Biologics Fill / Finish Services Market (3rd Edition), 2022-2035

Biologics Fill / Finish Services Market (3rd Edition), 2022-2035

The advent of biologics marked the beginning of a new era in the pharmaceutical industry. Over time, the growing promise of biopharmaceuticals has captured the interest of various industry and academic stakeholders. Currently, more than 200 biologics are commercially available and over 10,000 candidates are under clinical evaluation. With the increasing demand and diversity of biologics, an increase in the demand for production capacity and aseptic fill / finish operations has been observed. Fill / finish refers to the process of filling the final drug products in sterile packaging containers (including vials, syringes, ampoules and cartridges). Of all the steps involved in the production of biologics, fill / finish is amongst the most critical steps and a heavily outsourced operation. In fact, even a minute error during the fill / finish process can lead to microbial contamination, which can subsequently result in the loss of drug product, production delays and, most importantly, pose risk to the patient’s health. As a result, various stakeholders are turning to contract service providers for their fill / finish related requirements and necessary infrastructure, to ensure the development of quality drug products.

With the growing pipeline of biologics, the demand for contract services for development and fill / finish has increased. Currently, close to 180 companies offer fill / finish services for a wide range of biologics. These stakeholders have taken several initiatives to expand their existing facilities and incorporate advanced technologies 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. Additionally, the biopharmaceutical industry has witnessed substantial number of partnerships and collaborations between drug developers and fill / finish service providers over the last few years. We believe that service providers are likely to continue undertaking similar initiatives to consolidate their presence in this field, distinguish themselves from the competition and cater to the diversified needs of their clientele. With outsourcing being increasingly accepted as a viable / beneficial business model and the anticipated growth in the biologics market, the opportunity for fill / finish service providers is expected to grow at a steady pace over the coming years.

The “Biologics Fill / Finish Services Market (3rd Edition) by Type of Packaging Containers (Ampoules, Cartridges, Syringes and Vials), Type of Biologics (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Biologics), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Large, Mid-sized and Small), Key Therapeutic Areas (Autoimmune Disorders, Oncological Disorders, Cardiovascular Disorders, Infectious Diseases and Other Disorders), Geographical Regions (North America, Europe, Asia Pacific, Middle East and North Africa and Latin America): Industry Trends and Global Forecasts, 2022-2035” 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 summary of the key insights captured in our research, offering 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.

A general introduction to biopharmaceuticals and contract manufacturing, featuring a detailed discussion on the need for outsourcing within the biopharmaceutical industry and key operations outsourced by the biologics drug developers, including fill / finish. It also provides information on the key considerations for selecting a fill / finish service provider, along with the benefits and risks associated with outsourcing fill / finish operations.

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, type of packaging container(s) used (ampoules, cartridges, syringes and vials), type of biologic(s) manufactured (antibody drug conjugates, antibodies, biosimilars, cell therapies, gene therapies, oligonucleotides, peptides / proteins, vaccines, viral products, and others), scale of operation (preclinical, clinical and commercial), type of additional drug product-related service(s) offered (lyophilization, labeling, quality testing, storage and distribution services) and including details relared to companies.

A detailed competitiveness analysis of the biologics fill / finish service providers headquartered in different geographies (North America, Europe, Asia-Pacific ad Rest of the World) and offering services across various packaging container(s), based on supplier strength (in terms of years of experience and company size), service strength (considering type of biologic(s) manufactured, scale of operation and type of packaging container(s) used) and service diversity (including number of additional drug product-related service(s) offered and number of facilities).

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, recent awards and accolades, and an informed future outlook.

A detailed analysis of the various partnerships and collaborations established by stakeholders in this domain since 2013. It includes a brief description of the partnership models (including service agreement, service alliance, product integration agreement and joint venture and acquisition) adopted by stakeholders in this domain. Further, it comprises of analysis based on year of partnership, scale of operation, type of service(s) offered, type of biologic(s) involved, type of process(es) involved and location of the facilities / headquarters. It also highlights the most active players (in terms of number of partnerships) in the domain.

A detailed analysis of the expansions undertaken by various service providers to enhance biologics fill / finish capabilities, based on various parameters, including year of expansion, type of expansion, geographical location of the facility, type of packaging container(s) involved, scale of operation (as mentioned in the expansion terms), type of service(s) offered, type of biologic(s) involved, 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.

