Prefilled Syringe Fill / Finish Services Market, 2020-2030

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May 12, 2020, 15:20 ET

NEW YORK, May 12, 2020 /PRNewswire/ -- INTRODUCTION
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.

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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.

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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market over the next decade, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the HPAPI and cytotoxic drugs contract manufacturing market and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to HPAPIs and cytotoxic drugs, featuring information on the classification of APIs based on potency, types of HPAPIs, and challenges in associated with handling HPAPIs. Additionally, it includes a detailed description of specific containment requirements for handling HPAPIs and cytotoxic drugs, and provides details related to the growing need for outsourcing the manufacturing of such products.

Chapter 4 provides an overview of the HPAPI and cytotoxic drugs contract manufacturing landscape. It includes information on over 115 contract manufacturers that claim to offer HPAPI and cytotoxic drug manufacturing services. In addition, it features an in-depth analysis of the market, based on a number of parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, facility size, type of service(s) offered (clinical manufacturing, commercial manufacturing, analytical testing, scale-up, process development / pre-formulation, formulation development, stability studies, regulatory support, fill / finish and packaging), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of pharmacological molecule (biologics and small molecules), type of highly potent finished dosage form manufactured (capsules, granules, injectables, liquids and tablets), and type of primary packaging used (ampoules, blisters, prefilled syringes, conventional syringes, vials and others).

Chapter 5 features an insightful company competitiveness analysis of HPAPI and cytotoxic drugs contract manufacturers based in North America, Europe and Asia Pacific. The analysis presents a comparison of the companies within each geography on the basis of supplier strength (based on company size and its experience in this field) and service strength (based on scale of operation, type of service(s) offered, type of product(s) manufactured, number and location of manufacturing facilities, type of highly potent finished dosage forms manufactured and type of primary packaging used).

Chapter 6 provides detailed profiles of the key players that are active in the HPAPI and cytotoxic drugs contract manufacturing market in North America. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.

Chapter 7 includes detailed profiles of some of the key players that are active in the HPAPI and cytotoxic drugs contract manufacturing market in Europe. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.

Chapter 8 includes detailed profiles of some of the key players that are active in the HPAPI and cytotoxic drugs contract manufacturing market in Europe. Each profile includes a brief overview of the company, its year of establishment, location of headquarters, number of employees and financial information (if available). In addition to this, the profile includes information on the various HPAPIs / cytotoxic dugs manufacturing services offered by the company, along with the location of their manufacturing facilities. Further, we have provided the recent developments of the company and an informed future outlook.

Chapter 9 features an analysis of the various partnerships and collaborations that have been inked amongst players in this domain, in the time period 2014-2019. It provides a brief description on the various types of partnership models (which include acquisitions, manufacturing agreements, technology licensing, R&D agreements, facility acquisitions, product development and commercialization, service alliances, product licensing and others) that have been adopted by stakeholders in this domain. Further, it includes analyses based on year of agreement, scale of operation, company size, amount invested in acquisitions, and most active players. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 10 presents a detailed analysis of the expansions that have taken place in the HPAPI and cytotoxic drugs contract manufacturing industry, since 2014. It includes information on the expansions carried out for increasing existing capabilities, as well as those intended for setting-up a new facility by manufacturers engaged in this domain. The expansion instances that we came across were analyzed based on various parameters, including year of expansion, type of expansion (capacity expansion, facility expansion and new facility), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), and location of manufacturing facility.

Chapter 11 features a detailed analysis of the global / regional capacity of contract manufacturers that are engaged in the manufacturing of HPAPIs and cytotoxic drugs. The analysis takes into consideration the individual manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs) in the market, using data from both secondary and primary research. It also examines the likely distribution of the global HPAPIs and cytotoxic drugs manufacturing capacity available across different types of companies (small-sized, mid-sized, large and very large CMOs), scales of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific, and rest of the world).

Chapter 12 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by highly potent developers while deciding whether to manufacture their respective products in-house or engage the services of a CMOs.

Chapter 13 presents an insightful market forecast analysis, highlighting the likely growth of the HPAPI and cytotoxic drugs contract manufacturing market till the year 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] type of product (HPAPIs and highly potent finished dosage forms), [B] company size (small, mid-sized and large / very large), [C] scale of operation (preclinical, clinical and commercial), [D] type of pharmacological molecule (small molecules and biologics), [E] type of highly potent finished dosage form (injectables, oral solids, creams and others), and [F] key geographical regions, covering North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Spain, Italy and rest of Europe), Asia Pacific (India, China, and rest of Asia-Pacific), and rest of the world.

Chapter 14 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of HPAPI and cytotoxic drugs contract manufacturing market, under a comprehensive SWOT framework.

Chapter 15 presents a case study on the antibody drug conjugates (ADCs) manufacturing market, highlighting a list of contract service providers and in-house manufacturers that are currently active in this space. Additionally, it includes a detailed review of the overall landscape of companies offering contract services for the manufacturing of ADCs, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number and location of manufacturing facilities, and type of service(s) offered.

Chapter 16 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of this market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of HPAPI and cytotoxic drugs contract manufacturers.

Chapter 18 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals), Stacy McDonald and Jennifer L. Mitcham (Group Product Manager and Director-Business Development, Catalent Pharma Solutions), Roberto Margarita (Business Development Director, CordenPharma), Allison Vavala (Senior Manager, Business Development, Helsinn), Javier E. Aznárez Araiz (Business Development, Idifarma), Dr. Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics), and Kevin Rosenthal (Business Head, Formulations and Finished Products, Alphora research).

Chapter 19 is an appendix that contains tabulated data for all the figures provided in the report.

Chapter 20 is an appendix that provides a list of companies and organizations mentioned in the report.

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