An antibody (Ab), also known as an immunoglobulin (Ig), is secreted by B cells of the adaptive immune system, mostly by differentiated B cells called plasma cells. Antibodies are used in the treatment of various cancers and other diseases such as rheumatoid arthritis and psoriasis.

Statistics:

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

Increasing demand for antibody-drug conjugates (ADCs) is expected to propel growth of the global antibodies market over the forecast period. ADCs use monoclonal antibodies to specifically bind tumour-associated target antigens and deliver a highly potent cytotoxic agent. This has led to increasing adoption of ADCs for the treatment of cancer.

Global Antibodies Market: Opportunities

Major players in the market can focus on expanding their presence in Africa, especially with focus on launching generic products. This is owing to high incidence of cancer in the region and regulatory reforms for development and registration of biosimilars. For instance, according to the World Health Organization, the number of new cancer cases diagnosed per year in Africa is expected to grow from over 1 million in 2018 to over 2.1 million in 2040. Moreover, in August 2014, Medicines Control Council of South Africa amended guidelines for the development and registration of biosimilars in South Africa to include requirements for registering monoclonal antibody biosimilars.

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Key Takeaways:

The monoclonal antibodies sub segment in the drug type segment in global antibodies market was valued at US$ 124,936.8 Mn in 2018 and is expected to reach US$ 367,264.6 Mn by 2027 at a CAGR of 12.6% during the forecast period.

Increasing approval and robust pipeline of novel human monoclonal antibodies is expected to aid in the segment growth. In the years 2014-2018, highest number of monoclonal antibodies (i.e. 6) were approved in the U.S. in 2018 and Europe witnessed highest number of monoclonal antibodies (i.e. 8) approval in 2017. Out of 8 approvals in Europe in 2017, 4 were biosimilar versions of Humira (adalimumab).

The cancer sub segment in disease indication segment held dominant position in the global antibodies market in 2018, accounting for 54.8% share in terms of value.

High prevalence of cancer and frequent approval and launch of novel monoclonal antibodies in the market is expected to significantly drive growth of the cancer segment over the forecast period. During the past five years (2014-2018), highest number of monoclonal antibodies for cancer treatment (i.e. 12) were approved in Europe in 2017. Out of 12 monoclonal antibodies approved in Europe for cancer treatment in 2017, 6 were biosimilar versions of Roche’s Rituxan (rituximab).

The hospitals sub segment in end user segment held dominant position in the global antibodies market in 2018, accounting for 86.4% share in terms of value, followed by long term care facilities, and research institutes, respectively.

Hospitals segment is expected to gain major market share in the global monoclonal antibodies as cancers drugs such as Herceptin, Avastin, and Rituxan need to be administered in hospitals.

Market Trends

The market is witnessing increasing development of site-specific drug conjugation that are based on introducing selectively reactive molecules at specific locations along the monoclonal antibodies. The approach enhances the therapeutic window of ADCs and reduces toxicity. Some of the widely used site-specific drug conjugation techniques include, conjugation via novel unpaired cysteine residues conjugation via transglutaminases and, conjugation via unnatural amino acids.

Major players in the market are also focused on introducing highly validated conjugated antibodies. For instance, in January 2020, Proteintech Group, an antibody manufacturer, launched over 500 antibodies directly conjugated with high-performance CoraLite488 and CoraLite594 dyes.

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Regulations

Europe

In the European Union (EU), biological products including therapeutic monoclonal antibodies are subject to the approval from European Medicines Agency (EMA) through centralized procedure

Manufacturers of all the biological products are required to get the marketing authorization application (MAA) prior to the marketing of any biological drugs in the European market

Centralized MAA for biological products obtained under Regulation (EC) No 726/2004 of the European Parliament And Of The Council allows the applicant to market their product in all the 27 member countries

For biological drugs which have got orphan drug designation should obtain MAA as per Regulation (EC) No 141/2000 of the European Parliament And Of The Council

For the development of biosimilar biologics, EMA released a guideline for regulatory approval of similar biologics in 2005

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

In January 2020, Iovance Biotherapeutics, Inc. obtained a license from Novartis to develop and commercialize an antibody cytokine engrafted protein, referred to as IOV-3001

In December 2019, Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. submitted a supplemental Biologics License Application for Crysvita (burosumab) – a recombinant fully human monoclonal IgG1 antibody indicated for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized – to the U.S. Food and Drug Administration.

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