Insights

In 2025, the life sciences industry has been characterized by a lower investor risk tolerance for novel, pre-market drug candidates coupled with a historic patent cliff for blockbuster branded drugs. This combination has spurred investor interest in manufacturers of generics, complex generics, and reformulated 505(B)2 drugs that can capitalize on a branded drug’s loss of exclusivity while mitigating the regulatory risk that comes with a novel drug. Private Equity investors that typically invest in pharma services have shown a particularly keen interest in these types of drug manufacturers given their relative aversion to FDA risk and preference for predictable revenue streams. Generic drugs play a vital role in the U.S. healthcare system, accounting for over 90% of all prescriptions filled—yet they represent less than 18% of total drug spending, according to the Association for Accessible Medicines. This cost-efficiency is enabled by the Hatch-Waxman Amendments of 1984, which were designed to accelerate the availability of generics and reduce healthcare costs. This whitepaper provides an overview of the U.S. generic drug market, covering key regulatory and legal frameworks, the typical lifecycle of a generic product, critical success factors for market entry, and strategic implications for investors and stakeholders across the pharmaceutical value chain. success in the next phase of the market.

The post-acute care landscape is undergoing a period of accelerated transformation, shaped by demographic shifts, rising acuity, labor shortages, and growing financial pressures. As the demand for post-acute care continues to rise, facilities are tasked with delivering high-quality care in a resource-constrained environment. To navigate these challenges, many facilities are turning to outsourced clinical services as a strategic solution. This whitepaper explores the evolution of clinical outsourcing in the post-acute care sector, its role in alleviating workforce constraints, and its growing alignment with value-based care (VBC) models. It also examines how forward-looking operators are leveraging outsourcing not only to stabilize operations but to enhance care quality.

The substance use disorder industry continues to attract investor interest driven by a large treatment population of 48 million Americans and provider fragmentation. Despite macroeconomic pressures and reimbursement variability, structural demand remains high. Providers and investors are increasingly focused on scalable, outcomes-driven models that balance access, quality, and financial sustainability. In this whitepaper, we examine the evolving substance use disorder (SUD) landscape through both a market and operational lens - highlighting key demand drivers, investment trends, and the strategic shifts reshaping provider models. Drawing on Marwood’s deep experience advising investors, payors, and providers across the behavioral health continuum, we explore how leading operators are adapting to reimbursement pressures, integrating technology, and aligning outcomes with value-based frameworks. The analysis underscores where growth opportunities remain strongest and what capabilities will define sustainable success in the next phase of the market.

Marwood Group’s whitepaper analyzes 2025 U.S. and EU life sciences policy shifts and their impact on biotech, pharma, MedTech, and the outsourced research, manufacturing, and commercialization partners they rely on.

Civil Investigative Demands (CIDs) are becoming one of the government’s most aggressive tools to investigate healthcare fraud. With the DOJ issuing a record number of CIDs and leveraging AI to flag outliers, healthcare organizations must be ready to respond with speed, accuracy, and insight. The tight deadlines and high stakes can create significant disruption for healthcare companies. Marwood combines regulatory expertise, proprietary analytics, and proven support to help clients respond to the government while minimizing disruption, and implement any required billing, coding, and compliance program changes.

The NHS 10-Year Health Plan, launched in July 2025, sets out a sweeping reform agenda in response to mounting pressures on the UK’s healthcare system. Triggered by Lord Darzi’s independent review, which warned that the NHS is in "critical condition", the Plan addresses deep-rooted challenges including long waiting times, workforce strain, and poor clinical outcomes. Framed around three core shifts - from hospital to community care, from analogue to digital systems, and from sickness to prevention - the Plan aims to modernise healthcare delivery, expand access, and improve long-term health outcomes. Key initiatives include a greater focus on primary and outpatient care, the rollout of a Single Patient Record, and new public health policies targeting chronic disease, obesity, and tobacco use. These reforms present significant opportunities for private sector providers across digital health, medtech, pharmaceuticals, outpatient services, and preventative care. However, success will require investors to navigate evolving market dynamics, regional implementation variations, and regulatory risks with careful, multi-level analysis.

