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Click the title above for a link to open the Pharmaceutical Commerce February 2025 issue in an interactive PDF format.

Pharmaceutical Commerce - February 2025 Issue (PDF)

2025 is upon us, officially marking a quarter of a century since Y2K and the midpoint of the decade. There is no doubt that time does quickly fly by, and with that, the

The first edition of the year is powered by a 

 at pharmaceutical third-party logistics providers (3PLs)—those organizations responsible for handling the logistics for a range of products that are unable to be accomplished by a manufacturer, distributor, or dispenser. This year, Editor Nicholas Saraceno once again provides a deep dive into the fluid role of 3PLs, the lessons they learned post-COVID-19, the key trends impacting industry, and more via a roundtable-type discussion with leaders in the sector.

Also examined this month is an issue impacting communities throughout the US—retail pharmacy closures. In fact, a December 2024 study from researchers at UC Berkeley School of Public Health and USC found that about one in three retail pharmacies in the country have closed their doors since 2010. As a result, pharmacy deserts—areas where city residents live more than a mile away from the nearest pharmacy—are increasing in frequency. In her 

, Jenni Zilka of Good Neighbor Pharmacy and Cencora elaborates on the troubling trend, sharing that pharmacy deserts are located in areas that are up to 40% more likely to have fewer primary care providers and higher social vulnerabilities, such as poverty and lack of access to transportation.

Switching gears to some of our column highlights: in 

 of his new “Popping the Gross-to-Net Bubble" series, Bill Roth of IntegriChain describes the steps that pharma manufacturers can take to address these revenue gaps. One is to revisit history to determine what approaches have been successful, including, for example, cross-functional collaboration.

And I would be remiss not to announce a sincere welcome to two new KOL voices to the regular 

 commentary slate in 2025. Sean O’Hearen of 1st Line Partners will present unique insights on brand protection and product integrity challenges in pharma, while Chris Dowd of ConnectiveRx will dig into the always changing and deeply layered issues prevalent in patient support. Both columns debut this month 

— Mike Hennessy Jr., President and CEO, MJH Life Sciences

Our February issue is highlighted by an examination of the latest trends and strategies from the perspective of third-party logistics providers, and introduces new expert commentary covering a pair of pivotal realms in the pharma supply chain journey. 

3PLs and New Voices

I am pleased to welcome you all to the first 

 marks the debuts of new guest columnists, Chris Dowd of ConnectiveRx and Sean O’Hearen of 1st Line Partners, who will be zeroing in on the topics of patient support and brand protection, respectively.

Dowd's background includes almost 30 years in leadership roles across Big Pharma, healthcare startups, and the patient support space. As for O’Hearen, after spending 20-plus years building brands in marketing and business development roles, a decade ago, he decided to shift his focus to protecting products from illicit trade. We are excited to have Chris and Sean aboard.

Shifting a bit, as Dowd references in his 

this month, the Centers for Medicare & Medicaid Services is fresh off revealing its choices for the 15 latest drugs to be covered under Part D for price negotiations. Headlining that list is Ozempic, Novo Nordisk's branded semaglutide—which, as most of you know, is a type of glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1s have traditionally treated type 2 diabetes, but surged in popularity for battling weight loss; they have also recently been approved in other indications, such as cardiovascular disease prevention and sleep apnea. Their influence cannot be ignored; in fact, a KFF Health Tracking Poll found that about one in eight adults (12%) report taking a GLP-1 drug.

I wanted to dig further into this phenomenon and found a cohort study published in 

, with more of a focus on individuals with obesity but without diabetes, a smaller subgroup of users. The study explores the drivers of semaglutide initiation in this patient group. Researchers “identified sociodemographic, healthcare, and clinical factors associated with semaglutide initiation within six months after obesity diagnosis using a novel machine learning approach. The associations ... were quantified using multivariable logistic regression, and use of common medications, insurance plan structure, employer industry type, and sex were all significantly associated with semaglutide initiation.”

The fact that there is currently limited evidence on clear factors associated with uptake in this subgroup leads me to believe that there is plenty left to be done in this setting, but AI, as chronicled in many other areas, appears to have the potential to make waves here as well.

I look forward to seeing what other GLP-1 clues surface in the New Year.

Nicholas Saraceno is Pharmaceutical Commerce's Editor. He can be reached at nsaraceno@mjhlifesciences.com.

Digging a little deeper into the drug class phenomenon reveals some interesting takeaways on a smaller subgroup of users.

Beyond the GLP-1 Headlines 

Industry professionals in the trade and channel space convened at the W Philadelphia for Informa Connect’s Trade & Channel Strategies to discuss a plethora of topics, including channel strategy, distribution, reimbursement, and product strategy, to name a few.

 was in attendance, providing behind-the-scenes coverage. The sessions covered included:

“2024 Year-in-Review and Preview of 2025” (Keynote)

“Pharmacy Evolved—Aligning Commercialization to the Changing Pharmacy Channel”

“Securing the US Supply Chain and Managing Global Products”

“Patient-Centric 3.0 — HowDirect-to-Patient is the NewCommercialization Model”

“Actions Needed to Mitigate and Prevent Drug Shortages”

“Health System Specialty Pharmacy Perspective: Lessons Learned and Considerations with Humira”

“Balancing the GTN Bubble with Market Access Priorities”

It’s important to note that no specific session was more valuable than another, but aside from Bill Roth’s keynote—which set the table for what’s to come this year—the “Actions Needed to Mitigate and Prevent Drug Shortages” seminar was successful in providing an overview of this vital issue impacting pharma supply chains today. During her presentation, Amy Sonderman, senior director of US advocacy and stakeholder engagement, US Pharmacopeia (USP), offered a look into the sources of shortages; shared approaches to holistic solutions; and presented potential ways that pharma supply chain stakeholders can work with Congress and one another to help mitigate and prevent shortages in the US.

