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Global Next-Generation Biologics Market 2016-2020

Global Next-Generation Biologics Market 2016-2020

About Next-generation Biologics

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.

Technavio’s analysts forecast the global next-generation biologics market to grow at a CAGR of 14.42% during the period 2016-2020.

Covered in this report

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
Technavio's report, 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 vendors
  • F. Hofmann-La Roche
  • Novo Nordisk
  • Sanofi
  • Takeda Pharmaceuticals
Other prominent vendors
  • 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 (Cardio3 BioSciences)
  • 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
  • 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?


Press Release

Technavio Announces the Publication of its Research Report – Global Next-generation Biologics Market 2016-2020

Technavio recognizes the following companies as the 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

Commenting on the report, an analyst from Technavio’s team said: “The use of regenerative medicine is an emerging treatment option for the treatment of various disorders such as musculoskeletal, CNS, metabolic and cardiovascular disorders, oncology, and dermatology. These regenerative medicines help in the healing process by replacement or regeneration of the human cells, tissues or organs, and thus assist in establishing the normal function. The various regenerative techniques include cell therapy, growth factor therapy, and the use of matrices such as fibrin, collagen, urinary bladder matrix, hyaluronic acid, and others. Apart from these companies, various research organizations such as Mayo Clinic and Center for Regenerative Medicine are also engaged in the development of regenerative medicines.”

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.

Companies Mentioned

Biogen, F. Hoffmann-La Roche, Novo Nordisk, Sanofi, Takeda Pharmaceuticals, 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, Zymeworks.

