By Manny Jurado, Associate Partner
Over 100 million Americans are classified as medically overweight, making obesity one of the fastest growing public health issues in the U.S. The anti-obesity medication (AOM) marketplace is rapidly expanding, with analysts estimating it to be worth $150 billion by 2032, fueled by the increasing demand for effective weight management (e.g., 15-25% weight loss) and metabolic health solutions. With potential Medicare coverage on the horizon and increasing patient demand, the obesity space promises to grow at an unprecedented rate.
The obesity space is burgeoning with significant competitive intensity, as numerous manufacturers invest into additional clinical pipeline assets, increasing the need to differentiate within the frantically evolving space. The diagram below illustrates a current snapshot of the intense competition in the weight loss landscape:
Visual Credit: Sophia Rawson, Chike Onyia, Nicholas Colaw
As the AOM market continues to grow, manufacturers must navigate a range of critical market dynamics, including emerging access dynamics, clinical differentiation needs, patient access challenges, and emerging opportunities for partnerships. These factors underscore the need for proactive strategies that capitalize on opportunities and mitigate potential barriers, to optimize future product market share and maintain a competitive edge.
Here are four strategies to stand out in this dynamic landscape:
1. Leverage Emerging Pathways for Access
Manufacturers must adapt and respond to increasing budget impact pressure for key access stakeholders and potential therapy restrictions implemented by emerging PBM/ coverage models.
Employer Coverage Trends
As a new stakeholder in the commercial space with decision making power, employers wield significant influence over GLP-1 coverage decisions. As the new calendar year unfolds, many employers are reassessing coverage options, balancing the potential benefits of improved employee health and satisfaction against their concern for budget impact due to the high cost of GLP-1s.
Education on GLP-1s and their benefit to employers may help shape future coverage decisions. Companies like Novo Nordisk and Eli Lilly are already engaging directly with employers, providing clinical value story evidence and cost-effectiveness data to support coverage decisions.
Alternative AOM Coverage Programs
The rise of carve-out programs and alternative PBM (pharmacy benefit manager; e.g., CapitalRx, Rightway, Waltz Health) models reflect the need for greater transparency in managing AOM coverage. These models enable employers and health plans to opt into AOM coverage with potential customized guardrails (e.g., restrictive HCP network, value-based milestones, pre-GLP-1 requirements). Most importantly, they offer higher levels of price predictability, rebate visibility, and spend transparency over time.
These are all important factors that enable those at-risk for pharmacy spend to gather more data to inform decisions and implement strategies to enable GLP-1 coverage. By understanding future PBM disruptors, manufacturers can better prepare messaging around optimized cost predictability and patient outcomes. Manufacturers could also benefit from monitoring restrictions and identifying alignment to GLP-1 clinical value story, while keeping eyes open for partnership opportunities.
Point Solutions
Select PBMs and employers provide digital health services such as point solutions (e.g., Vida Health, OptumRx Weight Management Program) that serve as a preliminary step to accessing AOMs. These programs often require patients to first complete a structured weight management program offered through the PBM before being approved for GLP-1 treatments, in an attempt to align clinical treatment with cost-effectiveness goals. Manufacturers may combat access restrictions through education on how concurrent solutions may be more beneficial to patients, emphasizing data in support of an initial synergistic therapy approach.
2. Identify Areas for Clinical Differentiation
To stand out clinically amidst increasing competition, manufacturers are moving beyond weight loss to explore expanding indications, novel clinical pathways, and additional therapeutic benefits. Exploring these alternative methods opens the door for potential key clinical differentiation from competitors.
Novel Indications
Trials are underway to assess GLP-1 efficacy in areas such as sleep apnea, cardiovascular risk reduction, neurodegenerative diseases (e.g., Alzheimer’s, Parkinson’s), and women’s health conditions like PCOS. Demonstrating improved outcomes across these diverse conditions could significantly enhance a product’s value proposition and improve opportunity for coverage.
Specific Outcomes
Even within weight loss, manufacturers have an opportunity to highlight more targeted outcomes, including preservation of lean muscle mass (emphasizing fat loss over muscle loss is critical, particularly for vulnerable populations like the elderly). Exploring mechanisms to prevent rebound weight gain after discontinuing therapy could also further differentiate products.
Emerging ROAs
Traditional injectable GLP-1 therapies are being complemented by oral and potentially sublingual formulations. These innovations aim to improve patient adherence and convenience, which could increase clinical value to patients.
Unique MOAs & Combinations
To achieve these unique outcomes, manufacturers are investigating novel mechanisms of action (MOAs) to target weight loss via multiple metabolic pathways. Trials assessing combinations of GLP-1 agents with GIP agonists and/or GCGR antagonists have proven to effectively produce both significant weight loss results and improvements in adjacent therapeutic areas. Leveraging the proven efficacy of current treatments with these new pathways may prove to be a lucrative value offering for manufacturers looking to stand out.