A couple of eye-opening statistics were shared during the session. One was that the sterile injectable medicines that are in shortage cost 8.5 times less than those that are currently not in a shortage—to put it into perspective, imagine $46 per unit compared to $392 per unit. As for solid orals in shortage, they cost five times less than those not in shortage, which would be $3.40/unit compared to $17.50/unit. These types of factors are contributing to the discontinuations of these products, a trend that increased by 40% last year, according to Sonderman. She put it into perspective by offering a real-life example.

“Think about that—if you have a child who needs ADHD medicine and your pediatrician prescribed it, you go to the pharmacy and they don't have it. You then spend hours as a caregiver calling around to pharmacies. The pediatrician has to then spend hours calling around to the pharmacy. The pharmacist, who should be assisting other patients, is spending hours calling wholesalers, calling hospitals. This is a huge waste of resources. It's a huge time-stop for the healthcare industry to just try to mitigate one shortage.”

The editorial team also conducted various video interviews with multiple key opinion leaders, including Kevin O’Meara, William Trombetta, PhD,Cheryl Allen, Jon Hamrick, and Lisa Arthurs.

For the latest in conference coverage, please visit 

pharmaceuticalcommerce.com/latest-conference

Trade & Channel Strategies conference explores the frontline issues related to strategy, distribution, and reimbursement—while digging into creative solutions to solve them. 

Conference Connect: Navigating the Future  of Pharma Trade

Third-party logistics providers (3PLs) have an essential role in the pharmaceutical supply chain: handling the logistics of certain products that are unable to be accomplished by a manufacturer, distributor, or dispenser, whether that be due to lack of resources, cost, product complexity, or other reasons.

sought to uncover the most pressing issues impacting pharma 3PLs—this time in 2025—while also investigating how the COVID-19 pandemic has affected the market’s current climate and may impact its future outlook through 2035.

, Global Head of Vertical Market Healthcare, DB Schenker

, Vice President/General Manager, Cardinal Health Third-Party Logistics and Packaging Solutions

, President, Channel Management, EVERSANA

, Vice President and General Manager, McKesson Third-Party Logistics

The following roundtable-style discussion has been edited for length and clarity.

 Could you provide a general overview of how the third-party logistics process works?

Now more than ever, a company is only as good as its supply chain. For some companies, a well-run third-party logistics solution can be the fastest path to reducing costly inventory, shortening the net trade cycle, and significantly reducing capital expenses.

However, this approach is not “one size fits all,” and it is certainly not a passive endeavor. Success relies upon driving economies of scale through the deployment of optimized multi-client operations, which enable client companies to benefit from infrastructure and technology investments, procurement experience, and capacity advantages that they would not be able to attain independently. It also allows for a turnkey solution that flexes when and where business conditions need it to, with coverage and capabilities already in place to enable accelerated growth. It all begins with collaboration. Partnering effectively means we can help companies move beyond seeing their supply chains as cost centers, rather than a strategic resource.

 Third-party logistics offers a complete range of supply chain management services for biopharma that are adaptable and scalable to help businesses swiftly respond to market demands. One critical element in partnering with a 3PL is the ability to maintain compliance with constantly changing laws and regulations, which can pose a significant challenge for manufacturers at launch. An ideal 3PL partner offers efficient and cost-effective solutions to assist companies that lack the infrastructure to handle warehousing, distribution, and order management.

 What factors should manufacturers consider when selecting a 3PL, and what array of services should a quality 3PL provide?

When manufacturers consider selecting a 3PL partner, I suggest a careful assessment to ensure they have the right partner to meet their specific goals and their customers’ needs. Having a partner that can operate free of conflict provides great flexibility in providing solutions unique to a specific manufacturer or their specific product.

That said, the tenets of speed, scale, and certainty come to my mind. First, speed comes from having a true partner that the manufacturer trusts and a provider that can quickly deploy the resources needed to implement the manufacturer’s program. Second, scale should be viewed as not only the provider's infrastructure and technology, but also its personnel. Is that 3PL right-sized for today’s manufacturer? What happens if growth comes faster than planned? What about future products in the portfolio or indications of the product?

Companies should seek out a provider that can offer tangible evidence through long-standing relationships with other manufacturers that have proven to grow with them.

Certainty is third. Will the provider deliver with confidence? What does their track record of success in launching products look like? What about launching new companies into the marketplace? Are the regulatory and quality controls in place? Are their operations resilient? Is the management team entrenched and engaged with the day-to-day, as well as with the manufacturers they serve?

While 3PL services in the pharmaceutical industry have been around for decades, the successful 3PL partner of today is more than just a service provider. They are a business collaborator that aligns with the manufacturer’s goals.

: Manufacturers should consider factors such as providers' expertise, technology, compliant processes, and geographic footprint. Their choice should be driven by patient well-being, along with the 3PL provider's ability to maintain the integrity of the product from end to end. This includes ensuring on-time, in-full delivery in the right conditions, as there is a patient at the end of the supply chain. Account management and training programs in place are also critical. Their portfolio of services should include inventory management, order fulfillment, transportation, freight management, customs, tracking, and reporting capabilities in a GxP (good practice)-compliant network.

