HOME Top Market Reports Biosimilars Market by Product (Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Interferons, rHGH), Glycosylated (Monoclonal Antibodies, EPO), Peptides (Glucagon, Calcitonin)) & Application (Oncology, Blood Disorders) - Global Forecast to 2020

Biosimilars Market by Product (Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Interferons, rHGH), Glycosylated (Monoclonal Antibodies, EPO), Peptides (Glucagon, Calcitonin)) & Application (Oncology, Blood Disorders) - Global Forecast to 2020

By: marketsandmarkets.com
Publishing Date: July 2015
Report Code: BT 2160

 

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The global biosimilars market is expected to reach $6.22 Billion by 2020 from $2.29 Billion in 2015, growing at a CAGR of 22.1% from 2015 to 2020. The growth of the global biosimilars market is driven by factors such as growing pressure to curtail healthcare expenditure, growing demand for biosimilar drugs due to their cost-effectiveness, rising incidences of various diseases, increasing number of off-patented drugs, positive outcome in the ongoing clinical trials, and rising demand for biosimilars in different therapeutic applications such as rheumatoid arthritis and blood disorders. However, factors such as high manufacturing complexities and costs, stringent regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

The biosimilars market is categorized into four major regions, namely, North America (U.S. and Canada), Europe (the U.K., Germany, France, Spain, Italy, and RoE), Asia-Pacific (India, China, Japan, South Korea, and RoAPAC), and the Rest of the World (RoW: Latin America, Africa, and the Middle East). Europe is the largest market for biosimilars, followed by Asia-Pacific. Among the Asia-Pacific countries, China and India are expected to grow at the fastest rate. Other countries such as the U.S., South Korea, and Brazil are also poised to register high growth over the next five years.

The key players in the global biosimilars market are Sandoz International GmbH (Germany), Hospira, Inc. (U.S.), and Teva Pharmaceutical Industries Ltd. (Israel), Dr. Reddy’s Laboratories (India), Biocon Limited (India), Mylan, Inc.(U.S.), Amgen (U.S.), Celltrion Inc. (South Korea), Roche Diagnostics (Switzerland), and Merck KGaA (Germany).

Scope of the Report

Global Biosimilars Market, by Product

  • Recombinant Nonglycosylated Proteins
    • Insulin
    • Human Growth Hormones
    • Granulocyte Colony-stimulating Factor (G-CSF)
    • Interferons
  • Recombinant Glycosylated Proteins
    • Erythropoietin
    • Monoclonal Antibodies
    • Follitropin
  • Recombinant Peptides
    • Glucagon
    • Calcitonin

Global Biosimilars Market, by Application

  • Oncology
  • Blood Disorders
  • Chronic and Autoimmune Diseases
  • Growth Hormone Deficiency
  • Infectious Diseases

Global Biosimilars Market, by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • U.K.
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Rest of Asia-Pacific
  • Rest of the World

Table of Contents

1 Introduction (Page No. - 15)
    1.1 Objectives of the Study
    1.2 Market Definition
    1.3 Market Scope
           1.3.1 Market Segmentation
           1.3.2 Years Considered for the Study
    1.4 Currency
    1.5 Limitations
    1.6 Stakeholders

2 Research Methodology (Page No. - 19)
    2.1 Market Size Estimation
    2.2 Market Breakdown and Data Triangulation
    2.3 Market Share Estimation
    2.4 Key Data From Secondary Sources
    2.5 Key Data From Primary Sources
    2.6 Key Industry Insights
    2.7 Assumptions for the Study

3 Executive Summary (Page No. - 29)
    3.1 Introduction

4 Premium Insights (Page No. - 33)
    4.1 Biosimilars Market
    4.2 Biosimilars Market, By Type
    4.3 Geographical Snapshot of the Biosimilars Market
    4.4 Biosimilars Market, By Type
    4.5 Recombinant Nonglycosylated Proteins Market, By Type
    4.6 Lifecycle Analysis, By Region

