Recombinant Therapeutic Antibodies and Proteins Market– A Novel Approach to Treat Rare and Chronic Diseases

Therapeutic proteins are engineered in the laboratory for pharmaceutical use, including non-covalent binders. These proteins are highly effective and serve as modernized treatment for rare as well as chronic diseases. Protein therapeutics offer custom-made treatment approach by supporting a specifically targeted therapeutic process by compensating the deficiency of an essential protein. Recombinant proteins have gained significant traction for therapeutic applications and the number of proteins either launched or approved into clinical trials has continually increased over the past two decades. According to the National Center for Biotechnology Information (NCBI) data of 2017, the U.S. Food and Drug Administration (FDA) approved over 140 recombinant therapeutic proteins for human use and several hundred are currently in development. Majority of these proteins are recombinant monoclonal antibodies.

The global recombinant therapeutic antibodies and proteins market size was valued at US$ 91.2 billion in 2017, and is expected to witness a robust CAGR of 12.2% over the forecast period (2018 – 2026).

Figure 1. Global Recombinant Therapeutic Antibodies and Proteins Market Share (%), By Drug Class

   Recombinant Therapeutic Antibodies & Proteins  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2018)

 

Advancements in recombinant therapeutic drugs are expected to bolster the recombinant therapeutic antibodies and proteins market growth

Integration of novel approaches and strategies to modify protein drug products is an important aspect. Advancements in recombinant protein technologies have allowed drug manufacturers and developers to adjust required functional characteristics of proteins of interest while maintaining product efficacy and safety.

Various recombinant technologies are currently in use to increase the half-life, functionality, and targeting of novel therapeutic protein drugs and increase product purity and volume. For instance, protein conjugation and derivatization methods, including albumin-fusion15, PEGylation and Fc-fusion are currently being used to extend a drug’s circulating half-life.

Monoclonal antibodies (mAbs) are most commonly used recombinant therapeutic products. The production of most monoclonal antibody products is easily amenable to effective platform-based approaches as antibodies are highly specific and the risk of unexpected safety issues in human clinical trials of mAb products is less as compared to other types of therapeutic products. The constant evaluation of monoclonal antibody drugs in new and expanded clinical indications results in constant demand for products in clinical studies ensuing increased sales in newly approved indications.

Figure 2. Recombinant Therapeutic Antibodies and Proteins Market (US$ Bn), By Region, 2017

Recombinant Therapeutic Antibodies & Proteins  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2018)

Increasing government support for novel drug development is expected to augment the market growth

Governments are supporting research and development of novel products due to rapid advancements in biomedical science and technology to address unmet medical needs. In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed to provide the FDA with the capability to establish breakthrough therapy designation (BTD), a new program within the Expedited Programs for Serious Conditions. It was designed to be available for drugs designed to treat a serious condition and that have been shown to exhibit initial clinical evidence of significant improvement over existing treatments.

Moreover, increasing number of rare diseases significantly impacting public health is expected to drive growth of the recombinant therapeutic antibodies and proteins market size. According to National institute of Health (NIH) 2018 report, an estimated 7,000 different disorders collectively affect about 10% of the U.S. population, mainly young children and many lack effective treatments. In order to encourage the development of drugs that specifically address unmet medical needs, in 2013, an orphan designation was given for drugs used for the treatment of less than 200,000 patients in the U.S.

However, government regulations are stringent for production and approval of recombinant therapeutic drugs in order to ensure that these products are effective and safe.

Major players operating in the global recombinant therapeutic antibodies and proteins market include Abbott, Amgen Inc., Biogen Inc., Eli Lilly and Company, F. Hoffmann-La Roche, Johnson and Johnson, Merck & Co., Novo Nordisk, Pfizer Inc., and Sanofi S.A.

Recombinant therapeutic protein drugs are an important class of medicines, which helps patients in need of novel therapies. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, inflammation/autoimmunity, genetic disorders, and exposure to infectious agents. The latest advancements in protein-engineering technologies have allowed drug manufacturers and developers to adjust desirable functional characteristics of proteins of interest maintaining product efficacy. Protein-based therapies are highly successful and experience unparalleled growth potential in terms of their efficacy.

Market Dynamics

Recombinant therapeutic proteins and antibodies have gained high traction in clinical applications. Due to development of antibody-based therapeutics, mammalian expression systems have experienced a major boost and microbial expression systems continue to be widely used in industries, which in turn will fuel growth of the market. However, variations in production methods of therapeutic antibodies can lead to differences in their structure, based on the selection of recombinant procedure. Most protein therapeutics available in the market are recombinant and majority of them are in clinical trials for therapy of immune disorders, cancers, infections, and other diseases. Various engineered proteins, including multi-specific fusion proteins, bi-specific monoclonal antibodies (mAbs) and mAbs conjugated small molecule drugs, and proteins with optimized pharmacokinetics are under development.

