Next Generation Biologics: R&D, Industry and Market 2014-2024

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Next-Generation Biologics:
R&D, Industry and Market
2014-2024

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Next-Generation Biologics: R&D,
Industry and Market 2014-2024
1.1 Next-Generation Biologics: World Market Review 2014
1.2 Report Contents
1.2.1 Benefits of this Report
1.3 Research and Analysis Methods
1.3.1 Financial Information in this Report
1.3.2 Who is this Report for?
1.4 An Introduction to Next-Generation Biologics
1.4.1 A Brief History of Biological Drug Development
1.4.2 Limitations to Current Generation Biologics
1.4.3 The Promise of Next-Generation Biologics
1.4.3.1 Defining Next-Generation Biologics
1.4.3.2 A Definition of Regenerative Medicine
1.4.3.3 Extending Half-Life: Pegylation and Other Novel Strategies
2.1 The Next-Generation Biologics Market 2013
2.1.1 Development of the Next-Generation Biologics Market 2008-2013
2.1.2 Rising Demand for Biological Therapies
2.1.3 Next-Generation Drugs as a Share of the Biologics Market 2013
2.1.4 Main Sectors of the Next-Generation Biologics Market: Antibodies and Regenerative
Medicine Lead the Way
2.1.5 Leading Companies in the Next-Generation Biologics Market 2013
2.2 The Next-Generation Biologics Market 2014-2024
2.2.1 The Biologics Market Forecast 2014-2024
2.2.1.1 Growth Drivers for Biological Drug Revenues 2014-2024
1. Executive Summary
2. The World Next-Generation Biologics Market: Outlook and
Forecast 2014-2024

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2.2.2 The Next-Generation Biologics Market Forecast 2014-2024
2.2.3 Product Launches in All Sectors to Drive Market Growth 2014-2024
2.2.4 Next-Generation Biologics: Market Restraints 2014-2024
2.2.5 Rising Market Shares for Next-Generation Insulins 2014-2024
3.1 Leading National Submarkets for Next-Generation Biologics 2013
3.1.1 National Submarket Forecasts 2014-2024
3.1.2 How Will National Submarket Shares Change to 2024?
3.2 Rising Disease Incidence in Major Markets 2014-2024
3.3 Approval of Next-Generation Biologics in Major National Submarkets
3.4 The US Will be the Largest Submarket for Next-Generation Biologics 2014-2024
3.4.1 US Submarket Forecast 2014-2024
3.5 Next-Generation Biologics in Japan 2014-2024
3.5.1. National Expertise in Stem Cell Research
3.5.2 Japanese Submarket Forecast 2014-2024
3.6 Next-Generation Biologics in Leading EU Nations 2014-2024
3.6.1 Regenerative Medicine Development in the EU
3.6.2 Market Access for Next-Generation Biologics in the EU
3.6.3 Germany: Submarket Forecast 2014-2024
3.6.4 France: Submarket Forecast 2014-2024
3.6.5 UK: Submarket Forecast 2014-2024
3.6.6 Italy and Spain: Submarket Forecasts 2014-2024
3.7 Next-Generation Biologics in Emerging Markets 2014-2024
3.7.1 Next-Generation Biologics Development in Emerging Markets
3.7.2 Chinese Submarket Forecast 2014-2024
3.7.3 Indian Submarket Forecast 2014-2024
3. Leading National Submarkets for Next-Generation Biologics 2014-
2024

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4.1 Strategies for Improving Antibody Therapies
4.1.1 Antibody-Drug Conjugates: Targeted Cytotoxic Therapies
4.1.2 Engineering Antibodies for Improved Potency
4.1.3 Bispecific Antibodies
4.2 Next-Generation Antibody Therapy Submarket 2012-2013
4.3 Next-Generation Antibody Therapy Submarket 2014-2024
4.3.1 Strong Revenue Growth for Next-Generation Antibodies 2014-2024
4.3.2 Blockbuster Potential Will Drive Growth to 2024
4.3.3 Next-Generation Antibodies: Submarket Restraints 2014-2024
4.4 Antibody-Drug Conjugates Submarket 2014-2024
4.4.1 Antibody-Drug Conjugates Submarket Forecast 2014-2024
4.4.1.1 Kadcyla and Adcetris: Revenue Forecast 2014-2024
4.4.2 What Will Drive Growth for ADCs to 2024?
4.4.3 A Long Pipeline of ADCs in Clinical Development
4.4.3.1 CMC544: NHL Development Halted but Trials in ALL Continue
4.4.3.2 CDX-011: Potential for Accelerated Approval in Breast Cancer
4.5 Engineered Antibodies Submarket 2014-2024
4.5.1 Engineered Antibodies Submarket Forecast 2014-2024
4.5.1.1 Gazyva Will Lead the Submarket in 2024
4.5.2 Portfolio Management to Drive Growth 2014-2024
4.5.3 Engineered Antibodies Pipeline 2014
4.5.3.1 Benralizumab (MedImmune/Kyowa Hakko Kirin)
4.6 Bispecific Antibodies Submarket 2014-2024
4.6.1 Bispecific Antibodies Submarket Forecast 2014-2024
4.6.2 Bispecific Antibodies: Submarket Drivers and Restraints 2014-2024
4.6.3 One Phase III and Two Phase II Bispecific Antibodies in 2014
4.6.3.1 Blinatumomab (Amgen): The Only Phase III Bispecific Antibody
4. Next-Generation Antibodies Submarket Outlook 2014-2024

