In the US healthcare system, innovation often collides with the structural realities of reimbursement. While scientific and technological advances continue to accelerate, the mechanisms that determine availability and adoption are rooted in reimbursement policies established by government and private insurers. These policies, determining which services and products are reimbursed and at what rate, remain largely cautious, evidence-driven, and slow to evolve.
A growing number of investor-backed healthcare companies are pursuing self-pay models as a pathway to accelerate market access and adoption. By operating outside of traditional reimbursement frameworks, these models enable rapid iteration, direct consumer engagement, and real-world evidence generation, serving as test beds to refine care delivery and demonstrate meaningful outcomes. The momentum is particularly evident in direct primary care, where the North American market was valued at approximately $5.0 billion in 2024 and is projected to more than double to $11.9 billion by 2033 (DataHorizzon Research, 2025). This growth signals strong consumer demand and the scalability of subscription-based care, which can take various forms such as membership-based care, retainer-based care, or concierge medicine. Reinforcing this trend, Pitchbook reports a corresponding surge in venture capital flowing into startups built around fixed-fee, relationship-driven models, underscoring investor confidence in their long-term viability (Pitchbook, 2022). These investments recognize that self-pay approaches offer value beyond merely revenue generation and validation of new clinical methodologies — they also create deliberate leverage for eventual payer integration by generating compelling evidence of both clinical efficacy and economic value.
For investors, entrepreneurs, and healthcare leaders, this two-pronged strategy offers a pragmatic blueprint for advancing commercialization through direct consumer engagement while managing the complexities of reimbursement.
This article examines the evolving self-pay commercial pathway and its growing impact on healthcare delivery, investment strategies, and leadership models. It highlights sectors where these approaches are transitioning from emerging concepts to scalable solutions, particularly in women’s health, advanced diagnostics, and integrative and functional medicine. For healthcare executives and investors, this shift demands new leadership competencies beyond traditional operational expertise, requiring vision to balance immediate revenue generation with long-term evidence collection while cultivating patient-centered care models.
The US healthcare landscape is shaped by a delicate balance between innovation and the reimbursement systems that govern market access. Payers, both public and private, act as custodians of healthcare resources. Their decisions hinge less on medical efficacy and more on cost-effectiveness, requiring rigorous evidence that a new treatment or care model is worth its price. This creates a paradox: innovations need real-world implementation to generate comprehensive evidence of economic value, but coverage decisions require that evidence to be available upfront.
This dynamic has historically slowed the adoption of promising healthcare solutions, particularly those that do not fit neatly into existing fee-for-service frameworks or coding structures.
To navigate reimbursement constraints, many healthcare entrepreneurs and investors are adopting a self-pay-first approach. Rather than immediately pursuing traditional reimbursement pathways, future-looking healthcare companies choose to begin with self-pay models that target affluent or otherwise highly motivated individuals willing to pay directly for services, while developing evidence that may eventually support broader adoption.
The approach reflects a strategic evolution in healthcare funding that builds upon earlier experiences. Initially, healthcare companies pursued employer-sponsored models, but this approach presented coordination challenges as employers needed to navigate numerous point solutions, service overlaps, and complex vendor relationships. In response, venture capital and private equity firms are now increasingly backing companies that operate outside conventional payment systems during their early development stages. By establishing direct consumer relationships first, companies can reduce reimbursement uncertainty, accelerate commercial scale, and create clearer valuation metrics — thus, positioning them as stronger candidates for follow-on investment to expand operations and refine their models.
This early focus on self-pay models serves as more than a revenue approach; it creates a pathway for building the evidence needed for potential integration with broader reimbursement regimes. When companies begin with a self-pay healthcare offering, they gain several advantages:
The typical development pathway follows a calculated progression: begin with high-net-worth consumers willing to pay directly for innovative services, use the phase to collect meaningful outcomes data and refine operations, then engage with payers to explore opportunities for broader coverage based on demonstrated value. As healthcare continues to evolve toward value-based approaches, this model offers innovators a unique opportunity to validate their solutions in real-world settings while providing impactful insights that drive the industry’s transformation toward more accessible, effective care.