 When considering a 3PL provider, organizations should consider one with a strong focus on the customer experience. Selecting a 3PL that thinks through the customer lens is crucial to ensure your business is represented in a way that aligns with your company’s mission and vision. Biopharma organizations should also assess things like the provider’s integrated packaging solutions, expertise in organization and leadership, and the nuanced capabilities a product may require. It’s important to ensure your provider has the facilities, equipment, capabilities, and specialized knowledge to scale and grow.

 Although we’re about five years removed from its onset, what valuable lessons did you learn during the COVID-19 pandemic that have helped improve efficiencies?

 During the pandemic, we saw how serious impacts on supply chains can be fully outside a company’s control. Taking a multi-modal approach isn’t just a good bet against managing disruption and risk; it also allows for the reality we’re all facing, as more fragile, complex, and temperature-sensitive treatments hit the market.

To make that work, however, you must have control and visibility. We have access to more data than ever before, but do you have the transportation and storage capabilities to act on it and vice versa? Less guesswork, less loss, and more deliveries made where they need to be at the right time and temperature. Rethinking supply chains also opens exciting opportunities for the future of patient care. These new levels of agility and resiliency can help spread and improve home health offerings, keeping patients out of clinics and hospitals, improving lab diagnostics for speedier, more accurate treatment plans, and increasing the speed and depth of clinical trials for new products. 

 Lessons from the COVID period include accelerated digitalization, enabling real-time tracking and data-driven decisions; faster transitions from concept testing to implementation for quicker logistics solutions; building more resilient supply chains to withstand disruptions; and enhancing adaptability and agility to react swiftly to changing demands.

 Several valuable lessons have been learned that have significantly improved 3PL efficiencies within the market. One of the most critical lessons is the importance of a strong and resilient supply chain infrastructure, which is essential for managing large-scale distribution efforts. The ability to quickly adapt and respond to unprecedented challenges has set a new standard for biopharma 3PL providers, emphasizing the need for flexibility and agility. Undoubtedly, the driving force behind the ongoing expansion of our technological and distribution capabilities is our most crucial asset: our people. Without a team of experienced, dedicated, and passionate professionals, a 3PL’s services mean nothing.

 Heading further into 2025, which trends affecting the pharmaceutical industry will 3PLs be on the lookout for?

 In 2025, 3PL companies will be on the lookout for several key trends:

Advanced cold chain solutions are no longer a competitive advantage but a basic requirement for participating in the 3PL space, given the increasing demand for temperature-sensitive medications. Expect increased attention and focus on cryogenic, frozen, and refrigerated storage capacity.

As the regulatory landscape continues to grow more complex, 3PLs must be quick to adapt and expand their compliance capabilities to ensure they meet all necessary standards. The FDA has extended the deadlines and offered exemption waivers for manufacturers [and their 3PLs] to fully meet the Drug Supply Chain Security Act requirements. 2025 will be a big year to ensure pharmaceutical supply chains are fully serialized, traceable, and compliant.

Additionally, service providers must be willing to innovate to meet the unique requirements of personalized medicines, which often involve more intricate logistics and handling processes. These trends will shape the strategies and services of 3PLs to better serve their clients and maintain a competitive edge.

As 3PLs, our heads are constantly on a swivel. There is so much change that it can be difficult to know where to focus. From changing delivery models due to shifts in retail drug chains, to online pharmacy fulfillment, continued consolidation of buying entities and acquisition of the providers/prescribers, pricing pressures on the manufacturers, ESG initiatives for sustainability, and more, new trends are constant across the industry, and manufacturers are looking to their 3PL partners to help collaborate and determine how to best address them.

In addition, [let’s not forget] the rise of biologics and cell and gene therapies, which will increase the demand for specialized cold chain logistics and highly coordinated support for 3PLs. Advanced technologies such as AI, machine learning, and blockchain will continue to enhance supply chain visibility and security. Sustainability initiatives revolving around reducing carbon footprints and using eco-friendly materials will remain a focus. We also cannot underestimate potential regulatory and market changes due to the arrival of the new administration.

The innovation in next-gen treatments is not only transforming the healthcare industry but also its underlying supply chain. Complex goods, including biologic drugs, will make up an ever-growing share of the international healthcare logistics market.

At the same time, these more complex pharma products are being more broadly distributed than ever before, creating a greater need for temperature control, digital visibility, and precisely timed delivery. Thanks to rising global living standards, there are rapidly growing international markets as well as growing home healthcare opportunities, where new channels for pharma distribution will accelerate with the aging population and prevalence of chronic disease. These trends bring ample opportunities, but also new challenges on how to serve that demand effectively and efficiently.

 What level of impact do you anticipate 3PLs and their role within the industry having over the course of the next decade?

 3PLs will have a significant impact in the next decade and beyond. COVID highlighted their crucial role, and as we face more disruptive events, their ability to ensure resilient, efficient, and adaptive logistics will be essential for global pharma supply chains.

Until now, supply chain excellence has been a differentiator and business advantage for those who possess it. Going forward, and especially for healthcare companies, it will be a requirement to be viable in the market. We’re seeing a real shift in debates about “outsourcing vs. insourcing” to more well-rounded assessments, in which combinations of integrated solutions create the most sustainable business and care advantage for patients, companies, stakeholders, and shareholders.

The need for 3PLs will only strengthen over the next decade as manufacturers seek to make better use of capital to ultimately focus on developing the therapies patients need. The expertise and operational efficiencies 3PLs provide will be of great benefit to manufacturers in a more complex and geographically expanding supply chain.