5 Market Overview (Page No. - 38)
    5.1 Introduction
    5.2 Biosimilars Market Segmentation
           5.2.1 Biosimilars Market Segmentation, By Product
           5.2.2 Biosimilars Market Segmentation, By Application
           5.2.3 Biosimilars Market Segmentation, By Region
    5.3 Market Dynamics
           5.3.1 Market Drivers
                    5.3.1.1 Growing Pressure to Curtail Healthcare Expenditure
                    5.3.1.2 Increasing Demand for Biosimilars Drug Due to Their Cost-Effectiveness
                    5.3.1.3 Rising Incidences of Diseases
                    5.3.1.4 Rise in Aging Population Triggers the Incidences of Chronic Disorders
                    5.3.1.5 Strategic Collaborations Lead to Enhance Productivity and Clinical Trial Activities for Biosimilars
                    5.3.1.6 Increasing Government Support and Initiatives to Develop and Promote Biosimilars
           5.3.2 Market Restrains
                    5.3.2.1 High Manufacturing Complexities and Costs
                    5.3.2.2 Innovative Strategies By Biologic Drug Manufacturers
                    5.3.2.3 Stringent Regulatory Requirements to Adversely Affect Investments in Biosimilars
           5.3.3 Opportunities
                    5.3.3.1 Emerging Markets
                    5.3.3.2 Untapped Indications
                    5.3.3.3 Biologic Products Set to Be Off-Patent Will Offer Opportunities for Biosimilars
           5.3.4 Burning Issues
                    5.3.4.1 Product Withdrawals Provide Significant Opportunities for New Entrants

6 Industry Insights (Page No. - 52)
    6.1 Porter’s Five Forces Analysis
           6.1.1 Threat From New Entrants
           6.1.2 Threat of Substitutes
           6.1.3 Intensity of Rivalry
           6.1.4 Bargaining Power of Suppliers
           6.1.5 Bargaining Power of Buyers
    6.2 Key Pipeline Products
    6.3 Regulatory Outlook
           6.3.1 U.S.
           6.3.2 Canada
           6.3.3 Europe
           6.3.4 Asia-Pacific
           6.3.5 China
           6.3.6 India
           6.3.7 Japan
           6.3.8 South Korea
           6.3.9 Rest of the World
           6.3.10 Brazil
           6.3.11 Mexico
           6.3.12 Argentina
           6.3.13 Saudi Arabia
    6.4 Biosimilars Services Industry Insights
           6.4.1 Introduction
           6.4.2 Contract Manufacturing Organizations
           6.4.3 Contract Research Organizations
           6.4.4 Other Services (Nonclinical & Bioinformatics)

7 Biosimilars Market, By Type of Product (Page No. - 63)
    7.1 Introduction
    7.2 Recombinant Non-Glycosylated Proteins
           7.2.1 Insulin
           7.2.2 Recombinant Human Growth Hormone (RHGH)
           7.2.3 Granulocyte Colony-Stimulating Factor (Filgrastim)
           7.2.4 Interferons
    7.3 Recombinant Glycosylated Proteins
           7.3.1 Erythropoietin (EPO)
           7.3.2 Monoclonal Antibodies (MABS)
           7.3.3 Follitropin
    7.4 Recombinant Peptides
           7.4.1 Glucagon
           7.4.2 Calcitonin

8 Biosimilars Market, By Application (Page No. - 85)
    8.1 Introduction
    8.2 Oncology
    8.3 Blood Disorders
    8.4 Chronic and Autoimmune Diseases
    8.5 Growth Hormone Deficiency
    8.6 Infectious Diseases
    8.7 Other Applications

9 Biosimilars Market, By Region (Page No. - 93)
    9.1 Introduction
    9.2 North America
           9.2.1 U.S.
           9.2.2 Canada
    9.3 Europe
           9.3.1 U.K.
           9.3.2 Germany
           9.3.3 France
           9.3.4 Spain
           9.3.5 Italy
           9.3.6 Rest of Europe
    9.4 Asia-Pacific
           9.4.1 China
           9.4.2 India
           9.4.3 Japan
           9.4.4 South Korea
           9.4.5 Rest of Asia-Pacific (ROAPAC)
    9.5 Rest of the World (RoW)

10 Competitive Landscape (Page No. - 124)
     10.1 Overview of Biosimilars
     10.2 Market Share Analysis
     10.3 Competitive Situation and Trends
             10.3.1 New Product Launches and Regulatory Approvals
             10.3.2 Agreements and Collaborations
             10.3.3 Expansions
             10.3.4 Acquisitions
             10.3.5 Other Developments

