Competitive landscape for targeted therapies in oncology (TO)

425 assets across 19 pharma companies, segmented by tumor type, phase of development, modality and ownership

Some takeaways & stats:

• TO includes drugs designed to treat cancer with a specific driver mutation, most often requiring patients to take a specific companion diagnostic test to confirm eligibility. ~50% of all cancers have a potential driver mutation and ~30% of these have an approved drug (Source: GS)
• TO drugs are traditionally associated with small molecules, but this analysis uses the term in a broader context, encompassing antibody biologics (i.e. CKIs, mAbs, ADCs, etc.) as well to show a more picture of active development across Pharma pipelines
• This is a mature market, with 147 marketed assets (~35% of the total) represented here alone. The rest by dev stage: Ph 1/2 (172 assets, ~40%), Ph 2 (58 assets, ~14%) and Ph 3 (48 assets, ~11%)
• The vast majority of assets are wholly owned: 337 or ~79%. The only companies with primarily partnered assets are Merck (~61%) and Sanofi (~75%)
• The overall split between biologics and small molecules here is roughly even (~48% vs ~52% respectively)
• Sales for small molecule TO drugs are >$30B globally, with '26E estimates at >$40B (although historically, these have been overly optimistic)

Antibodies are on a different scale - global sales for the class exceed $100B, with Keytruda alone anticipated to reach $30B by 2028

As the space has evolved, we've seen a few recurring themes:

• The initial playbook was finding a validated target and getting to market as fast as possible, oftentimes via the FDA's accelerated approval pathway (showing impressive ORR in a Phase 2 with maximum tolerated dose)
• FDA reforms around the AA pathway (i.e. getting tougher on starting a RCT), Project Optimus (dosing) + kinase targets getting picked over have changed this. Innovation has shifted towards higher risk, higher reward plays: less validated targets, drugging approaches & technology

Examples include Amgen's Lumakras and Mirati's Adagrasib (KRAS G12C) or novel approaches within ADCS or bispecific antibodies

• The space is overall incredibly competitive. Emblematic of broader crowding across the industry, nearly every target / approach has H2H data
• Lastly, a lot of initial acquisitions in this space (i.e. Lilly / Loxo, Pfizer / Array) were done on overly optimistic forecasts that later saw significant downward revisions.

M&A had been slow, but perhaps now reversing, headlined by BMS / Mirati earlier this year ($5.8B)