Global Biologics Market By Product (MABs, Vaccines, Hormones), By Source (Microbial, Mammalian, and Others), By Disease (Oncology, Immunological Disorders), By Manufacturing (Outsourced and In-house), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies), By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2023-2032

Report Overview

The global biologics market size is expected to be worth around USD 893.83 Billion by 2032 from USD 382.81 Billion in 2022, growing at a CAGR of 9.10% during the forecast period from 2022 to 2032.

These products enable cutting-edge scientific research as well as the most recent scientific discoveries. Such discoveries can lead to new treatments for patients. It is possible to develop targeted treatments for certain diseases due to a better understanding of their genetic and molecular causes.

Recombinant proteins help the immune system identify and attach foreign substances. Biotechnology is expected to experience lucrative growth because of the declining productivity of small molecule drug R&D.

In order to keep their market position, pharmaceutical companies have begun to focus on the development of biopharmaceutical products. The increased efficacy of oral products for Crohn’s and rheumatoid disease and Crohn’s will likely attract more moderate patients to these branded and novel treatments.

The development of manufacturing capabilities is expected to increase biopharmaceutical production. These innovations also include the introduction of single-use systems to manufacture and process biopharmaceuticals. Researchers are also working to discover new species and expression systems. It is anticipated that revenue generation will be stimulated through the development of reagents, cell lines, and other means to increase productivity.

Market Scope

Source Analysis

The microbial Expression segment dominated the market

Based on the source of biopharmaceuticals they were manufactured from, they can be classified into mainly mammalian, microbial, and possibly other sources such as avian, insect, or transgenic animals. The largest revenue generation was achieved by Microbial Expression Systems due to the large number of drugs that are generated from these products.

Microbial expression systems usually cover Escherichia Coli as well as yeast. Products developed by these systems include recombinant insulin, granulocyte-macrophage colony-stimulating factor, platelet-derived growth factor,  and recombinant interferon. Companies that are implementing microbial systems include Novartis and Johnson & Johnson.

Product Analysis

The biologics market was dominated by the microbial sector in 2022

Microbial expression systems generated the most revenue due to the large number of pharmaceuticals they produce. Microbial expression systems often include yeast and E. coli. In the coming years, the mammalian segment will develop at the fastest rate.

These expression systems have produced platelet-derived growth factor, insulin recombinant, and interferon. The Monoclonal Antibody (MAB) segment was the dominant market for biologics. Monoclonal antibodies held the largest revenue share due to their increased use in multiple therapeutic areas.

Monoclonal antibodies can be used to target sick cells without harming healthy cells. On the other hand, the vaccines sector is expected to grow at the fastest rate in the coming years. Vaccines will expand rapidly because they are used as prophylactic measures in infectious diseases.

On the other hand, the cardiovascular diseases segment is expected to grow at the fastest rate in the coming years. This is due to an increase in the prevalence of blood vessels and heart diseases.

Disease Analysis

The oncology segment held the largest revenue share in the market

The largest share of R&D investments in oncology was due to the increasing incidence of cancer and the existence of various R&D projects. These include antisense and gene therapies for cancer eradication. Oncology will continue to dominate the biologics market during the forecast period. The projected growth is due to the increasing adoption of products that can reduce the adverse effects of chemotherapy for cancer.

Manufacturing Analysis

The manufacturing segment accounts large share of the biologics market

Manufacturing is an important step in biologics production. It also accounts for a large share of the market. The mode of manufacturing is important to consider since it represents both outsourcing and in-house activities. Many companies are choosing to make their own products rather than purchase an entity or outsource services.

This has resulted in a greater share of biologics manufacturing being done in-house. Companies invest in their own bioprocessing capabilities. CMOs can invest in increasing commercial biopharmaceutical manufacturing capabilities. However, outsourcing contracts have a lower value than the overall market. They would not be able to drive the same sector growth as the pharmaceutical market.

Distribution Channel Analysis

Hospital and online distribution channels will grow faster than all others.

Over the forecast period, this segment will continue to be a reliable source of revenue. Owing to the growing popularity of e-commerce platforms such as India and China, manufacturers are being forced to adapt their retail strategies to these emerging markets.

Key Market Segments

Based On Source 

• Microbial
• Mammalian
• Others

Based on Product 

• MABs
• Vaccines
• Hormones
• Therapeutic Enzymes
• Recombinant Proteins
• Antisense, RNAi & Molecular Therapy
• Blood Factors and Anticoagulants
• Allergenic extracts
• Human Cells and Tissues
• Proteins
• Gene Therapies
• Cellular Therapies
• Others

Based on Disease

• Oncology
• Immunological Disorders
• Cardiovascular Disorders
• Hematological Disorders
• Others

Based on Manufacturing

• Outsourced
• In-house

Based on Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

Market Dynamics

Drivers

Advancements in Biomedical Science to Fuel Market Growth 

Monoclonal antibodies have been the most widely approved biological drugs to date. Research is ongoing on novel biologic drugs like nanobodies, fusion proteins, and antisense RNAi therapeutics. Market growth will be driven by multiple such products currently in clinical development and their approval. Biologics market growth will be driven by, for example, the U.S. approval of Tidvak (an antibody-drug conjugate) in September 2021 and Abecma (a cell-based gene treatment) in March 2021.

