Abstract
This report analyzes the world market for diamond tools by total consumption
value, demand trends, end-user markets and applications. Each product section
contains detailed breakdowns including supplier sales and market share,
consumption value and volume by region/product type, demand by end-user
industry. Market trends and forecasts are provided for the years 2008-2013.
By 2020, the current renaissance of biotechnology will have resulted in a
broad range of products that will, almost without exception, involve a degree
of protein engineering. This report discusses new developments in therapeutic
protein engineering and developments that are likely to occur through 2020.
Contents include:
- State of the current technology and where the immediate development
vectors are pointing
- Current efforts to engineer developability into protein drug candidates
- How major regulatory agencies might address engineered proteins
- 60 company profiles providing a cross-section of the corporate protein
engineering environment in 2011
- Directions the protein engineering business is likely to take in the
context of technical, strategic, and financial terms
- How globalization in the protein engineering and design field may imply
sharper competition but also increased transnational cooperation
Engineering Next-Generation Therapeutic Proteins: Markets and Trends To 2020
discusses new developments in therapeutic protein engineering: The science and
technology of modifying proteins (and the conditions of their manufacture)
toward specific predefined properties that allow them to act as biological
drugs. Although pharmaceutical protein engineering can target any type of
protein, the focus of this report is on antibodies, and more specifically on
modifications, derivatives, and analogs of monoclonal antibodies.
We introduce the nomenclature, review the state of current technology,
evaluate progress made and problems encountered, and examine those areas where
immediate development is likely. We focus on the many types of antibody
fragments and on display technologies, which play a major role in antibody
screening and maturation and have seen huge improvements during recent years.
Also discussed are current efforts to avoid predictable properties that would
made the new protein difficult to express, purify, or formulate or would
compromise its stability.
Although there is a clear innovational and regulatory distinction between
biosimilars and new biological drugs that result from protein engineering,
this report provides a brief excursion into the biosimilars scenery. The way
in which major regulators handle the issues of biological and pharmaceutical
equivalence provides valuable clues to how they might address engineered
proteins. While these would have to pass the same full regulatory review
process as any new drug, many references will be made based on
first-generation products that address the same target or have other similar
properties of significance.
Engineering Next-Generation Therapeutic Proteins: Markets and Trends To 2020
profiles 53 companies that focus on the development of new drugs based on
protein engineering, along with the status of their product candidates and
alliances. An additional seven companies have been selected from the group
that does not attempt to develop new therapeutic entities but provides
developers with specific tools (methods, equipment, or software) to achieve
their goals.
The final section of this report examines potential future trends in the
protein engineering business. During the years to 2020, many protein
engineering tools will continue to evolve, especially those which employ
software for structure prediction and in silico immunology, while others will
experience only refinements to what exists today. Major evolution will occur
in protein characterization, with some new technologies but mostly through
intelligent combinations of approaches which are already employed today and
use different principles. Synthetic biology, designed to target biological
effector sites that are not even known today, might then start the next round
of innovation in pharmaceutical protein engineering.
About the Author
Hermann AM Mucke, PhD, spent 17 years in academia and industry before
he founded H.M. Pharma Consultancy in 2000 to become an
independent pharmaceutical consultant, analyst, and science author. His last
industry position was Vice President R&D in a European pharmaceutical company,
which he helped take public on the Frankfurt Stock Exchange in 1999. Since
then, Dr. Mucke, who holds a PhD in biochemistry from the University of Vienna
(Austria), has become a consultant and advisory board member for several
European and American pharmaceutical companies and a regular reviewer of drugs
and patents for Thomson Current Drugs and Ashley Publications. Dr. Mucke is
based in Vienna.
Table of Contents
Executive Summary
Chapter - 1
INTRODUCTION
- 1.1. From Esoteric Basic Science to the Bioengineered Protein Drug
- Structure as the Key to Protein Form and Function
- Antibodies: Immune Proteins Naturally Designed For Combinatorial Diversity
- 1.2. Leaving the Hype Cycle Legacy Behind
- Why the Markets Overestimated Biotech in the 1980s
- Biologicals as the Fastest-Growing Pharma Market Segment
Chapter - 2
PERSPECTIVES AND CHALLENGES IN BIOLOGICS DISCOVERY AND DESIGN
- 2.1. Types of Protein Drugs
- Hormones, Cytokines, and Enzymes
- Antibodies and Their Fab Fragments
- 2.2. Characterizing Targets with “Protein Druggability”
- Affinity vs. Avidity
- 2.3. The Technologies
- Display Technologies: Phages and Yeast
- 2.4. Engineering “Developability” Into Therapeutic
Proteins
- Combinatorial Mutagenesis and Directed Evolution
- Rational Design: Bioinformatics and Modeling For In Silico Immunology
- Synthetic Gene Design and Optimization
- Modifying Glycosylation and Other Critical Post-Translational Modifications
- 2.5. Antibody Derivatives and Biobetters
- Toolboxes for Immunoglobulin Design and Engineering
- 2.6. New Developments in Display Technologies and Screening
Strategies
- The Changing Concept of the “Antibody Library”
- New Developments in Display Technologies
- Antibody Selection and Optimization beyond Cell Display Technologies
Chapter - 3
BUSINESS WITH PROTEIN ENGINEERING
- 3.1. The Protein Engineering Company: A Breed of its Own
- 3.2. Development and Financing Profiles for Protein Drugs
- The Lengthening Timeline
- Risk and Capital Investment
- Product Pricing and Competition by Small-Molecule Drugs: Pharmacoeconomics
is Key
- Engineering Proteins to Marketing Strategy
- Patenting Strategies for Engineered Proteins
- Protein Engineering to Avoid Manufacturing Issues
- 3.3. The Biosimilars Are Coming - the Biobetters Will Follow
- The Distinctive Complexity of Biologicals
- Comparables, Not Generics: Strategic Dilemma and Potential
- The FDA' s Long and Unfinished Way to Biosimilars
- Biosimilar Introduction and Market Penetration: Will Europe and Asia Set a
Pattern for the United States?