While the healthcare landscape is experiencing adoption of self-pay models to overcome barriers to traditional reimbursement systems, three sectors stand out as particularly promising ground for this approach: women’s health, advanced diagnostics, and integrative and functional medicine. Each faces distinct reimbursement barriers that create both immediate market opportunities and pathways for building evidence that may eventually support broader adoption.
The women’s health sector represents a compelling investment opportunity driven by significant gaps in care and market expansion potential. BCG research identifies a $100+ billion market opportunity by 2030 across just four conditions, highlighting the scale of this underserved market (BCG, 2025):
Menopause: With 65 million US women in some stage of menopause by 2030, yet only 25% currently seeking treatment, this segment could expand eightfold to $40+ billion. Employer recognition is growing, with 18% of companies planning to offer menopause benefits by 2025, up from just 4% in 2023.
Osteoporosis: This market could grow from $5 billion to $21-27 billion by 2030, with significant opportunities in pharmaceuticals ($19 billion) and digital health solutions ($1-5 billion). Currently, more than two-thirds of women with the condition remain undiagnosed.
Alzheimer’s disease: Women represent two-thirds of Alzheimer’s patients, yet face unique diagnostic challenges. This market could expand tenfold from roughly $2 billion today to $20+ billion by 2030 through improved early detection and treatment access.
Cardiovascular disease: Affecting 45% of women, this segment could grow to $20 billion by 2030 through better recognition of women-specific symptoms and risk factors. Ischaemic heart disease is the leading cause of death for women worldwide, and addressing this disease in the female population could yield significant annual gains, including an estimated 9.1 million disability-adjusted life years (DALYs) and $43 billion in global GDP (McKinsey, 2025).
Self-pay models offer advantages in addressing these opportunities:
Self-pay innovations that demonstrate improved outcomes position themselves for eventual integration with broader payment systems, particularly as employers increasingly recognize these needs. The self-pay solutions in US women’s health represent an immediate market opportunity and, at the same time, a strategic approach to addressing fundamental gaps in coverage, research, and care delivery.
The advanced diagnostics sector represents a significant growth opportunity driven by technological innovation and increasing demand for personalized medicine. Market analysis indicates substantial expansion potential across multiple segments:
Molecular diagnostics: The North American molecular diagnostics market is projected to grow from $11.5 billion in 2025 to $15.9 billion by 2030, at a CAGR of 6.6% (Mordor Intelligence, 2025). This growth is driven by significant technological advancements, including the integration of AI, machine learning, and automation into diagnostic platforms. The industry is increasingly focused on personalized medicine and precision diagnostics, particularly in oncology and genetic testing, where molecular diagnostics play a crucial role in identifying specific genetic markers. A trend towards integrated solutions that combine multiple testing capabilities on a single platform is improving laboratory efficiency while maintaining diagnostic accuracy. The market’s transformation is further enhanced by advancements in cellular imaging technologies and novel testing methods that enable more precise visualization of genetic material at the cellular level.
Liquid biopsy: This non-invasive testing approach is poised for significant growth in North America, with projections indicating an increase from $6.1 billion in 2024 to $11.5 billion by 2030, at a CAGR of 11.2% (Grand View Research, 2024). The rapidly evolving field of liquid biopsy primarily utilizes blood samples, which account for 81.1% of the market, to detect cancer, guide treatment decisions, and track disease recurrence. Despite being relatively new, liquid biopsy technologies are gaining traction, with several biotechnology companies present in the market and a growing number of FDA-approved tests becoming available. Various organizations, including the American Society of Clinical Oncology, are actively supporting the implementation of liquid biopsy, which is expected to further increase adoption and drive revenue growth in this market.
AI-enabled diagnostics: AI is revolutionizing clinical and molecular diagnostics, with the global market projected to grow from $2.6 billion in 2024 to $8.9 billion by 2029, at an impressive CAGR of 27.6% (BCC Research, 2024). This remarkable growth is driven by AI’s unique ability to analyze vast datasets and identify patterns undetectable to human observers. The technology is transforming multiple diagnostic domains: enhancing medical imaging through superior abnormality detection in X-rays, CT scans, and mammograms; accelerating pathology analysis by highlighting regions of interest in tissue samples; enabling real-time patient monitoring through wearable devices; and revolutionizing molecular diagnostics through automated genomic sequencing, biomarker discovery, and predictive modelling.
