Biologics Market Size, Share & Trends Analysis Report By Source (Microbial, Mammalian), By Products (Monoclonal Antibodies, Vaccines, Recombinant Proteins, Antisense, RNAi), By Disease Category, By Manufacturing, And Segment Forecasts, 2020 - 2025

Industry Insights

The global biologics market size was valued at USD 315.32 billion in 2019 and is expected to expand at a compound annual growth rate (CAGR) of 3.9% from 2020 to 2025. These products represent cutting-edge research and also enable the latest scientific discoveries. Such discoveries can be translated into novel therapies that provide new treatment options for patients.

Moreover, an increased understanding of the genetic and molecular basis of disease has opened up the development of a range of targeted treatments. For instance, recombinant proteins aid the immune system in the identification and binding of foreign substances.

Owing to the fact that small molecule drug R&D productivity is declining, biologics are expected to register lucrative growth in the coming years. Pharmaceutical companies are focusing on the development of several biopharmaceutical products in order to maintain the market position.

Improving efficacy from oral products for rheumatoid arthritis and Crohn’s disease is anticipated to pull more moderate patients to the novel and branded treatments. In addition, novel molecules provide options for treatment-experienced patients and often show superior safety and efficacy.

Advancements pertaining to the development of manufacturing capabilities are projected to boost biopharmaceutical production capacity. These advancements also include the use of single-use systems in the manufacture and processing of biopharmaceuticals.

Furthermore, scientists are engaged in the investigation of species and expression systems that can be more productive. The development of reagents and cell lines that enhance the productivity of the biological products is anticipated to fuel revenue generation.

Biologics Market Trends

Monoclonal antibodies are the most common biologic drugs that have been approved till now. However, novel biologic drugs such as nanobodies, synthetic vaccines, fusion proteins, antisense RNAi therapeutics, gene and cell therapy are currently under clinical trials. Presence of multiple such products in the clinical development pipeline and their subsequent approval is expected to drive market growth. For instance, the U.S. approval Tidvak, an antibody-drug conjugate, in September 2021, and the approval of Abecma, a cell based gene therapy in March 2021 is expected to drive market growth.

The enormous success of biologics has been aided by rapid advances in biotechnology. Rapid advancements in biotechnology, funding, government initiatives, and collaborations have contributed to the huge success of biologics. The new developments in the field antibody drug conjugates, immunotherapies, cell and gene therapies are further contributing to the growth of biologics market. For instance, in January 2021, Biocon Biologics received USD 75 million investment from Abu Dhabi based ADQ. Such investments are playing important role in advancement of biotechnology sector which is playing a big role to increase the biologics market.

Increasing prevalence chronic diseases is one of the major factors driving the global biologics market.  Some of the most common chronic diseases are cardiovascular diseases, cancer, respiratory diseases and diabetes amongst others. As per Globocan estimates, the incidence of cancer is expected to increase from 19.3 million in 2020 to 24.6 million in 2030. Additionally, the number of people living with diabetes is expected to increase to 587 million by 2030.

Continuous advancements in biotechnology and biomedical science techniques have dramatically enhanced the process of biologics development for management of several chronic conditions. The products have change from simple monoclonal antibodies to targeted drugs such as antibody-drug conjugates, radio-immunotherapies, and bispecific antibodies that can target multiple sites at the same time.

As multiple biologic drugs have lost patents and many more a set to lose patent protection during the forecast period, the entry of biosimilars is expected to act as a restraint for the growth of the market. As of 2021, there were around 65 biosimilar products approved in Europe and around 33 approved biosimilars in the U.S. The availability of biosimilars has led to savings of about USD 6.1 billion in Europe. Thus the approval and uptake of biosimilars during the forecast period is expected to restrain market growth.

Management of several chronic diseases has been revolutionized by the use of biologic therapy. However, these therapeutics are reported to have unintended effects on the immune function, leading to serious infections. There is an increase in the risk for a number of opportunistic infections in patients who are receiving biologics that inhibit certain immune system functions. This factor may hamper the adoption rate of biologic therapy, thereby affecting revenue generation negatively.

Source Insights

On the basis of the source used for the manufacturing of these biopharmaceuticals, they are categorized into mainly microbial, mammalian, with an addition of some other sources including transgenic models, avian, insect, and transgenic animals.

Microbial expression systems registered the largest revenue generation due to a substantial number of drugs generated by using these products. Microbial expression systems typically cover Escherichia Coli and yeast.

Products developed through these expression systems include recombinant insulin, platelet-derived growth factor, granulocyte-macrophage colony-stimulating factor, and recombinant interferon. Johnson & Johnson, Novartis, and Genentech are the companies implementing the usage of microbial systems.

Product Insights

Monoclonal antibodies (MABs) dominated the market with the largest revenue share due to higher usage of this category of drugs in different therapeutic areas. MABs allow targeting of unhealthy cells without harming the healthy cells.

