Prefilled Syringe Fill Finish Manufacturing Market

Prefilled Syringe Fill Finish Manufacturing Market by Therapeutic Area, Syringe Barrel Material, Barrel Chamber, Drug Molecule, Scale of Operation and Key Geographical Regions: Industry Trends and Global Forecasts, 2020-2030

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Prefilled Syringe Fill Finish Manufacturing Market Overview

The prefilled syringe fill finish manufacturing market is estimated to be worth $931 million in 2020 and is expected to grow at CAGR of 11.9% during the forecast period. Among drug delivery devices, prefilled syringes represent one of the fastest growing primary packaging formats, which are also designed for dose administration. In fact, over the past ten years, there has been an evident increase in the development of parenteral drugs (especially with the introduction of several classes of biologics), which has resulted in an increased consumption of prefilled syringes, by approximately three fold.  The sustained preference for such products can be attributed to the fact that prefilled syringes are safe and easy-to-use, and current variants are designed with provisions to reduce dosing errors, the risk of occlusions, extravasation and phlebitis.  Owing to the aforementioned benefits, several injectable drugs (such as Humira®, Enbrel®, Avastin®, PREVNAR 13®, ALPROLIX® and Benefix®), diluents and other products requiring parenteral administration, are packaged in prefilled syringes.  In fact, over the past seven years, around 90 drugs have been approved in combination with prefilled syringes across different geographies, including the North America, Europe and Asia-Pacific.  Moreover, several clinical-stage drugs are being evaluated in combination with prefilled syringes, across different phases of development.  

This image highlights the context of Prefilled Syringe Fill Finish Services Market report. The numerous benefits offered by prefilled syringes, coupled to the growing self-medication trend, have led to the approval of a number of drugs in combination with such devices, resulting in an increase in need to outsource fill / finish operations This image provides list of Prefilled Syringe Fill Finish Service Providers. Over 100 companies across the globe claim to provide contract fill / finish services for prefilled syringes; close to 50% of these service providers are large companies with over 500 employees This image presents current market landscape of Prefilled Syringe Fill Finish Services Providers. The market landscape features the presence of well- established players in the domain, most of which claim to operate at various scales of operation and are located in different geographies

Prefilled syringe fill finish manufacturing is considered to be one of the most crucial steps in the pharmaceutical production process. Proper prefilled syringe fill finish, carried out under aseptic conditions, is a necessity for not only maintaining pharmacological efficacy and quality, but also ensuring end user safety. The prefilled syringe fill finish manufacturing operation is considered complex as it requires close monitoring of both the syringe fill volume as well as the headspace between the liquid in the syringe and the bottom of the plunger.  Additionally, the rise in complexity of small molecule APIs and the increasing diversity of biologic drugs have also contributed towards the demand for advanced aseptic fill / finish operations.  A number of small-sized companies and some large companies have outsourced their fill / finish operations to contract service providers. According to the 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, biomanufacturers have been shown to outsource over 30% of their fill / finish operations. With the increase in the demand for prefilled syringes, along with the growing complexity of fill / finish processes, the outsourcing of these operations is likely to increase further in the future.  Currently, over 100 companies are actively providing fill / finish services for prefilled syringes. In order to cope up with the current and future market demand, service providers are actively investing in expanding their existing infrastructure and capabilities; companies are also expanding their client reach through service agreements in the past few years. Given that around 55% of drug candidates in the global R&D pipeline are injectables, the opportunities for prefilled syringe developers / manufacturers and affiliated service providers is anticipated to continue to grow over the next decade.  In addition, owing to the recent COVID-19 pandemic, an increase in the development initiatives for the vaccines is likely to be witnessed in the near future. This is expected to significantly raise the demand for prefilled syringes, providing an additional impetus to the overall prefilled syringe fill finish manufacturing market. Owing to this, the market is likely to witness substantial market growth during the forecast period.

This image highlights the geographical distribution of Prefilled Syringe Fill Finish Service Providers. In order to acquire competencies across the supply chain and cater to the evolving needs of clients, companies offering services across different scales of operation have established presence in various geographies This image highlights the partnership and expansion initiatives undertaken by players engaged in Prefilled Syringe Fill Finish Services Market. Fill / finish service providers are actively investing in expansion projects to upgrade existing capabilities and capacity; several partnerships, mostly focused on offering contract services, have also been forged This image provides information on global installed capacity Prefilled Syringes. As expected, majority of the installed contract fill / finish capacity for prefilled syringes belongs to the large service providers, accounting for around 80% of the available global capacity

Key Companies in Prefilled Syringe Fill Finish Manufacturing Market

Examples of key companies engaged in providing fill finish services for prefilled syringes market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Ajinomoto Bio-Pharma Services, AMRI, BioPharma Solutions, Emergent BioSolutions, Patheon (a Thermo Fisher Scientific Company), Consort Medical, EVER Pharma, GlaxoSmithKline, IDT Biologika, Rentschler Biopharma, Siegfried, Vetter Pharma, Biocon, Intas Pharmaceuticals, Kemwell Biopharma and Square Pharmaceuticals. This market report includes an easily searchable excel database of all the contract service providers for prefilled syringe fill / finish, worldwide.

