Global Biosimilars Business and Investment Opportunities 2023: Attractive Approval Numbers Present Fertile Ground for New Entrants

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Apr 18, 2023, 13:45 ET

DUBLIN, April 18, 2023 /PRNewswire/ -- The "Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update" report has been added to ResearchAndMarkets.com's offering.

The global biosimilars market is expected to grow from $15.67 billion in 2021 to $19.10 billion in 2022 at a compound annual growth rate (CAGR) of 21.8%. The biosimilars market is expected to reach $42.30 billion in 2026 at a CAGR of 22%.

In the upcoming years, the economy is predicted to undergo a moderate recession, financial conditions are expected to deteriorate, and monetary policy tightens even further, it will have an impact on various markets across the globe in terms of commodity prices, supply chain disruptions causing increased inflation across products and services.

In these volatile market conditions, the biosimilars market is still expanding dramatically, and the outlook is as promising. After the launch of the first US biosimilar in 2015, other pharmaceutical companies have entered the fray to take advantage of their biologic development and manufacturing skills and join the trend. The active ingredients of biologics and biosimilars must be produced by living organisms, therefore they cannot be exact duplicates of branded small molecule drugs like a generic can be. Nonetheless, they must show that they function similarly.

Current approval numbers remain attractive

Since 2006, the EMA has approved 86 biosimilar medications followed by a rigorous examination and tracking for the past 15 years, clinical results have demonstrated that they are interchangeable and comparable to their reference products in terms of efficacy, immunogenic reactions, and safety profile.

The COVID-19 pandemic produced some disruptions that slowed the growth of the biosimilars industry, but in 2022 it has recovered owing to the FDA's approval of six products, including the first biosimilars in the field of retina-ophthalmology.

The market for biosimilars in the US is anticipated to expand significantly over the next year and beyond, in part due to increased demand and a speeding up of FDA product introductions.
Major illnesses including cancer, diabetes, and rheumatoid arthritis can now be treated more effectively because of increased access for patients and healthcare providers to better therapeutic options. There will be more activity in the field of the biosimilars market. 2023 may prove to be a turning point for the market, with at least seven biosimilars referencing AbbVie's popular Humira (adalimumab) scheduled to be on sale in the following year. The most prominent pharmaceutical medicine in the world, Humira, which is used to treat a variety of inflammatory illnesses, is expected to bring in more than $20 billion in revenue in 2021. Seven biosimilars referencing Humira have received FDA approval yet; Amgen's biosimilar is scheduled to go on sale in the first quarter of 2023.

Biosimilar market will be the most jam-packed in future

The FDA has now approved 8 adalimumab biosimilars with the approval of adalimumab-aacf (Idacio; Fresenius Kabi) in December 2022.
Five other biosimilars are being developed at various stages, and all are anticipated to go on sale in 2023. The market for biosimilars will be the most jam-packed to date.
The pipeline for the creation of biosimilar tumour necrosis factor inhibitors is also functional and strong. The exclusivity of ustekinumab (Stelara), an autoimmune biopharmaceutical, will end in 2023. There are nine biosimilars in various stages of research, with two awaiting FDA clearance in 2023, however, there isn't a ustekinumab biosimilar as of yet.
The long-awaited biosimilar versions of Actemra (tocilizumab) are also about to go on sale. In 2023, it is anticipated that Biogen Inc, Bio-Thera Solutions, Ltd, and Fresenius would apply to the FDA for approval of their tocilizumab biosimilars. Within the next three to five years, Celltrion, Mycenax Biotech Inc., and Gedeon Richter Plc. are anticipated to apply for FDA clearance of their etanercept biosimilars.
After 2024, Xolair (omali-zumab) will go up against biosimilar competition since phase 3 trials are underway for both Celltrion and Teva Pharmaceuticals' biosimilar prospects. Despite the fact that Sandoz and Polpharma Biologics already have a biosimilar that is waiting for FDA approval, Tysabri (natalizumab) won't lose its exclusivity until 2027.
In 2022, the first biosimilar competition involving ophthalmology treatments was observed. In the US, there are two biosimilars to Lucentis (ranibizumab): Ranibizumab-nuna (Byooviz; Biogen Inc.) was introduced in July 2022, while ranibizumab-eqrn (Cimerli; Coherus BioSciences, Inc.), an interchangeable biosimilar, was introduced in October 2022.

The increased prevalence of chronic diseases such as arthritis, asthma, and cancer is likely to fuel the biosimilars market

Chronic diseases are common, and biosimilars are increasingly utilised to treat them. The causes of chronic diseases include insufficient physical activity, and bad eating and drinking habits. Biosimilars stimulate the immune system's attack on cancerous cells, assisting the body's defences in getting rid of the disease-causing cells. As a result, the market for biosimilars is expected to be driven by the rising prevalence of chronic diseases and the need for biosimilars

Up to 106 biosimilars are being developed, including not only cancer treatment drugs but also fresh therapeutic categories like ophthalmology, immunosuppressants, and bone health. Because biosimilars for cancer treatment and support have been so successful, there will inevitably be greater competition in these therapeutic categories.

