US Biosimilars Market Opportunity & Clinical Pipeline Analysis
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Pharmaceutical companies benefited from the revolution in biotechnology that hit US market in 1980’s. Some of the blockbuster biologics have been introduced in market helping pharmaceutical companies to occupy major market shares. Their presence could be felt in every disease segment as they were improved with time. Over the years, biologics lost patent giving way to biosimilars. US is late entrant and its market is largely untouched by biosimilars resulting in lots of commercialization opportunities. Now, US has become center of attraction for generating significant revenues by introducing biosimilars in different disease categories. Future prospects of US biosimilars markets have yet to be deciphered as this market is at nascent stages offering unique opportunities and challenges.
Biosimilars in US has been approved after a long-time while they have been introduced in other places over a decade ago. Late entry in US market has prevented the patients from getting benefit of biosimilars. Also, spending on healthcare could have been mitigated but absence of proper regulatory framework prevented commercialization of biosimilars in US. Number of indication under biosimilar coverage are also less, single at present, which is going to have modest effect on US market. Number of indications will increase in coming years till then US biosimilar market is expected to grow at modest rates. Slow market growth is of great concern as it is also related to cost cutting by regulators in health care spending. US biosimilars market is at nascent stage and it would take few years to become suitable niche for biosimilars.
Biologics have dominated the US market for several decades due to absence of worthy competitor in different disease segment. In coming years, this situation is expected to change as biosimilars are expected to be commercialized. Zarxio, first US biosimilar, has created lot of enthusiasm among masses but some physicians, investigators and payers have reservation against biosimilars. This scenario may cause hindrance in uptake of biosimilars in coming years. To increase acceptance rates, biosimilar developers have to produce head-to-data confirming pharmacological efficacy. Biosimilars are also expected to have higher cost-effectiveness promoting patients to switch from biologics. In this way, biosimilar developers would be able to generate more revenues by developing positive attitude towards biosimilars.
Newly developed biosimilars in US market are expected to face hard time as regulations are not in place. Both patient and payers are expected to suffer from this issue that has to be resolved as soon as possible. Implication of new rules is expected to take some time as lots of issues have to be solved. Naming of biosimilars and assigning of appropriate billing code is one of the fore most necessities. This situation is likely to deteriorate when monoclonal antibodies will be introduced in US market. Substitution and reimbursement will become easy if clear demarcation is made between which molecule belongs to which category. Regulators are likely to resolve these issues in coming years as they have just entered in biosimilars segment.
“US Biosimilars Market Opportunity & Clinical Pipeline Analysis” Report Highlight:
Pharmaceutical companies benefited from the revolution in biotechnology that hit US market in 1980’s. Some of the blockbuster biologics have been introduced in market helping pharmaceutical companies to occupy major market shares. Their presence could be felt in every disease segment as they were improved with time. Over the years, biologics lost patent giving way to biosimilars. US is late entrant and its market is largely untouched by biosimilars resulting in lots of commercialization opportunities. Now, US has become center of attraction for generating significant revenues by introducing biosimilars in different disease categories. Future prospects of US biosimilars markets have yet to be deciphered as this market is at nascent stages offering unique opportunities and challenges.
Biosimilars in US has been approved after a long-time while they have been introduced in other places over a decade ago. Late entry in US market has prevented the patients from getting benefit of biosimilars. Also, spending on healthcare could have been mitigated but absence of proper regulatory framework prevented commercialization of biosimilars in US. Number of indication under biosimilar coverage are also less, single at present, which is going to have modest effect on US market. Number of indications will increase in coming years till then US biosimilar market is expected to grow at modest rates. Slow market growth is of great concern as it is also related to cost cutting by regulators in health care spending. US biosimilars market is at nascent stage and it would take few years to become suitable niche for biosimilars.
Biologics have dominated the US market for several decades due to absence of worthy competitor in different disease segment. In coming years, this situation is expected to change as biosimilars are expected to be commercialized. Zarxio, first US biosimilar, has created lot of enthusiasm among masses but some physicians, investigators and payers have reservation against biosimilars. This scenario may cause hindrance in uptake of biosimilars in coming years. To increase acceptance rates, biosimilar developers have to produce head-to-data confirming pharmacological efficacy. Biosimilars are also expected to have higher cost-effectiveness promoting patients to switch from biologics. In this way, biosimilar developers would be able to generate more revenues by developing positive attitude towards biosimilars.
Newly developed biosimilars in US market are expected to face hard time as regulations are not in place. Both patient and payers are expected to suffer from this issue that has to be resolved as soon as possible. Implication of new rules is expected to take some time as lots of issues have to be solved. Naming of biosimilars and assigning of appropriate billing code is one of the fore most necessities. This situation is likely to deteriorate when monoclonal antibodies will be introduced in US market. Substitution and reimbursement will become easy if clear demarcation is made between which molecule belongs to which category. Regulators are likely to resolve these issues in coming years as they have just entered in biosimilars segment.
