Lewes, DE -- (SBWIRE) -- 01/09/2017 -- Report forecast the global next-generation biologics market to grow at a CAGR of 14.42% during the period 2016-2020.

According to the section 351 of the Public Health Service Act of the US FDA, a biological product is defined as a "virus, therapeutic serum, antitoxin, vaccine, toxin, blood, blood component or derivative, analogous product or allergenic product, applicable to the treatment, prevention, or cure of a condition or disease of human beings." Biologic therapeutics include virus, toxins, allergenic products, therapeutic serums, antitoxin, blood components or derivatives, vaccines, blood, proteins (except any chemically synthesized polypeptide), or analogous products, or arsphenamine or derivative of arsphenamine intended for the treatment, prevention, or cure of a disease or condition.

The differences between the small molecules and biologics includes the molecular weight, structure, procedure of synthesis, and immunogenicity. Biologics usually have a higher molecular weight and a complex molecular structure. They are usually derived from living organisms, which is another important feature that differentiates it from small molecules. Biologics are also vulnerable to extreme temperatures and light.

The report covers the present scenario and the growth prospects of the global next-generation biologics market for 2016-2020. To calculate the market size, the report considers the revenue generated from the sales of next-generation biologics. The report also considers the revenues to be generated from the sales of drugs that are expected to be launched into the market during the forecast period.

The market is divided into the following segments based on geography:

- Americas
- APAC
- EMEA

According to the report, the US FDA's Office of Orphan Products Development (OOPD) aims to develop and evaluate drugs and biologics that effectively treat and diagnose rare diseases or conditions, and provides incentives to companies that develop drugs for rare disorders. It also grants orphan status to drugs and biologics proven to be effective and safe in treating rare diseases. The Orphan Products Grants Program (OPGP) funds clinical research tests to check the efficacy and safety of drugs and biologics.

Further, the report states that unlike small molecule drugs, biologics are prepared from living organisms. Hence, the manufacturing process involved is very complex and time-consuming. The process involves steps such as fermentation, clarification, separation, and purification. The process of separation is also difficult as different molecules differ slightly from each other. The purification process is also lengthy and the risk of contamination is high as the drug is produced in the biological medium. Analytical methods such as high-performance liquid chromatography and spectroscopy are to be used to analyze the products. All through the process, proper temperature, pressure, and pH have to be maintained. For instance, Eprex, a biosimilar, was found to be structurally unidentical to Amgen's Epogen as small differences were found in the hydrodynamic structure and the degree of alfa helicity, which affected the stability of the product. Thus, the variation between products manufactured by different companies underscores the challenge in producing biopharmaceutical proteins to consistent standards.

Global Next-generation Biologics Market 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

key players in the global next-generation biologics market: Biogen, F. Hoffmann-La Roche, Novo Nordisk, Sanofi, and Takeda Pharmaceuticals

Other Prominent Vendors in the market are: Aastrom Biosciences, AbbVie, AbGenomics, Acologix, ADC Therapeutics, Adocia, Agensys, AlloCure, AlloSource, ALMAC Group, Alphatec Spine, Ambrx, Amorcyte, Argos Therapeutics, Astellas Pharma, AstraZeneca, Athersys, Avita Medical, Baxter, Bayer HealthCare, Bellicum Pharmaceuticals, BioCardia, Biocon, Biodel, BIOGENOMICS, BioLife Solutions, BioRestorative Therapies, BioTissue Technologies, Bluebird Bio, Boehringer Ingelheim, BrainStorm Cell Therapeutics, Calimmune, Capricor, CARBOGEN AMCIS, Cell Medica, Celldex Therapeutics, Celyad, Cesca, CryoLife, CSL Behring, Cynata Therapeutics, Daiichi Sankyo, Dance Biopharm, Dendreon, Diasome Pharmaceuticals, DiscGenics, Endo Pharmaceuticals, Esperance Pharmaceuticals, Exsulin, Fate Therapeutics, Fibrocell Science, Formation Biologics, Forticell Bioscience, Fortress Biotech, Gamida Cell, GENEREX, Genmab, Geron, GlaxoSmithKline, Harvard Apparatus Regenerative Technology, Healthpoint, Histogen, Histogenics, Humacyte, Immunocellular Therapeutics, Immunogen, Integra LifeSciences, InVivo Therapeutics, ISTO Technologies, Juno Therapeutics, Juventas Therapeutics, Kairos Therapeutics, Kensey Nash, Kiadis Pharma, Kinetic Concept, Living Cell Technologies, MacroGenics, MannKind, MaxCyte, MedImmune, Medtronic, Mersana Therapeutics, Mesoblast, MiMedx, Nanofiber Solutions, Nanotope, Neuralstem, NewLink Genetics, NGM Biopharmaceuticals, Northwest Biotherapeutics, Novartis, NovaRx, Ocata Therapeutics, Opexa Therapeutics, Oramed Pharmaceuticals, Organovo, Orteq, Orthofix, Osiris Therapeutics, Osteotech, OXFORD BioTherapeutics, Pfizer, PhaseBio Pharmaceuticals, Pluristem Therapeutics, Prima BioMed, Q Therapeutics, ReproCELL, RhinoCyte, RTI Surgical, SanBio, Sangamo, Shire Regenerative Medicine, STEMCELL Technologies, Stemcentrx, Stratatech, Synthon Biopharmaceuticals, TEI Biosciences, Tengion, Thermalin Diabetes, TiGenix, Tissue Genesis, TissueGene, Tolerion, VentriNova, Vericel, VeroScience, ViaCyte, VistaGen Therapeutics, vTv Therapeutics, Wockhardt, XOMA, Zimmer-Biomet, and Zymeworks

Market driver
- Advanced technological innovations
- For a full, detailed list, view our report

Market challenge
- Complexities in manufacturing of biologics
- For a full, detailed list, view our report

Market trend
- Development of gene and cell therapy-based products
- For a full, detailed list, view our report

Key questions answered in this report
- What will the market size be in 2020 and what will the growth rate be?
- What are the key market trends?
- What is driving this market?
- What are the challenges to market growth?
- Who are the key vendors in this market space?
- What are the market opportunities and threats faced by the key vendors?
- What are the strengths and weaknesses of the key vendors?

Spanning over 124 pages and 86 Exhibits "Global Next-Generation Biologics Market 2016 - 2020" report covers Executive summary, Scope of the report, Market research methodology, Introduction, Market landscape, Market segmentation by application, Geographical segmentation, Market drivers, Impact of drivers, Market challenges, Impact of drivers and challenges, Market trends, Vendor landscape, Key vendor analysis, Appendix.

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