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

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?