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Top Selling Biologics Market, 2021-2030: Focus on Product Landscape Assessment, Ongoing Clinical Trials, Promotional Content Analysis, Other Life Cycle Management Strategies, Competition from Biosimilars, Annual Treatment Cost Comparison, Sales Evolution and Future Opportunity

  • ID: 5359104
  • Report
  • April 2021
  • Region: Global
  • 242 Pages
  • Roots Analysis

FEATURED COMPANIES

  • AbbVie
  • AstraZeneca
  • Bristol-Myers Squibb
  • Genentech
  • Immunex
  • Merck

Overview

Less than half a century ago, the pharmaceutical market was dominated by small molecule drugs. However, owing to concerns, such as off target toxicity and low specificity, associated with chemical moieties, and the need to shift from the one-size-fits-all approach to personalized medicine, a better class of pharmacological interventions was required. The first biologic, humanized insulin, was approved in 1982; over time, this class of target specific therapeutics have revolutionized the healthcare industry. Briefly, biologics offer several benefits, including target specificity, better therapeutic efficacy and, consequently, favorable safety profiles compared to conventional chemical-based drugs. Moreover, these molecules have also demonstrated the ability to access elusive biological targets and treat diseases that were previously considered undruggable. Presently, biologics represent the fastest growing product segment within the global pharmaceutical industry. In fact, as of September 2020, over 430 biological interventions were approved for the treatment of various disease indications in the US and Europe. Given the advantages they offer, biologics are in high demand for the treatment of different disease indications. It is a well-known fact that antibodies emerged as the major therapeutic breakthroughs and have seen significant success in the past two decades. There are other vast opportunities for biologics in the foreseeable future. This segment of healthcare industry is in the midst of numerous innovations; examples include antibody drug conjugates, immunotherapies, bispecific antibodies, combination therapeutics, and cell and gene therapies. These developments have set the stage for significant disruption, creating more therapeutic targets and, ultimately, taking personalized healthcare to new and astounding heights.

Despite their complex and cost intensive manufacturing protocols, biopharmaceuticals (once approved) are highly profitable assets. In the recent past, many biological interventions have achieved blockbuster status (in some cases, registering revenues worth over USD 4 billion in a year); prominent examples include (as per decreasing revenues generated in 2020) Humira®, Keytruda®, Stelara®, Opdivo®, Avastin®, Trulicity®, Enbrel®, Ocrevus™ and Rituxan®. The aforementioned products together, generated sales worth close to USD 80 billion in 2020 alone. Although the patents protecting some of these blockbuster drugs have already expired, the sales of the original product have not been significantly impacted. For instances, there are multiple approved biosimilar versions of Abbvie’s Humira®, but the company reported annual global revenues worth around USD 19 billion from the sales of this drug alone. For several other top selling biologic drugs, patents covering the affiliated intellectual property are soon expected to expire, opening the market to competition from follow-on biologics. However, there are ways in which innovators can extend their marketing exclusivity, and delay the entry of biosimilars; popular product lifecycle management strategies include gaining marketing authorization (and exclusivity) in a new geography, proving therapeutic benefit for a different disease indication (than the one the product was originally cleared to treat), developing a new formulation of the drug, demonstrating therapeutic benefit in combination with another drug/therapy, and making the product available in a novel drug delivery device/system. In other words, companies that have developed blockbuster biologic products are expected to continue benefiting from their respective high-value assets in the short-mid term. However, we anticipate the market for such products to grow steadily and then plateau, before gradually declining over time, as impending patent expiries (including those that have been extended) pave way for biosimilars.

Scope of the Report

The “Top Selling Biologics Market, 2021-2030: Focus on Product Landscape Assessment, Ongoing Clinical Trials, Promotional Content Analysis, Other Life Cycle Management Strategies, Competition from Biosimilars, Annual Treatment Cost Comparison, Sales Evolution and Future Opportunity” report features an extensive study of the current market landscape and future potential of the top selling biologics available for the treatment of a variety of disease indications. The study includes an in-depth analysis, highlighting the key initiatives undertaken by various stakeholders engaged in this domain. 