  • Executive summary
    • Highlights
  • Scope of the report
    • Market overview
    • Top-vendor offerings
      • Table Product offerings
  • Market research methodology
    • Research methodology
    • Economic indicators
  • Introduction
    • Key market highlights
      • Table Global next-generation biologics market
  • Market landscape
    • Market overview
      • Table Overview of next-generation biologics market 2016-2020
      • Table Key strategies in global next-generation biologics market
      • Table Global next-generation biologics market snapshot: Developed and emerging markets 2015
      • Table Global next-generation biologics market 2015-2020 ($ billions)
      • Table Opportunities faced by biologics industry today
    • Five forces analysis
      • Table Five forces analysis
  • Market segmentation by application
    • Table Global next-generation biologics market segmentation by therapies
    • Table Market share of next-generation biologics by application
    • Global regenerative medicine market
      • Table Market overview of global regenerative medicine market
      • Table Sub-segmentation in regenerative medicine market
      • Table Global regenerative medicine market 2015-2020 ($ billions)
      • Table Funds from federal agencies for regenerative medicine research in 2014 ($ millions)
      • Table Cell therapy overview
      • Table Gene therapy products available in Europe
      • Table R&D in tissue scaffold
      • Table Opportunity analysis of global regenerative medicine market
    • Global next-generation antibodies market
      • Table Market overview of next-generation antibodies
      • Table Sub-segmentation in next-generation antibodies market
      • Table Global next-generation antibodies market 2015-2020 ($ billions)
      • Table Global next-generation antibodies market: Present and future scenario
      • Table Opportunity analysis of global next-generation antibodies market
    • Global next-generation insulin products market
      • Table Market overview of next-generation insulin products
      • Table Factors affecting global next-generation insulin products market
      • Table Global next-generation insulin products market 2015-2020 ($ millions)
      • Table Opportunity analysis of global next-generation insulin products market
    • Global next-generation recombinant coagulation factors market
      • Table Market overview of next-generation recombinant coagulation factors
      • Table Global next-generation recombinant coagulation factors market 2015-2020 ($ billions)
      • Table Opportunity analysis of global next-generation recombinant coagulation factors market
      • Table Impact of factors affecting the market 2015 and 2020
  • Geographical segmentation
    • Table Global next-generation biologics market: Segmentation by geography (2015-2020)
    • Table Global next-generation biologics market segmentation by region: Market growth lifecycle analysis 2015
    • Next-generation biologics market in Americas
      • Table Overview of next-generation biologics market in Americas
      • Table Next-generation biologics market in Americas 2015-2020 ($ billions)
      • Table Stem cell research policies in Americas
    • Next-generation biologics market in EMEA
      • Table Overview of next-generation biologics market in EMEA
      • Table Distribution of major cell therapy vendors in Europe 2011
      • Table Next-generation biologics market in EMEA 2015-2020 ($ billions)
      • Table Stem cell research policies in EMEA
    • Next-generation biologics market in APAC
      • Table Overview of next-generation biologics market in APAC
      • Table Global next-generation biologics market revenue by geography 2015-2020 ($ billions)
      • Table Key regenerative medicine market developments in Japan by global vendors 2015
      • Table Next-generation biologics market in APAC 2015-2020 ($ billions)
      • Table Stem cell research policies in APAC
  • Market drivers
    • Increase in demand for ADCs
      • Table ADC molecules currently under clinical trials
    • Advanced technological innovations
      • Table Advances in ADCs technology
      • Table Technologies used in next-generation biologics
    • Reimbursement support for next-generation biologics
      • Table Breakdown of CIRM funding in various stem cell research funding in 2014 ($ billions)
      • Table Active programs under CIRM in 2014
      • Table EC funding
    • Special regulatory drug designations for biologics
      • Table Some of special regulatory designations approved by US FDA
      • Table Special regulatory designation approved by EU
  • Impact of drivers
    • Table Impact of drivers
  • Market challenges
    • Complexities in manufacturing of biologics
    • Complicated regulatory framework
    • Difficulties in patient recruitment for conducting clinical trials, high cost, and failure rate in clinical trials Recruitment
    • Critical ethical challenges in clinical trial design
      • Table Ethical issues that are faced by various institutes at different phases of cell therapy research
  • Impact of drivers and challenges
    • Table Impact of drivers and challenges
  • Market trends
    • Table Impact of trends on global next-generation biologics market
    • Focus on regenerative medicines
      • Table Some of the regenerative medicines under development for the treatment of various musculoskeletal disorders
      • Table Planned clinical trials of iPS cell-based therapies
      • Table Regenerative medicines for IBS under development
      • Table Some of the mid- and late-stage pipeline products for regenerative medicine
    • Focus on oral insulin therapies
      • Table Oral insulin pipeline portfolio
    • Development of gene and cell therapy-based products
      • Table Gene therapies under development for hemophilia
    • Emergence of targeted and combination therapies
  • Vendor landscape
    • Competitive scenario
      • Table Geographical presence of key vendors
      • Table Competitive scenario of global next-generation biologics market vendors 2015-2020
    • Key news
    • Other prominent vendors
  • Key vendor analysis
    • Biogen
      • Table Biogen: Key highlights
      • Table Biogen: Strength assessment
      • Table Biogen: Strategy assessment
      • Table Biogen: Opportunity assessment
    • F. Hoffmann-La Roche
      • Table F. Hoffmann-La Roche: KADCYLA pipeline products
      • Table F. Hoffmann-La Roche: Key highlights
      • Table F. Hoffmann-La Roche: Strength assessment
      • Table F. Hoffmann-La Roche: Strategy assessment
      • Table F. Hoffmann-La Roche: Opportunity assessment
    • Novo Nordisk
      • Table Novo Nordisk: Highlights
      • Table Novo Nordisk: Strength assessment
      • Table Novo Nordisk: Strategy assessment
      • Table Novo Nordisk: Opportunity assessment
    • Sanofi
      • Table Sanofi: Highlights
      • Table Sanofi: Strength assessment
      • Table Sanofi: Strategy assessment
      • Table Sanofi: Opportunity assessment
    • Takeda Pharmaceuticals
      • Table Takeda Pharmaceuticals: Highlights
      • Table Takeda Pharmaceuticals: Strength assessment
      • Table Takeda Pharmaceuticals: Strategy assessment
      • Table Takeda Pharmaceuticals: Opportunity assessment
  • Appendix
    • List of abbreviations
  • Explore Technavio

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