New Delhi [India], June 7 (ANI): The speed of semaglutide genericisation and GLP-1 pricing after 2031/32 will likely depend less on demand and more on peptide API manufacturing capacity, Goldman Sachs expects. China already leads in synthetic API supply and is likely to be the key source for global generic players launching semaglutide ahead of patent expiry in 2027. The big unknown is whether CDMO capacity built for branded drugs gets diverted to generics, and whether SPPS can scale fast enough to meet a market Goldman models at ~99,000 kg of peptide API by 2030.

Goldman Sachs models US GLP-1 sales at $66 billion by 2030, split 50/50 between orals and injectables. To serve that market, about 35,000 kg of peptide API will be needed by 2030 and 57,000 kg by 2035. Outside the US and China, ex-US ex-China AOM sales are projected at $43 billion by 2030, requiring roughly 32,000 kg of API by 2030 and 48,000 kg by 2035. In China, where generic injectable semaglutide will dominate, $4.5 billion of AOM sales by 2030 translates to about 12,000 kg of API, rising to 13,000 kg by 2035.

On manufacturing, two routes dominate: fermentation/genetic engineering used by Novo Nordisk for semaglutide, liraglutide and planned zenagamatide; and synthetic SPPS used for tirzepatide, retatrutide and survodutide. Goldman expects most generic manufacturers to use SPPS because upfront capex is much lower than fermentation, though SPPS is harder to scale. The analysis assumes all non-Novo peptide AOMs will use SPPS.

Novo's fermentation approach likely keeps it the lowest-cost producer. Global peptide CDMOs are currently focused on branded products and long-term partnerships, which could be a risk if part of that capacity shifts to generic supply. Significant peptide API capacity via SPPS already exists in China, but visibility is low and questions remain on yields, utilisation and output. If oral semaglutide demand stays high and price elasticity drives volumes, implied capacity utilisation could rise sharply.

Goldman cautions that brand loyalty, price elasticity and the 'consumerised' nature of obesity add uncertainty to how fast semaglutide genericises. Upcoming launches in Canada, Brazil, India, Mexico and China will offer early signals, but those may not fully apply to the global AOM market. With limited industry data, the report highlights directional relationships that will be updated as capacity and yield data become available. (ANI)