세계의 바이오의약품 첨가제 시장 : 업계 동향 및 예측 - 생물 제제 유형별, 첨가제 유형별, 기업 규모별, 사업 규모별, 주요 지역별

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: OVERVIEW

As per Roots Analysis, the biopharmaceutical excipients market is estimated to grow from USD 2.73 billion in the current year to USD 4.58 billion by 2035, at a CAGR of 4.8% during the forecast period, till 2035.

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

Type of Biologics

• Antibodies
• Vaccines
• Cell Therapies
• Other Biologics

Type of Excipient

• Carbohydrates
• Polymers
• Solubilizers / Surfactants
• Polyols
• Proteins / Amino Acids
• Others

Company Size

• Small
• Mid-sized
• Large / Very Large

Scale of Operation

• Preclinical
• Clinical
• Commercial

Key Geographical Regions

• North America
• Europe
• Asia
• Latin America
• Middle East and North Africa
• Rest of the World

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: GROWTH AND TRENDS

The demand for biopharmaceutical excipients has grown considerably in the past few years as they play a critical role in development of biologics. These biopharmaceutical excipients enhance solubility and bioavailability of biologics, by controlling pH and tonicity of the active pharmaceutical ingredients (APIs). However, due to the highly complex and capital-intensive manufacturing processes of biopharmaceutical excipients, many contemporary biologic developers prefer to rely on CMOs for the supply of GMP grade excipients. Further, in order to cater to the growing demand for biopharmaceutical excipients across both clinical and commercial scales, CMOs with expertise in this field are expected to expand their capabilities and existing capacities in the coming years.

During our research, we identified various players that offer manufacturing services of biopharmaceutical excipients, including lipids, trehalose, lactose, mannitol, succinate, Tween 20 and benzyl alcohol. These companies are placing greater emphasis on developing co-processed multifunctional biopharmaceutical excipients to enhance the stability and efficacy of innovative biotherapeutics. In fact, over the past three decades biopharmaceutical manufacturers have developed some exceptional excipients which claim to increase the biopharmaceutical formulation shelf life by three times.

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: KEY INSIGHTS

The report delves into the current state of the global biopharmaceutical excipients market and identifies potential growth opportunities within industry. Some key findings from the report include:

• Presently, around 45 players claim to provide various types of biopharmaceutical excipients to biologic developers; these companies operate in compliance to global regulatory standards.
• In order to cater to the evolving needs of sponsors, companies offering biopharmaceutical excipients have established their presence in various geographical regions.

• The market landscape is fragmented, featuring the presence of both established players and new entrants involved in the manufacturing of excipients for different types of biologics.
• Close to 90% of companies claim to have the required capabilities and expertise to offer excipients for liquid drug formulations at all scales of operations.
• Although majority (~75%) of the manufacturers are based in developed regions, many players have recently emerged in some Asian countries, such as India and China.
• Nearly 60% of the manufacturers claim to provide biopharmaceutical excipients for vaccines and protein / peptide-based therapeutics.
• Companies are steadily expanding their existing capabilities in order to enhance their respective portfolios and drive compliance to evolving industry benchmarks.
• A rise in partnerships, focused on biopharmaceutical excipients, validates the growing interest of stakeholders in this domain; maximum number of such deals were signed in the last three years.
• Since 2020, the partnership activity has increased at a steady pace in this domain. It is worth mentioning that majority of the deals were established in the last two years.
• Over 40 agreements have been inked in the last 5 years in this domain; 32% of which were distribution agreements. Other popular types of partnership models adopted by players engaged in this domain include acquisitions (23%) and supply agreements (13%).
• Established players have forged multiple deals for biopharma excipients; most of these were focused on distribution of proprietary biopharmaceutical excipients.
• Examples of firms that have signed multiple deals within North America include (in alphabetical order) ABITEC, Aceto, Evonik, Merck and Roquette.
• To keep pace with the growing demand for biopharmaceutical excipients, manufacturers have undertaken many expansion initiatives in the recent past; ~80% of such instances involved facilities based in Europe.
• More than 45% of expansion initiatives were focused on capacity expansion of manufacturing facilities, followed by those undertaken for expanding existing facilities (43%). It is worth mentioning that most of the expansion initiatives (78%) were carried out in Europe and North America.
• The supply-side of this market is driven by mid-sized and large biopharmaceutical excipient manufacturers; interestingly, close to 40% of the currently available capacity is installed in production plants located in Europe.
• Approximately 95% of the total installed capacity is dedicated to commercial scale manufacturing. The remaining 5% of the installed capacity is focused on preclinical / clinical scale manufacturing of biopharmaceutical excipients. In addition, over 50% of the total current global, installed biopharmaceutical excipient manufacturing capacity is installed in Europe.
• With the growing focus on biologics based therapeutic interventions, the biopharmaceutical excipients market is likely to grow at a steady pace over the next decade.
• The opportunity is expected to be segregated across a variety of biologics, scales of operation and key geographical regions.
• North America and Europe are anticipated to capture over 70% of the market share by 2035. In addition, the market in Asia Pacific is likely to grow at a relatively faster pace (6.4%) in the long term. Further, in 2035, biopharmaceutical excipient manufacturing market for antibodies is expected to capture the majority share (~52%) of the total market.