Self-pay models offer advantages in addressing the diagnostic innovation/reimbursement gap:
Healthcare providers developed self-pay diagnostic models that combine membership-based access with concierge-level service for advanced diagnostics and preventive screening. The premium membership approach provides patients with extended consultation time, rapid results delivery, integrated care coordination, and personalized risk assessments based on comprehensive biomarker testing and advanced imaging. This model creates a controlled environment for evidence generation while delivering immediate value to participating patients.
Radence, an RA Capital Management Venture, exemplifies this approach, offering members access to advanced early detection services focused on health span optimization. Their self-pay model provides comprehensive biomarker testing and advanced imaging technologies that identify potential health issues before symptoms appear. By using a multimodal approach, encompassing curated testing and predictive technology, this proactive approach to precision care enables personalized health monitoring and intervention strategies based on individual risk profiles.
The self-pay pathway in advanced diagnostics serves as a bridge between cutting-edge technology and broader healthcare adoption. By creating controlled environments for evidence generation, this practice demonstrates how advanced diagnostic data can be comprehensively tracked and analyzed. With this, the self-pay approach functions not merely as an alternative revenue strategy but as a critical developmental phase in the lifecycle of diagnostic innovations — creating a link between initial concept and evidence-based adoption that ultimately benefits patients across the socioeconomic spectrum while fostering continued progress in care delivery.
The integrative and functional medicine sector is experiencing rising consumer demand for personalized, root-cause approaches to health and a shift towards disease-agnostic prevention and longevity. Integrative medicine combines conventional medical treatments with complementary and alternative therapies to create comprehensive care models that address the whole person, considering physical, emotional, mental, social, spiritual, and environmental factors.
Functional medicine takes this personalization further through a systems biology-based approach that identifies underlying causes of disease rather than simply managing symptoms. By understanding each individual’s unique biological makeup and the complex interactions within the body, practitioners aim to prevent and treat conditions more effectively through tailored interventions.
Market analysis reveals significant growth potential.
Market size and growth: The global integrative health market size was valued at $80 billion in 2023 and is expected to reach $155 billion by 2032, growing at a CAGR of 7.6% during the forecast period (Dataintelo, 2025). In the US, a major policy milestone significantly contributing to growth was the formation of the National Center for Complementary and Integrative Health (NCCIH, formerly NCCAM) in the late 1990s (currently operating under a continuing resolution). This laid the groundwork for clinical research, inter-institutional collaboration, and data-driven recommendations for integrative therapies, further solidifying their role within mainstream healthcare.
Consumer base: Over the past two decades, from 2002 to 2022, US adults shifted their approach to healthcare, with a notable increase in utilization of integrative medicine services. Not only did the overall use of complementary health approaches rise, but there was also a marked increase in the use of these approaches specifically for managing pain — a trend accelerated by growing awareness of opioid risks and the search for safer alternatives. The data highlights the growing popularity of seven key complementary health approaches: yoga, meditation, massage therapy, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation. In 2002, approximately 19.2% of adults reported using at least one of these seven approaches; by 2022, this number had nearly doubled, with 36.7% of adults incorporating these integrative practices into their healthcare routines (National Center for Complementary and Integrative Health, 2024).
Practice expansion: According to a survey conducted by the Functional Medicine Practitioner Research Network, the number of functional medicine practitioners in the US increased from just over 5,000 in 2010 to nearly 40,000 in 2020. Additionally, the survey found that functional medicine practitioners saw an average of 22 patients per week, with a total of over 1.2 million patient visits per year (Calcium Digital Health Platform, 2022).
Self-pay dominance: While comprehensive data on payment models for integrative and functional medicine is limited, a significant portion of these services is paid out-of-pocket by consumers. Some employers offer Health Savings Accounts (HSAs) or Flexible Spending Accounts (FSAs) for their employees, which might cover the out-of-pocket costs (American Cancer Society, 2025).
