Dublin, Jan. 29, 2025 (GLOBE NEWSWIRE) -- The "Biologics Fill Finish Services Market: Industry Trends and Global Forecasts to 2035" report has been added to ResearchAndMarkets.com's offering.
The global biologics fill finish manufacturing market is estimated to grow from USD 5.3 billion in the current year to USD 11.6 billion by 2035, at a CAGR of 7.4% during the forecast period, until 2035.
Biopharmaceuticals, commonly referred to as biologics, are a class of therapeutic products that are either derived from living organisms or semi-synthesized from biological sources. Unlike traditional small molecules, these macromolecules are complex and are developed to target specific protein receptors in the body. It is worth mentioning that, over the years, these therapies have gained immense popularity owing to their favorable therapeutic outcomes demonstrated across various therapeutic areas, such as oncological disorders, infectious diseases and neurovascular disorders.
Furthermore, the evolution of drug development process has led to technical advancements that have further streamlined the entire process of manufacturing these complex biologics. However, it is worth noting that the biopharmaceutical industry has dealt with several challenges, in terms of inadequate capital investments, sterility issues, and stringent quality standards imposed by different regulatory authorities globally. As a result, outsourcing of manufacturing and fill / finish operations for biologics has emerged as a suitable option to meet the evolving demand of the industry.
Driven by the growing demand for biologics and technological advancements (such as use of automation and robotics) in fill finish operations, the biologics fill finish manufacturing market is anticipated to witness substantial market growth, during the forecast period.
Biologics Fill Finish Services Market: Key Insights
The report delves into the current state of the biologics fill finish services market and identifies potential growth opportunities within the industry.
Some key findings from the report include:
- Presently, 240+ service providers are engaged in offering fill / finish services for various biologic molecules; close to 35% of these companies are headquartered in the US.
- 80% of the service providers operate at all scales of operation to cater to the diverse fill / finish requirements of their clients; notably, vials have emerged as the most adopted primary packaging container format.
- In pursuit of building a competitive edge, stakeholders are actively upgrading their existing capabilities and enhancing their respective service offerings to comply with the evolving industry benchmarks.
- Over the past few years, the field has witnessed a notable increase in expansion and partnership activity for biologics fill / finish capabilities.
- The global, installed biologics fill / finish capacity is spread across various geographies; interestingly, more than 90% of the total capacity is installed at the facilities owned by large and very large players.
- Given the growing pipeline of biologic drug products, the demand for fill-finish services has upsurged; by 2035, it is anticipated to reach over 28.5 million liters, across clinical and commercial scales of operation.
- With the rapid increase in the demand for biologics for the treatment of chronic conditions, the BFF market is poised to grow at a CAGR of 7.4%, till 2035; the market in Asia-Pacific is likely to grow at a faster pace.
- Close to 30% of the market is expected to be captured by revenues generated from fill / finish services of biologics for oncological disorders; vials are expected to capture majority share (over 65%) of the market by 2035.
Biologics Fill Finish Services Market: Key Segments
Currently, Vials Occupy the Largest Share of the Biologics Fill Finish Services Market
Based on the type of primary packaging container, the market is segmented into ampoules, cartridges, syringes and vials. At present, the vials segment holds the maximum share of the biologics fill finish services market and this trend is likely to remain the same in the short-mid term. Vials offer various benefits, such as the ability to pre-sterilize the containers using various terminal sterilization techniques, ease of filling and minimal risk of breakage during handling, and transportation. It is worth highlighting that syringes segment is likely to grow at a relatively higher CAGR during the forecast period.
Antibodies Segment is Likely to Dominate the Biologics Fill Finish Services Market During the Forecast Period
Based on the type of biologic manufactured, the market is segmented into antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics. Given that monoclonal antibodies have high specificity and low toxicity, these molecules are widely adopted for various applications leading to the highest share in the biologics fill finish manufacturing market. This trend is unlikely to change in the near future.