Amongst other elements, the report features:

  • A detailed assessment of the current market landscape of top selling biologics, along with information on developers (such as year of establishment, company size, location of headquarters and current portfolio of top selling biologics), type of biologic, route of administration, target gene/antigen, type of packaging format, disease indication and target therapeutic area. 
  • It also provides an in-depth analysis of key therapeutic areas, such as oncological disorders, metabolic disorders, autoimmune disorders, gastrointestinal disorders, ophthalmic disorders, CNS/ Neurological disorders, cardiovascular disorders, blood disorders, respiratory disorders, bone disorders and others, in companies that are engaged in the development of top selling biologics.  
  • A detailed analysis of revenues generated by top selling biologics (60+) between 2016 and 2020. It includes information on reasons for significant increase/decrease in their sales in the given time span. It also includes the analysis of revenues generated by top selling biologics in 2020, based on several relevant parameters, such as type of biologic and developer. 
  • An analysis of the completed, ongoing and planned clinical studies for top selling biologics. The trials considered in the analysis were analyzed based on several relevant parameters, such as trial registration year, trial recruitment status, enrolled patient population, study design, target therapeutic area, geographical location of trials and leading organizations. It is worth highlighting that these studies were registered to evaluate the already approved top selling biologics for potential combinations, device evaluations and comparisons. 
  • A detailed analysis on the key promotional strategies that are being/have been adopted by developers of top selling biologics. It further includes a detailed Harvey ball analysis highlighting the extent of promotional content on product websites of all biologics (60+) that fall into this criterion. Additionally, it features detailed profiles, presenting promotional strategies implemented for top 7 blockbuster biologics (in terms of revenues), along with information on their promotional content on product websites (covering key messages for patients and healthcare professionals), details of patient support programs and a brief section on DTC advertisements. 
  • A brief analysis of the product lifecycle management strategies, such as geographical expansion, approval for additional disease indications, reformulations, combination therapies, exploiting alternate routes of administration reimbursement programs and pricing strategies, that have been adopted by stakeholders engaged in the development of top selling biologics, during the period 2016-2020. The information in detail has been provided for top 10 biologics (in terms of revenues).
  • An elaborate analysis representing annual treatment cost of top selling biologics. It includes grid representations, providing information on 60+ top selling biologics, based on type of biologic.

One of the key objectives of the report was to estimate the existing market size and future growth potential within the top selling biologics market, over the coming decade. Based on multiple parameters, such as historical sales, future competition from other biologics and biosimilars, as well as impending patent expiries, we have provided informed estimates on the financial evolution of the market for the period 2020-2030. It further includes sales-based forecasts of 60+ top selling biologics. The report also provides details on the likely distribution of the current and forecasted opportunity across type of biologic (monoclonal antibody, hormone, enzyme, fusion protein, interferon, gene therapy and others) and key players. In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

Key Questions Answered

  • Which biologics have achieved blockbuster status in the last 1-2 years?
  • Who are the leading players engaged in the development of top selling biologics?
  • Which key clinical conditions are presently targeted by top selling biologics?
  • What are the historical global sales of top selling biologics?
  • Which product life cycle management strategies are most commonly adopted by players to extend the life of their top selling products?
  • What is the current annual treatment cost associated with top selling biologics?
  • Which regions have emerged as key hubs for conducting clinical studies focused on top selling biologics?
  • How has the biosimilars landscape in this market evolved over the past few years?
  • Which factors are likely to influence the evolution of this market?
  • How is the current and future market opportunity likely to be distributed across key market segments?
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • AbbVie
  • AstraZeneca
  • Bristol-Myers Squibb
  • Genentech
  • Immunex
  • Merck

