Growing number of innovative product launches and expansion of therapeutic indications for already approved antibody therapeutics will continue to drive the growth of the antibodies market. In biopharmaceutical drugs, monoclonal antibody-based therapeutics are the dominant form of biologic drugs — 6 of 10 top-selling drugs in 2017 were antibodies. The antibodies market is expected to witness impressive growth due to growing new drug approvals across the globe. Number of antibody-based therapeutics granted first approval reached double-digits for the first time in 2017 and a total of 9 antibody candidates were undergoing regulatory review. Future Market Insights forecasts that the global antibodies market is projected to expand at a robust CAGR of 12.5% over 2016–2026.
Harmonization of international drug regulatory pathways is likely to be instrumental in driving the number of new antibody-based therapeutics approved for commercial sales in the US and Europe and thus, will be a strong driving factor for antibodies market. As the European Union (EU) and the U.S. possesses distinct but overlapping schemes for the biologics regulations, both the authorities are making harmonization efforts with respect to some of the technical requirements for biologic applications.
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As a result, regulatory procedures in two major markets are getting more streamlined to comply with common standards and practices between EMEA and U.S. FDA. Moreover, evolution of the clear regulatory approval process for biosimilar in emerging markets represents additional opportunity for antibody based products. This is expected to provide key contribution to the expansion of the antibodies market at a global front. Future Market Insights estimates that the global antibodies market value is expected to surpass US$ 341 Bn by 2026 end.
Significant technological advances in the fields of immunology and protein science are driving the development of antibody-based drugs in a range of therapeutic areas. Antibody-based drugs cover the big spread of disease indications, including autoimmune diseases, such as arthritis & transplant rejection, various cancers, dermatological disorders, hematological disorders and inflammatory diseases, among others.
Novel technologies will enhance the therapeutic potential of antibodies. Development of antibody drug conjugates (ADCs) and bispecific antibodies have opened up new opportunities in immunotherapeutic research. Since the FDA approval of first ADC in 2011, ADCs have become the major developmental candidates in the pipeline of many companies. Furthermore, diagnostic antibodies are increasingly gaining acceptance in diagnosis of certain conditions, such as myeloid & lymphoid malignancies, tissue typing, etc. This growth in antibodies as a therapeutic and diagnostic agent was made possible partly by the development of large-scale production techniques, such as mammalian cell culture, which allowed production in quantities that meet the market requirements.
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Based on company announcements and estimated primary completion dates, above 18 late stage clinical candidates of antibody drug class and marketing applications for 12 candidates are expected to be submitted to regulatory authorities (FDA & EU) by 2018 end. Percentage contribution of non-cancer monoclonal antibodies indication segment is rising steadily and collective revenue share of non-cancer antibodies is estimated to exceed 40% of global antibodies market by 2026 end.
Sales of antibody-based therapeutics and diagnostics is likely to remain concentrated in the regulated markets of Europe, the U.S. and Japan. However, the launch of biosimilar antibodies is expected to fuel the demand for antibody-based therapeutics in emerging markets. Asia Pacific excluding Japan (APEJ) market for antibodies lags behind in technology due to comparatively late beginning of clinical development of therapeutic antibodies in the region. As a result, currently approved and marketed products in APEJ are technologically outsourced from key players in established markets, such as Roche and Merck & Co.
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Overall, the global antibodies market is highly competitive with over 22 big biopharma companies operating in it. Introduction of biosimilar antibodies has further increased the competition intensity in the last two years. Despite this, the global antibodies market is expected to gain significant momentum over the forecast period.