Currently, Commercial Scale Occupies the Largest Share of the Biologics Fill Finish Services Market
Based on the scale of operation, the market is segmented into preclinical / clinical and commercial scale. At present, the commercial scale holds the maximum share of the biologics fill finish services market. This trend is likely to remain the same in the forthcoming years.
Oncological Disorders Segment Accounts for the Largest Share of the Biologics Fill Finish Services Market
Based on the therapeutic area, the market is segmented into autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders. While oncological disorders account for a relatively higher market share, it is worth highlighting that autoimmune disorders segment is expected to witness substantial market growth in the coming years.
Small Companies Offering Biologics Fill Finish Services are the Fastest Growing Segment of the Biologics Fill Finish Services Market During the Forecast Period
Based on the company size, the market is segmented into small companies, mid-sized companies, and large companies. It is worth highlighting that, at present, large companies hold a larger share in the biologics fill finish services market. This trend is likely to remain the same in the coming decade.
Pharmaceutical / Biopharmaceutical Companies are Likely to Dominate the Biologics Fill Finish Services Market During the Forecast Period
Based on the end-users, the market is segmented into pharmaceutical / biopharmaceutical companies and contract manufacturing organizations / others. It is worth highlighting that the majority of the current biologics fill finish services market is captured by pharmaceutical / biopharmaceutical companies. This trend is likely to remain the same in the coming decade.
Industry Players are Likely to Dominate the Biologics Fill Finish Services Market During the Forecast Period
Based on the type of player, the market is segmented into industry players and non-industry players. It is worth highlighting that majority of the current biologics fill finish services market is captured by industry players. This trend is likely to remain the same in the coming decade.
Europe Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the world. Majority share is expected to be captured by drug developers based in Europe. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.
Sample Players in the Biologics Fill Finish Manufacturing Market Profiled in the Report:
- AbbVie Contract Manufacturing
- Asymchem
- Boehringer Ingelheim BioXcellence
- Catalent Biologics
- Charles River
- Evonik
- Fareva
- Fresenius Kabi
- GSK
- Hetero
- Lonza
- Patheon Pharma Services
- Pierre Fabre
- Recipharm
- Sandoz
- Syngene
- WACKER
- WuXi Biologics
Biologics Fill Finish Manufacturing Market: Research Coverage
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the biologics fill finish manufacturing market, focusing on key market segments, including [A] type of primary packaging container, [B] type of biologic manufactured, [C] scale of operation, [D] therapeutic area, [E] end-users, [F] type of player, [G] company size and [H] key geographical regions.
- Market Landscape: A comprehensive evaluation of companies involved in the biologics fill finish manufacturing market, considering various parameters, such as [A] year of establishment, [B] company size (in terms of number of employees), [C] location of headquarters, [D] location of fill finish facilities, [E] scale of operation, [F] type of biologic manufactured, [G] type of dosage form, [H] type of primary packaging container used and [I] additional services offered.
- Company Profiles: In-depth profiles of key industry players offering biologics fill finish services, focusing on [A] company overviews, [B] financial information (if available), [C] fill / finish service portfolio, [D] recent developments and [E] an informed future outlook.
- Company Competitiveness Analysis: A comprehensive competitive analysis of biologics fill finish manufacturing service providers, examining factors such as [A] supplier strength, [B] portfolio strength and [C] service strength.
- Partnerships and Collaborations: An analysis of partnerships established in this sector, based on several parameters, such as [A] year of partnership, [B] type of partnership (including service agreement, service alliance, product integration agreement and joint venture and acquisition), [C] scale of operation, [D] type of service offered, [E] type of process involved, [F] type of biologic involved, [G] location of headquarters or location of facility and [H] most active players (in terms of number of partnerships).
- Recent Expansion Initiatives: An examination of the different expansion efforts made by contract manufacturing organizations to enhance biologics fill finish capabilities. This analysis considers various factors, including the [A] year of expansion, [B] type of expansion, [C] type of primary packaging container used, [D] type of service offered, [E] type of biologic involved, [F] scale of operation, [G] most active players (in terms of number of expansion initiatives) and [H] expansion details.