Recent Developments in Prefilled Syringe Fill Finish Manufacturing Market:

Several recent developments have taken place in the field of prefilled syringe fill finish manufacturing 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 July 2023, KORU Medical Systems announced the 510(K) Submission for Freedom60® Infusion System with Hizentra® 50 mL Prefilled Syringes. 
  • In May 2023, Nexus Pharmaceuticals announced the FDA approval of single-dose prefilled syringes for Emerphed® (ephedrine sulfate injection) used for the treatment of clinically important hypotension occurring in the setting of anesthesia. 
  • In April 2023, the FDA approved a new 50mL/10gm prefilled syringe for Hizentra® (immune globulin subcutaneous [human] 20% liquid).

Scope of the Report

The ‘Prefilled Syringe Fill Finish Manufacturing Market, 2020-2030’ market report features an extensive study of the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the prefilled syringe fill finish manufacturing market. The market research report features an in-depth analysis of the key drivers and trends related to prefilled syringe fill finish manufacturing market.

This image highlights the global demand for Prefilled Syringe Fill Finish Services. The demand for fill / finish services for prefilled syringes is likely to steadily increase in the coming years; we believe stakeholders may have to expand their respective capacities to ensure a consistent supply This image highlights the geographical distribution of Likely Partners for Prefilled Syringe Fill Finish Service Providers. An evaluation of prefilled syringe combination product developers revealed that Europe and North America have emerged as the key regions for partnering opportunities for fill / finish service providers This image provides list of Prefilled Syringe Manufacturers. Around 70 prefilled syringes are being manufactured by large companies, most of  which claim to be capable of fabricating syringe barrels from both glass and plastic materials

Amongst other elements, the market research report includes: 

  • A detailed review of the overall landscape of companies offering contract fill / finish services for prefilled syringes, along with analyses based on a number of relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of the headquarters, location of fill / finish facilities, type of drug molecule (small molecule and biologic), syringe barrel material (glass and plastic), syringe fill volume and additional services offered (drug formulation, regulatory support, labelling and packaging, terminal sterilization, storage and logistics). In addition, the chapter includes details on prefilled syringe fill / finish installed capacity of the service providers.    
  • Tabulated profiles of key players (shortlisted based on a proprietary criterion) across key geographies, such as North America, Europe and Asia-Pacific. Each profile provides an overview of the company, information on its overall service portfolio, fill / finish facilities, financial performance (if available), and details on recent developments as well as an informed future outlook. 
  • An analysis of the recent developments (since 2015) pertaining to contract fill / finish services, based on various parameters, such as year of development, type of activity / development (collaboration and expansions), scale of operation of the project, location of expanded facility, type of drug molecule involved and additional services offered. 
  • An estimate of the global, contract fill / finish capacity of prefilled syringes, by taking into consideration the capacities of various fill / finish service providers (as available on respective company websites), collected via secondary and primary research. The study examines the distribution of number of prefilled syringe units and volume of drug filled, based on the company size of manufacturer (small-sized, mid-sized and large), scale of operation (preclinical / clinical and commercial), location of headquarters and fill / finish facilities (North America, Europe and Asia-Pacific) and type of drug molecule (small molecule and biologics).
  • An informed estimate of the annual demand for fill / finish of prefilled syringes (in number of units), taking into account the marketed drugs available in prefilled syringes and other relevant parameters, such as target patient population, dosing frequency and dose strength. The study provides the distribution of the annual demand, based on the geography (North America (US), Europe (UK, France, Italy, Spain, Germany and rest of Europe), Latin America (Brazil, Mexico, Argentina and rest of Latin America), Asia-Pacific (Japan, China, India, South Korea and rest of Asia-Pacific), and the Middle East and Africa (Saudi Arabia, UAE, Africa and rest of the Middle East)), type of drug molecule (small molecule and biologics), therapeutic area (blood disorders, infectious diseases, metabolic disorders, oncological disorders and others), syringe barrel material (glass and plastic) and number of barrel chambers (single chamber and dual chamber).
  • A detailed demand and supply assessment of geographies, based on a number of parameters, such as the number of prefilled syringe combination product developers, number of prefilled syringe manufacturers, number of prefilled syringe fill / finish service providers, number of prefilled syringe fill / finish facilities, capacity and demand for prefilled syringes in that particular geographical region. 
  • An analysis presenting potential strategic partners (primarily drug developers) for prefilled syringe fill / finish service providers, based on different parameters, such as developer strength, pipeline strength, type of drug molecule, target therapeutic area and location of the headquarters of the company. 
  • A discussion on the potential growth areas, such as growing injectable drugs pipeline, increasing popularity of prefilled syringes, rise in preference for  outsourcing of fill / finish operations, technological advancements in aseptic fill / finish processes, and growing opportunities in the Asia-Pacific region. 
  • A review of the landscape of prefilled syringe manufacturers, featuring a list of key prefilled syringes and their manufacturers, analyzed based on a number of relevant parameters, such as syringe barrel material (glass and plastic), number of barrel chambers (single chamber and dual chamber), type of needle system (fixed needle system, luer lock and luer cone) barrel volume, year of establishment and location of the headquarters of manufacturers.

