Biobetters Market Report Overview
Biobetters are improved versions of originator biologics which are similar to existing biologics entities by action, potency, and other factors. Biobetters are formed as a result of chemical modification, protein fusion, altered amino acid sequence, or humanization of the glycosylation pattern, which aims for the same target as the original biological, but has its effect longer period, typically at lower doses and with fewer side effects. Biobetters are therapeutically more efficient medicines as compared to their respective originator biologic drugs.
Biobetters Market Dynamics and Trends
The global bio betters market growth is driven by the increasing usage of therapeutically more effective drugs for the treatment of chronic diseases is expected to drive the growth of the biobetters market. Higher efficacy and lower adverse effects are among the important factors that are expected to fuel the growth of the bio betters market over the forecast period.
The advantages of bio betters such as superior therapeutic efficacy, and lower adverse effects, are driving the growth of the market
With the developments in biotechnology, advances are being made in the treatment of most diseases. One such important advent is biobetters. The major drivers of the bio betters market are the advantages of bio betters such as superior therapeutic efficacy, lower adverse effects, easier and less costly manufacturing processes, non-patent and market exclusivity, longer product half-life, less dosing frequency and availability of high investment opportunities in this sector.
A bit better can be assigned a premium price for its improved characteristics, compared to other similar biologics. However, due to a reduction in the number of dosages required, significant cost savings can be achieved. Hence, this impacts the willingness of payers to purchase the product. One such example is Neulasta- a Biobetter of Amgen Inc, to its own drug Neupogen. A single treatment cycle of Neupogen costs USD 6000, whereas Neulasta is USD 3400, though the per unit price of Neupogen is USD 300 and Neulasta is USD 3400. Hence, there is a 40% reduction in the overall cost to the healthcare provider. Thus, the bio betters market is estimated to grow rapidly during the forecast period.
Growing investment in developing therapeutic agents of higher efficacy is anticipated to stimulate market growth.
The pressing need for finding out a way to improve the safety and efficacy of biologics has made bio betters a tough contender against biosimilars. Growing investment in developing therapeutic agents of higher efficacy and safety profiles for cancers and autoimmune diseases has shaped the growth dynamics of the bio betters market. Over the past few years, there have been concerted efforts in reducing the economic burden of these diseases. Expanding array of monoclonal antibodies has also made a positive bearing on the biobetters market. The growing incidence of chronic diseases such as chronic kidney disease and chemotherapy-induced anemia has also added to the expansion of the market. The development of biobetters is also followed as a defense strategy by the originator companies, to protect their market niche against biosimilars and also to overcome patent issues. For instance, the subcutaneous formulation of Roche’s trastuzumab was released into the market in 2013, before Roche’s Herceptin (intravenous trastuzumab) patent expired in 2014. These factors are driving the growth of the market in the forecast period.
Increasing biosimilar competition is likely to hinder the market growth
On the contrary, high investment in research and development and the increasing biosimilar competition is restraining the market growth in the forecast period.
COVID-19 Impact on Biobetters Market Growth
People with certain underlying medical conditions may have a higher risk of severe illness from COVID-19. These conditions include diabetes, cancer, renal disease, and neurodegenerative disease. Specifically, the available evidence suggests that people with type 2 diabetes have a higher risk of severe illness from COVID-19, according to the Centers for Disease Control and Prevention (CDC). n general, infections are more serious in people with diabetes. One reason is that diabetes affects the way the immune system works, making it harder for the body to fight viruses. Also, diabetes causes high blood sugar levels, and the International Diabetes Federation observe that the novel coronavirus “may thrive in an environment of elevated blood glucose. The COVID-19 pandemic has impacted virtually every aspect of cancer care and research, from introducing new risks for cancer patients to disrupting the delivery of cancer treatment and the continuity of cancer research. These factors create an opportunity for the bio betters market in the forecast period.
Biobetters Market Segment Analysis
The insulin bio betters segment is expected to grow at the fastest CAGR during the forecast period (2023-2030)
As per the CDC, more than 100 million adults in the United States are living with diabetes and prediabetes. According to the International Diabetes Federation, 463 million people are living with diabetes across the globe in 2019, and is expected to increase to 578 million by 2030. The health expenditures for diabetes are expected to rise from USD 760 billion in 2019 to USD 825 billion in 2030. Also, the increasing geriatric population and adoption of various lifestyles have been leading to an increase in the diabetic population. Due to the higher prevalence of diabetes during the forecast period, the segment of insulin bio betters is expected to show huge market growth across the globe.
Some companies have developed devices that allow the safe and less painful delivery of Insulin biobetters thus making the device a market differentiator even though it’s chemically equivalent to the branded product. Many companies in emerging economies have started developing insulin bio betters due to the favorable regulatory requirements as compared to the companies in developed countries where stringent regulatory requirements. As the regulatory requirements for the approval process of bio betters are considerably higher than those required for generic drugs and entail a comprehensive analysis of each of its characteristics. These factors are driving the growth of the market in the forecast period.
The hospital pharmacy is expected to dominate the bio betters market during the forecast period
The hospital pharmacies held the largest share in the Biobetters Market. This is mainly owing to the increasing number of patients suffering from conditions that are treated in hospitals equipped with advanced infrastructure and adequate facilities. Moreover, a growing number of hospitals along with adequate reimbursement policies is also contributing to the growth of this segment.
Biobetters Market Geographical Share
North America region holds the largest market share global Biobetters market
North American region is dominating the global bio betters market and accounted for the largest market share in 2020. The United States is the global leader in the bio betters market. According to the Pharmaceutical Research and Manufacturers Association, over half of the world’s R&D in pharmaceuticals (USD 75 billion) and Intellectual Property Rights of most new medicines are held by the United States. Also, most of the bio betters in the US are getting into collaborations and partnerships with regional players and investing funds in research and development. For instance, the Kadcyla drug developed by Roche, approved in 2019 is an adjuvant treatment for HER2- positive early breast cancer in patients affected by residual invasive disease post neoadjuvant taxane-trastuzumab-based treatment.
Asia-pacific has the highest growth rate due to various large and medium-sized pharmaceutical and biopharmaceutical companies looking to develop bio betters as the process of manufacturing is comparatively easier. Partnerships with various global players are enabling the regional market players to enhance their product offerings as well as technology transfer in return for their higher regional reach.
Biobetters Companies and Competitive Landscape
The Biobetters market is moderately competitive with the presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Amgen Inc., F. Hoffmann-La Roche AG, Merck & Co. Inc., Sanofi SA, SERVIER, Porton Biopharma Limited, Eli Lily and Company, Novo Nordisk A/S, Biogen Inc., CSL Behring GmbH, and Teva Pharmaceutical Industries Ltd., among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Biobetters market globally.
Sanofi S.A
Overview: Sanofi is a healthcare company, focused on patient needs and engaged in the research, development, manufacture, and marketing of therapeutic solutions. Its segments are Pharmaceuticals, Human Vaccines (Vaccines), and Others. The Pharmaceuticals segment comprises the commercial operations of various franchises, including Specialty Care (Rare Diseases, Multiple Sclerosis, and Oncology), Diabetes and Cardiovascular, Established Prescription Products, Consumer Healthcare and Generics, and research and development, production, and marketing activities for all of the Company’s pharmaceuticals operations.
Product Portfolio: The Company’s portfolio comprised of drugs, generic medicines, food supplements, cosmetics, and medical devices such as cancer, cardiology, gynecology, and diabetes.
The global bio betters market report would provide access to approximately 45+ market data tables, 40+ figures, and 180 pages.