Phase 3 Isn’t Just a Regulatory Milestone: It’s the Start of Product Differentiation
- Harris Kaplan
- Jul 17
- 3 min read
When Rosser Reeves introduced the idea of the Unique Selling Proposition in the 1960s—the foundation of modern product differentiation—he made the case for a new product to succeed, it must:
Offer a clear benefit to its customers
Distinguish itself meaningfully from alternatives
Do so in a way that motivates customers to take action
Sixty years later, that principle still holds. In today’s biopharma market, however, achieving meaningful differentiation has become significantly more complex—and more urgent.
In today’s biotech landscape, many companies are chasing similar science. As a result, markets get crowded very quickly. Consider GLP-1 agonists: 39 programs across 34 companies are currently in development. While the science is promising, many of these programs will not be commercially viable and will disappoint their investors. When everyone is solving the same problem in the same way, true differentiation becomes the exception, not the rule. The likely winners are either early entrants or those with deep enough “financial pockets” to buy their way into gaining traction and market share.
Product Differentiation Needs to be at the Center of a Company’s Clinical Programs
Too often, companies assume that differentiation will emerge naturally from good science or that they can define it once they file for approval and have a commercial team onboard. But differentiation isn’t something you layer on after approval. It needs to be embedded from the start. That’s why one of the costliest mistakes we see is designing late-stage trials with regulatory approval as the sole objective, leaving commercial strategy as an afterthought. Regulatory approval does not guarantee commercial success.
The problem? Your clinical trial endpoints shape your label, your label shapes your message, and your message drives access, adoption, and ultimately value. If you haven’t built differentiation into your clinical design, you risk a weak commercial story and a weak return on investment. We’ve seen strong assets falter due to payer pushback, lackluster prescriber interest, and promotional spend that fails to move the needle.
Too often companies cite Lipitor, the 5th statin to enter the market, as the poster child for late entrants being successful. Having worked on that product’s development and launch, it’s worth remembering that Lipitor was more effective at lowering LDL than any of the previous statins. Pfizer changed the launch playbook for a late entrant by a massive investment in sales and marketing supported by exceptional positioning, targeted communication, and laser focused execution. The massive spend alone would have never resulted in their success without the meaningful differentiation (more effective LDL lowering) that Lipitor had when it launched. This underscores the importance of making product differentiation a cross-functional priority that needs to be the compass driving a company’s clinical trial programs.
The View from the Crow’s Nest
At Spinnaker, we help biotech teams align science with commercial requirements. Our experience spans more than 125 product strategies, and we’ve seen time and again that success depends on connecting clinical realities with commercial opportunity well before the label is locked. As one example of our capabilities, our RAMPx™ model helps teams assess the strength of their value proposition and understand how their story stacks up against the standard of care from the customer’s perspective. It highlights both your new product’s strengths and weaknesses in a contemporary framework we’ve dubbed Commercialization 3.0 that includes not only product attributes but also how easy the product will be to access and any perceived risk customers may feel by being an early adopter. (See more on Commercialization 3.0 in Spinnaker’s articles in Citeline’s In Vivo here and here.)
Differentiation doesn’t happen by chance—it happens by design. For teams preparing to make big development decisions, the question isn’t just “Can we get this approved?”—it’s “What will make this the obvious choice in the market?”
