6 Pharma Trends for 2025: Trump’s Return, AI Breakthroughs, and Market Access Challenges

  • Andre Moa
  • 21 Jan 2025
  • 21 minute read

 

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Most of this year’s trends emerge in the shadow of Donald Trump’s second inauguration as US president. While territories like China are closing the gap, the US cannot be ignored as a leader for drug innovation, pricing and market access worldwide. The country’s influence on global pharma market strategies is enormous. As we look at pharma trends for 2025, we consider how these dynamics are likely to play out over the rest of the year and beyond.

Unsurprisingly, everything tends to come down to market access as a core pillar of pharmaceutical industry functionality. These trends focus on what market access is, how to get it, and how it is changing, as well as new technologies and strategies with the potential to expand market access or accelerate progress towards it.

For companies launching products or trying to optimise existing portfolios, 2025 promises to be no less challenging than any other year. The Trump inauguration provides an extra dash of uncertainty. However, the pharmaceutical industry is ultimately about problem-solving within a very challenging environment. We can expect to see companies harnessing all of their ingenuity, new technologies and diverse resources to meet those challenges head-on over the coming months.

Pharmaceutical Trends for 2025

Trend #1. Better the devil you know? Trump could be a mixed blessing for pharma

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Had Kamala Harris won the US presidential election for the Democrats last November, the industry could at least have braced for a continuation, if not intensification, of the less pharma-friendly policies pursued by the Biden administration. With Donald Trump taking up the reins on 20th January 2025, the pharma outlook is considerably less predictable. Little emerged during Trump’s election campaign to give the industry any clear direction.

Pharma-bashing, especially on drug prices, was a feature of Trump’s previous campaign, cementing his populist credentials. In office, Trump went after drug prices and perceived anti-competitive pharma practices with some zeal, if few concrete outcomes. The Biden administration picked up the ball on pricing, with the radical imposition of direct price negotiations for expensive Medicare Part D drugs under the Inflation Reduction Act (IRA), while disincentivising profiteering by pharmacy benefit managers (PBMs).

Harris would likely have expanded/accelerated Medicare price negotiations, while consolidating other Biden measures such as monthly caps on out-of-pocket expenditure for insulin products. But what will the new president do? Among potential Trump administration health policies, there are whispers that the IRA will be repealed. However, this might be a stretch legally, could alienate Trump loyalists, and would eliminate a welcome source of Medicare savings. More feasibly, Trump might moderate or draw a line under some of the IRA’s provisions.

He seems to have cooled somewhat on the ‘favoured nations’ scheme, whereby Medicare drug prices would be referenced to lower levels in other markets. Still, Republican control of both the Senate and House will give the president more leeway to push through combative measures. As some commentators have noted, taming drug prices has previously attracted bipartisan support, even if not one Republican voted in favour of the IRA bill during its congressional passage.

Pharma may ultimately have more to fear from wild-card Trump appointments geared to a deregulatory, new-broom agenda. This might look like an opportunity for pharma to benefit, for example, from more aggressive accelerated approvals and stripped-down bureaucracy at the Food and Drug Administration (FDA). On the other hand, a consistent operating environment, procedural stability and the perception that medicines are tightly regulated are vital to industry’s always vulnerable public profile.

“Pharma may ultimately have more to fear from wild-card Trump appointments geared to a deregulatory, new-broom agenda.”

Trump’s choice for FDA Commissioner, Martin Makary, appears to be a relatively safe pair of hands, despite Makary advocating for herd immunity during the COVID-19 pandemic. Trump also wants him to help ‘course-correct’ the FDA. Nominating vaccine sceptic Dave Weldon as the next Director of the Centers for Disease Control and Prevention may ring some alarm bells. So may, in terms of domestic health priorities, Trump’s immediate executive order for the US to withdraw from the World Health Organization (WHO), even if it is a characteristic declaration of independence. 