The specialty care referral process represents a complex intersection of clinical decision-making, operational efficiency, and financial performance. In an era of rising cost, an increasingly complex and value-based healthcare landscape, the seamless transition of patients from primary care to specialty services is paramount. For multi-specialty physician practices, a well-structured referral management system is not merely an administrative function but a strategic asset. Breakdowns in the referral process are common and a significant impediment to revenue growth, with a significant percentage of referrals not resulting in a completed appointment. This "leakage" represents a missed opportunity for both the patient and the specialty practice. In this whitepaper we provide a roadmap for multi-specialty practices to build a robust referral management ecosystem that addresses these challenges head-on.

The Labour Party’s victory in the July 2024 general election has ushered in a wave of policy commitments with new implications for Special Educational Needs and Disabilities (SEND) provision. Labour has signalled its intent to address longstanding challenges in the SEND sector, particularly through a “community-wide approach” to enhance inclusivity and support structures in mainstream education. However, the details of this approach remain ambiguous, prompting concerns among SEND stakeholders about practical implementation. Cost pressures from National Living Wage and National Insurance Contribution increases may threaten the viability of smaller independent SEND providers but could present opportunities for consolidation for larger players. For investors in independent special schools, Labour’s agenda presents potential risks and opportunities. The government’s commitment to maintaining special schools for children with the most complex needs offers some stability for high-acuity placements. However, broader moves toward mainstream inclusion, stronger local authority oversight, and evolving funding allocations could shift demand dynamics in the independent SEND sector. In this piece, Marwood examines Labour’s key SEND policies, the implications of new cost pressures for independent SEND providers, and the evolving funding landscape. We assess how these developments may affect the viability of independent special schools and explore strategic considerations for investors navigating this evolving market.

Historically, dermatology has been a key sector in the physician practice management (PPM) space for private equity (PE) firms, largely because the dermatology industry is characterized by diversity in payor and service mix, low concern from a cost management perspective, and favorable reimbursement variability. During COVID-19, investor interest in PPMs diminished due to utilization and revenue pressure, staffing shortages, and regulatory oversight of investment activity under the Biden administration. However, as we progress into the second Trump administration, PPMs are positioned for a reemergence in healthcare. Dermatology is well suited for this reemergence, as the sector is established, meaning it is not risky to be a first mover in, but does not see stagnation in development and demand. In this piece, Marwood explores the outlook for the dermatology PPM market, and why opportunities still exist for investors to add value.

As global demand for pharmaceutical and biotech products continues to rise, the market for CDMOs is expanding rapidly. Reports suggest that the European CDMO market is set to expand at a compound annual growth rate (CAGR) of 7.6% from 2025 to 2034, attracting significant attention from investors. Driving this surge is the rising demand for biologics and personalized medicine, along with cost pressures that are pushing pharmaceutical companies to increasingly outsource to CDMOs. While the market remains fragmented, consolidation is underway, with larger, PE-backed firms acquiring smaller CDMOs. High-growth segments, such as biologics, cell and gene therapies, and niche formulations, offer substantial investment opportunities.

Healthcare M&A is anticipated to surge significantly over the next five years. Several factors are fueling this trend, including an increase in both deal volume and size, a focus on rural healthcare, financial pressures, strategic consolidation, and the integration of new technologies. A critical yet often underestimated enabler of successful healthcare M&A is IT integration. Each deal presents unique challenges, shaped by market dynamics, organizational needs, and the nuances of different healthcare sectors. In this article, Marwood explores the growing trend of mergers and acquisitions (M&A) in healthcare, emphasizing the crucial role of IT integration in these complex transactions. It examines the factors driving M&A activity, the strategic importance of IT, potential challenges, and the key success factors. The aim is to demonstrate how effective IT integration can serve as a powerful tool for success in healthcare M&A.