As 3PLs adopt newer, more advanced technologies, manufacturers and their end customers will benefit from enhanced efficiency and reduced costs. 3PLs also have the potential to facilitate global market expansion and manage international logistic complexities by putting an emphasis on sustainability and implementing eco-friendly practices. Strong partnerships between 3PL providers, manufacturers, and stakeholders will be crucial for addressing industry needs and positioning pharmaceutical manufacturers for success. In the end, a successful partnership is a win for everyone—for the manufacturer, the 3PL provider, and, most importantly, patients in need.

 3PLs have the ability to revolutionize the client experience by how well they flex and scale with the biopharma organizations they support. Putting processes in place to review evolving client needs over time will be critical as we operate in a dynamic and rapidly changing environment. 3PLs have the ability to make a positive impact on environmental sustainability, ultimately resulting in keeping patient costs low.

 I believe 3PLs will have a significant impact over the course of the next decade and beyond. Market research by Nova One Advisor estimates suggest that the biopharma 3PL market will nearly double over the next 10 years, primarily driven by the increasing demand for specialty therapeutics and personalized medicines. The growing need for expertise and innovation in cold chain logistics will be crucial for long-term success, as these solutions are becoming a fundamental requirement rather than a competitive edge.

Additionally, regulatory challenges are not going away, and 3PLs must be prepared to adapt and flex to ensure continuous and compliant distribution. These factors will position 3PLs as indispensable partners in the pharmaceutical industry, driving efficiency, reliability, and innovation.

Leaders with top third-party logistics providers discuss the evolving landscape for the sector in 2025—and the new strides made in their quest to help transform the pharma supply chain. 

3PLs: From Resilience  to Sustainability 

In recent years, the landscape of retail pharmacy has changed significantly due to massive financial, legislative, and social pressures, creating a challenging environment for both large and small pharmacies, and resulting in some having to close their doors.

With news of pharmacy closures frequently making headlines, questions have arisen about the consequences for communities that rely on pharmacies for care. Moreover, there are growing concerns that continued closures will lead to an increase in pharmacy deserts—or areas where access to essential pharmacy and healthcare services is severely limited—particularly in underserved communities.

Pharmacy deserts are defined as areas where residents live more than a mile away from the nearest pharmacy in cities, more than two miles in suburbs, and over 10 miles in rural areas. According to data aggregated by Cencora, approximately 35 million people in the US live in pharmacy deserts.

In communities with pharmacy deserts, people cannot easily access a pharmacy to fill prescriptions and obtain necessary health services. These deserts, found in both rural and urban settings, are located in areas that are up to 40% more likely to have fewer primary care providers

 and higher social vulnerabilities, such as poverty and lack of access to transportation. In short, the absence of pharmacies in a community most likely means a synonymous lack of other care options.

The rise of pharmacy deserts contrasts starkly with the reputation of pharmacists as accessible healthcare providers (HCPs), especially in underserved communities. Independent pharmacies, in particular, are known for their organic care of underserved and socially vulnerable populations, due to the high-touch nature of their services and their natural presence in these communities. For example, 20% of Good Neighbor Pharmacy stores directly serve or are adjacent to pharmacy deserts, according to data from the National Council for Prescription Drug Programs, CDC Social Vulnerability Index, and the US Census and American Community Survey.

In underserved communities, where other HCPs may be scarce, patients depend on their pharmacies not only for prescriptions, but also for comprehensive health advice and services. Pharmacists in those settings serve as a critical resource, addressing health questions and concerns that extend well beyond dispensing medications. But this perception of pharmacists as care providers isn’t limited to these communities. The pharmacist’s role was highlighted during the COVID-19 pandemic, when local pharmacists played a pivotal role in testing, treatment, and vaccination services. Today, their role extends beyond medication dispensing to address a broader range of public health needs, with patients increasingly relying on them for various care services.

 nearly half (45%) of Americans regularly visit their local pharmacy for care, and 58% are likely to turn to pharmacies as their first stop for non-emergency medical issues. Pharmacies remain the most common sites for COVID vaccinations,

 administering 31.3 million doses between September 2023 and April 2024, compared to 2.5 million doses administered by physician medical offices during the same period. There is a similar trend for flu vaccinations, with pharmacies administering 38 million doses, compared to 26 million by physicians’ offices between August 2023 and May 2024.

Beyond vaccines, pharmacists have also shown they can effectively address other gaps in medical care, consultation, and education for various health conditions. A 2020 national study

 found that pharmacists improved medication adherence for diabetes patients, increased the use of statin medications, ensured annual flu vaccinations, completed HbA1c tests, and helped patients maintain a tobacco-free status. Their interventions closed 79.8% of care gaps, suggesting that collaboration between physicians and local pharmacists can be an effective strategy to engage patients and deliver essential care.

Despite their accessibility and proven ability to provide essential patient care services beyond dispensing medications, pharmacies are struggling to remain financially viable, primarily due to inadequate reimbursement rates for the medicines they dispense and the care services they provide. As these reimbursement rates decline—or even disappear altogether with the expiration of the COVID public health emergency—pharmacies are finding it increasingly difficult to remain financially solvent and maintain the high level of care they provide to patients.

For example, on the national level, Medicare Part B does not currently recognize or reimburse pharmacists as providers. With the expiration of the public health emergency status from the pandemic, Medicare beneficiaries are no longer covered for services provided by pharmacists. Congressional legislation to remedy this—the Equitable Community Access to Pharmacist Services Act—had been introduced last Congress with robust bipartisan support, aiming to ensure Medicare beneficiaries’ prompt access to essential services for vaccination, testing, and treatment of common infectious diseases by establishing Medicare Part B reimbursement for pharmacists to deliver these services. However, the bill was not included in the end-of-year health package passed by Congress in December 2024. As a new Congress convenes this year, Cencora will be engaged as part of a coalition to address this important reform.