Overhauling the FDA is one ambition of John F Kennedy Jr, Trump’s maverick pick for Secretary of Health and Human Services. The Kennedy nomination could run into difficulties at Senate confirmation hearings in early 2025, but until then, it may unsettle both pharma and the broader healthcare community, already challenged by Trump’s declared aim to dismantle or replace President Obama’s historic Affordable Care Act (ACA).

Kennedy brings to the table a history of vaccine criticism, a fondness for alternative medicine and controversial stances such as linking cancer to fluoride in drinking water. Nonetheless, his vow to combat chronic disease, aligned with Trump’s directive to Make America Healthy Again, could feasibly find a place in pharma agendas. Less encouraging was that Trump marked the nomination with an attack on “drug companies who have engaged in deception, misinformation, and disinformation.”

The industry might be on firmer ground if Trump takes his new broom to the Federal Trade Commission, which under Biden has been notably tougher on pharma mergers and acquisitions (M&A) and licensing and on PBM profiteering (which Trump himself has condemned). While M&A scrutiny is expected to ease up under the new administration, with particular gains for biotechs, industry would applaud a further clampdown on PBMs.

A reduced corporate tax burden might also help to balance out downward pressure on drug prices and sweeten the overall business environment. As ever with Trump, though, it is hard to separate reality from grandstanding, at least until the legal and regulatory gears are set in motion.

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Trend #2. The big squeeze: EU pharmaceutical reforms 2025 and some transatlantic jitters

The European Commission’s sweeping reforms of EU pharmaceutical legislation may not actually come into force until 2028-29. In the meantime, there is plenty for pharma to think about and plan for, amidst some disconcerting noises from across the Atlantic.

As things stand, the EU’s pharmaceutical revisions are still working their way through the regulatory process. The European Parliament adopted the revised package in April 2024 and was picked up by the new Parliament following the European elections in June 2024. Industry has been working hard to damp down provisions threatening pharma market access and sustainability.

Key provisions affecting pharma include:

  • A minimum regulatory data protection (RDP) period of seven and a half years for newly approved medicines, plus two years of market protection. The Commission had proposed reducing baseline RDP from eight to six years. Parliament’s position offers additional data protection if a product meets other criteria, such as addressing an unmet medical need (+12 months).
  • Parliament retained the Commission’s proposal that baseline market exclusivity for orphan drugs should be reduced from 10 to nine years. Orphan products based on bibliographic data would get only four years of exclusivity, while those addressing high unmet medical needs (HUMNs) would qualify for 11 years of exclusivity.            
  • Parliament removed a controversial requirement for companies to supply new drugs continuously in all Member States within two years of approval if they wanted to claw back two years of lost RDP. There is still an obligation to file nationally for pricing and reimbursement of new medicines, but only in Member States requesting submissions.
  • The parliamentary review left unchanged proposals to reduce the time taken to evaluate new medicines centrally in the EU. The EMA would have to assess products within 180 days (150 days for medicines of ‘major public health interest’), down from 210 days currently. Another retained measure was the notion of regulatory sandboxes, with adaptive frameworks including real-world data collection to expedite approval of novel therapies.

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If industry associations like EFPIA still have some issues with the revised proposals, they certainly look less daunting now for research-based players. Industry will be watching carefully to see what happens between now and 2028/29.

The Trump inauguration has taken place, and what that might now mean for transatlantic trade in medicines. The US president-elect has been vocal about his plans to place tariffs on a range of goods imported into the US and to beef up local manufacturing. Pharma is a global business with manufacturing plants and suppliers all over the world, dependent on factors such as cost, convenience, supply-chain management and the interplay of government industrial/market access policies.

If the COVID-19 pandemic prompted a shift towards shorter supply chains and some element of ‘reshoring’, Trump’s campaign promises threatened to hit much harder. Even so, the main tariff targets were countries like China—a leading supplier of active ingredients for generics used in the US—as well as Canada and Mexico.

