Who ’ s on top in pharma ?
Despite the many challenges it has faced , the pharmaceuticals industry continues to develop drugs , get them through clinical trials and market them commercially . This year , analysts believe that its total value will top $ 1.5 trillion , while total R & D spending will be over $ 250 billion .
FDA approvals are continuing upwards . When Loqtorzi was approved on 27 October for combination treatment of recurrent or metastatic nasopharyngeal carcinoma , the number of large and small new molecular entities ( NMEs ) approved in 2023 to date reached 46 , compared with 37 in 2022 and 42 in 2021 .
Oncology remains the most important indication , accounting for nine approvals and 38 % of product launches in the US so far this year . However , the most successful launches of recent years have been in obesity and diabetes : Novo Nordisk ’ s Ozempic , and Wegovy , and Eli Lilly ’ s Mounjaro . Their success has inspired many more such therapies in clinical trials .
By far the biggest deal so far in 2023 has been Pfizer ’ s acquisition of Seagen for $ 43 billion . This was driven by oncology , to unite Seagen ’ s ADC technology with Pfizer ’ s existing expertise , as well as to boost a thinning pipeline . It dwarfed the second largest , Merck & Co . buying Prometheus Biosciences for about $ 10.8 billion to boost its immunology pipeline .
Most other big acquisitions – such as Astellas buying Iveric Bio , Novartis buying Chinook Therapeutics , Sanofi buying New Jersey – based Provention Bio – were also in biopharma but none had exceeded $ 6 billion . This continued the trend from 2022 , which was also a relatively quiet year for M & A , in large part because of increasingly stringent scrutiny by the US Federal Trade Commission , as well as high biotech valuations .
With Seagen and other acquisitions from 2021 and 2022 , Pfizer will remain by far the largest pharmaceutical company . It was already a clear leader at the end of 2022 , when sales grew by 1 % to just over $ 100 billion despite the fall in sales for the COVID vaccine Comirnaty that had been its top seller in 2021 .
The buy makes Pfizer much more than twice as big as second-placed AbbVie , which itself made the largest acquisition in 2022 in Horizon Therapeutics to take sales to $ 58 billion . Johnson & Johnson ranks third and Merck fourth , both at just over $ 52 billion . Merck ’ s recent rise has been driven by its blockbuster cancer immunotherapy treatment , Keytruda , which is expected to become the world ’ s bestselling drug in 2023 .
The flip side of new drugs is patent expiries . Merck will be among the hardest hit by these in 2023 . Evaluate Pharma expects it to lose over $ 2 billion / year in sale from the loss of exclusivity for the DPP-4 inhibitors Januvia and Janmet and $ 4.2 billion / year on the COVID-19 antiviral Lagevrio . Likewise , Sanofi will be hit by biosimilar competition to its insulin product Lantus .
Top rank in new drug development at the start of 2023 belonged to Roche , which had 194 products in its pipeline . Novartis was in second place . The two Swiss firms were fifth and sixth in terms of sales at the start of 2023 , following muted growth for the former and a small fall in sales for the latter in 2022 , in large part because of the spin-offs of generics maker Sandoz and the biosimilars division .
“ There was a lot of inventory build-up during COVID ,” said Brian Shaughnessy , newly appointed chief commercial officer at Suven Pharma an Indian CDMO that is now PEowned and looking to go global . “ Now companies are stocked up and ready , leading to some CDMO overcapacity but investment is continuing .”
Judy Boan , director of business development at Sterling Pharma Solutions , also noted the distorting effects of the COVID spike , since when the industry has been playing catch-up and there have been supply-demand imbalance . ADHD and some oncology drugs , for example , are in short supply and some cholesterol treatments are in overcapacity .
Nonetheless , Sterling has enjoyed continued growth this year . “ We have lots of specialisms , so we can pivot to one if another is down ,” she said .
“ On the customer side , we are definitely through some of the pandemic-triggered adjustments , like reductions in elective surgeries . We have also seen recovery in demand for our analgesics , so we are back to a steady state in terms of supply chain ,” said Shackley of Veranova .
Markus Blocher , CEO of Dottikon , said that the company had doubled its end-to-end GMP capacity , with the final parts coming onstream shortly . “ We are mostly looking for German sponsors here ,” he said . “ We have seen more late-stage chiral projects but also more early market projects from emerging pharma .”
New modalities
In addition , Roth noted , COVID , drug shortages and other ongoing supply chain issues have led the US Congress have sought to find out more on where pharmaceutical ingredients of all kinds come from . This has led to some rather heavy-handed demands for information that are still being worked on .
“ That said , it ’ s an area of interest to the CDMO space as we try to understand what we are making , where things are coming from and who should be accountable for these things ”
18 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981