Biologics Fill / Finish Services Market, 2019 - 2030

Wednesday, July 24, 2019 General News
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NEW YORK, July 24, 2019 /PRNewswire/ --

INTRODUCTIONBiologics constitute a majority of the top selling drugs and presently represent one of the fastest growing segments of the overall pharmaceutical industry. In fact, since the launch of recombinant protein-based therapies around three decades earlier, the overall biologics market has grown at an annualized

rate of over 12%. It is also worth highlighting that more than 5,000 biopharmaceutical product candidates are currently under development. Despite the fact that biopharmaceuticals offer significant profit margins, the sponsors of such pharmacological interventions are plagued by high costs of development and complex production protocols. As a result, several start-ups / small-sized companies and certain pharma giants have begun outsourcing different aspects of their business operations to contract service providers. According to the 2017 Nice Insight CDMO survey, about 54% of 700 respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development projects. Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are known to offer significant benefits, such as reduction in capital investment, access to larger production capacities, reductions in time-to-market and reduced commercialization risk.Read the full report: https://www.reportlinker.com/p05797102/?utm_source=PRN Specifically, fill / finish is the final step in the production process and is considered among the most crucial stages of drug product manufacturing. Biologics drug products require special procedures and equipment for fill / finish operations in order to ensure product integrity and safety. As this operation is heavily outsourced, the rise in demand for biologics has resulted in an equivalent need for flexible aseptic fill / finish technologies. Pharmaceutical drug manufacturers have not hesitated to collaborate with contract service providers to leverage the latter's experience and expertise in the latest fill / finish technologies. Currently, over 115 companies are actively providing fill / finish services for biologics. In the recent past, many service providers have also forged alliances / acquired other players in order to enhance their service offerings.SCOPE OF THE REPORTThe 'Biologics Fill / Finish Service Providers, 2019-2030' report features an extensive study on the contract service providers offering drug product manufacturing services within the biopharmaceutical industry. The study features in-depth analysis, highlighting the capabilities of a diverse set of companies that claim to specialize in fill / finish operations. Amongst other elements, the report includes:A detailed review of the overall landscape of contract fill / finish services market for biopharmaceuticals, featuring a list of active service providers and detailed analysis based on a number of relevant parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics filled (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), year of establishment, company size and geographical location of the service provider, count and location of affiliated fill / finish facilities, number of additional services offered (lyophilization, labelling, quality testing, storage and distribution services), dosage forms handled (liquid and lyophilized), and types of primary packaging containers handled (ampoules, cartridges, syringes and vials), including details on fill / finish capacity and fill volume range.A region-wise, company competitiveness analysis, highlighting prominent fill / finish service providers across various packaging types, based on supplier strength (considering experience and company size of the service provider), service strength (considering number of fill / finish facilities, number of continents where the aforementioned facilities are located, number of additional services offered and scale of operation) and types of biologics handled. Elaborate profiles of key players across key geographies (North America, Europe and Asia-Pacific), which were shortlisted based on our proprietary company competitiveness analysis. Each profile provides an overview of the company, information on its overall service portfolio, fill / finish facilities, financial performance (if available), and details on partnerships, expansions and recent awards and accolades, as well as an informed future outlook.An analysis of the recent collaborations (signed since 2013) focused on the contract fill / finish services for biologics, based on various parameters, such as year of agreement, type of agreement, scale of operation of the project, focus area, types of services mentioned in the deal, types of biologics involved and location of facility where the project is to be executed.A detailed analysis of the expansions undertaken (since 2013) by various service providers for augmenting their respective fill / finish service portfolios, based on a number of parameters, including year of expansion, type of expansion (capacity expansion and new facility), geographical location of facility, type of packaging container involved, scale of operation (as mentioned in the expansion terms), types of services and biologics involved, expansion details (in terms of new area added to existing facilities, if available) and most active players (in terms of number of instances).An estimate of the global, contract fill / finish capacity, 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 packaging units and volume of biologics filled, across various types of packaging containers (ampoules, cartridges, syringes, and vials), based on the size of the company / organization (small-sized, mid-sized and large) and geography (North America, Europe and Asia Pacific).An informed estimate of the annual demand for fill / finish of biologics, taking into account the top 20 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 the abovementioned products.An analysis to identify the key performance indicators for service providers active in the domain, based on information gathered via secondary research (for top-ten pharmaceutical players) and primary research.A case study to highlight the benefits of using robotic / automated equipment for aseptic fill / finish processes; the study provides 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; the study provides 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 Asia-Pacific region, which are likely to present in the coming years.