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The Oral Thin Films (OTF) market is projected to grow from USD 3.30 billion in 2025 to USD 5.21 billion by 2030, at a compound annual growth rate (CAGR) of 9.56% (source). This growth is governed by the need for dosage forms that are easy to administer, bypass first-pass metabolism, and deliver rapid therapeutic effects.
However, selecting the right pharmaceutical partner for Oral Thin Film R&D is a critical decision.
The capabilities of a contract development and manufacturing organization to translate lab-scale reproducible, scalable, and commercially viable products require a strategic partnership. Inaccurate formulation or poor process control can affect both clinical outcomes and commercial feasibility.
Oral Thin Films are particularly relevant for pediatric, geriatric, and chronic-care populations, where swallowing difficulties and adherence issues are common. Choosing a CDMO with scientific and technical expertise ensures these therapies are both effective and manufacturable.
Oral Thin Films are small, dissolving strips of polymer embedded with an active pharmaceutical ingredient (API). They dissolve quickly when placed on the tongue or buccal cavity. This allows fast absorption into the systemic circulation or localised delivery, depending on the formulation.
Key capabilities should include:
However, producing Oral Thin Films at scale can be an arduous undertaking for any pharmaceutical company. It requires precise control over drug loading, polymer composition, film thickness, and dissolution rate. Minor variations can lead to inconsistent dosing or altered pharmacokinetics. A CDMO with expertise in polymer chemistry, process engineering, and analytical validation is therefore essential.
The CDMO must have experience with a range of APIs, including poorly soluble, hydrophilic, or heat-sensitive compounds.
They should be capable of:
For potent APIs, slight inconsistencies in loading or thickness can affect safety. A skilled CDMO applies validated methods to minimise variability and improve reproducibility across batches.
Key manufacturing techniques include hot-melt extrusion, solvent casting, and multilayer film formation. These methods enable precise control over film properties and ensure scalability.
Advanced technologies such as nano-milling for enhanced bioavailability and microfluidisation for liposomal delivery allow the development of complex formulations without extensive in-house investment.
The CDMO should also have:
Compliance with GMP, FDA, EMA, and WHO standards is non-negotiable. A capable CDMO integrates regulatory considerations from the outset of development, including:
Uniformity and dosage precision are central to Oral Thin Films. CDMOs must implement:
For microgram-level dosing, these controls are critical to ensure both safety and therapeutic consistency.
Effective research and development requires clear and structured communication. A pharmaceutical partner for Oral Thin Film R&D should also provide:
Timely and transparent communication helps stakeholders make informed decisions and adjust development strategies as needed.
Research and development involves proprietary processes and formulations. The CDMO should maintain strict IP security, including:
This ensures that sensitive information is protected throughout the R&D and manufacturing process.
The CDMO should have sufficient production capacity to support both clinical trials and commercial batches. They should be able to scale up without affecting quality or reproducibility. This includes:
Scalability is especially significant for novel therapies or reformulated products where commercial demand may be unpredictable.
Pharmaceutical companies should have clear cost structures:
Transparent cost reporting reduces surprises and allows companies to plan budgets accurately.
Working with a specialised CDMO for Oral Thin Films offers practical benefits grounded in scientific and operational considerations.
OTFs require precise control of drug loading, polymer matrices, and dissolution profiles. A CDMO with formulation expertise can optimise these parameters for bioavailability, stability, and patient compliance. This reduces variability in clinical studies and increases confidence in experimental results.
Existing APIs can be reformulated into thin films to address new patient needs or extend the
product lifecycle. CDMOs with experience in both pre-formulation and scale-up can evaluate physicochemical properties and adjust processing conditions to maintain efficacy while meeting regulatory requirements.
High-precision OTF production relies on equipment such as hot-melt extruders, solvent-casting lines, and multilayer film systems. Partnering with a CDMO allows access to these technologies without capital investment, while also providing the process control necessary to ensure batch-to-batch reproducibility.
Regulatory compliance is critical for global distribution. CDMOs experienced in OTFs can integrate quality-by-design principles, stability data, and documentation practices into development workflows. This reduces the risk of delays during regulatory review and ensures alignment with international standards.
Scientific and patient-focused trends, such as personalised dosing, paediatric formulations, and nutraceutical films, require adaptable development and manufacturing strategies. Collaborating with a knowledgeable CDMO enables companies to explore these formats while maintaining scientific rigour and regulatory compliance.
This Concludes:
Choosing a pharmaceutical partner for Oral Thin Film R&D is a decision that affects experimental reproducibility, regulatory compliance, patient safety, and scalability. Pharmaceutical manufacturing companies should prioritise:
Working with a certified pharmaceutical company ensures reliable R&D, reproducible results, and scalable manufacturing.
ZIM Laboratories Limited is a therapy-agnostic and innovative drug delivery solution provider focusing on enhancing patient convenience and treatment adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes to develop, manufacture, and supply innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs, we provide our customers with a comprehensive range of oral solid value-added, differentiated generic products in semi-finished and finished formulations. These include granules, pellets (sustained, modified, and extended-release), taste-masked powders, suspensions, tablets, capsules, and Oral Thin Films (OTF).
