The combination product services market is anticipated to grow at a CAGR of around 10%, till 2035

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Growing interest for combination products, coupled with the ongoing challenges of combining drug / biologic with a medical device, is anticipated to drive the demand for outsourcing combination products development and testing.

Roots Analysis has announced the addition of “Combination Product Services Market, 2022-2035” report to its list of offerings.


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 order to overcome these challenges and enhance overall patient experience, several developers are outsourcing their operations to companies that offer services for testing and validation of combination products.


Key Market Insights


Currently, more than 25 service providers claim to offer services for combination products

The market is dominated by the presence of small (11-50 employees) and mid-sized (51-500 employees) players, who represent over 55% of the contemporary market landscape. Additionally, it is worth noting that majority (81%) of the service providers are based in North America.


Around 70% of the players engaged in this industry offer services for drug delivery device / system

Over 65% of the aforementioned players offer services for product development. Further, 60% of the combination product service providers offer services for prefilled syringes. Notably, over 70% of the total players engaged in this space also offer process development and validation services.


Go / No-Go framework can be used to assist players in the outsourcing decision-making process

The framework enables evaluation of the current capabilities of prefilled syringe combination product developers and aids them to take the crucial decision of outsourcing / in-house development and testing of prefilled syringe combination products based on 5+ parameters.


Expansion activity within this field has grown significantly between 2017 and 2022

Maximum number of expansion initiatives (38%) were undertaken in 2021. It is worth highlighting that majority of the expansions were facility expansions. Notably, over 70% of the expansion initiatives have been undertaken for facilities based in North America.


North America and Europe are anticipated to capture larger share (over 65%) of market by 2035

Growth in this domain is anticipated to be primarily driven by the rising demand of combination products. Players providing performance testing services are anticipated to capture more than 75% of the market by 2035.


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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?

The financial opportunity within the Combination Product Services (Focus on Particle Testing, Performance Testing and Product Development) Market has been analyzed across the following segments:

  • Type of Device
    • Autoinjectors
    • Prefilled Syringes
    • Large Volume Wearable Injectors
    • Other Types of Devices
  • Service Focus Area
    • Particle Testing
    • Performance Testing
    • Product Development
  • Company Size
    • Very Small
    • Small
    • Mid-sized
    • Large
    • Very Large
  • Geographical Regions 
    • North America
    • Europe
    • Asia
    • Rest of the World

The research also includes detailed profiles of key players (listed below) that offer services for combination products; each profile features an overview of the company, its financial information (if available), details on product portfolio, recent developments and an informed future outlook.

  • EKG Labs
  • Eurofins Medical Device Testing
  • Exponent
  • Kymanox
  • Medical Engineering Technologies
  • Pace Analytical Services
  • Suttons Creek
  • West Pharmaceutical Services


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About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector.



Ben Johnson

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