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5.1 Next-Generation Antibody Fragments: Beyond Fab Fragments
5.1.1 Antibody-Like Proteins Mimic Antibody Therapies
5.1.2 There Are Advantages to Using Fragments and Novel Scaffolds
5.2 Antibody Fragment and ALP Submarket 2014-2024
5.2.1 Antibody Fragment and ALP Submarket Forecast 2014-2024
5.2.2 Pharma Is Investing Strongly in Antibody Fragments and ALPs
5.2.3 Limited Late-Stage Pipeline to Restrain Growth to 2024
5.3 Outlook for Next-Generation Antibody Fragments 2014-2024
5.3.1 Next-Generation Antibody Fragment Submarket Forecast 2014-2024
5.3.2 One Platform Leads the Pipeline in 2014
5.3.2.1 Three Nanobodies in Development for Rheumatoid Arthritis
5.3.2.2 Caplacizumab (Ablynx): Targeting an Orphan Indication
5.4 The Antibody-Like Protein Submarket 2014-2024
5.4.1 Antibody-Like Protein Submarket Forecast 2014-2024
5.4.2 Four ALPs in Clinical Development in 2014
5.4.2.1 AGN-150998: Development of the Lead Clinical ALP Delayed
5.5 Will Next-Generation Immunotoxins Impact the Market to 2024?
5.5.1 Challenges with First Generation Immunotoxins
5.5.2 Fusion Protein Conjugates: Pipeline 2014
5.5.2.1 Moxetumomab Pasudotox
5.5.3 Humanised Immunotoxins
5.5.3.1 Using Granzyme B in Immunotoxins
5.5.3.2 Immunornases: A Future Development Opportunity for Immunotoxins
5. Antibody Fragments and Novel Antibody-Like Drugs: Commercial
Potential 2014-2024

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6.1 Strategies for Next-Generation Insulin Development
6.1.1 Reformulating Insulin for Convenient Administration
6.1.1.1 Oral Insulin
6.1.1.2 Inhaled Insulin
6.1.1.3 Exubera: A Failed Attempt at Reformulated Insulin
6.2 Next-Generation Insulin Submarket 2012-2013
6.2.1 Tresiba: Approved in the EU and Japan
6.2.1.1 Tresiba: Revenue Forecast 2014-2024
6.3 Next-Generation Insulin Submarket 2014-2024
6.3.1 Next-Generation Insulin Submarket Forecast 2014-2024
6.3.2 Product Launches in the US and EU Will Drive Submarket Growth 2014-2024
6.3.3 Next-Generation Insulin Submarket Restraints 2014-2024
6.3.3.1 Biosimilar Insulins Will be Available from 2015
6.4 Oral Insulin Submarket 2014-2024
6.4.1 Oral Insulin Submarket Forecast 2014-2024
6.4.2 Oral Insulin: Submarket Drivers and Restraints 2014-2024
6.4.3 A Limited Clinical-Stage Pipeline for Oral Insulin 2014
6.4.3.1 Oramed Pharmaceuticals: Oral Insulin in Phase II
6.4.3.2 Novo Nordisk
6.4.3.3 IN-105: Biocon Partners with Bristol-Myers Squibb for Development
6.4.3.4 Diabetology: Multiple Deals Signed for Emerging Markets
6.5 Ultra-Rapid Acting Insulin Submarket 2014-2024
6.5.1 Ultra-Rapid Acting Insulin Submarket Forecast 2014-2024
6.5.1.1 Will Inhaled Insulins Drive Revenue Growth to 2024?
6.5.2 Other Submarket Drivers and Restraints 2014-2024
6.5.3 Ultra-Rapid Acting Insulin Pipeline 2014
6.5.3.1 FIAsp (Novo Nordisk)
6. Next-Generation Insulin Submarket: Outlook 2014-2024