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Types of Therapeutic Molecules
3.3. Biologics 
3.3.1. Type of Biologics
3.3.1.1. Peptides
3.3.1.2. Monoclonal Antibodies
3.3.1.3. Gene Therapies
3.3.1.4. Growth Factors
3.3.1.5. Hormones
3.3.1.6. Enzymes
3.3.1.7. Vaccines
3.3.1.8. Blood and Related Products
3.3.2. Regulatory Considerations
3.3. Competition from Biosimilars
3.4. Key Market Drivers and Associated Trends

4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Top Selling Biologics: Developer Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Number of Top Selling Biologics
4.3. Top Selling Biologics: Market Landscape
4.3.1. Analysis by Type of Biologic
4.3.2. Analysis by Route of Administration
4.3.3. Analysis by Target Antigen/Gene
4.3.4. Analysis by Type of Biologic and Route of Administration
4.3.5. Analysis by Type of Biologic and Target Antigen/Gene
4.4. Information on Dose Strength and Type of Packaging
4.5. Top Selling Biologics: Key Disease Indications
4.5.1. Analysis by Key Indications
4.6.1 Top Selling Biologics: Target Therapeutic Areas
4.6.2. Analysis by Type of Oncological Disorder
4.6.3. Analysis by Type of Metabolic Disorder
4.6.3.1. Analysis by Type of Autoimmune Disorder
4.6.3.2. Analysis by Type of Gastrointestinal Disorder
4.6.3.3. Analysis by Type of Ophthalmic Disorder
4.6.3.4. Analysis by Type of CNS/Neurological Disorder
4.6.3.5. Analysis by Type of Cardiovascular Disorder
4.6.3.6. Analysis by Type of Blood Disorder
4.6.3.7. Analysis by Type of Respiratory Disorder
4.6.3.8. Analysis by Type of Bone Disorder

5. GLOBAL SALES ANALYSIS OF TOP SELLING BIOLOGICS
5.1. Chapter Overview
5.2. Top Selling Biologics: Global Sales (2020)
5.2.1. Analysis of Global Sales by Type of Biologic
5.2.2. Analysis of Global Sales by Developer
5.2.3. Genentech/Roche: Portfolio of Top Selling Biologics
5.2.3.1. Genentech/Roche: Historical sales of Top Selling Enzymes
5.2.3.2. Genentech/Roche: Historical sales of Top Selling Monoclonal Antibodies
5.2.3.3. Genentech/Roche: Historical sales of Top Selling Hormones
5.2.3.4. Genentech/Roche: Historical sales of Top Selling Other Biologics
5.2.4. AbbVie: Portfolio of Top Selling Biologics
5.2.4.1. AbbVie: Historical sales of Top Selling Monoclonal Antibodies
5.2.4.2. AbbVie: Historical sales of Top Selling Fusion Proteins
5.2.5. Janssen Biotech/Johnson & Johnson: Portfolio of Top Selling Biologics
5.2.5.1. Janssen Biotech/Johnson & Johnson: Historical sales of Top Selling Monoclonal Antibodies
