Cancer Biologics Market: Information by Type (Monoclonal Antibodies, Growth Factor, Blood and Blood Products, Vaccines, Toxoids and Others), and Regions— Forecast Period 2020–2029

Dec 01, 2020   The global cancer biologics market was valued at USD 31,179.71 million in 2019 and is expected to grow at 6.7% CAGR during the forecast study period, and is expected to reach USD 1789.59 million. The biologic drug is a product produced from living organisms and includes various products derived from animals, humans, or microorganisms by using biotechnology. Types of biologics drugs include blood, vaccines, cells, allergens, tissues, genes, and recombinant proteins. These drugs alter the method ...
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Report Description

The global cancer biologics market was valued at USD 31,179.71 million in 2019 and is expected to grow at 6.7% CAGR during the forecast study period, and is expected to reach USD 1789.59 million.

The biologic drug is a product produced from living organisms and includes various products derived from animals, humans, or microorganisms by using biotechnology. Types of biologics drugs include blood, vaccines, cells, allergens, tissues, genes, and recombinant proteins. These drugs alter the method of operation of natural biologic cellular and intracellular actions.

Rising Incidence and Prevalence of Cancer Globally

The rising prevalence of cancer cases across the globe is creating a high demand for advanced treatment therapies. According to evaluations from the International Agency for Research on Cancer (IARC), in 2018, there were around 17.0 million new cancer incidences and 9.5 million cancer deaths across the globe. The World Cancer Research Fund (WCRF) predicts the number of cancer cases worldwide to exceed 24 million by 2035. Genetic abnormalities and environmental variables such as cigarette smoke, pollution, and alterations in eating habits are the leading etiological causes of cancer. The growing prevalence of these causes has led directly to the increased incidence of cancer globally.

The increasing geriatric population is expected to fuel the cancer biological therapy industry's growth during the projected years. According to the WHO's data, it is predicted that the global population aging 60 years and above will reach 2 billion by 2050. According to the American Cancer Society, in 2016, individuals aged 50 and above accounted for around 87% of cancer patients in the U.S. Aging population is more susceptible to cancer. Such high incidences impart the need for biological therapy to treat cancer.

Advances in the Research and Development of Cancer Biomarkers

The surge in research is expected to raise the demand for cancer care. According to the report by the IMS Institute for Healthcare Informatics, the oncology drug pipeline has expanded by 63% over the past ten years. Developments in genomics, proteomics, metabolomics, and imaging have enabled a comprehensive analysis of tumor cells. As cancer etiology differs in patients, the adoption of predictive biomarkers helps study tumor growth in patients. It helps in deciding treatment regimens and in the early detection of cancer, therefore facilitating cost-effective therapies for patients. Chemotherapy has several side effects, such as the destruction of healthy cells, nausea, and a weakened immune system. Hence, alternative therapies such as biologics and precision medicine will gain high acceptance in the coming years, causing less or no side effects.

Several pharmaceutical companies are investing heavily in the development of cancer biologics. Therefore, many biological molecules for cancer therapy are in the late stages of development. Besides, regulatory agencies have fastened biologic cancer approvals, leading to new biologics for cancer care. During the forecast era, a robust pipeline and the acceptance of new medicines are projected to fuel development on the global cancer biologics market.

Research organizations such as cancer research, National Cancer Institute (NIC), National Institutes of Health (NIH), and cancer research U.K. are involved in comprehensive research on cancer biological therapies and funding in various research projects. These organizations are also involved in spreading awareness and promoting cancer biologics amongst patients.

Robust Biologics Pipeline

Companies are implementing innovative approaches to develop advanced therapies such as investing in multi-targeting therapies, working with combination therapies to make treatment more effective, and developing biologics to produce precision medicines. These firms are conducting breakthrough research to unlock gene therapy's potential and leverage artificial intelligence and advanced digital technologies to empower patients to manage cancer better. Sanofi's 31 drugs are currently in the pipeline.

