Monoclonal Antibodies Market

Monoclonal Antibodies Market Snapshot (2022 to 2032)

The global Monoclonal Antibodies Market was valued at USD 186 Billion in 2021 and is projected to exhibit a CAGR of 12% from 2022 to 2032.

The rising prevalence of chronic diseases such as cancer, cardiovascular diseases, and others is increasing the demand for biologics, which is anticipated to serve as a key factor driving the monoclonal antibodies (mAbs) market.

Similarly, increasing applications of mAb therapies for targeted therapies and rising awareness about such therapies amongst patients and physicians is expected to significantly contribute toward the market growth.

Increased usage of Monoclonal antibodies in the treatment of many cancers in industrialized countries, is leading to a rapid rise in the worldwide monoclonal antibody market. As per the GLOBOCAN 2020 research, there were 19.3 million new cancer diagnoses and approximately 10 million cancer-related deaths worldwide.

In order to control the rising number, research & development activities in the market are creating new opportunities. New gene-based therapy, new research related to the application of monoclonal antibodies in treating other deadly diseases, such as COVID-19, disease diagnostics, and treatment of other diseases, including auto-immune, viral disease treatment, and government approval of new antibodies may all contribute to the market's growth.

For instance, Union Chimique Belge (UCB) signed a license agreement with Roche and Genentech in July 2020 for the manufacturing and commercialization of UCB0107, a potent monoclonal antibody for the treatment of progressive supranuclear palsy (PSP) and Alzheimer's disease, but it is still being studied.

Data Points	Key Statistics
Estimated Base Year Value (2021)	USD 186 Billion
Expected Market Value (2022)	USD 208.32 Billion
Anticipated Forecast Value (2032)	USD 647.01 Billion
Projected Growth Rate (2022 to 2032)	12% CAGR

2017 to 2021 Monoclonal Antibodies Demand Analysis vs. Forecast 2022 to 2032

The global demand for Monoclonal Antibodies is projected to increase at a CAGR of 12% during the forecast period between 2022 and 2032, reaching a total of USD 647.01 Billion in 2032, according to a report from Future Market Insights (FMI). From 2017 to 2021, sales witnessed significant growth, registering a CAGR of 6.1%.

Human mAbs offer efficient modulation in effector functions and are less immunogenic as compared to chimeric or humanized mAbs. Such antibodies can be produced through the use of phage display and hybridoma technologies in transgenic mice.

As a result, with recent technological progress in genetic engineering, the production of fully human mAbs is anticipated to gain traction in the near future.

Humanized mAbs are expected to reveal the fastest CAGR in the forecast period due to their widespread use against a broad range of target antigens such as cancer cells, immunosuppression, and immunomodulatory molecules.

Demand for such antibodies is also supported by their lower immunogenicity as compared to chimeric mAbs. However, these antibodies are more immunogenic as compared to human mAbs, which may restrict the market growth.

Which are Some Prominent Drivers of the Monoclonal Antibodies Market?

Extensive Uptake during the Pandemic Crisis for Developing Drugs provided a Major Boost in past years

The COVID-19 pandemic has increased the market expansion prospects by fueling the development of several mAbs directed against the SARS-CoV-2 virus. As mAbs represent a promising alternative for the mitigation of COVID-19 due to their safety and effectiveness, several such antibodies have attained emergency use authorizations (EUA) from the USA FDA.

For instance, in February 2022, the USA FDA granted a EUA to Eli Lilly’s bebtelovimab for the treatment of COVID-19 patients that are at risk of developing severe disease or who may need hospitalization.

In addition, the USA Department of Health and Human Services announced the distribution of at least 600,000 free bebtelovimab courses, along with an optional purchase of 500,000 additional doses in the future, thus creating new opportunities for growth of mAbs/Key advantages offered by mAb therapies over previous therapies in terms of specificity, effectiveness, and ease of delivery have led to numerous new product launches and approvals in this domain.

Over 100 mAb products have been approved by the US FDA and the scope of therapeutic mAb applications is expected to grow further due to the development of antibody fragments, antibody derivatives, and bispecific antibodies that offer advanced treatment options.

Increased Number of Strategic Initiatives Presenting Lucrative Opportunities for Monoclonal Antibodies

The market is also favored by the strategic initiatives undertaken by key players for the development and marketing of mAb products. For instance, in October 2021, T-Cure Bioscience, Inc. collaborated with Atlas Antibodies AB for the production and supply of CT83 mAbs.

Similarly, in January 2022, Ono Pharmaceutical Co., Ltd. and Neurimmune AG collaborated on the creation of mAb drugs against new therapeutic targets for neurodegenerative diseases. Such initiatives are expected to open new growth opportunities and positively affect market growth.

