Fill-Finish 제조 시장 규모, 점유율, 예측 및 동향 분석 : 제공(포장 유형, 장비, 서비스), 제제(경구용, 비경구용), 용도(생물학적 제제, 저분자)별, 최종 사용자별 - 세계 예측(-2031년)

Fill-finish Manufacturing Market Size, Share, Forecast, & Trends Analysis by Offering (Packaging Type {Vial, Syringe, Cartridge} Equipment, Service) Formulation (Oral, Parenteral) Application (Biologics, Small Molecule) End User-Global Forecast to 2031

The Fill-finish Manufacturing Market is Projected to Reach $19.14 Billion by 2031, at a CAGR of 9.9% from 2024 to 2031.

Succeeding extensive secondary and primary research and in-depth analysis of the fill-finish manufacturing market scenario, the report comprises the analysis of key industry drivers, restraints, challenges, and opportunities. The growth of the fill-finish manufacturing market is driven by the growth of the biopharmaceutical industry, initiatives by pharmaceutical & biopharmaceutical companies to expand their production capacities, advancements in fill-finish manufacturing processes, and the increasing demand for pre-filled syringes. However, high operational costs and challenges in maintaining drug potency throughout the manufacturing process may restrain the market's growth.

Moreover, initiatives aimed at increasing vaccination rates, increasing focus on biosimilar development, and rising investments in the development of new biologics are expected to create market growth opportunities. However, stringent regulatory requirements governing fill-finish manufacturing and the complexities associated with accurately filling specific medication doses are some of the challenges impeding the market's growth.

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry over four years (2020-2024). The key players operating in the fill-finish manufacturing market are Syntegon Technology GmbH (Germany), Becton, Dickinson and Company (U.S.), Industria Macchine Automatiche S.p.A. (Italy), West Pharmaceutical Services, Inc. (U.S.), Catalent, Inc. (U.S.), AbbVie Inc. (U.S.), Gerresheimer AG (Germany), AptarGroup, Inc. (U.S.), OPTIMA packaging group GmbH (Germany), Baxter International Inc. (U.S.), C.H. Boehringer Sohn AG & Co. KG (Germany), Schott Pharma AG & Co. KGaA (Germany), SGD Pharma (France), and Stevanato Group (Italy).

Among the offerings covered in this report, in 2024, the packaging type segment is expected to account for the largest share of the fill-finish manufacturing market. The packaging type segment is further sub-segmented into vials, syringes, cartridges, ampoules, and accessories. The large market share of this segment is attributed to the increasing approval for biologics, increasing demand for parenteral formulations, recurring demand for fill-finish packaging, and advancements in fill-finish technology. Additionally, there is an increasing demand for fill-finish services is increasing for vials, cartridges, and other packaging types to reduce product wastage and maintain sterility while filling the drug.

Among the formulations covered in this report, in 2024, the parenteral segment is expected to account for the largest share of the fill-finish manufacturing market. Vials, syringes, cartridges, and ampoules are commonly used for the packaging of parenteral drug formulations. The increasing demand for injectables, technological advancements in materials, and designs of pre-fillable syringes and vials are contributing to the large market share of this segment. Additionally, the increasing number of approvals for injectables is further contributing to the segment growth. For instance, in September 2023, Pfizer Inc. (U.S.) and BioNTech SE (Germany) obtained supplemental Biologics License Application approval from the U.S. FDA for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

Among the sterilization processes covered in this report, in 2024, the aseptic processing segment is expected to account for the largest share of the fill-finish manufacturing market. The demand for aseptic processing is driven by the need to sterilize heat-sensitive drugs such as biologics, vaccines, and other parenteral medications. Moreover, there is a growing demand for aseptic processing for handling heat-sensitive drugs such as antibiotics, nasal sprays, ear drops, oral drops, and diabetes medications.

Among the applications covered in this report, the biologics segment is projected to register a higher CAGR during the forecast period. The segment's rapid growth can be attributed to the rising demand for biologics, expansion of biologics manufacturing facilities, rising approvals for biologic products, and product launches by key market players. For instance, in June 2023, UCB (Belgium), a biopharmaceutical company, received U.S. FDA approval for RYSTIGGO (rozanolixizumab-noli) under Priority Review designation for the treatment of generalized myasthenia gravis (gMG) in adult patients.

Among the end users covered in this report, in 2024, the CROs & CDMOs segment is expected to account for the largest share of the fill-finish manufacturing market. The surge in clinical trials and rapid growth in the healthcare and life sciences sectors are accelerating the outsourcing trend to ensure efficient and cost-effective drug filling. Additionally, strategic partnerships between pharmaceutical companies and CROs & CDMOs and stringent regulatory requirements governing fill-finish processes are contributing to the largest share of the segment.