11 Company Profiles (Page No. - 132)
     11.1 Introduction
     11.2 Hospira, Inc.
             11.2.1 Business Overview
             11.2.2 Product Offerings
             11.2.3 Recent Developments
             11.2.4 MnM View
     11.3 Roche Diagnostics (A Division of F. Hoffmann-La Roche Ltd.)
             11.3.1 Business Overview
             11.3.2 Product Offerings
             11.3.3 Recent Developments
     11.4 Sandoz International GmbH (A Division of Novartis International Ag)
             11.4.1 Business Overview
             11.4.2 Product Offerings
             11.4.3 Recent Developments
             11.4.4 MnM View
     11.5 Teva Pharmaceutical Industries Ltd.
             11.5.1 Business Overview
             11.5.2 Product Offerings
             11.5.3 Recent Developments
             11.5.4 MnM View
     11.6 Amgen
             11.6.1 Business Overview
             11.6.2 Product Offerings
             11.6.3 Recent Developments
     11.7 Biocon Ltd.
             11.7.1 Business Overview
             11.7.2 Product Offerings
             11.7.3 Recent Developments
     11.8 Dr. Reddy's Laboratories
             11.8.1 Business Overview
             11.8.2 Product Offerings
             11.8.3 Recent Developments
     11.9 Celltrion, Inc.
             11.9.1 Business Overview
             11.9.2 Product Offerings
             11.9.3 Recent Developments
     11.10 Mylan, Inc.
             11.10.1 Business Overview
             11.10.2 Product Offerings
             11.10.3 Recent Developments
     11.11 Merck KGAA
             11.11.1 Business Overview
             11.11.2 Product Offerings
             11.11.3 Recent Developments

12 Appendix (Page No. - 156)
     12.1 Discussion Guide
     12.2 Introducing RT: Real-Time Market Intelligence
     12.3 Available Customizations
     12.4 Related Reports of Biosimilars

List of Tables (84 Tables)

Table 1 Biologics Going Off-Patent to Boost the Market Growth for Biosimilars
Table 2 Stringent Regulatory Requirements in Major Countries Restraining the Growth for the Biosimilars Market
Table 3 List of Key Biologics Under the Threat of Patent Expiry
Table 4 Growth Prospects in Emerging Markets Fuel the Market Growth
Table 5 Status of Regulatory Pathway in North America Region
Table 6 Substitution Status in European Countries
Table 7 Status of Regulatory Pathway in the Asia-Pacific Region
Table 8 Status of Regulatory Pathway in the RoW
Table 9 Joint Ventures Between Cmos & Pharmaceutical Companies for Biosimilars
Table 10 Biosimilars Market Size, By Product Type, 2013–2020 ($Million)
Table 11 Recombinant Non-Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 12 Recombinant Non-Glycosylated Proteins Market Size, By Region, 2013–2020 ($Million)
Table 13 North America: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 14 Europe: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 15 Asia-Pacific: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 16 Insulin is Expected to Grow at the Highest CAGR in the Forecast Period
Table 17 Insulin Market Size, By Region, 2013–2020 ($Million)
Table 18 Recombinant Human Growth Hormone Market Size, By Region, 2013–2020 ($Million)
Table 19 List of Approved Products From 2012 to 2015.
Table 20 Granulocyte Colony-Stimulating Factor Market Size, By Region, 2013–2020 ($Million)
Table 21 Interferons Market Size, By Region, 2013–2020 ($Million)
Table 22 Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 23 Recombinant Glycosylated Proteins Market Size, By Region, 2013–2020 ($Million)
Table 24 North America: Recombinant Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 25 Europe: Recombinant Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 26 Asia-Pacific: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 27 Erythropoietin Market Size, By Region, 2013–2020 ($Million)
Table 28 Monoclonal Antibodies Market Size, By Region, 2013–2020 ($Million)
Table 29 Follitropin Market Size, By Region, 2013–2020 ($Million)
Table 30 Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 31 Recombinant Peptides Market Size, By Region, 2013–2020 ($Million)
Table 32 North America: Recombinant Peptides Market Size, By Country, 2013–2020 ($Million)
Table 33 Europe: Recombinant Peptides Market Size, By Country, 2013–2020 ($Million)
Table 34 Asia-Pacific: Recombinant Peptides Market Size, By Country, 2013–2020 ($Million)
Table 35 Glucagon Market Size, By Region, 2013–2020 ($Million)
Table 36 Calcitonin Market Size, By Region, 2013–2020 ($Million)
Table 37 Biosimilars Market Size, By Application, 2012–2019 ($Million)
Table 38 Biosimilars Market Size for Oncology, By Region, 2012–2019 ($Million)
Table 39 Biosimilars Market Size for Blood Disorders, By Region, 2012–2019 ($Million)
Table 40 Biosimilars Market Size for Chronic and Autoimmune Diseases, By Region, 2012–2019 ($Million)
Table 41 Biosimilars Market Size for Growth Hormone Deficiency, By Region, 2012–2019 ($Million)
Table 42 Biosimilars Market Size for Infectious Diseases, By Region, 2012–2019 ($Million)
Table 43 Biosimilars Market Size for Other Applications, By Region, 2012–2019 ($Million)
Table 44 Biosimilars Market Size, By Region, 2013–2020 ($Million)
Table 45 North America: Biosimilars Market Size, By Country, 2013–2020 ($Million)
Table 46 North America: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 47 North America: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 48 North America: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 49 North America: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 50 North America: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 51 Recombinant Peptides Will Drive the Growth of the Biosimilars Market in the U.S.
Table 52 U.S.: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 53 Canada: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 54 Europe: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 55 Europe: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 56 Europe: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 57 Europe: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 58 Europe: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 59 U.K.: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 60 Germany: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 61 France: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 62 Spain: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 63 Italy: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 64 RoE: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 65 Asia-Pacific: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 66 Asia-Pacific: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 67 Asia-Pacific: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 68 Asia-Pacific: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 69 Asia-Pacific: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 70 China: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 71 India: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 72 Japan: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 73 South Korea: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 74 ROAPAC: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 75 RoW: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 76 RoW: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 77 RoW: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 78 RoW: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 79 RoW: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 80 Recent New Product Launches and Regulatory Approvals, 2012–2015
Table 81 Recent Agreements and Collaborations, 2012–2015
Table 82 Recent Expansions, 2012–2015
Table 83 Recent Acquisitions 2012–2015
Table 84 Recent Other Developments, 2012–2015


List of Figures (39 Figures)

Figure 1 Global Biosimilars Market, By Product
Figure 2 Research Design
Figure 3 Top-Down Approach
Figure 4 Bottom-Up Approach
Figure 5 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 6 Data Triangulation Methodology
Figure 7 Market Snapshot: Recombinant Nonglycosylated Proteins to Dominate the Market
Figure 8 Asia-Pacific to Grow at the Highest Rate
Figure 9 Europe to Dominate Nonglycosylated Proteins Market During 2015-2020
Figure 10 Geographical Analysis of the Biosimilars Market
Figure 11 Biosimilars Market to Grow at A High Rate During the Forecast Period
Figure 12 Recombinant Nonglycosylated Proteins Segment Held the Largest Market Share in 2014
Figure 13 Europe Dominated the Biosimilars Market in 2014
Figure 14 Recombinant Nonglycosylated Proteins Will Continue to Lead the Biosmilar Market in the Forecast Period
Figure 15 Insulin Segment to Witness Highest Growth Rate From 2015 to 2020
Figure 16 Asia-Pacific to Witness High Growth in the Biosimilars Market During the Forecast Period
Figure 17 Biosimilars Market: Drivers, Restraints, & Opportunities
Figure 18 Erythropoietin is Expected to Dominate the Market in the Forecast Period
Figure 19 Glucagon Will Continue to Dominate the Market in the Forecast Period
Figure 20 Oncology Dominates the Biosimilars Applications Market
Figure 21 Geographic Snapshot (2015): Emerging Markets Hold Significant Growth Opportunities for Biosimilars
Figure 22 Asia, an Attractive Market for Biosimilars
Figure 23 Growing Demand for Biopharmaceutical Drugs is Driving Market Growth
Figure 24 Recombinant Glycosylated Proteins Will Continue to Hold the Largest Share in the European Market
Figure 25 Biosimilars Market Growing at the Highest CAGR in Asia-Pacific
Figure 26 Major Players Adopted the Strategy of Approvals to Enhance Their Market Positions in the Biosimilars Market
Figure 27 Global Biosimilars Market Share, By Key Player, 2014
Figure 28 Battle for Market Share: New Product Launches and Regulatory Approvals Was the Key Strategy Adopted By Market Players
Figure 29 Product Benchmarking for Top 3 Players
Figure 30 Hospira, Inc.: Company Snapshot
Figure 31 Roche Diagnostics: Company Snapshot
Figure 32 Sandoz International GmbH: Company Snapshot
Figure 33 Teva Pharmaceutical Industries Ltd.: Company Snapshot
Figure 34 Amgen: Company Snapshot
Figure 35 Biocon Ltd.: Company Snapshot
Figure 36 Dr. Reddy's Laboratories: Company Snapshot
Figure 37 Celltrion, Inc.: Company Snapshot
Figure 38 Mylan, Inc.: Company Snapshot
Figure 39 Merck KGAA: Company Snapshot

The biosimilars market is expected to reach $6.22 Billion by 2020 from $2.29 Billion in 2015, growing at a CAGR of 22.1% from 2015 to 2020. Key factors such as growing pressure to curtail healthcare expenditure, growing demand for biosimilar drugs due to their cost-effectiveness, rising incidences of various diseases, increasing number of off-patented drugs, positive outcomes in the ongoing clinical trials, and rising demand for biosimilars in different therapeutic applications such as rheumatoid arthritis and blood disorders are propelling the growth of the global market. However, factors such as high manufacturing complexities and costs, stringent regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

The global biosimilars market is segmented on the basis of products and applications. On the basis of products, the market is segmented into recombinant nonglycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant nonglycosylated proteins market is further segmented into insulin, granulocyte colony-stimulating factor (G-CSF), interferons, and human growth hormone; whereas, the recombinant glycosylated proteins market is further segmented into erythropoietin, monoclonal antibodies, and follitropin. The recombinant peptides market is segmented into calcitonin and glucagon. The recombinant glycosylated proteins segment is expected to witness the highest growth rate owing to the increased demand for monoclonal antibodies in the treatment of cancer (oncology), autoimmune disorders, blood disorders, and infectious diseases.

On the basis of applications, the biosimilars market is segmented into oncology, blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, and other applications (female infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, and chronic kidney failure). Oncology accounts for the largest share of the global market, owing to the launch of new biosimilars, namely, Remsima (monoclonal antibody) in Europe, and Neutroval and tbo-filgrastim in the U.S. On the other hand, the chronic and autoimmune disorders segment is expected to grow at the highest CAGR of 25.7% from 2015 to 2020. The high growth in this segment can be attributed to the rising incidences of autoimmune disorders such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, Type 1 diabetes, and psoriasis.

Geography, the biosimilars market is segmented into North America, Europe, Asia-Pacific, and the RoW (Latin America, Middle East, and Africa). In 2015, Europe is expected to dominate the global market; growth in this market can be attributed to the growing pressure to curtail healthcare costs, patent expiry of biologic products, launch of new biosimilar products, rising incidences of chronic disorders (such as cancer, diabetes, and rheumatoid arthritis), and emergence of new market participants in this region. However, the Asia-Pacific market is expected to grow at the highest CAGR from 2015 to 2020, owing to the developing healthcare infrastructure, presence of a large patient population, increasing funding/investment towards the development of biosimilars, and growing focus of both international and domestic players on Asia-Pacific countries.

New product launches and expansions are the key strategies adopted by major players to strengthen their positions in the global biosimilars market. Moreover, strategies such as partnerships, agreements, collaborations, joint ventures, and acquisitions were also adopted by a significant number of market players to strengthen their product portfolios and expand their geographic presence.

The key players in the global biosimilars market include Sandoz International GmbH (Germany), Hospira, Inc. (U.S.), Teva Pharmaceutical Industries Ltd. (Israel), Dr. Reddy’s Laboratories (India), Biocon Limited (India), Mylan, Inc. (U.S.), Amgen (U.S.), Celltrion Inc. (South Korea), Roche Diagnostics (Switzerland), and Merck KGaA (Germany).

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