Impact Analysis of Covid-19

The complete version of the REPORT will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.

Antibodies Market – Insights

Antibody, also called as immunoglobulin, is a protein produced by plasma cells in response to specific antigens. These antibodies can be used as therapeutic as well as diagnostic purposes for several indications, including cancers, autoimmune disorders, inflammatory & infectious diseases and others.

The global antibodies market is estimated to account for US$ 147,385.1 Mn in terms of value and is expected to reach US$ 384,011.6 Mn by the end of 2027.

Global Antibodies Market: Drivers

Therapeutic monoclonal antibodies find wide application in oncology, neurobiology, autoimmunology, and cardiology. Increasing prevalence of chronic disease is expected to propel growth of the global antibodies market. For instance, according to the World Health Organization, around 18.1 million new cases and 9.6 million deaths were registered due to cancer worldwide in 2018.

Moreover, availability of inexpensive biosimilar antibody therapeutics is also expected to aid in growth of the market. For instance, in December 2019, the World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab –– a monoclonal antibody for the treatment of early stage breast cancer. On an average trastuzumab costs US$ 20,000. However, the biosimilar version of trastuzumab is generally 65% cheaper than the originator.

North America region held dominant position in the global antibodies market in 2018, accounting for 44.5% share in terms of value, followed by Europe.

Antibodies  | Coherent Market Insights

Global Antibodies Market: Restraints

High cost of therapeutic antibodies is expected to hamper growth of the global antibodies market. For instance, in the U.S., the monthly treatment cost for rheumatoid arthritis with Humira is over US$ 5,500.

Use of antibodies may lead to some side effects such as serum sickness, acute anaphylaxis, and specific target-related adverse effects, which is also expected to hinder the market growth.

Global Antibodies Market: Opportunities

The patent of several blockbuster antibody products is set to expire in the near future. Therefore, key players in the market can focus on launching biosimilar antibodies to enhance their market share.

Moreover, evolution of clear regulatory approval process for biosimilars in emerging markets represents additional opportunity for antibody-based products. For instance, in 2012, Central Drugs Standard Control Organization, Gov. of India released regulatory requirements for marketing approval of similar biologics in India, which was revised in 2016 for more clarity. According to the revision, the reference biologic may be approved or marketed either in India or any other International Council for Harmonization countries.

Antibodies  | Coherent Market Insights

Drug type segment in the global antibodies market was valued at US$ 131,472.4 in 2018 and is expected to reach US$ 384,011.6 by 2027 at a CAGR of 12.5% during the forecast period.

Market Trends/Key Takeaways

The adoption of antibody-based drugs for the treatment of cancer has significantly increased. Monoclonal antibody therapeutics offer high specificity, activity, favorable pharmacokinetics, and standardized manufacturing processes. Moreover, antibodies can increase immune response against cancer cells through complement-dependent cytotoxicity or antibody dependent cellular cytotoxicity.

The use of antibodies as a diagnostic reagents for the identification of disease markers or proteins based on immunoassays has decreased. This is attributed to increasing accuracy of molecular diagnostic tools.

Regulations:

North America

U.S.

  • Therapeutic antibodies are the biological products which are regulated by both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER)
  • Therapeutic antibody products (including monoclonal antibody, antibody drug conjugates, Fc fragment proteins) are subject to submission of biologics license application (BLA)
  • Manufacturers of therapeutic antibody products thus needed to submit BLA to CBER or CDER under 21 CFR 601.2, which contains safety, purity and potency data from clinical and non-clinical laboratory studies and other manufacturing information
  • Whereas, diagnostic antibodies are classified under in vitro diagnostic device (IVD) as Analyte Specific Reagents (ASR) and thus subject to regulations under 21CFR864.4020
  • Diagnostic antibodies which are used in immunological testing of infectious diseases are classified as Class II IVDs whereas antibodies used for diagnosis of highly contagious diseases such as HIV, TB are classified as Class III IVDs, both of which require to obtain premarket approval under section  510 (k) of  S. federal food drug and cosmetics (FD&C) act
  • In U.S., biosimilar biologics product approval is submitted to FDA under section 351(k) of the Public Health Service Act

Antibodies  | Coherent Market Insights

Global Antibodies Market: Competitive Landscape

Major players operating in the global antibodies market include, Novartis AG, F. Hoffmann-La Roche Ltd., Johnson & Johnson Services, Inc., Takeda Pharmaceutical Company Limited, Amgen Inc., Biogen Inc., Bristol-Myers Squibb Company, AbbVie Inc., Sanofi, Eli Lilly and Co., Iovance Biotherapeutics, Inc., Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd.