Consequences of Inflation Reduction Act on the fast-growing Biosimilars market

Although the U.S. biosimilars market is anticipated to grow significantly, recent legislation, most notably the Inflation Reduction Act of 2022 (IRA), has introduced policies that could influence the business. To maintain its goal of making all biosimilars eligible for pass-through payment - and not only the first biosimilar biological product for a reference product - the Centers for Medicare & Medicaid Services (CMS) recently finalised the proposed rule. The Inflation Reduction Act caused an increase in Medicare Part B biosimilar product reimbursement that took effect in October.

To address disinformation, close existing gaps in biosimilar uptake, and promote provider and patient acceptance, education is essential

Similar in efficacy to biologics, biosimilars are produced from cell lines. Yet, a lack of familiarity with biosimilars makes it less likely that doctors will recommend the medications to their patients, which has an impact on the market's demand for new biosimilars. Hence, the expansion of the biosimilars industry is constrained by primary care physicians and specialist's lack of knowledge regarding biosimilars. The availability of products, how to prescribe them, the interchangeability designation and procedure in their state, as well as how the products are covered, must all be understood by the providers. Thus, it is crucial to continue education on interchangeability.

The global and regional perspective of Biosimilars is enticing in the forthcoming years

The prospects for biosimilars grow as regulatory regimes change, particularly in the United States, China, and Japan. This dynamic is already in play in Europe, where more than 60 medicines have received approval and where the region has 50% of the value of the worldwide biosimilars industry.

As markets grow, pricing dynamics take shape more quickly, with businesses providing significant discounts or rebates sooner in a product's commercial life cycle for certain channels or major accounts. For instance, compared to earlier drugs, early price reductions for recently released biosimilars like adalimumab are substantially larger.
The Chinese biosimilars business has existed since the 1990s. Under a tight new system established in 2015, the first four biosimilars were authorised in 2019 and were added to the National Reimbursement Drug List in 2019, following the inclusion of rituximab and trastuzumab in 2017. These additions have increased the uptake of biologics and will enable the market to grow even more. 400 different biosimilar products are reportedly being actively developed in China, according to estimates.

Despite the dawdling movement of biosimilars in Japan, the introduction of biosimilars for big patient populations might hasten the market's expansion. Recent legislative modifications have also aided uptake; for instance, the new guidelines announced by the Japanese Ministry of Health, Labor, and Welfare in April 2020 offer incentives for medical centres to recommend self-injecting biosimilars.

This report presents an in-depth analysis of the current market scenario, with an emphasis on the future trajectory of potential opportunities in the biosimilars industry. In addition to a combination of exhaustive secondary research along with primary research, the research methodology leverages a proprietary predictive analytics platform to provide unbiased business intelligence and answer key questions related to the biosimilars market.

It provides a detailed analysis of biosimilar market dynamics, covering clinical trials, patent data, financial deals, and company profiling details. It details market opportunities and risks across key segments - by product, by type of cell, by imaging technique, by procedure, by the source of manufacturing, by applications, by type of technology, and by end users. It also details market dynamics across various end-use sectors to assess emerging opportunities.

In addition, this report provides analyst commentary on key trends, drivers, strategies, innovations, and regulations in the field of biosimilars.

Report Scope
Insights and data in the report have been segmented under the following six modules:

Biosimilar Market Size By Product

Monoclonal Antibody Biosimilars
Insulin Biosimilar
Biosimilar Interferons
Other Biosimilar

Biosimilar Market Size By Type of Cell

Mammalian
Non-Mammalian

Biosimilar Market Size By Imaging Technique

Magnetic Resonance Imaging Scanners
Computed Tomography Scanners
Positron Emission Tomography Scanners
Others

Biosimilar Market Size By Procedure

Invasive
Non-Invasive

Biosimilar Market Size By Source of Manufacturing

In-House
Contract Manufacturing

Biosimilar Market Size By Applications

Oncology
Blood Disorders
Growth Hormonal Deficiency
Chronic & Autoimmune Disorders
Infectious Diseases
Others

Biosimilar Market Size By Type of Technology

Mass Spectroscopy
Chromatography
Recombinant DNA technology
Electrophoresis
Others

Biosimilar Market Size By End User

Hospital & Clinics
Diagnostic Centres
Others

Biosimilar Market Size By Regions

North America
United States
Canada
Mexico
Europe
France
United Kingdom
Germany
Italy
Spain
Asia-Pacific
China
Japan
Australia
India
South Korea
MEA region
Israel
South Africa
Turkey
Saudi Arabia
Latin America
Brazil
Argentina
Colombia

Key Companies Covered

Amgen Inc
Novartis
Eli Lilly and Company
Celltrion Inc
Dr. Reddy's Laboratories Ltd
Fresenius SE & Co. KGAA
Samsung Biologics
Biocon Limited

For more information about this report visit https://www.researchandmarkets.com/r/urgmrr

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