The pharmaceutical industry plays a key role in global healthcare, but today it faces more challenges than ever. Scientific progress is accelerating, while economic and regulatory pressures continue to grow. In order to keep delivering effective treatments, the industry has to address a multitude of complex and interconnected issues.

This article outlines the 11 most important challenges currently shaping the pharma sector and explores practical, forward-looking solutions for each of them.

1. Decreasing R&D productivity

The first challenge the pharmaceutical industry faces is a decrease in the productivity of research and development pipelines. Deloitte conducted a comprehensive study on the problem, which revealed the current state of R&D in pharma:

  • Biopharma’s rate of R&D investment returns has decreased twofold since 2014.

  • The top 20 pharmaceutical companies have to increase their R&D spending by at least 5% every year to meet more complex trial requirements, frequent regulatory changes, and inflation risks.

  • The cost of medical trial failure represents around 60% of all development costs.

In addition, Daniel Chancellor, a renowned pharma advisor, declared that by 2030, R&D margins in pharma are expected to decline significantly, from 29% to 21% of total revenue.

So, why is this? Well, several factors contribute to this situation. For starters, the commercial success of new drug launches has become increasingly difficult to predict due to intense competition and the industry’s shift toward personalized medicine. At the same time, the cost of bringing new drugs to market continues to rise, driven by more expensive clinical trials, longer development timelines, and declining success rates. Together, these pressures lead to higher pipeline attrition, with more drug candidates failing at different stages of development.

How to solve:

  • 1

    Strategic planning.

    Using strategic activities aimed at finding new markets and target audiences. Pharma companies should pay close attention to building a comprehensive portfolio of successful launches and finding new channels for promotion.

  • 2

    Digitalized data-driven decision making.

    Companies can adopt AI for advanced data processing and analytics to improve decision-making across pharma workflows. In parallel, using 3D medical and scientific visualization helps clearly explain mechanisms of action and microanatomy processes to healthcare professionals, stakeholders, and regulatory bodies. Together, these solutions support more efficient analytics and clearer communication, helping optimize development timelines and reduce trial costs.

  • 3

    Applying to accelerated pathways (for U.S. residents).

    The Accelerated Approval Program is a special program launched by the United States FDA to allow for earlier approval of drugs that treat serious conditions. Instead of waiting for final clinical outcomes, approval is based on surrogate endpoints, such as lab results or imaging findings, that are expected to predict clinical benefit. This approach can significantly reduce the time needed to bring a drug to market.

2. Patient cliff

The patient cliff is one of the crucial moments in the drug’s lifecycle. It marks the point at which the medicine starts losing its exclusivity on the market, leading to a rapid patient outflow and financial losses. For the past few years, the situation has deteriorated. The Deloitte study indicates that over 190 drugs will lose their exclusivity by 2030. The report also presents data from the world’s top 10 pharma companies, projecting a 46% revenue decline by 2029-2030 due to the patient cliff.

This situation is largely driven by increased competition, particularly among companies producing generic drugs for mass markets, as well as rising manufacturing costs.

How to solve:

  • 1

    Strategic partnership building.

    To succeed, pharma companies should proactively form alliances with generic or regional partners to launch more affordable versions of a soon-to-expire branded drug. For example, Roche partnered with Emcure to launch Biceltis, a more affordable brand of its blockbuster Herceptin (trastuzumab) in certain markets, effectively competing with itself to retain market share.

  • 2

    Conducting organizational changes.

    To reduce patient loss, pharmaceutical companies should rethink how they manage products at different life-cycle stages. Mature brands require a different, more cost-efficient approach than new launches. Separating mature products into a dedicated business unit allows companies to focus on extending their value for patients and the business while freeing innovation teams to concentrate on new product development.

  • 3

    Manufacturing delegation.

    To reduce costs and operational risks, companies can outsource the development and manufacturing of late-stage products to CMO/CDMO partners. This approach offers flexible production capacity, lower fixed costs, and access to specialized manufacturing expertise without the need to maintain in-house facilities.

3. Pricing pressure

Pharmaceutical companies face constant economic pressure linked to market access and the complexity of global supply networks.

For example, in October 2025, the U.S. government imposed 25% tariffs on imported medicine and active pharma ingredients. This act had the strongest impact on generic drug production companies. The increased competition makes the market unstable, and the new tariffs increase the drug development costs. The situation gets even worse, as the government intends to cut drug prices by almost 90%.