- Targets for Biosimilars and Companies Developing Them
- 3.4. Biobetters: Engineering beyond Biosimilars
Chapter - 4
PERSPECTIVES FOR PROTEIN ENGINEERING
- 4.1. Recent Patenting Reveals Current Earliest-Stage R&D Patterns
- 4.2. The Evolution of the Protein Engineering Tools
- In Silico Immunology and Immunological Bioinformatics
- Synthetic Biology
- Protein Characterization Tools: The “Orthogonal Approach”
- 4.3. Alternative Expression Systems
- Beyond Today' s Bioreactors: Plants and Insects
- Unconventional Microbial Expression Systems
- Human Cell Lines
- 4.4. Biotech Drugs for “Undruggable” Pathways: A
Realistic Option?
- 4.5. Engineering Proteins for Delivery Devices
- 4.6. Evolution of Regulatory Guidelines and Practices
- 4.7. Perspectives for Financing: Market-Tailored Strategies Are
Needed
- Have an Eye on the Regions: Protein Engineering is Globalizing
Chapter - 5
COMPANIES IN THE PROTEIN ENGINEERING BUSINESS
- 5.1. Examples of Developer Companies in the Protein Engineering
Business
- 4-Antibody AG
- Abbott Bioresearch Center, Inc.
- Ablynx NV
- Adimab, Inc.
- Affimed Therapeutics AG
- Affitech A/S
- Alexion Pharmaceuticals, Inc.
- Amunix, Inc.
- Apeiron Biologics AG
- Apexigen, Inc.
- Applied Integrin Science, Inc.
- Avipep Pty Ltd.
- BioInvent International AB
- Biogen Idec
- Biotecnol SA
- BioTransformations Ltd.
- Complix NV
- Corimmun GmbH
- Covagen AG
- Crescendo Biologics Ltd.
- Dyax Corp.
- Emergent BioSolutions, Inc.
- Fabrus LLC
- f-star GmbH
- Genmab A/S
- Glythera Ltd.
- ImmunGene, Inc.
- ImmunoGen, Inc.
- Immunomedics, Inc.
- ioGenetics, LLC
- Ixo Therapeutics Ltd.
- Kymab Ltd.
- MacroGenics, Inc.
- MedImmune
- Merus B.V.
- Micromet, Inc.
- Molecular Templates, Inc.
- MorphoSys AG
- NovImmune SA
- Pieris AG
- Perseid Therapeutics, LLC
- PharmAbcine
- Roche Glycart AG
- Seattle Genetics, Inc.
- SpectraMab GmbH
- Sutro Biopharma, Inc.
- Trion Pharma AG
- Trellis BioScience
- Viventia Biotechnologies, Inc.
- X-BODY Biosciences
- Xencor, Inc.
- XOMA (US), LLC
- Zyngenia, Inc.
- 5.2. The “Toolbox” Companies: Technology Vendors for
Protein Engineering
- Accelrys, Inc.
- Attana AB
- Bioceros B.V.
- DNA2.0, Inc.
- Novozymes Biopharma US, Inc.
- Selexis, Inc.
- Zymeworks, Inc.
References
Company Index with Web Addresses
FIGURES
- Figure 1.1. Schematic of an IgG Antibody
- Figure 1.2. The Technology Hype Cycle
- Figure 2.1. Typical Glycosylation Pattern of a Monoclonal Antibody
- Figure 2.2. Antibody-Like Constructs Derived From Single-Chain Variable Fragments (scFv)
- Figure 2.3. Schematic of a Dual Variable Domain Immunoglobulin (DVD-Ig)
- Figure 2.4. Selected Types of Engineered Antibodies and Antibody-Derived Fragments
- Figure 2.5. Nanobodies vs. Standard IgG Antibodies
- Figure 2.6. Schematic of a Synbody
- Figure 2.7. Schematic of a Structure-Based Antibody Library Design In Silico
- Figure 2.8. Abmaxis' Adapter-Directed Display Technology
