One of the important factors in drug development is biomarker co-development. It is usually considered that efficacy-predicting biomarkers can secure a success of the clinical development by stratifying the responders from non-responders, which means identifying a group of patients who are [more] sensitive to the treatment. This strategy is very wise indeed. But why not considering the biomarker development as a venture of its own? Is there any market for that and how big can it be?
“The global biomarkers market is estimated to reach USD 53.34 Billion by 2021 from USD 27.95 Billion in 2016, at a CAGR of 13.8% from 2016 to 2021.” MarketsAndMarkets
The biomarkers market is segmented on the basis of product, type, application, disease indication, and region.
1. On the basis of product, the market is segmented into consumables, services, and software. The consumables segment is estimated to account for the largest share of the global market in 2016. The large share of this segment is primarily attributed to the lower price of consumables than that of screening and automation instruments.
2. Based on type, the market is segmented into safety, efficacy, and validation biomarkers. The efficacy biomarkers segment is further classified into predictive, surrogate, pharmacodynamic, and prognostic biomarkers. In 2016, the safety biomarkers segment is expected to account for the largest share of the market. However, the efficacy biomarkers segment is estimated to register the highest CAGR during the forecast period. (Source here)
In other words, there is a considerable market for developing a new efficacy biomarker for Temodex or Temozolomide as an independent product. Who will benefit from systemic temozolomide the most? Who will instead benefit from Temodex? Who needs both? Who needs something third?
Good biomarkers are supposed to answer that questions before the treatment is initiated and prevent both unnecessary suffering of the patient and unnecessary high healthcare costs, as the biomarker kit price is usually incomparably lower than the price of the therapeutic treatment(s). Market-wise, more than 26,000 patients with primary malignant tumors are expected to be diagnosed this year only in US, and majority of them can potentially benefit from use of either Temodex, systemic temozolomide, or both.
What more can be said today? The sample collection and initial screening is currently ongoing for patients receiving both local Temodex and systemic temozolomide (https://press.aktietorget.se/DoubleBondPharmaceuticalInternational/82136/629402.pdf).
P.S. For those who want to know how this process usually goes enjoy FDA’s video here explaining the basics.