Pfizer has the following biologics pipeline to treat cancer:

Compound Name

Indication

Phase

Submission type

Bavencio (avelumab)

1st Line Merkel Cell Carcinoma (MCC) (Biologic)

Phase 2

Product Enhancement

Bavencio (avelumab)

1st Line Non-Small Cell Lung Cancer (Biologic)

Phase 3

Product Enhancement

Bavencio (avelumab)

1st Line Urothelial Cancer (Biologic)

Phase 3

Product Enhancement

PF-06804103

Cancer (Biologic)

Phase 1

New Molecular Entity

PF-06647020

Cancer (Biologic)

Phase 1

New Molecular Entity

Bavencio (avelumab)

Cancer (Biologic)

Phase 1

Product Enhancement

Bavencio (avelumab)

Combo w/ Talzenna (talazoparib) and binimetinib for Solid Tumors (Biologic)

Phase 1

Product Enhancement

PF-06863135

Multiple Myeloma (Biologic)

Phase 1

New Molecular Entity

PF-06801591 + Bacillus Calmette-Guerin (BCG)

Non-Muscle-Invasive Bladder cancer (Biologic)

Phase 3

New Molecular Entity

PF-06940434

Solid Tumors (Biologic)

Phase 1

New Molecular Entity

PF-07062119

Solid Tumors (Biologic)

Phase 1

New Molecular Entity

The FDA approved novel indications to 47 biologics for oncology in 2018, and 20 such approvals had already been approved in 2019. The ongoing clinical trials also comprise research on several types of biological therapies such as adoptive cell transfer, angiogenesis inhibitors, Bacillus Calmette-Guerin therapy, bio-chemotherapy, cancer vaccines, chimeric antigen receptor (car) T-cell therapy, cytokine therapy, gene therapy, immune checkpoint modulators, immunoconjugates, monoclonal antibodies, oncolytic virus therapy, and targeted drug therapy.

Segmental Analysis

The global cancer biologics market is segmented into type and region. The type segment is divided into monoclonal antibodies, growth factors, blood and blood products, vaccines and toxoids, and others.

The below-mentioned info-graph depicts the estimated share of the segment in the global cancer biologics market:

Monoclonal antibodies dominated the cancer biologics market with a value of USD 17,450.60 million in 2019 and will grow at a CAGR of 6.9% in the forecast time. Monoclonal antibodies (mAbs), a category of monospecific antibodies, consisting of identical antibody molecules formed by a single clone of cells or cell lines. The rising prevalence of cancer, increasing emphasis on research and developments in genomics, and the advent of innovative genetic technologies, such as next-generation sequencing, have also positively impacted market growth. Furthermore, the affordability of the technologies needed to build mAbs for research has also led to market development.

Other factors that positively impact the industry are the awareness among patients and clinicians about mAb therapy applications, availability of improved drugs, the use of therapeutic antibodies in cost-sensitive markets, and fast acceptance of innovative therapies regulators. Furthermore, fast approvals of groundbreaking mAbs' are expected for a high adoption rate. For instance, the industry will be further bolstered by popular medications like Herceptin, Avastin, Rituxan, and Remicade based on FDA clearance. Besides, numerous mAbs awaiting therapeutic approval are undergoing clinical trials, and therefore the rising drug pipeline is projected to provide this sector with potential growth opportunities.

CUSABIO introduces 45 superior quality human monoclonal antibodies that had been effectively applied in immunohistochemistry with pathological samples for cancer research. Furthermore, as of 31 December 2017, 10 monoclonal antibody drugs were approved globally by the FDA and EMA. The overall number of monoclonal antibody drugs (including drugs withdrawn after approval for different reasons, except Fc fusion protein) exceeded 73. In the research process, innovative ventures are increasingly going forward with ambitious targets and new trial evidence approaches that will accept broader promise for monoclonal antibody drugs.

Regional Analysis

The regional analysis has been made considering the cancer biologics trends in North America, Europe, Asia-Pacific, South America, the Middle East, and Africa.

