Visiongain has published a new report entitled Biosimilars and Follow-on Biologics 2023-2033. It includes profiles of Biosimilars and Follow-on Biologics and Forecasts Market Segment by Type of Manufacturing (In-House, CMOs), Market Segment by Type (Monoclonal Antibodies, Fusion Proteins, Insulin, Erythropoietin, Granulocyte-Colony Stimulating Factor, Interferon, Growth Hormones, Fertility Hormones, Others), Market Segment by Application (Blood Disorders, Oncology Diseases, Chronic & Autoimmune Diseases, Growth Hormone Deficiencies, Others), Market Segment by Technology (RDNA Technology, MAbs Technology, Bioassay Technology), plus COVID-19 Impact Analysis and Recovery Pattern Analysis (“V”-shaped, “W”-shaped, “U”-shaped, “L”-shaped), Profiles of Leading Companies, Region and Country.
The biosimilars and follow-on biologics market is valued at US$19,668.3 million in 2022 and is projected to grow at a CAGR of 31.14% during the forecast period 2023-2033.
Digital Transformations as a Key Enabler to Strengthen Research in Biosimilars Industry
As a consequence of quick technical advancements, alterations in the market environment, and changes in stakeholder behaviour as a result of the pandemic, the potential for digital & analytics applications in the pharmaceutical and biotechnology sector has expanded considerably in recent years. The biosimilars sector might benefit significantly from digital advancements across the whole value chain.
In spite of the lack of frequent face-to-face interactions, technology has already been crucial in keeping the sector, healthcare professionals, and pharmacists engaged. Digital engagement models are increasingly being used to augment traditional, face-to-face detailing-based marketing tactics, and this trend is projected to continue. This will not only help the industry strengthen its ties and boost the adoption of biosimilar medicines, but it will also give the industry a financially sound way to quickly expand its reach into regions that would otherwise be untapped because of the limitations of the representative-based economic model.
By enhancing productivity, producing higher-quality outcomes, and establishing a setting with zero variation, digital and analytics have the potential to considerably enhance capacity on the backend. Future medication development and product transfers may be significantly sped up with the use of simulations and in-silico batch modelling.
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How has COVID-19 had a Significant Impact on the Biosimilars and Follow-on Biologics Market?
The COVID-19 pandemic has demonstrated how susceptible and vulnerable global supply networks are to disruption. Because of this, several governments have intensified their attempts to build up local production capacities and on-/near-shore supplies for a variety of drugs. While these initiatives may speed up localised production in a number of economies around the world, they run the risk of reinforcing protectionist (an economic policy that restricts imports from other countries) trends, which could have a significant impact on overall product availability and economic viability. In addition to a loss of scale that would raise prices for patients, fragmenting the production footprint of a product among numerous sites might make it very challenging to maintain standards of high quality and compliance. On the other hand, these continue to be high on the regulatory agenda and have steadily rising requirements. Negative inspection findings have, as in the past, led to supply disruptions in addition to an increase in the industry's cost base. Environmental standards are getting more stringent due to rising investor, consumer, government, and employee demand. This has significant ramifications for the whole pharmaceutical sector.
How will this Report Benefit you?
Visiongain’s 336-page report provides 127 tables and 154 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the biosimilars and follow-on biologics market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Biosimilars and Follow-on Biologics. Get financial analysis of the overall market and different segments including Type of Manufacturing, Type, Application, and Technology capture higher market share. We believe that there are strong opportunities in this fast-growing biosimilars and follow-on biologics market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.
What are the Current Market Drivers?
Increasing Demand for Biosimilar Drugs Due to Their Cost-Effectiveness
A biosimilar's cost-effectiveness is determined by its relative efficacy since it is anticipated to be less expensive than the biological counterpart. The American Journal of Managed Care reports that the cost of biosimilars is around 30% less than that of their parent or branded counterparts. Biosimilars offer patients access to highly effective therapies while also saving money. In comparison to innovator biologics, the cost of developing biosimilars is cheaper. The price of a biosimilar will be cheaper since R&D expenses will be reduced. Due to manufacturer pricing rivalry, less expensive biosimilars frequently cause reference biologics to cost less. In the upcoming years, demand for biosimilar medications is anticipated to rise due to its notable cost-to-benefit ratio.
Incentivizing Providers to Adopt Biosimilars
Provider incentives, like those for other medical products, may affect the usage of biologics and biosimilars. Internal reference pricing is a significant strategy for promoting the adoption of lower-cost medications in Europe. The current status quo condition of Medicare and most other U.S. insurance plans, where payment rates are unique to each product, provides a far greater incentive to move to lower-cost biosimilars.
Doctors in European nations have also been given biosimilar prescription goals, which are often accompanied by financial incentives to encourage physicians to prescribe biosimilars. Consider the following scenario:
- In the UK, specific prescription goals & incentives encourage doctors to utilise biosimilars as part of a quality-improvement programme run by the National Health Service (NHS). Providers that use 90% of the best value generics/biologics for new patients within a quarter of the time advice is available, and 80% for current patients within a year of the time guidance is published, will get a 1% incentive on high-cost medicines.
- In France, three molecules have recently been approved for shared savings or "gainsharing" agreements between hospitals and the Social Security department that covers medical costs: adalimumab, insulin glargine, and etanercept. For each biosimilar prescription, hospitals get 20-30% of the savings above reference product costs under these agreements.
- Gainsharing agreements have been put in place in Germany to encourage doctors to adopt biosimilars. For example, some regional physicians’ group & payer group has agreed to share the savings realised by substituting infliximab for Remicade in patients with ulcerative colitis or Crohn's disease. These regionally negotiated agreements have led to the country's high biosimilar adoption rate.
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Where are the Market Opportunities?
Companies Can Use Information of Original Innovator thus Shorten Development & Approval Processes
Biosimilars are not biologically identical to the original version, but they are "very similar" to it. This suggests that companies may make extensive use of the data produced by the first innovative firm during regulatory reviews. This might reduce development and approval times by many years. For instance, an enhanced comparative quality study is frequently accepted in place of thorough clinical and non-clinical research to support product registration. By 2023, the patents on the majority of formulations will have expired, creating the perfect environment for the development of biosimilars.
Competitive Landscape
The major players operating in the biosimilars and follow-on biologics market are 3SBio, Inc., AMEGA Biotech, Amgen Inc., Apotex, Inc., BIOCAD, Biocon Limited, Biogen, Inc., Celltrion Healthcare Co.,Ltd., Coherus BioSciences, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Gedeon Richter PLC, Intas Pharmaceutical Ltd., Mabxience SA, Viatris Inc. (Mylan NV), Novartis AG, Pfizer Inc., Samsung Bioepis Co. Ltd., Stada Arzneimittel AG, and Teva Pharmaceutical. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.
Recent Developments
- In November 2022, STADA Arzneimittel AG and Xbrane Biopharma AB announced that the European Commission granted a marketing authorization for Ximluci®(ranibizumab), a biosimilar candidate referencing Lucentis®.
- In July 2022, Sandoz announced that the US Food and Drug Administration (FDA) accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics.
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