USD 210 billion
Monoclonal Antibodies Market Size, Share, Growth Analysis, By Source type(Murine, Chimeric, Humanized, Human), By Production Type(In Vivo, In Vitro), By Application(Oncology, Autoimmune Diseases, Infectious Diseases, Neurological Diseases), By End-use(Hospitals, Specialty Centers, Others), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35H2248 |
Region:
Global |
Published Date: September, 2024
Pages:
211
|Tables:
119
|Figures:
75
Monoclonal Antibodies Market Insights
Global Monoclonal Antibodies Market size was valued at USD 211 billion in 2022 and is poised to grow from USD 235.27 billion in 2023 to USD 562.03 billion by 2031, growing at a CAGR of 11.5% during the forecast period (2024-2031).
An increase in requirement for biologics, especially mAbs, is mainly fuelled by the ever-rising prevalence of chronic diseases such as cancer, cardiovascular disease, and autoimmune diseases. Such trends are predicted to mark the dominating presence of the mAbs market. Increasing levels of awareness among patients and doctors are being created as monoclonal antibodies for targeted treatment start to work for significant numbers of health-care professionals. Since monoclonal antibodies can selectively interact with and neutralize disease-causing chemicals, it has emerged as one of the direct medical needs in the fight against a broad spectrum of diseases.
Global-leading companies in the industry have made great efforts in developing and commercializing mAb drugs. For instance, T-Cure Bioscience, Inc. collaborated with Atlas Antibodies AB in October 2021 to improve CT83 mAbs production and supply in cancer treatment applications. Of a similar sort, Ono Pharmaceutical Co., Ltd. and Neurimmune AG agreed in January 2022 to collaborate for developing mAb drugs targeting novel therapeutic targets of neurodegenerative diseases. These new and innovative partnerships are most expected to unlock opportunities for growth of the mAbs sector with regard to improved treatment options and betterment of patient care for most chronic conditions.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
In Vitro
Fastest Growth
Humanized
Growth Rate
11% CAGR
Global Monoclonal Antibodies Market ($ Bn)
Country Share for North America Region (%)
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Monoclonal Antibodies Market Segmental Analysis
Global Monoclonal Antibodies Market is segmented by Source type, Production Type, Application, End-use, and region. Based on Source type, the market is segmented into Murine, Chimeric, Humanized, and Human. Based on Production Type, the market is segmented into In Vivo, and In Vitro. Based on Application, the market is segmented into Oncology, Autoimmune Diseases, Infectious Diseases, Neurological Diseases, and Others. Based on End-use, the market is segmented into Hospitals, Specialty Centers, and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.
Analysis by Source Type
In 2023, the human source type was reportedly at 54.3% of the total market value of monoclonal antibodies. Preferably, human mAbs are used instead of chimeric or humanized mAbs since these have less immunogenicity and effectively control effector functions. Increasing their efficacy is the production of these antibodies in transgenic mice through advanced methods such as phage display and hybridoma technology. The increasing capacity of current genetic engineering to produce fully human mAbs is improving the availability for therapeutic use, and the demand for human mAbs will be predicted to increase with developing research that will significantly expand this market sector.
The Humanized mAbs segment is expected to expand with the highest compound annual growth rate (CAGR) of 11.6% because they are being increasingly used against a wide number of target antigens such as cancer cells and various immunosuppressor and immunomodulatory molecules. Their design retains lower levels of immunogenicity compared to chimeric mAbs but allows for higher levels of therapeutic efficiency. Although humanized mAbs are more immunogenic than fully human mAbs, which would limit market growth, this is expected to expand significantly in the next few years because the demand for targeted therapeutics continues and innovative approaches continue to emerge.
Analysis by Production Type
The In-vitro production type had the highest market share of 76.9% in 2023 mainly because it was economically viable for extended production runs, and it posed less danger of contamination with foreign antigens. Innovations such as serum-free culture mediums and semi-permeable membrane-based systems enhance the viability and efficiency of biomanufacturing processes which is rewarding to this approach. These technologies speed up sector growth through cheaper production and reduced operating costs. However, several challenges persist, mainly concerning the differences in hybridoma characteristics that can lead to denaturation or even antibody inactivation and which limits the possible total growth for the manufacturing in vitro market.