The key objective of prefilled syringe fill finish manufacturing market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for prefilled syringe fill finish manufacturing market during the forecast period. Based on parameters, such as growth of the overall pharmaceutical and biopharmaceutical market, cost of goods sold, direct manufacturing costs, share of drug product manufacturing costs, and outsourcing trends related to fill / finish operations, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the time forecast period 2020-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] scale of operation (preclinical, clinical and commercial), [B] key geographical regions (North America (the US), Europe (the UK, France, Italy, Spain, Germany and rest of Europe), Asia-Pacific (Japan, China, India, South Korea and rest of Asia-Pacific), Latin America (Brazil, Mexico, Argentina and Rest of Latin America), Middle East and Africa (Saudi Arabia, UAE, Africa and Rest of MEA)), [C] type of drug molecule (small molecule and biologic),  [D] key therapeutic areas (blood disorders, infectious diseases, metabolic disorders, oncological disorders, neurological disorders, autoimmune disorders and others), [E] syringe barrel material (glass and plastic) and [F] number of barrel chambers (single chamber and dual chamber). To account for the uncertainties associated with the fill / finish of prefilled syringes and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following industry stakeholders:

  • Gilles Devillers, President and Cofounder, Bio Elpida
  • Kirti Maheshwari, Chief Technical Officer, Intas Pharmaceuticals
  • Gregor Kawaletz, Chief Commercial Officer, IDT Biologika
  • Michael Dekner, Associate Director, Head of Process Sciences Formulation and Fill / Finish, Takeda
  • Purushottam Singnurkar, Research Director and Head of Formulation Development, Syngene
  • Jesse Fourt, Design Director, IDEO 

All actual figures have been sourced and analysed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is a prefilled syringe?

Answer: A prefilled syringe refers to a disposable syringe which is pre-loaded with the therapeutic medicine to be administered.

Question 2: How big is the prefilled syringe fill finish manufacturing market?

Answer: The prefilled syringe fill finish manufacturing market size is estimated to be worth $931 million in 2020.

Question 3: What is the projected market growth of the prefilled syringe fill finish manufacturing market?

Answer: The prefilled syringe fill finish manufacturing market is expected to grow at compounded annual growth rate (CAGR) of 11.9% during the forecast period 2020 – 2030.

Question 4: Who are the leading companies in the prefilled syringe fill finish manufacturing market?

Answer: Examples of key companies engaged in prefilled syringe fill finish manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Ajinomoto Bio-Pharma Services, AMRI, BioPharma Solutions, Emergent BioSolutions, Patheon (a Thermo Fisher Scientific Company), Consort Medical, EVER Pharma, GlaxoSmithKline, IDT Biologika, Rentschler Biopharma, Siegfried, Vetter Pharma, Biocon, Intas Pharmaceuticals, Kemwell Biopharma and Square Pharmaceuticals.

Question 5: How many companies are currently engaged in the prefilled syringe fill finish manufacturing market?

Answer: Over 100 companies are currently engaged in the prefilled syringe fill finish manufacturing market, having the desired capability to offer fill / finish services for prefilled syringes.

Question 6: What is the opportunity for companies engaged in the prefilled syringe fill finish manufacturing market over the forecast period?

Answer: Given that around 55% of drug candidates in the global R&D pipeline are injectables, the opportunities for players engaged in the prefilled syringe market is anticipated to continue to grow over the forecast period.

Question 7: What is the estimated demand for prefilled syringes by 2030 worldwide?

Answer: By 2030, the global demand for prefilled syringes is anticipated to exceed over 6 billion units.

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