Compounding Pharmacies play an important role in the US pharmacy ecosystem by fulfilling the need for customized drugs unmet by mass-produced products and by addressing commercial supply shortages. The market is an area of growing interest with favorable drivers driven by awareness and preference for personalized therapies, favorable population demographics, increasing disposable income, and frequent drug shortages in recent years. In this piece, Marwood explores the outlook for the Compounding Pharmacy market, including market sizing, dynamics of the top therapeutic areas, and key trends in the market.

The NHS priorities and operational planning guidance for 2025/26 presents an evolving landscape for investors and service providers, characterised by greater flexibility in funding, digital enhancements, and workforce optimisation. With increased financial flexibility granted to local systems, streamlined procurement processes, and an emphasis on best-value frameworks, this changing landscape presents investors with new opportunities. Investors and operators who are able to strategically align with these priorities may stand to capitalise on the UK healthcare sector’s shift towards sustainability, efficiency and modernisation.

NHS dentistry has been significantly impacted in recent years, with the COVID-19 pandemic exacerbating systemic weaknesses. Pre-existing issues including chronic underfunding, workforce issues, and unattractive NHS contracts have collided with pandemic-related disruptions to leave millions of patients waiting for care. With the recent uplift in NHS dental contract falling short of the recommendations from the Review Body on Doctors’ and Dentists’ Remuneration (DDRB), the Labour government has failed to alleviate the funding challenges associated with NHS dentistry, and intensified financial pressures on NHS dental providers. As investors look towards the rest of 2025 and beyond, one key question is this: how are these challenges accelerating uptake of private dentistry within the UK dental landscape, and what new investment opportunities may they present in the future? In this paper, Marwood examines the implications of the NHS contract uplift and broader funding constraints, assessing their impact on the competitive landscape of UK dentistry. We explore key market trends, identify potential areas of growth for private providers, and outline strategic considerations for investors seeking to capitalise on emerging trends in dental care.

Penetration of VBC initiatives in Medicaid, particularly those that are risk-based, has historically lagged the more significant growth in VBC within the Medicare Advantage population. However, as Medicaid Managed Care plans and states face cost pressures while aiming to improve outcomes and increase access, there has been an increasing shift away from fee-for-service reimbursement models tied to volume and towards alternative payment models (APMs) that more closely tie reimbursement to outcomes and align incentives by gradually encouraging providers to take on more risk. As a result, there is growing interest among a diverse group of stakeholders including investors, providers, MCOs, and healthcare technology companies in pursuing new revenue opportunities within Medicaid VBC. Programs that effectively realign incentives to prioritize outcomes and value can generate savings for states and MCOs and lead to improvement in the overall quality of care for patients. Herein we address opportunities for VBC for the Medicaid population, identify major challenges facing stakeholders, and examine differences between states that may facilitate greater adoption and success.

Italy is expanding the scope of its Innovative Medicines Fund which will undergo a restructure to now include specific spending ceilings for conditionally innovative medicines and specific antibiotic drugs in 2025, as indicated by the 2025 Budget Law. Alongside this, the Italian Medicines Agency (AIFA) is expected to review the current evaluation criteria for the attribution of innovative status by 31 March 2025, and is likely to include new criteria which are expected to focus on a wider combination of technological and clinical factors that spans the entire pharmaceutical life cycle such as production technology and impact on patients’ lives. This reform presents an important shift for the innovative medicine landscape in Italy by offering ring-fenced funding for specific drug categories and allowing more drugs to be eligible for funding. In this piece, Marwood analyses the changing landscape for innovative pharmaceuticals in Italy and how this may impact investors as well as manufacturers.