Self-pay models offer advantages in addressing the unique challenges of integrative and functional medicine.
The self-pay pathway in integrative and functional medicine represents an approach to developing evidence-based, personalized care models that address root causes of disease. By addressing the whole person — including social, environmental, and lifestyle factors — integrative medicine offers a route to more equitable and effective healthcare that aligns with emerging evidence on the determinants of health outcomes. This approach meets immediate consumer demand for more comprehensive health solutions and demonstrates how personalized, preventive care could contribute to economic benefits through improved health outcomes and reduced long-term healthcare costs.
The approach of using self-pay care delivery models requires a shift in leadership capabilities. As organizations navigate this journey, they need to cultivate a multifaceted leadership profile that goes beyond traditional operational excellence to embrace consumer engagement, innovation, and scalability.
Historically, healthcare leadership prioritized operational efficiency, regulatory compliance, and clinical excellence — all essential competencies in a complex healthcare environment. Building on this foundation, the self-pay pathway calls for an expanded leadership toolkit that demands several key areas critical for navigating the evolving landscape of consumer-driven healthcare.
Consumer-centric mindset. Successful leaders in the self-pay space cultivate profound insights into the factors that motivate healthcare decisions, shape preferences, and drive loyalty beyond clinical outcomes alone. These executives excel by demonstrating:
Innovation and technology fluency. As technology transforms every aspect of healthcare delivery, forward-thinking leaders must serve as both strategic technology evaluators and innovation catalysts within their organizations. This digital leadership acumen manifests through:
Experience design expertise. As healthcare transitions from patient processing to consumer engagement, leaders must master the art of creating exceptional end-to-end experiences that drive loyalty, satisfaction, and positive outcomes. Successful executives in this space demonstrate the following competencies:
Strategic agility. In an environment where consumer preferences, technologies, and market dynamics evolve rapidly, healthcare leaders must develop organizational nimbleness that enables quick adaptation without compromising care quality or patient safety. This requires cultivating the following competencies:
Early innovation phase
Scaling phase
Analytics and financial acumen. Leaders in the self-pay space must develop sophisticated capabilities to measure outcomes and build sustainable economic models that bridge from initial self-pay adoption to potential broader implementation. These executives demonstrate:
The self-pay care delivery model demands a fundamentally different leadership approach than traditional healthcare models. Organizations pursuing this strategy must intentionally develop leadership capabilities that bridge clinical excellence with consumer-centricity, technological innovation, and strategic agility.
To achieve this balance, successful organizations typically assemble leadership teams with complementary strengths across multiple domains rather than seeking individuals who embody all required capabilities. This multidisciplinary, team-based approach creates a collaborative leadership environment where various perspectives and expertise converge to maintain clinical integrity while at the same time developing the consumer-centric capabilities essential for self-pay success.
Key leadership domains:
Organizations can build these capabilities through intentional talent strategies that blend healthcare expertise with consumer and technology perspectives:
The most successful leaders navigate this journey by following a deliberate progression that builds both market traction and evidence for broader adoption.
The leadership framework outlined above — consumer-centric mindset, innovation and technology fluency, experience design expertise, strategic agility, and analytics and financial acumen — provides a roadmap for developing the capabilities needed at each stage of this journey. Organizations that intentionally cultivate these leadership dimensions can successfully navigate the journey from self-pay model to broader adoption, ultimately expanding access to vital healthcare solutions while building sustainable businesses.
American Cancer Society(2025). Understanding integrative (holistic) medicine.
BCC Research (2024). AI-powered diagnostics: Advancements in clinical and molecular medicine.
BCG (2025). Improving women’s health is a $100 billion–plus opportunity.
Dataintelo (2025). Integrative health market.
Grand View Research (2024). North America liquid biopsy market size & outlook.
National Human Genome Research Institute (2025). Regulation of genetic tests.
Pitchbook (2022). The rise of subscription healthcare.
Radiology Business (2024). Policies and regulations shaping radiology in 2025.