How to solve:

  • 1

    Adopting proactive scenario-based planning.

    This strategy implies the on-purpose creation of various “what-if” scenarios aimed to simulate the unpleasant economic situations (like new tariffs or another inflationary jump). It means that you assess possible mitigation options in advance and are ready when the trouble hits.

  • 2

    Implementing ‘digital twins’.

    This approach involves creating a virtual replica of the global supply network to identify potential bottlenecks and vulnerabilities. The method has already been implemented by Johnson & Johnson, who use it to run scenario planning for real-time sourcing alternatives evaluation.

  • 3

    Conducting global licensing deals.

    This can help pharmaceutical companies address pricing challenges through partnerships with regional manufacturers and distributors. To do that, they have to clearly define the markets and fields they aim to work with, build a firm network base (taking part in dedicated conferences and partnering with research centers), and apply to legal, financial, and negotiation specialists with expertise to structure complex terms and agreements. Such an approach allows for adjusting prices to regional specifications, reducing operational costs, leveraging local expertise, and sharing financial risks.

4. Barriers to market access

Another issue is market access capabilities. According to a dedicated study by Deloitte Insights, 57% of drug launch failures were caused by limited market access. The main reasons for that were a misunderstanding of market needs and poor product differentiation.

How to solve:

  • 1

    Implementing comprehensive market access analytics.

    Build a unified approach to collecting and analyzing healthcare data (market needs, payer behavior, patient demographics, clinical outcomes) to better differentiate products and align launch strategies with real market demand.

  • 2

    Adopting cloud-based data integration platforms.

    Use centralized data repositories to combine key data sources such as EHRs, HCP, and distributor claims, and internal sales data into a single environment, enabling consistent and scalable analytics.

  • 3

    AI-driven predictive modeling.

    Apply AI and ML tools to process large datasets, predict regional market access risks, and estimate uptake scenarios based on efficacy, safety, and patient profiles. According to a Pharmaceutical Executive report, ML-based modeling reduced prediction errors from 18% to 7%.

5. Regulatory & compliance hurdles

Right now, pharmaceutical companies are facing numerous challenges around regulatory adherence. For example, paper-based systems make it hard to control document versions, approvals, and retention timelines, leading to incomplete records, missing signatures, and version control issues. The result is poor data integrity and subsequent warning letters.

In addition, companies feel constant pressure from audits and inspections. Manual preparation for audits can take weeks, involving multiple departments, and missing or inconsistent records neglected during preparations often result in non-compliance findings.

How to solve:

  • 1

    Adoption of digital data control systems.

    Implement electronic batch records (EBR) and audit trail-enabled digital systems to maintain secure, traceable, and validated data. These systems provide real-time visibility into who changed what, when, and why, and ensure compliance with USFDA 21 CFR Part 11 and EU Annex 11.

  • 2

    DAMS integration.

    Digital audit management systems integrated into development and manufacturing pipelines provide real-time audit readiness. Automation helps track training compliance and documentation updates, making it easy to generate audit reports instantly and demonstrate traceability during inspections.

  • 3

    Compliance ecosystem implementation.

    Automated regulatory intelligence tools integrated into a compliance management system notify departments of upcoming regulatory changes and help update operational processes and training programs accordingly.

  • 4

    DMS adoption.

    Document Management Systems (DMS) integrated into CRMs ensure that documents are properly versioned, approved, and archived.

A female pharmaceutical industry specialist examines files in a digital document management system displayed on a screen in a modern pharma laboratory.

6. Building a resilient supply chain

The next challenge for pharma companies is securing the ingredients and equipment needed for drug production. A 2025 Deloitte US study found that 48% of medtech and pharma executives believe supply chain risks could strongly affect their strategy, with shortages driven by geopolitical tensions and new economic laws being the main concern.

How to solve:

  • 1

    IoT and unique identifiers integration.

    Combining IoT sensors with unit-level serialization gives pharma companies real-time visibility across the supply chain. Tracking location, environmental conditions, and product authenticity helps prevent losses, detect disruptions early, and protect drug quality from production to delivery.

  • 2

    System architecture building.

    It’s necessary to acquire Enterprise Resource Planning (ERP) systems for order-to-cash synchronization, Manufacturing Execution Systems (MES) for production data linking, Quality Management Systems (QMS) for deviation tracking, and digital regulation systems for compliance monitoring and reporting.

  • 3

    Strategic roadmap creation.

