In the past 12 months, over 450 deals involving diagnostics were signed, based on analysis of data in the Cortellis database from Clarivate Analytics. Breaking these deals down according to the therapeutic area where possible (Fig. 1a), the most common defined applications were in oncology—an area in which a lot of work is being focused on identifying biomarkers, particularly those involved in the immune response that could support immuno-oncology therapies. Such therapies have already had a major impact on the treatment of several cancers, but despite this success, typically a substantial proportion of patients do not respond to treatment, and so there is considerable interest in approaches that could identify biomarkers of treatment response. For example, NanoString Technologies and HalioDx entered into a collaboration to develop and commercialize gene expression assays for immuno-oncology applications in April 2016. Shortly before this, NanoString Technologies also began a collaboration with Merck and Co. to develop and commercialize a novel diagnostic assay to predict response to Merck ‘s immune checkpoint inhibitor Keytruda (pembrolizumab).
The second-highest number of diagnostic deals with a defined therapeutic area were for infectious disease applications. Among these deals, those related to viral infections—particularly Zika virus— and Clostridium difficile infection were prominent—the focus of six deals and eight deals, respectively. For example, the US government provided funding to several developers of diagnostics for Zika virus infection, including Clinical Research Management, Hologic, InBios International, OraSure and DiaSorin.
Diseases of the central nervous system were the third most prominent focus. One of the leading categories in this segment was Alzheimer’s disease, with 13 deals signed, reflecting the key need to identify patients earlier in the course of the disease to increase the likelihood that disease-modifying therapeutics could have an impact. A frequent focus of such deals was tracers for positron emitting tomography (PET) imaging, which can be used to monitor the levels of pathogenic amyloid plaques in the brain.
A breakdown of the type of deals being signed is shown in Fig. 1b. We also reviewed the deals for which a value was disclosed (Table 1). The top deal in this category was Grifols’ acquisition of the nucleic-acid-testing donor-screening unit from Hologic for transplantation and transfusion screening for $1,850 million. The second-highest deal was another acquisition, of specialty pharma company Mallinckrodt’s nuclear imaging business by IBA Molecular. The deal includes an up-front payment of $574 million and a line of diagnostics products.
Figure 1: Diagnostic deals in the past year. A total of 457 diagnostic method deals were collected for the period March 2016–March 2017 from the Clarivate Analytics Cortellis database. Diagnostic methods covers deals such as those involving assays, biomarkers, genomics, imaging, instruments, medical devices, screening and radiolabelling. (a) Deals broadly categorized by therapy area (where possible). (b) Deals categorized by deal type, using the four top-level categories company, drug, patent and technology.
Table 1: Selected major diagnostic deals by value in the past 12 months. Source: Clarivate Analytics Cortellis database. BARDA, Biomedical Advanced Research and Development Authority; NS, not specified.
