Digital Health Integration Assessment and Maturity of the United States Biopharmaceutical Industry: Forces Driving the Next Generation of Connected Autoinjectable Devices

Abstract

Autoinjectable devices continue to provide real-life benefits for patients with chronic conditions since their widespread adoption 30 years ago with the rise of macromolecules. Nonetheless, issues surrounding adherence, patient administration techniques, disease self-management, and data outcomes at scale persist despite product design innovation. The interface of drug device combination products and digital health technologies formulates a value proposition for next-generation autoinjectable devices to power the delivery of precision care at home and achieve the full potential of biologics. Success will largely be dependent on biopharma's digital health maturity to implement this framework. This viewpoint measures the digital health maturity of the top 15 biopharmaceutical companies in the US biologics autoinjector market and establishes the framework for next-generation autoinjectable devices powering home-based precision care and the need for formal digital health training.

Keywords: artificial intelligence; autoimmune; autoinjector; biopharma; digital health; disease management; drug delivery; injectable devices; oncology; rare diseases.

Figure 1

Framework for biopharma digital maturity assessment. This figure demonstrates biopharma’s overall approach toward digital health based on a segmentation analysis covering clinical research and drug discovery, lifecycle management, product commercialization, and beyond the molecule. Companies were classified within three distinct digital health maturity categories. Radar charts show individual company ratings for each segment, and shaded regions represent the average for each category.

Figure 2

(A) Distribution of biopharma’s digital health partnerships, investments, and acquisitions from 2010 to 2020. Investments included direct investments from biopharma or a subsidiary arm of the parent company. Partnerships are the preferred format for achieving digital health maturity. (B) Digital health companies with at least three different biopharma interactions (eg, investment, partnership, and acquisition) were plotted against the four digital health segments. Currently, clinical research and drug discovery digital health companies encapsulate the largest segment of investments or partnerships from biopharma. None: the analysis did not return any digital health companies focusing on the beyond the molecule segment, which met the minimum criteria of at least three different biopharma interactions.

Figure 3

Biopharma portfolios and pipeline by therapeutic areas. Heatmaps showing (A) marketed molecules across all routes of administration, (B) marketed injectable molecules, and (C) phase I to III pipeline molecules proposed for injectable administration. Biopharma pipeline assessment for the US market was conducted via the EvaluatePharma database as of October 1, 2020. Therapeutic areas defined in this paper were standardized across each biopharmaceutical company. For Novartis and Pfizer, generic manufacturing has been included in the count.

Figure 4

Framework for next-generation connected autoinjectable devices. This framework for next-generation connected autoinjectors demonstrates the technological hierarchy of design (left) that transitions the simple device to a connected therapeutic. Through this design evolution, the autoinjector shifts to become the focal point of decentralized precision care for many chronic conditions, powering artificial intelligence disease management systems that impact overall patient care (right).