Excipients

Europe leads the way in the €10Bn Global Excipient’s market

Strengthening Europe’s excipient sector is critical to securing patients’ access to medicines, sustaining innovation, and ensuring global competitiveness.

Driving Innovation and Safety:

The Critical Role of EUropean Pharmaceutical Excipients

What are pharmaceutical excipients?

EU-manufactured excipients are essential to the safety, performance and scalability of modern medical products. Strengthening the EU’s excipients industry is critical to sustaining pharmaceutical innovation, supply security and global competitiveness. They:

Ensure stability and integrity of APIs throughout shelf life

Control ​​delivery and releaseto achieve the desired therapeutic effect

Enhance bioavailability of complex and poorly soluble molecules

Improve patient usability and adherence

Enable robust, cost-effective and scalable manufacturing

Alongside APIs, pharmaceutical excipients are essential to medicinal products manufacturing—supporting innovation, supply resilience, and Europe’s strategic autonomy while ensuring medicines are stable, effective, and safe for patients.

In every medicinal product, the API is the payload, delivering the therapeutic effect that treats, prevents or manages disease. Excipients are the propulsion system, enabling medicines to reach their destination safely and effectively.

Pharmaceutical excipients at a glance

%

Up to 95% of a medicine’s mass is excipients

Global market size

External Market Report - Pharmaceutical Process Materials Global Market Size and Dynamics - 2024 - Oliver Wyman

%

With around 38% of global market share, Europe is the largest regional market for pharmaceutical excipients

Pharma Excipients Market to Project USD 16.12 Bn by 2035

Diverse origins

synthetic, bio-based and mineral

Excipients power innovation in modern medicines

Enable delivery of complex APIs

Unlock advanced drug delivery systems

Offer patient -friendly solutions

Innovative excipients enable more patient-friendly options, improving access and adherence. Example: they can allow biologics to be taken orally instead of by injection, maintaining the same therapy with greater convenience for patients.

EU-manufactured excipients

A global benchmark for sustainability, quality and supply security

Rigorous EU regulatory and quality standards, including broadly applied voluntary schemes3

Leadership in bio-based
and sustainable materials

Fully transparent
and traceable supply chains

Structurally lower carbon footprint

Strong social and governance standards

Excipient are subject to the scrutiny of multisector EU regulatory bodies. Given the diverse origin of excipients, IPEC & EXCiPACT define guides and standards to define the appropriate GMP, GDP & Quality Standards, with high uptake of EXCiPACT Certifications among European pharmaceutical excipients manufacturers.

The EU pharmaceutical excipients industry

With a global market size of approximately €10 billion annually, excipients underpin the development, manufacturing and supply of modern medicines. As the second largest excipients market globally, Europe plays a central role in:

Ensuring secure and reliable supply chains

Supporting innovation in advanced therapies and complex formulations

Maintaining high quality and regulatory standards

However, this position is not guaranteed. Increasing global competition, cost pressures and shifting supply chains risk eroding Europe’s leadership.Sustained investment and policy support are essential to:

Ensure long-term patient access to safe and effective medicines

Safeguard Europe’s strategic autonomyin medicines

Maintain a competitive and innovative industrial base

Five levers, one mission.

Elevating awareness of excipients

Excipients are essential to patient safety, medicine efficacy and supply security a strategic sector in which the EU is a global leader.

Shaping EU policies

Strengthening competitiveness, supporting innovation and attracting investment in the sector.

Advancing sustainability

As a global differentiator, not a hurdle.

Driving collaborative dialogue

With policy makers and industry stakeholders.

Complementing IPEC Europe’s work

Ensuring a 360° representation of the sector vis-à-vis regulatory and business requirements.

www.ipec-europe.org

Europe leads the way in the €10Bn global excipients market.

Strengthening Europe’s excipient sector is critical to securing patients’ access to medicines, sustaining innovation, and ensuring global competitiveness.

Source: External Market Report - Pharmaceutical Process Materials Global Market Size and Dynamics - 2024 - Oliver Wyman

Global excipients market