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 Insights
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
Reasons to Buy this Report
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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. Methodology and Key Parameters
8.3. Biologics Fill / Finish Service Providers Based in North America
8.4. Biologics Fill / Finish Service Providers Based in Europe
8.5. 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
10. RECENT EXPANSIONS
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
13.3.5. Conclusion
14. REGIONAL CAPABILITY ANALYSIS
15. CASE STUDY: ROBOTICS IN PHARMACEUTICAL PACKAGING
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
15.7. Concluding Remarks
16. CASE STUDY: READY-TO-USE PACKAGING COMPONENTS FOR ASEPTIC FILL / FINISH
17. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
18. GLOBAL BIOLOGICS FILL / FINISH MANUFACTURING MARKET
19. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY TYPE OF PRIMARY PACKAGING CONTAINER
20. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY TYPE OF BIOLOGIC MANUFACTURED
21. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY SCALE OF OPERATION
22. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY THERAPEUTIC AREA
23. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY END-USERS
24. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY TYPE OF PLAYER
25. BIOLOGICS FILL / FINISH MANUFACTURING MARKET, BY COMPANY SIZE
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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