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A key benefit for companies when outsourcing formulation development is the broad experience they can gain from a dedicated service provider, particularly for niche markets.
By the year 2026, the global outsourcing market for formulation development is expected to reach a value worth $12.65 billion, growing at a 7.2% compound annual rate (1). Factors driving this market growth include the rising demand for innovation of novel drugs due to the increasing number of patent expirations for major drugs and the fact that many pharmaceutical and biotechnological companies are trending toward outsourced services for formulation development (1).
To learn more about outsourced formulation development services, including various industry trends impacting the sector, challenges for outsourcing partners, and key benefits for outsourcing formulation development, Pharmaceutical Technology spoke with Lynn Allen, vice-president of Business Development at MedPharm.
PharmTech: Could you provide insights into industry trends that have affected the formulation development outsourcing market?
Allen (MedPharm): The pharmaceutical industry continues to adapt to new business conditions. Life cycle management continues to drive the need for outsourced formulations, often in developing products for alternate routes of delivery.
Companies that are looking to improve patient compliance or reduce systemic side effects can look at new formulations for local delivery through topical dosing. Based on MedPharm’s experiences, there have been increases in the demand for formulation services of ophthalmic preparations and respiratory delivery, primarily intranasally. An increase in the number of biologics with targeted topical delivery routes has also been a trend. As a contract development and manufacturing organization (CDMO) that specializes in dermatological, nail, eye, airway, mucosal membrane, and otic product development, MedPharm continues to support topical formulation development services for local delivery market needs.
Additionally, proprietary nonclinical models that test formulations for effectiveness at early stages continue to be an asset to the company’s client base. For example, MedPharm’s reconstructed human nasal epithelia model is a living representation of the nasal membrane, and allows formulations that are targeted for the different regions of the nose (local, systemic, or brain) be tested to evaluate formulation parameters such as delivery, irritancy, mucoadhesion, and effectiveness.
PharmTech: What type of formulation work is more commonly outsourced currently?
Allen (MedPharm): There is continued growth in product development by specialty and virtual pharmaceutical companies. As large pharma looks for investments in late-stage assets, start-up companies that effectively deliver well-developed products with effective clinical data are highly sought out for licensing and acquisition deals.
Consequently, start-up companies require formulation expertise at the earliest stages of development and often do not have extensive research labs to perform critical assessments 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 early start-up and specialty pharma companies.
PharmTech: 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 challenging to ensure that all stakeholder needs are being articulated at the start of formulation activities and continue through the development process. When sponsors have not conveyed all needs or if they are not prepared to make decisions on formulation priorities when challenges arise during development, it can often mean repeating activities or delaying timelines.
PharmTech: How do outsourcing partners overcome these challenges?
Allen (MedPharm): One key aspect that must be stressed at the start of any program is the necessity of 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 considerations of development. Internal expertise is also critical which includes program management, development, or regulatory resources.
PharmTech: What are the key benefits of outsourcing formulation development?
Allen (MedPharm): When formulation development is not an internal strength or if the delivery route is outside of in-house formulation expertise, the broad experience of a service provider dedicated to these services can save time, money, and avoid the pitfalls of an ineffective, poorly developed formulation. CROs [contract research organizations] and contract development and manufacturing organizations, particularly those focused on niche markets like MedPharm, have broad experience and can pull from decades of experience and current real-time learnings to guide development activities in the constantly changing regulatory environment. Service providers can also offer more dedicated resources when companies need to prioritize critical programs.
1. Mordor Intelligence, Formulation Development Outsourcing Market—Growth, Trends, COVID-19 Impact, and Forecasts (2021–2026), Market Report (May 2021).
Felicity Thomas is the European editor for Pharmaceutical Technology Group.
Supplement: Biopharma Outsourcing Innovation 2022
When referring to this article, please cite it as F. Thomas, “Gaining Formulation Expertise through Partnerships,” Biopharma Outsourcing Innovation 2022 (February 2022).