Example Players in the Biopharmaceutical Excipients Market

• ABITEC
• Avantor
• BASF
• Corden Pharma
• DFE Pharma
• Evonik
• Kirsch Pharma
• Merck KGaA
• Pfanstiehl
• Roquette
• Spectrum Chemical Manufacturing
• SPI Pharma

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: RESEARCH COVERAGE

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global biopharmaceutical excipients market, focusing on key market segments, including [A] type of biologics, [B] type of excipient, [C] company size, [D] scale of operation and [E] key geographical regions.
• Market Landscape: A comprehensive evaluation of the current biopharmaceutical excipients, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of manufacturing facilities, [E] type of excipient, [F] scale of operation, [G] type of formulation, [H] type of biologic and [I] global regulatory compliance.
• Company Competitiveness Analysis: A comprehensive competitive analysis of biopharmaceutical excipient manufacturers, examining factors, such as [A] supplier power and [B] company competitiveness.
• Company Profiles: In-depth profiles of companies engaged in this domain, focused on [A] company overview, [B] financial information (if available), [C] biopharmaceutical excipients portfolio, [D] manufacturing facilities and [E] recent developments and an informed future outlook.
• Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the biopharmaceutical excipient market, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] type of excipient, [D] type of drug molecule, [E] most active players (in terms of the number of partnerships signed) and [F] geography.
• Recent Expansions: In-depth analysis of recent expansions undertaken by various biopharmaceutical excipient manufacturers, focused on [A] year of expansion, [B] type of expansion, [C] company size, [D] location of headquarters, [E] location of expanded facility, [F] type of excipient, [G] type of drug molecule, [H] most active players and [I] geographical distribution.
• Capacity Analysis: A detailed analysis of the global installed capacity for biopharmaceutical excipients considering the capacities of various biopharmaceutical excipient manufacturers, based on several relevant parameters, such as [A] company size, [B] scale of operation and [C] key geographical regions.

KEY QUESTIONS ANSWERED IN THIS REPORT

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• 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?

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.

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TABLE OF CONTENTS

1. PREFACE

• 1.1. Scope of the Report
• 1.2. Research Methodology
  • 1.2.1. Research Assumptions
  • 1.2.2. Project Methodology
  • 1.2.3. Forecast Methodology
  • 1.2.4. Robust Quality Control
  • 1.2.5. Key Considerations
    • 1.2.5.1. Demographics
    • 1.2.5.2. Economic Factors
    • 1.2.5.3. Government Regulations
    • 1.2.5.4. Supply Chain
    • 1.2.5.5. COVID Impact / Related Factors
    • 1.2.5.6. Market Access
    • 1.2.5.7. Healthcare Policies
    • 1.2.5.8. Industry Consolidation
• 1.3 Key Questions Answered
• 1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

• 3.1. Chapter Overview
• 3.2. Biopharmaceutical Excipients
• 3.3. Properties of Ideal Excipients
• 3.4. Classification of Biopharmaceutical Excipients
  • 3.4.1. Classification based on Route of Administration
  • 3.4.2. Classification of Excipients based on Structure
  • 3.4.3. Classification of Excipients based on Function
  • 3.4.4. Classification based on Ability to Interfere with Metabolization and Efflux Mechanisms
• 3.5. Applications of Biopharmaceutical Excipients
• 3.6. Regulatory Scenario
• 3.7. Concluding Remarks