Global Antibodies Market: Key Developments

Key players in the market are focused on adopting partnership and collaboration strategies to expand their product portfolio. For instance, in January 2020, MorphoSys AG collaborated with Incyte Corporation for development and commercialization of MorphoSys’ tafasitamab, a humanized Fc-engineered monoclonal antibody against CD19.

Similarly, in January 2020, Ligand Pharmaceuticals Inc. entered into a license agreement with Pandion Therapeutics, under which the later will use Ligand’s OmniAb antibody discovery platform in exchange of an up-front platform access fee, development and regulatory milestone payments, and potential royalties on sales of marketed products.

Antibodies are used in therapeutic application for the treatment of diseases such as cancer, autoimmune diseases, hematological diseases, infectious diseases, and others. Increasing prevalence of cancer is expected to create lucrative opportunities for growth of manufacturers in the market. For instance, according to the National Cancer Institute, 2016, the number of new cancer cases per year is expected to increase to 23.6 million by 2030, worldwide. Antibodies products come under biologic therapeutic products. Biologic manufacturers require approval (similar to pharma drug approval) from the U.S. Food & Drug Administration prior to bringing the product in the market. However, unlike drugs, biologics require Biologics License Applications (BLA) to be filed with the Center for Biologics Evaluation and Research (CBER). Moreover, various government authorities are focused on controlling/lowering drug prices by adding reforms. For instance, the U.S. government is seeking to lower patients out-of-pocket spending in Medicare by curbing deals that drug manufacturers make with its distribution channel partners such as pharmacy benefit managers, February 2019 (these deals are responsible for increasing list price of drugs).

Restraints of the Global Antibodies Market

High cost of monoclonal antibodies therapies makes it unaffordable for the population in the low- and middle-income group to opt for these therapies, which in turn restrains growth of the market. For instance, Keytruda (Pembrolizumab), a monoclonal antibody for the treatment of various types of cancer, costs around US$ 2,250 for a vial of 50 mg.

Key features of the study:

  • This report provides in-depth analysis of the global antibodies market and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2019–2027), considering 2018, as the base year
  • It elucidates potential revenue opportunity 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, regional outlook, and competitive strategy adopted by leading players
  • It profiles leading players in the global antibodies market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Novartis AG, F. Hoffmann-La Roche Ltd., Johnson & Johnson Services, Inc., Takeda Pharmaceutical Company Limited, Amgen Inc., Biogen Inc., Bristol-Myers Squibb Company, AbbVie Inc., Sanofi, Eli Lilly and Co., Iovance Biotherapeutics, Inc., Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd.
  • Insights from this report would allow marketers and the management authorities of companies to make informed decision regarding future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global antibodies 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 market.

