세계의 바이오베터 시장 : 제품 유형별, 최종 사용자별, 지역별 - 산업 분석, 규모, 점유율, 성장, 동향 및 예측(2024-2031년)

Persistence Market Research, a renowned market research firm, has conducted an in-depth analysis of the global Biobetters Market. This comprehensive report provides valuable insights into key market dynamics, growth drivers, challenges, and emerging trends. It offers a detailed overview of the biobetters segment within the biopharmaceutical industry, presenting exclusive data and statistics projecting the market's growth trajectory from 2024 to 2031.

Key Insights:

• Biobetters Market Size (2024): USD65.75 Bn
• Projected Market Value (2031): USD117.1 Bn
• Global Market Growth Rate (CAGR 2024 to 2031): 8.6%

Biobetters Market - Report Scope:

The Biobetters Market encompasses a diverse range of biopharmaceutical products and therapeutic modalities designed to improve upon existing biologic drugs, known as biobetters or biosuperiors. This market serves biopharmaceutical companies, contract research organizations (CROs), regulatory agencies, and healthcare providers, offering innovative biobetter formulations, delivery systems, and manufacturing technologies for enhanced therapeutic efficacy, safety, and patient outcomes. Biobetters represent an evolution of biologic drugs, offering optimized pharmacokinetics, reduced immunogenicity, and improved patient convenience compared to their reference biologics. Market growth is driven by increasing demand for biobetter therapies, patent expirations of biologic drugs, and regulatory pathways facilitating the development and approval of biosimilars and biobetters.

Market Growth Drivers:

The global Biobetters Market benefits from several key growth drivers. Biopharmaceutical companies are investing in research and development to develop biobetter candidates with enhanced therapeutic profiles, such as improved efficacy, safety, and dosing regimens, compared to originator biologics. Moreover, advancements in bioprocessing technologies, protein engineering, and formulation science enable the design and optimization of biobetter molecules with desired properties and characteristics. Additionally, the increasing availability of biosimilar reference products and supportive regulatory frameworks encourage innovation and competition in the biobetters space. Furthermore, the growing prevalence of chronic diseases, personalized medicine initiatives, and patient-centric care models create opportunities for biobetter therapies tailored to individual patient needs and treatment preferences.

Market Restraints:

Despite its promising growth prospects, the Biobetters Market faces challenges related to development costs, regulatory requirements, and market access. The high cost and complexity of biobetter development, including preclinical and clinical studies, manufacturing scale-up, and regulatory submissions, may deter investment and delay market entry. Moreover, stringent regulatory standards for demonstrating comparability, safety, and efficacy of biobetter candidates compared to reference biologics impose regulatory hurdles and uncertainty. Additionally, market competition from biosimilars, generics, and innovative biologics may impact pricing, reimbursement, and market share for biobetter products. Addressing these barriers requires collaboration between industry stakeholders, regulatory agencies, and healthcare payers to streamline development pathways, incentivize innovation, and ensure patient access to biobetter therapies.

Market Opportunities:

The Biobetters Market presents significant growth opportunities driven by technological innovations, market differentiation, and therapeutic innovation. Emerging trends such as precision medicine, targeted drug delivery, and personalized biologics offer new avenues for biobetter development and commercialization. The integration of novel drug delivery systems, such as nanoparticles, micelles, and antibody-drug conjugates (ADCs), enhances the pharmacokinetics, tissue targeting, and therapeutic index of biobetter molecules. Moreover, the adoption of patient-centric formulations, such as subcutaneous injections, oral tablets, and autoinjectors, improves treatment adherence, convenience, and patient satisfaction. Furthermore, strategic partnerships, licensing agreements, and co-development collaborations enable companies to leverage complementary expertise, resources, and capabilities for biobetter discovery, optimization, and commercialization.

Key Questions Answered in the Report:

• How much is the Biobetters Market worth?
• What are the restraints in the Biobetters Market?
• What are the key factors driving the market?
• Who are the top players in the market?

Competitive Intelligence and Business Strategy:

Leading players in the global Biobetters Market, including biopharmaceutical companies, CROs, and contract manufacturing organizations (CMOs), focus on innovation, collaboration, and market expansion to gain a competitive edge. These companies invest in research and development to discover and develop biobetter candidates with superior clinical profiles, such as improved efficacy, safety, and patient convenience. Moreover, strategic partnerships with academic research institutions, technology providers, and regulatory consultants enable companies to access novel technologies, scientific expertise, and regulatory insights to accelerate biobetter development and commercialization. Furthermore, emphasis on manufacturing optimization, supply chain efficiency, and cost-effective production processes enhances product quality, affordability, and global market access in the competitive landscape of biobetter therapies.

