Drug Reconstitution Market

Drug Reconstitution Market by Type of Container, Fabrication Material, Physical State of Drug in Syringe and Cartridge, Physical State of Drug in Infusion Bag, Volume of Container, Key Geographical Regions: Industry Trends and Global Forecasts, 2021-2035

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Drug Reconstitution Market Overview

The drug reconstitution market is estimated to be worth $3.96 billion in 2021 and is expected to grow at compounded annual growth rate (CAGR) of 8% during the forecast period. Over the last few years, numerous biologics and small molecule drugs have made their way to the market. Most of these biologic products are not stable as liquid formulations, and tend to lose efficacy with alterations in their pharmacokinetic and pharmacodynamic properties, thereby, making it difficult to preserve them for longer period of time. In order to achieve longer shelf life, lyophilization has emerged as the preferred choice for making dry biopharmaceutical formulations. In fact, around 30% of the FDA approved parenteral drugs are in lyophilized form. Since 2014, the FDA had approved more than 20 applications for lyophilized new drugs.  Evidently, this method of producing stabilized formulations has witnessed widespread adoption and the affiliated market opportunity is estimated to be USD 3 billion. The increased adoption of such drugs has led to the rise in demand for reconstitution systems that allow proper mixing of lyophilized drug with the diluent and administration of required dose. The traditional reconstitution methods involve manual extraction and transfer of diluent into the vials containing the lyophilized product, using syringe and transfer needle. Given the large number of steps involved and multiple containers, this method is associated with the risk of reconstitute medicationerrors and needle-stick injuries. In addition, the complexity associated with these conventional systems restricts the injection of lyophilized drugs only by the healthcare workers within the confined area of healthcare facilities.

The existing challenges in the conventional reconstitution method have prompted the pharmaceutical industry to develop advanced reconstitution devices, which allow the patients and caregivers to administer drugs without healthcare provider’s intervention. These systems contain premeasured dose of drug and diluent, which essentially reduces the chances of dosing errors and needle-stick injuries. Moreover, these advanced systems enhance the portability, efficiency and optimum delivery of the lyophilized drugs and have the potential to reduce the number of steps significantly, which enable the dilution and reconstitution at the time of delivery. Owing to their multiple benefits, various pharmaceutical companies are considering these systems for lifecycle management of their drugs in order to enhance the provision of healthcare. Further, it is worth mentioning that over 1,800 patent applications have been filed / granted for reconstitution systems and affiliated technologies. We believe that such efforts are likely to drive market growth in drug reconstitution market over the forecast period. 

Context of Drug Reconstitution Market List of Dual or Multi Chambered Novel Drug Reconstitution Systems in Drug Reconstitution Market Current Market Landscape and Market Trends in Drug Reconstitution Market

Key Companies in Drug Reconstitution Market 

Examples of key companies engaged in drug reconstitution market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Baxter, ICU Medical, B. Braun, Vetter Pharma, Nipro and SCHOTT-KAISHA. This market report includes an easily searchable excel database of all the companies providing drug reconstitution systems, worldwide.

Company Competitiveness Analysis in Drug Reconstitution Market List of One Step Reconstitution Systems and Conventional Reconstitution Devices in Drug Reconstitution Market Patent Analysis Drug Reconstitution Market

Scope of the Report

The ‘Drug Reconstitution Market  by Type of Container (Cartridge, Infusion Bag and Prefilled Syringe), Fabrication Material (Glass and 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, and Rest of the World): Industry Trends and Global Forecasts, 2021-2035’ market report features an extensive study on the current market landscape, market size, market share, market forecast, market outlook and future opportunities for the drug reconstitution market. In addition, it features an elaborate discussion on the likely opportunity for the players engaged in drug reconstitution market, over the forecast period. Amongst other elements, the market research report includes:

