Pharma R&D Annual Review 2021
Pharma R&D Annual Review 2021Ian Lloyd, Senior Director, PharmaprojectsIntroductionWelcome to Pharmaprojects’ 2021 review of trendsin pharmaceutical R&D. For almost 30 years now,I’ve been taking an annual look at the evolutionof pharma R&D, and in this article I’ll examinethe state of play at the start of 2021. We’ll assessindustry trends by examining the pipeline bycompany, therapeutic area, disease, target anddrug type, using data from Informa PharmaIntelligence’s Pharmaprojects, part of the Citelinesuite of products, which has been tracking globaldrug development since 1980. This report will befollowed up by our annual supplement reviewingthe New Active Substance launches for the yearjust passed. But here, we will be entering thematrix databank, travelling through time backthrough 2020, and using our findings to projectthe course for pharma R&D as it navigates itsway through one of the most turbulent periodsof modern history, hopefully towards a new,gleaming, technologically advanced future.Regular readers of this report (which has beenrunning since 1993) will know that in recent years,I’ve threaded a different theme through eachedition, to highlight points, to draw analogies,and to give a little turbo thrust into what couldotherwise be a rather lengthy voyage through thesubspace world of statistics, charts and tables.Themes selected so far have included astronomy,movies, the natural world, music and, last year,food and drink. After completing the 2020 reportearly last February, I thought science fiction mightbe a fun topic for 2021’s report. Little did I know atthat point that 2020 would turn out to resemble aparticularly grim science fiction movie for all of us.A long time ago, in a galaxy far, far away – or lastJanuary as I prefer to call it – the world was a very2/ February 2021different place indeed. Sure, there was this viraloutbreak in China, but we’d been through thesekinds of things before with SARS, MERS, swine flu,etc, right? Surely it would just fade away as before,and we and the pharma industry would continueour relentless march into the sunlit uplands of ourgolden futures.Wrong. As SF author Frank Herbert wrote inhis acclaimed Dune novel: “Deep in the humanunconscious is a pervasive need for a logical universethat makes sense. But the real universe is always onestep beyond logic.” It’s already become a cliché,but few people would have believed what theywould see if they had been able to jump into atime machine last year and travel forward 12months. Our hospitals under huge pressure, amounting global death toll, economies devastatedand our streets deserted. The latter has often ledto citations of the 2002 British sci-fi film 28 DaysLater, where a man emerges from a coma to findLondon deserted following an outbreak of a rageinducing virus. Another ‘pandemic’ science fictionmovie, Contagion, from 2011, is probably closer tothe mark, and reportedly received a huge spike inviewings during the year on streaming platformNetflix. Fears of alien invaders of all kinds areof course a staple of science fiction, dating fromHG Wells’ The War of the Worlds, published wayback in 1898. Alien invasions have been coveredthroughout SF history, right through 1950sB-movie classics like The Day the Earth Stood Still,with its giant robot, Gort, and the chilling paranoiaof Invasion of the Body Snatchers, up to moremodern fare like the bombastic IndependenceDay. And different aliens seemed to be invadingthe same corner of Southeast England every few Informa UK Ltd 2021 (Unauthorized photocopying prohibited.)
