2025’s Therapy Area Growth Drivers And Brakes: Part Two

Another near-term catalyst for Darzalex’s growth are potential approvals in the US and Europe for first-line transplant eligible patients off the back of the product’s PERSEUS trial data presented at the America Society of Hematology congress in 2023 (Also see "Sanofi Touts Sarclisa’s Late-Bloomer Status In Frontline Myeloma" - Scrip, 11 Dec, 2023.). J&J is also confident that its second-generation combination product, Darzalex Faspro, will help it maintain sales in the face of potential Inflation Reduction Act rebates. (Also see "Darzalex, Medicare Negotiation And The Strategic Importance Of Combination Products" - Pink Sheet, 25 Jul, 2024.)

Two more of the top five growth drivers in this category are MM treatments developed by Johnson & Johnson – Carvykti and Tecvayli. Both Carvykti, an anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy, and Tecvayli, a BCMA and CD3 bispecific antibody, have been  approved recently. Whilst Darzalex does a great deal of the heavy lifting in this segment for J&J, the company has strong belief in its wider myeloma portfolio. In the second-quarter 2023 earnings call, CEO Joaquin Duato said the expectation was that three out of every four myeloma patients would be on a treatment containing a J&J drug by 2030. According to Evaluate’s forecast data, J&J’s products will represent 65% of all MM sales come 2025. 

The third largest growth driver in blood and blood malignancies is BeiGene, Ltd.’s Brukinsa. Brukinsa is a Bruton's tyrosine kinase (BTK) inhibitor forecast to make the majority of its sales in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia (CLL). Brukinsa has seen impressive growth in CLL in particular since its US approval in January 2023. Current forecasts show Brukinsa incrementally gaining market share on current leaders Venclexta, Imbruvica and Calquence. By 2026, Beigene is predicted to have the second-largest slice of the CLL pie, after AstraZeneca PLC’s Calquence, with a 22% share of the $9.8bn market.

Dermatoses

Two of AbbVie Inc.’s immunology offerings, Skyrizi and Rinvoq, feature in the top five growth drivers for dermatoses. Skyrizi and Rinvoq are forecast, according Evaluate consensus, to be AbbVie’s best selling assets by 2030 and the company’s biggest hope of offsetting the decline in Humira sales in the wake of its patent expiry. (Also see "AbbVie’s Ex-Humira Immunology Business Is Booming" - Scrip, 25 Jul, 2024.)

Psoriasis sales are forecast to make up the 75% of Skyrizi’s income in 2025, however, this share of the anti-IL-23 antibody’s topline sales is predicted to fall to 50% by 2030 – as sales in Crohn’s disease and ulcerative colitis gather momentum. However, despite this relative decline, Skyrizi is set to continue growing in psoriasis through to 2030 – when it will make up over a third of the indication’s $29.5bn sales. Rinvoq, on the other hand, is forecast to make just $1.4bn of its $7.3bn total from dermatitis and eczema sales in 2025. Still,  this represents an 8% share in the indication market and current forecasts show AbbVie holding onto this cut through to 2030.

The Regeneron Pharmaceuticals, Inc. and Sanofi product, Dupixent, is the current market leader in atopic dermatitis, according to Evaluate data, having made nearly $9bn in sales in 2023. This value is forecast to rise to $11.4bn in 2025. Dupixent’s market share in dermatitis is predicted to fall after 2023 – from 75% down to 52% in 2030 – despite sales growth through to 2031 – as the market fragments to newer entries.

Almirall SA and Eli Lilly and Company’s Ebglyss has had a successful launch after its approvals in the EU and the UK. (Also see "Almirall Pleased With Promising Start For Ebglyss" - Scrip, 22 Jul, 2024.). However, the main driver of the product's $434m growth in 2025 is FDA approval, which had been delayed. Lilly received a "manufacturing complete" response letter in October 2023 for the atopic dermatitis drug but has since refiled and, if successful, can look forward to $1.7bn in sales by 2030.

Cosentyx, Novartis AG’s IL-17A antagonist, was approved for plaque psoriasis in 2015 in the US, Japan, and the EU. This makes it one of the older drugs in the growth driver category. Although the drug is still experiencing sales growth in its expanded psoriasis settings these gains are, according to Evaluate forecasts, due to taper off after 2026 then go into decline as Cosentyx loses its exclusivity come 2029. However, Novartis has already committed to a comprehensive lifecycle management program with an expanded indication profile including some dermatology treatment areas.

Generalized Cardiovascular Disease

The largest growth driver in the generalized cardiovascular disease is the Merck & Co., Inc. and Bristol Myers Squibb Company therapy, Winrevair. The pulmonary hypertension treatment is forecast to grow by more than three times as much as the next largest driver – adding $1.3bn in growth over its previous year’s total. The activin signaling inhibitor was approved in March 2024 and saw a very successful first-quarter of sales – although this has been aided by stocking. Winrevair is currently forecast to capture over 45% of the pulmonary hypertension market by 2030 with Merck aiming to expand the drug into patients with earlier as well as more advanced disease states. (Also see "Merck Investors Keeping A Close Watch On Winrevair Uptake" - Scrip, 25 Apr, 2024.)

Two familial hypercholesterolaemia treatments, Novartis’s Leqvio and Esperion Therapeutics, Inc.’s Nexletol, also made it into the top growth drivers for cardiovascular diseases. These products are forecast to be the top two market leading assets in familial hypercholesterolaemia come 2030. Novartis hopes that Leqvio’s sales growth will offset the decline in Entresto sales after its patent expires in 2025. However, Leqvio’s launch has been somewhat hindered by reimbursement challenges. Esperion’s lipid lowering drug Nexletol saw a large upgrade to its forecast sales potential in March 2024 when the FDA broadened its label by some margin – including for usage alongside statins and in primary hyperlipidemia as well as cardiovascular risk reduction. This event added nearly $200m to Nexletol’s 2025 consensus forecast.

Although Bristol’s Camzyos is one of the top growth drivers in CVD, the sell-side has become less confident in its potential as Cytokinetics, Inc.’s competing myosin inhibitor, aficamten, gathers clinical momentum. Camzyos’s forecasts for 2026, the first predicted full-year of aficamten’s sales, have been downgraded by nearly $300m over the last year. However, Camzyos is still forecast to hold the market lead in hypertrophic cardiomyopathy until 2028 and to still maintain a healthy share of the indication’s sales beyond that. (Also see "Cytokinetics’ Aficamten Data Could Be Best In Class, Cardiologists Say" - Scrip, 13 May, 2024.)

The growth of Amgen’s Repatha was largely driven by increasing volume thanks to changes in formulary coverage at the expense of net sales prices. However, on the company’s fourth-quarter 2023 earnings call, it was stated the increase in volume more than offset the decline in price. (Also see "Amgen Sees Strong Q4 Growth Even Without Horizon Contribution" - Scrip, 6 Feb, 2024.)

Repatha is, according to Evaluate data, forecast to remain the market leader in hyperlipidaemia until at least 2030, at which time it could still retain 25% of the market share – more than twice that of its next nearest competitor Viatris Inc.’s Lipitor.

In part three of this series, In Vivo will examine the remaining four of the top ten largest growth driving therapy areas for 2025.