Product Introduction Milestones

Last updated: 2026-03-27

Overview

Tracking the journey of a health product from development to introduction is essential for strategic planning. This document defines the key milestones tracked in the ALIGN Global Hub.

Tracked Milestones

The Hub monitors the following critical points in a product’s lifecycle:

1. Proof of Concept

Definition: The point at which a product has demonstrated its intended effect in a relevant model (e.g., animal model or early human trials).
Significance: Marks the transition from discovery to formal development.

2. Marketing Authorization

Definition: Formal approval from a National Regulatory Authority (NRA) or a global body (e.g., WHO PQ, US FDA) to market and sell the product.
Significance: A prerequisite for procurement and large-scale introduction.

3. First Launch in LMICs

Definition: The first time the product is commercially available or introduced through a public health program in a Low- or Middle-Income Country.
Significance: A key indicator of global access and equitable introduction.

4. 20% Market Uptake

Definition: The milestone at which the product has reached 20% of its target population in LMIC markets.
Significance: Indicates that the product has successfully moved beyond initial introduction into a scaling phase.

Data and Projections

Observed Milestones: Dates for milestones that have already occurred are captured from clinical trial registries, regulatory databases, and manufacturer announcements.
Projected Milestones: For products still in development, the Hub provides estimated dates based on the Mao et al. (2025) forecasting methodology.

Use Cases

These milestones support several decision points:

Prioritization: Identifying which products are closest to market.
Sequencing: Planning the order of product introductions based on expected timelines.
Financing Alignment: Aligning budget cycles with projected procurement dates.

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