Define your differentiators: Carve a unique niche in the market

This article is part 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.  

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Market leaders and emerging companies know there is an enormous market for effective drugs to treat cardiometabolic disorders but 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 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 (Table 2). Patients value weight loss efficacy and durability 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. 

Table 2. Stakeholders diverge on the value of product differentiators.

Source: Health Advances qualitative interviews and secondary data analysis. CV = cardiovascular.

Some drugs in development may provide a better tolerability profile than approved GLP-1s. Those with fewer gastrointestinal side effects could enable patients to titrate up to effective doses faster and improve long-term compliance, which clinicians would value. Products that achieve comparable weight loss efficacy and durability with less frequent dosing or more convenient routes of administration could be preferred by patients. 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.” Traditional cardiovascular outcome trials (CVOTs)—which evaluate how a drug affects CV outcomes, including death, myocardial infarction, stroke, and other major adverse CV events—require large patient cohorts and years of follow-up. Large pharmaceutical companies often conduct them because payers value the data; regulators may mandate them in some indications. However, smaller biotechs may struggle to invest in CVOTs because of their cost and scale. 

Before investing heavily in a clinical development plan centered around a differentiating product attribute, sponsors must ensure it’s important to stakeholders. For example, products associated with the preservation of lean body mass appeal to patients because they result in a healthier and more favorable body composition profile during weight loss. Recently, we worked with a biotech, developing a next-generation obesity asset that preserves lean muscle mass. We helped them validate the number and types of patients who view muscle loss as a problem by conducting surveys and seeking advice from patient advisory groups (PAGs) and practitioners. Verifying what matters and sizing the related opportunity before starting efficacy trials is critical and can be much less expensive than finding out later.

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.¹  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.

Anticipate the efficacy threshold and pricing needed for commercial viability.

One hazard of planning for commercial viability is underestimating the difference in efficacy from a comparator needed to differentiate a new weight loss drug. Sponsors must show 20 to 25 percent weight loss to beat best-in-class approved products before differentiating on other factors. It’s a lofty target. We partner with developers to define minimal and optimal target product profiles for the obesity market. 

At Health Advances, we help emerging companies prepare their investor presentations. Most would like to forecast a $5-10 billion market for their weight loss agent, citing the overall market of $100 billion growing at 20 percent year over year. However, current trends are not likely to persist. For example, in January 2025, Medicare selected semaglutide (sold under the brand names Rybelsus, Ozempic, and Wegovy in different indications and formulations; see Table 2) for price negotiations.²  In a follow-up statement, the Centers for Medicare & Medicaid Services (CMS) indicated that the Trump administration would continue with the plan while considering “greater transparency” in the program. 

Market leaders will be able to decrease prices as events unfold, so later market entries will need to rely on high volumes at lower prices to forecast potential returns on investment. We perform secondary market analyses and qualitative and quantitative surveys, including in-depth interviews with knowledge opinion leaders and patients, to accurately size markets for investor presentations.  
 

Resources

1. Metabolic Dysfunction-Associated Steatohepatitis (MASH), Cleveland Clinic Disease Fact Sheet (Accessed March 17, 2025).
2. HHS Announces 15 Additional Drugs Selected for Medicare Drug Price Negotiations in Continued Effort to Lower Prescription Drug Costs for Seniors, CMS.gov Press Release (January 17, 2025).

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