Global Next-Generation Biologics Market 2016-2020

  • ID: 3985320
  • Report
  • Region: Global
  • 124 pages
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FEATURED COMPANIES

  • Aastrom Biosciences
  • Biocon
  • Diasome Pharmaceuticals
  • InVivo Therapeutics
  • Northwest Biotherapeutics
  • Sangamo
  • MORE
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.

The 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

The 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 drivers
- Advanced technological innovations
- For a full, detailed list, view the full report

Market challenges
- Complexities in manufacturing of biologics
- For a full, detailed list, view the full report

Market trends
- Development of gene and cell therapy-based products
- For a full, detailed list, view the full 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?

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FEATURED COMPANIES

  • Aastrom Biosciences
  • Biocon
  • Diasome Pharmaceuticals
  • InVivo Therapeutics
  • Northwest Biotherapeutics
  • Sangamo
  • MORE
Part 01: Executive summary
  • Highlights
Part 02: Scope of the report
  • Market overview
  • Top-vendor offerings
Part 03: Market research methodology
  • Research methodology
  • Economic indicators
Part 04: Introduction
  • Key market highlights
Part 05: Market landscape
  • Market overview
  • Five forces analysis
Part 06: Market segmentation by application
  • Global regenerative medicine market
  • Global next-generation antibodies market
  • Global next-generation insulin products market
  • Global next-generation recombinant coagulation factors market
Part 07: Geographical segmentation
  • Next-generation biologics market in Americas
  • Next-generation biologics market in EMEA
  • Next-generation biologics market in APAC
Part 08: Market drivers
  • Increase in demand for ADCs
  • Advanced technological innovations
  • Reimbursement support for next-generation biologics
  • Special regulatory drug designations for biologics
Part 09: Impact of drivers

Part 10: 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
  • Critical ethical challenges in clinical trial design
Part 11: Impact of drivers and challenges

Part 12: Market trends
  • Focus on regenerative medicines
  • Focus on oral insulin therapies
  • Development of gene and cell therapy-based products
  • Emergence of targeted and combination therapies
Part 13: Vendor landscape
  • Competitive scenario
  • Key news
  • Other prominent vendors
Part 14: Key vendor analysis
  • Biogen
  • F. Hoffmann-La Roche
  • Novo Nordisk
  • Sanofi4
  • Takeda Pharmaceuticals
Part 15: Appendix
  • List of abbreviations
Part 16: About the Author