weeks in the 1970s in the long-running UK TV showDoctor Who.So 2020 has been a bit like living inside a sci-fimovie, strange and fantastical, in all the wrongways. However, if a year ago you’d told me aboutthe pandemic, and told me that we’d already havesix vaccines developed and being rolled out, lessthan a year since we made ‘first contact’ with thevirus, then I really would have thought you hadtaken leave of your senses and entered a paralleluniverse. The global response, particularly from thepharmaceutical industry, has been nothing short ofphenomenal. The previous record for developinga vaccine against a new pathogen was held bythe Ebola virus vaccine, which took five years todevelop. A decade is more commonplace. Butinstead of 10 years, we did this in 10 months. As aresult, we can see a light at the end of the tunnel.The US government even borrowed a Star Trek termto help us to get here, calling its COVID-19 vaccineacceleration programme ‘Operation Warp Speed’.In the meantime, another effect of the pandemic,or rather measures introduced to attempt tocontrol it, is the way it has made each of ourworlds shrink. I was reminded of this recentlywhile re-watching one of my favourite episodesof Star Trek: The Next Generation, ‘Remember Me’.In the story, Dr Beverly Crusher’s son Wesley’sscience experiment traps her in a bubble universe,unbeknownst to her. Gradually, people in her lifeseem to be disappearing or people don’t seem toremember them. What is going on? It transpiresthat the bubble universe is contracting, and whenher entire universe becomes smaller than the sizeof The Enterprise, it turns into a race against time torescue the good doctor before the ship breaks upor the universe shrinks to nothing. (I won’t spoil itby telling you what happens in the end, but you canprobably guess.) This story seemed to me to haveresonance for how our own personal universesshrank through 2020 as a result of COVID-19. A year3/ February 2021ago, I was looking forward to a holiday in Thailandin February (which, fortunately, I was still able toenjoy), but since then international travel has allbut disappeared, I’ve only left London once sinceMarch, and now I no longer even travel as far asinto the office. As I write, the UK is in another strictlockdown and my universe has shrunk further topretty much extend only as far as the walls of myapartment and the neighbourhood supermarket.Meanwhile, many friends have ‘disappeared’ frommy personal universe, hopefully temporarily, andcurrently even close friends can only be glimpsedvia the technological wonder of Zoom meetings. Theeffect of all this on people’s mental health can bedevastating, and, at times, you can feel like you’redisappearing down your own personal wormhole.‘Is there anybody out there?’ indeed.One effect of this most science fiction-like of yearshas been to put the pharmaceutical industry centrestage like it never has been before. Who wouldhave thought a year ago that we’d all become suchexperts on vaccine types, cytokine storms and Rnumbers? While the likes of Pfizer and AstraZenecawere probably household names beforehand, fewoutside of our own industry would have heard ofBioNTech and Moderna a year ago. The pharmaindustry, which, let’s face it, didn’t have the greatestof public images, is now riding to all of our rescues.Whereas previously many viewed big pharma assome kind of nefarious shadowy enterprise, akinperhaps to the Tyrell Corporation in the 1982SF masterpiece Blade Runner, now it is comingtogether to save the world more in the mannerof Avengers Assemble. It is to be hoped that it cancontinue to build on its enhanced reputation in themonths ahead as the vaccine challenge moves tobe one which is more logistical than scientific. Butwe shouldn’t underestimate the enormity of thatchallenge, for both pharma and governments. It’sa sobering thought that tuberculosis, a diseasefor which there have been not only vaccines butdrug treatments for decades, still manages to kill Informa UK Ltd 2021 (Unauthorized photocopying prohibited.)
around 1.5 million people (just lower than the totalnumber killed by COVID thus far) every single year.The challenge will not only be how to get vaccinesto people in the developed world, but, as with TB, toget them to the world’s poorest.Aside from the fantastical nature of the eventswe’re all living through, science fiction has alwaysproved a useful tool for illuminating our lives. Whilemuch of the genre is speculative to the extreme,there has always been a place for SF to be used toreflect issues in today’s world. The TV series BlackMirror has in recent years used the technique ofseemingly taking us only a little into the future tohighlight very real misgivings about technology andour social media use. Back in the 1960s, the originalStar Trek series presented us, only 20 years after theend of the Second World War, with a hopeful futurewhere alliances across a federation of planets andraces had brought peace and understanding, whiledealing more directly with contemporary issuesin specific episodes like racism in ‘Let That Be YourLast Battlefield’ or social inequality in ‘The CloudMinders’. Doctor Who’s nemeses the Daleks had clearallegorical comments on Nazism’s obsession withracial purity. Going further back, George Orwellcritiqued totalitarian regimes of the day in AnimalFarm and 1984. Sometimes, SF holds a lens up tohelp us to see ourselves better.And let’s not forget, science fiction is often greatfun. I myself have been a lifelong fan, and it’sentirely possible that it was the influence of SF TV asa child which led me to pursue a career in sciencefact. Being British, my number one was, and stillis, Doctor Who, which has been running (with onenotable hiatus) since 1963 (even slightly longer thanI have). This eccentric and very British show mayhave had an alien flying around time and space in apolice box fighting all manner of bizarre monstersand despots, but, crucially, the Doctor always winsthe day by using logic, reason and science – notviolence. This had a profound effect on me as ayoung boy.So, in this report, I hope to use analogies from,and references to, science fiction books, films andTV shows to highlight and illuminate the changeswhich the pharmaceutical industry is going through,and what has changed for it over recent years.The effect of the COVID-19 pandemic has, as weshall see, made a significant impact in a very shortspace of time, so I’ll be returning to it a lot. WhileI hope to keep the writing fun and lively, I do notwish to be flippant about the very real horror weare living through now, and appreciate that manyreaders will have been personally affected. For thisreason, I want to dedicate this 18th edition of thePharma R&D Annual Report to all those who havelost people to the pandemic, and all of you who areworking tirelessly to help us get out of this situation,which I’m sure we will. If there’s one thing a goodsci-fi B-movie has taught us, it’s the indomitablenature of humanity. Together, we’ll see off thisparticular alien invader.“I, for one, bet on science ashelping us. Science has given usmore lives than it has taken; wemust remember that.”- Philip K Dick4/ February 2021 Informa UK Ltd 2021 (Unauthorized photocopying prohibited.)
