The skin cancer market

Both actinic keratosis (AK) and basal cell carcinoma (BCC) are very common diseases. 

  • AK is by far the most prevalent skin cancer condition affecting up 60 million people in the US alone.
  • Current drug therapies for AK include topical chemotherapy such as 5-Fluorouracil (5-FU) and the immune modifier imiquimod that are both associated with severe local skin reactions.
  • BCC is the most common type of skin cancer. In the US alone there are an estimated 4 million new cases each year. There a limited number of therapies available for BCC and most tumors are removed by surgery that may cause pain and scarring.
  • Few drug therapies are available for BCC and may be associated with significant side effects. Hence there is a market opportunity for a safe and efficacious treatment of BCC.
  • The global basal cell carcinoma market was estimated to be valued at 6.7 B US$ in 2021, of this approximately 40% is the drug market and hence the value of drugs is estimated at 2.7 BUS$ and is forecasted to reach 3 BUS$ by 2025.

BCC is the most common type of skin cancer with a, the global market annual sale of is valued 6.7 billion USD.

Actinic Keratosis

Actinic keratosis is the most common precancerous skin condition

60% of Caucasians older than 60 years has actinic keratosis (AK) ranging from 10% in people aged between 20 and 30 years, whereas it is more than 90% in people over 80 years. There is substantial evidence that AK may develop into squamous cell carcinoma (SCC), and it may also serve as a marker for higher risk of developing BCC and even malignant melanoma.

Existing topical treatments

  • Diclofenac, is a topical non-steroidal anti-inflammatory agent, applied twice daily for 8-12 weeks, with expected 25-40% clearance after 2 months. The recurrence rates after the end of treatment is high but local skin reactions are mild.
  • Imiquimod, is a topical immune modulating agent applied once daily for 2 weeks, followed by 2 weeks rest and 2 weeks treatment. It has an expected 40% clearance after 2 months with moderate recurrence rates after end of treatment. There are several side effects of the treatment which can be severe.
  • 5-FU, is a topical cytotoxic chemotherapeutic agent applied twice daily for 2-4 weeks. It typically results in up to 90% clearance rate of lesions but is associated with side effects that can be severe.
  • The side effects of existing treatments are often associated with debilitating severe local skin reactions (LSR). The LSR’s are transient and resolve after end of treatment, however they may impact the quality of life and adherence which limits the effect of the treatments.
Local skin reactions of existing treatments affect patient adherence to therapy and therefore compromise patient satisfaction.

There is a clear unmet need for safe and effective treatments for AK.

Basal cell carcinoma

BCC is a very common cancer disease

Basal cell carcinoma is the most common non-melanoma skin cancer, accounting for about 80% of all cases of non-melanoma skin cancer. Newly diagnosed cases (incidence) in US alone is 3.6 million patients with BCC each year. The global market is estimated to annual sales of 6.7 B USD in 2021, of this more than 50% are from medical procedures, 40% are from medical treatment and 10% with other treatments, hence the value of medical treatment is estimated at approximately an annual sale of 2.7 B USD and forecasted to grow to reach 3 B USD by 2025.

The most common treatment for BCC is surgery. For superficial BCC, approved medications such as immune modulators (imiquimod) and topical chemotherapy (topical 5-fluorouracil) are available, as are medical procedures such as photodynamic therapy, lasers and cryosurgery.

For more serious cases, radiotherapy and the systemic treatment vismodegib with severe side effects is available. Vismodegib is branded under the name Erivedge from Roche, and has a revenue in 2021, approximately 800 million SEK.

Locally advanced basal cell carcinoma on the scalp of an 89-year-old woman a) before and b) after 10 weeks of therapy with the hedgehog signal pathway inhibitor vismodegib.
Multiple BCC on back of a 62-year-old man with nevoid BCC syndrome c) before and d) after 8 months of therapy with a hedgehog signal pathway inhibitor LDE225. His seborrheic keratoses did not change during therapy.

Vismodegib is branded under the name Erivedge from Roche.
Yearly revenue in 2021, around 800 million SEK.