GLOBAL DRUG DEVICE COMBINATION PRODUCTS MARKET: GROWTH AND TRENDS
Non-adherence to prescribed medication regimens is a significant issue that not only negatively impacts patient health but also increases the overall burden on the pharmaceutical industry. As recently reported by Contract Pharma, medication non-adherence is estimated to cost drug developers over USD 250 billion each year. Additionally, the lack of effective solutions for sustained or controlled release of active pharmaceutical ingredients (APIs) at targeted delivery sites remains a major challenge in drug delivery. In fact, inadequate control over API release can lead to fluctuations in plasma drug levels, which may result in various side effects. This has led to a rise in the demand for effective drug delivery treatment options for patients.

Notably, in the recent past the development of combination products has attracted significant interest from pharmaceutical companies. These products integrate two or more FDA-regulated components to enable controlled release of APIs. However, creating drug-device combination products is a complex and lengthy process that demands innovative technologies, substantial investment, and specialized expertise. Additional challenges include ensuring drug-device compatibility, addressing user requirements, conducting release testing, and meeting production and packaging standards. To address these hurdles and improve patient outcomes, many developers are now outsourcing key operations to specialized companies that provide testing and validation services for combination products.
GLOBAL DRUG DEVICE COMBINATION PRODUCTS MARKET: KEY INSIGHTS
The report delves into the current state of global drug device combination products market and identifies potential growth opportunities within industry. Some key findings from the report include:
- At present, more than 25 companies across the globe offer services for the development and testing of various drug-device combination products.
- Service providers claim to have the necessary expertise to provide a wide range of services for different types of combination products; majority (~20%) of these services are focused on performance testing.
- Majority of the players (over 85%) that support development and testing of drug delivery devices / systems are headquartered in North America.
- Over 45% of the service providers assist the performance testing and product development of combination products; of these, 40% are large / very large players.
- Around 75% of the combination product service providers perform the process development and validation; examples include BS, EKG Labs, Exponent and Surpass.

- In order to gain an edge in this competitive industry, service providers are continuously undertaking initiatives to upgrade their existing service offerings.
- To keep pace with the growing demand, many companies have undertaken expansion initiatives, such as establishing new facilities (~40%) or expanding their existing capabilities (~50%), to strengthen their service portfolio.
- Majority of the expansion initiatives were undertaken by combination product service providers based in the US; examples include DDL, NAMSA, and Nelson Labs.
- Majority expansions were undertaken in order to meet the increasing demand for testing services related to combination products.
- Most of the expansions reported were local initiatives; some companies based in the US have undertaken international expansions initiatives as well.
- Presently, over 210 combination products have been / are being developed for the treatment of various clinical conditions; these can be used for both parenteral as well as non-parenteral drug delivery.
- The pipeline features a variety of combination products that have been / are being developed for various therapeutic areas; majority of the products are being evaluated for the administration of biologics.
- Majority of the large volume WI combination products (~80%) that are currently under development are being developed to provide basal dose.
- A sizeable proportion of large volume WI combination products are being developed for the treatment of neurological disorders (33%); examples include D-mine(R) Pump, and ND0701.
- Over 90% of the prefilled syringe combination products have been / are being developed to administer biologics; of these, majority are antibody-based molecules (48%).
- Combination product developers are anticipated to forge strategic alliances with service providers for the development and testing of their proprietary combination products.
- Built on our intellectual capital, we have proposed a proprietary framework to allow developers to decide whether to outsource manufacturing or keep it in-house; we expect majority of the small firms to outsource such operations.

- With the rising demand for combination products, the affiliated market for service providers is expected to grow at a steady annualized rate over the coming decade.
Example Players in the Drug Device Combination Products Market
- EKG LABS
- Eurofins Medical Device Testing
- Exponent
- Kymanox
- Medical Engineering Technologies
- Pace Analytical Services
- Suttons Creek
- West Pharmaceutical Services
GLOBAL DRUG DEVICE COMBINATION PRODUCTS MARKET: RESEARCH COVERAGE
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global drug device combination products market, focusing on key market segments, including [A] type of device, [B] service focus area, [C] company size and [D] key geographical regions.
- Market Landscape: A comprehensive evaluation of combination product service providers, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] type of combination product(s), [E] type of device(s), [F] service focus area(s), [G] type of service(s) offered, [H] location of facility and [I] leading players (in terms of number of services offered).
- Company Competitiveness Analysis: A comprehensive competitive analysis of combination product service providers, examining factors, such as [A] supplier power and [B] service portfolio strength.
- Company Profiles: In-depth profiles of companies that offer services for development and testing of combination products, focusing on [A] company overviews and [B] recent developments and an informed future outlook.
- Recent Expansions: An insightful analysis of recent expansions undertaken by various combination product service providers, based on various relevant parameters, such as [A] year of expansion, [B] type of expansion, [C] location of expanded facility, [D] most active players (in terms of number of recent expansions) and [E] geographical distribution.
- Case Study: A detailed discussion on the 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.
- Likely Partner Analysis: A comprehensive analysis of more than 90 combination product developers that are likely to partner with combination product service providers. These players analyzed based on various parameters, such as [A] pipeline strength, [B] developer strength and [C] product strength.
- Go or No-Go Framework Analysis: In-depth analysis highlighting the various factors that need to be considered by combination product developers while deciding whether to develop their respective products in-house or engage the services of a service provider.
KEY QUESTIONS ANSWERED IN THIS REPORT
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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