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
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).
Monoclonal Antibodies Market Report Coverage
||Market Size in 2020:
||US$ 143.5 Bn
|Historical Data for:
||2016 to 2019
||2020 to 2027
|Forecast Period 2020 to 2027 CAGR:
||2027 Value Projection:
||US$ 368.8 Bn
- 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
- 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.
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.
- 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.
||1st indication approved / reviewed
||Europe approval year
||U.S. approval year
|BCMA; Humanized IgG1 ADC
||CD38; Chimeric IgG1
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
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
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.