Prefilled Syringe Fill / Finish Services Market, 2020-2030

Overview

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.

The filling of sterile drugs into prefilled syringes (and other primary drug containers) is considered to be one of the most crucial steps in the pharmaceutical production process. Proper fill/finish operations, 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 filling 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 of 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 fill/finish services market.

Scope of the Report

The ‘Prefilled Syringe fill/finish Service Providers, 2020-2030’ report features an extensive study of the current market landscape and future opportunities for contract service providers offering fill finish services for prefilled syringes. The study features an in-depth analysis of the key drivers and trends related to this evolving domain.

Amongst other elements, the 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, quality control, 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, additional services offered and most active players (based on the number of instances of collaborations/expansions).
• 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 of 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 pipeline strength, number of target therapeutic indication(s), type of drug molecule, year of establishment, company size and location of the headquarters of the company.
• A discussion on the potential growth areas, such as growing injectable drugs pipeline, increasing fill/finish outsourcing operations, rising preference of self-medication, increasing popularity of prefilled syringes and technological advancements in aseptic fill/finish processes.
• 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, company size and location of the headquarters of manufacturers.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. 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 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) and Asia-Pacific (Japan, China, India, South Korea and rest of Asia-Pacific), [C] type of drug molecule (small molecules and biologics), [D] key therapeutic areas (blood disorders, infectious diseases, metabolic disorders, oncology 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 report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

• Kirti Maheshwari, Chief Technical Officer, Intas Pharmaceuticals
• Gregor Kawaletz, Chief Commercial Officer, IDT Biologika
• Jesse Fourt, Design Director, IDEO
• Purushottam Singnurkar, Research Director and Head of Formulation Development, Syngene
• Anonymous, Associate Director, Head of Process Sciences Formulation and fill/finish, a large CMO

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