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Antibodies market analysis | Coherent Market Insights


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Title: Antibodies market analysis | Coherent Market Insights

Coherent Marketing Insights
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  • Antibodies Market, By Product Type (Monoclonal
    antibodies, Polyclonal antibodies, Antibody-drug
    complexes (ADCs)), By Disease Indication (CNS
    Disorders, Cardiovascular Diseases, Cancer,
    Autoimmune Disorders), By End User (Hospitals,
    Long-term Care Facilities, Research institutes),
    and By Region (North America, Europe, Asia
    Pacific, Latin America, Middle East Africa) -
    Size, Share, Outlook, and Opportunity Analysis,
    2019 - 2027

  • 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.

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

  • 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

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.

  • North America
  • U.S.
  • Therapeutic antibodies are the biological
    products which are regulated by both the FDAs
    Center for Drug Evaluation and Research (CDER)
    and Center for Biologics Evaluation and Research
  • 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
  • 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 (FDC) act
  • In U.S., biosimilar biologics product approval is
    submitted to FDA under section 351(k) of the
    Public Health Service Act

  • 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 Ligands 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.

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About Us
  • Coherent Market Insights is a global market
    intelligence and consulting organization focused
    on assisting our plethora of clients achieve
    transformational growth by helping them make
    critical business decisions. We are headquartered
    in India, having office at global financial
    capital in the U.S. Our client base includes
    players from across all business verticals in
    over 150 countries worldwide.
  • What We ProvideCustomized Market Research
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Contact Us
  • Mr. Shah
  • Coherent Market Insights Pvt. LTD.Coherent
    Market Insights 1001 4th Ave, 3200 Seattle, WA
    98154, U.S.Phone 1-206-701-6702
  • Email

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