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.
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.
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.
- 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
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.