“If the COVID-19 pandemic prompted a shift towards shorter supply chains and some element of ‘reshoring’, Trump’s campaign promises threatened to hit much harder.”

Recently, there have been suggestions—derided by Trump as ‘fake news’—that the new president might limit tariffs to sectors regarded as critical to US national or economic security. These could include pharmaceuticals. However, aggressive tariffs on imported medicines might push up US prices—not a good fit with Trump’s campaign remarks against drug-price inflation—and lead to politically embarrassing supply shortages.

Nonetheless, the EU remains a leading trading partner of the US and a net exporter, with a positive goods balance of around €158 billion in 2023. Furthermore, medicinal and pharmaceutical products were the leading export category from the EU into the US in 2023, to the tune of €55.6 billion. If they do materialise, proposed import tariffs of 10-20% on suppliers worldwide may not be as cataclysmic as the 60% rate threatened for China, but they will hurt.

As always, Trump’s real intentions are hard to gauge. But, with market access for medicines in the EU and worldwide unlikely to get any easier, now is not the time to be complacent about a potential EU-US trade war.

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Trend #3. Predictive analytics: Understanding and pricing value in a cost-driven market

Value-based pricing (VBP) for medicines remains less established or inclusive than some stakeholders would like it to be. Significant barriers to uptake include affordability ceilings, complexity, evidence requirements, incompatibility of healthcare payment systems, and defining and measuring mutually acceptable outcomes.

Another key obstacle is how licence holders, payers and healthcare systems can adjust for indication-based pricing, especially when the prevalence of rare-disease therapies and other speciality medicines has made indication-building a core pharmaceutical development strategy. Moreover, value is always open to interpretation.

VBP is likely to mean different things to different people, with diverging levels of emphasis on budgetary impact, holistic health system implications, societal value, quality-of-life (QoL) considerations, long-term cost offsets and redesigning disease pathways. Yet pharmaceutical companies cannot afford to ignore the potential of value-based pricing models to resolve mounting tensions between premium pricing for better-targeted, more effective medicines and the relentless financial pressures on healthcare systems.

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Among the trends shaping the pharmaceutical industry in 2025 is predictive analytics, a digital resource that can help pricing and market access specialists plot a pathway for VBP. As market access consultants Remap points out, traditional drug-pricing models tend to rely on historical data and expert opinion, potentially diluting accuracy and efficiency.

Machine learning algorithms, on the other hand, can process real-time data from multiple sources, including clinical trials, market trends, patient outcomes, payer databases, stakeholder feedback and competitor information. This enables users to dynamically predict optimal pricing strategies and encapsulate a broad range of value parameters.

By churning through vast volumes of data at speed, predictive analytics are an efficient and cost-effective means of teasing out insights that better define market needs and frameworks for VBP by:

  • Accounting for crucial factors such as the product profile, therapeutic and clinical benefits, R&D costs, associated disease burden, market competition, trends in the therapy area or payer attitudes and expectations;
  • Addressing uncertainties over the long-term effects of innovative medicines in the absence of a viable comparator drug or standard of care and
  • Working out what kind of demonstrable value will substantiate a VBP model that can be modified for real-world evidence development and new indications, etc.

As a PwC report points out, with predictive analytics and other artificial intelligence (AI) solutions, companies can design, simulate and evaluate different pricing and contracting scenarios, weaving in variables such as market segmentation, price sensitivity, elasticity of demand, budget impact, cost-effectiveness, risk-sharing and outcomes-based agreements.

"These analytical tools should give pharmaceutical companies the visibility and flexibility to make better-informed, more value-oriented pricing decisions geared to multiple stakeholder perspectives."

These analytical tools should give pharmaceutical companies the visibility and flexibility to make better-informed, more value-oriented pricing decisions geared to multiple stakeholder perspectives. Ideally, this will lead to more sustainable pricing and improved patient access to breakthrough medicines. Payers and healthcare systems first need to be amenable to and equipped for VBP models, however well-designed and well-populated these may be.