5.2.5.2. Janssen Biotech/Johnson & Johnson: Historical sales of Top Selling Hormones
5.2.6. Merck: Portfolio of Top Selling Biologics
5.2.6.1. Merck: Historical sales of Top Selling Hormones
5.2.6.2. Merck: Historical sales of Top Selling Monoclonal Antibodies
5.2.6.3. Merck: Historical sales of Top Selling Vaccines
5.2.7. Amgen: Portfolio of Top Selling Biologics
5.2.7.1. Amgen: Historical sales of Top Selling Monoclonal Antibodies
5.2.7.2. Amgen: Historical sales of Top Selling Hormones
5.2.7.3. Amgen: Historical sales of Top Selling Hormones
5.2.8. Eli Lilly: Portfolio of Top Selling Biologics
5.2.8.1. Eli Lilly: Historical sales of Top Selling Monoclonal Antibodies
5.2.8.2. Eli Lilly: Historical sales of Top Selling Hormones
5.2.8.3. Eli Lilly: Historical sales of Top Selling Fusion Proteins
5.2.9. Sanofi: Portfolio of Top Selling Biologics
5.2.9.1. Sanofi: Historical sales of Top Selling Monoclonal Antibodies
5.2.9.2. Sanofi: Historical sales of Top Selling Enzymes
5.2.9.3. Sanofi: Historical sales of Top Selling Hormones
5.2.10. Bristol Myers Squibb: Portfolio of Top Selling Biologics
5.2.10.1. Bristol Myers Squibb: Historical sales of Top Selling Monoclonal Antibodies
5.2.10.2. Bristol Myers Squibb: Historical sales of Top Selling Fusion Proteins
5.2.11. Novo Nordisk: Portfolio of Top Selling Biologics
5.2.11.1. Novo Nordisk: Historical sales of Top Selling Hormones
5.2.12. Novartis: Portfolio of Top Selling Biologics
5.2.12.1. Novartis: Historical sales of Top Selling Monoclonal Antibodies
5.2.13. Alexion Pharmaceuticals: Portfolio of Top Selling Biologics
5.2.13.1. Alexion Pharmaceuticals: Historical sales of Top Selling Monoclonal Antibodies
5.2.13.2. Alexion Pharmaceuticals: Historical sales of Top Selling Enzymes
5.2.14. AstraZeneca: Portfolio of Top Selling Biologics
5.2.14.1. AstraZeneca: Historical sales of Top Selling Monoclonal Antibodies
5.2.15. Biogen: Portfolio of Top Selling Biologics
5.2.15.1. Biogen: Historical sales of Top Selling Monoclonal Antibodies
5.2.15.2. Biogen: Historical sales of Top Selling Gene Therapy
5.2.16. UCB: Portfolio of Top Selling Biologics
5.2.16.1. UCB: Historical sales of Top Selling Monoclonal Antibodies
5.2.17. GlaxoSmithKline: Portfolio of Top Selling Biologics
5.2.17.1. GlaxoSmithKline: Historical sales of Top Selling Monoclonal Antibodies
5.2.18. Biomarin: Portfolio of Top Selling Biologics
5.2.18.1. Biomarin: Historical sales of Top Selling Enzymes
5.2.19. Bayer: Portfolio of Top Selling Biologics
5.2.19.1. Bayer: Historical sales of Top Selling Interferons