Lift-Off: Total Pipeline SizePharma’s universe continues to expand, despite 2020’s dark matterLet’s engage our warp drive and jump straight intoour analysis by looking at the overall size of theobservable pharma universe: the total number ofdrugs currently in the pipeline. It’s worth startingoff with a definition of what we mean by pipeline,since all of the analyses in this report will befocusing on this set of drugs. By pipeline, we meanthat we are counting all drugs in developmentby pharmaceutical companies, from those at thepreclinical stage, through the various stages ofclinical testing and regulatory approval, and upto and including launch. Launched drugs are stillcounted, but only if they are still in developmentfor additional indications or markets. Drugs whosedevelopment has stopped, or whose development iscomplete, are not included. All data were collectedon January 4th, 2021.A key question to answer this year is going to bewhat effect COVID-19 has had on pharma R&Das a whole. Many may have been left with theimpression that the sudden stampede into all thingscorona-shaped has shifted resources away fromother diseases, and slowed development, partly dueto inevitable delays to clinical trials. This isn’t alwayseasy to tease out from the data, but a good placeto start is to look at the total size of the pipelinenow compared to that of a year ago. Should we besetting phasers to stun to reflect another big growthin the pipeline, or has the pandemic effectively putthe industry into cryogenic sleep for the duration ofthe long voyage through 2020?Well, Figure 1 does show a further increase in theoverall pipeline size, but it is somewhat less thanstratospheric. At 18,582 drugs, the pharma R&Dpipeline has increased by 4.76% – still a reasonablerate of expansion, but only around half that seen inthe previous 12 months, when it came in at 9.62%.5/ February 2021But, for context, this sits roughly in the middle ofthe 2019 and 2018 figures of 5.99% and 2.66%,respectively, so it’s by no means an outlier in termsof recent growth rates.This means that there are 845 more drugs indevelopment now than there were this timelast year. But how much of this increase can beaccounted for by new therapies and vaccines totreat or prevent COVID-19 itself? We’ll be lookinginto that in more detail later, but we can report 798new COVID-specific drugs or vaccines were added tothe database during the year. Does this mean thatthe rest of pharma R&D went into stasis?In fact, there were 5,544 new drugs added to thePharmaprojects database during the year, whichcompares to 4,730 through 2019. So, by this metric,those new COVID drugs were just extra; the industrydiscovered almost exactly the same number of nonCOVID drugs as in the pre-COVID days. No evidencehere then of industry endeavour curtailed by thedisease – the Force is still very much with it!In fact, there is another factor complicating anyassessment of COVID-related impact on this figure:improving editorial rigour. This time last year,around 9% of active drugs had not been updatedfor more than 12 months, whereas this year thatfigure is closer to 4%. The end result of the reviewwhich we conduct for many drugs which haven’tbeen updated for over a year is a move of thatdrug to the ‘No Development Reported’ (NDR)status, thus taking it out of the Active data set. So,improved scrutiny of drugs for which little newinformation has been released can lead to morebeing marked as Inactive, thus suppressing thisyear’s Active total. This can be confirmed by lookingat the number of drugs moved to NDR in each year:in 2019, it was 3,170; whereas in 2020, it was up Informa UK Ltd 2021 (Unauthorized photocopying prohibited.)