With continuing uncertainty over drug-pricing prospects in key pharmaceutical markets such as the US, companies must not only leverage predictive analytics to their best advantage for agile VBP strategies but also convince payers and other key stakeholders that drug innovation really can be balanced with affordability.

Trend #4Could weight management be a pathfinder for holistic HTA?

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Industry has long argued for health technology assessment (HTA) that assesses drug value more holistically. It wants reimbursement gatekeepers to look beyond basic budget impact and towards disease pathways, resource allocation in healthcare systems, ripple effects in society and the economy, and what QoL really means for patients.

Innovation, meanwhile, keeps knocking at the payer’s door, with ever more ingenious ways to spend money. One example is the much-hyped repurposing of GLP-1 inhibitors, such as Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Mounjaro/Zepbound (tirzepatide), from diabetes to weight-loss therapies.

The treatments are not cheap. For example, the original list prices for a month’s supply of Wegovy and Zepbound in the US were around $1,349 and $1,069, respectively. Prospective treatment populations are substantial. This has led to rigorous access conditions, such as concomitant health problems (e.g., high blood pressure or cholesterol), time limits on treatment, or patient commitment to weight-management programmes.

Obesity is a global issue that is escalating. Worldwide, 43% of adults aged 18 years and over were overweight in 2022, while 16% were living with obesity. In England, where around 64% of adults are considered overweight or obese, the National Health Service (NHS) estimated that around 2.8 million patients would be eligible for treatment with Mounjaro, based on draft recommendations from the National Institute for Health and Care Excellence (NICE).

If 70% of those patients took up treatment, the cumulative cost of Mounjaro in its second year of use would be about £2.9 billion, equivalent to 28% of the entire primary-care medicines budget, according to NHS England (NHSE). Small wonder they filed a funding-variation request asking for Mounjaro to be rolled out over a 12-year period.

NHSE also wanted the qualifying treatment threshold raised from a body mass index (BMI) of 35 kg/m2 (plus at least one weight-related comorbidity) to 40 kg/m2 for the first two or three years of the roll-out. NICE stuck with 35 kg/m2 in its final draft guidance on Mounjaro, while prioritising patients already receiving specialist-weight management services, followed by those with the highest clinical need.

NICE also directed NHS England to develop a plan to determine who else would be offered tirzepatide over the next three years. During this period, real-world data would be gathered to inform a NICE re-evaluation of how Mounjaro might best be rolled out to a broader population.

Care costs for obesity include related conditions like cardiovascular disease, diabetes, or depression, as well as associated reductions in mobility, productivity, or QoL. A counter-argument could, therefore, be made that since obesity has such far-reaching effects, should cost-benefit assessments for weight-loss therapies not be made in the same broad terms?

"Since obesity has such far-reaching effects, should cost-benefit assessments for weight-loss therapies not be made in the same broad terms?"

Novo Nordisk and Eli Lilly have pursued this logic in ongoing clinical trial programmes, generating evidence for Wegovy and Mounjaro/Zepbound in reducing overall cardiovascular risk (now FDA-approved for Wegovy) or lowering blood pressure. This additional data should give the companies leverage to persuade payers that long-term treatment benefits go beyond weight loss.

Zepbound, for example, gained FDA approval in December 2024 for obesity with moderate-to-severe forms of obstructive sleep apnoea (OSA). It is now covered for this additional use by US Medicare Part D plans which, along with many other insurers, will not pay for Zepbound or Wegovy to treat only obesity (Wegovy is covered for reducing cardiovascular risk).

One strand of Mounjaro’s market access programme in the UK is a strategic collaboration with the government which involves Eli Lilly investing £279 million into the country. It also includes a five-year study (SURMOUNT-REAL UK) to assess the real-world effectiveness of tirzepatide in weight loss, diabetes prevention, and preventing obesity-related complications in obese adults.