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6.5.3.2 Adocia: Eli Lilly Opts to Discontinue Partnership
6.5.3.3 Halozyme Therapeutics
6.5.3.4 Biodel: Multiple Ultra Rapid Acting Candidates
6.5.3.5 Afrezza: Inhaled Insulin Nearing the Market
6.5.3.6 Adagio: A Second-Generation Inhaled Insulin
6.6 Ultra-Long Acting Insulin Submarket 2014-2024
6.6.1 Ultra-Long Acting Insulin Submarket Forecast 2014-2024
6.6.2 Revenue Growth Driven by Uptake of Tresiba
6.6.3 Ultra-Long Acting Insulin Pipeline 2014
6.6.3.1 U300: Sanofi’s Next-Generation Insulin Analogue
6.6.3.2 LY2605541 (Eli Lilly)
6.6.3.3 FT-105 (Flamel Technologies)
6.6.3.4 LAPS-Insulin
7.1 Defining Next-Generation for Other Recombinant Protein Sectors
7.1.1 Next-Generation Interferon Beta: Plegridy Set for Approval in 2014
7.1.1.1 Plegridy: Revenue Forecast 2014-2024
7.1.1.2 Plegridy May Compete with Other Long-Acting Interferon Beta Therapies 2014-
2024
7.1.2 Next-Generation G-CSF: Teva Expands its Filgrastim Franchise
7.1.2.1 Other Clinical-Stages Advances in Filgrastim Therapy 2014
7.2 Next-Generation Recombinant Coagulation Factors 2014-2024
7.2.1 Next-Generation Recombinant Coagulation Factors Submarket Forecast 2014-2024
7.2.2 Submarket Drivers and Restraints 2014-2024
7.2.3 Clinical Pipeline for Recombinant Coagulation Factors 2014-2024
7.2.3.1 BAX 855 (Baxter)
7.2.3.2 BAY94-9027 (Bayer)
7. Next-Generation Developments for Other Recombinant Proteins
2014-2024

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7.2.3.3 N8-GP for Haemophilia A
7.2.3.4 N9-GP for Haemophilia B
7.2.3.5 Fused Factors: Biogen Idec’s Eloctate and Alprolix
7.2.3.6 rIX-FP (CSL Behring): Albumin-Bound Coagulation Factors
7.2.4 Gene Therapy as a New Treatment Option for Haemophilia
7.3 Next-Generation Growth Hormones 2014-2024
7.3.1 Next-Generation Growth Hormone Submarket Forecast 2014-2024
7.3.2 Brand Loyalty Will Restrain Uptake of Next-Generation Hormones 2014-2024
7.3.3 Long-Acting Growth Hormones
7.3.3.1 Biopartners/LG Life Sciences: The First Long-Acting Growth Hormone
7.3.3.2 Prolor Biotech/OPKO Health
7.3.3.3 Novo Nordisk: Looking to Extend its Market-Leading Position
7.3.3.4 Versartis: XTEN Technology for Half-Life Extension
7.3.4 Reformulated Growth Hormones: Offering Convenient Dosing for Paediatric Patients
7.3.4.1 Critical Pharmaceuticals: Nasal Delivery of Somatropin
8.1 The Regenerative Medicine Submarket 2012-2013
8.1.1 Defining Regenerative Medicine
8.2 The Regenerative Medicine Submarket: Revenue Projections 2014-2024
8.2.1 Stem Cell and Gene Therapy Launches to Drive Growth 2014-2024
8.3 The Stem Cell Therapies Submarket 2014-2024
8.3.1 Prochymal (Mesoblast) for GvHD
8.3.1.1 The Future for Prochymal: Approval in Crohn’s Disease?
8.3.2 A Note on Stem Cell Transplants
8.3.3 Stem Cell Therapies Submarket Forecast 2014-2024
8.3.4 Stem Cell Therapies: Submarket Drivers and Restraints 2014-2024
8.3.4.1 Will iPSCs Prove Effective for Stem Cell Therapy?
8.3.5 Stem Cell Therapies Late-Stage Pipeline 2014
8. Regenerative Medicine: Commercial Outlook 2014-2024

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8.3.5.1 Cx601 (TiGenix)
8.3.5.2 Mesoblast: Mesenchymal Stem Cell Therapies
8.3.5.3 Baxter Pharmaceuticals: A Leading Cardiovascular Candidate
8.3.5.4 StemEx (Gamida Cell)
8.4 The Gene Therapies Submarket 2014-2024
8.4.1 Glybera Approved and Set for Launch in the EU
8.4.2 Gene Therapies Submarket: Revenue Projections 2014-2024
8.4.3 Glybera’s Approval to Drive Submarket Growth from 2014
8.4.4 There Are More Than Five Gene Therapies in Late-Stage Development
8.4.4.1 ProstAtak: Gene Therapy for Prostate Cancer
8.4.4.2 TVEC (Amgen)
8.4.4.3 Generx (Cardium Therapeutics)
8.4.4.4 Spark Therapeutics: Established in 2013 for Ophthalmic Gene Therapy
8.5 Outlook for Tissue Engineering 2014-2024
8.5.1 Two Sectors Lead the Market: Wound and Cartilage Repair
8.5.1.1 Apligraf Leads the Wound Repair Submarket
8.5.1.2 Organogenesis Will Market Apligraf and Dermagraft from 2014
8.5.2 Tissue Engineering Submarket Forecast 2014-2024
8.5.3 Tissue Engineering: Submarket Drivers and Restraints 2014-2024
8.5.4 Future Developments in Cartilage Repair: Pipeline 2014
8.5.5 Organ Repair and Engineering: The Next Step in Tissue Engineering?
8.5.5.1 Engineered Skin
8.5.5.2 Engineered Veins
8.5.5.3 Organ Transplant: A Long-Term Tissue Engineering Opportunity
9.1 Next-Generation Biologics: Market Strengths 2014
9.2 Next-Generation Biologics: Market Weaknesses 2014
9.3 The Next-Generation Biologics Market: STEP Analysis 2014-2024
9. Next-Generation Biologics: Industry Trends 2014-2024

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9.3.1 Social Factors: Rising Disease Incidence and Demands for Convenience
9.3.1.1 Rising Incidence in Cancer, Diabetes and Cardiovascular Disease
9.3.1.2 Next-Generation Biologic Development in Emerging Markets
9.3.2 Technological Developments 2014-2024
9.3.3 Economic Pressures 2014-2024
9.3.3.1 High Drug Costs and Healthcare Spending
9.3.3.2 Limited Commercial Potential in Emerging Markets?
9.3.4 Political Issues: Regulatory Developments 2014-2024
9.4 Next-Generation Biologics: Development Trends 2014-2024
9.4.1 Improving Patient Convenience
9.4.2 Sustained Release Biologics: Pegylation and Beyond
9.4.3 Therapeutic Focus for Next-Generation Biologics
9.4.4 Next-Generation Biologics as Personalised Medicine
9.5 Manufacturing Challenges and Opportunities for Next-Generation Biologics
9.5.1 Contract Manufacturers Invest to Follow Development Trends
9.6 Commercialising Next-Generation Biologics
9.6.1 Product Lifecycle Management for First Generation Biologics
9.6.2 Proving Benefit in Next-Generation Products
9.6.3 Biosimilars as a Challenger 2014-2024
9.7 Partnering for Next-Generation Biologic Development
9.7.1 The Role of Big Pharma in the Next-Generation Biologics Market
9.7.2 Most Development Platforms Stem from Small Biotechs
10.1 Dr Fredrik Frejd, CSO, Affibody
10.1.1 Affibody
10.1.2 Challenges with Current Biological Therapies
10.1.2.1 Current Half-Life Extension Technologies
10.1.3 The Benefits of Affibodies Over Current Antibody Therapies
10. Research Interviews from Our Survey

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10.1.4 Focus on Inflammation and Autoimmune Diseases
10.1.5 Development of SOBI002
10.1.6 Regulatory Challenges for Novel Biologics
10.2 Dr Mike Romanos, CEO, Crescendo Biologics
10.2.1 Crescendo Biologics
10.2.2 The Benefits in Antibody Fragment Therapies
10.2.3 Treatment of Inflammation Indications with Antibody Fragments
10.2.4 Crescendo’s Fragment Pipeline
10.2.5 Development and Production Platforms for Antibody Therapies
11.1 The Next-Generation Biologics Market Will Grow Strongly to 2024
11.2 Next-Generation Antibody Development Will Lead the Market
11.3 New Treatment Regimens Will Drive Demand for Next-Generation Biologics
11.4 Challenges Remain in Developing and Commercialising Next-Generation Biologics
About Visiongain’s Bespoke Research Service
Appendix A: About Visiongain
Appendix B: Visiongain Report Evaluation Form
11. Conclusions to Our Study
Appendices

