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 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.

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.

Product Code: RA100375

1. PREFACE

1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Introduction to Combination Products
3.3. Challenges Associated with Development of Combination Products
3.4. Outsourced Combination Products Operations / Services
3.5. Advantages of Outsourcing Operations for Combination Products
3.6. Key Considerations while Selecting a CDMO
3.7. Future Perspectives

4. COMBINATION PRODUCTS SERVICE PROVIDERS: MARKET LANDSCAPE

4.1. Chapter Overview
4.2. Combination Products Service Providers: Overall Market Landscape
- 4.2.1. Analysis by Year of Establishment
- 4.2.2. Analysis by Company Size
- 4.2.3. Analysis by Location of Headquarters
- 4.2.4. Analysis by Type of Combination Product
- 4.2.5. Analysis by Type of Device
- 4.2.6. Analysis by Service Focus Area(s)
- 4.2.7. Analysis by Type of Service(s) Offered
- 4.2.8. Analysis by Location of Facility
- 4.2.9. Leading Combination Products Service Providers: Analysis by Number of Service(s) Offered
- 4.2.10. 4D Bubble Representation: Analysis by Company Size, Location of Headquarters (Region), Number of Service Focus Area(s) and Number of Service(s) Offered
- 4.2.11. Mekko Representation: Analysis by Company Size and Number of Service Focus Area(s)

5. COMPANY COMPETITIVENESS ANALYSIS

5.1. Chapter Overview
5.2. Assumptions / Key Parameters
5.3. Methodology
5.4. Combination Products Service Providers: Company Competitiveness Analysis
- 5.4.1. Combination Products Service Providers based in North America
- 5.4.2. Combination Products Service Providers based in Europe and Asia

6. COMBINATION PRODUCTS SERVICE PROVIDERS: COMPANY

PROFILES

6.1. Chapter Overview
6.2. EKG LABS
- 6.2.1. Company Overview
- 6.2.2. Recent Developments and Future Outlook
6.3. Eurofins Medical Device Testing
- 6.3.1. Company Overview
- 6.3.2. Recent Developments and Future Outlook
6.4. Exponent
- 6.4.1. Company Overview
- 6.4.2. Recent Developments and Future Outlook
6.5. Kymanox
- 6.5.1. Company Overview
- 6.5.2. Recent Developments and Future Outlook
6.6. Medical Engineering Technologies
- 6.6.1. Company Overview
- 6.6.2. Recent Developments and Future Outlook
6.7. Pace Analytical Services
- 6.7.1. Company Overview
- 6.7.2. Recent Developments and Future Outlook
6.8. Suttons Creek
- 6.8.1. Company Overview
- 6.8.2. Recent Developments and Future Outlook
6.9. West Pharmaceutical Services
- 6.9.1. Company Overview
- 6.9.2. Recent Developments and Future Outlook
6.10. Concluding Remarks: Initiatives Undertaken by Industry Players

7. RECENT EXPANSIONS

7.1. Chapter Overview
7.2. Combination Products Service Providers: List of Recent Expansions
- 7.2.1. Analysis by Year of Expansion
- 7.2.2. Analysis by Type of Expansion
- 7.2.3. Analysis by Location of Expanded Facility
- 7.2.4. Analysis by Type of Expansion (Country-wise)
- 7.2.5. Most Active Players: Analysis by Number of Expansions
- 7.2.6. Geographical Analysis

