LONDON, Oct. 16, 2019 /PRNewswire/ -- The report "Protein Expression Global Market Report 2019" published By TheBusinessResearchCompany.com is about Protein Expression Market which is spread across 150+ pages and provides latest industry data, market trends, allowing you to identify the products and key players.
The protein expression market (https://www.thebusinessresearchcompany.com/report/protein-expression-global-market-report) in the U.S. is governed by the Food and Drug Administration (FDA) that lays down a series of guidelines for the manufacturers and retailers of this industry. Within the FDA, the Center for Drug Evaluation and Research (CDER) regulates biological products under FDA 101 which includes gene therapy products and vaccines. These regulations ensure quality, safety and efficacy of biological therapeutics products, and speed up innovations that make these products safer and effective. 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, and orphan drugs for rare diseases, while preserving the safety and efficacy standards. In 2016, the FDA also removed a rule (Section 610.21 of the FDA code) which specified minimal potency limits for certain antibodies and antigens. The European Medicines Agency has also introduced policies which include a provision to waive the scientific advice fee, which encourage more academic groups and small companies to propose candidates for biologics.
Stringent Regulations Will Hinder The Global Protein Expressions Market Growth
Government regulations related to protein therapeutics and production of biologics may hinder the protein expression market growth. Government regulations on biologics to undergo rigorous preclinical and clinical trials prior to regulatory approval, and time-consuming process for approval of biologics with regards to health and the safety of any individual are restraining the market growth. Marketing and distribution of biologics including insulin, hormones, therapeutic antibodies, and vaccines depends upon the successful completion of clinical trials, which is a long, expensive, and uncertain process. According to the FDA, for an approval of a new biologic, under the regulations (21 CFR 314.81(b)(2)(vii) and 601.70, a clinical trial approval usually takes 10-12 months where firms are required to submit a report annually on the status of clinical safety, clinical efficiency, clinical pharmacology, and nonclinical toxicology study.
Protein expression is a process in which proteins are synthesized, modified, regulated and controlled in living organisms according to the host cell. Protein expression includes yeast expression, insect expression, and bacterial expression, algal expression and mammalian cell expression. The global protein expression market was valued at about $1.74 billion in 2018 and is expected to grow to $2.63 billion at an annual growth rate of nearly 11% through 2022. Request for Sample Copy @ https://www.thebusinessresearchcompany.com/sample.aspx?id=2493&type=smp
Growing Demand For Biologics Will Drive The Protein Expression Market
Increase in demand for biologics to counter various genetic disorders and chronic diseases is a major factor driving the research and sales of protein expression. Biologics is a medicine produced from living organisms or contains components of living organisms such as protein, tissue, genes, allergens, cells, blood components, blood, and vaccines. The increasing use of biologics (therapeutic protein and others) to cure chronic diseases such as cancer, cardiovascular conditions and genetic disorders, is increasing the demand for protein expression devices and equipment. According to the World Health Organization, chronic disease prevalence is expected to rise by 57% globally, by the year 2020. According to an article published by Chemistry World in the year 2018, analysts expect the biologics market to hold a market share of more than a quarter of the entire pharmaceutical industry by 2020. The global biologics market is expected to grow at 9.9% during 2018-2024.
Microfluidics Technology- A Trend In The Protein Expression Market
Companies in the protein expression industry are increasingly adopting Microfluidics technology to enhance protein expression tests in order to reduce the time, cost, labor, and increase the accuracy and performance. The microfluidics technology effectively analyzes biological samples than the traditional (macroscale) instruments. Microfluidics technology is used to measure the expression of proteins on cells and optimizes the output to generate results regarding protein expression. Therapeutics-on-a-chip (TOC) uses microfluidic platform and is able to synthesize proteins in a point-of-care setting to reduce cost associated with storage and transportation of therapeutic proteins. For instance, companies such as MissionBio, NanoCellect Biomedical, RainDance Technologies and Sphere fluidics have implemented this technology in protein expression test. Place a Direct Purchase Order of Complete Report @ https://www.thebusinessresearchcompany.com/purchaseoptions.aspx?id=2493
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Therapeutic Proteins Market Report @ https://www.thebusinessresearchcompany.com/report/therapeutic-proteins-global-market-report
Biologics Market Report @ https://www.thebusinessresearchcompany.com/report/biologics-market
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