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Biologics Fill / Finish Services Market by Type of Primary Packaging Container, Type of Biologic, Scale of Operation, Key Therapeutic Areas, Geographical Regions : Industry Trends and Global Forecasts, 2021-2030

·16-min read

INTRODUCTION Over the last few decades, as a consequence of the therapeutic efficacy and favorable safety profiles of various marketed candidates and those under development, the biopharmaceutical industry has witnessed tremendous growth.

New York, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Biologics Fill / Finish Services Market by Type of Primary Packaging Container, Type of Biologic, Scale of Operation, Key Therapeutic Areas, Geographical Regions : Industry Trends and Global Forecasts, 2021-2030" - https://www.reportlinker.com/p06130491/?utm_source=GNW
The overwhelming success of this upcoming class of products has prompted both established and novice pharmaceutical innovators to develop assets in this arena. Currently, there are close to 400 approved products and more than 4,000 biologic candidates in clinical trials, being developed for the treatment of a wide variety of diseases. , As the number of commercialized products and clinical stage therapy candidates increases, the demand for adequate manufacturing capacities and affiliated capabilities is also on the rise. In the production cycle, the (aseptic) fill / finish process is a crucial step. Biopharmaceutical fill / finish operations are relatively more complicated, involving sterilization of all affiliated components before use, filling in a sterile environment, and the use of appropriate post filling sterilization methods. Even minute errors during the aforementioned step can have catastrophic consequences, resulting in heavy losses for the innovator company. Therefore, it is important for companies to establish fill / finish related expertise and build / maintain the necessary infrastructure.

To meet some the abovementioned challenges, drug developers have not hesitated to outsource fill / finish operations to capable contract service providers. Currently, around 170 companies claim to be actively providing fill / finish services for biologics. As is generally the trend among service providers, stakeholders in this domain are making active attempts to adopt the latest technological innovations, in order to meet the growing demand for fill / finish services, reduce cost of operation / increase efficiency, and comply to evolving safety and regulatory requirements, and thereby, differentiate themselves amidst the competition. Over the last few years, the fill / finish services industry has witnessed more than 120 instances of expansion, most of which were intended to increase capacity. We believe that the companies involved this segment of the industry are likely to continue to undertake similar initiatives to cater to the growing needs of their clientele. In addition, significant partnership activity between sponsors and services providers has also been reported in the recent past; a substantial number of deals were observed to have been inked between vaccine developers and CMOs, focused on the fulfilment of fill / finish requirements for multiple vaccines against COVID-19. Considering the anticipated growth in the biologics market, the corresponding opportunity for fill / finish service providers is expected to grow at a steady pace over the coming years.