8. CASE STUDY: LARGE VOLUME WEARABLE INJECTORS AND PREFILLED SYRINGES COMBINATION PRODUCTS

8.1. Chapter Overview
8.2. Large Volume Wearable Injector Combination Products
- 8.2.1. Large Volume Drug Device Combination Products: Market Landscape
  - 8.2.1.1. Analysis by Phase of Development
  - 8.2.1.2. Analysis by Type of Device
  - 8.2.1.3. Analysis by Drug Compatibility
  - 8.2.1.4. Analysis by Type of Dosage
  - 8.2.1.5. Analysis by Route of Administration
  - 8.2.1.6. Analysis by Method of Administration
  - 8.2.1.7. Analysis by Therapeutic Area
  - 8.2.1.8. Analysis by Storage Volume / Capacity
  - 8.2.1.9. Analysis by Usability
  - 8.2.1.10. Analysis by Technology Used
  - 8.2.1.11. Analysis by Mechanism of Action
  - 8.2.1.12. Analysis by Type of Drug Container
- 8.2.2. Large Volume Drug Device Combination Products: Developer Landscape
  - 8.2.2.1. Analysis by Year of Establishment
  - 8.2.2.2. Analysis by Company Size
  - 8.2.2.3. Analysis by Location of Headquarters
  - 8.2.2.4. Most Active Players: Analysis by Number of Products Manufactured
8.3. Prefilled Syringes Combination Products
- 8.3.1. Prefilled Syringe Combination Products: List of Approved Drugs, 2013-2021
  - 8.3.1.1. Analysis by Type of Drug Molecule
  - 8.3.1.2. Analysis by Approval Year
  - 8.3.1.3. Analysis by Geography
  - 8.3.1.4. Analysis by Route of Administration
  - 8.3.1.5. Analysis by Therapeutic Area
  - 8.3.1.6. Analysis by Dosage Strength
  - 8.3.1.7. Analysis by Other Approved Dosage Forms
- 8.3.2. Prefilled Syringe Combination Products: List of Clinical Stage Drugs
  - 8.3.2.1. Analysis by Type of Drug Molecule
  - 8.3.2.2. Analysis by Phase of Development
  - 8.3.2.3. Analysis by Route of Administration
  - 8.3.2.4. Analysis by Therapeutic Area
- 8.3.3. Prefilled Syringes Combination Products: Information on Developers
  - 8.3.3.1. Analysis by Year of Establishment
  - 8.3.3.2. Analysis by Company Size
  - 8.3.3.3. Analysis by Location of Headquarters

9. LIKELY PARTNER ANALYSIS

9.1. Chapter Overview
9.2. Large Volume Wearable Injectors Combination Products
- 9.2.1. Scoring Criteria and Key Assumptions
- 9.2.2. Scope and Methodology
- 9.2.3. Potential Strategic Partners
  - 9.2.3.1. Most Likely Partners
  - 9.2.3.2. Likely Partners
  - 9.2.3.3. Less Likely Partners
9.3. Prefilled Syringes Combination Products
- 9.3.1. Scoring Criteria and Key Assumptions
- 9.3.2. Scope and Methodology
- 9.3.3. Potential Strategic Partners
  - 9.3.3.1. Most Likely Partners
  - 9.3.3.2. Likely Partners
  - 9.3.3.3. Less Likely Partners

10. OUTSOURCING: GO / NO-GO FRAMEWORK

10.1. Chapter Overview
10.2. Outsourcing: Go / No-Go Framework
10.3. Prefilled Syringes Combination Products Developers: Go / No-Go Framework
- 10.3.1. Assumptions and Key Parameters
- 10.3.2. Methodology
- 10.3.3. Results and Interpretations
  - 10.3.3.1. Outsourcing: Go / No-Go Framework for Very Small and Small Companies
  - 10.3.3.2. Outsourcing: Go / No-Go Framework for Mid-sized Companies
  - 10.3.3.3. Outsourcing: Go / No-Go Framework for Large Companies

11. MARKET FORECAST

11.1. Chapter Overview
11.2. Key Assumptions and Forecast Methodology
11.3. Global Combination Products Service Providers Market, 2022-2035
- 11.3.1. Global Combination Products Service Providers Market: Distribution by Type of Device, 2022 and 2035
  - 11.3.1.1. Combination Products Service Providers Market for Large Volume Wearable Injectors
  - 11.3.1.2. Combination Products Service Providers Market for Autoinjector Combination Products
  - 11.3.1.3. Combination Products Service Providers Market for Prefilled Syringe
  - 11.3.1.4. Combination Products Service Providers Market for Other Types of Combination Products
- 11.3.2. Global Combination Products Service Providers Market: Distribution by Service Focus Area, 2022 and 2035
  - 11.3.2.1. Combination Products Service Providers Market for Particle Testing
  - 11.3.2.2. Combination Products Service Providers Market for Performance Testing
  - 11.3.2.3. Combination Products Service Providers Market for Product Development
- 11.3.3. Global Combination Products Service Providers Market: Distribution by Company Size, 2022 and 2035
  - 11.3.3.1. Combination Products Service Providers Market for Very Small Companies
  - 11.3.3.2. Combination Products Service Providers Market for Small Companies
  - 11.3.3.3. Combination Products Service Providers Market for Mid-sized Companies
  - 11.3.3.4. Combination Products Service Providers Market for Large Companies
  - 11.3.3.5. Combination Products Service Providers Market for Very Large Companies
- 11.3.4 Combination Products Service Providers Market: Distribution by Region, 2022 and 2035
  - 11.3.4.1. Combination Products Service Providers Market in North America, 2022-2035
  - 11.3.4.2. Combination Products Service Providers Market in Europe, 2022-2035
  - 11.3.4.3. Combination Products Service Providers Market in Asia, 2022-2035
  - 11.3.4.4. Combination Products Service Providers in Rest of the World, 2022-2035

12. CONCLUDING REMARKS

13. EXECUTIVE INSIGHTS

14. APPENDIX 1: TABULATED DATA

15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS