Visiongain Publishes Biosimilars and Follow-On Biologics Market Report 2021-2031
04 November 2021
Visiongain has launched a new report Biosimilars and Follow-On Biologics Market Report 2021-2031: Forecasts by Type of Manufacturing (In-House, CMOs), by Type (Monoclonal Antibodies, Fusion Proteins, Insulin, Erythropoietin, Granulocyte-Colony Stimulating Factor, Interferon, Growth Hormones, Fertility Hormones, Others), by Application (Blood Disorders, Oncology Diseases, Chronic & Autoimmune Diseases, Growth Hormone Deficiencies, Others), by Technology (rDNA Technology, mAb Technology, Bioassay Technology) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies AND COVID-19 Recovery Scenarios.
Global Biosimilars and Follow-on Biologics R&D Market Outlook
According to Visiongain analysis, Global Biosimilars and Follow-on biologics R&D market was valued at US$xx million in 2020. The global market is expected to reach US$xx million in 2026 from its previous value of US$xx million in 2021 while growing at a CAGR of xx% from 2021 to 2026. Visiongain further anticipates that the worldwide biosimilars and follow-on biologics R&D market will reach US$xx million in 2031 while growing at a CAGR of xx% from 2021 to 2031.
What are the Market Drivers?
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: For instance:
• 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.
What are the Market Opportunities?
Companies Can Use Information of Original Innovator thus Shorten Development & Approval Processes
Biosimilars are ‘highly similar' to the innovator version, while not being physiologically identical. This implies that businesses may re-use a lot of the information generated by the original innovative company during regulatory evaluations. This may shorten development and approval processes by several years: for example, in order to support product registration, an improved comparative quality study is usually acceptable in lieu of comprehensive clinical and non-clinical investigations. By 2019, more than 14 novel biological products have lost their orphan designation commercial exclusivity, with another 34 joining them by 2029. Most formulations' patents will expire by 2023, providing ideal circumstances for the development of biosimilars.
Diversity in Approach Amongst the Authorities
The different agencies' agreement on how to manage biosimilars has been improving, however still it is a daunting task. European Medicines Agency's (EMA) efforts to constantly develop guidelines and offer appropriate assistance to bring these medicines to market, more than 70 biosimilars have been registered in the EU and others are being evaluated. To offer access to biosimilars, each national drug authority in Europe, as well as the Heads of Medicines Agencies (CMDh), has made commendable efforts. Until there is a unified approach to interchangeability in Europe, each member state's national medicine authority will be allowed to decide on a case-by-case basis, and each country will continue to manage and roll out biosimilars in its own manner. The image that's emerging is potentially complicated, but with such a large market potential, it's an opportunity worth exploring for market players.
Some of the major companies operating in the global 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 among other prominent players.
To gain a competitive edge, biosimilars and follow-on biologics companies adopt a variety of strategies. These include product launch, investment in R&D, partnerships, regional business expansion, mergers & acquisitions, and facility expansion. As per Visiongain analysis, Sandoz (Novartis AG) led the global biosimilars market in 2020. Sandoz’s biosimilar drug natalizumab has been added to its portfolio, which now includes small molecules, complicated generics, biosimilars, and innovative medicines, allowing patients to access patented and off-patent treatments. Sandoz has its presence in immunology, cancer, and endocrinology, in addition to entering complex and underserved areas such as MS (multiple sclerosis). With eight commercialised biosimilars and another ten or more under development, this division of Novartis AG has a strong global portfolio.
COVID-19 Impact Analysis on Biosimilars and Follow-on Biologics R&D Market
The pandemic of COVID-19 has shown the susceptibility and vulnerability of global supply networks to interruption. The scarcity of supply sources, especially for APIs and KSMs, has arisen as a threat to the industry's supply chain, and the pandemic has brought this issue to the forefront, given the shortage of COVID-related products that were prioritised for local demand. As a result, several governments have stepped up efforts to develop local manufacturing capabilities and on-/near-shore supply for a wide range of medications.
While these efforts have the potential to expedite localised production in a several economies across the globe, such policies combined with already existing push for local manufacturing face the risk of spilling over into protectionist (economic policy of restricting imports from other countries) trends, which may have a major effect on total product availability and economic viability. Fragmenting product manufacturing footprints over several sites may result in not only a loss of economies of scale, resulting in higher costs for patients, but also significant difficulties in maintaining high quality and compliance requirements across locations. These factors remain high on the regulatory agenda, with ever-increasing requirements over time. As in the past, these factors have resulted in not just a rise in the industry's cost base, but also supply interruptions as a consequence of negative inspection results. With increasing demand from investors, consumers, authorities, and workers, environmental requirements are becoming increasingly rigorous. These regulatory requirements have affected the pharmaceutical industry as a whole.
Discover sales predictions for the global biosimilars and follow-on biologics R&D market and submarkets
Along with revenue prediction for the overall world market, there are 4 segmentations of the biosimilars and follow-on biologics R&D market, with forecasts for 2 Types of Manufacturing, 9 Types, 5 Applications, 3 Technologies, each forecasted at a global, regional, and country level, along with COVID-19 impact recovery pattern analysis for all segments.
Who are the leading players analysed in the market?
• 3SBio, Inc.
• AMEGA Biotech
• Amgen Inc.
• Apotex, Inc.
• 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
• Teva Pharmaceutical
Notes for Editors
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