As we prepare to step into 2025, I find myself reflecting on the twists and turns of 2024—a year that left a profound mark on the pharmaceutical world and reshaped our expectations for the future. From navigating widespread drug shortages to grappling with the implications of the Inflation Reduction Act, we saw challenges that tested our resilience and opportunities that sparked new conversations about the future of healthcare. As the industry continued to evolve amidst these shifts, I am reminded of the human connections and shared purpose that drive us forward.
In the spirit of reflection and anticipation, I’d like to share my thoughts on what we can expect in the year ahead.
Ongoing Pricing and Reimbursement Pressures
The pharmaceutical industry is under increasing scrutiny from governments, insurers, and the public regarding drug prices. These calls have reached an extreme, and only time will tell how far the federal government might go to enact change in this space. A shift toward value-based pricing and reimbursement models is becoming inevitable. Manufacturers will face continued pressure to clearly demonstrate the clinical and economic benefits of their products, reshaping how they approach pricing and market access strategies.
Potential Supply Chain Disruptions
With a new administration in the wings, supply chain challenges, particularly around the potential for significant tariffs, could create dramatic disruptions. These obstacles may push the industry to accelerate reshoring manufacturing capabilities to reduce reliance on foreign suppliers. However, questions linger about how quickly this shift can happen and the disruptions it might create.
In addition, sourcing raw materials and maintaining compliance with Good Manufacturing Practices (GMP) remain ongoing struggles. These issues, coupled with geopolitical uncertainty, could continue to fuel drug shortages and hinder efforts to stabilize supply chains.
The Rise of Patient-Centric Healthcare Models
Technology and access to information will continue empowering patients to take the reins of their healthcare experience, particularly as personalized medicine and targeted therapies gain traction. The consumer is becoming the CEO of their healthcare journey, fundamentally altering the dynamic between patients and providers.
For manufacturers, identifying, reaching, and engaging niche patient populations for rare and orphan diseases will continue to present significant challenges. The industry’s focus on improving patient adherence and outcomes will drive innovative strategies to catch, capture, and keep patients engaged in their care plans – a true art form.
AI, Digital Transformation, and Cybersecurity
The age of digital has fully arrived, and navigating the integration of AI, machine learning, and data analytics in drug discovery, development, and commercialization will remain a central challenge. While these technologies promise significant advancements, they also introduce complexity and operational hurdles. These advancements will likely be paired with continued cybersecurity threats, targeting sensitive research and patient data emphasizing the need for robust protections.
Additionally, implementing digital transformation across traditionally siloed organizations with legacy systems will require strategic partnerships. Partnering with small, innovative partners that can “get you there faster” will be the key to success (or survival) for many.
Continued Regulatory Complexities
Whether you are a manufacturer, hospital, pharmacy/specialty pharmacy, or provider, ongoing and updated regulatory requirements continue to pose a significant burden. A few examples:
- According to the American Hospital Association, the average community hospital dedicates approximately 59 full-time employees (FTEs) to managing regulatory compliance, with over a quarter comprising physicians, nurses, and allied health staff. This is only one example of the burden we'll continue to see in the new year.
- Specialty pharmacies face additional challenges due to the high cost of medications and their wide geographic reach. These entities must comply with mandates from over 70 state and regulatory organizations.
- For manufacturers, balancing stringent quality standards while accelerating time-to-market remains a daunting task, all while managing financial resources and with continued evolving guidelines for biologics, biosimilars, and cell and gene therapies.
A Competitive Workforce and Talent Shortages
The already existing challenge of a qualified workforce will become even more challenging when looking to attract and retain talent in specialized areas like biomanufacturing, AI, and data analytics. The healthcare industry now competes with other high-tech industries for skilled people, which places additional pressure on both employee availability and affordability. The need to upskill existing employees for new technologies and processes will be critical, making training and development investments essential to an organization’s survival in the new year.
The pharmaceutical industry is entering 2025 at a pivotal moment with a laundry list of challenges to navigate – both new and old. From pricing pressures and regulatory complexities to supply chain disruptions and the transformative power of digital technologies, every corner of our industry continues to evolve. Navigating these challenges in 2025 will require agility, innovation and the ability to build collaborative relationships with stakeholders across the healthcare value chain. Further, partnership with innovators will be required to be able to adapt and keep up with the ever-increasing pace of change.
Though our industry shifts, our commitment at D2 Solutions remains the same for 2025: delivering better, together.
This past year we had the privilege of working with over 100 partners across our industry to optimize their operations, improve patient outcomes and navigate these complex regulatory and market dynamics. By combining strategic solutions with tactical implementation and digital transformation, we look forward to helping more do the same in 2025.
To client-partners new and old, I wish you the best in 2025 and look forward to delivering better, together.
Dean Erhardt
Interested in learning more about D2 can support your organization in 2025?