Moreover, these drugs are particularly useful in cancer management, treatment of autoimmune diseases, including rheumatoid arthritis. Vaccines are anticipated to witness the fastest growth in the coming years owing to usage as a preventative tool in infectious diseases.

The development of a virus-based therapeutic vaccine is in the process of development for melanoma treatment. This is a genetically-modified product for in tumor cells and expresses a gene for an immune-stimulating protein.

Manufacturing Insights

Manufacturing is a part of the major steps of biologics production and comprises of a significant share of the biologics market. Mode of manufacturing is an important aspect to be considered, as it represents the outsourcing and in-house activities of the sector.

Companies are opting to manufacture than to purchase an entity or outsource the services. This has led to the larger share of in-house manufacturing for biologics. Companies are engaged in investing on own bioprocessing capabilities.

There are investments done by the CMOs for increasing the commercial biopharmaceutical manufacturing capacity. But, the value of the outsourcing contracts is comparatively lower than for the overall market and would be unable to drive sector growth as it does in the pharmaceutical market.

Disease Category Insights

Oncology accounted for the largest share as a consequence of the rising incidence of cancer coupled with the presence of different R&D projects. These projects include gene therapies and antisense therapies for cancer eradication.

Furthermore, oncology is anticipated to maintain its dominance over the forecast period. Drivers for the projected growth include the rising adoption of products in order to reduce the series of adverse events associated with the usage of cancer chemotherapy.

Regional Insights

North America biologics market accounted for the largest share of 73.54% in 2019 owing to the presence of major companies, favorable reimbursement policies, and high investment in R&D. Biologics accounts for around 38% of the total drug spending in the United States. Approval of new biologic drugs is expected to further drive market growth during the forecast period, for instance, in 2021, the U.S. FDA gave approval to 21 BLA’s. U.S market for biologics accounted for significant share in 2021 owing to rising R&D spending for the biologic development coupled with the presence of large number of FDA approved biologics in the country.

Germany accounts for the highest share in the Europe biologics market. The presence of advanced manufacturing sector, favourable reimbursement, availability of multiple approved drugs and target patient population are contributing to the dominance of this market in Europe.

Continuous efforts by the regulators, policy makers, and the pharmaceutical industry jointly to address both affordability and availability of biologics, especially mAbs, are anticipated to expand the Chinese market size of biologics in the coming years. One of the key drivers responsible for the growth of the Chinese biologic market is continuous proliferation of biologic developing plants in the country. For instance, in November 2021, WuXi Biologics announced the successful launch of GMP operations at it drug production facility in China. The 12,000 m² plant will manufacture around 60 million vials for commercial drug every year.

Competitive Insights

Major entities operating in this market include Eli Lilly & Company, Samsung Biologics, F Hoffman La Roche, Celltrion, Addgene, Amgen, Abbvie Inc., Sanofi, Pfizer Inc., Merck & Co. Inc, Novo Nordisk A/S, and Johnson & Johnson Services Inc.

The pharma-biotech market involves huge capital investment and is research-intensive in nature. This pronounces the innovator companies to safeguard their intellectual property rights through patenting in target markets.

Companies are embracing the trend of developing delivery devices in order to gain a competitive edge. A proactive approach to delivery technologies is poised to beat the expected growth of biosimilars and bio betters. 

Biologics Market Report Scope

Global Biologics Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest trends in each of the sub-segments from 2014 to 2025. For the purpose of this report, Grand View Research has segmented the global biologics market report on the basis of source, product, disease category, manufacturing, and region:

• Source Outlook (Revenue, USD Billion; 2014 - 2025)

  • Microbial

  • Mammalian

  • Others

• Product Outlook (Revenue, USD Billion; 2014 - 2025)

  • Monoclonal Antibodies

    • MABs by application

      • Diagnostic

        • Biochemical Analysis

        • Diagnostic Imaging

      • Therapeutic

        • Direct MAB Agents

        • Targeting MAB Agents

      • Protein Purification

      • Others

    • MABs by type

      • Murine

      • Chimeric

      • Humanized

      • Human

      • Others

  • Vaccines

  • Recombinant Proteins

  • Antisense, RNAi, & Molecular Therapy

  • Others

• Disease Category Outlook (Revenue, USD Billion; 2014 - 2025)

  • Oncology

    • By Product

      • MABs

      • Vaccines

      • Recombinant Proteins

      • Antisense, RNAi, & Molecular Therapy

      • Others (Certain products under trials related to blood products etc)

  • Infectious Diseases

    • By Product

      • Vaccines

      • MABs

      • Antisense, RNAi, & Molecular Therapy

      • Recombinant Proteins

      • Others

  • Immunological Disorders

  • Cardiovascular Disorders

  • Hematological Disorders

  • Others

• Biologics Manufacturing Outlook (Revenue, USD Billion; 2014 - 2025)

  • Outsourced

  • In-house

• Regional Outlook (Revenue, USD Billion; 2013 - 2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

  • Middle East and Africa (MEA)

    • South Africa