The novel drug reconstitution systems market is anticipated to grow a sustained rate, claims Roots Analysis

Published: October 2021

Driven by the growing pipeline of lyophilized drugs, and increasing preference for self-medication, the demand for novel drug reconstitution systems is expected to rise in the coming years


Roots Analysis has announced the addition of “Novel Drug Reconstitution Systems Market, 2021-2030” report to its list of offerings. 

Given the large number of steps involved, multiple containers, and risk of medication errors associated with the use of traditional reconstitution methods, the pharmaceutical industry has progressed towards developing novel drug reconstitution systems. These advanced systems contain premeasured dose of drug and diluent, which essentially reduces the chances of dosing errors, enhance the portability, efficiency and optimum delivery of lyophilized drugs, thereby improving the provision of healthcare.

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Key Market Insights 

Currently, around 55 novel drug reconstitution systems are available in the market
More than 45% of the reconstitution systems are infusion bags (dual and multi chambered), followed by prefilled syringes (39%) and cartridges (14%). Examples include (in alphabetical order, no selection criteria) DebioPass™ (prefilled syringe), Duplex® (infusion bag), Lyo-DCPS™ (prefilled syringe) and V-LK® (cartridge). It is worth noting that more than 25 reconstitution systems are made of plastic materials, such as ethynyl vinyl acetate, polypropylene, cyclic olefin polymer and polyvinyl chloride.

Around 35 companies claim to manufacture novel drug reconstitution systems
Presently, the market is dominated by very large companies (having more than 5,000 employees) and mid-sized companies (having 51-200 employees). It is worth noting that majority (47%) of the firms engaged in this domain are based in Europe, followed by Asia Pacific (32%) and North America (18%).

Close to 20 one step reconstitution systems and 30 conventional reconstitution devices are presently available / being developed
Majority (44%) of the one step reconstitution systems use vials for the storage and reconstitution of lyophilized drugs. About 90% of these systems are disposable and intended for single use only, while the others are designed to be reusable. Examples include (in alphabetical order, no selection criteria) Clip’n’Ject™ (West Pharmaceutical Services), Mixpro® (Novo Nordisk) and Multi-Ad® Fluid Dispensing System (B.Braun).

Analysis of over 350 drugs approved in past seven years, highlighting the growing need for efficient packaging materials
Over 70% of the drugs approved since 2014, are small molecules, while the rest are biologics. About 70% of the biologics are stored and reconstituted in vials. It is worth highlighting that, 23% of the biologic drugs are administered using prefilled syringes / pens.

More than 1,800 patents have been filed / granted related to novel drug reconstitution systems, since 2011
Of these, majority of the patents (49%) were filed / granted in North America, followed by Europe where 38% patents were filed / granted. Leading players, in terms of the number of patents filed / granted, include (in decreasing order of number of patents filed) Sanofi, Baxter, Deka Products, Becton Dickinson and Carefusion.

Over 50 global events related to novel drug reconstitution systems were organized in the past couple of years
Most of the events related to novel drug reconstitution systems were organized in Europe, particularly the UK (around 30%). It is worth highlighting that the agendas of the events organized in 2020 include, considerations of closed system transfer devices, transition from vials to prefilled syringes and next generation innovations in drug delivery.

The demand for novel drug reconstitution systems is expected to grow at an annualized rate of 8%
The current demand for novel drug reconstitution systems is estimated to be worth over 2.5 billion units and is likely to reach more than 5 billion units by 2030. Further, North America and Europe represents the highest share in terms of demand for novel drug reconstitution systems, compared to other regions.

The market is anticipated to grow at a CAGR of over 6%, during the period 2021-2030 
North America (primarily the US) and Europe are expected to capture over XX% of the market share by 2030, in terms of the sales-based revenues. Further, majority of the market is captured by dual chamber prefilled syringes mainly used for the reconstitution and administration of lyophilized drugs.

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Key Questions Answered 
  • Who are the key players engaged in the development of novel drug reconstitution systems?
  • What is the relative competitiveness of different novel drug reconstitution system manufacturers?
  • What is the packaging trend in terms of container and closure for the drugs approved since 2014?
  • Who are the leading players focused on the development of lyophilized drugs?
  • What is the focus area of various conferences related to novel drug reconstitution systems?
  • How has the intellectual property landscape of novel drug reconstitution systems evolved over the years?
  • What are the emerging trends related to pharmaceutical packaging?
  • What are the key agenda items being discussed in various global events / conferences related to novel drug reconstitution systems?
  • How is the current and future market opportunity likely to be distributed across key market segments?

The USD XX billion (by 2030) financial opportunity within the novel drug reconstitution systems market has been analyzed across the following segments:

  • Type of Container
  • Prefilled Syringe 
  • Cartridge
  • Infusion Bag
  • Fabrication Material
  • Glass
  • Plastic
  • Physical State of Drug in Syringe and Cartridge
  • Liquid / Powder
  • Liquid / Liquid
  • Physical State of Drug in Infusion Bag
  • Liquid Mixture
  • Frozen Mixture
  • Volume of Container
  • <1 mL, 1-2.5 mL, 2.5-5 mL, >5 mL for prefilled syringe and cartridge
  • 250 mL, 250-500 mL, 500-1,000 mL, >1,000 mL for infusion bag
  • Key Geographical Regions 
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and North Africa

The research includes detailed profiles of key players (listed below), each profile features an overview of the company, its financial information (if available), product portfolio, details on recent developments, as well as an informed future outlook. 

  • Baxter
  • B. Braun
  • ICU Medical
  • Nipro
  • Vetter Pharma

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3.    Medical Device Batteries Market, 2020-2030

Gaurav Chaudhary
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