Overall, with positive industry changes not guaranteed, pharmacists, along with their industry peers and trade organizations, must actively advocate for changes in scope of practice and reimbursement legislation at both state and national levels. Such advocacy is essential to ensure accessible healthcare for patients nationwide. This effort is unquestionably the industry’s primary defense against the spread of pharmacy deserts.

Diversifying revenue and meeting patient needs

Although dispensing medications was once the primary source of income for pharmacies, declining reimbursement rates have necessitated the diversification of their revenue streams. A significant opportunity to increase revenue and enhance patient care lies in offering additional clinical services, such as expanding vaccination programs and point-of-care testing, thanks to the organic proximity and accessibility of pharmacies. Despite variations in the authority to provide certain services and receive reimbursement across states, pharmacists are skillfully navigating these inconsistencies to identify and deliver more care services to their communities.

Many pharmacies have excelled in compounding prescriptions, providing nutritional counseling, and stocking over-the-counter (OTC) products such as cold medications and nutritional supplements. These OTC products, part of the pharmacy’s front end, can help diversify revenue amid reimbursement challenges and cater to patient needs.

The importance of maintaining a robust front-end store presence—stocking consumable products in a sustainable way for the pharmacy, while catering to the unique wants and needs of their patient base and demographic—is a prominent industry topic and distinct area of focus for us.

As the industry faces financial, legislative, and social pressures leading to closures and the rise of pharmacy deserts, it is crucial for pharmacies, organizations, advocates, and other peers to relentlessly push for legislative changes that protect and enhance the profession.

1. Pharmacy Deserts: Identifying Challenges and Addressing Gaps in Access to Healthcare. Cencora. 

https://www.cencora.com/resources/pharmacies/addressing-pharmacy-deserts

2. Catalano G,; Khan, M.M.M.; Chatzipanagiotou, O.P.; Pawlik, T.M. Pharmacy Accessibility and Social Vulnerability. 

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2822776

3. Wolters Kluwer’s Pharmacy Next Survey Shows 58% of Americans Likely to First Seek Non-Emergency Healthcare at Pharmacies. Wolters Kluwer. May 17, 2023. 

https://www.wolterskluwer.com/en/news/survey-shows-americans-seek-non-emergency-healthcare-at-pharmacies

4. COVID-19 Vaccinations Administered in Pharmacies and Medical Offices*, Adults 18 Years and Older, United States. US Centers for Disease Control and Prevention. January 15, 2025. 

https://data.cdc.gov/Vaccinations/Weekly-Cumulative-Estimated-Number-of-Updated-2023/w76m-r924/about_data


5. Impact of Pharmacist Interventions to Close Care Gaps tor Patients With Diabetes. MN Community Measurement. December 9, 2020. 

https://mncmsecure.org/website/Reports/Spotlight%20Reports/2020%20Pharmacy%20Public%20Report%20-%20Chartbook.pdf

How chain and local closures are impacting healthcare access.

The Prominence of Pharmacy Deserts

2024 was a pivotal year for the patient support landscape, as the space underwent a substantial shift shaped by market dynamics, regulatory changes, and the evolving needs of patients.

After a quarter marked by intense discussions at industry conferences and candid conversations with pharmaceutical leaders grappling with unprecedented change, one thing is clear: 2025 will fundamentally transform how drugs are covered, paid for, and filled in America.

Here are five predictions for how the landscape will shift in the year ahead:

By mid-2025, we'll witness the most significant healthcare policy battle since the Affordable Care Act. The Republican-controlled Senate, pursuing Trump administration priorities, is likely to substantially challenge key Inflation Reduction Act (IRA) provisions, particularly around drug price negotiations. While the slim Senate and House majorities could make it difficult to institute a full repeal of the IRA, parts of it are vulnerable.

As North Star Opinion Research Vice President Jon McHenry noted in a recent panel discussion, Republicans will likely use unspent IRA funds to help offset the continuation of Trump-era tax cuts expiring in late 2025. However, the $2,000 out-of-pocket cap for Medicare beneficiaries will likely survive, creating an interesting dynamic where manufacturers must navigate a hybrid policy landscape.

To stay ahead of the IRA roller coaster in the coming year, stakeholders in the patient support ecosystem—from providers to hub and patient services teams—need to work overtime to understand the evolving nuances of what’s changing and communicate it effectively. A PDR survey of US healthcare providers (HCPs) reveals that 38% of providers “know nothing” about the pharmaceutical provisions in the IRA, while an additional 55% only know “a little.” This highlights myriad opportunities for pharma manufacturers to also provide welcome education to HCPs about changes in access to their branded drugs.

The death of the dominance and attention on “traditional” copay programs, the surge in prevalence of accumulator adjustment and maximizer programs, and the continued usage of alternative funding programs will force a complete reimagining of manufacturer support. By Q3 2025, we'll see the emergence of matrix support programs that combine product access, procedure coverage, treatment-journey assistance, and patient success programs in entirely new ways.

Buy-and-bill programs already account for half of specialty product assistance. With the gross-to-net (GTN) pressure on brands to do more with less, including the evolution of copay affordability programs over the last five years, these matrix support programs will only continue to grow in necessity. High-end specialty medications are a prime example: In the same way biologics took the market by storm over the last seven to 10 years despite initial skepticism, cell and gene therapy pipelines and approvals are continuing to escalate—and programs supporting their adoption and adherence will be key.