  • A detailed assessment of the current market landscape of novel drug reconstitution systems, providing information on the type of device (prefilled syringe, cartridge, infusion bags), type of chamber (dual chamber, multi chamber), physical state of drug (lyophilized, liquid), container fabrication material (glass, plastic), device usability (single use, multi-use), and volume of container. In addition, the chapter includes details related to novel drug reconstitution system manufacturers, along with information on their year of establishment, company size, location of headquarters and key players (in terms of number of products manufactured).
  • A detailed landscape of the reconstitution devices and systems featuring information on type of container or device, volume of primary container, physical state of drug, device usability and provision for self-administration. In addition, the chapter includes details related to the manufacturers, along with information on their year of establishment, company size and location of headquarters.
  • Elaborate profiles of prominent players engaged in drug reconstitution market. Each profile includes a brief overview of the company, details related to its financial information (if available), information on product portfolio, recent developments and an informed future outlook.
  • A detailed analysis on the trends in packaging of over 350 drug products (including both biologics and small molecule drugs) that were approved by the FDA between 2014 and H1 2021, featuring an assessment of the packaging requirements of various container-closure systems based on several parameters, such as year of approval of drug, type of molecule (small molecule, biologic), type of biologic (allogeneic cell therapy, autologous cell therapy, fusion proteins, hormones, interferons, monoclonal antibodies, recombinant enzymes, recombinant protein and viral cell therapy), type of primary packaging container used (vials, pouches / packets, bottles, IV / sealed bags, prefilled syringes / pen , tubes, cartridge, blister packaging, others), type of packaging material(s) used for manufacturing primary container, type of closure used (cap / needle shield, seal, plunger, stopper and others), type of packaging material(s) used for manufacturing closures, dosage form, route of administration, holding temperature. In addition, the chapter provides information on the developers of the aforementioned drugs and an analysis based on year of establishment, company size, location of headquarters and leading drug developers (in terms of number of  drugs approved).
  • An insightful analysis of the patents filed / granted for novel drug reconstitution systems, since 2011, taking into consideration various relevant parameters, such as type of patent, publication year, geographical location, CPC symbols, emerging focus areas, leading players (in terms of number of patents granted / filed in the given time period), patent characteristics and geography. In addition, the chapter includes a detailed patent benchmarking and an insightful valuation analysis.
  • A competitiveness analysis of novel drug reconstitution system manufacturers based on various relevant parameters, such as supplier power (in terms of experience / expertise of the manufacturer) and key product specifications (number of systems, type of systems, type of drugs and number of chambers).
  • An in-depth analysis of recent events (summits / forums / conferences / annual meetings) that were organized for stakeholders in drug reconstitution market, highlighting the evolution of discussion topics related to novel drug reconstitution systems. The analysis also provides details on type of event, regional distribution, emerging agendas, popular organizers, active industry and non-industry players, and a schematic mapping of upcoming events.
  • A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall novel drug reconstitution systems market.
  • An in-depth analysis to estimate the current and future demand for various novel drug reconstitution systems, including cartridges, infusion bags and prefilled syringes.  
  • An elaborate discussion on emerging trends that are likely to have an impact on the future adoption of novel drug reconstitution systems. It presents a Harvey ball analysis, highlighting the relative effect of each trend on the adoption of novel drug reconstitution systems including dual chamber systems.

The key objective of drug reconstitution market report is to provide a detailed market analysis in order to estimate the existing market size, market trends, market value, statistics and future opportunity for drug reconstitution market during the forecast period. Based on various parameters, such as target consumer segments, likely adoption rates and expected prices of such products, we have provided informed estimates on the evolution of the market for the forecast period 2021-2035. The market report also features the likely distribution of the current and forecasted opportunity across [A] type of reconstitution system (prefilled syringe / cartridge / infusion bag), [B] physical state of drug (liquid / powder, liquid / liquid for prefilled syringes and cartridges; liquid mixture and frozen mixture for infusion bags), [C] type of fabrication material (glass, plastic / type of plastic for infusion bags), [D] volume of container (<1 mL, 1-2.5 mL, 2.5-5 mL and >5 mL for prefilled syringes and cartridges; 0-250 mL, 250-500 mL, 500-1,000 mL and >1,000 mL for infusion bags), [E] key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa). 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 research report are in USD, unless otherwise specified.

Global Event Analysis of Drug Reconstitution Market Packaging Trends Analysis for Approved Drugs in Drug Reconstitution Market Global Demand for Novel Drug Reconstitution Systems in Drug Reconstitution Market

Frequently Asked Questions

Question 1: What is drug reconstitution?

Answer: Drug reconstitution refers to the process of mixing dried pharmaceutical components with a sterile diluent in order to reformulate the drug into a liquid formulation prior to its administration.

Question 2: How big is the drug reconstitution market?

Answer: The drug reconstitution market size is estimated to be worth $3.96 billion in 2021.

Question 3: What is the projected market growth of the drug reconstitution market?

Answer: The drug reconstitution market is expected to grow at compounded annual growth rate (CAGR) of over 8% during the forecast period 2021 - 2030.

Question 4: Who are the leading companies in the drug reconstitution market?

Answer: Examples of key companies engaged in drug reconstitution market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Baxter, ICU Medical, B. Braun, Vetter Pharma, Nipro and SCHOTT-KAISHA.

Question 5: How many patents have been filed / granted related to the drug reconstitution systems till date?

Answer: Over 1,800 patents have been filed / granted related to the drug reconstitution systems till date.

Question 6: How many companies are currently engaged in the drug reconstitution market?

Answer: Over 35 companies are currently engaged in the drug reconstitution market, providing more than 55 reconstitution systems.

Question 7: Which region emerged as the hub for companies engaged in the drug reconstitution market?

Answer: Europe emerged as the hub for companies engaged in the drug reconstitution market, with over 45% of the players established in the region.

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