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Special Report



                          Small-molecule generics sales continued to grow in 2023
                Global generics market by region   2018-2023 contribution to  Over the past fi ve years...
                            $Bn                    sales growth by region: %
                                     +4%                  100                Europe contributed almost ~30%
                                           307                    ROW
                                281  289                                       of generics market growth
                    262   266                             29%     US               (EU4+UK=18%)
              247              24%   25%   26%
                    23%  23%                                      India
             22%                      9%    9%            4%                   US still has ~ 30% market
                    7%    8%    8%                        10%     China
              7%                           16%                                shrare, but it contributed <5%
             17%   19%   18%   18%   17%                  12%     LATAM            to global growth
                                                                  Europe
             20%    20%  20%   20%   21%   22%            17%                  Non-core markets including
                                                                              CIS (11% CAGR). India (10%)
              33%   31%  31%   30%   28%   27%            28%                   LATAM (9%) have seen
                                                                                   stronger growth
              2018  2019  2020  2021  2022  2023       2018-2023
               US       Europe       China        LATAM       ROW
                                          Fig. 3: Small-Molecules Generics Market
       Notes: Generics include unbranded and branded generics, Rx only, biosimilars are  excluded;
       Argentina and Turkey excluded due to Fx fl uctuations.
       Bn is billion, LATAM is Latin America. ROW is rest of world. EU4 is France, Germany, Italy & Spain. CAGR is compound annual growth rate.
       Source: IQVIA MIDAS Q4 2023
       tains more than 200 active substances of  supply by making demand more predict-  Fine Chemicals Group (EFCG), supports
       medicines considered critical for health-  able,  encouraging  diversifi cation,  and  potential  policy  moves  to  advance  fi ne
       care systems across the EU/European  boosting manufacturing in the EU.  chemical manufacturing in the EU.
       Economic Area, for which continuity of
       supply is a priority and for which short-  Those efforts will also be part of   Cefi c’s EFCG issued a set of recom-
       ages should be avoided.  The list con-  discussions in the Alliance, which will  mendations last November (November
       tains active substances of innovator and  help the European Commission to iden-  2023), which included fostering sup-
       generic drugs covering a wide range of  tify what it terms as “pipeline investment  portive legislative  policies  for  EU  API
       therapeutic areas and includes vaccines  projects,” which could benefi t from EU  manufacturers  that  emphasized  sustain-
       and medicines for rare diseases. It refl ects  and national funding to strengthen manu-  able growth and reshoring initiatives
       the outcome of a review of 600 active  facturing in  the EU.  The  Alliance  will  while investing in innovation and shift-
       substances taken from six national lists of  also look at how market incentives, such  ing procurement focus on supply security
       critical medicines. The goal is update that  as capacity reservation contracts and joint  and social-environmental standards. In
       list on an annual basis.          procurement, can be used to enhance  making those recommendations, EFCG
                                         security of supply of critical medicines.  pointed to the continued decline of Euro-
          The European Commission carried  In addition, the  Alliance is taking a  pean-based API production with respect
       out an analysis of supply-chain vulner-  holistic view of the supply chain, and  to the supply of critical medicines. From
       abilities for a fi rst tranche of 11 critical  its members will seek to identify new  a global production share of 53% in 2000,
       medicines on the Union list, published  synergies to work with each other more  the EU’s share of API production in 2020
       in April 2024. The outcome of this work  effectively, including creating new part-  fell to 25% due to increased competition
       will inform the scope of the mandate  nerships. Given the global nature of the  from lower-cost countries and EU pricing
       of the Critical Medicines  Alliance. In  supply chain, these new partnerships  and procurement policies not favourable
       addition, the European Commission will  could  bring  the  diversifi cation  of  the  to EU-based domestic manufacturing,
       proceed with evaluating the remaining  supply chain of critical medicines.  according to information from EFCG.
       medicines in the Union list. It will then
       recommend priority actions for the near   The European Chemical Industry  REFERENCE
       future and propose new tools to address  Council  (Cefi c),  which  represents  EU  1.  P. Van Arnum, “Global Pharma Indus-
       the challenges it has identifi ed. In parti-  chemical  manufacturers, is  a member   try Outlook: The Ups and Downs &
       cular, the recommendations will focus  of the Critical Medicines Alliances, and   Projections Near Term,” DCAT Value
       on mitigating structural risks, reinforcing  through its sector group, the European   Chain Insights, May 30, 2024.


       190                                                                       Chemical Weekly  July 2, 2024


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