Le marché des biosimilaires devrait passer de 18 435,89 millions de dollars US en 2021 à 136 069,53 millions de dollars US d'ici 2028 ; on estime qu'il enregistrera un TCAC de 34,8 % de 2022 à 2028.
Le biosimilaire est un produit biologique similaire à un produit biologique approuvé par la FDA d'un autre fabricant. En raison des complexités associées au développement et à la fabrication de produits biosimilaires, ceux-ci sont fabriqués par des entreprises disposant d'une main-d'uvre hautement qualifiée et d'une expertise scientifique approfondie. Le processus d'approbation de la FDA pour les produits biosimilaires est rigoureux et permet une sécurité élevée pour les utilisateurs finaux.
Informations stratégiques
Informations sur le marché des biosimilaires
Le rapport coût-efficacité des médicaments biosimilaires stimule la croissance du marché des biosimilaires
Les biosimilaires offrent des avantages potentiels à tous les acteurs du système de santé en offrant une option de traitement moins coûteuse mais tout aussi efficace, comme les produits biologiques. En 2017-2018, le National Health Service (NHS) a économisé 401,10 millions de dollars en passant de l'utilisation de dix médicaments coûteux à des alternatives plus économiques et tout aussi efficaces telles que les produits biologiques, dans l'espoir de réaliser encore plus d'économies à l'avenir. Les économies potentielles résultant de l'utilisation de biosimilaires peuvent également être utilisées pour financer d'autres nouveaux traitements. L'adoption des biosimilaires a été plus lente aux États-Unis que dans les pays de l'Union européenne (UE). L'UE est en tête des approbations, de l'utilisation et de la sensibilisation aux économies de biosimilaires.
La plupart des systèmes de santé ont développé des protocoles, des incitations et diverses politiques de remboursement et d'approvisionnement pour garantir que les biosimilaires améliorent le potentiel des économies. Cependant, la décision de prescrire ou de passer à un médicament biologique pour un patient individuel, qu'il s'agisse d'un médicament d'origine ou d'un médicament biosimilaire, est prise par le clinicien responsable en consultation avec le patient et sa famille/soignants.
Selon le rapport sur les biosimilaires de Cardinal Health en 2022, les options de traitement biosimilaires se sont avérées aussi sûres et efficaces que les produits biologiques d'origine. Les biosimilaires sont approuvés par une voie abrégée de la FDA pour élargir l'accès des patients à des soins de haute qualité et à moindre coût. En janvier 2022, il y avait 33 biosimilaires approuvés par la FDA aux États-Unis, 21 disponibles dans le commerce sur le marché. L'entrée sur le marché des biosimilaires entraîne une plus grande concurrence, réduisant ainsi les coûts et augmentant l'accessibilité et l'abordabilité de ces traitements essentiels. Par conséquent, la rentabilité des médicaments biosimilaires alimente la croissance du marché des biosimilaires.
Expiration du brevet des produits biologiques les plus vendus pour offrir de nombreuses opportunités au marché pendant la période de prévision
Les produits biologiques représentent de nouvelles thérapies prometteuses pour des maladies auparavant incurables et deviennent très importants sur le marché pharmaceutique. Les brevets sur les produits biologiques d'origine devraient expirer dans les années à venir.
Les dates d'expiration estimées des brevets et des exclusivités pour les produits biologiques les plus vendus sont indiquées dans le tableau suivant.
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Source : Generics and Biosimilars Initiative (GaBI) Journal
L'expiration du brevet et d'autres droits de propriété intellectuelle droits pour les produits biologiques d'origine créeront un besoin d'introduire de nouveaux biosimilaires à l'avenir. En conséquence, la concurrence entre les acteurs du marché des biosimilaires augmentera dans l'industrie dans les années à venir. Ainsi, l'expiration du brevet des produits biologiques à succès devrait créer des opportunités lucratives pour le marché des biosimilaires au cours de la période de prévision.
Informations basées sur l'indication de la maladie
Basées sur l'indication de la maladie, le marché des biosimilaires est segmenté en cancer, diabète, maladies auto-immunes et autres indications de la maladie. Le segment du cancer détenait la plus grande part de marché en 2021. Le marché du segment des maladies auto-immunes devrait croître au rythme le plus élevé au cours de la période de prévision.
Marché des biosimilaires, par indication de maladie &ndash ; 2021 et 2028
(image) Aperçus basés sur la classe de médicaments
Le marché des thébiosimilaires, basé sur la classe de médicaments, est segmenté en facteurs de stimulation des colonies de granulocytes, hormone de croissance humaine, insuline, TNF Bloqueurs & Anticorps monoclonaux, agents stimulants stimulant l'érythropoïétine et autres. Le segment des facteurs de stimulation des colonies de granulocytes représentait la plus grande part du marché en 2021 et devrait enregistrer le TCAC le plus élevé de 35,8 % au cours de la période de prévision.