Key Companies Profiled:

• Amgen Inc.
• F. Hoffmann-La Roche AG
• Merck & Co. Inc.
• Sanofi SA
• SERVIER
• Porton Biopharma Limited
• Eli Lily and Company
• Novo Nordisk A/S
• Biogen Inc.
• CSL Behring GmbH
• Teva Pharmaceutical Industries Ltd.

Biobetters Market Research Segmentation:

Biobetters Market by By Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

Biobetters Market By Molecule Type

• G-CSF Biobetters
• Insulin Biobetters
• Erythropoietin Biobetters
• Monoclonal Antibodies Biobetters
• Others

Biobetters Market by Disease Indication

• Cancer
• Diabetes
• Genetic disease
• Neurological Disorders
• Others

Biobetters Market by Region

• North America
• Latin America
• Europe
• Asia Pacific
• Middle East & Africa (MEA)"

Table of Contents

1. Executive Summary

• 1.1. Global Market Outlook
• 1.2. Market Analysis
• 1.3. Analysis and Recommendations

2. Market Overview

• 2.1. Market Coverage / Taxonomy
• 2.2. Market Definition / Scope / Limitations

3. Key Market Trends

• 3.1. Key Trends Impacting the Market
• 3.2. Product Innovation / Development Trends

4. Key Success Factors

• 4.1. Recent Product Launches
• 4.2. Promotional Strategies, by Manufacturers
• 4.3. Regulatory Scenario

5. Global Biobetters Market Demand (in Value or Size in US$ Mn) Analysis 2019-2023 and Forecast, 2024-2031

• 5.1. Historical Market Value (US$ Mn) Analysis, 2019-2023
• 5.2. Current and Future Market Value (US$ Mn) Projections, 2024-2031
  • 5.2.1. Y-o-Y Growth Trend Analysis
  • 5.2.2. Absolute $ Opportunity Analysis

6. Market Background

• 6.1. Macro-Economic Factors
  • 6.1.1. Global Healthcare Spending Outlook
  • 6.1.2. Global Pharmaceutical Outlook
  • 6.1.3. Regional Healthcare Market Outlook
• 6.2. Forecast Factors - Relevance & Impact
  • 6.2.1. Innovation of New Products
  • 6.2.2. Increasing Research & Developmental Activities
  • 6.2.3. Increasing Number of Biotechnology Industries And Research Institutes
  • 6.2.4. Adoption of New Technologies In Research Field
• 6.3. Market Dynamics
  • 6.3.1. Drivers
  • 6.3.2. Restraints
  • 6.3.3. Opportunity Analysis

7. Global Biobetters Market Analysis 2019-2023 and Forecast 2024-2031, by Product Type

• 7.1. Introduction / Key Findings
• 7.2. Historical Market Size (US$ Mn) Analysis By Product Type, 2019-2023
• 7.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Product Type, 2024-2031
  • 7.3.1. Erythropoietin Biobetters
  • 7.3.2. G-CSF Biobetters
  • 7.3.3. Interferon Biobetters
  • 7.3.4. Insulin Biobetters
  • 7.3.5. Monoclonal Antibodies Biobetters
  • 7.3.6. Anti-haemophilic Factor
  • 7.3.7. Others
• 7.4. Market Attractiveness Analysis By Product Type

8. Global Biobetters Market Analysis 2019-2023 and Forecast 2024-2031, By Indication

• 8.1. Introduction / Key Findings
• 8.2. Historical Market Size (US$ Mn) Analysis By Indication, 2019-2023
• 8.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Indication, 2024-2031
  • 8.3.1. Diabetes
  • 8.3.2. Cancer
  • 8.3.3. Renal Disease
  • 8.3.4. Neurodegenerative Disease
  • 8.3.5. Genetic Disorders (Haemophilia)
  • 8.3.6. Others
• 8.4. Market Attractiveness Analysis By Indication

9. Global Biobetters Market Analysis 2019-2023 and Forecast 2024-2031, By Route of Administration

• 9.1. Introduction / Key Findings
• 9.2. Historical Market Size (US$ Mn) Analysis By Route of Administration, 2019-2023
• 9.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Route of Administration, 2024-2031
  • 9.3.1. Subcutaneous
  • 9.3.2. Intravenous
• 9.4. Market Attractiveness Analysis By Route of Administration

