Gain formulation expertise through partnerships

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A key advantage for companies that outsource formulation development is the extensive experience they can gain from a dedicated service provider, especially for niche markets.

By 2026, the global formulation development outsourcing market is expected to reach a value of $12.65 billion, growing at a compound annual rate of 7.2%(1). Factors driving this market growth include increasing demand for new drug innovation due to increasing number of patent expirations for major drugs and the fact that many pharmaceutical and biotech companies tend to resort to outsourced services for the development of formulations (1).

To learn more about outsourced formulation development services, including various industry trends impacting the sector, challenges for outsourcing partners, and key benefits of outsourcing formulation development, Pharmaceutical technology spoke with Lynn Allen, Vice President of Business Development at MedPharm.

Industry trends

Pharma Tech: Could you provide information on industry trends that have affected the formulation development outsourcing market?

Allen (MedPharm): The pharmaceutical industry continues to adapt to new business conditions. Lifecycle management continues to drive the need for outsourced formulations, often in product development for alternate delivery routes.

Companies looking to improve patient compliance or reduce systemic side effects may consider new formulations for local administration by topical dosing. Based on MedPharm’s experiences, there has been an increase in demand for ophthalmic preparation formulation and respiratory delivery services, primarily intranasally. An increase in the number of biologics with targeted topical routes of administration has also been a trend. As a contract development and manufacturing organization (CDMO) specializing in the development of dermatology, nail, eye, respiratory, mucous membrane and ear products, MedPharm continues to support the development services of topical formulations for local delivery market needs.

Additionally, proprietary non-clinical models that test the efficacy of formulations at early stages continue to be an asset to the company’s customer base. For example, MedPharm’s Reconstructed Human Nasal Epithelium Model is a living representation of the nasal membrane and allows targeted formulations to be tested for different regions of the nose (local, systemic, or cerebral) to assess formulation parameters such as as administration, irritation, mucoadhesion and efficacy.

Growth areas

Pharma Tech: What type of formulation work is most commonly outsourced today?

Allen (MedPharm): There is continued growth in product development by specialty and virtual pharmaceutical companies. As big pharma seeks investments in late-stage assets, start-ups that efficiently deliver well-developed products with effective clinical data are highly sought after for licensing and acquisition deals.

Therefore, start-up companies need formulation expertise from the early stages of development and often do not have extensive research labs to perform critical evaluations such as screening multiple APIs. Outsourcing of these early research activities continues to grow and MedPharm continues to invest in these services to support both start-ups and specialty pharma companies.

The biggest challenges

Pharma Tech: What are the biggest challenges for outsourcing partners when working on a formulation project?

Allen (MedPharm): In the fast-paced environment of drug development, it can be difficult to ensure that all stakeholder needs are articulated at the start of formulation activities and continue throughout the development process. When sponsors have not conveyed all requirements or are not prepared to make decisions on formulation priorities when challenges arise during development, this can often mean repeating activities or delaying deadlines.

Pharma Tech: How do outsourcing partners overcome these challenges?

Allen (MedPharm): A key aspect that should be emphasized at the start of any program is the need for a well-defined target product profile. The key attributes of what the formulation should achieve and, particularly in the topical space, how it should feel when applied or how it should be packaged and used by the patient are critical development considerations. Internal expertise is also essential, including program management, development or regulatory resources.

Benefits of extensive experience

Pharma Tech: What are the main benefits of outsourcing formulation development?

Allen (MedPharm): Where formulation development is not an in-house force or the delivery route is outside of in-house formulation expertise, the extensive experience of a service provider dedicated to these services can save time, effort and effort. money and avoid the pitfalls of an inefficient and poorly developed formulation. . CRO [contract research organizations] and development and contract manufacturing organizations, especially those focused on niche markets like MedPharm, have extensive experience and can leverage decades of experience and current real-time learnings to guide development activities in an ever-changing regulatory environment. Service providers can also offer more dedicated resources when businesses need to prioritize critical programs.

Reference

1. Intelligence of Mordor, Formulation Development Outsourcing Market – Growth, Trends, Impact of COVID-19 and Forecast (2021-2026)market report (May 2021).

Author Details

Felicity Thomas is the European Editor of Pharmaceutical Technology Group.

Item Details

Pharmaceutical technology
Supplement: Biopharma Outsourcing Innovation 2022
February 2022
Pages: s14–s15

Quote

When referencing this article, please cite it as F. Thomas, “Gaining Formulation Expertise through Partnerships,” Biopharma Outsourcing Innovation 2022 (February 2022).

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