What are the Challenges Faced by the Monoclonal Antibodies Market?

High Development Costs of Monoclonal Antibodies Hindering Growth

High costs associated with the development of mAbs and the resultant increase in prices for mAb therapeutics can impede market growth in the near future. For instance, COVID-19 treatment mAbs such as Regeneron’s REGEN-COV (casirivimab and imdevimab), and GlaxoSmithKline & Vir Biotechnology’s sotrovimab cost around USD 1,250 and USD 2,100 per infusion, respectively.

Such high drug prices can limit access to mAb therapies for large patient populations in developing countries and restrict mAbs adoption.

Country-Wise Insights

What Makes North America the Largest Market for Monoclonal Antibodies?

Expansion of the Healthcare Sector in the USA Will Drive the Adoption of Monoclonal Antibodies

North America recorded the largest market share of 46.2% in 2021 due to the presence of a highly developed healthcare infrastructure, high patient awareness, and growth in cancer research prospects, among other factors.

Moreover, increasing government expenditure for cancer research and the presence of key players such as Pfizer Inc., Amgen, Inc., and Merck & Co., among others, are expected to boost market growth.

Why is Asia Pacific Considered a Lucrative Region for the Monoclonal Antibodies Market?

Increasing Medical Tourism in Asia Pacific is Spurring Demand for Monoclonal Antibodies

Asia Pacific region is projected to exhibit the fastest growth rate in the forecast period due to the increasing disposable income, availability of a large patient pool for mAb cancer therapeutics, and rising focus on healthcare.

Countries such as India and China offer attractive investment opportunities for clinical research and are anticipated to positively drive research and development prospects for mAbs.

Category-wise Insights

By Production Type, Which Monoclonal Antibody is Driving Market Growth?

In-vivo Production Type is expected to grow at a Significant Rate

In vivo production held the largest market share in 2021 due to its economic viability in long production runs and lower propensity for contamination with foreign antigens.

In addition, the availability of serum-free culture media and semi-permeable membrane-based systems has increased the feasibility of biomanufacturing operations and is likely to accelerate segment growth. However, the production type is limited by variations in hybridoma characteristics that can lead to the denaturation or inactivation of antibodies and restrict segment growth.

In vivo production type is expected to grow at a significant rate in the forecast period due to its highly cost-effective production as compared to in vitro techniques and its ability to produce a high concentration of mAbs.

These mAbs are used in the diagnostic industry, wherein cost considerations are of prime importance, and optimization of in vivo procedures can be done to increase the secretion of mAbs.

Which End User Shows Higher Implementation in Monoclonal Antibodies Market?

Demand for Monoclonal Antibodies in Hospitals to Gain Traction

The hospital end-use segment held the largest market share of 40.8% in 2021 due to the increasing adoption of mAbs for cancer treatment at hospitals.

Rising healthcare expenditure across the world, increasing patient awareness levels, and availability of advanced hospital infrastructure in developed countries are factors expected to result in the dominance of the segment during the forecast period.

Specialty centers accounted for a significant market share in 2021 due to the increasing government support in recent years. For instance, the National Cancer Institute’s Cancer Centers Program is establishing standards for transdisciplinary cancer centers focused on the prevention, diagnosis, and treatment of various types of cancers.

Such initiatives are expected to positively affect segment growth.

Which Application of Monoclonal Antibodies is Expected to Drive the Market?

Oncology Segment to account for Dominant Application of Monoclonal Antibodies

The oncology segment dominated the applications market for mAbs and accounted for 50.1% of the market value in 2021. This can be attributed to the high number of regulatory approvals for mAbs aimed at cancer treatment.

The surge in the incidence of cancer is a key factor anticipated to drive the growth of mAbs therapeutics as these can have minimal adverse effects as compared to other drugs and chemotherapy interventions. Currently, available mAb therapeutics include those targeted against non-small cell lung, brain tumor, ovarian, breast, gastric, melanoma, colorectal, Hodgkin’s lymphoma, and others.

Applications of mAbs for the treatment of autoimmune diseases are projected to grow at a lucrative rate due to the increasing prevalence of autoimmune conditions such as rheumatoid arthritis.

Furthermore, with growth in the number of cytokine proteins identified in inflammatory pathways that can be targeted for disease mitigation, applications of mAbs in this domain are anticipated to witness growth.

The Start-Up Ecosystem: How Key Players are Opening Frontiers for Future Growth?

