Der Biosimilars-Markt wird voraussichtlich von 18.435,89 Millionen US-Dollar im Jahr 2021 auf 136.069,53 Millionen US-Dollar im Jahr 2028 wachsen; Es wird geschätzt, dass zwischen 2022 und 2028 eine jährliche Wachstumsrate von 34,8 % verzeichnet wird.
Biosimilar ist ein biologisches Produkt, das einem von der FDA zugelassenen biologischen Produkt eines anderen Herstellers ähnelt. Aufgrund der Komplexität, die mit der Entwicklung und Herstellung von Biosimilar-Produkten verbunden ist, werden diese von Unternehmen hergestellt, die über hochqualifizierte Arbeitskräfte und umfassende wissenschaftliche Expertise verfügen. Der FDA-Zulassungsprozess für Biosimilar-Produkte ist streng und ermöglicht eine hohe Sicherheit für Endverbraucher.
Strategische Einblicke
Biosimilars-Markteinblicke
Die Kosteneffizienz von Biosimilar-Medikamenten treibt das Wachstum des Biosimilars-Marktes voran
Biosimilars bieten potenzielle Vorteile für alle Beteiligten im Gesundheitssystem, indem sie eine kostengünstigere, aber ebenso wirksame Behandlungsoption wie Biologika bieten. Im Zeitraum 20172018 sparte der National Health Service (NHS) 401,10 Millionen US-Dollar ein, indem er von zehn teuren Medikamenten auf preisgünstigere und ebenso wirksame Alternativen wie Biologika umstieg, und geht davon aus, dass in Zukunft noch mehr Einsparungen erzielt werden können. Die potenziellen Einsparungen durch den Einsatz von Biosimilars können auch zur Finanzierung anderer neuer Behandlungen genutzt werden. Die Verbreitung von Biosimilars verlief in den USA langsamer als in den Ländern der Europäischen Union (EU). Die EU ist führend bei der Zulassung, Verwendung und dem Bewusstsein für Kosteneinsparungen von Biosimilars.
Die meisten Gesundheitssysteme haben Protokolle, Anreize und verschiedene Erstattungs- und Beschaffungsrichtlinien entwickelt, um sicherzustellen, dass Biosimilars ihr Potenzial verbessern Ersparnisse. Die Entscheidung, einem einzelnen Patienten ein biologisches Arzneimittel zu verschreiben oder auf ein biologisches Arzneimittel umzusteigen, unabhängig davon, ob es sich um ein Originalpräparat oder ein Biosimilar handelt, wird jedoch vom verantwortlichen Arzt in Absprache mit dem Patienten und seinen Familienangehörigen/Betreuern getroffen.
Laut dem Bericht über Biosimilars von Cardinal Health aus dem Jahr 2022 sind Biosimilars-Behandlungsoptionen nachweislich genauso sicher und wirksam wie Original-Biologika. Biosimilars werden über einen verkürzten FDA-Zulassungsweg zugelassen, um den Zugang der Patienten zu hochwertiger und kostengünstigerer Versorgung zu erweitern. Mit Stand Januar 2022 gibt es in den USA 33 von der FDA zugelassene Biosimilars, von denen 21 kommerziell auf dem Markt erhältlich sind. Der Markteintritt von Biosimilars führt zu mehr Wettbewerb, wodurch die Kosten gesenkt und die Zugänglichkeit und Erschwinglichkeit dieser wichtigen Behandlungen erhöht werden. Daher fördert die Kosteneffizienz von Biosimilars-Medikamenten das Wachstum des Biosimilars-Marktes.
Patentablauf der meistverkauften Biologika bietet reichlich Marktchancen im Prognosezeitraum
Biologicals stellen vielversprechende neue Therapien für bisher unheilbare Krankheiten dar und gewinnen im Pharmamarkt zunehmend an Bedeutung. Es wird erwartet, dass Patente auf biologische Originalpräparate in den kommenden Jahren auslaufen.
Die geschätzten Ablaufdaten der Patente und Exklusivrechte für die meistverkauften Biologika sind in der folgenden Tabelle aufgeführt.
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Quelle: Generics and Biosimilars Initiative (GaBI) Journal
Der Patentablauf und anderes geistiges Eigentum Rechte für Original-Biologicals werden in Zukunft die Notwendigkeit schaffen, neue Biosimilars einzuführen. Infolgedessen wird der Wettbewerb zwischen den Biosimilars-Marktteilnehmern in der Branche in den kommenden Jahren zunehmen. Daher wird erwartet, dass der Patentablauf von Blockbuster-Biologika im Prognosezeitraum lukrative Möglichkeiten für den Biosimilar-Markt schaffen wird.