“US Biosimilars Market Opportunity & Clinical Pipeline Analysis” Report Highlight:
- US Biosimilars Market Introduction
- US Biosimilars Regulatory Scenario
- Unique Features of US Biosimilars Market
- Impact of Biosimilars in US Market
- Impact of Reimbursement Policies on US Biosimilars Market
- Zarxio: First Approved Biosimilar in US
- US Biosimilar Clinical Pipeline By Company, Indication & Phase
- US Biosimilar Clinical Pipeline: 104 Biosimilars
- Marketed Biosimilars: 1 Biosimilar
1. US BIOSIMILARS MARKET INTRODUCTION
2. US BIOSIMILARS REGULATORY SCENARIO
3. UNIQUE FEATURES OF US BIOSIMILARS MARKET
4. IMPACT OF BIOSIMILARS IN US MARKET
5. NEW BIOSIMILAR CATEGORIES WITH HIGH COMMERCIALIZATION POTENTIAL
5.1 High Cost-Effectiveness
5.2 Competition
5.3 Nature of Indication
5.4 Nature of Biosimilars
5.5 Cost-Effective Production
5.6 Readily Availability of Biosimilars
6. IMPACT OF REIMBURSEMENT POLICIES ON US BIOSIMILARS MARKET
7. BIOBETTERS: MIDDLE GROUND BETWEEN BIOSIMILARS & BIOLOGICS
8. US BIOSIMILARS MARKET OVERVIEW
8.1 Current Market Scenario
8.2 US Biosimilar Clincal Pipeline Overview
9. ZARXIO: FIRST APPROVED BIOSIMILAR IN US
10. US BIOSIMILARS MARKET DYNAMICS
10.1 Research & Development
10.2 Increasing Demand for Biosimilars
10.3 Increasing Numbers Off-Patent Biologics
10.4 Lesser Competition
10.5 Strong Clinical Pipeline
10.6 Large Number of Indications to be Introduced
11. US BIOSIMILARS COMMERCIALIZATION CHALLENGES
12. US BIOSIMILARS FUTURE PROSPECTS
13. US BIOSIMILARS MARKET GUIDELINES
13.1 Scientific Considerations in Demonstration Biosimilarity to a Reference Product
13.2 Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product
13.3 Nonproprietary Naming of Biological Products
13.4 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a
Reference Product
14. US BIOSIMILAR CLINICAL PIPELINE BY COMPANY, INDICATION & PHASE
14.1 Research
14.2 Preclinical
14.3 Phase-I
14.4 Phase-I/II
14.5 Phase-II
14.6 Phase-III
14.7 Preregistration
14.8 Registered
15. SUSPENDED & DISCONTUED BIOSIMIALRS IN CLINICAL PIPELINE
15.1 No Development Reported
15.2 Discountinued
15.3 Preregistration Submission Withdrawal
16. COMPETITIVE LANDSCAPE
16.1 Amgen
16.2 Apotex
16.3 Boehringer Ingelheim
16.4 Celltrion
16.5 Coherus BioSciences
16.6 Eli Lilly
16.7 EPIRUS Biopharmaceuticals
16.8 Finox Biotech
16.9 Harvest Moon Pharmaceuticals
16.10 Hospira
16.11 Intas Biopharmaceuticals
16.12 Juno Therepeutics (Opus Bio)
16.13 Merck
16.14 Momenta Pharmaceuticals
16.15 Mylan
16.16 Nora Therapeutics
16.17 Novartis
16.18 Oncobiologics
16.19 Pfenex
16.20 Pfizer
16.21 Sandoz
16.22 Wockhardt
2. US BIOSIMILARS REGULATORY SCENARIO
3. UNIQUE FEATURES OF US BIOSIMILARS MARKET
4. IMPACT OF BIOSIMILARS IN US MARKET
5. NEW BIOSIMILAR CATEGORIES WITH HIGH COMMERCIALIZATION POTENTIAL
5.1 High Cost-Effectiveness
5.2 Competition
5.3 Nature of Indication
5.4 Nature of Biosimilars
5.5 Cost-Effective Production
5.6 Readily Availability of Biosimilars
6. IMPACT OF REIMBURSEMENT POLICIES ON US BIOSIMILARS MARKET
7. BIOBETTERS: MIDDLE GROUND BETWEEN BIOSIMILARS & BIOLOGICS
8. US BIOSIMILARS MARKET OVERVIEW
8.1 Current Market Scenario
8.2 US Biosimilar Clincal Pipeline Overview
9. ZARXIO: FIRST APPROVED BIOSIMILAR IN US
10. US BIOSIMILARS MARKET DYNAMICS
10.1 Research & Development
10.2 Increasing Demand for Biosimilars
10.3 Increasing Numbers Off-Patent Biologics
10.4 Lesser Competition
10.5 Strong Clinical Pipeline
10.6 Large Number of Indications to be Introduced
11. US BIOSIMILARS COMMERCIALIZATION CHALLENGES
12. US BIOSIMILARS FUTURE PROSPECTS
13. US BIOSIMILARS MARKET GUIDELINES
13.1 Scientific Considerations in Demonstration Biosimilarity to a Reference Product