As the market shifts from traditional copay programs to more sophisticated matrix programs, pharma brands need to seek out best-in-class support options to serve patients. They should consider establishing working groups in their organizations to meet with their field reimbursement managers as well as marketing and managed care teams to stay on top of what patients and providers are expecting (and demanding) in order to build programs that raise the bar.

Pharmacy benefit managers (PBMs) currently “don’t have any friends in Washington,” as McHenry noted in the recent panel. Pressure on PBMs by both federal and state governments in the form of anti-PBM legislation is unprecedented, and, considering RFK Jr.’s reformist views and the power he could wield, their influence will likely wane in the coming year.

With that in mind, the bipartisan "Patient Before Monopolies Act" will pass in 2025, fundamentally restructuring the PBM industry. As Sens. Elizabeth Warren and Josh Hawley's unlikely alliance pushes the legislation forward, we'll see initial steps to dismantle vertical integration between insurers, PBMs, and pharmacies. This will create immediate market disruption but ultimately lead to more transparent drug pricing models by year's end.

Staying on top of these developments is paramount. Whether through internal or external resources, manufacturers should remain in ongoing contact with state government relations teams to understand how legislation is evolving and how they can react.

4. The rise of ‘anti-abandonment’ programs

Even with a mature patient services model, fewer than half of specialty patients make it through payer controls to fill their prescriptions at 90 days, according to the IQVIA Institute.

With new-to-brand abandonment rates hitting 35% to 40% and the industry losing billions in potential revenue, 2025 will see manufacturers pivot away from traditional adherence programs, toward sophisticated early-intervention models. These programs will leverage predictive analytics to identify at-risk patients before they abandon therapy, combining financial support, behavioral interventions, and digital engagement in novel ways. This shift is particularly crucial as the industry grapples with expanding formulary exclusion lists from major PBMs such as CVS Caremark, Express Scripts, and OptumRx.

Leveraging patient data and AI-driven targeting models can help brands build effective anti-abandonment programs. By scoring key demographic information such as age, drug class, prior experiences, and previous adherence (or lack thereof), early-intervention algorithms can help determine the likelihood of abandonment. From there, brand teams can build tailored programs to improve adherence.

In 2025, GLP-1 agonists will face unprecedented restrictions and rejection rates from payers due to cost, demand, and indication alignment (e.g., trends that include moves by Kaiser, Independence Blue Cross, and Blue Cross Blue Shield of Michigan). While Medicare may expand coverage under the new administration, commercial payers will simultaneously implement a new generation of sophisticated access barriers that go far beyond traditional prior authorization—requiring documented participation in behavioral health programs, mandatory step therapy through lower-cost alternatives, and possibly even time-limited authorizations tied to demonstrable outcomes. And to further complicate the long-term GLP-1 reimbursement landscape, the US Department of Health and Human Services has announced that Ozempic, Rybelsus, and Wegovy will be included in the 2025 round of Medicare drug price negotiations, with adjusted prices becoming effective in 2027. Taken together, these multiple challenges will push pharmaceutical manufacturers to repeatedly reimagine GLP-1 access and support.

Learning from oncology's experience with advanced patient support programs that integrate financial, clinical, and behavioral support, we will see companies move away from traditional copay assistance toward more holistic “lifestyle support hubs” that combine financial assistance with digital coaching, behavioral modification tracking, and outcomes documentation. Traditional support models that “help with copays and prior authorization” will be enhanced by end-to-end patient success programs that help patients navigate increasingly complex payer requirements while supporting long-term therapy success. According to Kevin Herwig, health policy manager at the HIV + Hepatitis Policy Institute, we've already seen this evolution in HIV treatment support programs, where successful adherence increasingly depends on providing comprehensive social, behavioral, and financial support—GLP-1s will accelerate this trend dramatically across all chronic conditions.

The multiple disruptions looming this year will create a clear divide between brands that embrace these changes and those that maintain traditional commercial approaches. For brand leaders, the time to prepare is now, while there's still opportunity to gain first-mover advantage in their therapeutic areas. The future belongs to the bold.

Chris Dowd, Senior Vice President, Market Development, at ConnectiveRx, is a new guest columnist for Pharmaceutical Commerce, covering the patient support space. With a nearly 30-year career spanning leadership roles across Big Pharma, healthcare startups, and patient support, Dowd is a preeminent industry voice in patient access and adherence.

From matrix programs to anti-abandonment strategies, predictions for a new era.


Breaking Point: How 2025 Will Reshape Patient Support Services

The pharmaceutical industry has witnessed a resurgence of mergers and acquisitions (M&As) as companies seek to gain a competitive edge, accelerate innovation, and drive growth. By consolidating resources, expanding market reach, and acquiring valuable intellectual property, pharmaceutical organizations are reshaping the industry landscape. However, these deals come with significant risks that must be carefully managed to ensure long-term success.

M&As are making a significant comeback in the life sciences. Companies are leveraging M&A strategies to strengthen their market positions, diversify pipelines, and access innovative technologies. This trend in dealmaking reflects the growing need for efficiency and competitive advantage.

Pipeline diversification remains a key driver of M&A activity, allowing companies to broaden their product offerings and mitigate risks tied to single-drug portfolios. Additionally, acquisitions often accelerate time-to-market for ground-breaking treatments by bypassing lengthy R&D phases. Another motivating factor is cost synergies, achieved through shared resources and economies of scale, which reduce operational expenses. Accessing emerging platforms, particularly in biotech and AI-driven drug discovery, also pushes companies toward strategic deals.

Recent notable deals underscore this resurgence. For example, Pfizer’s acquisition of Seagen in 2023

 highlighted its focus on advancing cancer therapies. Similarly, Amgen’s purchase of Horizon Therapeutics in the same year

 aimed to expand its presence in rare diseases, aligning with a long-term growth strategy. Each deal exemplifies the industry’s commitment to combining strengths and adapting to market demands.