    It implies dividing the process of end-to-end supply chain monitoring implementation into stages. Starting from IoT integration within 1-2 manufacturing lines, you scale it further, defining the final point of supply chain digitalization.

  • 4

    Establishing cross-functional governance.

    You should organize a few tracking and execution centers and departments that would be responsible for supply chain digitalization, track-and-trace capabilities, and overall data and supply quality.

  • 5

    AI implementation.

    Operational teams can identify potential bottlenecks and disruptions in supply processes early thanks to ML-empowered data analytics.

7. HCP & patient engagement gap

This challenge stems from healthcare professionals (HCPs) feeling they don’t interact enough with pharmaceutical companies. A Deloitte report on customer engagement in European pharma found that 42% of HCPs consider limited interaction with pharma reps a major issue. The report also shows that over half of providers are actively looking for more information on how to use specific medications. The problem is compounded by the fact that most HCPs are overloaded with information daily, leaving them little time to fully comprehend pharma products.

On the contrary, patients are often more motivated and empowered to learn, but they lack medical expertise, so clear and accessible information is required. Through that, communicating complex scientific concepts becomes a major hurdle.

How to solve:

In that situation, the strategic solution would be clear and compelling visual communication conducted with both healthcare professionals and patients. It can be built with the help of high-quality pharmaceutical video production. For example, VOKA creates high-resolution 3D biopharma videos that are essential for:

  • 1

    Communicating with HCPs.

    Using detailed mechanism of action (MoA) animations, you will explain how a new drug works far more effectively than in voice or plain text.

  • 2

    Patient education.

    Creating simple, engaging videos that explain a patient's condition or treatment improves patient adherence and trust.

  • 3

    Investor and stakeholder engagement.

    Using immersive 3D visuals in storytelling to convey the value of a new medicine.

8. Driving digital transformation

Even as 2026 arrives, many pharmaceutical companies still struggle with the digitalization of their processes. The survey, conducted by Pharmaceutical Technology magazine, demonstrates the following statistics:

  • In 2025, a shortage of specific digital skills and talent was reported by almost 50% of healthcare and pharma professionals.

  • 40% of respondents identified that insufficient budgets are the major barrier to poor innovation.

  • 36% of healthcare and pharma specialists pointed out that organizational silos slow down the implementation of new technologies.

How to solve:

  • 1

    Building a technology-oriented partnership.

    As a pharma manufacturer, you can collaborate with either big tech for AI/cloud infrastructure implementation and digital health platforms development for patient engagement, or small and medium enterprises for niche solutions. In doing so, you access specialized expertise and accelerate time-to-value with no need to build everything in-house.

  • 2

    Upskilling the existing team.

    Again, you can collaborate with tech startups, academia, or digital health companies to oversee and train your staff via dedicated courses. Through that, you lower the need for external specialists, yet raise the overall digital literacy of your team.

9. The war for talent

A diverse team of five pharmaceutical scientists holds a meeting in a modern conference room, discussing data shown on a large wall-mounted monitor.

Major staff shortages are another challenge for pharma companies. For instance, a study by the German Hospital Institute showed that by the beginning of the 2020s, 28% of lab workers in Germany were aged over 55, and 24% of German hospitals had unfilled lab positions.

How to solve:

  • 1

    Building a high-performance work system (HPWS).

    This approach implies the company promoting intelligent scheduling and flexible working hours, as well as the possibility for remote work (if possible).

  • 2

    Establishing transparent hiring workflows.

    It is vital to avoid any incompleteness while interacting with the candidates. At this point, pharma manufacturers should provide mandatory salary bands in all job postings, as well as a clear guide to all the interview and hiring stages. In addition, you have to maintain stable communication with the potential employee throughout the process and provide comprehensive feedback, no matter the decision. It is also recommended to inform the candidate of your decision within 72 hours of the final interview.

  • 3

    Train non-medical scientists.

    Some pharma companies offer specialized courses and training for lab staff and scientists. For example, the German Society for Clinical Chemistry and Laboratory Medicine planned a postgraduate master’s program integrated into the five-year training path to become a clinical chemist or laboratory medicine specialist.

10. Complex shift to personalized medicine

The growing demand for targeted therapies and precision diagnostics is significantly driving the expansion of the personalized medicine market. In 2026, this market size is expected to reach over 660 billion USD in value, and the number will likely double by 2034.

