These products, commonly referred to as combination products, have made a tremendous impact on the healthcare landscape in recent years, given their potential for significant therapeutic advantages over conventional dosage forms, maintaining dosage compliance, thereby improving patient experience.
In simpler terms, a combination product can be defined as a product which is composed of two or more pharmacological products. A combination product is comprised of two or more regulated components – drug / device, drug / biologic, or drug / device / biologic. Each drug, device, and biologic included in a combination product is referred to as a constituent part of the combination product. According to the United States Food and Drug Administration (USFDA), a combination product can be classified based on its constituent parts. The combination product services market is likely to witness a significant growth in the coming years.
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However, development and testing of combination products is a highly complex process, fraught with multiple of challenges, such as need for advanced technologies, consistent drug volume, multiple interactions between the drug and the device, and safety and efficacy-related issues. Given the growing demand for combination products and technical complexities associated with the manufacturing of such products, developers are increasingly relying on organizations that can provide services related to development and testing of combination products.
As highlighted above, there are various types of combination products and manufacturing platforms / technologies available for their production. The methods for manufacturing such complex products are usually associated with high degrees of complexity. It is worth mentioning that several contract organizations, across the globe offer a wide range of services to cater to the development / testing needs of various pharmaceutical companies. The presence of such organizations has significantly reduced commercial risk and deployment of capital to develop in-house facilities. According to our proprietary scoring criteria, very small / small - prefilled syringe combination product developers, are likely to have high value addition on outsourcing their product development and testing operations. The drug device combination product is used for delivery of biologics via the subcutaneous route.
Given the challenges associated with the development of combination products has increased the extent of outsourcing activity in this domain. Numerous service providers with varying strengths and capabilities, are contributing actively in the testing / development of the device constituent and / or the finished product. Driven by the growing demand for such advanced medical products, expanding existing capabilities and augmenting efforts to develop, test and pack combination products and contributions of several big pharma players. this market is anticipated to witness tremendous growth in the coming years.
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