The strategic rationale for these transactions is clear: companies are seeking to maintain relevance in a rapidly evolving landscape. Whether by enhancing product pipelines, reducing costs, or securing cutting-edge technologies, M&A activity is shaping the future of pharma. This resurgence signals an exciting phase of innovation, collaboration, and growth for the industry.

Risks associated with M&As in small pharma companies

M&As in smaller-sized organizations can drive growth and innovation, but they also carry significant risks. Addressing these challenges requires careful planning and strategic execution to ensure success post-merger.

Navigating the complex regulatory landscape is one of the biggest challenges in M&As for small pharma. Each merger involves aligning with different regulatory frameworks, which can delay deal completion or increase costs. Post-merger, ensuring ongoing compliance is equally daunting, especially as regulations evolve across global markets. Failing to address these issues can lead to costly penalties or loss of market access.

. Combining two distinct organizations often brings cultural and operational conflicts. Merging diverse workforces and integrating different IT systems can cause disruptions, leading to inefficiencies and delays. Without proper planning, these challenges may result in productivity losses, potentially derailing the intended benefits of the merger.

. Economic downturns and geopolitical events can significantly impact the value of M&A deals. Fluctuating valuations may lead to higher deal premiums, making transactions riskier for small companies. Furthermore, unexpected market shifts post-merger can compromise the financial stability of the combined entity.

. Shareholder dilution is a common concern in M&A transactions. When deals involve issuing new shares or acquiring debt, existing shareholders may experience reduced ownership percentages, which can impact long-term value and investor confidence.

. The practical aspects of combining supply chains and manufacturing processes also pose challenges. Supply chain disruptions, quality control issues, and operational bottlenecks are potential risks that can delay product delivery and harm brand reputation. These problems are particularly pronounced in those industries with strict compliance standards, such as the pharma sector.

M&As in small pharma companies can unlock growth and innovation, but only if the associated risks are carefully managed. Addressing regulatory, integration, market, and operational challenges with proactive strategies ensures that these transactions deliver their intended value. For small pharma, success lies in preparation, adaptability, and a keen understanding of the unique challenges inherent in the industry.

Mitigating risks and ensuring a smooth exit

M&As can be transformative for companies, offering growth and market expansion opportunities. However, to ensure a successful and smooth exit, careful planning and post-acquisition risk management are essential.

 Addressing key factors in strategic planning, due diligence, integration, risk management, financial planning, and legal considerations can significantly improve outcomes.

A successful M&A begins with a well-defined strategy that aligns with the company’s long-term objectives. This involves identifying potential acquisition targets that offer strategic value, such as complementary products or market presence. Assessing the strategic fit ensures that the merger strengthens the company’s position while minimizing the risk of misalignment.

Due diligence is crucial to uncovering hidden risks and liabilities. This process involves analyzing the target company’s financial health, intellectual property, and regulatory compliance.

For example, reviewing contracts and patents helps identify potential legal issues, while evaluating operational practices ensures compatibility with the acquiring company. Thorough due diligence lays the groundwork for a seamless transition and avoids surprises post-merger.

Integration challenges often derail the benefits of an M&A deal. A comprehensive integration plan can mitigate this risk by addressing key operational and cultural differences. Clear communication channels should be established to foster collaboration and align teams across both organizations. Leveraging technology, such as unified IT systems, can streamline processes, improve efficiency, and reduce disruptions during the transition.

Identifying and managing risks early in the M&A process is critical. Companies should develop contingency plans for potential disruptions, such as supply chain interruptions or regulatory hurdles. Implementing robust risk management frameworks allows for agile responses to unforeseen challenges, ensuring stability throughout the integration process.

Adequate financing is essential to cover acquisition costs and post-merger integration expenses. Life sciences companies must evaluate the financial impact of the deal on cash flow and the balance sheet, ensuring sustainability. This analysis helps prevent over-leverage, which can strain resources and jeopardize long-term success.

Navigating complex legal and tax implications requires experienced advisors. Ensuring compliance with relevant regulations and addressing potential tax liabilities are critical to avoiding penalties or delays. Proper legal guidance ensures a smoother transaction and safeguards against unforeseen complications.

Mitigating risks in M&A transactions demands strategic planning, detailed due diligence, and proactive integration and risk management.

By aligning financial, legal, and operational frameworks, companies can ensure a smooth exit and maximize the value of their merger. A well-executed approach not only reduces risks but also sets the stage for long-term success.

Justin Kozak is the Executive Vice President at Founder Shield, a tech-enabled commercial insurance brokerage. He leads the life sciences practice, having 10+ years of experience in risk management with Hub International, PBC, and now Founder Shield.

1. Pfizer Completes Acquisition of Seagen. Pfizer press release. December 14, 2023. 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-seagen

2. Amgen Completes Acquisition of Horizon Therapeutics Plc. Amgen press release. October 6, 2023. 

https://www.amgen.com/newsroom/press-releases/2023/10/amgen-completes-acquisition-of-horizon-therapeutics-plc

3. Hamory, W. Post-Acquisition Insurance & M&A Risk Management Guide. Founder Shield. September 22, 2024. 

https://foundershield.com/blog/post-acquisition/

4. Saraceno, N. Consequences of Non-Compliance. 

https://www.pharmaceuticalcommerce.com/view/consequences-non-compliance

What factors should be considered—and how can both parties benefit long-term?


