Interviews with SMEs and larger companies
Seven large companies and 17 small and medium sized companies are included, and the business areas range from drug development, development of diagnostics and service providers. Some of companies both develop drugs and diagnostics, while others develop diagnostics and are service providers as well.
The interviewed large companies seem to have the same approach to developing and marketing biomarkers i.e. that it depends on the needs seen from a medical, marketing and regulatory perspective. Are there any unmet medical needs or regulatory demands from authorities to develop biomarkers?
The increasing demand for biomarkers for clinical studies may increase the market volume, but before starting the development of biomarkers, it is mandatory to clarify certain issued. What are the costs of the illness/burden of disease? How common is the disease (market volume)? Are there alternative solutions? Alternatively, is there a market demand such as competitors developing companion diagnostics for competitive drugs?
The key criteria in large pharmaceutical and research companies’ development of biomarkers are:
- Pharmaceutical companies closely follow the regulatory authorities such as the FDA and their regulations and demands for biomarkers
- Development of biomarkers is exclusively based on market needs and cost benefit analyses
- Pharmaceutical companies mostly develop companion diagnostics
- Development of biomarkers follows the clinical development process of the drug it should be a companion to (see illustration)
- Only biomarkers that are patented, and clinically validated with a demonstrated proof of concept fulfills the criteria for entering into a collaboration with a pharmaceutical company
- The large drug development companies are continuously looking for biomarker candidates and are scouting to find interesting biomarker projects.
- The drug development companies are willing to collaborate and take biomarker development further, when the inventors have achieved patent status, as well as validation and proof of concept.
- Today there seem to be a development gap between the identification of a biomarker and the clinical validation.
Advice from drug development companies to SME’s: Enter into joint projects as for instance a coalition of hospital/dedicated clinicians, a university research group, a diagnostic company and a drug development company. Some institutional investors have technology scouts who screen the scene for promising start-ups.