Global Monoclonal Antibodies Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

Monoclonal Antibodies Market Analysis

Over the last few years, various monoclonal antibodies targeting immunological checkpoints such as CTLA-4, PD-1, and PD-L1 have been approved, each with its own mode of action. Manufacturers are concentrating their efforts on creating medications from many classifications to treat various disorders, from cancer to rare diseases. Monoclonal antibodies combined with chemotherapeutic drugs are increasingly being used to treat various malignancies. For instance, the United States Food and Drug Administration (FDA) approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone in 2017 to treat patients with multiple myeloma who had previously received two treatments.

Monoclonal Antibodies Market Size                              

Global monoclonal antibodies market size was valued at USD 263.22 billion in 2024 and is projected to reach USD 719.81 billion by 2032, with a CAGR of 13.40% during the forecast period of 2025 to 2032.

Report Scope and Market Segmentation       

Monoclonal Antibodies Market Definition

Monoclonal antibodies are a form of immunotherapy in which many copies of a single antibody are produced in a laboratory. The United States Food and Drug Administration (FDA) has approved several monoclonal antibodies to treat inflammatory, cancer, and other disorders. Monoclonal antibodies are classified as murine, chimeric, humanized, or human, depending on the source. Murine antibodies are produced solely from a murine source, while chimeric antibodies combine murine and human regions. Human antibodies are formed of human antibodies with many mouse or rat monoclonal antibodies.

Monoclonal Antibodies Market Dynamics

Drivers

• Rise in the prevalence of cancer

The surging prevalence of cancer is a major factor driving the monoclonal antibodies market's growth rate during the forecast period of 2025-2032. Monoclonal antibodies are becoming increasingly used in the treatment of many cancers in industrialized countries, owing to the rapid rise of the worldwide monoclonal antibody market. As per the GOLOBOCAN 2020 research, there were 19.3 million new cancer diagnoses and approximately 10 million cancer-related deaths worldwide.

• Emergence of COVID-19 pandemic

The emergence of COVID-19 pandemic is anticipated to propel the ' 'market's growth rate. The sudden increase in the number of people with COVID-19 and the related mortality risk has prompted the development of viable treatments. Furthermore, due to the virus's potential to reduce disease burden, various industry participants are actively involved in the development of novel monoclonal antibodies for prevention and therapy of COVID-19 virus.

Furthermore, rising initiatives by public and private organizations to spread awareness and rising healthcare expenditure will expand the monoclonal antibodies market. Additionally, sedentary lifestyle of people and surging geriatric population will result in the expansion of monoclonal antibodies market. Along with this, rising demand for personalized medicine and surging prevalence of chronic and infectious diseases will enhance the market's growth rate.

Opportunities

• Increase in the number of research and development activities         

The rising number of research and development activities is estimated to create new opportunities for the monoclonal antibodies market growth in coming years. 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.

• Rising regulatory approvals and launch of therapies

Regulatory agencies' increasing approval of monoclonal antibodies is supporting the launch of new medicines, which is likely to fuel market growth over the forecast period. For instance, in 2018, Chugai Pharmaceutical Co., Ltd. (a subsidiary of Roche Holding AG) reported that its medication, Satralizumab, has obtained Breakthrough Therapy Designation from the US FDA. In May 2018, Johnson & Johnson got FDA clearance for Darzalex, a monoclonal antibody used in conjunction with Velcade, melphalan, and prednisone to treat patients with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant (ASCT).

Moreover, rising investment for the development of advanced technologies and an increase in the number of emerging markets will provide beneficial opportunities for the monoclonal antibodies market growth during the forecast period.

Restraints/Challenges

On the other hand, high cost associated with monoclonal antibodies will obstruct the growth rate of market. The lack of healthcare infrastructure in developing economies and dearth of skilled professionals will challenge the monoclonal antibodies market. Additionally, strict government regulations and loss of patent will act as restrain and further impede the growth rate of market during the forecast period of 2025-2032.

This monoclonal antibodies market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the monoclonal antibodies market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Patient Epidemiology Analysis

Monoclonal antibodies market also provides you with detailed market analysis for patient analysis, prognosis and cures. Prevalence, incidence, mortality, adherence rates are some of the data variables that are available in the report. Direct or indirect impact analyses of epidemiology to market growth are analysed to create a more robust and cohort multivariate statistical model for forecasting the market in the growth period.

Monoclonal Antibodies Market Scope

The monoclonal antibodies market is segmented on the basis of production methods, source, indication, route of administration, end-users and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Production Methods

• In Vivo
• In Vitro

Source

• Murine
• Chimeric
• Humanized
• Human
• Others

Indication

• Cancer
• Autoimmune Diseases
• Inflammatory Diseases
• Infectious Diseases
• Others

Route of Administration

• Intravenous
• Subcutaneous
• Intravitreal
• Others

End-Users

• Hospitals
• Specialty Clinics
• Homecare
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
• Others

Monoclonal Antibodies Market Regional Analysis

The monoclonal antibodies market is analyzed and market size insights and trends are provided by country, production methods, source, indication, route of administration, end-users and distribution channel as referenced above.

The countries covered in the monoclonal antibodies market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America

North America dominates the monoclonal antibodies market in terms of market share and market revenue and will continue to flourish its dominance during the forecast period. This is due to the presence of major key players and rising healthcare expenditure will further propel the ' 'market's growth rate in this region. Additionally, the increase in the number of research and development activities and the high prevalence of chronic diseases will further propel the ' 'market's growth rate in this region.

Asia-Pacific is expected to grow during the forecast period of 2025-2032 due to surging level of disposable income in this region. Also, development of healthcare infrastructure and rise in number of generic manufacturers will further propel the ' 'market's growth rate in this region.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Monoclonal Antibodies Market Share

The monoclonal antibodies market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to monoclonal antibodies market.

Monoclonal Antibodies Market Leaders Operating in the Market Are:

• Pfizer Inc. (U.S.)
• GlaxoSmithKline plc (U.K.)
• Novartis AG (Switzerland)
• Mylan N.V. (U.S.)
• Teva Pharmaceutical Industries Ltd.(Israel)
• Sanofi (France)
• F. Hoffmann-La Roche Ltd. (Switzerland)
• Zydus Cadila (India)
• Lupin (India)
• Amneal Pharmaceuticals LLC. (U.S.)
• Regeneron Pharmaceuticals Inc. (U.S.)
• Biogen (U.S.)
• Eli Lilly and Company (U.S.)
• AbbVie Inc. (U.S.)
• Eisai Co., Ltd. (Japan)
• Amgen Inc. (U.S.)
• Bayer AG (Germany)
• Bristol-Myers Squibb Company (U.S.)
• AstraZeneca (U.K.)
• Johnson & Johnson Private Limited (U.S.)

Latest Developments in Monoclonal Antibodies Market

• In November 2021, Bristol-Myers Squibb Company had received the U.S. 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 programme was used to review this application, which aims to ensure that safe and effective medicines are offered to patients as soon as feasible.

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