- Capacity Analysis: Estimation of global biologics fill finish capacity, derived from data provided by various industry stakeholders in the public domain. This analysis emphasizes the distribution of the available capacity on the basis of [A] company size (small, mid-sized, and large and very large firms) and [B] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).
- Demand Analysis: Informed estimates of the annual demand for biologics fill-finish manufacturing based on several relevant parameters, such as [A] target patient population, [B] dosing frequency and [C] dose strength of the aforementioned products.
- Key Performance Indicators: An analysis highlighting the key performance indicators to evaluate service providers engaged in the biologics fill finish domain, based on information gathered via secondary research (for top-ten biopharmaceutical players) and primary research.
- Capability Assessment: A comprehensive regional capability assessment framework that evaluates key geographies by various parameters, including [A] number of biologics fill finish service providers, [B] number of biologics fill finish facilities, [C] scale of operation, [D] installed biologic fill/finish capacity and [E] annual demand in that particular geographical region.
- Case Study 1: 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 industry.
- Case Study 2: 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.
- Market Impact Analysis: The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.
Reasons to Buy this Report
- The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
- Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
- The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
Additional Benefits
- Complimentary PPT Insights Packs
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Key Topics Covered:
1. PREFACE
2. RESEARCH METHODOLOGY
3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
4. EXECUTIVE SUMMARY
5. INTRODUCTION
6. MARKET LANDSCAPE
6.1. Chapter Overview
6.2. Biologics Fill / Finish Service Providers: Overall Market Landscape
6.2.1. Analysis by Year of Establishment
6.2.2. Analysis by Company Size
6.2.3. Analysis by Location of Headquarters
6.2.4. Analysis by Location of Fill / Finish Facilities
6.2.5. Analysis by Scale of Operation
6.2.6. Analysis by Type of Biologic Manufactured
6.2.7. Analysis by Type of Dosage Form
6.2.8. Analysis by Type of Primary Packaging Container Used
6.2.9. Analysis by Additional Services Offered
7. COMPANY PROFILES
7.1. Chapter Overview
7.2. Detailed Company Profiles of Biologics Fill / Finish Service Providers
- AbbVie Contract Manufacturing
- Asymchem
- Boehringer Ingelheim BioXcellence
- Catalent Biologics
- Fresenius Kabi
- Lonza
- Patheon pharma services
- Recipharm
- WACKER
- WuXi Biologics
7.3. Short Company Profiles of Other Prominent Biologics Fill / Finish Service Providers
- Charles River
- Elements Material Technology
- Evonik
- Fareva
- GSK
- Hetero
- Pierre Fabre
- Sandoz
- Syngene
8. COMPANY COMPETITIVENESS ANALYSIS
8.1. Chapter Overview
8.2. Biologics Fill / Finish Service Providers Based in North America
8.3. Biologics Fill / Finish Service Providers Based in Europe
8.4. Biologics Fill / Finish Service Providers Based in Asia-Pacific and Rest of the World
9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Biologics Fill / Finish Service Providers: Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Scale of Operation
9.3.4. Analysis by Type of Service Offered
9.3.5. Analysis by Type of Process Involved
9.3.6. Analysis by Type of Biologic Involved
9.3.7. Most Active Players: Analysis by Number of Partnerships
9.3.8. Analysis by Geography
10. RECENT EXPANSIONS
10.1. Chapter Overview
10.2. Biologics Fill / Finish Service Providers: Recent Expansions
10.2.1. Analysis by Year of Expansion
10.2.2. Analysis by Type of Expansion
10.2.3. Analysis by Type of Packaging Container Used
10.2.4. Analysis by Type of Service Offered
10.2.5. Analysis by Type of Biologic Involved