10. Global Biobetters Market Analysis 2019-2023 and Forecast 2024-2031, By Distribution Channel

• 10.1. Introduction / Key Findings
• 10.2. Historical Market Size (US$ Mn) Analysis By Distribution Channel, 2019-2023
• 10.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Distribution Channel, 2024-2031
  • 10.3.1. Hospital Pharmacies
  • 10.3.2. Retail Pharmacies
  • 10.3.3. Online Pharmacies
• 10.4. Market Attractiveness Analysis By Distribution Channel

11. Global Biobetters Market Analysis 2019-2023 and Forecast 2024-2031, by Region

• 11.1. Introduction
• 11.2. Historical Market Size (US$ Mn) Analysis By Region, 2019-2023
• 11.3. Current Market Size (US$ Mn) Analysis and Forecast By Region, 2024-2031
  • 11.3.1. North America
  • 11.3.2. Latin America
  • 11.3.3. Europe
  • 11.3.4. East Asia
  • 11.3.5. South Asia
  • 11.3.6. Oceania
  • 11.3.7. MEA
• 11.4. Market Attractiveness Analysis By Region

12. North America Biobetters Market Value (US$ Mn) Analysis 2019-2023 and Forecast 2024-2031

• 12.1. Introduction
• 12.2. Historical Market Size (US$ Mn) Trend Analysis By Market Taxonomy, 2019-2023
• 12.3. Market Size (US$ Mn) Forecast By Market Taxonomy, 2024-2031
  • 12.3.1. By Country
    • 12.3.1.1. U.S.
    • 12.3.1.2. Canada
  • 12.3.2. By Product Type
  • 12.3.3. By Indication
  • 12.3.4. By Route of Administration
  • 12.3.5. By Distribution Channel
• 12.4. Market Attractiveness Analysis
  • 12.4.1. By Country
  • 12.4.2. By Product Type
  • 12.4.3. By Indication
  • 12.4.4. By Route of Administration
  • 12.4.5. By Distribution Channel
• 12.5. Key Market Participants - Intensity Mapping
• 12.6. Drivers and Restraints - Impact Analysis

13. Latin America Biobetters Market Value (US$ Mn) Analysis 2019-2023 and Forecast 2024-2031

• 13.1. Introduction
• 13.2. Historical Market Size (US$ Mn) Trend Analysis By Market Taxonomy, 2019-2023
• 13.3. Market Size (US$ Mn) Forecast By Market Taxonomy, 2024-2031
  • 13.3.1. By Country
    • 13.3.1.1. Brazil
    • 13.3.1.2. Mexico
    • 13.3.1.3. Rest of Latin America
  • 13.3.2. By Product Type
  • 13.3.3. By Indication
  • 13.3.4. By Route of Administration
  • 13.3.5. By Distribution Channel
• 13.4. Market Attractiveness Analysis
  • 13.4.1. By Country
  • 13.4.2. By Product Type
  • 13.4.3. By Indication
  • 13.4.4. By Route of Administration
  • 13.4.5. By Distribution Channel
• 13.5. Key Market Participants - Intensity Mapping
• 13.6. Drivers and Restraints - Impact Analysis

14. Europe Biobetters Market Value (US$ Mn) Analysis 2019-2023 and Forecast 2024-2031

• 14.1. Introduction
• 14.2. Historical Market Size (US$ Mn) Trend Analysis By Market Taxonomy, 2019-2023
• 14.3. Market Size (US$ Mn) Forecast By Market Taxonomy, 2024-2031
  • 14.3.1. By Country
    • 14.3.1.1. Germany
    • 14.3.1.2. Italy
    • 14.3.1.3. France
    • 14.3.1.4. U.K.
    • 14.3.1.5. Spain
    • 14.3.1.6. BENELUX
    • 14.3.1.7. Russia
    • 14.3.1.8. Rest of Europe
  • 14.3.2. By Product Type
  • 14.3.3. By Indication
  • 14.3.4. By Route of Administration
  • 14.3.5. By Distribution Channel
• 14.4. Market Attractiveness Analysis
  • 14.4.1. By Country
  • 14.4.2. By Product Type
  • 14.4.3. By Indication
  • 14.4.4. By Route of Administration
  • 14.4.5. By Distribution Channel
• 14.5. Key Market Participants - Intensity Mapping
• 14.6. Drivers and Restraints - Impact Analysis

