Favorable Government Regulations Drove the US Biologics Market to be the Largest at $67 Billion in 2018: The Business Research Company
LONDON, July 30, 2019 /PRNewswire/ -- The US Food and Drug Administration (FDA) has revised its regulations on biologics, which drove the US biologics market to $67 billion in 2018, the largest among all major countries of the world. The revised regulations eliminate outdated biologics requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity and potency of biologics can now be obtained from sources other than FDA's Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant. The FDA has also removed a rule (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, the FDA is updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products. In May 2014, the US's FDA announced a fast-track initiative to review its drugs and biologics policy to speed the availability of therapies to patients with serious conditions, orphan drugs for rare disease, while preserving the safety and efficacy standards. Read More On The Business Research Company's Biologics Market Report @ https://www.thebusinessresearchcompany.com/report/biologics-market.
Governments across the world are encouraging the research and development of biopharmaceutical drugs in order to develop more targeted therapies for various diseases. The European Medicines Agency has also introduced policies which include a provision to waive the scientific advice fee, which could encourage more academic groups and small companies to propose candidates for biologics, thus driving the global biologics market.
Demand For Biologics In The Treatment Of Complex Diseases
Biologics are being widely used to provide effective treatment for many complex diseases such as rheumatoid arthritis, psoriasis, Crohn's disease that have limited treatment options. There has been a significant advance in the treatment of rheumatoid arthritis patients who do not respond to traditional disease-modifying anti-rheumatic drugs. The key biologics used for the treatment of rheumatoid arthritis include Abatacept (Orencia), Adalimumab (Humira), Anakinra (Kineret), Infliximab (Remicade), and Rituximab (Rituxan). Key biologics used to treat psoriasis include Adalimumab (Humira), Etanercept (Enbrel), Infliximab (Remicade), Secukinumab ( Cosentyx). Cimzia (certolizumab pegol), Humira (adalimumab), and Remicade (infliximab), Tysabri (natalizumab) are biologics that are used to treat Crohn's disease.
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Development And Increasing Demand For Next Generation Biologics
Antibody drug conjugates (ADCs) are being used to treat diseases such as inflammatory, oncology and respiratory diseases. ADCs are monoclonal antibodies that have the ability to discriminate between healthy and diseased tissues and kill the diseased tissues when detected. ADCs are also being used in cancer treatment by attaching them to cancer-killing drugs that kill cancerous cells, leaving healthy tissues unaffected.
Companies in the biologics market are investing in technologies to develop next generation biologics such as ADCs, bispecifics, fusion proteins, cell and gene therapy that will be more effective. These next generation biologics are expected to have better potency against the target disease as well as have the ability to treat more than one aspect of the disease. They are being manufactured with the help of technology, along with drug delivery systems. Some next generation biologics brands include Kadcyla, Tresiba, Alprolix, Adcetris, Eloctate, Plegridy, and Afrezza. Companies such as Roche, Bristol-Myers Squibb and Novartis are investing heavily in the development of next generation biologics. The scope of market growth seems to be very high as the technology giant Samsung, through its subsidiary Samsung BioLogics Co., is investing around $740 million for the production of next-gen biologics.
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