A comprehensive analysis of the global biologics 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), scale of operation (preclinical / clinical and commercial) and location of headquarters (North America, Europe, Asia-Pacific and Middle East and North Africa) and location of fill / finish facility (North America, Europe, Asia-Pacific and Middle East and North Africa and Rest of the World).

An estimate of the annual demand for fill / finish for biologics (in terms of number of units of packaging container), 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 on the key performance indicators of service providers based on the information available for top ten biopharmaceutical players on various public platforms, as well as inputs obtained from primary research.

A regional capability assessment framework, which compares the biologics 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 biologic fill / finish capacity in that particular geographical region.

A discussion on the potential growth drivers for the biologics fill / finish services market, takes into consideration 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.

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

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.

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 13 years. Based on multiple parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, direct manufacturing costs, share of other 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 2022-2035. 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 type of packaging containers (ampoules, cartridges, syringes and vials), type of biologics (antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics), key therapeutic areas (autoimmune disorders, oncological disorders, cardiovascular disorders, infectious diseases and other disorders), scale of operation (preclinical / clinical and commercial), company size (large, mid-sized and small), and key geographical regions, (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America). 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.

MARKET SEGMENTATION

Biologics Fill / Finish Services Market (3rd Edition), 2022-2035: Market Segmentations

Market Segments Details

Forecast Period 2022 – 2035

Type of Packaging Containers

Vials

Syringes

Ampoules

Cartridges

Type of Biologics

Vaccine

Recombinant Proteins

Antibodies

Oligonucleotides

Gene Therapies

Cell Therapies

Other Biologics

Therapeutic Area

Autoimmune Disorders

Oncological Disorders

Cardiovascular Disorders

Infectious Disorders

Other Disorders

Scale of Operation

Preclinical / Clinical

Commercial

Company Size

Large

Mid-sized

Small

Geographical Regions

North America

Europe

Asia-Pacific

Middle East and North Africa

Latin America

Source: Roots Analysis

KEY QUESTIONS ANSWERED

Who are the key players offering biologics fill / finish services?

In which regions are the majority of the biologics 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 types of expansion initiatives are being undertaken by players in this domain?

What is the current, global demand for biologics 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 2022-2035, 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 180 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, type of packaging container(s) (ampoules, cartridges, syringes and vials), type of biologic(s) manufactured (antibody drug conjugates, antibodies, biosimilars, cell therapies, gene therapies, oligonucleotides, peptides / proteins, vaccines, viral products, and other biologics), scale of operation (preclinical, clinical and commercial), type of additional drug product-related service(s) offered (lyophilization, labeling, 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 based on the type of packaging used for fill / finish services, supplier strength (considering experience and company size of service provider), service strength (considering type of biologic(s) manufactured, scale of operation and type of packaging container(s) used) and service diversity (including, number of additional drug product-related service(s) offered and number of facilities).

Chapter 6 includes detailed and tabulated 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 and tabulated 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 and tabulated 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 partnerships and collaborations that have been inked amongst players since 2013. It includes a brief description of the partnership models (including service agreement, service alliance, product integration agreement and joint venture and acquisition) adopted by stakeholders in this domain. Further, it comprises of analysis based on year of partnerships, the scale of operation, type of service(s) offered, type of biologic(s) involved, type of process(es) involved and location of the facilities / headquarters. It also highlights the most active players (in terms of number of partnerships) in the domain.

Chapter 10 presents a detailed analysis of the expansions undertaken by various service providers to enhance biologics fill / finish capabilities, based on various parameters, including year of expansion, type of expansion, geographical location of the facility, type of packaging container(s) involved, scale of operation (as mentioned in the expansion terms), type of service(s) offered, type of biologic(s) involved, 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 biologics 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), scale of operation (preclinical / clinical and commercial) and location of headquarters (North America, Europe, Asia-Pacific and Middle East and North Africa) and location of fill / finish facilities (North America, Europe, Asia-Pacific and Middle East and North Africa and Rest of the World).

Chapter 12 provides an estimate of the annual demand for fill / finish for biologics (in number of units of packaging container), 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 biologics fill / finish capability across key geographies (North America, Europe, Asia-Pacific ad Rest of the World), 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 2035. In order to provide an informed future outlook, our projections have been segmented on the basis of type of packaging containers used for fill / finish (ampoules, cartridges, syringes and vials), type of biologics (antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics), key therapeutic areas (autoimmune disorders, oncological disorders, cardiovascular disorders, infectious diseases and other disorders), scale of operation (preclinical, clinical and commercial), company size (large, mid-sized and small), and key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa and Latin America).

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.