Some of the start-ups in the monoclonal antibodies market include-

• The US-based start-up Aridis Pharmaceuticals develops monoclonal antibody discovery platforms for tackling antibiotic-resistant infections. These platforms find and recover B-cells from individuals who have survived antibiotic-resistant infections. Their development pipeline includes drugs targeting staphylococcus aureus, pseudomonas aeruginosa, as well as Acinetobacter baumannii infections.
• French start-up Igyxos is developing a monoclonal antibody-based treatment for female and male infertility. The startup designs the antibody to potentiate the bioactivity of endogenous and exogenous gonadotropins. In addition, the solution induces ovulation in women and regulates spermatogenesis in men by bio-activating gonadotrophins.
• The US-based start-up Yurogen Biosystems is developing humanized mAbs. The startup’s single-cell-based monoclonal antibody (SMab) platform produces mAbs from different host species such as rabbits, monkeys, and humans. The startup offers antibody humanization services for many different kinds of mAbs.

Market Competition

Key players in the Monoclonal Antibodies market are Novartis AG; Pfizer Inc; GlaxoSmithKline plc; Amgen Inc.; Merck & Co., Inc.; Daiichi Sankyo Company, Limited; Abbott Laboratories; AstraZeneca plc; Eli Lilly And Company; Johnson & Johnson Services, Inc. and many more.

• In November 2021, Bristol-Myers Squibb Company received the US Food and Drug Administration approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer.
• Patients with squamous or non-squamous illness, independent of PD-L1 expression, are eligible for the treatment. 1 The FDA's Real-Time Oncology Examine (RTOR) pilot program was used to review this application, which aims to ensure that safe and effective medicines are offered to patients as soon as feasible.
• In March 2022, Sanofi S.A. and Blackstone Life Sciences entered a collaboration for accelerating the development of a subcutaneous formulation of Sarclisa mAb for the treatment of patients with multiple myeloma.

Report Scope

Report Attributes	Details
Market Value in 2022	USD 208.32 Billion
Market Value in 2032	USD 647.01 Billion
Growth Rate	CAGR of 12% from 2022 to 2032
Base Year for Estimation	2021
Historical Data	2017 to 2021
Forecast Period	2022 to 2032
Quantitative Units	Revenue in USD Billion and CAGR from 2022 to 2032
Report Coverage	Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis
Segments Covered	Production Type, Source Type, End-User, Application,Region
Regions Covered	North America; Latin America; Europe; Asia Pacific; Middle East & Africa(MEA)
Key Countries Profiled	The US, Canada, Brazil, Argentina, Germany, The UK, France, Spain, Italy, Australia, New Zealand, China, Japan, South Korea, Singapore, Thailand, Indonesia, GCC, South Africa, Israel
Key Companies Profiled	Novartis AG; Pfizer Inc.; GlaxoSmithKline Plc.; Amgen Inc.; Merck & Co. Inc.; Daiichi Sankyo Company Limited; Abbott Laboratories; AstraZeneca Plc.; Eli Lilly & Company; Johnson & Johnson Services Inc.; Bayer AG; Bristol Myers Squibb; F. Hoffman-La Roche Ltd.; Viatris Inc.; Biogen Inc.; Thermo Fisher Scientific Inc.; Novo Nordisk A/S; Sanofi S.A.
Customization	Available Upon Request

Key Segments Profiled in the Monoclonal Antibodies Market Industry Survey

By Production Type:

• In Vivo
• In Vitro

By Source Type:

• Murine
• Chimeric
• Humanized
• Human

By End User:

• Hospitals
• Specialty Centers
• Others

By Application:

• Oncology
• Autoimmune Diseases
• Infectious Diseases
• Neurological Diseases
• Others

By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)

Frequently Asked Questions

What is the anticipated growth of the market Monoclonal Antibodies until 2032?

FMI projects the global Monoclonal Antibodies market to expand at a 12% value CAGR by 2032.

What is the estimated market value of the Monoclonal Antibodies market expected in 2022?

The global Monoclonal Antibodies market is estimated at a market value of USD 208.32 Billion.

What is the estimated market value of the Monoclonal Antibodies market expected in 2032?

The global Monoclonal Antibodies market is expected to garner a market value of USD 647.01 Billion.

Which region is forecast to be the most lucrative for Monoclonal Antibodies market growth?

FMI has projected North America to be one of the key regions for the Monoclonal Antibodies market, with the US expected to account for over 46.2% of the North American market during the forecast period.

Which are some prominent Monoclonal Antibodies manufacturers?

Novartis AG; Pfizer Inc; GlaxoSmithKline plc; Amgen Inc.; Merck & Co., Inc. are some prominent Monoclonal Antibodies manufacturers.

Which Source of Monoclonal Antibodies is expected to Account for the Largest Share in the Forecast Period 2022 to 2032?

The human source type held the largest share and accounted for 54.07% of the market value in 2021.