Detailed Segmentation

  •  Global Antibodies Market, By Product Type:
    • Monoclonal antibodies
    • Polyclonal antibodies
    • Antibody-drug complexes (ADCs)
  • Global Antibodies Market, By Disease Indication:
    • CNS Disorders
    • Cardiovascular Diseases
    • Cancer
    • Autoimmune Disorders
  • Global Antibodies Market, By End User:
    • Hospitals
    • Long-term Care Facilities
    • Research institutes
  • Global Antibodies Market, By Geography:
    • North America
      • By Product Type
        • Monoclonal antibodies
        • Polyclonal antibodies
        • Antibody-drug complexes (ADCs)
      • Disease Indication
        • CNS Disorders
        • Cardiovascular Diseases
        • Cancer
        • Autoimmune Disorders
      • By End User
        • Hospitals
        • Long-term Care Facilities
        • Research institutes
      • By Country:
        • U.S.
        • Canada
    • Europe
      • By Product Type
        • Monoclonal antibodies
        • Polyclonal antibodies
        • Antibody-drug complexes (ADCs)
      • Disease Indication
        • CNS Disorders
        • Cardiovascular Diseases
        • Cancer
        • Autoimmune Disorders
      • By End User
        • Hospitals
        • Long-term Care Facilities
        • Research institutes
      • By Country:
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Product Type
        • Monoclonal antibodies
        • Polyclonal antibodies
        • Antibody-drug complexes (ADCs)
      • Disease Indication
        • CNS Disorders
        • Cardiovascular Diseases
        • Cancer
        • Autoimmune Disorders
      • By End User
        • Hospitals
        • Long-term Care Facilities
        • Research institutes
      • By Country:
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • By Product Type
        • Monoclonal antibodies
        • Polyclonal antibodies
        • Antibody-drug complexes (ADCs)
      • Disease Indication
        • CNS Disorders
        • Cardiovascular Diseases
        • Cancer
        • Autoimmune Disorders
      • By End User
        • Hospitals
        • Long-term Care Facilities
        • Research institutes
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East:
      • By Product Type
        • Monoclonal antibodies
        • Polyclonal antibodies
        • Antibody-drug complexes (ADCs)
      • Disease Indication
        • CNS Disorders
        • Cardiovascular Diseases
        • Cancer
        • Autoimmune Disorders
      • By End User
        • Hospitals
        • Long-term Care Facilities
        • Research institutes
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Product Type
        • Monoclonal antibodies
        • Polyclonal antibodies
        • Antibody-drug complexes (ADCs)
      • Disease Indication
        • CNS Disorders
        • Cardiovascular Diseases
        • Cancer
        • Autoimmune Disorders
      • By End User
        • Hospitals
        • Long-term Care Facilities
        • Research institutes
      • By Country/Region:
        • Central Africa
        • South Africa
        • North Africa
  • Company Profiles
    • Novartis International AG*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
    • F. Hoffmann-La Roche Ltd.
    • Johnson & Johnson Services, Inc.
    • Takeda Pharmaceutical Company Limited
    • Amgen Inc.
    • Biogen Inc.
    • Bristol-Myers Squibb Company
    • AbbVie Inc.
    • Sanofi S.A.
    • Eli Lilly and Co.
    • Iovance Biotherapeutics, Inc.
    • Ultragenyx Pharmaceutical Inc.
    • Kyowa Kirin Co., Ltd.

“*” 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 Type
      • Market Snippet, By Disease Indication
      • Market Snippet, By End User
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Key Developments
    • Technological Advancement
    • Regulatory Scenario
  4. Global Antibodies Market, By Drug Type, 2017 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2019–2027
      • Segment Trends
    • Monoclonal Antibodies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
      • Segment Trends
    • Polyclonal Antibodies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
      • Segment Trends
    • Antibody-drug complexes (ADCs)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
      • Segment Trends
  5. Global Antibodies Market, By Disease Indication, 2017 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2019–2027
      • Segment Trends
    • CNS Disorders
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
    • Cardiovascular Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
    • Cancer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
    • Autoimmune Disorders
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
  6. Global Antibodies Market, By End User, 2017 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2019–2027
      • Segment Trends
    • Hospitals
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
    • Long-term Care Facilities
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
    • Research institutes
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
  7. Global Antibodies Market, By Regions, 2017 – 2027 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2019–2027
      • Segment Trends
    • North America
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
        • U.S.
        • Canada
    • Europe
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019 – 2027, (US$ Mn)
        • North Africa
        • Central Africa
        • South Africa
  8. Competitive Landscape
    • Company Profiles
      • Novartis International AG
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Hoffmann-La Roche Ltd.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Johnson & Johnson Services, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Takeda Pharmaceutical Company Limited
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Amgen Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Biogen Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Bristol-Myers Squibb Company
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • AbbVie Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Sanofi S.A.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Eli Lilly and Co.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Iovance Biotherapeutics, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Ultragenyx Pharmaceutical Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Kyowa Kirin Co., Ltd.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 36 market data tables and 27 figures on “Antibodies Market – Global forecast to 2027.

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