Biotechnology’s rapid advancements have been instrumental in the immense success of biologics. The huge success of biologics has been made possible by rapid biotech advances, funding, government initiatives, and collaborations.

New developments in the fields of antibody-drug conjugates, immunotherapies, and cell and gene therapies are also contributing to the biologics market growth. Biocon Biologics, an Abu Dhabi-based company, received a US$ 75 million investment in January 2021. These investments are important in the advancement and growth of the biotechnology industry, which plays a major role in increasing the biologics market.

Growing Occurrence of Chronic Diseases Will Drive the Adoption of Biologics

One of the main drivers for the global biologics market is the increasing prevalence of chronic diseases. Some of the most common chronic conditions include diabetes, heart disease, cancer, respiratory disease, and asthma. Globocan estimates that the incidence rate of cancer will increase from 19.3 million in 2020 to 24.6 million in 2030. In addition, 587 million people with diabetes are expected to be living by 2030.

The process of developing biologics to manage chronic conditions has been greatly facilitated by continuous advances in biotechnology. The products have changed 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. In the United States, there were 33 approved biosimilars, and 65 in Europe. There have been savings of around USD 6.1 million in Europe due to the availability of biosimilars.

Restraints

Biosimilars are expected to increase competition for the early generation of biologics. 

This is because patent protection is ending for the early generation. Biosimilars are pharmaceuticals that have the same properties as biological drug that is already approved. Governments around the globe are encouraging biosimilars to increase healthcare costs. Since 2003, the EU has had a process for approval of biosimilar medicines.

These cheaper alternatives improve the biologics market’s competitiveness, which in turn reduces the market’s price and increases the market value, and restrain the market growth.

Market growth will be limited by the approval of and uptake of biosimilars over the forecast period. The use of biological therapy has revolutionized the treatment of many chronic illnesses. Biologic therapy can cause serious infections if it has unintended side effects.

Patients who are taking biologics that affect certain immune functions have a higher risk of contracting opportunistic diseases. This can negatively impact revenue generation by reducing the rate of adoption of biological therapy.

Opportunity

One area that is expected to see significant development is physiology simulation modeling.

This period will see continued market growth driven by technology. This area will see a rise in efficiency and benefit markets like this. Pfizer and Eli Lilly have used Amazon’s Elastic Compute Cloud platform (EC2) to run simulation models for early drug discovery.

These models were operational in hours, whereas traditional models took weeks. Lilly also launched the Open Innovation Drug Discovery program to improve the research and development of biologics. These technological advancements are likely to lower costs and speed up the development phase of biologics. This will allow companies to launch products earlier.

Trends

The rising prevalence and diagnosis of chronic illnesses have driven the global biologics market. This has necessitated the development of new diagnostics and treatments. Biologics can be genetically engineered so that they target the part of your immune system that causes inflammation.

Scientists and researchers are also examining the expression of species to improve the productivity and efficacy of biological products. Many pharmaceutical companies also engage in Research and Development (R&D), which aims to improve oral products for Crohn’s and rheumatoid disease.

COVID-19 Impact Analysis

The market was significantly affected by the COVID-19 pandemic. The market grew largely because of the high demand for biologics in the period following the pandemic.

In Canada, for example, CanSino Biologics, a CanSino Biologics based in China, and the National Research Council of Canada collaborated in May 2020 on the clinical development of a COVID-19 vaccination. The pandemic saw significant growth in the biologics market due to the extensive research and development that was done for COVID-19. The pandemic is over but the demand for biologics will continue to rise as it becomes more important for different therapeutics.

Major drivers of the market are growing capital investment by key players, the rising burden of chronic illnesses, loss of patent exclusivity for the top biologic drugs, and increasing demand and acceptance of innovative therapies. The WHO estimates that non-communicable diseases (NCDs), which account for 71% of total deaths, cause 41 million deaths annually. Between the ages of 30 and 69, more than 15 million people are affected by non-communicable diseases.

These “premature deaths” account for around 85% of all deaths in low- or middle-income countries. 77% of all deaths from non-communicable diseases occur in low- or middle-income countries. The leading cause of non-communicable disease deaths each year is cardiovascular disease (17.9 million), followed closely by cancer (9.3 million), respiratory diseases (4.21 million), and diabetes (1.55 million).