However, the in-vivo production type is anticipated to experience major growth in the forecast period due to its potential production of massive amounts of monoclonal antibodies (mAbs) at a significantly lower cost than those produced through in vitro procedures and its expected growth. It is highly beneficial for this method of production in the diagnostics area where any cost issues are crucial for sustaining profitability. Furthermore, in vivo process development could result in higher mAb secretion levels, and the fact that more efficient production can be achieved will become even more perceivable. As demand increases for less expensive diagnostic solutions, the in vivo production market will continue to grow and gain a solid foothold in becoming an alternative to conventional in vitro methods.
Global Monoclonal Antibodies Market By Production Type
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Monoclonal Antibodies Market Regional Insights
North America remained the largest market in 2023, accounting for a share of around 46.1%, mainly due to an advanced healthcare system and high patient awareness, and promising future for research in cancer. This area benefits from massive funding by governments to advance cancer research, thereby rapidly transforming the creation and availability of monoclonal antibodies for medicinal use. The presence of these important industry participants such as Pfizer Inc., Amgen, Inc., and Merck & Co. helps generate a competitive environment conducive to cooperation and innovation. The North American market is expected to continue its leadership position while being poised to have stable growth in the next few years through these companies continuing their efforts on their R&D operations.
Besides several critical factors, Asia-Pacific is expected to grow at the fastest rate in the forecast period—12.1%. The rising disposable income of the region, combined with a highly significant patient pool requiring mAb cancer treatments, further expands market potential. Sustained investment in high-tech medical technology and increasing attention to health care improvement also form a propitious environment for the development of mAb. Pharmaceutical industries in countries such as China and India have thus enormous potential, hence are particularly inviting for investments in clinical research. This focus on R&D is predicted to drive the growth of the monoclonal antibodies market in the region significantly.
Global Monoclonal Antibodies Market By Geography
- Largest
- Fastest
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Monoclonal Antibodies Market Dynamics
Drivers
Increasing Rate of Chronic Diseases
- The growing rate of the incidence of chronic diseases such as cancer and autoimmune diseases has mainly contributed to the increase in the monoclonal antibodies (mAbs) market. The demand for targeted drugs, such as monoclonal antibodies, increases as the average age of the population rises and people become more prone to lifestyle-related health issues. Pharmaceutical companies have put a lot of money into researching and developing new monoclonal antibodies (mAb) drugs because of the high demand for such treatment drugs.
Technological Developments in The Production of mAb
- Advances in genetic engineering and biotechnology significantly enhance the efficiency and effectiveness of monoclonal antibodies' production. Phage display, hybridoma, and recombinant DNA technology allow for improved quality and a decrease in mAb production, which in turn makes the product more accessible for therapeutic use. Most of these improvements simplify the manufacturing process and reduce costs; thus, they stimulate the market by giving the companies an opportunity to increase their prices on mAb products.
Restraints
High Development and Manufacturing Costs
- The major hindrance against the market is the high expense for generating and producing the mAbs. The long and intricate processes needed to obtain mAbs, such as expensive testing and compliance with legal processes, can be excessively costly in an enormous way. The high-priced prices might prevent small companies from entering the market and might also limit patient access to such complex therapies, hence eventually impeding the further growth of the market.
Regulatory Barriers and Delays
- There exist several tough regulatory barriers in the monoclonal antibodies market that could delay timely launches of newly approved products. It is clear that strict criteria relating to the safety and efficacy of monoclonal antibodies must be met through extensive clinical studies, which can be expensive and time-consuming. Their entry into the market would consequently be delayed due to the time lag involved in acquiring regulatory clearances. This may thus dampen market growth overall and reduce the level of availability of advanced treatment options for patients.