6. CLINICAL TRIAL ANALYSIS
6.1. Chapter Overview
6.2. Scope and Methodology
6.3. Top Selling Biologics: Clinical Trial Analysis
6.3.1. Analysis by Trial Registration Year
6.3.2. Analysis by Trial Registration Year and Recruitment Status
6.3.3. Analysis by Trial Registration Year and Enrolled Patient Population
6.3.4. Analysis by Study Design
6.3.5. Analysis by Patient Segment
6.3.6. Geographical Analysis by Number of Clinical Trials
6.3.7. Leading Organizations: Analysis by Number of Registered Trials
6.3.8. Analysis by Target Therapeutic Area
6.3.9. Analysis by Key Biologics

7. PROMOTIONAL ANALYSIS
7.1. Context and Background
7.2. Top Selling Biologics: Product Website Analysis 
7.3. Top Selling Biologics: Patient Support-related Services Provided for Top Selling Biologics
7.4. Humira®: Promotional Analysis
7.4.1. Product Website Analysis
7.4.1.1. Messages for Healthcare Professionals
7.4.1.2. Messages for Patients
7.4.1.3. Informative Downloads
7.4.2. Patient Support Services
7.4.3. Advertisements
7.5. Keytruda®: Promotional Analysis
7.5.1. Product Website Analysis
7.5.1.1. Messages for Healthcare Professionals
7.5.1.2. Messages for Patients
7.5.1.3. Informative Downloads
7.5.2. Patient Support Services
7.5.3. Advertisements
7.6. Opdivo®: Promotional Analysis
7.6.1. Product Website Analysis
7.6.1.1. Messages for Healthcare Professionals
7.6.1.2. Messages for Patients
7.6.1.3. Informative Downloads
7.6.2. Patient Support Services
7.6.3. Advertisements
7.7. Avastin®: Promotional Analysis
7.7.1. Product Website Analysis
7.7.1.1. Messages for Healthcare Professionals
7.7.1.2. Messages for Patients
7.7.1.3. Informative Downloads
7.7.2. Patient Support Services
7.8. Rituxan®: Promotional Analysis
7.8.1. Product Website Analysis
7.8.1.1. Messages for Healthcare Professionals
7.8.1.2. Messages for Patients
7.8.1.3. Informative Downloads
7.8.2. Patient Support Services
7.9. Stelara®: Promotional Analysis
7.9.1. Product Website Analysis
7.9.1.1. Messages for Healthcare Professionals
7.9.1.2. Messages for Patients
7.9.1.3. Informative Downloads
7.9.2. Patient Support Services
7.9.3 Advertisements
7.10. Herceptin: Promotional Analysis
7.10.1. Product Website Analysis
7.10.1.1. Messages for Healthcare Professionals
7.10.1.2. Messages for Patients
7.10.1.3. Informative Downloads
7.10.2. Patient Support Services
7.11. Enbrel: Promotional Analysis
7.11.1. Product Website Analysis
7.11.1.1. Messages for Healthcare Professionals
7.11.1.2. Messages for Patients
7.11.1.3. Informative Downloads
7.11.2. Patient Support Services
7.11.3. Advertisements

8. PRODUCT LIFECYCLE MANAGEMENT STRATEGIES
8.1. Introduction
8.2. Key LCM Strategies
8.2.1. Geographical Expansion
8.2.2. Approval for Additional Disease Indications
8.2.3. Reformulations
8.2.4. Combination Therapies
8.2.5. Exploiting Alternate Routes of Administration
8.2.6. Reimbursement Programs
8.2.6.1. Humira®
8.2.6.2. Keytruda®
8.2.6.3. Opdivo®
8.2.6.4. Avastin®
8.2.6.5. Rituxan®
8.2.6.6. Stelara®
8.2.6.7. Herceptin®
8.2.6.8. Enbrel®
8.2.6.9 Remicade®
8.2.6.10 Trulicity®
8.2.7. Pricing Strategies
8.2.7.1. Humira®
8.2.7.2. Keytruda®
8.2.7.3. Opdivo®
8.2.7.4. Avastin®
8.3. Concluding Remarks

9. COST PRICE ANALYSIS
9.1. Chapter Overview
9.2. Factors Contributing to the Price of Biologics
9.3. Annual Treatment Cost of Top Selling Biologics
9.3.1. Price Comparison across Target Therapeutic Areas
9.3.1.1. Oncological Disorders
9.3.1.2. Metabolic Disorders
9.3.1.3. Autoimmune Disorders
9.3.1.4. Gastrointestinal Disorders
9.3.1.5. Ophthalmic Disorders
9.3.1.6. CNS/Neurological Disorders
9.3.1.7. Cardiovascular Disorders
9.3.1.8. Blood Disorders
9.3.1.9. Respiratory Disorders
9.3.1.10. Bone Disorders
9.4 Concluding Remarks

10. BIOSIMILARS
10.1. Chapter Overview
10.2. Introduction to Biosimilars
10.3. Need For Biosimilars
10.4. Biosimilars of Top Selling Biologics
10.4.1. Analysis by Highest Phase of Development
10.4.2. Analysis by Geography
10.4.3. Biosimilar of Top Selling Biologics: Developers Landscape
10.4.3.1. Analysis by Distribution Network
10.4.3.2. Analysis by Location of Headquarters
10.5. Biosimilars VS Top Selling Biologics
10.5.1. Manufacturing
10.5.2. Clinical Trials
10.2.3. Marketing
10.5.4. Safety

