Combination Product Services Market (Focus on Particle Testing, Performance Testing and Product Development, 2022-2035

Combination Product Services Market (Focus on Particle Testing, Performance Testing and Product Development, 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.

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 wearble 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 Wearble 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 therpies).

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.

MARKET SEGMENTATIONS

Combination Product Services: Market Segmentations

Market Segments Details

Forecast Period 2022 – 2035

Type of Device Autoinjectors

Large Volume Wearable Injectors

Prefilled Syringes

Other Types of Devices

Service Focus Area Particle Testing

Performance Testing

Product Development

Company Size Very Small

Small

Mid-sized

Large

Very Large

Key Geographical Regions North America

Europe

Asia

Rest of the World

Source: Roots Analysis

RESEARCH METHODOLOGY

The data presented in this report has been gathered via primary and secondary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This information is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been validated from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent views on various non-commercial trends emerging in this industry. The opinions are solely based on our knowledge, research and understanding of the relevant market trends gathered from various secondary and primary sources of information.

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?

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured during our research. It offers a high-level view on the current state of the combination product service providers market and its likely evolution in the mid to long term.

Chapter 3 provides an overview of combination products, along with information on various types of combination products. Additionally, it includes information on the various challenges associated with development and testing of combination products. Further, it features a brief discussion on the growing need for outsourcing within this domain.

Chapter 4 provides a detailed review of the overall landscape of combination product service providers along with information on over 25 service providers that claim to provide development and testing services for combination products. Additionally, it features an in-depth analysis of 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).

Chapter 5 features a detailed company competitiveness analysis of the combination product service providers, based on several relevant parameters, such as 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.

Chapter 6 provides detailed profiles of the key players (shortlisted based on a proprietary criterion) that are active in the combination product services market. Each profile provides an overview of the company, along with information on year of establishment, location of headquarters, number of employees, key executives, details on recent developments, and an informed future outlook.

Chapter 7 presents 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 additions), location of expanded facility, most active players (in terms of number of recent expansions) and geographical distribution.

Chapter 8 features an elaborate discussion on combination products, with special focus on large volume wearable injectors and prefilled syringes. The chapter includes a detailed analysis based on specific parameters for each product category, namely [A] large volume wearable injector combination products based on their 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 and [B] prefilled syringe combination products (therapies that have approved / are being developed in combination prefilles syringes) 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).

Chapter 9 features a list of 90+ stakeholders that are anticipated to partner with combination product service providers in the foreseen future. The players have been shortlisted based on a detailed analysis of relevant parameters, namely pipeline strength (in terms of number of product that have been / are being developed by the player), developer strength (based on player’s experience in the domain) and product strength.

Chapter 10 presents an insightful analysis that highlights the various factors that need to be taken into consideration by combination product developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO. Further, the analysis highlights all the key parameters that must be considered by players of different company sizes (very small, small, mid-sized, and large) while taking the aforementioned decision.

Chapter 11 features a comprehensive market forecast analysis, highlighting the likely growth of the combination product services market, for the period 2022-2035. Additionally, the report features the likely distribution of the current and forecasted opportunity 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).

Chapter 12 is a summary of the entire report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 13 provides the transcripts of interviews conducted with representatives from renowned organizations, which are engaged in the domain of combination product services.

Chapter 14 is an appendix, that provides tabulated data and numbers for all the figures included in the report.

Chapter 15 is an appendix that provides the list of companies and organizations that have been mentioned in the report.