Pharmaceutical Formulation Development: A Guide to Outsourcing Formulation Development

Your guide to choosing the right partner for Pharmaceutical Formulation Development

In the high-stakes world of pharmaceutical development, every decision has significant consequences. One crucial area that can make or break your drug’s journey is formulation development. Creating the ideal delivery system for your molecule – the tablet, capsule, or injection that brings it to life – requires intricate scientific expertise and agile problem-solving.

However, in today’s fast-paced environment, pharmaceutical companies face increasing pressure. Deadlines are approaching, budgets are tightening, and regulatory hurdles are increasing. This is where outsourcing formulation development comes in. It transforms a complex internal process into a strategic partnership, empowering you to speed up development, reduce costs, and navigate regulatory landscapes with confidence.

Understanding formulation development

Pharmaceutical formulation development is the systematic and scientific process of designing and creating a final dosage form for a drug or active pharmaceutical ingredient (API). It involves transforming a potent drug compound into a stable, effective, and suitable medication that can be administered to patients. The goal of formulation development is to optimise the drug’s delivery system, ensuring that it meets the required specifications for efficacy, safety, stability, and patient acceptability.

During this process, various factors are taken into consideration, including the physical and chemical properties of the drug, desired therapeutic effects, route of administration, and the specific needs of the target patient population. The formulation may be developed in various dosage forms such as tablets, capsules, injections, creams, or liquid solutions, depending on the intended use and patient requirements.

Key aspects of pharmaceutical formulation development include:

• Bioavailability: Ensuring that the drug is absorbed and reaches the systemic circulation at the desired rate and extent to achieve the intended therapeutic effect.

• Stability: Maintaining the chemical and physical stability of the drug throughout its shelf life, considering factors such as temperature, humidity, and exposure to light.

• Patient Compliance: Designing dosage forms that are convenient and acceptable to patients, promoting adherence to the prescribed treatment regimen.

• Manufacturability: Developing formulations that can be efficiently and reproducibly manufactured on a large scale, considering factors such as cost, ease of production, and regulatory requirements.

• Safety: Ensuring that the formulation is safe for use, with appropriate consideration of excipients and potential interactions.

Market trends and key drivers

The Global Formulation Development Outsourcing Market size is expected to grow from USD 25.02 billion in 2023 to USD 33.73 billion by 2028, at a CAGR of 6.16% during the forecast period (2023-2028).
Source: Mordor Intelligence

Pharmaceutical organisations are increasingly focusing on their R&D activities to stay competitive and flexible. As per the estimates of Evaluate Pharma, pharmaceutical R&D spending accounted for USD 182 billion in 2018, whereas in 2021 it increased by 16.5% and accounted for USD 212 billion. Growing R&D spend is expected to improve the demand. Formulation development services are majorly adopted by small and medium-sized pharmaceutical companies that lack the necessary resources for formulation development. 

Market trends

The pharmaceutical formulation development market, a crucial bridge between discovery and delivery of life-saving medications, is a dynamic landscape constantly reshaping under the influence of evolving needs and technological advancements. Here are some key trends worth watching:

Outsourcing Surge

Recognising the advantages of cost-effectiveness, access to specialized expertise, and accelerated development timelines, pharmaceutical companies are increasingly turning to outsourcing for formulation development. This trend is expected to see a sustained CAGR of 8-11% until 2030, solidifying the role of external partners in drug advancement.

Biologics Boom

The surge in development of complex biologics like recombinant proteins and gene therapies pushes the demand for specialized formulation strategies. Expertise in handling sensitive biomolecules, stabilizing their structure, and designing targeted delivery systems becomes increasingly valuable.

Digital Transformation

Embracing data analytics, automation, and artificial intelligence revolutionises the formulation development process. High-throughput screening, virtual modelling, and simulation tools accelerate development, optimise formulations, and predict drug behaviour, leading to faster and more efficient outcomes.