15. South Asia Biobetters Market Value (US$ Mn) Analysis 2019-2023 and Forecast 2024-2031

• 15.1. Introduction
• 15.2. Historical Market Size (US$ Mn) Trend Analysis By Market Taxonomy, 2019-2023
• 15.3. Market Size (US$ Mn) Forecast By Market Taxonomy, 2024-2031
  • 15.3.1. By Country
    • 15.3.1.1. India
    • 15.3.1.2. Thailand
    • 15.3.1.3. Indonesia
    • 15.3.1.4. Malaysia
    • 15.3.1.5. Rest of South Asia
  • 15.3.2. By Product Type
  • 15.3.3. By Indication
  • 15.3.4. By Route of Administration
  • 15.3.5. By Distribution Channel
• 15.4. Market Attractiveness Analysis
  • 15.4.1. By Country
  • 15.4.2. By Product Type
  • 15.4.3. By Indication
  • 15.4.4. By Route of Administration
  • 15.4.5. By Distribution Channel
• 15.5. Key Market Participants - Intensity Mapping
• 15.6. Drivers and Restraints - Impact Analysis

16. East Asia Biobetters Market Value (US$ Mn) Analysis 2019-2023 and Forecast 2024-2031

• 16.1. Introduction
• 16.2. Historical Market Size (US$ Mn) Trend Analysis By Market Taxonomy, 2019-2023
• 16.3. Market Size (US$ Mn) Forecast By Market Taxonomy, 2024-2031
  • 16.3.1. By Country
    • 16.3.1.1. China
    • 16.3.1.2. Japan
    • 16.3.1.3. South Korea
  • 16.3.2. By Product Type
  • 16.3.3. By Indication
  • 16.3.4. By Route of Administration
  • 16.3.5. By Distribution Channel
• 16.4. Market Attractiveness Analysis
  • 16.4.1. By Country
  • 16.4.2. By Product Type
  • 16.4.3. By Indication
  • 16.4.4. By Route of Administration
  • 16.4.5. By Distribution Channel
• 16.5. Key Market Participants - Intensity Mapping
• 16.6. Drivers and Restraints - Impact Analysis

17. Oceania Biobetters Market Value (US$ Mn) Analysis 2019-2023 and Forecast 2024-2031

• 17.1. Introduction
• 17.2. Historical Market Size (US$ Mn) Trend Analysis By Market Taxonomy, 2019-2023
• 17.3. Market Size (US$ Mn) Forecast By Market Taxonomy, 2024-2031
  • 17.3.1. By Country
    • 17.3.1.1. Australia
    • 17.3.1.2. New Zealand
  • 17.3.2. By Product Type
  • 17.3.3. By Indication
  • 17.3.4. By Route of Administration
  • 17.3.5. By Distribution Channel
• 17.4. Market Attractiveness Analysis
  • 17.4.1. By Country
  • 17.4.2. By Product Type
  • 17.4.3. By Indication
  • 17.4.4. By Route of Administration
  • 17.4.5. By Distribution Channel
• 17.5. Key Market Participants - Intensity Mapping
• 17.6. Drivers and Restraints - Impact Analysis

18. Middle East and Africa Biobetters Market Value (US$ Mn) Analysis 2019-2023 and Forecast 2024-2031

• 18.1. Introduction
• 18.2. Historical Market Size (US$ Mn) Trend Analysis By Market Taxonomy, 2019-2023
• 18.3. Market Size (US$ Mn) Forecast By Market Taxonomy, 2024-2031
  • 18.3.1. By Country
    • 18.3.1.1. GCC Countries
    • 18.3.1.2. Turkey
    • 18.3.1.3. Northern Africa
    • 18.3.1.4. South Africa
    • 18.3.1.5. Rest of Middle East and Africa
  • 18.3.2. By Product Type
  • 18.3.3. By Indication
  • 18.3.4. By Route of Administration
  • 18.3.5. By Distribution Channel
• 18.4. Market Attractiveness Analysis
  • 18.4.1. By Country
  • 18.4.2. By Product Type
  • 18.4.3. By Indication
  • 18.4.4. By Route of Administration
  • 18.4.5. By Distribution Channel
• 18.5. Key Market Participants - Intensity Mapping
• 18.6. Drivers and Restraints - Impact Analysis

19. Market Structure Analysis

• 19.1. Market Analysis by Tier of Companies
• 19.2. Market Share Analysis of Top Players
• 19.3. Market Presence Analysis
  • 19.3.1. By Regional footprint of Players
  • 19.3.2. Product foot print by Players
  • 19.3.3. Channel Foot Print by Players