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 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 period 2019-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] types of primary packaging containers used for fill / finish (ampoules, cartridges, syringes and vials), [B] types of biologics (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), [C] company size (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial), [E] key therapeutic areas (cancer, infectious diseases, autoimmune diseases, cardiovascular diseases and other indications), and [F] 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)). To account for the uncertainties associated with the fill / finish of biopharmaceuticals 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:Ales Sima, Business Development Manager, oncomed manufacturingGregor Kawaletz, Chief Commercial Officer, IDT BiologikaJos Vergeest, International Business Developer, HALIXPurushottam Singnurkar, Research Director and Head of Formulation Development, Syngene InternationalAll 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 METHODOLOGYThe 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 includeAnnual reportsInvestor presentationsSEC filingsIndustry databasesNews releases from company websitesGovernment policy documentsIndustry analysts' viewsWhile 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 OUTLINESChapter 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 biopharmaceutical fill / finish contract services market in the mid to 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 pharmaceutical players, including fill / finish. It includes an overview of the fill / finish operations, along with information on key factors that need to be considered during the selection of fill / finish service providers, as well as the advantages and disadvantages associated by outsourcing fill / finish operations .Chapter 4 provides an overview of the overall biopharmaceutical fill / finish contract services landscape. It includes information related to over 115 contract service providers that are currently active in this domain. It features in-depth analyses of the market, based on a number of relevant parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics filled (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), year of establishment, company size and geographical location of the service providers, location of fill / finish facilities, number of additional services (lyophilization, labelling, quality testing, storage and distribution services), dosage forms handled (liquid and lyophilized), information on various types of primary packaging containers (ampoules, cartridges, syringes and vials), highlighting details on the fill / finish capacity and fill volume range.Chapter 5 features a comprehensive company competitiveness analysis of service providers based in North America, Europe and Asia-Pacific, that we came across during our research. The analysis compares companies within each geography 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, number of continents where aforementioned facilities are based, number of additional services and highest scale of operation) and type of biologics. Chapter 6 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in North America. Each profile presents a brief overview of the company, its overall contract service offerings highlighting the capabilities of drug product facilities (if available), financial information (if available), recent developments comprising of partnerships, expansions and, awards and accolades, and a section on future outlook.Chapter 7 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in Europe. Each profile presents a brief overview of the company, its overall contract service offerings highlighting the capabilities of drug product facilities (if available), financial information (if available), recent developments comprising of partnerships, expansions and, awards and accolades and a section on future outlook.Chapter 8 features detailed profiles of some of the key players that are active in the biopharmaceutical contract manufacturing market in the Asia-Pacific region. Each profile presents a brief overview of the company, its overall contract service offerings highlighting the capabilities of drug product facilities (if available), financial information (if available), recent developments comprising of partnerships, expansions and, awards and accolades and a section on future outlook.Chapter 9 features an elaborate analysis and discussion of the various collaborations and partnerships that have been inked amongst players since 2013. It includes a brief description of the purpose 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 services provided, types of biologics and location of the facilities where the project is to be executed.Chapter 10 presents detailed analyses of the recent fill / finish specific expansions that have taken place since 2013. It comprises of expansions for increasing existing capabilities as well as setting-up of new facilities by the service providers. These have been analyzed 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, type of biologics involved, expansion details (in terms of new area added to the existing facilities) and 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 study examines the distribution of global biopharmaceutical fill / finish capacity of the industry in terms of number of packaging units, type of packaging container (ampoules, cartridges, syringes and vials), size of the player (small-sized, mid-sized and large) and geography (North America, Europe and Asia-Pacific).Chapter 12 features a comprehensive analysis of the annual demand for fill / finish of biologics (in number of units) by type of packaging container, taking into account the top 20 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 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 from primary research.Chapter 14 highlights the potential growth drivers for contract service providers offering fill / finish services in the biopharmaceutical market. It highlights the various 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 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 a detailed 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] types of biologics filled (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, viral products, oligonucleotides and others), [C] company size (small-sized, mid-sized and large / very large), [D] scale of operation (preclinical, clinical and commercial), [E] key therapeutic areas (cancer, infectious diseases, autoimmune diseases, cardiovascular diseases and other indications, and [F] 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).Chapter 16 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, highlighting the role of robotics in various manufacturing operations. It also includes list of companies providing robots for use in pharmaceutical production processes.Chapter 17 is a case study which describes 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 18 is a summary of the entire report. It provides the key takeaways and presents our independent opinion on the biopharmaceutical fill /finish contract services 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 biopharmaceutical fill / finish service providers.Chapter 19 contains the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the biopharmaceutical fill / finish contract manufacturing domain. In this study, we spoke to Ales Sima (Business Development Manager, oncomed manufacturing), Gregor Kawaletz (Chief Commercial Officer, IDT Biologika), Jos Vergeest (International Business Developer, HALIX) and Purushottam Singnurkar (Research Director and Head of Formulation Development, Syngene International).Chapter 20 is an appendix that contains tabulated data and numbers for all the figures provided in the report.Chapter 21 is an appendix that provides the list of companies and organizations mentioned in the report.Read the full report: https://www.reportlinker.com/p05797102/?utm_source=PRN About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001

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