4. MARKET LANDSCAPE

• 4.1. Chapter Overview
• 4.2. Biopharmaceutical Excipient Manufacturers: Overall Market Landscape
  • 4.2.1. Analysis by Year of Establishment
  • 4.2.2. Analysis by Company Size
  • 4.2.3. Analysis by Location of Headquarters
  • 4.2.4. Analysis by Location of Biopharmaceutical Excipient Manufacturing Facilities
  • 4.2.5. Analysis by Type of Excipient based on Chemical Composition
  • 4.2.6. Analysis by Type of Excipient based on Function
  • 4.2.7. Analysis by Type of Excipient based on Chemical Structure
  • 4.2.8. Analysis by Scale of Operation
  • 4.2.9. Analysis by Type of Formulation
  • 4.2.10. Analysis by Type of Biologic
  • 4.2.11. Analysis by Global Regulatory Compliance

5. COMPANY COMPETITIVENESS ANALYSIS

• 5.1. Chapter Overview
• 5.2. Assumptions and Key Parameters
• 5.3. Methodology
• 5.4. Biopharmaceutical Excipient Manufacturers: Company Competitiveness Analysis
  • 5.4.1. Company Competitiveness Analysis: Small Companies
  • 5.4.2. Company Competitiveness Analysis: Mid-Sized Companies
  • 5.4.3. Company Competitiveness Analysis: Large Companies
  • 5.4.4. Company Competitiveness Analysis: Very Large Companies

6. COMPANY PROFILES: BIOPHARMACEUTICAL EXCIPIENT MANUFACTURERS

• 6.1. Chapter Overview
• 6.2. ABITEC
  • 6.2.1. Company Overview
  • 6.2.2. Biopharmaceutical Excipient Offerings
  • 6.2.3. Manufacturing Facilities
  • 6.2.4. Recent Developments and Future Outlook
• 6.3. Avantor
  • 6.3.1. Company Overview
  • 6.3.2. Financial Information
  • 6.3.3. Biopharmaceutical Excipient Offerings
  • 6.3.4. Manufacturing Facilities
  • 6.3.5. Recent Developments and Future Outlook
• 6.4. BASF Pharma
  • 6.4.1. Company Overview
  • 6.4.2. Financial Information
  • 6.4.3. Biopharmaceutical Excipient Offerings
  • 6.4.4. Manufacturing Facilities
  • 6.4.5. Recent Developments and Future Outlook
• 6.5. Corden Pharma
  • 6.5.1. Company Overview
  • 6.5.2. Biopharmaceutical Excipient Service Offerings
  • 6.5.3. Manufacturing Facilities
  • 6.5.4. Recent Developments and Future Outlook
• 6.6. DFE Pharma
  • 6.6.1. Company Overview
  • 6.6.2. Biopharmaceutical Excipient Offerings
  • 6.6.3. Manufacturing Facilities
  • 6.6.4. Recent Developments and Future Outlook
• 6.7. Evonik
  • 6.7.1. Company Overview
  • 6.7.2. Financial Information
  • 6.7.3. Biopharmaceutical Excipient Offerings
  • 6.7.4. Manufacturing Facilities
  • 6.7.5. Recent Developments and Future Outlook
• 6.8. Kirsch Pharma
  • 6.8.1. Company Overview
  • 6.8.2. Biopharmaceutical Excipient Offerings
  • 6.8.3. Manufacturing Facilities
  • 6.8.4. Recent Developments and Future Outlook
• 6.9. Merck KGaA
  • 6.9.1. Company Overview
  • 6.9.2. Financial Information
  • 6.9.3. Biopharmaceutical Excipient Offerings
  • 6.9.4. Manufacturing Facilities
  • 6.9.5. Recent Developments and Future Outlook
• 6.10. Pfanstiehl
  • 6.10.1. Company Overview
  • 6.10.2. Biopharmaceutical Excipient Offerings
  • 6.10.3. Manufacturing Facilities
  • 6.10.4. Recent Developments and Future Outlook
• 6.11. Roquette
  • 6.11.1. Company Overview
  • 6.11.2. Biopharmaceutical Excipient Offerings
  • 6.11.3. Manufacturing Facilities
  • 6.11.4. Recent Developments and Future Outlook
• 6.12. Spectrum Chemical Manufacturing
  • 6.12.1. Company Overview
  • 6.12.2. Biopharmaceutical Excipient Offerings
  • 6.12.3. Manufacturing Facilities
  • 6.12.4. Recent Developments and Future Outlook
• 6.13. SPI Pharma
  • 6.13.1. Company Overview
  • 6.13.2. Biopharmaceutical Excipient Offerings
  • 6.13.3. Manufacturing Facilities
  • 6.13.4. Recent Developments and Future Outlook

