Impact Analysis of Covid-19

The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.

Monoclonal antibodies are a type of immunotherapy, which are made in a laboratory and are several copies of a single antibody. Several monoclonal antibodies to treat inflammatory, cancer, and other diseases have been approved by the U.S. Food & Drug Administration (FDA). Depending on the source, there are four types of monoclonal antibodies: murine, chimeric, humanized, and human. Murine antibodies are entirely derived from a murine source, and chimeric antibodies contain variable regions from murine origin and constant regions from human origin. Humanized antibodies are derived from a human source with a small part of a mouse or rat monoclonal antibody and human antibodies are entirely derived from a human source. Monoclonal antibodies are majorly used in cancer treatment along with certain inflammatory, infectious, and other diseases. Depending upon the functions of monoclonal antibodies (for cancer), they are further classified into subtypes such as radiolabeled antibodies, chemo labeled antibodies, and bispecific monoclonal antibodies. Commercially available monoclonal antibodies include Iplimumab, Nivolumab, Rituximab, Blinatumomab, Proleukin, Gardasil, and Kymriah.

The global monoclonal antibodies market size is estimated to be valued at US$ 143.5 billion in 2020 and is expected to exhibit a CAGR of 14.4% over the forecast period (2020-2027).

Figure 1. Global Monoclonal Antibodies Market Value (US$ Bn), by Region, 2020

Monoclonal Antibodies  | Coherent Market Insights

Increasing regulatory approvals and launch of therapies are expected to propel the market growth over the forecast period

Rising approval of monoclonal antibodies by regulatory agencies is favoring launch of innovative therapeutics, which is expected to drive growth of the market over the forecast period. For instance, in 2018, Chugai Pharmaceutical Co., Ltd. (part of Roche Holding AG) announced that it received Breakthrough Therapy Designation from the U.S. FDA for its product, Satralizumab. Also, in May 2018, Johnson & Johnson received the U.S. Food and Drug Administration’s approval for its monoclonal antibody, Darzalex (daratumumab), in combination with Velcade (bortezomib), melphalan, and prednisone, for the treatment of patients with newly diagnosed multiple myeloma, not eligible for autologous stem cell transplant (ASCT).

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Monoclonal Antibodies Market Report Coverage

Report Coverage Details
Base Year: 2019 Market Size in 2020: US$ 143.5 Bn
Historical Data for: 2016 to 2019 Forecast Period: 2020 to 2027
Forecast Period 2020 to 2027 CAGR: 14.4% 2027 Value Projection: US$ 368.8 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Source: Human, Chimeric, Murine, Humanized.
  • By Application: Cancer, Autoimmune Disease, Hematological Disease, Infectious Disease, Others.
  • By Distribution Channel: Hospital Pharmacy, Retail Pharmacy, Online Pharmacy.
Companies covered:

Pfizer Inc., Novartis AG, Bayer AG, Sanofi S.A., F. Hoffmann-La Roche AG, Eli Lilly and Co., Merck & Co., Inc., GlaxoSmithKline Plc., AbbVie Inc., Bristol-Myers Squibb, and Regeneron Pharmaceuticals Inc.

Growth Drivers:
  • Increasing regulatory approvals and launch of therapies
  • Increasing prevalence of cancer
  • Increasing research collaborations for the development of robust drugs pipeline
Restraints & Challenges:
  • High cost of monoclonal antibodies
  • Patent losses

Figure 2. Approval in the U.S. and Europe.

Molecule Name Brand name Target/Format 1st indication approved / reviewed Europe approval year U.S. approval year
Belantamab mafodotin

BLENREP

BCMA; Humanized IgG1 ADC Multiple myeloma 2020 2020
Isatuximab Sarclisa CD38; Chimeric IgG1 Multiple myeloma 2020 2020

Cancer is a class of chronic diseases characterized by uncontrolled growth of cells. The rising number of cancer cases is expected to increase demand for monoclonal antibodies and thereby drive the market growth. According to GLOBOCAN, in 2018, an estimated 43.6% new cases of breast cancer were registered in Asia Pacific. According to World Health Organization (WHO), around 18.1 million cancer cases and 9.6 million deaths were registered globally in 2018.

Figure 3. Global Monoclonal Antibodies Market Share (%), by Source, 2020

Monoclonal Antibodies  | Coherent Market Insights

Increasing research collaborations for the development of robust drugs pipeline is expected to drive the market growth over the forecast period

Many pharmaceuticals, biotech companies, universities, and cancer centers are focusing on investing in development of novel monoclonal antibodies. Several monoclonal antibodies such as immune-checkpoint inhibitors, immuno-oncology drugs (antibodies), and others have been introduced in the market, which is significantly contributing to growth of the market. According to the Tufts Center for the Study of Drug Development (CSDD) report, 2016, over 130 biotech and 20 pharma companies globally are developing immuno-oncology therapies. This is expected to fuel growth of the monoclonal antibodies market over the forecast period.