An in-depth analysis of the geographical scenario of the global fill-finish manufacturing market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. Asia-Pacific is projected to register the highest CAGR of over 11.3% during the forecast period. The growth of this regional market is driven by the growth of the pharmaceutical market, increasing investments in R&D by pharmaceutical & biopharmaceutical companies, and favorable regulatory policies. Additionally, China has become an attractive destination for international pharmaceutical companies seeking to streamline product timelines and minimize production costs.

Scope of the Report:

Fill-finish Manufacturing Market Assessment-by Offering

• Packaging Type
  • Packaging Type, by Product
• Vials
• Liquid Vials
• Lyophilized Vials
• Powder Filled Vials
• Syringes
• Cartridges
• Ampoules
• Accessories
  • Packaging Type, by Material
• Polymer
• Glass
• Other Materials
• Packaging Instruments
  • Packaging Instruments, by System Type
• Integrated Systems
• Standalone Systems
  • Packaging Instruments, by Machine Type
• Automated Machines
• Semi-automated Machines
  • Packaging Instruments, by Type
• Processing Instruments
• Packaging Instruments
• Bottle Filling & Capping Equipment
• Blow-Fill-Seal (BFS) Equipment
• Aseptic Filling Equipment
• Pharmaceutical Spray Filling Equipment
• Other Packaging Instruments
• Packaging Services
  • Vials & Ampoules Filling
  • Injection Filling
  • Cartridge Filling
  • Other Packaging Services

Note: Other Materials include rubber, metal, and paper.

Other Packaging Instruments include powder sachet filling & packaging equipment, nested filling systems, tube filling equipment, and cream filling equipment.

Other Packaging Services include capsule filling, tube filling, sachet filling, and powder filling.

Fill-finish Manufacturing Market Assessment-by Formulation

• Oral
• Parenteral
• Topical
• Other Formulations

Note: Other Formulations include nasal, ocular, intradermal, and transcutaneous (TC) formulations

Fill-finish Manufacturing Market Assessment-by Sterilization Process

• Aseptic Processing
• Terminal Sterilization

Fill-finish Manufacturing Market Assessment-by Application

• Biologics
  • Biologics, by Type
• Monoclonal Antibodies
• Recombinant Hormones/Proteins
• Vaccines
• Cellular Based Biologics
• Gene-Based Biologics
  • Biologics, by Development Phase
• Clinical/preclinical
• Commercial
• Small Molecules
  • Clinical/preclinical
  • Commercial

Fill-finish Manufacturing Market Assessment-by End User

• Pharmaceutical & Biopharmaceutical Companies
• CROs & CDMOs
• Compounding Pharmacies

Fill-finish Manufacturing Market Assessment-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K
  • Italy
  • Spain
  • Switzerland
  • Ireland
  • Belgium
  • Denmark
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• 1.1. Market Definition & Scope
• 1.2. Market Ecosystem
• 1.3. Currency & Limitations
• 1.4. Key Stakeholders

2. Research Methodology

• 2.1. Research Approach
• 2.2. Process of Data Collection & Validation
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
• 2.3. Market Sizing and Forecasting
  • 2.3.1. Market Size Estimation Approach
  • 2.3.2. Growth Forecast Approach
  • 2.3.3. Market Share Analysis
• 2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

• 4.1. Overview
• 4.2. Drivers
  • 4.2.1. Growth of the Biopharmaceutical Industry
  • 4.2.2. Initiatives by Pharmaceutical & Biopharmaceutical Companies to Expand Their Production Capacities
  • 4.2.3. Advancements in Fill-finish Manufacturing Processes
  • 4.2.4. Increasing Demand for Pre-filled Syringes
• 4.3. Restraints
  • 4.3.1. High Operational Costs
  • 4.3.2. Challenges in Maintaining Drug Potency Throughout the Manufacturing Process
• 4.4. Opportunities
  • 4.4.1. Initiatives Aimed at Increasing Vaccination Rates
  • 4.4.2 Rising Investments in the Development of New Biologics
  • 4.4.3. Increasing Focus on Biosimilar Development
• 4.5. Challenges
  • 4.5.1. Stringent Regulatory Requirements Governing Fill-finish Manufacturing
  • 4.5.2. Complexities Associated With Accurately Filling Specific Medication Doses.
• 4.6. Factor Analysis
• 4.7. Trends
• 4.8. Regulatory Analysis
• 4.9. Pricing Analysis
• 4.10. Porter's Five Force Analysis