13.2 Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product
13.3 Nonproprietary Naming of Biological Products
13.4 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a
Reference Product
14. US BIOSIMILAR CLINICAL PIPELINE BY COMPANY, INDICATION & PHASE
14.1 Research
14.2 Preclinical
14.3 Phase-I
14.4 Phase-I/II
14.5 Phase-II
14.6 Phase-III
14.7 Preregistration
14.8 Registered
15. SUSPENDED & DISCONTUED BIOSIMIALRS IN CLINICAL PIPELINE
15.1 No Development Reported
15.2 Discountinued
15.3 Preregistration Submission Withdrawal
16. COMPETITIVE LANDSCAPE
16.1 Amgen
16.2 Apotex
16.3 Boehringer Ingelheim
16.4 Celltrion
16.5 Coherus BioSciences
16.6 Eli Lilly
16.7 EPIRUS Biopharmaceuticals
16.8 Finox Biotech
16.9 Harvest Moon Pharmaceuticals
16.10 Hospira
16.11 Intas Biopharmaceuticals
16.12 Juno Therepeutics (Opus Bio)
16.13 Merck
16.14 Momenta Pharmaceuticals
16.15 Mylan
16.16 Nora Therapeutics
16.17 Novartis
16.18 Oncobiologics
16.19 Pfenex
16.20 Pfizer
16.21 Sandoz
16.22 Wockhardt
LIST OF FIGURES
Figure 1-1: Benefits of Biosimilar Introduction in US
Figure 1-2: Present Limitations of Biosimilars in US
Figure 1-3: FDA’s Requirements for Biosimilar Products
Figure 2-1: Criterias for Similarity Formulated by Food and Drug Administration (FDA)
Figure 4-1: Global Sales of Neupogen/Neulasta (USD Million), 2012-2014
Figure 4-2: Global Sales of Epogen (USD Million), 2012-2014
Figure 4-3: Global Sales of Neulasta (USD Million), 2012-2014
Figure 4-4: Shares of Amgen Products Exposed to Biosimilars Competition (USD Million), 2014
Figure 5-1: Factors Responsible for Significant Revenue Generation
Figure 7-1: Properties of Biobetters
Figure 7-2: Few Advantages of Biobetters
Figure 7-3: Disadvantages of Biobetters
Figure 8-1: US- Estimated Humira Sales (USD Million), 2012-2014
Figure 8-2: Global Remicade Sales (USD Million), 2012-2014
Figure 8-3: US- MabThera/Rituxan Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015
Figure 8-4: US-Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014- Q3 2015
Figure 8-5: Global Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015
Figure 8-6: Estimated Global Aranesp Sales (USD Million), 2012-2014
Figure 8-7: US- Estimated Aranesp Sales (USD Million), 2012-2017
Figure 8-8: Estimated Sales of Selected Biologics Exposed to Biosimilars Competition, 2014 (USD Million)
Figure 8-9: Estimated Shares of Selected Biologics Exposed to Biosimilars Competition (USD Million), 2014
Figure 8-10: Rank of US among Different Diabetes Prone Countries
Figure 8-11: US Biosimilar Pipeline by Phase (%),2016
Figure 8-12: US Biosimilar Pipeline by Phase (Number),2016
Figure 8-13: No Development Reported US Biosimilar All Pipeline by Phase (%),2016
Figure 8-14: No Development Reported US Biosimilar All Pipeline by Phase (Number),2016
Figure 8-15: Discontinued US Biosimilar All Pipeline by Phase (%),2016
Figure 8-16: Discontinued US Biosimilar All Pipeline by Phase (Numbers),2016
Figure 16-1: Amgen Clinical Pipeline
Figure 16-2: Coherus Bioscience Clinical Pipeline
Figure 16-3: EPIRUS Biopharmaceuticals- Clinical Pipeline
Figure 16-4: Merck Clinical Pipeline
Figure 16-5: Novartis Clinical Pipeline
Figure 16-6: Oncobiologics-Clinical Pipeline
Figure 16-7: Pfenex Clinical Piepline
Figure 16-8: Sandoz Clinical Pipeline
Figure 1-1: Benefits of Biosimilar Introduction in US
Figure 1-2: Present Limitations of Biosimilars in US
Figure 1-3: FDA’s Requirements for Biosimilar Products
Figure 2-1: Criterias for Similarity Formulated by Food and Drug Administration (FDA)
Figure 4-1: Global Sales of Neupogen/Neulasta (USD Million), 2012-2014
Figure 4-2: Global Sales of Epogen (USD Million), 2012-2014