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Monoclonal Antibodies Market Competitive Landscape
To raise revenues, monoclonal antibody companies need to pay attention to their time-to-market and hasten the speed at which they commercialize their products. Any company looking to get an edge over the others in the same market where they operate to launch their product rapidly will realize that alliances and partnerships work best. Besides the prospects of alliances and partnerships, government funding and initiatives to facilitate medical research on monoclonal antibodies also promise much for players in the monoclonal antibody market.
Top Player’s Company Profiles
- Novartis AG (Switzerland)
- Pfizer Inc. (US)
- GlaxoSmithKline plc (UK)
- Amgen Inc. (US)
- Merck & Co., Inc. (US)
- Daiichi Sankyo Company, Limited (Japan)
- Abbott Laboratories (US)
- AstraZeneca plc (UK)
- Eli Lilly and Company (US)
- Johnson & Johnson Services, Inc. (US)
- Bayer AG (Germany)
- Bristol Myers Squibb (US)
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Viatris Inc. (US)
- Biogen Inc. (US)
- Thermo Fisher Scientific, Inc. (US)
- Novo Nordisk A/S (Denmark)
- Sanofi S.A. (France)
- Merck KGaA (Germany)
- Genmab A/S (Denmark)
- Regeneron Pharmaceuticals, Inc. (US)
- Incyte Corporation (US)
Recent Developments
- Roche, the leading pharmaceutical company from Switzerland, announced in March 2024 that the company will launch the monoclonal antibodies for the two serious eye conditions in the Indian market. The newly launched Vabysmo is aimed at treating diabetic macular edema (DME) and neovascular or "wet" age-related macular degeneration (nAMD).
- The newly formed Calluna Pharma, which resulted from the merger of Oxitope Pharma and Arxx Therapeutics, revealed in January 2024 that it has received USD 81 million in cash through a Series A funding round. With a pipeline of four highly promising prospects in monoclonal antibodies, the company will continue to use these funds.
- KBI Biopharma has just launched a new platform in December 2023 that speeds the development and manufacturing of monoclonal antibodies. The newest offering, SUREmAb, is built on top of KBI's SUREtechnology Platform.
Monoclonal Antibodies Key Market Trends
- Growth of Biosimilars: One of the significant trends in the market is the emergence of biosimilars. Biosimilars are becoming popular as many known mAbs have patents expiring, where cheaper alternatives are now available. This trend brings in economies of scale with increased numbers of accessions to drugs, to the benefit of patients and pharmaceutical firms alike. It is predicted that market dynamics will shift in response to acceptance of biosimilars, encouraging more competition and innovation.
- Methods in Personalized Medicine: This is due to the fact that the trend towards personalized treatment is slowly and steadily influencing the market of monoclonal antibodies. Technology advancement in genetics and biotechnology allowed for the development of customized targeted mAbs for individual patients. Growing tendency toward more personalized therapy approaches enhances therapeutic effectiveness and reduces side effects related to drugs, whereas patients are also relatively more compliant. The demand for the new mAb therapies designed particularly for selected patient groups is expected to rise to a vast extent with the increasingly adopted personalized medicine approach in healthcare systems.
Monoclonal Antibodies Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the monoclonal antibodies market is expected to experience rapid growth owing to the growing incidence of chronic diseases and the significant progress achieved in biotechnology. Further developments in mAb manufacture will also improve the prospects of the market with the adoption of biosimilars growing. Development may be constrained by barriers such as high development prices and red tape. The trend in personalized medicine further illustrates how the mAbs may add tailored treatment plans into the fold for improving patient outcomes. On balance, a sector is ready to change-providing opportunities to established companies and newcomers alike, each of whom is committed to advancing medicinal treatments in this very critical area of healthcare.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 211 billion |
| Market size value in 2031 | USD 562.03 billion |
| Growth Rate | 11.5% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Monoclonal Antibodies Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Monoclonal Antibodies Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Monoclonal Antibodies Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Monoclonal Antibodies Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Monoclonal Antibodies Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Monoclonal Antibodies Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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