As chronic diseases become more common, the demand for biologics to treat chronic diseases will increase. The overall market growth has also been aided by the increasing number of investments. Biocon Ltd announced that its subsidiary Biocon Biologics Limited had approved an investment by ADQ in primary equity. ADQ is one of the largest Abu Dhabi holding companies.

The agreement stipulates that ADQ will invest INR 55 crore to acquire a 1.80% stake in Biocon Biologics’ biosimilar business. This will give Biocon Biologics a post-money value of USD 4.17 trillion. These investments will boost the market’s growth over the next few years.

The market is also supported by the increasing research and development in biologics. The University of Texas at Austin’s College of Natural Sciences, Cockrell School of Engineering, has launched the TXBio Pilot Grant program.

It focuses on early development, clinical translation, and discovery of biotherapeutics developed at UT Austin. TXBio (Texas Biologics), which is funded by philanthropic donations, is being used to improve the intellectual climate and infrastructure at UT Austin that are relevant to biological discovery and translation.

The biologics market growth will also be driven by product launches by key market players. Cadila Pharmaceuticals (Cadila), for instance, launched two similar biologics in India in October 2021. These were NuPTH, which is a teriparatide-based biologic, and Cadalimab which is a similar biologic to the auto-immune treatment, Adalimumab.

Amgen also reported in May 2021 that AstraZeneca, its partner, had submitted a Biologics License Application (BLA), to the US Food and Drug Administration for tezepelumab. This is a possible first-in-class treatment for severe asthma. The market is expected to grow in the next five years due to the factors mentioned above. The market’s growth will be impeded by strict regulatory processes, high capital investments, and the loss of patent exclusivity.

Regional Analysis

The North American biologics market was the largest Market. This is due to the presence and favorable reimbursement policies of large companies as well as high investment in R&D.

Market growth is expected to continue during the forecast period. For example, 21 BLAs were approved by the U.S. FDA in 2021. The U.S. market for biologics was a significant part of the global market in 2021, due to increased R&D spending and a large number of FDA-approved biologics.

Germany holds the largest share of the Europe biologics market. The biologics market is dominated by the European presence of an advanced manufacturing sector, favorable reimbursement, multiple approved drugs, and a target patient population.

The Chinese biologics market will grow in the future due to the ongoing efforts of regulators, policymakers, and the pharmaceutical sector to improve the affordability and accessibility of biologics. WuXi Biologics, for example, announced in November 2021 that it had launched GMP operations at its drug production facility in China. Each year, the 12,000 m 2plant will produce around 60 million vials of the commercial drug.

Key Regions

North America 

• The US
• Canada
• Mexico

Eastern Europe

• Russia
• Poland
• The Czech Republic
• Greece
• Rest of Eastern Europe

Western Europe

• Germany
• France
• The UK
• Spain
• Italy
• Portugal
• Ireland
• Austria
• Switzerland
• Benelux
• Nordic
• Rest of Western Europe

APAC

• China
• Japan
• South Korea
• India
• Australia & New Zealand
• Indonesia
• Malaysia
• Philippines
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Colombia
• Chile
• Argentina
• Costa Rica
• Rest of Latin America

Middle East & Africa

• Algeria
• Egypt
• Israel
• Kuwait
• Nigeria
• Saudi Arabia
• South Africa
• Turkey
• United Arab Emirates
• Rest of MEA

Market Share & Key Players Analysis

The Biologics market is dominated by major players such as Eli Lilly & Company and Samsung Biologics. F Hoffman La Roche, Celltrion and Celltrion are also involved.

The pharma-biotech industry requires large capital investments and is highly research-intensive. Innovators companies must protect their intellectual property rights by patenting in target markets.

To gain an edge in the marketplace, companies are adopting the trend of creating delivery devices. It is possible to take a proactive approach to delivery technologies and beat the expected growth in biosimilar, as well as bio betters.

Recent Developments

• February 2021: GlaxoSmithKline plc announced a new EUR150m collaboration with CureVac N.V., building on their existing relationship. The goal of the collaboration is to jointly develop next-generation mRNA vaccines (COVID-19) and to address evolving variants within a single vaccine.
• April 2021: BMS announced plans to construct a new manufacturing facility in the Netherlands for its cell therapy division.

Market Key Players

With the presence of many local and regional players, the market for Biologics is fragmented. Market players are subject to intense competition from top market players, particularly those with strong brand recognition and high distribution networks. To stay on top of the market, companies have gained various expansion strategies such as partnerships and product launches.

The following are some of the major players in the global Biologics industry: 

• Amgen Inc.
• F. Hoffmann-La Roche Ltd
• AbbVie Inc.
• AstraZeneca plc
• Merck KGaA
• Sanofi
• GlaxoSmithKline plc
• Johnson & Johnson
• Pfizer Inc.
• Novartis AG
• Eli Lilly and Company

Report Scope