Biologics Fill Finish Services Market by Type of Primary Packaging Container (Ampoules, Cartridges, Syringes and Vials), Type of Biologic Manufactured (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other

Biologics Fill Finish Services Market by Type of Primary Packaging Container (Ampoules, Cartridges, Syringes and Vials), Type of Biologic Manufactured (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Biologics), Scale of Operation (Preclinical / Clinical and Commercial), Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Oncological Disorders and Other Disorders), End-users (Pharmaceutical / Biopharmaceutical Companies and Contract Manufacturing Organizations / Others), Type of Player (Industry and Non-Industry), Company Size (Small, Mid-sized and Large) and Key Geographical Regions (North America (US, Canada and Mexico), Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific) and Rest of the World (Argentina, Brazil, Iran, Israel and Other Countries)): Industry Trends and Global Forecasts, Till 2035

BIOLOGICS FILL FINISH SERVICES MARKET: OVERVIEW

As per Roots Analysis, 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, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Primary Packaging Container

Ampoules

Cartridges

Syringes

Vials

Type of Biologic Manufactured

Antibodies

Cell Therapies

Gene Therapies

Oligonucleotides

Recombinant Proteins

Vaccines

Other Biologics

Scale of Operation

Preclinical / Clinical

Commercial

Therapeutic Area

Autoimmune Disorders

Cardiovascular Disorders

Infectious Diseases

Metabolic Disorders

Oncological Disorders

Other Disorders

End Users

Pharmaceutical / Biopharmaceutical Companies

Contract Manufacturing Organizations / Others

Type of Player

Industry

Non-Industry

Company Size

Small

Mid-sized

Large

Key Geographical Regions

North America (US, Canada and Mexico)

Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe)

Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific)

Rest of the World (Argentina, Brazil, Iran, Israel and Other Countries)

BIOLOGICS FILL FINISH SERVICES MARKET: GROWTH AND TRENDS

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. Further, 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:

1. 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.

2. 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.

3. 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.

4. Over the past few years, the field has witnessed a notable increase in expansion and partnership activity for biologics fill / finish capabilities.

5. 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.

6. 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.

7. 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.

8. 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.

Example Players in the Biologics Fill Finish Manufacturing Market

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

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Former Chief Commercial Officer, IDT Biologika

Vice President of Business Development, Alcami

Vice President, Syngene

Former-Vice President of Business Development and Marketing, Cytovance Biologics

Head of Business Development, oncomed manufacturing

Business Development Manager, Eurofins BioPharma Product Testing Netherlands

Former -Technology Watch Manager, Yposkesi

Former Global Business Development Manager, HALIX

Business Development Specialist, Mabion

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.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading companies in this market?

What kind of partnership models are commonly adopted by industry stakeholders?

What is the current annual demand for biologics?

What factors are likely to influence the evolution of this market?

What is the current and future market size?

What is the CAGR of this market?

How is the current and future market opportunity likely to be distributed across key market segments?

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