20. Competition Analysis

• 20.1. Competition Dashboard
• 20.2. Competition Benchmarking
• 20.3. Competition Deep Dive
  • 20.3.1. Amgen Inc.
    • 20.3.1.1. Overview
    • 20.3.1.2. Product Portfolio
    • 20.3.1.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.1.4. Sales Footprint
    • 20.3.1.5. Strategy Overview
      • 20.3.1.5.1. Marketing Strategy
      • 20.3.1.5.2. Product Strategy
      • 20.3.1.5.3. Channel Strategy
  • 20.3.2. F. Hoffmann-La Roche AG
    • 20.3.2.1. Overview
    • 20.3.2.2. Product Portfolio
    • 20.3.2.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.2.4. Sales Footprint
    • 20.3.2.5. Strategy Overview
      • 20.3.2.5.1. Marketing Strategy
      • 20.3.2.5.2. Product Strategy
      • 20.3.2.5.3. Channel Strategy
  • 20.3.3. Merck & Co. Inc.
    • 20.3.3.1. Overview
    • 20.3.3.2. Product Portfolio
    • 20.3.3.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.3.4. Sales Footprint
    • 20.3.3.5. Strategy Overview
      • 20.3.3.5.1. Marketing Strategy
      • 20.3.3.5.2. Product Strategy
      • 20.3.3.5.3. Channel Strategy
  • 20.3.4. Sanofi SA
    • 20.3.4.1. Overview
    • 20.3.4.2. Product Portfolio
    • 20.3.4.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.4.4. Sales Footprint
    • 20.3.4.5. Strategy Overview
      • 20.3.4.5.1. Marketing Strategy
      • 20.3.4.5.2. Product Strategy
      • 20.3.4.5.3. Channel Strategy
  • 20.3.5. SERVIER
    • 20.3.5.1. Overview
    • 20.3.5.2. Product Portfolio
    • 20.3.5.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.5.4. Sales Footprint
    • 20.3.5.5. Strategy Overview
      • 20.3.5.5.1. Marketing Strategy
      • 20.3.5.5.2. Product Strategy
      • 20.3.5.5.3. Channel Strategy
  • 20.3.6. Porton Biopharma Limited
    • 20.3.6.1. Overview
    • 20.3.6.2. Product Portfolio
    • 20.3.6.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.6.4. Sales Footprint
    • 20.3.6.5. Strategy Overview
      • 20.3.6.5.1. Marketing Strategy
      • 20.3.6.5.2. Product Strategy
      • 20.3.6.5.3. Channel Strategy
  • 20.3.7. Eli Lily and Company
    • 20.3.7.1. Overview
    • 20.3.7.2. Product Portfolio
    • 20.3.7.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.7.4. Sales Footprint
    • 20.3.7.5. Strategy Overview
      • 20.3.7.5.1. Marketing Strategy
      • 20.3.7.5.2. Product Strategy
      • 20.3.7.5.3. Channel Strategy
  • 20.3.8. Novo Nordisk A/S
    • 20.3.8.1. Overview
    • 20.3.8.2. Product Portfolio
    • 20.3.8.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.8.4. Sales Footprint
    • 20.3.8.5. Strategy Overview
      • 20.3.8.5.1. Marketing Strategy
      • 20.3.8.5.2. Product Strategy
      • 20.3.8.5.3. Channel Strategy
  • 20.3.9. Biogen Inc.
    • 20.3.9.1. Overview
    • 20.3.9.2. Product Portfolio
    • 20.3.9.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.9.4. Sales Footprint
    • 20.3.9.5. Strategy Overview
      • 20.3.9.5.1. Marketing Strategy
      • 20.3.9.5.2. Product Strategy
      • 20.3.9.5.3. Channel Strategy
  • 20.3.10. CSL Behring GmbH
    • 20.3.10.1. Overview
    • 20.3.10.2. Product Portfolio
    • 20.3.10.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.10.4. Sales Footprint
    • 20.3.10.5. Strategy Overview
      • 20.3.10.5.1. Marketing Strategy
      • 20.3.10.5.2. Product Strategy
      • 20.3.10.5.3. Channel Strategy
  • 20.3.11. Teva Pharmaceutical Industries Ltd.
    • 20.3.11.1. Overview
    • 20.3.11.2. Product Portfolio
    • 20.3.11.3. Profitability by Market Segments (Product/Channel/Region)
    • 20.3.11.4. Sales Footprint
    • 20.3.11.5. Strategy Overview
      • 20.3.11.5.1. Marketing Strategy
      • 20.3.11.5.2. Product Strategy
      • 20.3.11.5.3. Channel Strategy

21. Assumptions and Acronyms Used

22. Research Methodology