Key features of the study:

  • This report provides in-depth analysis of recombinant therapeutic antibodies and proteins market and provides market size (US$ Million) and cumulative annual growth rate (CAGR %) for the forecast period (2018 – 2026), considering 2017 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategy adopted by the leading players
  • It profiles leading players in the global recombinant therapeutic antibodies and proteins market based on the following parameters – company overview, financial performance, product portfolio, market presence, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Abbott, Amgen Inc., Biogen Inc., Eli Lilly and Company, F. Hoffmann-La Roche, Johnson and Johnson, Merck & Co., Novo Nordisk, Pfizer Inc., and Sanofi S.A.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launch, technology up-gradation, market expansion, and marketing tactics
  • The global recombinant therapeutic antibodies and proteins market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the recombinant therapeutic antibodies and proteins market

Detailed Segmentation:

  • Global Recombinant Therapeutic Antibodies and Proteins Market, By Drug Class:
    • Plasma Protein
    • Growth Factors
    • Fusion Proteins
    • Monoclonal Antibodies
    • Hormones
    • Enzyme
    • Coagulation Factors
    • Others
  • Global Recombinant Therapeutic Antibodies and Proteins Market, By Application:
    • Oncology
    • Hematology
    • Immunology
    • Endocrinology
    • Infectious Disease
    • Cardiovascular Diseases
    • Others
  • Global Recombinant Therapeutic Antibodies and Proteins Market, By Geography:
    • North America Recombinant Therapeutic Antibodies and Proteins Market
      • By Drug Class:
        • Plasma Protein
        • Growth Factors
        • Fusion Proteins
        • Monoclonal Antibodies
        • Hormones
        • Enzyme
        • Coagulation Factors
        • Others
      • By Application:
        • Oncology
        • Hematology
        • Immunology
        • Endocrinology
        • Infectious Disease
        • Cardiovascular Diseases
        • Others
      • By Country:
        • U.S.
        • Canada
    • Latin America Recombinant Therapeutic Antibodies and Proteins Market
      • By Drug Class:
        • Plasma Protein
        • Growth Factors
        • Fusion Proteins
        • Monoclonal Antibodies
        • Hormones
        • Enzyme
        • Coagulation Factors
        • Others
      • By Application:
        • Oncology
        • Hematology
        • Immunology
        • Endocrinology
        • Infectious Disease
        • Cardiovascular Diseases
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe Recombinant Therapeutic Antibodies and Proteins Market
      • By Drug Class:
        • Plasma Protein
        • Growth Factors
        • Fusion Proteins
        • Monoclonal Antibodies
        • Hormones
        • Enzyme
        • Coagulation Factors
        • Others
      • By Application:
        • Oncology
        • Hematology
        • Immunology
        • Endocrinology
        • Infectious Disease
        • Cardiovascular Diseases
        • Others
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific Recombinant Therapeutic Antibodies and Proteins Market
      • By Drug Class:
        • Plasma Protein
        • Growth Factors
        • Fusion Proteins
        • Monoclonal Antibodies
        • Hormones
        • Enzyme
        • Coagulation Factors
        • Others
      • By Application:
        • Oncology
        • Hematology
        • Immunology
        • Endocrinology
        • Infectious Disease
        • Cardiovascular Diseases
        • Others
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East Recombinant Therapeutic Antibodies and Proteins Market
      • By Drug Class:
        • Plasma Protein
        • Growth Factors
        • Fusion Proteins
        • Monoclonal Antibodies
        • Hormones
        • Enzyme
        • Coagulation Factors
        • Others
      • By Application:
        • Oncology
        • Hematology
        • Immunology
        • Endocrinology
        • Infectious Disease
        • Cardiovascular Diseases
        • Others
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa Recombinant Therapeutic Antibodies and Proteins Market
      • By Drug Class:
        • Plasma Protein
        • Growth Factors
        • Fusion Proteins
        • Monoclonal Antibodies
        • Hormones
        • Enzyme
        • Coagulation Factors
        • Others
      • By Application:
        • Oncology
        • Hematology
        • Immunology
        • Endocrinology
        • Infectious Disease
        • Cardiovascular Diseases
        • Others
      • By Country:
        • North Africa
        • South Africa
        • Central Africa
  • Company Profiles
    • Abbott Laboratories*
      • Company Overview
      • Product Portfolio
      • Key Highlights
      • Financial Overview
      • Market Strategy
    • Amgen Inc.
    • Biogen Inc.
    • Eli Lilly and Company
    • F. Hoffmann-La Roche
    • Johnson and Johnson
    • Merck & Co.
    • Novo Nordisk
    • Pfizer, Inc.
    • Sanofi S.A.

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Drug Class
      • Market Snippet, By Application
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Market Trends
    • Pipeline Analysis
    • Drug Development Challenges
    • New Market Entrants
    • Regulatory Scenario
    • PEST Analysis
    • Porter’s Analysis
  4. Global Recombinant Therapeutic Antibodies and Proteins Market, By Drug Class, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • Plasma Protein
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Growth Factors
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Fusion Proteins
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Monoclonal Antibodies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Hormones
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Enzyme
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Coagulation Factors
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  5. Global Recombinant Therapeutic Antibodies and Proteins Market, Application, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • Oncology
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Hematology
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Immunology
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Endocrinology
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Infectious Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Cardiovascular Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  6. Global Recombinant Therapeutic Antibodies and Proteins Market, By Region, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
      • Regional Trends
    • North America
      • Market Size and Forecast, By Drug Class, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Drug Class, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Drug Class, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • Germany
        • U.K.
        • France        
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Drug Class, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • Market Size and Forecast, By Drug Class, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Drug Class, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • South Africa
        • Central Africa
        • North Africa
  7. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Abbott*
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Amgen Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Biogen Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Eli Lilly and Company
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • F. Hoffmann-La Roche
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Johnson and Johnson
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Merck & Co.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Novo Nordisk
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Pfizer Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
      • Sanofi S.A.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Market Strategy
    • Analyst Views
  8. Section
    • References
    • Research Methodology
    • About us and Sales Contact

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