Combination Product Services Market by Type of Device Service Focus Area, Company Size, and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035

Non-adherence to prescribed medication regimen is one of the major factors that not only causes negative implications on the patient’s health, but also adds to the overall pharmaceutical industry’s burden. According to an article published by Contract Pharma in April 2022, non-adherence to prescribed medicines is estimated to cost more than USD 250 billion annually to the drug developers. Further, lack of effective methods / solutions for sustained / controlled release of active pharmaceutical ingredient (API) at the targeted delivery sites is another challenge in efficient drug delivery. Notably, inadequate methods to control the release of API into the body cause fluctuations in plasma levels, leading to various side effects. Among other approaches used for efficient drug delivery, the introduction of combination products has garnered the attention of many developers within the pharmaceutical industry. Combination products comprise of two or more FDA- regulated components that provide controlled release of the APIs. However, the development of drug-device combination products is a long-drawn-out process that not only requires novel technologies and processes but also a huge amount of capital and expertise. In addition, drug-device compatibility, user needs, release testing / testing methods, production, and packaging requirements are other factors that add to complexity in commercialization of combination products. In order to overcoming these challenges and enhance patient experience, several combination product developers are outsourcing their operations to companies that offer services for testing and validating the efficacy of their combination products.

Presently, there are several combination product service providers which claim to employ various strategic approaches to support product development and testing to provide safe, effective combination products that meet user needs. These players provide the most suitable characterization methods that help manufacturers throughout the development and manufacturing process. Some of the common features provided by the combination product service providers include providing access to GMP-certified facilities, larger capacities, new technologies, and greater operational flexibility. Further, in order to address the existing challenges in combination product development and manufacturing, service providers are actively expanding their current geographical reach and broadening their respective services portfolio. With rising need for effective drug delivery in terms of controlled drug release and the increased focus of service providers towards the development and commercial manufacturing of combination products, the combination product services market is likely to witness a significant growth in the coming years.

Scope of the Report

The “Combination Product Services Market (Focus on Particle Testing, Performance Testing and Product Development) by Type of Device (Autoinjectors, Prefilled Syringes, Large Volume Wearable Injectors and Other Types of Devices) Service Focus Area (Particle Testing, Performance Testing and Product Development), Company Size (Very Small, Small, Mid-sized, Large and Very Large Companies), and Key Geographical Regions (North America, Europe, Asia, and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” report features an extensive study of service providers engaged in development and testing of combination products. The study features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this domain. Amongst other elements, the report features:

• A detailed assessment of the market landscape of combination product service providers based on several relevant parameters, such as year of establishment, company size (very small, small, mid-sized, large and very large), location of headquarters, type of combination product(s) (drug delivery device / system, device coated / impregnated with drug, and other types of combination products), type of device(s) (autoinjectors, pen-injectors, prefilled syringes, large volume wearable injectors and other types of devices), service focus area(s) (particle testing, performance testing, and product development), type of service(s) offered (chemical characterization / testing, closure integrity testing, packaging validation, process development and validation, stability studies and other types of services), location of facility and leading players (in terms of number of services offered). 
• A detailed company competitiveness analysis of combination product service providers, based on supplier power (based on the experience of the developer in this industry) and service portfolio strength based on several relevant parameters, such as type of combination product(s) (device coated / impregnated with drug, drug delivery device / system, and other types of combination products), type of device(s) (autoinjectors, pen-injectors, prefilled syringes, large volume wearable injectors and other types of devices), service focus area(s), (particle testing, performance testing, and product development), types of service(s) offered (chemical characterization / testing, closure integrity testing, packaging validation, process development and validation, stability studies and other types of services), and number of accreditations / certifications.
• Elaborate profiles of key players that offer services for development and testing of combination products. Each profile features a brief overview of the company, along with information on year of establishment, location of headquarters, number of employees, key executives, recent developments and an informed future outlook.
• A detailed analysis of the recent expansions undertaken by various combination product service providers, based on several relevant parameters, such as year of expansion, type of expansion (capacity expansions, facility expansions and new facility addition), location of expanded facility, most active players (in terms of number of recent expansions) and geographical distribution.
• A case study on most advanced and popular combination products, including large volume wearable injectors and prefilled syringes combination products, providing information on their developer(s) and combination product specific features. Details of specific parameters captured for different product categories are mentioned as follows:
• Large Volume Wearable Injector Combination Products: These products have been analyzed based on phase of development, type of device, drug compatibility, type of dosage, route of administration, method of administration, therapeutic area, storage volume / capacity, usability, technology used, mechanism of action and type of drug container.
• Prefilled Syringe Combination Products: These therapies that have been approved / are being developed in combination with prefilled syringes have been analyzed based on type of drug molecule, year of approval (for approved therapies), geography (for approved therapies), route of administration, therapeutic area, dose strength (for approved therapies), and other available dosage forms (for approved therapies).
• A list of more than 90 combination product developers that are likely to partner with combination product service providers (with regard to likely collaboration opportunities for combination product development and testing). These players have been shortlisted based on various parameters, such as pipeline strength, developer strength and product strength.
• An insightful outsourcing: go or no go framework analysis, highlighting the various factors that need to be taken into consideration by combination product developers while deciding whether to develop their respective products in-house or engage the services of a service provider. Further, the analysis highlights all the key parameters that must be considered by players based on company sizes (very small, small, mid-sized, and large), while taking the aforementioned decision.

One of the key objectives of the report was to evaluate the existing market size, primary growth factors and future opportunity within the combination product service providers market in the mid to long term. Our year-wise projections of the current and future opportunity within the combination product service providers market have further been segmented across types of devices (autoinjectors, prefilled syringes, large volume wearable injectors and other types of devices), service focus areas (particle testing, performance testing and product development), company size (very small, small, mid-sized, large and very large), and key geographical regions (North America, Europe, Asia and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry.

Key Questions Answered

• Who are the key players that provide services for the development and testing of combination products?
• What are the most common services offered by combination product service providers?
• What are the different types of expansion initiatives being undertaken by combination product service providers?
• Who are the leading players that are currently engaged in the development / commercialization of combination products?
• What are the most advanced features of combination products?
• Which factors are likely to influence the decision of combination product developers for outsourcing development and testing operations?
• How is the current and future market opportunity likely to be distributed across key market segments?

Please note: This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.