SCOPE OF THE REPORT
The “Biologics Fill / Finish Services Market (2nd Edition) by Type of Primary Packaging Container (Ampoules, Cartridges, Syringes and Vials), Type of Biologic (Antibodies, Cell Therapy, Gene Therapy, Oligonucleotides, Recombinant Proteins, Vaccines and Others), Scale of Operation (Preclinical / Clinical and Commercial), Key Therapeutic Areas, Geographical Regions (North America, Europe, Asia Pacific, MENA and Latin America and Rest of the World): Industry Trends and Global Forecasts, 2021-2030” report features an extensive study on the biologics fill / finish service providers. The study features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. Amongst other elements, the report includes:
• A detailed review of the overall landscape of the companies offering fill / finish services for biopharmaceuticals / biologics, along with analyses based on a number of relevant parameters, such as year of establishment, company size, location of headquarters, location of fill / finish facilities, types of packaging form (ampoules, cartridges, syringes and vials), type of biologic filled (ADC, antibodies, biosimilars, cell therapies, gene therapies, oligonucleotides, peptides / proteins, vaccines, viral products, and others), scale of operation (preclinical, clinical and commercial), type of additional services offered (lyophilization, labelling, quality testing, storage and distribution services) and including details on fill / finish capacity and fill volume range.
• A detailed competitiveness analysis of the fill / finish service providers based in different geographies offering services across various packaging types, based on supplier strength (in terms of experience and company size), service strength (in terms of number of fill / finish facilities, geographical reach and scale of operation) and types of biologics handled.
• Elaborate profiles of key players based in North America, Europe and Asia-Pacific. Each profile provides an overview of the company, information on its service offerings, fill / finish facilities, financial information (if available), details on partnerships, expansions and recent awards and accolades, and an informed future outlook.
• An analysis of the partnerships and collaborations focused on the fill / finish operations of biologic drug products, which were established since 2013, based on year of agreement, type of agreement, scale of operation, types of services mentioned in the deal, types of biologics involved and location of fill / finish facilities involved.
• A review of the recent expansions (since 2015) undertaken by biologics fill / finish service providers, including a detailed analysis based on various parameters, such as year of expansion, type of expansion (capacity expansion and new facility), type of packaging form, types of services offered, types of biologics involved, scale of operation (preclinical, clinical and commercial), the most active players and geographical location of the added facility.
• An estimate of the global fill / finish capacity for filling of biologics, by taking into consideration the capacities of various fill / finish service providers. The fill / finish capacity has been analyzed in terms of number of units and volume of biologics filled, across various type of packaging containers (ampoules, cartridges, syringes, and vials), for the service providers distributed on the basis of company size (small, mid-sized and large) and geographical location (North America, Europe and Asia Pacific).
• An informed estimate of the annual demand for fill / finish of the top 25 biologics, based on various relevant parameters, such as target patient population, dosing frequency, dose strength, type of packaging container and volume of the packaging container of these products.
• A regional capability assessment framework, which compares the fill / finish capabiility across key geographies, based on a number of parameters, such as the number of biologic fill / finish service providers, number of biologic fill / finish facilities, number of biologic fill / finish partnerships inked in that particular geographical region, number of facility expansions and installed biologic fill / finish capacity in that particular geographical region.
• An analysis to identify the key performance indicators for service providers engaged in this domain, based on information gathered via secondary research and primary research.
• A case study to highlight the benefits of using robotic / automated equipment for aseptic fill / finish processes, providing a list of equipment manufacturers providing robots suitable for pharmaceutical operations.
• A case study to highlight the role of ready-to-use packaging containers in aseptic fill / finish operations, providing a list of suppliers providing the ready-to-use components.
• A discussion on the potential growth areas, such as growing biopharmaceutical pipeline, increasing outsourcing of fill / finish operations, rising focus on self-administration enabling drug delivery devices and growing opportunities in the Asia-Pacific region.
One of the key objectives of this report was to estimate the current market size and the future opportunity in the biologics fill / finish services market, over the coming decade. Based on parameters, such as growth of the overall 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 short to mid-term and long term, for the period 2021-2030. In order to provide a detailed future outlook, year-wise projections of the current and future opportunity have been further segmented on the basis of [A] types of packaging containers used for fill / finish (ampoules, cartridges, syringes and vials), [B] scale of operation (preclinical, clinical and commercial), [C] types of biologics (antibodies, cell therapy, gene therapy, oligonucleotides, recombinant proteins, vaccines and others), [D] key therapeutic areas (autoimmune disorders, cardiovascular disorders, infectious disorders, oncological disorders and other disorders), and [E] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy, Spain and rest of the Europe), Asia-Pacific (Japan, China, South Korea, India and Australia), MENA, Latin America and Rest of the World). To account for the uncertainties in the market 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 this report are backed by a deep understanding of key insights generated from both secondary and primary research. The perceptions presented in this study were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry and non-industry players:
• Gregor Kawaletz (Chief Commercial Officer, IDT Biologika)
• Matt Delaney (Vice President Business Development & Marketing, ?Cytovance Biologics)
• Purushottam Singnurkar (Research Director and Head of Formulation Development, Syngene International)
• Ales Sima (Business Development Manager, Oncomed Manufacturing)
• Amit Chandra (Technology Watch Manager, Yposkesi)
• Jos Vergeest (International Business Developer, HALIX)
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED
• Who are the leading contract service providers with expertise in fill / finish services for biologics?
• In which regions are majority of the biologic fill / finish facilities located?
• What percentage of ampoules, cartridges, vials and syringes are filled annually with biologics?
• Which partnership models are most commonly adopted by stakeholders in this industry?
• What type of expansion initiatives are being carried out by players in this domain?
• What is the current, global demand for biologic fill / finish services?
• How is the current and future market opportunity likely to be distributed across key market segments?

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 beneficial for us to draw opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been validated 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 laid on forecasting the market over the time period 2021-2030, the report also provides our independent views on various technological and non-commercial trends emerging in the industry. The opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the likely evolution of the biologics fill / finish service providers market in the short to mid-term, and long term.

Chapter 3 provides a general introduction to biopharmaceuticals and contract manufacturing. The chapter features a detailed discussion on the need for outsourcing within the biopharmaceutical industry and highlights the key operations outsourced by the biologic drug developers, including fill / finish. Additionally, the chapter highlights the key considerations for selecting a fill / finish service provider, along with the benefits and risks associated with outsourcing fill / finish operations.

Chapter 4 provides an overview of the overall biologics fill / finish contract services landscape. It includes information on close to 170 contract service providers currently engaged in this domain. Additionally, it features an in-depth analysis of service providers, based on a number of relevant parameters, such as year of establishment, company size, location of headquarters, location of fill / finish facilities, types of packaging form (ampoules, cartridges, syringes and vials), type of biologic filled (ADC, antibodies, biosimilars, cell therapies, gene therapies, oligonucleotides, peptides / proteins, vaccines, viral products, and others), scale of operation (preclinical, clinical and commercial), type of additional services offered (lyophilization, labelling, quality testing, storage and distribution services) and including details on fill / finish capacity and fill volume range.

Chapter 5 features a detailed competitiveness analysis of the service providers based in North America, Europe and Asia-Pacific. The companies within each geography have been compared on the basis of the type of packaging used for fill / finish services, supplier strength (considering experience and company size of service provider), service strength (considering number of fill / finish facilities, geographical reach, number of additional services offered and highest scale of operation) and type of biologics involved.