M&A in Pharma: Balancing Growth and Risk

Illicit trade activity (ITA) in the pharmaceutical industry has been on a steady rise globally since the Pharmaceutical Security Institute (PSI) began reporting annual incident statistics more than 22 years ago. According to PSI data, in 2023, pharmaceutical crime hit an all-time high, with 6,897 incidents reported.

 Over the five years of 2019-2023, incidents climbed about 8% yearly. These incidents cut across every therapeutic category and every region of the world. Risks related to ITA include activities such as counterfeiting, diversion, tampering, theft, and trademark infringement. As the problem grows, both the pharma industry and the public sector continue to direct more attention and resources toward dealing with this challenge and protecting patients, along with the integrity of our drug supply chains.

is introducing this new column to address issues related to ITA and to promote a dialogue regarding what we, collectively as an industry and through collaboration with the public sector, can do to combat the problem and protect patients and product integrity.

Unsurprisingly, criminals and bad actors involved in ITA prioritize profits over patient safety and health. They operate in the shadows, clandestinely, seeking to avoid detection, exposure, and accountability for their crimes. They comprise the “dark side” of pharmaceutical commerce, which we will aim to shed light on, stimulate discussion about, and help readers understand best practices, both proactive and reactive, for managing and controlling ITA risk.

It's important to understand that ITA risk, to varying degrees, touches virtually every phase of pharmaceutical product development, manufacturing, and distribution—from “make to take”—and every segment of a product’s lifecycle—from “launch to legacy.” Bad actors spot market opportunities and exploit vulnerabilities throughout the system with alacrity, ingenuity, and sophistication, not to mention greater agility than those of us who play by the rules. Their fraudulent schemes and methods are innumerable and dynamic, and it’s difficult for the good guys, the protectors, to prevail.

To effectively oppose the dark side, we have to think differently than we do when thinking about our legitimate business activities. We have to view our manufacturing and distribution system holistically and through a “product integrity lens,” meaning we have to ask ourselves: how can bad actors exploit and/or circumvent the regulated delivery system to achieve their nefarious aims?

Thus, the objective of this column will be to broaden the aperture of our product integrity lens and look at this problem and solution set from various angles, through case studies and exploration of current events, hot topics, and themes raised by the 

On that note, this issue covers topics such as retail pharmacy closures, pharmacy deserts, and third-party logistics (3PLs). To emphasize my point, all three topics have significant product integrity concerns related to them, which we don’t have the column space to get into now. However, I’ll briefly highlight some of the issues as an example of more to come in this space.

A key knock-on effect of pharmacy closures and subsequent pharmacy deserts is that people turn to the internet for their medicines. From a product integrity perspective, this is generally a bad idea. As the Alliance for Safe Online Pharmacies states on its home page,

 “At any given time, there are around 35,000 active online pharmacy websites—about 95% of which do not comply with applicable laws and pharmacy standards.” Online pharmacies are rife with illicit products, and manufacturers must invest significant resources in online monitoring and enforcement.

In terms of third-party logistics, this is an area that can keep pharmaceutical security leaders up at night. 3PLs are a key area of focus of product integrity programs, mainly due to cargo theft risk, especially in certain parts of the world, such as Brazil, Mexico, and South Africa. Proper vetting, auditing, and oversight of 3PLs is critical, as well as having processes and procedures in place for route planning, incident response, and regulatory compliance, to name a few.

I’m excited to have this forum and opportunity to raise awareness and understanding of product integrity challenges, which should concern everyone in this industry, not just those responsible for mitigating and managing ITA risk. I look forward to engaging with the 

 community going forward, and appreciate any feedback, questions, or suggestions readers have for future topics.

Sean O’Hearen is Founder and Principal Consultant at 1st Line Partners.

1. Latest publicly available PSI data at 

2. Alliance for Safe Online Pharmacies home page. 

Introducing a new Pharma Commerce column focused on combating illicit trade and protecting product integrity—and ultimately patients.

Welcome to the 'Dark Side'

A bipartisan government funding deal at the end of last year initially included reforms of pharmacy benefit managers (PBMs) that would limit their ability to use rebates as a major profit center. PBM reform was excluded from the final government funding deal, but there continues to be strong support in Congress to address the subject. Focus is now on what the incoming Trump administration will do, and how this may impact the pharmaceutical market in the US.

A handful of PBMs handle patient access to prescription drugs on behalf of health insurance companies, extracting rebates in exchange for a favorable position on the drug formulary. Particularly for drugs that are deemed “interchangeable,” PBMs extract substantial rebate payments without affecting the publicly visible price. Rebates have formed a substantial part of PBMs’ incomes, although some of the rebates are claimed to be passed on to the payers.

In my opinion, there are a few problems with the rebate model:

Formulary choices are based on drug rebate maximization, not patient benefit and clinical goals.

PBMs are potentially skimming profits but add limited value beyond claims handling.

Finding the optimal balance in pharmacy benefit manager reform.


Pharmaceutical Commerce - February 2025

Pharmaceutical Commerce - February 2025 Issue (PDF)

3PLs and New Voices

Beyond the GLP-1 Headlines

Conference Connect: Navigating the Future of Pharma Trade

3PLs: From Resilience to Sustainability

The Prominence of Pharmacy Deserts

Breaking Point: How 2025 Will Reshape Patient Support Services

M&A in Pharma: Balancing Growth and Risk

Welcome to the 'Dark Side'

Rebates or Patients?

Closing the Health Literacy and Diversity Gaps in Clinical Trials

Popping the Gross-to-Net Bubble, Part II: What Manufacturers Can Do About It

Why Pharmaceutical Products Need Sustainable Packaging