However, high cost of monoclonal antibody therapies make it unaffordable for the population in the low- and middle-income group to opt for these therapies, which in turn restrains growth of the market. For instance, Keytruda (Pembrolizumab), a monoclonal antibody for the treatment of various types of cancer, costs around US$ 2,250 for a vial of 50 mg. Loss of patents is also expected to hinder the market growth over the forecast period. For instance, Rituximab (Rituxan) product of Genentech, Inc. (Roche) lost its patent in the U.S. and Europe.

Global Monoclonal Antibodies Market – Impact of Coronavirus (Covid-19) Pandemic

The coronavirus (COVID 19) pandemic and lockdown in various countries across the globe have impacted the financial status of businesses in all sectors. The lockdown in various countries due to the pandemic has placed an economic burden on the healthcare sector.

The guidelines issued by the U.S. Food and Drug Administration (FDA) include general considerations to assist sponsors and researchers, which ensure the safety of trial participants, compliance with good clinical practice (GCP), and minimize risks to trial integrity for the duration of the COVID-19 public health emergency.

The appendix of the guidelines also provides answers to some general questions, which the U.S. Food and Drug Administration (FDA) had received from various sponsors and researchers about conducting clinical trials during the COVID-19 public health emergency.

Furthermore, healthcare facilities and researchers are adhering to the following safety measures for ongoing clinical trials:

  • The healthcare providers obtain consent from patients over the phone or through video conferences. According to a survey conducted by Medidata Solutions, Inc., on April 23, 2020, 45% respondents opted for virtual/telemedicine for consultancy.
  • The patients receive a phone call for screening of COVID-19 symptoms before the scheduled in-person visits
  • The assessments of the studies are done in single outpatient areas

Key Players

Major players operating in the global monoclonal antibodies market include Pfizer Inc., Novartis AG, Bayer AG, Sanofi S.A., F. Hoffmann-La Roche AG, Eli Lilly and Co., Merck & Co., Inc., GlaxoSmithKline Plc., AbbVie Inc., Bristol-Myers Squibb, and Regeneron Pharmaceuticals Inc.

Different monoclonal antibodies with unique mechanism of actions have been approved over the past few years, which work on immune checkpoints such as CTLA-4, PD-1, and PD-L1. Manufacturers are focusing on developing drugs belonging to various classes in order to treat variety of diseases ranging from cancer to rare diseases. Monoclonal antibody coupled with chemotherapy agents is becoming a viable treatment option to treat various cancers. For instance, in 2017, the U.S. Food & Drug Administration (FDA) approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients suffering from multiple myeloma, who have received two prior therapies. These factors are expected to support growth of the market over the forecast period.

Market Dynamics

Rising incidence of cancer and other chronic diseases is a major factor that is expected to boost the monoclonal antibodies market growth over the forecast period. According to GLOBOCAN, in 2018, an estimated 43.6% new cases of breast cancer were registered in Asia Pacific. Also, according to the American Cancer Society, 2017, cancer was the second most common cause of death in the U.S., which accounted for around 1 out of every 4 deaths.

Market players are focused on combining monoclonal antibodies with other therapies such as chemotherapy drugs, which is expected to assist the market growth over the forecast period. For instance, combination of nivolumab and ipilimumab for the treatment of intermediate- or poor-risk patients with previously untreated advanced renal cell carcinoma was approved in the U.S. in 2018 and in January 2019 in Europe.

Moreover, efforts of manufacturers to increase number of indications (oncology) for monoclonal antibodies is further expected to boost the market growth over the forecast period. For instance, in June 2018, the U.S. Food & Drug Administration (FDA) expanded the indication of pembrolizumab (Keytruda) to include recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Key features of the study:

  • This report provides in-depth analysis of the global monoclonal antibodies market, and provides market size (US$ Bn) and compound annual growth rate (CAGR%) for the forecast period (2020–2027), considering 2019 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new drug launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global monoclonal antibodies market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Pfizer Inc., Novartis AG, Bayer AG, Sanofi S.A., F. Hoffmann-La Roche AG, Eli Lilly and Co., Merck & Co., Inc., GlaxoSmithKline Plc., AbbVie Inc., Bristol-Myers Squibb, and Regeneron Pharmaceuticals Inc.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future launches, market expansion, and marketing tactics
  • The global monoclonal antibodies market report caters to various stakeholders in this industry including investors, suppliers, manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global monoclonal antibodies market

Detailed Segmentation:

  • Global Monoclonal Antibodies Market, By Source:
    • Human
    • Chimeric
    • Murine
    • Humanized
  • Global Monoclonal Antibodies Market, By Application:
    • Cancer
    • Autoimmune Disease
    • Hematological Disease
    • Infectious Disease
    • Others
  • Global Monoclonal Antibodies Market, By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • Global Monoclonal Antibodies Market, By Region:
    • North America
      • By Source:
        • Human
        • Chimeric
        • Murine
        • Humanized
      • By Application:
        • Cancer
        • Autoimmune Disease
        • Hematological Disease
        • Infectious Disease
        • Others
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Source:
        • Human
        • Chimeric
        • Murine
        • Humanized
      • By Application:
        • Cancer
        • Autoimmune Disease
        • Hematological Disease
        • Infectious Disease
        • Others
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Source:
        • Human
        • Chimeric
        • Murine
        • Humanized
      • By Application:
        • Cancer
        • Autoimmune Disease
        • Hematological Disease
        • Infectious Disease
        • Others
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Source:
        • Human
        • Chimeric
        • Murine
        • Humanized
      • By Application:
        • Cancer
        • Autoimmune Disease
        • Hematological Disease
        • Infectious Disease
        • Others
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Source:
        • Human
        • Chimeric
        • Murine
        • Humanized
      • By Application:
        • Cancer
        • Autoimmune Disease
        • Hematological Disease
        • Infectious Disease
        • Others
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Source:
        • Human
        • Chimeric
        • Murine
        • Humanized
      • By Application:
        • Cancer
        • Autoimmune Disease
        • Hematological Disease
        • Infectious Disease
        • Others
      • By Distribution Channel:
        • Hospital Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Pfizer Inc.*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • Novartis AG
    • Bayer AG
    • Sanofi S.A.
    • Hoffmann-La Roche AG
    • Eli Lilly and Co.
    • Merck & Co., Inc.
    • GlaxoSmithKline Plc.
    • AbbVie Inc.
    • Bristol-Myers Squibb
    • Regeneron Pharmaceuticals Inc.

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Source
      • Market Snippet, By Application
      • Market Snippet, By Distribution Channel
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Major Product Approvals and Launches
    • Collaborations, Partnerships, and Acquisitions
    • Epidemiology
    • Patient Assistance Programs by Manufacturers
    • Pipeline Analysis
    • Reimbursement Scenario
    • Monoclonal Antibodies Packaging and Stability
    • Cold Chain Requirements
    • Novel Manufacturing Techniques
    • Regulatory Approval/Manufacturing In LMICs
    • Regulatory Scenario
    • PEST Analysis
    • Porter’s Analysis
    • Pricing Analysis & Manufacturing Cost
  4. Global Monoclonal Antibodies Market – Impact of Coronavirus (Covid-19) Pandemic
    • Government Initiatives to Combat COVID-19
    • Demand and Supply Impact
    • Initiatives Taken to Conduct Ongoing Clinical Trials
    • Monoclonal Antibodies (MABs) in the Treatment of COVID-19 – Clinical Trial Analysis
    • COVID-19 Impact on the Overall Healthcare Market
  5. Global Monoclonal Antibodies Market, By Source, 2016 – 2027, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • Human
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Chimeric
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Murine
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Humanized
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
  6. Global Monoclonal Antibodies Market, By Application, 2016 – 2027, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • Cancer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Autoimmune Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Hematological Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Infectious Disease
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
  7. Global Monoclonal Antibodies Market, By Distribution Channel, 2016 – 2027, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • Hospital Pharmacy
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Retail Pharmacy
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
    • Online Pharmacy
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Bn)
  8. Global Monoclonal Antibodies Market, By Region, 2016 – 2027, (US$ Bn)
    • Introduction
      • Market Share Analysis, By Region, 2020 and 2027 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2027
    • North America
      • Market Size and Forecast, By Source, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Bn)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Source, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Bn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Source, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Bn)
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Source, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Bn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • Market Size and Forecast, By Source, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Bn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Source, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2027, (US$ Bn)
      • Market Size and Forecast, By Country/Region, 2016 – 2027, (US$ Bn)
        • South Africa
        • Central Africa
        • North Africa
  9. Competitive Landscape
    • Heat Map Analysis
    • Market Share Analysis
      • Pfizer Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Novartis AG
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Bayer AG
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Sanofi S.A.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Hoffmann-La Roche AG
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Eli Lilly and Co.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Merck & Co., Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • GlaxoSmithKline Plc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • AbbVie Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Bristol-Myers Squibb
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Regeneron Pharmaceuticals Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Analyst Views
  10. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 37 market data tables and 26 figures on "Monoclonal Antibodies Market” - Global forecast to 2027

Frequently Asked Questions

The global monoclonal antibodies market size is estimated to be valued at US$ 143.5 billion in 2020 and is expected to exhibit a CAGR of 14.4% between 2020 and 2027.
Increasing regulatory approvals and launch of therapies, increasing prevalence of cancer, and increasing research collaborations for the development of robust drugs pipeline are bolstering the market growth.
Among source, the humanized segment is expected to be the leading segment in the monoclonal antibodies market.
High cost of monoclonal antibodies and patent losses are the key factors hampering growth of the market.
Major players operating in the global monoclonal antibodies market include Pfizer Inc., Novartis AG, Bayer AG, Sanofi S.A., F. Hoffmann-La Roche AG, Eli Lilly and Co., Merck & Co., Inc., GlaxoSmithKline Plc., AbbVie Inc., Bristol-Myers Squibb, and Regeneron Pharmaceuticals Inc.
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