HOME Research Insight The Monoclonal Antibodies Segment Is the Fastest Growing with About 50 MAbs in the Pipeline



The Monoclonal Antibodies Segment Is the Fastest Growing with About 50 MAbs in the Pipeline


Many biologic drugs such as Neupogen, Lantus, Humira, and Remicade are expected to go off-patent by 2020. The ongoing patent expirations of these biologics are expected to open up a broad range of new business opportunities for drug manufacturers in the biosimilars industry. The demand for biosimilars is expected to be high among patients suffering from cancer, rheumatoid arthritis, leukemia, infertility, hepatitis, erythropenia, diabetes, and growth hormonal disorders. This increased demand can be attributed to the low prices of biosimilars as compared to biologics.

With about eight biologic MAb drugs expected to go off-patent from 2013 to 2018, the monoclonal antibody biosimilars market is an attractive market for drug makers. The drugs that are expected to lose their patent protections are Rituxan/MabThera, Remicade, Herceptin, Humira, Avastin, Synagis, Erbitux, and Lucentis. The three most-targeted products for biosimilars are Rituximab, Infliximab, and Adalimumab because of their high worldwide sales and approvals for multiple indications. Various key industry players of the generics market have started working on the manufacturing and clinical trial activities of MAbs. At present, approximately 50 biosimilar MAbs are in the pipeline. Bioexpress Therapeutic (Switzerland) has 16 biosimilar candidates of MAbs that are in the pipeline. The other players that have invested in the production of MAbs are GeneTechno Science (Japan), Celltrion (South Korea), Zydus-Cadila (India), Biocon (India), and Samsung Biologics (South Korea).

Developed countries are faced with the challenges of burgeoning healthcare costs and R&D spending on the drug development process. Lack of proper standards and strict regulatory pathways in the U.S. are also a major challenge for biosimilar drugs to receive approval under 351(k) section of FDA regulations. China and India are considered to be the most lucrative markets for biosimilar drugs. Both these markets are considered as attractive destinations for R&D outsourcing for foreign biosimilar manufacturing companies that look to reduce their growing R&D costs and increase the number of drug applications and approvals. The factors positioning China and India as major outsourcing destinations are low labor costs, low laboratory setup costs, and high knowledge resources. China’s 12th five-year plan (2011 to 2015) allotted $1.7 trillion for the development of biopharmaceutical drugs. This plan focuses on developing generic versions of branded biologics and expanding contract research and manufacturing services. Furthermore, under the 13th five-year plan, the Chinese government will spend an additional $11.8 billion for advancing innovations in biotechnology. The lack of any government regulations regarding the approval of biosimilars and low IP protection of biologic compounds are factors that have enabled domestic manufacturers to market the generic versions of biologic compounds at low prices.

Australia, Brazil, Mexico, and Saudi Arabia are other prominent destinations for the biosimilars market. Factors impacting the growth in these countries are government initiatives, semi-regulatory pathways, stable economic conditions, and rise in incidences of chronic disorders. Thus, these countries will evolve as lucrative destinations for drug makers to generate high returns on investment.

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Biosimilars Market Product [Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application (Oncology, Blood Disorders) - Global Forecast to 2018

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