10.2.6. Analysis by Type of Biologic Involved and Scale of Operation
10.2.7. Most Active Players: Analysis by Number of Expansions
10.2.8. Analysis by Geography
11. CAPACITY ANALYSIS
11.1. Chapter Overview
11.2. Global Installed Biologics Fill / Finish Capacity for Ampoules (Number of Units)
11.3. Global Installed Biologics Fill / Finish Capacity for Cartridges (Number of Units)
11.4. Global Installed Biologics Fill / Finish Capacity for Syringes (Number of Units)
11.5. Global Installed Biologics Fill / Finish Capacity for Vials (Number of Units)
11.6. Concluding Remarks
12. DEMAND ANALYSIS
12.1 Chapter Overview
12.2. Assumptions and Methodology
12.3. Global Annual Demand for Biologics Fill / Finish Manufacturing
13. KEY PERFORMANCE INDICATORS FOR BIOLOGIC MANUFACTURING AND FILL / FINISH
13.1. Chapter Overview
13.2. Biologics Manufacturing and Fill / Finish: Key Performance Indicators
13.2.1. Financial Indicators
13.2.2. Process and Capability Indicators
13.2.3. Market Reputation Indicators
13.2.4. Other Important Performance Indicators
14. REGIONAL CAPABILITY ANALYSIS
15. CASE STUDY: ROBOTICS IN PHARMACEUTICAL PACAKGING
15.1. Chapter Overview
15.2. Role of Robotic Systems in Pharmaceutical Industry
15.3. Biologics Fill / Finish Service Providers: List of Equipment Offered
15.4 Role of Robotic Systems in Fill / Finish Operation
15.5. Companies Providing Robots to be Used in the Pharmaceutical Industry
15.6. Companies Providing Isolator based Aseptic Filling Systems
16. CASE STUDY: READY-TO-USE PACKAGING COMPONENTS FOR ASEPTIC FILL / FINISH
16.1. Chapter Overview
16.2. Role of Ready-to-Use Packaging Components in Aseptic Fill / Finish Operations
16.3. Companies Providing Ready-to-Use Packaging Components 16.4. Concluding Remarks
17. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
18. GLOBAL BIOLOGICS FILL / FINISH MANUFACTURING MARKET
18.1. Chapter Overview
18.2. Key Assumptions and Methodology
18.3. Global Biologics Fill / Finish Manufacturing Market, Historical Trends (since 2018) and Forecasted Estimates (till 2035)
19. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY TYPE OF PRIMARY PACKAGING CONTAINER
19.1. Chapter Overview
19.2. Biologics Fill / Finish Manufacturing Market: Distribution by Type of Primary Packaging Container, 2018, 2024 and 2035
20. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY TYPE OF BIOLOGIC MANUFACTURED
20.1. Chapter Overview
20.2. Key Assumptions and Methodology
20.3. Biologics Fill / Finish Manufacturing Market: Distribution by Type of Biologic Manufactured, 2018, 2024 and 2035
21. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY SCALE OF OPERATION
21.1. Chapter Overview
21.2. Biologics Fill / Finish Manufacturing Market: Distribution by Scale of Operation, 2018, 2024 and 2035
22. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY THERAPEUTIC AREA
22.1. Chapter Overview
22.2. Biologics Fill / Finish Manufacturing Market: Distribution by Therapeutic Area, 2018, 2024 and 2035
23. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY END-USERS
23.1. Chapter Overview
23.2. Key Assumptions and Methodology
23.3. Biologics Fill / Finish Manufacturing Market: Distribution by End-users, 2018, 2024 and 2035
24. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY TYPE OF PLAYER
24.1. Chapter Overview
24.2. Key Assumptions and Methodology
24.3. Biologics Fill / Finish Manufacturing Market: Distribution by Type of Player, 2018, 2024 and 2035
25. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY COMPANY SIZE
25.1. Chapter Overview
25.2. Key Assumptions and Methodology
25.3. Biologics Fill / Finish Manufacturing Market: Distribution by Company Size, 2018, 2024 and 2035
26. BIOLOGICS FILL / FINISH MANUFACTURING MARKET: BY KEY GEOGRAPHICAL REGIONS
27. EXECUTIVE INSIGHTS
- IDT Biologika
- Alcami
- Cytovance Biologics
- Syngene
- oncomed manufacturing
- Eurofins BioPharma Product Testing Netherlands
- Yposkesi
- HALIX
- Mabion
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