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Therapeutic Proteins to 2016
Drugs, Devices, Diseases,
Markets and Forecasts
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Publication: May 2012
Product Code: DTP268B
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In recent years, the number of protein‐based pharmaceuticals
reaching the marketplace has increased exponentially. The
clinical application of these drugs is limited by a lack of
desirable attributes for adequate absorption or
distribution. It therefore becomes critical to formulate
these drugs into safe, stable and efficacious delivery
systems. Because these drugs face formidable enzymatic and
penetration barriers when administered orally, peptide and
protein drugs continue to be developed almost exclusively
for parenteral administration. These combination drug-device
products, where the drug and device are clinically tested
and approved as a single product entity, are becoming one of
the fastest new drug categories. The growth of protein drug
products is having a significant effect on the way drugs and
devices are developed. Cooperation between device designers
and drug developers is occurring much earlier in the drug
development cycle, allowing device designs in many cases to
be tailored to the bioavailability targets and
pharmacokinetic profiles of specific drug therapies. |
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Highlights |
· Analyzes approved
therapeutic protein products and pipeline candidates and
assesses the market potential for existing and
probable future protein drugs
· Examines protein
delivery design issues, packaging, distribution and
technology factors
· Assesses the role of
protein formulation decisions on therapeutic protein
commercialization and market potential
· Examines historical
protein drug data for nine major therapeutic segments
and provides forecasts by disease segment to 2016
· Profiles therapeutic
protein companies, their commercial
products, product development activity,
and business strategies
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Summary of Contents |
Executive Summary
Protein Therapeutics
Market Dynamics
The Protein Therapeutics
Marketspace
Clinical Trials and Drug Approvals
The Competitive Landscape
Demographics, Managed
Care and Growth
Risks and Opportunities
Therapeutic Protein
Commercialization - Success Factors
Formulating Protein Drugs
Formulation
Strategies
Stability
Half‐Life & Therapeutic Protocols
Immunogenicity
Protein Formulation
Technologies
Post‐translational Modification
Encapsulation Technologies
Lyophilization
Dosing Frequency and
Treatment Compliance
Protein Packaging &
Delivery
Injection
Pen Injectors - Dominant in Chronic Disease
Prefilled Syringes - Evolving Technology, Expanding
Reach
Emerging Protein Injection Options
Inhalation
Dry
Powder Inhalers -– Stability at a Price
Sprays/Aerosols - The Technical Challenges
Development-stage Packaging & Delivery Technologies
Oral
Proprietary Processes and Pipeline Prospects
Commercialization Potential & Risk Factors
Transdermal
Transdermal
- Obstacles and Limitations
Microneedles - Engineering & Economics
Protein
Drug Distribution Strategies
Protein Drugs –
Drug Classes and Therapeutic Targets
Antibodies
Enzymes
Growth
Factors
Hematopoietics
Hormones
Immune
Modulators
Other Protein Therapy Classes
Protein Drug Therapeutics – Disease Segment
Analysis & Forecasts
Autoimmune Diseases
Dominance of Antibodies & Cytokines
B-Cell
Depleting Agents
Interferons
Interleukin Receptor Agonists
TNF
Inhibitors
T-Cell Blocking Agents
Development-stage
Candidates
Demand Patterns and Forecasts
Hematology
Anemia
Hemoglobinuria
Thrombocytopenia
Demand Patterns and Forecasts
Hereditary Diseases
Infectious Diseases
Hepatitis
RSV
Demand Patterns and Forecasts
Hormone Replacement
Increasing Competition
in a Crowded Market
Demand Factors and
Forecasts
Oncology
Key Therapeutic
Sectors & Therapeutic Target Selection
Expanding Indications & Therapeutic Endpoints
Leading Oncology Protein Drug Products
Pipeline Candidates
Demand Data and
Forecasts
Reproductive Medicine
Dominance of Leutinizing Hormones
Demand
Data and Forecasts
Transplantation/Organ
Rejection
Approve Protein Drugs
The Market Opportunity
Emerging Therapeutic
Segments
Market and Regulatory Factors
Regulatory Issues
Ease‐of‐Use and Patient
Compliance
IP and Biosimilars
Protein Drug
Therapeutics - Company Profiles
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