Erkenntnisse auf Basis von Krankheitsindikationen
Basierend Hinsichtlich der Krankheitsindikation ist der Biosimilars-Markt in Krebs, Diabetes, Autoimmunerkrankungen und andere Krankheitsindikationen unterteilt. Das Krebssegment hatte im Jahr 2021 den größten Marktanteil. Der Markt für das Segment Autoimmunerkrankungen dürfte im Prognosezeitraum am stärksten wachsen.
Biosimilars-Markt, nach Krankheitsindikation – 2021 und 2028
Arzneimittelklassenbasierte Einblicke
Der Biosimilars-Markt ist basierend auf der Arzneimittelklasse in Granulozytenkolonie-stimulierende stimulierende Faktoren, menschliches Wachstumshormon, Insulin und TNF unterteilt Blocker & Monoklonale Antikörper, Erythropoetin-stimulierende stimulierende Mittel und andere. Das Segment der Granulozyten-Kolonie-stimulierenden Faktoren hatte im Jahr 2021 den größten Marktanteil und wird im Prognosezeitraum voraussichtlich die höchste CAGR von 35,8 % verzeichnen.
Verabreichungsweg -Basierende Erkenntnisse
Basierend auf dem Verabreichungsweg ist der Biosimilar-Markt in intravenöse, subkutane und andere unterteilt. Das intravenöse Segment hatte im Jahr 2021 den größten Marktanteil und wird im Prognosezeitraum voraussichtlich die höchste CAGR von 36,0 % verzeichnen.
Endbenutzerbasierte Erkenntnisse
Der Biosimilars-Markt ist basierend auf Endbenutzern in Krankenhäuser, Spezialkliniken, häusliche Pflege und andere unterteilt. Das Krankenhaussegment hatte im Jahr 2021 den größten Marktanteil, während das Homecare-Segment im Prognosezeitraum voraussichtlich die höchste CAGR von 36,6 % verzeichnen wird.
Unternehmen in der Der Biosimilars-Markt verfolgt anorganische und organische Strategien wie Fusionen und Übernahmen. Nachfolgend sind einige wichtige Marktentwicklungen aufgeführt:
- Im November 2022 schloss Biocon Biologics, eine Tochtergesellschaft von Biocon Ltd., die Übernahme von Viatris ab. Globales Biosimilars-Geschäft. Durch die Übernahme erhält Biocon Biologics direkte kommerzielle Kapazitäten und unterstützende Infrastruktur in den entwickelten Märkten und mehreren Schwellenmärkten und rückt das Unternehmen näher an Patienten, Kunden und Kostenträger heran. Mit dieser Übernahme wird Biocon Biologics voraussichtlich zu einem weltweit führenden Biosimilar-Anbieter mit acht kommerzialisierten Produkten werden.
- Im September 2022 erhielt Celltrion USA die US-amerikanische FDA-Zulassung für sein Onkologie-Biosimilar Vegzelma zur Behandlung von sechs Krebsarten, darunter metastasierter Darmkrebs ; rezidivierender oder metastasierter nicht-plattenepithelialer nicht-kleinzelliger Lungenkrebs (nsNSCLC); wiederkehrendes Glioblastom; metastasiertes Nierenzellkarzinom; anhaltender, wiederkehrender oder metastasierter Gebärmutterhalskrebs; und epithelialer Eierstock-, Eileiter- oder primärer Peritonealkrebs. Vegzelma ist das dritte Onkologie-Biosimilar von Celltrion, das von der US-amerikanischen FDA die Zulassung erhalten hat.
- Im Februar 2021 erwarb Coherus BioSciences Inc. die Exklusivrechte in den USA und Kanada für die gemeinsame Entwicklung und Kommerzialisierung von Junshi Biosciences; Toripalimab, ein PD-1-blockierender Antikörper.
- Im Dezember 2021 gaben Prestige BioPharma und Dr. Reddy’s eine Partnerschaft zur Vermarktung des Trastuzumab-Biosimilars bekannt ausgewählte Länder in Lateinamerika und Südostasien. Trastuzumab (HD201) von Prestige BioPharma ist ein vorgeschlagenes Biosimilar zu Herceptin von Roche und kann zur Behandlung von HER2-positivem Brustkrebs und metastasiertem Magenkrebs verschrieben werden. Die Lizenzvereinbarung gewährt Dr. Reddy's die exklusiven Rechte zur Vermarktung des vorgeschlagenen Biosimilars in ausgewählten Ländern Lateinamerikas und Südostasiens.
Unternehmensprofile
- 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
This text is related
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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