Over the last few years, the biotech market has grappled with a global pandemic, numerous drug shortages, burdensome supply chain disruptions, escalating trade tensions, and a difficult funding environment. Underlying these broader issues is the threat to each nation’s biosecurity. Historically, the term has mostly referred to practices that prevent the spread of harmful pathogens, such as disinfection or quarantine. Today, nations have broadened the term to encompass practices that improve the health of their biotech industries. After all, fostering domestic biotech innovation with self-sustaining, high-quality supply chains inarguably does bolster a nation’s biosecurity. On the other hand, enabling a country’s biotech startups to access foreign, low-cost supplies and services also fosters domestic innovation. Providing citizens with expedited access to breakthrough treatments approved in foreign countries also bolsters a nation’s biosecurity. China, as the world’s fastest-growing hub for biotech development, manufacturing, and research services, is now causing western nations to grapple with this delicate balance; some through domestic stimulus and others through punitive restrictions. As the current market leader in biotech innovation, the US seems to favor the latter approach.

The Autumn Budget 2024 is the first budget by a Labour Government in more than a decade. On 30 October 2024, Rachel Reeves, Chancellor of the Exchequer delivered a one-year budget (Phase 1) setting out both an updated 2024/25 spend and planned funding for next year. A longer-term Spending Review will follow in Spring of 2025 (Phase 2). A public audit in July 2024 showed that the new Labour Government inherited a budget deficit with a projected overspend of £22 billion in 2024/25. Therefore, this Budget’s objectives are to keep public spending on a sustainable path, grow day-to-day departmental spending to support public services, and to boost capital investments with a greater focus on value for money and long-term growth. This is a significant event for investors in healthcare and provider entities as it highlights the Labour Party’s priorities and ambitions. In this publication, Marwood provides an overview of key budgetary announcements that affect the health and social care sectors in the UK.

In recent years, the European Union (EU) has commenced several reforms in the life sciences sector. However, to drive the EU towards a more competitive environment in the health and life sciences sectors, more needs to be done. This is the assessment of Mario Draghi’s new competitiveness strategy, published in September 2024. In the second of a two-part series, Marwood examines how the recommendations from the European Commission’s (EC) new competitiveness strategy will steer the EC’s work to improve attractiveness in the fields of Artificial Intelligence (AI) and digital health. In this piece Marwood provides insights on the impact that the new recommendations may have on the EU’s AI and digital health sector over the next few years.

The European Union (EU) has undertaken several reforms in the life sciences sector, such as in pharmaceuticals, clinical trials, Artificial Intelligence (AI), and digital health. To guide the EU on a path towards a more competitive environment in the healthcare and life sciences sectors, the European Commission (EC) published a new competitive strategy in September 2024, and its findings will steer the EC’s work to improve its attractiveness to this industry. In the first of a two-part series, Marwood analyses how these recommendations may develop over the medium-term and assesses the impact they may have on the EU’s pharmaceutical and clinical trials sectors.

Following the two-year anniversary of the signing of the Inflation Reduction Act (IRA), Marwood takes a closer look at the state of clinical trials. In this piece, Marwood analyzes the IRA’s potential impact on clinical trial starts for industry-sponsored mid-(Phase II) and late-stage (Phase III) trials. Additionally, Marwood examines Phase I trial starts, which is likely more closely linked to early-stage biopharma companies. Marwood notes that for early stage companies the current challenging capital market environment may also be an influence on clinical trial activity.

Skilled home healthcare is a growing area of interest as the industry experiences strong tailwinds driven by an aging US demographic. Home health has always appealed to patients and providers as it allows patients to remain in their preferred setting and reduces costs for providers. The increase in the US population that typically receives home healthcare creates an opportunity and challenges, such as staff shortages, that must be addressed to serve this growing market. In this piece, Marwood explores the outlook for the skilled home healthcare market, including growth drivers and ways in which providers are navigating through potential challenges to prepare for the increasing market demand.

Following The Labour Party’s election win on 04 July 2024, Marwood takes a closer look at how the change in Government may impact the volume of National Health Service (NHS) outsourcing to the Independent Sector (IS). In this piece, Marwood examines Labour’s 2024 manifesto pledges around reducing wait times for elective care in the context of the current economic and social climate, as well as historic precedence. On the one hand, Labour campaigned hard on saving our NHS, implying a negative impact on the IS, and on the other they promised reductions in waiting times and lists for elective care. In this piece Marwood weighs these seemingly conflicting policies and examines the net potential impact of this change on NHS outsourcing of elective activity to the IS.