Figure 4-3: Global Sales of Neulasta (USD Million), 2012-2014
Figure 4-4: Shares of Amgen Products Exposed to Biosimilars Competition (USD Million), 2014
Figure 5-1: Factors Responsible for Significant Revenue Generation
Figure 7-1: Properties of Biobetters
Figure 7-2: Few Advantages of Biobetters
Figure 7-3: Disadvantages of Biobetters
Figure 8-1: US- Estimated Humira Sales (USD Million), 2012-2014
Figure 8-2: Global Remicade Sales (USD Million), 2012-2014
Figure 8-3: US- MabThera/Rituxan Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015
Figure 8-4: US-Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014- Q3 2015
Figure 8-5: Global Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015
Figure 8-6: Estimated Global Aranesp Sales (USD Million), 2012-2014
Figure 8-7: US- Estimated Aranesp Sales (USD Million), 2012-2017
Figure 8-8: Estimated Sales of Selected Biologics Exposed to Biosimilars Competition, 2014 (USD Million)
Figure 8-9: Estimated Shares of Selected Biologics Exposed to Biosimilars Competition (USD Million), 2014
Figure 8-10: Rank of US among Different Diabetes Prone Countries
Figure 8-11: US Biosimilar Pipeline by Phase (%),2016
Figure 8-12: US Biosimilar Pipeline by Phase (Number),2016
Figure 8-13: No Development Reported US Biosimilar All Pipeline by Phase (%),2016
Figure 8-14: No Development Reported US Biosimilar All Pipeline by Phase (Number),2016
Figure 8-15: Discontinued US Biosimilar All Pipeline by Phase (%),2016
Figure 8-16: Discontinued US Biosimilar All Pipeline by Phase (Numbers),2016
Figure 16-1: Amgen Clinical Pipeline
Figure 16-2: Coherus Bioscience Clinical Pipeline
Figure 16-3: EPIRUS Biopharmaceuticals- Clinical Pipeline
Figure 16-4: Merck Clinical Pipeline
Figure 16-5: Novartis Clinical Pipeline
Figure 16-6: Oncobiologics-Clinical Pipeline
Figure 16-7: Pfenex Clinical Piepline
Figure 16-8: Sandoz Clinical Pipeline
LIST OF TABLES
Table 2-1: Major Regulatory Differences Related to Biosimilars in US & EU
Table 2-2: Differences between Biosimilars Applications & Biologics License Applications
Table 4-1: Comparison of Neupogen vs. Zarxio Cost
Table 4-2: Competition to Neupogen
Table 4-3: Amgen’s Biosimilar Competitors in US
Table 4-4: Categories with Potential to Generate Significant Revenues in US Market
Table 5-1: Biosimilars under Food and Drug Administration (FDA) Review
Table 6-1: Categories of Medicare Plan
Table 6-2: Estimated Reimbursement of Zarxio according to Medicare B
Table 7-1: Few Examples of Biologics, Biosimilars and Biobetters
Table 8-1: Biosimilars with High Commercialization Potential in US, 2013-2024
Table 8-2: Companies Involved in Marketing of Rituximab
Table 8-3: Categories with High Potential for Biosimilar Revenue Generation
Table 16-1: Celltrion Clinical Pipeline
Table 2-1: Major Regulatory Differences Related to Biosimilars in US & EU
Table 2-2: Differences between Biosimilars Applications & Biologics License Applications
Table 4-1: Comparison of Neupogen vs. Zarxio Cost
Table 4-2: Competition to Neupogen
Table 4-3: Amgen’s Biosimilar Competitors in US
Table 4-4: Categories with Potential to Generate Significant Revenues in US Market
Table 5-1: Biosimilars under Food and Drug Administration (FDA) Review
Table 6-1: Categories of Medicare Plan
Table 6-2: Estimated Reimbursement of Zarxio according to Medicare B
Table 7-1: Few Examples of Biologics, Biosimilars and Biobetters
Table 8-1: Biosimilars with High Commercialization Potential in US, 2013-2024
Table 8-2: Companies Involved in Marketing of Rituximab
Table 8-3: Categories with High Potential for Biosimilar Revenue Generation
Table 16-1: Celltrion Clinical Pipeline