Voie d'administration -Based Insights
Sur la base de la voie d'administration, le marché des biosimilaires est segmenté en intraveineux, sous-cutané et autres. Le segment intraveineux représentait la plus grande part du marché en 2021 et devrait enregistrer le TCAC le plus élevé de 36,0 % au cours de la période de prévision.
Informations basées sur l'utilisateur final
Le marché des biosimilaires, basé sur l'utilisateur final, est segmenté en hôpitaux, cliniques spécialisées, soins à domicile et autres. Le segment des hôpitaux représentait la plus grande part du marché en 2021, tandis que le segment des soins à domicile devrait enregistrer le TCAC le plus élevé de 36,6 % au cours de la période de prévision.
Les entreprises du Le marché des biosimilaires adopte des stratégies inorganiques et organiques telles que les fusions et acquisitions. Quelques développements récents clés du marché sont répertoriés ci-dessous :
- En novembre 2022, Biocon Biologics, une filiale de Biocon Ltd., a finalisé l'acquisition de Viatris&rsquo ; Commerce mondial des biosimilaires. L'acquisition fournit à Biocon Biologics des capacités commerciales directes et une infrastructure de soutien dans les marchés avancés et plusieurs marchés émergents, la rapprochant des patients, des clients et des payeurs. Avec cette acquisition, Biocon Biologics devrait émerger en tant que leader mondial des biosimilaires avec huit produits commercialisés.
- En septembre 2022, Celltrion USA a reçu l'approbation de la FDA américaine pour son biosimilaire oncologique Vegzelma pour le traitement de six types de cancer tels que le cancer colorectal métastatique ; cancer du poumon non à petites cellules non squameux récurrent ou métastatique (NSCLCns); glioblastome récurrent; carcinome à cellules rénales métastatique; cancer du col de l'utérus persistant, récurrent ou métastatique; et cancer épithélial de l'ovaire, de la trompe de Fallope ou du péritoine primitif. Vegzelma est le troisième biosimilaire oncologique de Celltrion à recevoir l'approbation de la FDA américaine.
- En février 2021, Coherus BioSciences Inc a acquis les droits exclusifs aux États-Unis et le Canada pour le co-développement et la commercialisation de Junshi Biosciences’ toripalimab, un anticorps bloquant PD-1.
- En décembre 2021, Prestige BioPharma et le Dr Reddy ont annoncé un partenariat pour commercialiser le trastuzumab biosimilaire dans certains pays d'Amérique latine et d'Asie du Sud-Est. Le trastuzumab (HD201) de Prestige BioPharma est un biosimilaire proposé à l'Herceptin de Roche et peut être prescrit pour le traitement du cancer du sein HER2 positif et du cancer gastrique métastatique. L'accord de licence accorde au Dr Reddy les droits exclusifs de commercialisation du biosimilaire proposé dans certains pays d'Amérique latine et d'Asie du Sud-Est.
Profils des entreprises
- Amgen Inc
- Celltrion Inc
- Sanofi SA
- Biocon Ltd
- Samsung Bioepis Co Ltd
- Coherus BioSciences Inc
- Eli Lilly and Co
- Sandoz AG
- Teva Pharmaceutical Industries Ltd
- Pfizer Inc
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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to country scope.
Frequently Asked Questions
The Biosimilars market majorly consists of the players, such as Biocon Ltd, Sanofi-Aventis, Celltrion Inc., Amgen Inc., Pfizer Inc., Samsung Bioepis, Sanofi SA, Coherus BioSciences Inc, Dr. Reddy’s Laboratories Ltd, Eli Lilly and Co, Sandoz AG, and Teva Pharmaceutical Industries Ltd.
The insulin segment held the largest share of the market in 2022. Also, the same segment is estimated to register the highest CAGR in the market during the forecast period.
The factors that are driving the growth of the biosimilars market are the increasing aging population, changing social behavior, and the rising adoption of a sedentary lifestyle by people with accelerating urbanization boost the prevalence of obesity and various chronic diseases, such as diabetes. Also,twin studies have long established that genes can cause chronic conditions such as cardiovascular disease (CVDs), diabetes, obesity, Alzheimer's disease (AD), and depression. These are some of the major factors contributing to the growth of the biosimilars industry.
The CAGR value of the biosimilars market during the forecasted period of 2022-2028 is 34.8%.
The Asia Pacific is expected to be the fastest-growing region in the Biosimilars market over the forecast period due to the increasing prevalence of chronic diseases and the cost-effectiveness of biosimilars drugs.
The Biosimilars market is estimated to be valued at US$ 22,676.15 million in 2022.
The Biosimilars market is expected to be valued at US$ 1,36,069.53 million in 2028.
Biosimilars are safe and effective treatment options for many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions, and cancer. A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDAâ€approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.
The List of Companies - Biosimilar Market
- Biocon Ltd
- Sanofi-Aventis
- Celltrion Inc.
- Amgen Inc.
- Pfizer Inc.
- Samsung Bioepis
- Sanofi SA
- Coherus BioSciences Inc
- Dr. Reddy’s Laboratories Ltd
- Eli Lilly and Co
- Sandoz AG
- Teva Pharmaceutical Industries Ltd.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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