Patient-Centric Focus

Formulations are tailored to individual patient needs and preferences, fostering adherence and improving clinical outcomes. Patient-friendly delivery systems like transdermal patches or long-acting injectables enhance convenience and compliance, particularly for chronic conditions.

Sustainability Imperative

Environmental consciousness permeates the industry, driving the development of eco-friendly formulations and manufacturing processes. Reducing waste, utilizing biodegradable materials, and minimising energy consumption are key priorities, reflecting a growing commitment to responsible R&D.

Precision Medicine Advancements

Tailoring medications to individual genetic profiles and disease characteristics leads to the development of personalised formulations. This trend necessitates innovative drug delivery systems and the ability to handle small-batch production for niche patient populations.

Regulatory Hurdles

The ever-evolving regulatory landscape presents both challenges and opportunities. Navigating complex compliance requirements for different regions and drug types demands expertise in regulatory affairs and robust quality control systems.

Collaboration is Key

Building strong partnerships between pharmaceutical companies, formulation development service providers, and academic institutions is crucial for overcoming complex challenges and driving innovation. Shared knowledge, expertise, and resources accelerate development and pave the way for breakthrough therapies.

Benefits of Outsourcing

Embracing formulation development outsourcing unlocks a treasure trove of benefits for pharmaceutical companies, including:

• Faster Time to Market: Get your drug to patients sooner, maximising market exclusivity and revenue potential.

• Reduced R&D Costs: Access specialist expertise without the hefty investment in internal labs and equipment.

• Enhanced Innovation: Tap into cutting-edge technologies and formulation concepts offered by outsourcing partners.

• Improved Regulatory Compliance: Leverage expert guidance to navigate complex regulatory landscapes.

• Flexible Scalability: Scale your development efforts up or down based on project needs, optimising resource allocation.

• Risk Mitigation: Share development risks with your outsourcing partner, minimising potential setbacks.

The Challenges of Outsourcing

While outsourcing offers a bounty of benefits, it’s important to acknowledge the potential hurdles:

• Finding the Right Partner: Identifying the best fit for your specific needs and project requirements takes time and careful evaluation.

• Intellectual Property Concerns: Protecting your confidential drug information requires robust intellectual property agreements.

• Communication and Collaboration: Building effective communication and collaboration channels with your outsourcing partner is crucial.

• Loss of Control: Letting go of some project control can be challenging for companies accustomed to full internal development.

Opportunities

• Technological advancements: Automation, miniaturisation, and high-throughput screening technologies offer solutions for accelerated development and efficiency gains.

• Data integration and analytics: Integrating formulation data with other research data provides deeper insights and enhances decision-making.

• Focus on patient-centricity: Developing patient-friendly and compliant formulations improves medication adherence and patient outcomes.

• Sustainability: Implementing eco-friendly formulation and manufacturing processes aligns with environmental responsibility and reduces environmental impact.

Key companies

To remain competitive, CROs around the world are expanding, acquiring, and forming partnerships, among other things.

• SGS S.A.
• Intertek Group plc
• Recipharm
• Lonza
• Charles River Laboratories International, Inc.
• Eurofins Scientific SE
• Element
• Labcorp
• Thermo Fisher Scientific, Inc. (Patheon)
• Catalent Inc.

How to find the right formulation development outsourcing partner

So, how do you navigate the maze of outsourcing providers and land on the perfect partner? Here are some key steps:

Define Your Needs: Clearly understand your project goals, timelines, budget constraints, and preferred expertise.

• Research Potential Partners: Shortlist providers based on their experience, capabilities, track record, and geographical location.

• Issue Requests for Proposals (RFPs): Craft a detailed RFP outlining your project requirements and evaluation criteria.

• Evaluate Proposals: Scrutinise responses based on factors like technical expertise, cost structure, intellectual property protection, and regulatory compliance.

• Conduct Due Diligence: Visit shortlisted providers, meet their team, and assess their facilities and quality control systems.

• Negotiate and Contract: Finalise terms and conditions, ensuring clear communication channels and project milestones.