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4.6.2 Bispecific Antibodies: Submarket Drivers and Restraints 2014-
2024
Table 4.17 identifies the main drivers and restraints that will impact the bispecific antibodies sector
between 2014 and 2024. Market drivers stem from the large number of technology platforms
available for bispecific development and the interest that these have attracted from Big Pharma
companies. Some developers have been able to attract potential billion-dollar deals with
pharmaceutical partners, with up-front fees in excess of $100m. This demonstrates a confidence in
the technology from the pharmaceutical industry.
In the second half of the period 2014-2024, submarket growth will be driven by the launch of new
bispecific antibodies, starting with Amgen’s blinatumomab. That drug is targeting a multibillion
dollar market sector - ALL - and could achieve revenues in excess of $0.50bn, we believe. A
steady stream of approvals from 2018 onwards will drive strong growth in the bispecifics
submarket. Although most of the advanced clinical programmes are targeting cancer indications,
clinical trials and pre-clinical studies have demonstrated that bispecific antibodies hold potential
outside that therapeutic sector.
Restraints in the bispecific antibodies submarket stem from the limited late-stage pipeline and low
revenues for currently approved products. In 2014 and 2015, the submarket will grow steadily as a
result of no new product launches and continued low revenue for the one approved bispecific,
Removab. While the number of platforms validated in pre-clinical studies indicates that there is
huge promise for the bispecific antibodies sector, the fact that few have been validated in clinical
studies means that the field is not yet reaching its potential, we believe.
2013 2014 2015 2016 2017 2018
Submarket Size ($bn) 0.00 0.00 0.00 0.06 0.07 0.19
Annual Growth (%) -2 8 1434 15 152
CAGR (%, 2013-2018) 116.0
2019 2020 2021 2022 2023 2024
Submarket Size ($bn) 0.34 0.55 0.74 0.90 1.06 1.23
Annual Growth (%) 81 63 33 23 17 16
CAGR (%, 2018-2024) 36.8
Source: visiongain 2014
Table 4.16 Bispecific Antibodies Submarket Forecast ($bn), 2013-2024

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4.6.3 One Phase III and Two Phase II Bispecific Antibodies in 2014
In 2014, visiongain believes that the clinical pipeline for bispecific antibodies is shorter for than
other leading sectors of the next-generation antibodies submarket. Despite multiple platforms
being validated pre-clinically, there are just 16 clinical-stage projects, two thirds of which stem from
three production platforms. Amgen’s BiTE platform accounts for five bispecific antibodies in clinical
trials. The company gained ownership of the platform through its acquisition of Micromet in
January 2012. BiTEs are bispecific T cell engagers manufactured by fusing single chain variable
fragments from an anti-CD3 antibody to single chain variable fragments from other antibodies. In
this respect, BiTE antibodies are similar to the antibody fragment molecules discussed in the next
chapter. The most advanced candidate to come from the BiTE platform is blinatumomab, the only
phase III candidate in the bispecific antibodies submarket in 2014 (Table 4.18).
We believe that MacroGenics’ DART (dual-affinity re-targeting) platform is the second highest-
profile bispecific antibody platform. MacroGenics reports that it has generated more than 100
bispecifics through its DART platform to date. The platform produces bispecific antibodies through
the conjugation of two Fv fragments through a covalent linker. The resulting molecules have high
stability, decreased immunogenicity and can be produced in microbial and mammalian cell
cultures. Although no DART-based bispecifics have yet reached clinical trials, visiongain believes
this is among the most promising platforms in the sector. MacroGenics has also developed an Fc
optimisation platform, which can improve the binding affinity of antibodies. If this can be used in
Drivers Restraints
Bispecifics overcome specificity problems found
with traditional monoclonal antibodies
Manufacturing and stability are concerns for
current bispecifics
There is already one product available on the
market
There is only one product in phase III trials that
will launch before the middle of the forecast
period
Leading bispecific platforms have attracted
interest from Big Pharma companies
Revenues for the one approved product remain
low in 2014
There are many platforms with candidates in pre-
clinical development
Bispecific antibodies have potential uses outside
of cancer
Source: visiongain 2014
Table 4.17 Bispecific Antibodies Submarket: Drivers and Restraints, 2014-2024

Next Generation Biologics: R&D, Industry and Market 2014-2024

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Next Generation Biologics: R&D, Industry and Market 2014-2024