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Special Report



       YEAR IN REVIEW

       The Top 10 news stories from the bio/pharma industry

       in 2023

             s we begin to look back at  market, grew by 5% in 2022, reaching   PATRICIA VAN ARNUM
             2023, what were the top news  a total value of $429-bn on a net price   Editorial Director
       Adevelopments from  the bio/      basis, according to a recent analysis by   Drug, Chemical & Associated
       pharma industry, which impacted the  the IQVIA Institute  for Human Data   Technologies Association,Inc. (DCAT)
       industry?                         Science. This was driven by a range of
                                         factors, including an increase in health  $76-bn in the fi rst nine months of 2022
       Innovation uptick                 services utilisation, which is now back  to $44-bn for the fi rst months of 2023.
          2023 saw a  sizable  uptick  in  new  to pre-pandemic levels, and the entry of
       drug approvals compared to 2022,  new medicines into the market. Balanc-  Its  changing  fortunes  lead  Pfi zer
       when new drug approvals were down  ing these drivers of growth, was a lack  to  launch an  enterprise-wide  cost re-
       comparative  to recent years.  As  of  of net price increases for branded drugs  alignment program earlier in 2023 that
       December 1, 2023, the US  Food and  and patient out-of-pocket costs  per  is expected to deliver annual net cost
       Drug Administration’s  (FDA)  Center  retail prescription remaining under $10.  savings of at least $3.5-bn, of which
       for Drug Evaluation  and  Research                                 approximately $1.0-bn is expected to be
       (CDER) had approved 52 new mole-    Total net medicine spending is pro-  realised in 2023 and at least an addi-
       cular entities (NMEs) and new thera-  jected to remain unchanged over the  tional $2.5-bn to be realised in 2024.
       peutic biological products, compared to  next  fi ve  years,  refl ecting  structural  Still, in its third-quarter 2023 fi nancial
       just 31 approvals at this time in 2022,  market dynamics and competition,  as  results released  on October  31, 2023,
       which saw only 37 new drug approvals  well as the effects of new policies and  Pfi zer  reaffi rmed  in  its  full-year  2023
       for the full-year 2022.           legislation. US market growth will re-  non-COVID  operational  revenue
                                         turn to pre-pandemic projections by  growth expectation of 6% to 8% com-
          The 52 approvals thus far in 2023  2024, but embeds new pressures on net  pared to 2022 and revenues projected at
       are on par with recent years, excluding  growth in later years, according to the  $58.0-bn to $61.0-bn for the full-year
       2022, when new drug approvals were  IQVIA analysis.                2023, which would keep the company
       down. In 2021, 46 NMEs and new thera-                              the number bio/pharma company based
       peutic biologics had been approved by   Growth from oncology, obesity and  on revenues.
       early December en route to a total of  neuroscience medicines will be signifi -
       50 new drug approvals (NMEs and new  cant, but will be offset by declines in  Off the charts for Lilly and Novo
       therapeutic biological products) in the  immunology and other areas, result-  Nordisk
       full-year 2021. A similar strong pace of  ing in a compound annual growth rate   On a product basis, two companies –
       new drug approvals by FDA’s CDER  of between -2% and +1% for the total  Eli Lilly and Company and Novo
       was seen in 2020, when 47 new drugs  market through 2027.          Nordisk –  have  seen  dramatic  growth
       were approved in early  December en                                thus far in 2023 for their diabetes and
       route to a total of 53 NMEs approved  Changing fortunes for Pfi zer  weight-management drugs,  respec-
       for the full-year 2020.  The 53 new   A  key  issue  for  Pfi zer  in  2023  tively Lilly’s  Mounjaro (tirzepatide)
       drugs approved in 2020 represented the  has been the drop in revenues for its  and Novo Nordisk’s  Ozempic (sema-
       second highest level of approvals in the  COVID-19 products – its COVID-19  glutide) for  diabetes,  Wegovy (sema-
       past decade, except for 2018 when 59  vaccine, Comirnaty, and oral treatment  glutide) for  weight-management,  and
       new drugs were approved.          for COVID-19, Paxlovid (nirmatrelvir/  Saxenda (liraglutide).
                                         ritonavir) – which drove a 41% opera-
       Slowing growth for the US bio/    tional  decrease in third-quarter  2023   Revenues for  Lilly’s  Mounjaro
       pharmaceutical market             revenues. The decline in these products  soared in the fi rst nine months of 2023
          The US  market for  medicines, the  contributed to an overall revenue dec-  to $2.96-bn from only $203-mn in the
       largest national market globally, repre-  line  of  42%  for  the  fi rst  nine  months  year-ago period. Mounjaro launched in
       senting approximately 40% of the global  of 2023, which saw revenues fall from  the US for the treatment of Type-2 dia-

       Chemical Weekly  January 9, 2024                                                                183


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