The below-mentioned info-graph depicts the estimated market share for the regions in 2019:

North America dominated the oncology biologics market with a value of USD 18,785.72 million in 2019 and is estimated to grow at 6.9% CAGR. As per the Cancer Atlas, in 2018, approximately 1.9 million novel cancer cases and 693,000 cancer deaths were assessed to have occurred in North America. The growth is primarily due to well developed and technologically advanced healthcare infrastructure and well-regulated policies. Rising government initiatives and surging research and development activities in cancer biologics accelerating new biologics and abundance of pharmaceutical and biotechnology firms in this region fosters the regional market growth. The trend towards developing fully-humanized monoclonal antibodies is predicted to increase, attributing to a perceived low level. About 70% of breast cancer cases, 55% of colorectal cancer cases are treated with biologics.

India's increasing biologic industry is the key driver of expansion, with respondents citing 'India's increasing domestic demand, bio-investment, and potential for expanded exports to developed markets. India has more than 95 licensed domestic biosimilars and market penetration, which is currently relatively small and projected to rise rapidly in the future. The biosimilar pipeline in India is also robust, mainly influenced by the Indian government's initiative to offer incentives to Indian biosimilar producers and the expiry of current biological patents and India's Central Drugs Regulation ConStandard Control Organization aligning guidelines closely with global regulators including the U.S. FDA, MHRA, and others. Recent reports indicate that more than 40 biosimilars were in the clinical development stage in India. In China, 20 to 25 %of newly diagnosed breast cancer patients are treated with biologics.

Competitive Landscape

Key Market Players

  1. Hoffmann-La Roche Ltd, Novartis AG, Eli Lilly and Company, Sanofi, CELGENE CORPORATION, Pfizer Inc., Bayer AG, Johnson and Johnson Services, Inc., Bristol-Myers Squibb Company, Merck & Co., Inc., and Amgen Inc.

Recent Developments

  • In December 2019, Biocon and its partner Mylan collaboratively launched a cancer drug Ogivri, a biosimilar to Herceptin, in the U.S. The drug is available in a 420mg multi-dose vial and a 150mg single-dose vial to treat all types of breast cancer and metastatic stomach cancer.
  • In November 2018, Roche and Abbvie received FDA approval for Venclexta, a BCL-2 inhibitor effective in treating leukemia. Venclexta is jointly commercialized by Abbvie and Genetech, a part of Roche.

Global Cancer Biologics Market: Market Segmentation

  • By Type
    • Monoclonal Antibodies
    • Growth Factor
    • Blood & Blood Products
    • Vaccines & Toxoids
    • Others
  • By Regions
    • North America
    • Europe
    • Asia-Pacific
    • Central andSouth America and the Caribbean
    • The Middle-East and Africa

 

The global cancer biologics market was valued at USD 31,179.71 million in 2019 and is expected to grow at 6.7% CAGR during the forecast study period, and is expected to reach USD 1789.59 million.

The biologic drug is a product produced from living organisms and includes various products derived from animals, humans, or microorganisms by using biotechnology. Types of biologics drugs include blood, vaccines, cells, allergens, tissues, genes, and recombinant proteins. These drugs alter the method of operation of natural biologic cellular and intracellular actions.

Rising Incidence and Prevalence of Cancer Globally

The rising prevalence of cancer cases across the globe is creating a high demand for advanced treatment therapies. According to evaluations from the International Agency for Research on Cancer (IARC), in 2018, there were around 17.0 million new cancer incidences and 9.5 million cancer deaths across the globe. The World Cancer Research Fund (WCRF) predicts the number of cancer cases worldwide to exceed 24 million by 2035. Genetic abnormalities and environmental variables such as cigarette smoke, pollution, and alterations in eating habits are the leading etiological causes of cancer. The growing prevalence of these causes has led directly to the increased incidence of cancer globally.

The increasing geriatric population is expected to fuel the cancer biological therapy industry's growth during the projected years. According to the WHO's data, it is predicted that the global population aging 60 years and above will reach 2 billion by 2050. According to the American Cancer Society, in 2016, individuals aged 50 and above accounted for around 87% of cancer patients in the U.S. Aging population is more susceptible to cancer. Such high incidences impart the need for biological therapy to treat cancer.