However, the pharma industry faces numerous problems regarding the expansion of personalized medication production.

First, it’s manufacturing complexity, as each batch uses patient-specific biological material. Maintaining consistent quality under these conditions is difficult, and traditional economies of scale don’t apply. In addition, producing targeted medicines involves processing large amounts of data (genomic information, patient histories, clinical outcomes, etc.), which requires secure storage, efficient access, and systems that can work seamlessly together. Finally, pharma companies must look for a balance between innovation, affordability, accessibility, and social consideration.

How to solve:

  • 1

    Intelligent production network building.

    Pharma companies can improve manufacturing reliability by using real-time quality monitoring and predictive tools to catch issues early. Decentralized production sites and automated microfactories near hospitals also help speed up manufacturing and support personalized treatments.

  • 2

    Advanced data analytics implementation.

    Collecting patient data through digital tools such as mobile apps, portals, or wearables allows companies to better understand treatment outcomes. When this data is stored centrally and analyzed with AI, it supports faster, more informed decisions across R&D and operations.

  • 3

    Geo-diversified infrastructure deployment.

    Manufacturers have to focus on establishing decentralized production hubs in underserved regions, ensuring geographic and genetic diversity of clinical trial populations, and partnering with local communities and governments.

11. Issues with public trust & transparency

The last but not least challenge lies in the ever-growing public distrust of the industry. The statistics say that for the period between September 2024 and September 2025, Gen Z’s satisfaction with pharma companies dropped from a net score of 7 to 4, while millennials demonstrated a 9 to 6 slide.

The main reason for such distrust is that people are mostly unfamiliar with the industry and don’t understand its processes. However, some measures can be taken to mitigate this particular problem and the wider issue of overall trust loss.

How to solve:

  • 1

    Embracing open science.

    This involves pre-competitive collaboration with academic institutes or other pharma production companies on foundational research (for example, target discovery), sharing negative trial data in industry magazines or as public reports to prevent duplication of failed efforts, and participating in open-access platforms for genetic and clinical data.

  • 2

    Participating in global healthcare initiatives.

    Such as making long-term commitments, joining international innovation programs, supporting public health emergencies, training healthcare workers, improving diagnostics, and helping manage diseases in underserved regions.

Conclusion

The challenges faced by the pharmaceutical industry are complex and demanding, but understanding them is essential for growth and success. From R&D efficiency and patent cliffs to personalized medicine and public skepticism, the sector is being pushed toward a clear future: more digital, more patient-focused, and more data-driven.

The companies that thrive will be those that combine scientific expertise with effective communication and smart, adaptable strategies.

FAQ

1. What is the single biggest challenge facing the pharmaceutical industry?

The main challenge is R&D productivity. Research and development drive the industry, but rising costs, frequent failures, and unpredictable results are making it harder to sustain. All other issues, like the patent cliff or drug pricing, are made worse by the pressure to fund expensive R&D.

2. Is the patent cliff still a major threat to the pharmaceutical industry?

Yes, absolutely. The patient cliff has a direct impact on revenue and market share. With Deloitte projecting over 190 drugs losing exclusivity by 2030, it remains a massive, systematic threat. The challenge is now more acute due to increased competition and pricing pressures, forcing companies to adopt proactive strategies like strategic partnerships and dedicated business units for mature products.

3. What are the key technology challenges in pharma beyond just adopting AI?

Digital transformation in pharma goes beyond simply adding AI. Companies face hurdles like breaking down organizational silos, training employees to develop digital skills, and implementing robust digital infrastructure such as cloud platforms, electronic batch records, and supply chain digital twins.

4. How can pharma companies effectively demonstrate the value of a new high-cost drug?

This requires a data-driven, well-coordinated approach to communication and market access. For healthcare professionals, complex efficacy and safety data should be explained clearly using advanced visual tools such as 3D MoA animations. For investors and health systems, value can be demonstrated through AI-powered predictive modeling and real-world data analytics that show clinical outcomes, cost offsets, and population-level impact.

5. What is the top non-scientific challenge for pharma?

Rebuilding public trust and transparency is the paramount non-scientific challenge. The decrease of trust, especially among younger generations, compromises social license, complicates regulatory interactions, and provides more excuses for pricing pressures. It is a challenge that influences all others. As the article concludes, it requires a fundamental shift in culture and operations, through pricing transparency, open science initiatives, and genuine engagement in global health equity, to rebuild a sustainable social contract.