What’s driving pharma outsourcing in 2025 and beyond?   

The pharmaceutical industry is evolving rapidly. Increasing regulatory requirements, market fluctuations, and technological advancements are making it more challenging for companies to manage everything in-house. As a result, many firms are turning to outsourcing to remain efficient, compliant, and competitive. 

After some of our team attended the 2025 EPA Conference in Amsterdam, Europe’s largest conference for market access, pricing and evidence, George Moss and Sarthak Sawlani look at five key trends – from new EU health regulations to AI-driven innovation – driving increased outsourcing in pharma today:  

1. The impact of EU HTA

The new EU Health Technology Assessment (HTA) regulation, passed in 2021 and coming into effect from this year, is set to transform how pharmaceutical companies bring new treatments to market across Europe. While it standardises assessment processes, it brings with it new compliance challenges. Under the new framework, companies must submit HTAs within a strict 90-day deadline, while also comparing treatments across multiple EU countries and managing large volumes of clinical data.  

To manage this, many pharma companies are outsourcing rather than building these capabilities in-house. Regulatory consultancies can provide guidance on submissions, helping to reduce potential delays or rejection. Market access specialists can support pricing negotiations and reimbursement strategies, making it easier to enter different European markets. Meanwhile, health economics and outcomes research (HEOR) experts can assess cost-effectiveness, helping companies prove the value of their treatments to regulators and payers. 

At the 2025 EPA Conference, it was highlighted that global drug spending has stayed at a steady percentage of total healthcare costs for the past decade, however pricing is coming under increased pressure and scrutiny. It raised the importance of communicating the value of new treatments and using the best technology and advice to position them in the market so as to succeed.  

2. Policy shifts and Inflation Reduction Act in the US

The US remains the largest pharmaceutical market in the world, but ongoing policy changes and pricing pressures are creating a more unpredictable environment for drug manufacturers. The Inflation Reduction Act (IRA) has introduced new Medicare price negotiations, and with the possibility of further changes under Trump, pharma companies need to rethink their pricing strategies and market access plans to stay competitive. One of the biggest challenges is the new Medicare price negotiation process for high-cost drugs. This could have a major impact on how companies set their prices and generate revenue.

Whilst pharmaceuticals products were initially exempted from the first tariff announcement, uncertainty remains whether specific pharmaceutical tariffs will be targeted in short order, and there clearly is now significant uncertainty across all sectors for global supply chains off the back of last week’s US tariff announcements.

With so much unpredictability, many businesses are turning to specialist expertise to help them navigate these changes. By outsourcing to regulatory and market access specialists, pharma companies can ensure they stay ahead of evolving FDA requirements, keep development pipelines focused and drug approvals on track.   

3. The rise of AI & Technology in pharma services 

Many pharma companies have access to huge volumes of data, opening up AI transformation possibilities, from drug development to commercialisation. The challenge is using the data effectively – most lack the in-house expertise making it difficult to fully unlock AI’s potential.

At the 2025 EPA Conference, AI was a key topic, with discussions on how it’s shaping pricing strategies, payer sentiment analysis and regulatory decision-making. The benefits of HTA sentiment analysis were highlighted as well as the opportunity to use AI to assess payer perceptions to help predict launch prices. Wayne Speechly, CEO of Global Pricing Innovations, emphasised that AI’s effectiveness depends on the quality of its datasets, noting that LLMs (large language models) can be affected by bias which is why GPI runs multiple models that can learn from one another. 

Despite its advantages, integrating AI into regulatory and commercial workflows remains complex, as they must meet strict FDA and EMA regulations. Pharma companies are taking very different stances on this, with some embracing AI and progressing trial deployments of it internally, while others are taking a much more cautious approach. Clearly, AI can speed up compliance, improve drug pricing strategies, and help design more efficient clinical trials. However, these benefits come with significant regulatory requirements. This is why technology-focussed outsourcing partners are playing an increasingly important role, enabling pharma companies to leverage AI’s full potential without the cost and complexity of building their own tools in-house.  

4. Real world data in clinical trials

For a while, regulators and payers have been looking beyond traditional clinical trials and asking for real-world evidence (RWE) to assess how well a drug works in everyday life. While clinical trials provide data from controlled settings before approval, RWE comes from real patient experiences, using data from patient registries, insurance claims and electronic health records both during and after trials.

Managing this large volume of data while ensuring accuracy and compliance can be a significant challenge, but significant leaps forward in technology and AI in particular are now starting to really unlock the potential here and deliver insights into how a particular drug or therapy performs in a patient population. This will ultimately result in better patient outcomes.  

5. M&A in pharma outsourcing

The pharma outsourcing industry is experiencing significant consolidation, with larger firms acquiring specialised providers to offer their customers full-service solutions. This means that instead of working with multiple vendors, customers can now partner with a single outsourcing partner that can offer services and technology across multiple areas from clinical trials delivery to addressing commercialisation and regulatory considerations. With increased costs on businesses through tarriffs, there are also strong drivers for providers to sell in the current market.

This trend is making outsourcing more accessible, mission-critical and efficient. As the industry grows and professionalises, pharma companies can more easily find partners with both the scale and expertise they need, helping them navigate everything from regulatory approvals to market entry without building these capabilities in-house.

If you would like to chat to ECI about how we can help your pharma services business – please get in touch with george.moss@ecipartners.com or sarthak.sawlani@ecipartners.com