Regulatory Considerations
Under specific FDA regulations, particularly during shortages, compounding pharmacies can produce non-identical versions of GLP-1 drugs, such as semaglutide and liraglutide. While this supports patient access, compounded therapies threaten the clinical value story of FDA-approved weight-loss therapies.
Manufacturers can differentiate from compounds with a distinct edge by highlighting safety concerns and regulatory differences. Compounded drugs often lack the rigorous quality control mandated for FDA-approved products. Counterfeit versions of branded drugs with harmful or inactive ingredients further exacerbate risks. Manufacturers should continue to highlight the safety and efficacy of FDA-approved products in their marketing efforts, emphasizing adherence to stringent regulatory standards. This strategy not only reassures patients but also aligns with broader advocacy efforts, such as Novo Nordisk’s and Eli Lilly’s petitions against unsafe compounding practices.
3. Optimize Patient Access
Manufacturers can gain an upper hand in market access differentiation by streamlining patient access to GLP-1s and draw in the AOM market by providing increased convenience and patient affordability. To compete effectively, there are a variety of approaches manufacturers may take to ensure patients can easily access their therapies.
Direct-to-Patient Platforms
Companies like Pfizer and Lilly are already leading the way with online programs that connect patients to telemedicine providers for streamlined access to treatment. These direct-to-patent platforms bypass the challenges of traditional in-person HCP visits such as appointment availability and travel, making at-home care easier. Bolt-on affordability solutions (e.g., copay cards, cash options) can further enhance financial accessibility to these therapies for patients.
Alternative Care Channels
Partnerships with medical spas and wellness centers present new avenues for distribution, expanding reach beyond traditional healthcare settings. These alternative care channels may attract new patients, and some locations are staffed with in-house MDs to prescribe and order GLP-1s efficiently.
PCP Channel Activation
Ongoing education and familiarization of primary care providers on the efficacy and appropriate utilization of GLP-1s is critical to market access pull-through, given that a great majority of GLP-1 prescriptions originate from the PCP channel.
4. Partner with Novel Supportive Technologies
Given the emergence and increased adoption of digital health in the U.S., collaborations with digital healthcare companies may enable manufacturers to offer surround-sound solutions that support enhanced clinical outcomes and the overall patient experience.
Digital Companion Apps
Non-regulated digital therapeutic tools (e.g., Livongo, Noom, Medisafe) can serve as valuable adjuncts to traditional pharmacotherapies, enhancing chronic condition management and driving improved patient outcomes. These digital solutions enable continuous patient monitoring, real-world data (RWD) collection, and follow-up engagement, which all serve to strengthen clinical development efforts. Additionally, personalized behavioral support features—such as cognitive behavioral therapy, live weight management coaching, symptom/side-effect tracking, and fitness/nutrition guidance—offer a more holistic approach to obesity and metabolic disease management, ultimately improving adherence and long-term success.
Combo Prescription Digital Therapeutics (PDTs)
Unlike traditional companion apps, combo PDTs undergo parallel clinical trials alongside pharmacotherapies, offering a rigorous, data-backed pathway to regulatory approval. These integrated digital solutions unlock greater clinical label expansion opportunities by increasing real-world evidence generation and product differentiation. Additionally, PDTs enable customized patient engagement strategies, such as drug-specific education and adverse event support, ensuring patients remain engaged throughout their treatment journey. As the U.S. healthcare landscape evolves, manufacturers who integrate PDTs into their market access strategy stand to gain a competitive advantage by aligning with evidence-driven, outcomes-based care models.
Emerging Third Party Technology: AI-Enabled Predictive Modeling, EMR Data Mining
New solutions such as EMR & AI technology continue to emerge within the healthcare space as tools that enable manufacturers to enhance their market offerings. As the bar for coverage and value of data heightens, opportunities emerge for solutions that enhance innovation within the obesity patient paradigm. An AI solution may be implemented to identify and predict current and future patients, improve clinical outcomes, or enhance transparency/predictability within the patient journey.
Additionally, manufacturers may consider working with sophisticated EMR vendors to implement internal flags or capture novel data sources that could facilitate brand growth through evidence generation. This could also support alignment to a future focus in value-based care, by increasing ease of execution for risk-based agreements. As opportunities continue to arise and develop, manufacturers can stay a step ahead through creative ideation and implementation of novel tools and unique partnerships.
Key takeaways from strategies to succeed in the obesity market:
- Monitor the evolving access landscape
- Identify high-value partnerships
- Develop novel HCP strategies
- Secure clinical and market access strategy differentiation
As the healthcare landscape evolves, successful strategies will depend on a data-driven understanding of key adoption trends, access stakeholder priorities (e.g., payer, employer, PBMs), and high-impact technological areas. This will empower manufacturers to proactively address market challenges, enhance product positioning, and maximize access success.
The AOM marketplace presents unparalleled opportunities for pharma manufacturers willing to innovate and differentiate. By expanding therapeutic benefits, improving access, and embracing digital and strategic partnerships, companies can secure their position in this crowded yet promising field.
Find out how The Dedham Group can help you navigate AOM strategies to stand out in the marketplace. Contact us.