Significantly, the study would collect data on “healthcare-resource utilisation, health-related quality of life and changes in participants’ employment status and sick days from work.” The attention to parameters such as healthcare resource utilisation or employment impact suggests a broader conception of value than may be available from standard HTA models used to make drug reimbursement decisions.

It is too early to say whether Eli Lilly’s real-world study will produce compelling evidence enough to change care pathways or whether GLP-1 inhibitors for weight loss will prove to be trailblazers for more holistic HTA applicable to other chronic diseases. But they are on the right track.

Trend #5Further than far out: Psychedelic medicines for mental health

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Prescription medicines and illegal drugs occasionally look like two sides of the same coin. After all, chemicals are chemicals, and people will always find ways to make themselves feel better. This trend accelerated with the emergence of lifestyle drugs that found a second life outside the regulatory system.

No respectable pharmaceutical company will condone drug diversion or overprescribing. Yet Viagra, Cialis and Levitra have a twilight existence as party drugs. Medical marijuana for treating pain and other indications has paved the way for the liberalisation of recreational use. Moreover, when Hollywood celebrities start enthusing about the weight-loss benefits of GLP-1 inhibitors, they are surely redefining the parameters of clinical obesity.

Now, the tide seems to be turning towards potentially legal and productive uses of illegal drugs. LSD, for example, was once entirely legal, used for experiments in psychiatry and the US military, and even distributed in huge quantities by Ken Kesey and his Merry Pranksters for the San Francisco-based Acid Tests.

Notable in this respect are other psychedelic therapies, such as psilocybin, MDMA (ecstasy) or ketamine (a legally approved anaesthetic but heavily abused as a recreational drug). These controlled substances have shown potential in mental health conditions such as treatment-resistant depression, post-traumatic stress disorder (PTSD), anxiety, obsessive-compulsive disorder and substance use disorders.

"These controlled substances have shown potential in mental health conditions such as treatment-resistant depression, post-traumatic stress disorder (PTSD), anxiety, obsessive-compulsive disorder and substance use disorders."

They are now in clinical trials, some of which are quite advanced. Lykos Therapeutics for example filed a New Drug Application with the FDA in February 2024 for midomafetamine (MDMA), combined with psychological intervention, as a treatment for PTSD. This would have been the first psychedelic-assisted therapy to be cleared as a prescription drug in the US. However, the FDA asked for an additional Phase III trial to further assess the safety and efficacy of midomafetamine. 

This suggests regulators are likely to proceed cautiously with therapeutic uses of psychedelics. There are also concerns about potentially dangerous side effects and about legitimate clinical development of psychedelics encouraging self-medication with compounds like psilocybin, the ‘trippy’ ingredient in magic mushrooms.

If some of these products are eventually marketed, which seems quite likely—even if FDA approval for psychedelics is now on the back-burner—licence holders may also face problems with stigmatisation, uncertainties around reimbursement and other barriers to acceptance by both patients and payers. These will pose unique challenges for market access teams.

All the same, prevalence rates for mental health and associated conditions have ballooned in recent years, with significant societal and economic consequences. In that sense, psychedelic research is to be welcomed, even if there may be qualms about the progressive medicalisation of what now seems to be an almost inexhaustible range of mental health problems.

Trend #6. Friendly robots: Advances in generative AI for pharmaceutical R&D

AI is already embedded in a comprehensive range of pharmaceutical processes and strategies, from drug discovery and research and development to regulatory affairs, pricing and reimbursement, market access, marketing, medical affairs, pharmacovigilance, manufacturing and the supply chain.

With pharmaceutical innovation increasingly subject to price scrutiny and health technology assessment, there is more pressure than ever now to ensure that multiple components of value are built into new product propositions from the earliest opportunity. This costs money, so anything that can streamline R&D processes, optimise productivity, and drive cost-efficiency will likely take pride in the industry’s toolbox.