11. MARKET SIZING AND OPPORTUNITY ANALYSIS
11.1. Chapter Overview
11.2. Scope and Limitations
11.3. Key Assumptions and Forecast Methodology
11.4. Global Top Selling Biologics Market, 2021-2030
11.4.1. Top Selling Biologics Market: Distribution by Type of Biologic, 2021-2030
11.4.2. Top Selling Biologics Market: Distribution by Key Players, 2021-2030
11.5. Top Selling Biologics Market: Product-wise Sales Forecast
11.3. Top Selling Biologics: Product Wise Forecast
11.3.1. Monoclonal Antibodies
11.3.1.1. Actemra®
11.3.1.2. Avastin®
11.3.1.3. Benlysta®
11.3.1.4. Cosentyx®
11.3.1.5. Cyramza®
11.3.1.6. Darzalex®
11.3.1.7. Dupixent®
11.3.1.8. Erbitux®
11.3.1.9. Fasenra®
11.3.1.10. Gazyva®
11.3.1.11. Hemlibra®
11.3.1.12. Herceptin®
11.3.1.13. Humira®
11.3.1.14. Ilaris®
11.3.1.15. Imfinzi®
11.3.1.16. Keytruda®
11.3.1.17. Lucentis®
11.3.1.18. Nucala®
11.3.1.19. Ocrevus™
11.3.1.20. Opdivo®
11.3.1.21. Perjeta®
11.3.1.22. Prolia®
11.3.1.23. Remicade®
11.3.1.24. Repatha®
11.3.1.25. Rituxan®
11.3.1.26. Soliris®
11.3.1.27. Stelara®
11.3.1.28. Synagis®
11.3.1.29. Taltz®
11.3.1.30. Tecentriq®
11.3.1.31. Tremfya®
11.3.1.32. Tysabri®
11.3.1.33. Vectibix®
11.3.1.34. Xgeva®
11.3.1.35. Xolair®
11.3.1.36. Yervoy®
11.3.2. Hormones
11.3.2.1. Forteo®
11.3.2.2. Gonal-f®
11.3.2.3. Humalog®
11.3.2.4. Humulin®
11.3.2.5. Lantus®
11.3.2.6. Levemir®
11.3.2.7. Mircera®
11.3.2.8. Neulasta®
11.3.2.9. Novolog®
11.3.2.10. Procrit/Eprex®
11.3.2.11. Toujeo®
11.3.2.12. Tresiba®
11.3.2.13. Victoza®
11.3.3. Enzymes
11.3.3.1. Activase®
11.3.3.2. Fabrazyme®
11.3.3.3. Myozyme®
11.3.3.4. Pulmozyme®
11.3.3.5. Strensiq®
11.3.3.6. Vimizim®
11.3.4. Fusion Proteins
11.3.4.1. Aranesp®
11.3.4.2. Botox®
11.3.4.3. Enbrel®
11.3.4.4. Epogen®
11.3.4.5. Orencia®
11.3.4.6. Trulicity®
11.3.5. Interferons
11.3.5.1. Avonex/Rebif®
11.3.5.2. Betaseron®
11.3.5.3. Kadcyla®
11.3.6. Gene therapies
11.3.6.1. Spinraza®
11.3.7. Antibody fragments
11.3.7.1. Cimzia®
11.3.8. Vaccines
11.3.8.1. Varivax®

12. CONCLUSION

13. APPENDIX 1: TABULATED DATA

14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Note: Product cover images may vary from those shown
  • AbbVie
  • Alexion Pharmaceuticals
  • Allergan
  • Amgen
  • AstraZeneca
  • Bayer
  • Biogen
  • Biomarin
  • Bristol-Myers Squibb
  • Chugai Pharmaceutical 
  • Daiichi Sankyo
  • Eli Lilly
  • Genentech
  • Genentech 
  • GlaxoSmithKline
  • ImClone
  • Immunex 
  • Janssen Biotech
  • Johnson & Johnson
  • MedImmune 
  • Merck
  • Novartis
  • Novo Nordisk
  • Regeneron Pharmaceuticals
  • Roche
  • Sanofi
  • Torii Pharmaceutical
  • UCB
  • Vifor Pharma
Note: Product cover images may vary from those shown

 

 

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