Chapter 6 includes detailed profiles of the key players in the biopharmaceutical fill / finish contract services market in North America. Each profile features a brief overview of the company, its overall contract service offerings highlighting the capabilities of fill / finish facilities (if available), financial information (if available), recent developments and an informed future outlook.

Chapter 7 includes detailed profiles of the key players in the biopharmaceutical fill / finish contract services market in Europe. Each profile features a brief overview of the company, its overall contract service offerings highlighting the capabilities of fill / finish facilities (if available), financial information (if available), recent developments and an informed future outlook.

Chapter 8 includes detailed profiles of the key players in the biopharmaceutical fill / finish contract services market in Asia-Pacific. Each profile features a brief overview of the company, its overall contract service offerings highlighting the capabilities of fill / finish facilities (if available), financial information (if available), recent developments and an informed future outlook.

Chapter 9 features a detailed analysis of the various collaborations and partnerships that have been inked amongst players since 2013. It includes a brief description of the partnership models (including acquisition, supply agreement, service alliance, merger and joint venture) adopted by stakeholders in this domain. Further, it comprises of analysis based on year of agreement, the scale of operation of the project, focus area, types of services provided, types of biologics and location of the facilities where the project is to be executed.

Chapter 10 presents a detailed analysis of the expansions undertaken by various service providers to enhance fill / finish capabilities, based on various parameters, including year of expansion, type of expansion, geographical location of the facility, type of packaging container involved, scale of operation (as mentioned in the expansion terms), types of services offered, types of biologics filled, and expansion details (in terms of new area added to the existing facilities). It also highlights the most active players (in terms of number of instances) in the domain.

Chapter 11 features a comprehensive analysis of the global fill / finish capacity, by taking into consideration the container processing capacities of various fill / finish service providers (as available on respective company websites). The global biopharmaceutical fill / finish capacity has been distributed across number of packaging units, type of packaging container (ampoules, cartridges, syringes and vials), company size of the manufacturer (small, mid-sized and large) and geographical location (North America, Europe and Asia-Pacific).

Chapter 12 provides an estimate of the annual demand for fill / finish of top 25 biologics (in number of units of packaging containers), based on various relevant parameters, such as target patient population, dosing frequency, dose strength, type of packaging container and volume of the packaging container of the abovementioned products.

Chapter 13 features an analysis on the key performance indicators of service providers based on information available for top-ten biopharmaceutical players on various public platforms, as well as inputs obtained from primary research.

Chapter 14 presents a regional capability assessment framework, which compares the fill / finish capability across key geographies, based on a number of parameters, such as the number of biologics fill / finish service providers, number of biologics fill / finish facilities, number of biologics fill / finish partnerships inked in that particular geographical region, number of facility expansions and installed biologics fill / finish capacity in that particular geographical region.

Chapter 15 presents a comprehensive market forecast analysis, highlighting the likely growth of the biologics’ fill / finish services market till the year 2030. In order to provide an informed future outlook, our projections have been segmented on the basis of [A] types of primary packaging containers used for fill / finish (ampoules, cartridges, syringes and vials), [B] scale of operation (preclinical, clinical and commercial), [C] types of biologics filled (antibodies, cell therapy, gene therapy, oligonucleotides, recombinant proteins, vaccines and others), [D] key therapeutic areas (cancer, infectious diseases, autoimmune diseases, cardiovascular diseases and other indications, and [E] key geographical regions (North America (US, Canada), Europe (UK, France, Germany, Italy, Spain and rest of the Europe), Asia (Japan, China, South Korea and India), MENA and Latin America and Rest of the World).

Chapter 16 includes a discussion on the various potential growth drivers for the biologics fill / finish services market, which takes into account the opportunities associated with the growing biopharmaceutical pipeline, increase in outsourcing of fill / finish operations, rising focus on self-administration of drugs / therapies and opportunities in the Asia-Pacific region.

Chapter 17 is a case study focused on use of robotic systems in fill / finish operations. It provides a list of equipment used by the service providers (wherever specified) for fill / finish operations, highlighting the purpose of robotics in various manufacturing operations. It also includes a list of companies providing robots for use in manufacturing processes carried in the pharmaceutical sector.

Chapter 18 is a case study on the use of ready-to-use packaging components in the aseptic fill / finish operations. It also provides a list of suppliers providing ready-to-use components.

Chapter 19 is a summary of the overall report wherein we have mentioned all the key facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the biologics fill / finish services market.

Chapter 20 contains the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the biopharmaceutical contract manufacturing and fill / finish domain. In this study, we spoke to Gregor Kawaletz (Chief Commercial Officer, IDT Biologika), Matt Delaney (Vice President Business Development & Marketing, ?Cytovance Biologics), Purushottam Singnurkar (Research Director and Head of Formulation Development, Syngene International), Ales Sima (Business Development Manager, oncomed manufacturing), Amit Chandra (Technology Watch Manager, Yposkesi) and Jos Vergeest (International Business Developer, HALIX).

Chapter 21 is an appendix, that contains tabulated data and numbers for all the figures provided in the report.

Chapter 22 is an appendix that provides the list of companies and organizations that have been mentioned in the report.
Read the full report: https://www.reportlinker.com/p06130491/?utm_source=GNW

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