Drug Device Combination Products Market

Drug Device Combination Products Market

The drug device combination products market (services) is estimated to be worth $252 million in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 10% during the forecast period. 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 drug device combination products market is likely to witness a significant market growth during the forecast period.

Key Service Providers in Drug Device Combination Products Market

Examples of key service providers engaged in drug device combination products market (which have also been profiled in this market report; the complete list of companies is available in the full report) include EKG LABS, Eurofins Medical Device Testing, Exponent, Kymanox, Medical Engineering Technologies, Pace Analytical Services, Suttons Creek and West Pharmaceutical Services. This market report includes an easily searchable excel database of all the companies providing drug device combination product services, worldwide.

Recent Developments in Drug Device Combination Products Market

Several recent developments have taken place in the field of drug device combination products market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In June 2023, Endo launched PREVDUO™ first and the only FDA approved Neostigmine-Glycopyrrolate Combination Pre-Filled Syringe with an aim to increase efficiency for hospitals and healthcare providers. 
• In May 2023, MoonLake Immunotherapeutic entered into a collaboration with SHL Medical, with an aim to develop an autoinjector for clinical and commercial supply of MoonLake’s Nanobody® sonelokimab which is used for the treatment of patients suffering from dermatologic and rheumatic inflammatory indications. 
• In May 2023, Innoviva Specialty Therapeutics announced the FDA approval of XACDURO® used for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia for intravenous use in patients 18 years of age and older. 

Scope of the Report

The “Drug Device Combination Products 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” market report features an extensive study of current market landscape, market size, market share, market forecast, market outlook and future opportunities for drug device combination products market. The market research report features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in drug device combination products market. Amongst other elements, the market 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.

The key objective of drug device combination products market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for drug device combination products market during the forecast period. 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 market 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 market report are in USD, unless otherwise specified.

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

Frequently Asked Questions

Question 1: What are drug device combination products?

Answer: In healthcare, a combination product entails multiple regulated components, including pharmaceutical entities and medical devices, which are chemically or physically combined to form a single unit.

Question 2: What is the drug device combination products market size for service providers?

Answer: The market size for service providers in the drug device combination products market is estimated to be worth $252 million in 2022.

Question 3: What is the projected market growth of services segment within the drug device combination products market?

Answer: The combination product services market is expected to grow at compounded annual growth rate (CAGR) of 10% during the forecast period 2022 - 2035.

Question 4: Who are the leading service providers in the drug device combination products market?

Answer: Examples of key service providers engaged in drug device combination products market (which have also been profiled in this market report; the complete list of companies is available in the full report) include EKG LABS, Eurofins Medical Device Testing, Exponent, Kymanox, Medical Engineering Technologies, Pace Analytical Services, Suttons Creek and West Pharmaceutical Services.

Question 5: How many companies presently claim to offer services for drug device combination products testing and development?

Answer: Presently, over 25 companies claim to offer services for drug device combination products testing and development globally.

Question 6: Which region is the hub for companies providing services for drug device combination products?

Answer: North America presently harbors the majority of the companies providing services for drug device combination products, with 29% of the companies being mid-sized in this region.

Question 7: Which type of service is primarily offered by companies engaged in the drug device combination products market?

Answer: Majority (75%) of the drug device combination products service providers offer process development and validation services for drug delivery systems / devices.

Question 8: What is an example of a drug device combination product?

Answer: Respimat inhaler is an example of a drug device combination product.