List of Exhibits

Exhibit 01: Product offerings
Exhibit 02: Global next-generation biologics market
Exhibit 03: Overview of next-generation biologics market 2016-2020
Exhibit 04: Key strategies in global next-generation biologics market
Exhibit 05: Global next-generation biologics market snapshot: Developed and emerging markets 2015
Exhibit 06: Global next-generation biologics market 2015-2020 ($ billions)
Exhibit 07: Opportunities faced by biologics industry today
Exhibit 08: Five forces analysis
Exhibit 09: Global next-generation biologics market segmentation by therapies
Exhibit 10: Market share of next-generation biologics by application
Exhibit 11: Market overview of global regenerative medicine market
Exhibit 12: Sub-segmentation in regenerative medicine market
Exhibit 13: Global regenerative medicine market 2015-2020 ($ billions)
Exhibit 14: Funds from federal agencies for regenerative medicine research in 2014 ($ millions)
Exhibit 15: Cell therapy overview
Exhibit 16: Gene therapy products available in Europe
Exhibit 17: R&D in tissue scaffold
Exhibit 18: Opportunity analysis of global regenerative medicine market
Exhibit 19: Market overview of next-generation antibodies
Exhibit 20: Sub-segmentation in next-generation antibodies market
Exhibit 21: Global next-generation antibodies market 2015-2020 ($ billions)
Exhibit 22: Global next-generation antibodies market: Present and future scenario
Exhibit 23: Opportunity analysis of global next-generation antibodies market
Exhibit 24: Market overview of next-generation insulin products
Exhibit 25: Factors affecting global next-generation insulin products market
Exhibit 26: Global next-generation insulin products market 2015-2020 ($ millions)
Exhibit 27: Opportunity analysis of global next-generation insulin products market
Exhibit 28: Market overview of next-generation recombinant coagulation factors
Exhibit 29: Global next-generation recombinant coagulation factors market 2015-2020 ($ billions)
Exhibit 30: Opportunity analysis of global next-generation recombinant coagulation factors market
Exhibit 31: Impact of factors affecting the market 2015 and 2020
Exhibit 32: Global next-generation biologics market: Segmentation by geography (2015-2020)
Exhibit 33: Global next-generation biologics market segmentation by region: Market growth lifecycle analysis 2015
Exhibit 34: Overview of next-generation biologics market in Americas
Exhibit 35: Next-generation biologics market in Americas 2015-2020 ($ billions)
Exhibit 36: Stem cell research policies in Americas
Exhibit 37: Overview of next-generation biologics market in EMEA
Exhibit 38: Distribution of major cell therapy vendors in Europe 2011
Exhibit 39: Next-generation biologics market in EMEA 2015-2020 ($ billions)
Exhibit 40: Stem cell research policies in EMEA
Exhibit 41: Overview of next-generation biologics market in APAC
Exhibit 42: Global next-generation biologics market revenue by geography 2015-2020 ($ billions)
Exhibit 43: Key regenerative medicine market developments in Japan by global vendors 2015
Exhibit 44: Next-generation biologics market in APAC 2015-2020 ($ billions)
Exhibit 45: Stem cell research policies in APAC
Exhibit 46: ADC molecules currently under clinical trials
Exhibit 47: Advances in ADCs technology
Exhibit 48: Technologies used in next-generation biologics
Exhibit 49: Breakdown of CIRM funding in various stem cell research funding in 2014 ($ billions)
Exhibit 50: Active programs under CIRM in 2014
Exhibit 51: EC funding
Exhibit 52: Some of special regulatory designations approved by US FDA
Exhibit 53: Special regulatory designation approved by EU
Exhibit 54: Impact of drivers
Exhibit 55: Ethical issues that are faced by various institutes at different phases of cell therapy research
Exhibit 56: Impact of drivers and challenges
Exhibit 57: Impact of trends on global next-generation biologics market
Exhibit 58: Some of the regenerative medicines under development for the treatment of various musculoskeletal disorders
Exhibit 59: Planned clinical trials of iPS cell-based therapies
Exhibit 60: Regenerative medicines for IBS under development
Exhibit 61: Some of the mid- and late-stage pipeline products for regenerative medicine
Exhibit 62: Oral insulin pipeline portfolio
Exhibit 63: Gene therapies under development for hemophilia
Exhibit 64: Geographical presence of key vendors
Exhibit 65: Competitive scenario of global next-generation biologics market vendors 2015-2020
Exhibit 66: Biogen: Key highlights
Exhibit 67: Biogen: Strength assessment
Exhibit 68: Biogen: Strategy assessment
Exhibit 69: Biogen: Opportunity assessment
Exhibit 70: F. Hoffmann-La Roche: KADCYLA pipeline products
Exhibit 71: F. Hoffmann-La Roche: Key highlights
Exhibit 72: F. Hoffmann-La Roche: Strength assessment
Exhibit 73: F. Hoffmann-La Roche: Strategy assessment
Exhibit 74: F. Hoffmann-La Roche: Opportunity assessment
Exhibit 75: Novo Nordisk: Highlights
Exhibit 76: Novo Nordisk: Strength assessment
Exhibit 77: Novo Nordisk: Strategy assessment
Exhibit 78: Novo Nordisk: Opportunity assessment
Exhibit 79: Sanofi: Highlights
Exhibit 80: Sanofi: Strength assessment
Exhibit 81: Sanofi: Strategy assessment
Exhibit 82: Sanofi: Opportunity assessment
Exhibit 83: Takeda Pharmaceuticals: Highlights
Exhibit 84: Takeda Pharmaceuticals: Strength assessment
Exhibit 85: Takeda Pharmaceuticals: Strategy assessment
Exhibit 86: Takeda Pharmaceuticals: Opportunity assessment
Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Aastrom Biosciences
  • Biocon
  • Diasome Pharmaceuticals
  • InVivo Therapeutics
  • Northwest Biotherapeutics
  • Sangamo
  • MORE
New Report Released: - Global Next-generation Biologics Market 2016-2020