Advances in the Research and Development of Cancer Biomarkers

The surge in research is expected to raise the demand for cancer care. According to the report by the IMS Institute for Healthcare Informatics, the oncology drug pipeline has expanded by 63% over the past ten years. Developments in genomics, proteomics, metabolomics, and imaging have enabled a comprehensive analysis of tumor cells. As cancer etiology differs in patients, the adoption of predictive biomarkers helps study tumor growth in patients. It helps in deciding treatment regimens and in the early detection of cancer, therefore facilitating cost-effective therapies for patients. Chemotherapy has several side effects, such as the destruction of healthy cells, nausea, and a weakened immune system. Hence, alternative therapies such as biologics and precision medicine will gain high acceptance in the coming years, causing less or no side effects.

Several pharmaceutical companies are investing heavily in the development of cancer biologics. Therefore, many biological molecules for cancer therapy are in the late stages of development. Besides, regulatory agencies have fastened biologic cancer approvals, leading to new biologics for cancer care. During the forecast era, a robust pipeline and the acceptance of new medicines are projected to fuel development on the global cancer biologics market.

Research organizations such as cancer research, National Cancer Institute (NIC), National Institutes of Health (NIH), and cancer research U.K. are involved in comprehensive research on cancer biological therapies and funding in various research projects. These organizations are also involved in spreading awareness and promoting cancer biologics amongst patients.

Robust Biologics Pipeline

Companies are implementing innovative approaches to develop advanced therapies such as investing in multi-targeting therapies, working with combination therapies to make treatment more effective, and developing biologics to produce precision medicines. These firms are conducting breakthrough research to unlock gene therapy's potential and leverage artificial intelligence and advanced digital technologies to empower patients to manage cancer better. Sanofi's 31 drugs are currently in the pipeline.

Pfizer has the following biologics pipeline to treat cancer:

Compound Name

Indication

Phase

Submission type

Bavencio (avelumab)

1st Line Merkel Cell Carcinoma (MCC) (Biologic)

Phase 2

Product Enhancement

Bavencio (avelumab)

1st Line Non-Small Cell Lung Cancer (Biologic)

Phase 3

Product Enhancement

Bavencio (avelumab)

1st Line Urothelial Cancer (Biologic)

Phase 3

Product Enhancement

PF-06804103

Cancer (Biologic)

Phase 1

New Molecular Entity

PF-06647020

Cancer (Biologic)

Phase 1

New Molecular Entity

Bavencio (avelumab)

Cancer (Biologic)

Phase 1

Product Enhancement

Bavencio (avelumab)

Combo w/ Talzenna (talazoparib) and binimetinib for Solid Tumors (Biologic)

Phase 1

Product Enhancement

PF-06863135

Multiple Myeloma (Biologic)

Phase 1

New Molecular Entity

PF-06801591 + Bacillus Calmette-Guerin (BCG)

Non-Muscle-Invasive Bladder cancer (Biologic)

Phase 3

New Molecular Entity

PF-06940434

Solid Tumors (Biologic)

Phase 1

New Molecular Entity

PF-07062119

Solid Tumors (Biologic)

Phase 1

New Molecular Entity

The FDA approved novel indications to 47 biologics for oncology in 2018, and 20 such approvals had already been approved in 2019. The ongoing clinical trials also comprise research on several types of biological therapies such as adoptive cell transfer, angiogenesis inhibitors, Bacillus Calmette-Guerin therapy, bio-chemotherapy, cancer vaccines, chimeric antigen receptor (car) T-cell therapy, cytokine therapy, gene therapy, immune checkpoint modulators, immunoconjugates, monoclonal antibodies, oncolytic virus therapy, and targeted drug therapy.

Segmental Analysis

The global cancer biologics market is segmented into type and region. The type segment is divided into monoclonal antibodies, growth factors, blood and blood products, vaccines and toxoids, and others.

The below-mentioned info-graph depicts the estimated share of the segment in the global cancer biologics market:

Monoclonal antibodies dominated the cancer biologics market with a value of USD 17,450.60 million in 2019 and will grow at a CAGR of 6.9% in the forecast time. Monoclonal antibodies (mAbs), a category of monospecific antibodies, consisting of identical antibody molecules formed by a single clone of cells or cell lines. The rising prevalence of cancer, increasing emphasis on research and developments in genomics, and the advent of innovative genetic technologies, such as next-generation sequencing, have also positively impacted market growth. Furthermore, the affordability of the technologies needed to build mAbs for research has also led to market development.

