Regulatory architecture as strategic constraint: How pharmaceutical marketing operates within a single-variable framework:evidence from a mixed-methods study at a French subsidiary of a global pharmaceutical company,updated with sector-wide evidence (2020–2025)

Abstract

Background

Classical marketing theory posits that firms compete across four strategic variables — Product, Price, Place, and Promotion (the 4P framework). The pharmaceutical sector presents a structurally distinct case: a heavily regulated environment in which three of these four variables are largely fixed by state authority, leaving promotion as the sole domain of active managerial discretion. While this constraint has been noted descriptively in sector-specific marketing literature, its systemic implications for strategy, organizational design, and competitive behaviour have not been fully theorized.

Objective

This paper examines how pharmaceutical marketing strategy is structured and enacted when regulatory architecture removes the firm’s agency over product design, pricing, and distribution. We further investigate how this structural constraint is experienced differently across hierarchical levels within a single organisation, and how the digital and AI-driven transformation of 2020–2025 has modified the dynamics of this framework.

Methods

A qualitative single case study was conducted at the French subsidiary of Astellas Pharma between April and July 2015. Fifteen semi-structured interviews were conducted with stakeholders across three hierarchical levels: market research analysts (n = 5), product managers (n = 6), and senior decision-makers (n = 4). Inductive thematic analysis was applied. For the 2025 update, secondary documentary analysis of LEEM data, IQVIA reports, and European regulatory texts was integrated as a triangulation layer.

Results

Across all informant groups, pharmaceutical marketing was consistently framed as effectively reduced to a single operative variable: promotion. Within this domain, further constraints from the Medical Visit Charter, anti-gift legislation (Loi Bertrand), and centralised headquarters messaging further compress subsidiary-level strategic space. A three-tier perception model emerged across hierarchical levels. The 2020–2025 period revealed a structural transformation of the promotional variable itself through digital technologies and artificial intelligence.

Conclusion

The pharmaceutical sector does not merely adapt classical marketing frameworks — it operates under a structurally distinct strategic logic, here termed the Single-Variable Promotional Model (SVPM). The digital and AI-driven transformation currently restructuring the promotional variable amplifies, rather than alters, the SVPM’s core constraint architecture, creating what we term SVPM 2.0: a model in which the unique promotional variable is simultaneously amplified in reach and precision, and increasingly inadequately governed by existing regulatory frameworks.