Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q2 2023 Update

According to the publisher, global biosimilar market size is expected to record a CAGR of 21.8% during 2023-2027 to reach US$51.235 million by 2027, increasing from US$20.221 million in 2023. Over the last five years, the sector has recorded a CAGR of 26.0% to reach US$16.049 million in 2022.

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 seem quite 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 2,019 and were added to the National Reimbursement Drug List in 2019, following the inclusion of rituximab and trastuzumab in 2,017. 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 publisher's 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.

This title provides global and regional insights along with data-centric analysis for the following 6 regions and 21 countries:

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

Scope

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

Module 1: Global Biosimilars Funding and Investments Outlook

This module provides insights and data related to biosimilars partnerships and investment (research and development, mergers and acquisitions, product development, commercialization, licensing, and manufacturing) and allows a peek into the futuristic trends of biosimilars technology investment area.

Module 2: Global Biosimilars Clinical Trial Data Assessment

This module evaluates the data available from clinical trials conducted utilising cell and gene technology, representing a bird’s eye view of emerging market dynamics and risks in the biosimilars sector.

Module 3: Global Biosimilars Patent Data Analysis

This module presents an exhaustive study of biosimilars patent analytics at various levels, including strategic research planning as well as analyzing their potential applications.

Module 4: Competitive Landscape

This module provides detailed information along with a scoring matrix of key companies related to the biosimilars industry, including their historical performance and the latest developments.

Module 5: Global Biosimilars Market Size and Forecast

This module provides projections on the market's development during the years 2018-2027 after the profound evaluation of market dynamics at the deeper segmentation level. This report also provides an in-depth, data-centric analysis of the global biosimilars market at regional and country levels:

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

Module 6 Regulatory Outlook

This module contains a detailed understanding of the ethical, legal, and social implications of biosimilars.

Reasons to buy

• Biosimilars Market Dynamics: Understand market opportunities and key trends along with forecast (2023-2027). Understand market dynamics across various segments such as by product, type of cell, imaging technique, procedure, source of manufacturing, applications, type of technology, and end users, and by geographical region.
• Competitive Landscape Analysis: Market position and snapshot of key players in the development of biosimilars. Each profile includes a brief overview of the company, information on its therapeutic pipeline, financial data (where available), the most recent events, and future direction of the market.
• Clinical Trial Analysis: Insights into opportunities across biosimilars field that have been completed or are still ongoing, using parameters such as trial status, trial registration year, an indication of the target disease, trial phase, patient enrolment, and sponsor/collaborator type.
• Develop Market-Specific Strategies: Identify growth segments based on a thorough analysis of the biosimilar patents that have been applied for or granted based on the patent type, the issuing agency, and patent offices involved, the Cooperative Patent Classification (CPC) symbols, the firm type, significant industry and non-industry participants (based on many patents), and discrete patent assignees.
• Financial Deals Insights: Get insights into various biosimilars partnerships that have been developed, including those for research and development (R&D), clinical trials, mergers and acquisitions, product development, commercialization, licencing, and manufacturing. A complete analysis of the various investments made in companies that specialise in developing drugs using biosimilars technologies.