Other factors that positively impact the industry are the awareness among patients and clinicians about mAb therapy applications, availability of improved drugs, the use of therapeutic antibodies in cost-sensitive markets, and fast acceptance of innovative therapies regulators. Furthermore, fast approvals of groundbreaking mAbs' are expected for a high adoption rate. For instance, the industry will be further bolstered by popular medications like Herceptin, Avastin, Rituxan, and Remicade based on FDA clearance. Besides, numerous mAbs awaiting therapeutic approval are undergoing clinical trials, and therefore the rising drug pipeline is projected to provide this sector with potential growth opportunities.

CUSABIO introduces 45 superior quality human monoclonal antibodies that had been effectively applied in immunohistochemistry with pathological samples for cancer research. Furthermore, as of 31 December 2017, 10 monoclonal antibody drugs were approved globally by the FDA and EMA. The overall number of monoclonal antibody drugs (including drugs withdrawn after approval for different reasons, except Fc fusion protein) exceeded 73. In the research process, innovative ventures are increasingly going forward with ambitious targets and new trial evidence approaches that will accept broader promise for monoclonal antibody drugs.

Regional Analysis

The regional analysis has been made considering the cancer biologics trends in North America, Europe, Asia-Pacific, South America, the Middle East, and Africa.

The below-mentioned info-graph depicts the estimated market share for the regions in 2019:

North America dominated the oncology biologics market with a value of USD 18,785.72 million in 2019 and is estimated to grow at 6.9% CAGR. As per the Cancer Atlas, in 2018, approximately 1.9 million novel cancer cases and 693,000 cancer deaths were assessed to have occurred in North America. The growth is primarily due to well developed and technologically advanced healthcare infrastructure and well-regulated policies. Rising government initiatives and surging research and development activities in cancer biologics accelerating new biologics and abundance of pharmaceutical and biotechnology firms in this region fosters the regional market growth. The trend towards developing fully-humanized monoclonal antibodies is predicted to increase, attributing to a perceived low level. About 70% of breast cancer cases, 55% of colorectal cancer cases are treated with biologics.

India's increasing biologic industry is the key driver of expansion, with respondents citing 'India's increasing domestic demand, bio-investment, and potential for expanded exports to developed markets. India has more than 95 licensed domestic biosimilars and market penetration, which is currently relatively small and projected to rise rapidly in the future. The biosimilar pipeline in India is also robust, mainly influenced by the Indian government's initiative to offer incentives to Indian biosimilar producers and the expiry of current biological patents and India's Central Drugs Regulation ConStandard Control Organization aligning guidelines closely with global regulators including the U.S. FDA, MHRA, and others. Recent reports indicate that more than 40 biosimilars were in the clinical development stage in India. In China, 20 to 25 %of newly diagnosed breast cancer patients are treated with biologics.

Competitive Landscape

Key Market Players

  1. Hoffmann-La Roche Ltd, Novartis AG, Eli Lilly and Company, Sanofi, CELGENE CORPORATION, Pfizer Inc., Bayer AG, Johnson and Johnson Services, Inc., Bristol-Myers Squibb Company, Merck & Co., Inc., and Amgen Inc.

Recent Developments

  • In December 2019, Biocon and its partner Mylan collaboratively launched a cancer drug Ogivri, a biosimilar to Herceptin, in the U.S. The drug is available in a 420mg multi-dose vial and a 150mg single-dose vial to treat all types of breast cancer and metastatic stomach cancer.
  • In November 2018, Roche and Abbvie received FDA approval for Venclexta, a BCL-2 inhibitor effective in treating leukemia. Venclexta is jointly commercialized by Abbvie and Genetech, a part of Roche.

Global Cancer Biologics Market: Market Segmentation

  • By Type
    • Monoclonal Antibodies
    • Growth Factor
    • Blood & Blood Products
    • Vaccines & Toxoids
    • Others
  • By Regions
    • North America
    • Europe
    • Asia-Pacific
    • Central andSouth America and the Caribbean
    • The Middle-East and Africa