North America Pharmaceutical Excipients Market - Databook 2025 to 2034

The North America pharmaceutical excipients market size surpassed USD 3.24 billion in 2024 and is predicted to reach around USD 5.77 billion by 2034, registering a CAGR of 5.94% from 2025 to 2034.

Highlights of the North America Pharmaceutical Excipients Market

• By functionality, the binders & fillers segment held a dominant presence in the market in 2024.
• By functionality, the coating agents segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034.
• By excipient type, the lactose-based segment accounted for a considerable share of the market in 2024.
• By excipient type, the cellulose-based segment is anticipated to grow with the highest CAGR in the market during the studied years.

Industry Valuation and Growth Rate Projection

Pharmaceutical excipients are inert substances, substituted as a carrier with no medicinal assets, that play a role in assisting characteristics that aid in the formation of a tablet. It entails all the substances being built up to produce a medicine. The demand to manufacture drugs involving excipients is expanding across the forecast period, due to the growing need for pharmacological products around the globe. The government offers incentives for research and development in areas such as new excipient technologies, novel formulation approaches, and alternative drug delivery systems. This can include grants, tax credits, and public-private collaborations to uplift innovation in the pharmaceutical industry.

Growth Factors

• The global thrust for novel drug delivery systems, like extended-release formulations, orally disintegrating tablets, and biologics, is boosting the demand for specialized excipients.
• Pharmaceutical firms are steadily investing in research and development to make excipients that feed into new-age drug formulations while managing compliance with evolving regulations.
• Modern drug formulations prioritize patient convenience, ease of administration, and palatability, contributing to a higher requirement for functional excipients.

Restraint

Stringent regulations that govern excipient acceptance processes generally contribute to delays in product introductions, hindering market penetration.

Opportunity

The advancement of smart excipients that can acknowledge specific stimuli or environmental states to regulate drug release. These intelligent materials can enhance drug efficacy, lessen side effects, and improve patient compliance by providing the right quantity of medication at the accurate time and to the precise location in the body.

Segmental Insights

Functionality Insights

The binders & fillers segment dominated the North American pharmaceutical excipients market in 2024. Binders improve the binding forces between powder particles, generating a cohesive mass that can be indurated into a tablet. In wet granulation, binders are attached as a solution to the powder, assisting in generating granules that are easier to compress. Fillers add bulk to the tablet, making it easier to handle and consume, mainly for low-dose formulations. Fillers can also be utilized in direct compression, where the powder mix is compressed directly into a tablet beyond prior granulation.

The coating agents segment shows lucrative growth during the forecast period. Coating agents play a vital role in improving the performance, quality, and patient experience of solid dosage forms such as tablets and capsules. They act as an obstacle against environmental causes, enhance appearance, alleviate swallowing, and can even permit controlled drug release.

Excipient Type Insights

The lactose-based segment is positioned to show promising growth in the coming year. North America is considered the leading contributor of pharmaceutical excipients, i.e., lactose. Lactose can be utilized as a carrier or diluent in capsule formulations, used to sustain the desired capsule flow and volume. Pharmaceutical-grade lactose is mainly manufactured to meet strict quality standards, guaranteeing its efficacy and safety. Lactose purity is vital to block potential concerns, such as allergenicity or the existence of impurities that can affect patient safety or drug release.

The cellulose-based segment saw its presence grow substantially in the forecast period. Cellulose-based excipients, such as microcrystalline cellulose (MCC), assist in binding active pharmaceutical ingredients (APIs) and a few excipients together throughout tablet manufacturing, ensuring tablet stability and strength. Some cellulose derivatives, such as hydroxypropyl methylcellulose (HPMC), can be utilized as gelling agents in liquid formulations, offering a smooth, uniform texture.