecules that are still asrare as rains in the desert: those that made it tomarket with a novel mechanism. They certainlycause the pharma landscape to bloom, andcan genuinely change patients’ lives. But first,let’s look to the skies and survey the entirety of2023’s new active substance launches. Of course, there are sunny days and thenthere are sunny days. Pharma doesn’t wantfine but chilly conditions, it wants to baskin the warmth of a hot drug launch. The sunshone brightest during 2023 on Merck & Co.’santicancer superstar Keytruda (pembrolizumab),which reportedly posted around $12 billion insales, outpacing AbbVie and Eisai’s Humira(adalimumab) with $7.5 billion and Novo 91 New Active Substance Launches2023 was pharma’s second-hottest year ever When all 10 of the hottest years on Earth have been recorded from 2010 onwards, even the mostardent climate change skeptics might have to concede that something is afoot. Indeed, 2023 wasthe hottest year yet, eclipsing even 2016, which previously held the record. Heat has been buildingrecently too in pharma in terms of the number of NAS introductions (although, unlike with climate,for the drug industry it’s the hotter the better). The year to beat for novel drug launches is 2021. So,how did 2023 fare? While not beating the record, 2023 came extremely close. As Figure 1 illustrates, 2023 saw 91 NASsacross 90 products (one product was a fixed-dose combination containing two NASs) making theirmarket debuts. As such, it fell just six short of 2021’s record haul, and made 2023 the second-bestyear ever in terms of the number of NAS launches. This was also 17 more than 2022 produced,a significant boost, although it’s worth noting that the numbers were supercharged by a recordnumber of novel vaccines: 19 in total. For non-vaccine NAS launches, 20