5. Fill-finish Manufacturing Market Assessment-by Offering

• 5.1. Overview
• 5.2. Packaging Type
  • 5.2.1. Packaging Type, by Product
    • 5.2.1.1. Vials
      • 5.2.1.1.1. Liquid Vials
      • 5.2.1.1.2. Lyophilized Vials
      • 5.2.1.1.3. Powder Filled Vials
    • 5.2.1.2. Syringes
    • 5.2.1.3. Cartridges
    • 5.2.1.4. Ampoules
    • 5.2.1.5. Accessories
  • 5.2.2. Packaging Type, by Material
    • 5.2.2.1. Polymer
    • 5.2.2.2. Glass
    • 5.2.2.3. Other Materials
• 5.3. Packaging Instruments
  • 5.3.1. Packaging Instruments, by System Type
    • 5.3.1.1. Integrated Systems
    • 5.3.1.2. Standalone Systems
  • 5.3.2. Packaging Instruments, by Machine Type
    • 5.3.2.1. Automated Machines
    • 5.3.2.2. Semi-automated Machines
  • 5.3.3. Packaging Instruments, by Type
    • 5.3.3.1. Processing Instruments
    • 5.3.3.2. Packaging Instruments
      • 5.3.3.2.1. Bottle Filling & Capping Equipment
      • 5.3.3.2.2. Blow-Fill-Seal (BFS) Equipment
      • 5.3.3.2.3. Aseptic Filling Equipment
      • 5.3.3.2.4. Pharmaceutical Spray Filling Equipment
      • 5.3.3.2.5. Other Packaging Instruments
• 5.4. Packaging Services
  • 5.4.1. Vials & Ampoules Filling
  • 5.4.2. Injection Filling
  • 5.4.3. Cartridge Filling
  • 5.4.4. Other Packaging Services

6. Fill-finish Manufacturing Market Assessment-by Formulation

• 6.1. Overview
• 6.2. Oral
• 6.3. Parenteral
• 6.4. Topical
• 6.5. Other Formulations

7. Fill-finish Manufacturing Market Assessment-by Sterilization Process

• 7.1. Overview
• 7.2. Aseptic Processing
• 7.3. Terminal Sterilization

8. Fill-finish Manufacturing Market Assessment-by Application

• 8.1. Overview
• 8.2. Biologics
  • 8.2.1. Biologics, by Type
    • 8.2.1.1 Monoclonal Antibodies
    • 8.2.1.2. Recombinant Hormones/Proteins
    • 8.2.1.3. Vaccines
    • 8.2.1.4. Cellular-based Biologics
    • 8.2.1.5. Gene-based Biologics
  • 8.2.2. Biologics, by Development Phase
    • 8.2.2.1. Clinical/preclinical
    • 8.2.2.2. Commercial
  • 8.2.3. Small Molecules
    • 8.2.3.1. Clinical/preclinical
    • 8.2.3.2. Commercial

9. Fill-finish Manufacturing Market Assessment-by End User

• 9.1. Overview
• 9.2. Pharmaceutical & Biopharmaceutical Companies
• 9.3. CROs & CDMOs
• 9.4. Compounding Pharmacies

10. Fill-finish Manufacturing Market Assessment-by Geography

• 10.1. Overview
• 10.2. North America
  • 10.2.1. U.S.
  • 10.2.2. Canada
• 10.3. Europe
  • 10.3.1. Germany
  • 10.3.2. France
  • 10.3.3. U.K.
  • 10.3.4. Italy
  • 10.3.5. Spain
  • 10.3.6. Switzerland
  • 10.3.7. Ireland
  • 10.3.8. Belgium
  • 10.3.9. Denmark
  • 10.3.10. Rest of Europe (RoE)
• 10.4. Asia-Pacific
  • 10.4.1. Japan
  • 10.4.2. China
  • 10.4.3. India
  • 10.4.4. South Korea
  • 10.4.5. Rest of Asia-Pacific (RoAPAC)
• 10.5. Latin America
  • 10.5.1. Brazil
  • 10.5.2. Mexico
  • 10.5.3. Rest of Latin America (RoLATAM)
• 10.6. Middle East & Africa

11. Competition Analysis

• 11.1. Overview
• 11.2. Key Growth Strategies
• 11.3. Competitive Benchmarking
• 11.4. Competitive Dashboard
  • 11.4.1. Industry Leaders
  • 11.4.2. Market Differentiators
  • 11.4.3. Vanguards
  • 11.4.4. Emerging Companies
• 11.5. Market Share Analysis/Market Ranking, by Key Players (2023)

12. Company Profiles (Company Overview, Financial Overview, Product Portfolio, Strategic Developments, and SWOT Analysis*)

• 12.1. Syntegon Technology GmbH
• 12.2. Becton, Dickinson and Company
• 12.3. Industria Macchine Automatiche S.p.A
• 12.4. West Pharmaceutical Services, Inc.
• 12.5. Catalent, Inc.
• 12.6. AbbVie Inc.
• 12.7. Gerresheimer AG
• 12.8. AptarGroup, Inc.
• 12.9. OPTIMA packaging group GmbH
• 12.10. Baxter International Inc.
• 12.11 C.H. Boehringer Sohn AG & Co. KG
• 12.12. Schott Pharma AG & Co. KGaA
• 12.13. SGD Pharma
• 12.14. Stevanato Group

(Note: SWOT Analyses of the Top 5 Companies Will Be Provided.)

13. Appendix

• 13.1. Available Customization
• 13.2. Related Reports