Define your differentiators: Carve a unique niche in the market

This is section 1 of Parexel's "Navigating to 2030" playbook series on differentiating next-generation obesity therapies. This series offers strategic insights across trial design, regulatory considerations, clinical operations, and patient retention strategies to support sponsors in this rapidly evolving and competitive market. To navigate to other sections, click the buttons below.

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Market leaders and emerging companies know there is an enormous market for effective drugs to treat cardiometabolic disorders, but they need differentiating strategies to gain entry and win market share. Companies with established diabetes and obesity therapies must defend their market position from competitors by expanding their portfolios to treat different patient segments, possibly with precision medicine strategies, beyond obesity indications. 

Companies seeking to enter the cardiometabolic market must precisely define and target unmet patient, provider, and payer needs. By 2030, approvals of new drug classes, options for routes of administration, and label expansions for first- and second-generation GLP-1s will crowd the therapeutic landscape, and only strongly differentiated products will succeed.

Understand how stakeholders value product differentiators. 

At Health Advances, we have analyzed how key stakeholders view the differentiating features of obesity drugs (Figure 2). Patients value weight-loss efficacy from treatment initiation through maintenance as the primary outcomes. Payers place the highest value on obesity drugs that improve long-term health outcomes by reducing cardiovascular (CV) adverse events (such as heart disease, stroke, hypertension, and dyslipidemia) and obesity-related comorbidities (such as Type 2 diabetes, metabolic-associated fatty liver disease, obstructive sleep apnea, depression, gout, and kidney disease), as these increase healthcare utilization.

Figure 2. Stakeholders diverge on the value of product differentiators, and new differentiators are emerging.

The oral approvals reset the differentiation map.

The oral semaglutide and orforglipron launches have changed the strategic terrain. In a category where the majority of US volume is cash-pay, price decreases for the oral products versus the injectables broaden the addressable population well beyond commercially insured patients, and oral dosing removes the refrigeration requirements that have constrained the injectable rollout globally. Several next-generation oral candidates, including high-efficacy small-molecule agents and emerging once-weekly oral peptides, are in late-stage development behind the leaders. For these developers, route of administration, dosing interval, and a credible switching or maintenance story now sit alongside efficacy and tolerability as primary differentiators (Figure 2). Lilly's Phase 3 ATTAIN-MAINTAIN trial added a key clinical pillar to this picture: patients who switched from injectable semaglutide or tirzepatide to oral orforglipron retained the majority of their weight loss, well above the placebo arm.¹ Sponsors increasingly come to us with questions about how to position next-generation products against this shifted landscape.

New ways to differentiate are emerging while established avenues persist.

As the obesity market becomes more crowded, new avenues for product differentiation are emerging beyond weight loss efficacy and route of administration. Maintenance dosing and long-term outcomes data may become increasingly important, particularly as stakeholders focus on the durability of effect and the ability to sustain weight loss over time. Lean mass preservation is another promising differentiator, as patients and clinicians may place greater value on therapies that support healthier body composition during treatment. These newer attributes may not carry equal weight across stakeholder groups, but they are likely to shape how products are positioned in the market. As a result, sponsors should evaluate early whether these features are truly valued by patients, providers, and payers before building a development strategy.

Some drugs in development may provide a better tolerability profile than approved GLP-1s. Fewer gastrointestinal side effects could enable patients to titrate to effective doses faster and improve long-term compliance, which clinicians would value. Patients might prefer products that achieve comparable weight-loss efficacy with less frequent dosing, including monthly maintenance regimens now in active development. However, for reimbursement, reducing the incidence and costs of obesity-related comorbidities is crucial. As one payer told us, “We don’t cover drugs just for obesity. It’s the comorbidities that drive our coverage.”

Cardiovascular outcome trials (CVOTs) now define the evidence bar for the GLP-1 class. Semaglutide's SELECT trial established meaningful CV risk reduction in overweight and obese patients without diabetes, raising the threshold for new entrants.² Payers and regulators increasingly expect data that either matches the class-level CV benefit or demonstrates differentiation against it. Large pharmaceutical companies can absorb these multi-year, large-cohort studies; smaller biotechs may struggle with the cost and scale and need to plan early how their CV evidence strategy will fit into a market where class-level CV benefit is no longer theoretical.

Explore obesity-driven adjacencies.

Preclinical and early clinical testing can reveal potential efficacy in obesity-adjacent indications that could differentiate a product. 

Recently, we worked with an obesity-focused company whose product showed early signs of efficacy in metabolic dysfunction-associated steatohepatitis (MASH), a serious and fast-growing comorbidity of obesity in which excess fat cells in the liver causes chronic inflammation and progressive liver damage. Left untreated, MASH can result in cirrhosis and liver failure. Up to 75 percent of overweight people and 90 percent of people with morbid obesity (BMI greater than 40) have the underlying conditions that lead to MASH.³ This represents a significant differentiating indication that has generated considerable investor and market enthusiasm for the sponsor. 

To advise on which non-obesity conditions to prioritize, we first understand the technical details of their platform or asset and then look at how it could fit into the current competitive landscape in relevant indications.

Carve out a meaningful unmet need niche for commercial viability.

Sponsors developing new GLP-1s face a difficult path as the obesity market grows crowded. Clinical efficacy alone may no longer be enough and products will increasingly need a meaningful niche on tolerability, convenience, adherence, body composition, long-term outcomes, or value in specific patient segments. At the same time, pricing pressure is likely to intensify as incumbent manufacturers scale, competition expands, and payers anticipate eventual generic entry, while direct-to-consumer and alternative distribution channels  add complexity to patient acquisition, fulfillment, support services, and economics. Success will depend not only on a clinically compelling product but on the evidence package, channel strategy, and pricing posture needed to secure payer access and sustain relevance as the field continues to expand.

At Health Advances, we partner with sponsors to test these questions early: which patients are most likely to use the product, what treatment algorithm it can realistically fit into, what evidence will convince patients, providers, payers, and investors, what price and access assumptions are achievable, and whether the asset can support a credible long-term franchise rather than a short-lived launch.  
 

Resources

1. Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial, Nature Medicine (May 13, 2026).
2. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes, The New England Journal of Medicine (November 11, 2023).     
3. Metabolic Dysfunction-Associated Steatohepatitis (MASH), Cleveland Clinic Disease Fact Sheet (Accessed March 17, 2025).

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