Innovation is not enough: Why at-home diagnostics is struggling to scale

Published on November 3, 2025

At-home diagnostics have made significant strides, yet widespread adoption continues to be a challenge. Discover the key barriers slowing growth and the strategic priorities diagnostics companies need to address to scale at-home testing.

The rise of home diagnostics has brought a wave of innovation - from AI-powered tools and wearables to smartphone-enabled testing - promising more accessible, decentralized healthcare. Despite these advancements, widespread adoption remains elusive. The challenge is no longer what is technically possible, but what is practically scalable.

The industry’s hurdles fall into three core areas:

  1. Regulatory systems are outdated 
    While there was some flexibility during the pandemic, many next-generation diagnostics still don’t fit within current regulatory frameworks. Approval processes remain lengthy, unclear, and ill-suited for home testing, causing even validated products to face…

    Simon-Kucher blog: Challenges of scaling at-home diagnostics