With generative AI based on machine learning, R&D organisations can take those efforts up a notch. A report by McKinsey estimates that generative AI can deliver value of $15-28 billion annually in research and early discovery, spanning processes such as extraction of scientific knowledge, in silico compound screening, maximising the potential of biopharmaceuticals and associated drug vectors, indication selection for asset strategies, and optimising clinical trial design.

"A report by McKinsey estimates that generative AI can deliver value of $15-28 billion annually in research and early discovery"

McKinsey says a potential $13-25 billion per year can be added by applying generative AI to clinical development. This might involve co-pilots to assess clinical trial performance, smart data management, generating regulatory intelligence, or content creation for regulatory submissions.

For example, generative AI can accelerate compound screening by using foundational chemistry models that can map millions of known chemical compounds by structure and function and then overlay that information with results from already tested molecules. McKinsey believes the potential impact is up to a 2.5-times increase in the performance of chemical compound activity models and a more than four-fold reduction (from months to weeks) in the time needed to identify new leads.                                                

As a trial performance co-pilot, generative AI can rapidly analyse vast quantities of structured and unstructured data, delivering insights into early interventions to enhance clinical trial outcomes, improving cross-functional coordination, and speeding up patient enrolment and study implementation. According to McKinsey, the potential impact could be around 20% more cost-efficiency and 10-20% faster patient enrolment.

Generative AI could benefit from forward-thinking regulators who are aware of its potential to accelerate the development of safer, more effective, better targeted, and more personalised medicines, ultimately benefiting patients and healthcare systems. With incoming president Donald Trump promising a more deregulatory climate in the all-important US market, the time may be ripe to put generative AI more conclusively into play.

The US FDA recently released draft guidance for industry on Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The EMA meanwhile adopted the final version of a reflection paper on AI in pharmaceutical R&D and the medicinal product lifecycle in September 2024.

The FDA’s draft guidance lays out a risk-based assessment framework for establishing and evaluating the credibility, in particular ‘contexts of use’, of AI models that support drug development and regulatory submissions. It also highlights the unique challenges presented by AI in drug development, such as variability in the datasets for training AI models that may introduce bias. Ethical and data-privacy considerations will add another layer of complexity when applying the technology in these contexts.

Moreover, as McKinsey points out, generative AI cannot deliver results without the proper data architecture in place. This requires a multi-pronged approach, capable of running both internal and external datasets, and calling for close collaboration between data scientists and other functions, such as business strategy, medical affairs and legal departments. Generative AI may be revolutionising pharma R&D with automated processes, but it still needs teamwork.

What’s next?

Our pharmaceutical trends for 2025 lean quite heavily on the potential implications of a returning Trump administration in the US. While it may be difficult to predict what Trump has in store for the pharmaceutical industry, market access managers and their teams can take stock and look ahead to another year of inevitable change and development.

Most importantly, they need to keep their finger on the industry’s pulse so they can anticipate any issues that may arise moving forward and continue delivering sustainable, affordable drug innovation. Innovative technologies will help shape market access and launch strategies for new medicines in the year ahead. Accelerating digital transformation in pharma will lead to better-informed, more responsive market access strategies with full visibility across brands and national borders.

"Accelerating digital transformation in pharma will lead to better-informed, more responsive market access strategies with full visibility across brands and national borders."

Launch readiness software such as SmartLaunch®, or digital tools geared to market access, like SmartAccess™, can help you better manage unpredictable timelines. They provide real-time visibility of HTA, reimbursement and launch status across multiple countries and corporate layers. Given the pressing challenges highlighted in this analysis, companies need the reassurance that new products can be taken up as quickly and effectively as possible.

One way to do that is by optimising digital solutions, specifically collaboration software, to maintain alignment across the board in pharmaceutical product launch and market access planning and execution. A 360, real-time view of progress and challenges from market to market will help ensure that 2025 market access barriers are a problem for your competitors and a competitive opportunity for your own business.

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