On May 6, 2024, the Food and Drug Administration (FDA) issued a landmark Final Rule clarifying that in vitro diagnostics (IVDs) marketed as laboratory developed tests (LDTs) under the Clinical Laboratory Improvements Amendment (CLIA) are now explicitly designated medical devices with the accompanying regulatory requirements. Although the FDA did carve out certain exceptions subject to their enforcement discretion including, most notably, grandfathering exceptions for certain quality system and FDA submission requirements, this decision will still be costly and burdensome for the IVD space as a whole. However, for those LDT diamonds in the rough with superior clinical validation, this Final Rule could instead present a significant market access opportunity if developers are quick to adapt.

Physician practices and other provider groups have always been at a disadvantage when it comes to negotiating with managed care companies and payors for initial fees or fee increases. Managed care organizations and payors have access to proprietary provider claims data, patient demographics and benefit utilization data that is not generally available to providers. In addition to access to proprietary data, payors have internal teams of professionals who are trained to specialize in provider reimbursement. Physician practices and other providers must be prepared to have detailed discussions with payors regarding reimbursement and other contractual obligations. Reimbursement, while important, should not be the only area of focus of a contractual relationship negotiation with a payor. This paper provides an overview of some of the key considerations for physician practices and other provider groups as they look to navigate the complexities of contracting with payors.

Pharmacy management systems (PMS) and associated software and data solutions are evolving as patients access a greater diversity of traditional and clinical services from pharmacies. At the intersection of patient, provider, payor, and other pharma industry stakeholders, interoperability is key. Stakeholders in PMS and broader pharmacy interoperability extend beyond health plans and manufacturers to other healthcare providers where bidirectional electronic health record (EHR) communication is vital. Regulation, legislation and resultant standards bodies are now actively engaged in developing recommendations to guide the industry and have moved swiftly, partly due to needs that expanded in magnitude during the pandemic. Correspondingly, more robust information exchange capabilities and pointed data solutions will continue to differentiate pharmacy-focused HIT market players. The analysis herein highlights historical challenges, evolving stakeholder needs, and resulting opportunities this has created for solutions providers in the space.

Over the past decade, the autism therapy sector has solidified itself as one of the fastest growing healthcare sectors. Federal and state mandates have driven broad coverage across payor types as the prevalence of Autism Spectrum Disorder (ASD) continues to increase, now 1 in 36 children (up from the previous rate of 1 in 44). Applied Behavior Analysis (ABA) is still considered one of the only evidence based treatments for children with ASD and continues to be the therapy modality most often covered by payors. Herein we address the history of the sector, some of the major challenges facing providers today, and opportunities providers will have to be successful over the next 5–10 years.

The infusion market has experienced remarkable growth over the past several years, fueled by an increasing number of infused medications across indications in an aging US population. Offsetting hospital and physician office demand has been the growth of alternative sites of care including site-based ambulatory infusion centers, home infusion and hybrid infusion suite models. Herein we compare and contrast provider, pharmacy, and payor roles in these sites of care and their reimbursement structure, delineating key considerations in evaluating opportunities in the space.

Over the past decade, durable medical equipment (DME) has become a growing area of interest for mergers and acquisitions (M&A) and investment activity as the industry experiences increasing levels of demand, product innovation, reimbursement stability, and a degree of market fragmentation across suppliers and manufacturers. In this piece, Marwood explores the outlook for the DME market, including growth drivers, payor contracting dynamics, and reimbursement considerations, while addressing how the space has evolved to meet the risk appetite of investors.

The European Union Artificial Intelligence Regulation, the world’s first comprehensive AI Regulation, will take effect from mid-2025 onwards with most of its provisions taking effect in 2026. In this piece, Marwood analyses the upcoming regulatory changes affecting AI systems in the EU and the potential impact it may have on companies developing or promoting AI applications in healthcare, or investors with existing or potential investments in these companies.