to 4,607. Without around 1,500 more drugs beingtaken out of the Active data set, our 2021 totalmight have been closer to 20,000 and posting anincrease of 13.2%. The effects of editorial practiceare unavoidable, and this should be borne in mindthroughout this report when looking at absolutenumbers. Fortunately, they have a systematiceffect, so comparisons within each analysis remainperfectly valid.Much like the real universe then, it seems that thepharma R&D universe continues to swell inexorably,and that not even evil alien invaders from theplanet Corona can halt the expansion of its empire.But science fiction is littered with examples offederations and empires which grew bloated andbecame toxic (Star Wars, TV’s Blake’s 7). Is a biggerpharma R&D pipeline necessarily better?To justify its ongoing expanding pipeline and theresulting increased costs, the pharma industry hasto do one simple thing – produce more new drugsapproved for use in patients. We will be analysinghow well it did this through 2020 in detail in ourfollow-up supplement to this report focusing onthe year’s New Active Substance (NAS) launches.But early indications are that, despite the factthat there were initial delays to drug launches inthe earlier part of the year, the pandemic did nothave a noticeable effect on depressing new drugdelivery, with NAS launches again exceeding 70.Coming on the back of two very successful years in2018 and 2019, it seems that, despite the attack ofthe COVIDs, the pharma empire is still very muchstriking ,00017,737Figure 1: Total R&D pipeline size, by year, 020012,000Source: Pharmaprojects , January 20216/ February 2021 Informa UK Ltd 2021 (Unauthorized photocopying prohibited.)
Into The Matrix: The 2021 Pipeline by PhaseHave clinical delays left R&D in cryosleep?Let’s break down those 18,582 drugs into how farup the evolutionary scale they have progressed.Figure 2 shows the pipeline divided by drug globalstatus and once again compares numbers fromJanuary 2021 to those seen a year ago, before wehad succumbed to the intergalactic plague weare currently battling. How well did the pharmastormtroopers fare in the face of the evil virusempire?It’s clear immediately that the vast majority of thegrowth in the pipeline came at the preclinical endof things. The number of drugs at this earlieststage of development rose this year to 10,223, upby 577, or a relatively modest 6.0% (the rate was13.2% last year). Clearly, this is where most of the‘churn’ happens; the majority of the 5,544 newdrugs added will be at the preclinical phase, as willa large proportion of the Death Star-sized 4,744Figure 2: Pipeline by development phase, 2021 versus 202010,2239,64610,2239,6462,5162,5162,676 2,694 2,7472,676 2,694 2,7471,324 1,3371,020 1,0291,020 1,029246 267130 150246 267130 1501,324 1,3376042101 916042101 91[N/A not applicable and is applied to companion diagnostics prelaunch] / Source: Pharmaprojects , January 20217/ February 2021 Informa UK Ltd 2021 (Unauthorized photocopying prohibited.)
drugs which met The Terminator and were eitherconfirmed as discontinued or moved to NDR status.So 2021’s set of preclinical drugs will undoubtedlybe a very different set to those from 2020. But it’sgood to see that the pandemic doesn’t seem tohave affected discovery as yet, although there couldstill be a delayed reaction as the effect of stay-athome orders will inevitably slow down the pace ofbasic research to some degree.quietly ejected from the airlock into deep space,might we be yet to see the impact of COVID-19 onclinical drug numbers? Might this play out over afew years, even if the pandemic is fixed this year?“Yes, that’s definitely possible,” says Andy Benson,Senior Director at Trialtrove. “Most of the impactedtrials from 2020 are now either back up and runningor terminated, but it (the COVID pandemic) couldhave a lingering impact on activity for sure.”As drugs progress down the development pathwaythrough clinical trials, we see the increases innumbers start to taper off. While the growth inPhase I numbers is still substantial at 6.4%, it is only2.0% at Phase II, and 0.9% at Phase III. This can beseen more clearly in Figure 3, which looks at clinicalphase trends back to 2007. We can see that whilePhase III has been stagnating for some time, therises at Phase I and Phase II have definitely slowedcompared to the previous couple of years.There are also some encouraging data suggestingthat the impact might not be as great as somemight have feared. Taking Oncology as an example,Trialtrove actually reported more trial starts in2020 than ever, with the figure of around 4,700representing an increase of 9.0%, somewhatterminating the idea that R&D into other diseaseshas suffered as everyone focused on the virus.However, this does pale in comparison with AntiInfective trial starts, which rose by 220%! The overallimpression is that, rather than diverting researchaway from other diseases, the industry just did awhole lot more. And while there must inevitably besome impact from delays and diversions, therewill also be positive effects which ripple out acrossthe pharma R&D universe from a period of suchan intense firing of
2/ February 2021 Informa UK Ltd 2021 (Unauthorized photocopying prohibited.) Pharma R&D Annual Review 2021 Ian Lloyd, Senior Director, Pharmaprojects Introduction Welcome to Pharmaprojects’ 2021 review of t
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