Antibodies market analysis | Coherent Market Insights

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• ANTIBODIES MARKET ANALYSIS
• 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

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• 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.

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• 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.

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• 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.

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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.

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Regulations

• 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
  (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 (FDC) act
• In U.S., biosimilar biologics product approval is
  submitted to FDA under section 351(k) of the
  Public Health Service Act

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Regulations

• 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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