The author of the report 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 the research 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.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.
Note: Product cover images may vary from those shown
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  • ADC Therapeutics
  • ALMAC Group
  • Aastrom Biosciences
  • AbGenomics
  • AbbVie
  • Acologix
  • Adocia
  • Agensys
  • AlloCure
  • AlloSource
  • Alphatec Spine
  • Ambrx
  • Amorcyte
  • Argos Therapeutics
  • Astellas Pharma
  • AstraZeneca
  • Athersys
  • Avita Medical
  • BIOGENOMICS
  • Baxter
  • Bayer HealthCare
  • Bellicum Pharmaceuticals
  • BioCardia
  • BioLife Solutions
  • BioRestorative Therapies
  • BioTissue Technologies
  • Biocon
  • Biodel
  • Biogen
  • Bluebird Bio
  • Boehringer Ingelheim
  • BrainStorm Cell Therapeutics
  • CARBOGEN AMCIS
  • CSL Behring
  • Calimmune
  • Capricor
  • Cell Medica
  • Celldex Therapeutics
  • Celyad
  • Cesca
  • CryoLife
  • Cynata Therapeutics
  • Daiichi Sankyo
  • Dance Biopharm
  • Dendreon
  • Diasome Pharmaceuticals
  • DiscGenics
  • Endo Pharmaceuticals
  • Esperance Pharmaceuticals
  • Exsulin
  • F. Hoffmann-La Roche
  • Fate Therapeutics
  • Fibrocell Science
  • Formation Biologics
  • Forticell Bioscience
  • Fortress Biotech
  • GENEREX
  • Gamida Cell
  • Genmab
  • Geron
  • GlaxoSmithKline
  • Harvard Apparatus Regenerative Technology
  • Healthpoint
  • Histogen
  • Histogenics
  • Humacyte
  • ISTO Technologies
  • Immunocellular Therapeutics
  • Immunogen
  • InVivo Therapeutics
  • Integra LifeSciences
  • Juno Therapeutics
  • Juventas Therapeutics
  • Kairos Therapeutics
  • Kensey Nash
  • Kiadis Pharma
  • Kinetic Concept
  • Living Cell Technologies
  • MacroGenics
  • MannKind
  • MaxCyte
  • MedImmune
  • Medtronic
  • Mersana Therapeutics
  • Mesoblast
  • MiMedx
  • NGM Biopharmaceuticals
  • Nanofiber Solutions
  • Nanotope
  • Neuralstem
  • NewLink Genetics
  • Northwest Biotherapeutics
  • NovaRx
  • Novartis
  • Novo Nordisk
  • OXFORD BioTherapeutics
  • Ocata Therapeutics
  • Opexa Therapeutics
  • Oramed Pharmaceuticals
  • Organovo
  • Orteq
  • Orthofix
  • Osiris Therapeutics
  • Osteotech
  • Pfizer
  • PhaseBio Pharmaceuticals
  • Pluristem Therapeutics
  • Prima BioMed
  • Q Therapeutics
  • RTI Surgical
  • ReproCELL
  • RhinoCyte
  • STEMCELL Technologies
  • SanBio
  • Sangamo
  • Sanofi
  • Shire Regenerative Medicine
  • Stemcentrx
  • Stratatech
  • Synthon Biopharmaceuticals
  • TEI Biosciences
  • Takeda Pharmaceuticals
  • Tengion
  • Thermalin Diabetes
  • TiGenix
  • Tissue Genesis
  • TissueGene
  • Tolerion
  • VentriNova
  • Vericel
  • VeroScience
  • ViaCyte
  • VistaGen Therapeutics
  • vTv Therapeutics
  • Wockhardt
  • XOMA
  • Zimmer-Biomet
  • Zymeworks
Note: Product cover images may vary from those shown
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