7. PARTNERSHIPS AND COLLABORATIONS

• 7.1. Chapter Overview
• 7.2. Partnership Models
• 7.3. Biopharmaceutical Excipients Manufacturing Market: Partnerships and Collaborations
  • 7.3.1. Analysis by Year of Partnership
  • 7.3.2. Analysis by Type of Partnership
  • 7.3.3. Analysis by Year and Type of Partnership
  • 7.3.4. Analysis by Type of Excipient
  • 7.3.5. Analysis by Type of Drug Molecule
  • 7.3.6. Most Active Players: Analysis by Number of Partnerships
  • 7.3.7. Analysis by Geography
    • 7.3.7.1. Intercontinental and Intracontinental Deals
    • 7.3.7.2. International and Local Deals

8. RECENT EXPANSIONS

• 8.1. Chapter Overview
• 8.2. Biopharmaceutical Excipient Manufacturing Market: Recent Expansions
  • 8.2.1. Analysis by Year of Expansion
  • 8.2.2. Analysis by Type of Expansion
  • 8.2.3. Analysis by Company Size and Location of Headquarters
  • 8.2.4. Analysis by Location of Expanded Facility
  • 8.2.5. Analysis by Type of Excipient
  • 8.2.6. Analysis by Type of Drug Molecule
  • 8.2.7. Most Active Players: Analysis by Number of Recent Expansions
  • 8.2.8. Geographical Analysis
    • 8.2.8.1. Region-wise Distribution
    • 8.2.8.2. Country-wise Distribution

9. CAPACITY ANALYSIS

• 9.1. Chapter Overview
• 9.2. Key Assumptions and Methodology
• 9.3. Biopharmaceutical Excipient Manufacturing: Installed Global Capacity
  • 9.3.1. Analysis by Company Size
  • 9.3.2. Analysis by Scale of Operation
  • 9.3.3. Analysis by Location of Manufacturing Facility
• 9.4. Concluding Remarks

10. MARKET FORECAST AND OPPORTUNITY ANALYSIS

• 10.1. Chapter Overview
• 10.2. Forecast Methodology and Key Assumptions
• 10.3. Global Biopharmaceutical Excipient Manufacturing Market, Till 2035
• 10.4. Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Biologic
• 10.5. Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Excipient
• 10.6. Biopharmaceutical Excipient Manufacturing Market: Distribution by Company Size
• 10.7. Biopharmaceutical Excipient Manufacturing Market: Distribution by Scale of Operation
• 10.8. Biopharmaceutical Excipient Manufacturing Market: Distribution by Region
  • 10.8.1. Biopharmaceutical Excipient Manufacturing Market in North America, Till 2035
  • 10.8.2. Biopharmaceutical Excipient Manufacturing Market in Europe, Till 2035
  • 10.8.3. Biopharmaceutical Excipient Manufacturing Market in Asia Pacific, Till 2035
  • 10.8.4. Biopharmaceutical Excipient Manufacturing Market in Latin America, Till 2035
  • 10.8.5. Biopharmaceutical Excipient Manufacturing Market in MENA, Till 2035
  • 10.8.6. Biopharmaceutical Excipient Manufacturing Market in Rest of the World, Till 2035

11. CONCLUDING REMARKS

12. EXECUTIVE INSIGHTS

• 12.1. Chapter Overview
• 12.2. Company A
  • 12.2.1. Company Snapshot
  • 12.2.2. Interview Transcript: Biopharma Sales Director

13. APPENDIX 1: TABULATED DATA

14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS