Biologics Market Size, Share & Trends Analysis Report By Source (Microbial, Mammalian, Others), By Manufacturing (In-house, Outsourced ), By Product (Monoclonal Antibodies , Vaccines, Recombinant Proteins, Antisense & RNAi Therapeutics, Others), By Disease Category (Oncology, Infectious Diseases, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, Others), By Type (Tumor Necrosis Factor (TNF) Inhibitor, T-cell Inhibitor, Selective Co-stimulation Modulators, Interleukin-6 (IL-6) or Interleukin-17 Blocker, Interleukin-1 (IL-1) Blocker, B-cell Inhibitor), By Drug Class (Monoclonal Antibody, Recombinant Insulin, Vaccine, Blood Factor, Human Growth Hormone, Erythropoietin, Fusion Protein, Recombinant Enzyme, Interferon, Colony-stimulating Factor, Gene Therapy, Cell Therapy, Oligonucleotides, Peptide, Botulinum Toxin, Others), By Drug Type (Branded Drugs, Generic Drugs), By Mode of Purchase (Prescription Drugs, Over-the-counter (OTC) Drugs), By Dosage Form (Injection, Tablets, Others), By Route of Administration (Parenteral, Oral, Others), By End-Users (Hospitals, Specialty Clinics, Homecare, Others), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2022-2030

Market Overview

The global biologics market size is expected to grow to USD 506 billion by 2030 at a CAGR of 4% from the early figures of USD 343 billion in 2021.

The biologics market is growing steadily because companies are spending a lot of money to improve their manufacturing facilities. The market is also expected to grow because biologics can be used in many ways to treat chronic diseases. These products come from different types of living things, like bacteria, mammals, and transgenic plants and animals. The large share of microbial-based biologic production can be explained by how easy it is to get microbial cell lines and how flexible and cheap it is to grow them.

The biologics market has many products, such as monoclonal antibodies (MAbs), vaccines, recombinant proteins, antisense, RNAi, molecular therapy, and more. MAbs are thought to have the most significant share of the market because they work so well in a wide range of clinical applications, from treating diseases to clinical research. 

Based on how MAbs are used in different areas of life science, these molecules are put into groups such as diagnostics, therapy, protein purification, and others. These molecules are further divided into murine, chimeric, humanized, human, and other groups based on where they came from. Making biologics is an important part of making biologics as a whole and a big part of the market for biologics as a whole.

There are both in-house and outside activities that go into making biologics. The in-house method of making biologics is thought to make up a larger share since a number of companies on the market make these products on their own. Also, these companies continue to put money into growing their ability to make things.

Market Dynamics

Prominent Growth Drivers Influencing Biologics Market

• Commercial Success Achieved by Biologics with Advancements in the Biomedical Sciences Shaping the Biologics Market

Earlier, only a small number of companies were able to handle the whole process of making biologics. This has changed a lot in recent years, as there are now a lot of companies in the market that are making biologics. New products have been made in this field, such as nanobodies, rDNA, synthetic vaccines, fusion proteins, soluble receptors, immunoconjugates, and immunotherapeutics. Biologics have changed the way diseases are treated and given researchers many chances to look into hybrid structures that combine biologics with well-defined chemical entities.

Rapid changes in biotechnology have helped biologics become a huge success. Biologics include antibodies, coagulation proteins, fusion proteins, growth factors, interferon, liposomes, vaccines, cell/tissue therapies, enzymes, hormones, interleukins, peptides, and others. Companies are interested in this field because biologics can interact with hard-to-reach targets that small molecules have been able to avoid.

Also, the commercial potential of biologics seems to be very promising because these things seem to be better for the economy as a whole than small molecules. Also, the rate of loss of effectiveness of biologics is lower than that of small molecules, which makes them easier to use.

• Latest Advancements in the Biomedical Sciences Driving Biologics Market in the Direction of Progress

Biotechnology and biomedical science techniques are always getting better, which has made it much easier to make biologics to treat a number of long-term conditions. With these changes, scientists hoped to learn more about how cell lines are made, how proteins are identified and expressed, and how they can be used in engineering. In the past few years, several biotechnology methods for making self-adjuvanting antigen-adjuvant fusion protein subunit vaccines have been developed.

It is thought that characterized platforms of new adjuvants help with the development of new vaccines. Also, the use of Nanosystems has grown over the past few years because they help solve the delivery problems that come with using mRNA therapeutics to treat diseases.

Findings show that the FDA's focus on required updates creates both problems and opportunities for companies making biologics and working on scaling up and transferring production technologies. The development of single-use and modular technologies and the continuous processing approach helped the industry update its old methods and reduce the risks that come with making big changes to existing systems.

The use of bioink, which allows biologics and other cells to be placed in a controlled pattern to make living tissues and organs, has also affected the growth of biologics in the current situation. Ongoing conferences and workshops are also driving the market on the future of biologics and their development. For example, in December 2015, a conference called New Horizons in Biologics & Bioprocessing was held. There, people talked about improvements, changes, new developments, the current trend in biologics development, and other parts of bioprocessing and biologics development. So, biomedical progress is a key part of the growth of biologics.

Global Biologics Market Restraints

• Development of Biosimilars and the Unintended Effects of Biologics on the Immune Function that Lead to Infections can be the Major Barrier to Market Growth

The number of biologics whose patents have run out has gone up in recent years. This has led to a shift toward the development of biosimilars. The growth of the biologics market is likely to slow down in the near future because there are so many biosimilars in different stages of development.

More than 160 biosimilars are in different stages of development right now. These biosimilars are like the best-selling biologics like Remicade, Humira, Herceptin, Avastin, Rituxan/MabThera, and Enbrel, which will soon no longer be protected by patents. The European Medicines Agency has approved biosimilars for infliximab in the past few years. Thus, the biologics market growth is likely to slow down in the coming years because biosimilars are doing so well.

Biologic therapy has changed the way that a number of long-term diseases are treated. But these medicines are said to have unintended effects on the way the immune system works, which can lead to serious infections. People who are taking biologics that stop the immune system from doing some of its jobs are more likely to get opportunistic infections. This could make it harder for people to use biologic therapy, which would be bad for making money.

MAbs, T and B cells, Antithymocyte Globulin (ATG), agents that interfere with T-cell co-stimulation signals, and anti-cytokine therapies are all types of biologics that raise the risk of infectious diseases. Biologic response modifiers are also said to make patients more likely to get some serious and opportunistic infections, especially mycobacterial and viral infections. Also, these products are said to play a key role in the development of autoimmune diseases or cancers, which could slow the growth of the market to some degree.

Future Growth Opportunities in Global Biologics Market

• Increase in Use of Biologics Products Creating Huge Opportunities in the Said Market Domain

During the forecast period, the overall growth rate of the biologics market is expected to be about 4.4%. Depending on how the products are used now and how they are expected to grow in the future, some segments are expected to grow in a way that will be profitable. Compared to other market segments, MAbs are seen to have high market penetration in the current market.

This large share can be explained by the fact that there are a lot of different products in this category and that market players keep spending money to improve the effect of MAbs in different ways of treating disease. On the other hand, vaccines are expected to bring in more money in the coming years because more money is being spent on research and development to make them better. Also, there are partnerships and ongoing research projects that aim to make biological products like recombinant proteins, antisense, RNAi, molecular therapy, and other things, which have opened a wide window of opportunities.

Regional Analysis

The global biologics market is primarily segmented into four regions, namely North America, Europe, Asia-Pacific, and Latin America, where North America has a sheer dominance over the global biologics market. 

North America

The North American region has the major share of the market with figures of USD 247 billion in 2021 and is expected to grow to USD 345 billion in 2030 at a CAGR of 4%. The reason behind the dominance is the impeccable growth rate of the healthcare facilities in the region.

Europe

Europe is the second leading region in the global market for biologics, with a market value of USD 57 billion in 2021, and is anticipated to reach USD 85 billion by 2030 at a CAGR of 5%.

Asia-Pacific

Asia-Pacific ranks third in this list but has the highest growth rate among other regions in the list. It accounts for a market value of USD 27 billion in 2021 and reaching at USD 57 billion by 2030 at an amazing CAGR of 8%.

Latin America

Latin America has the least market share accounting for a market value of USD 5 billion in 2021, and is expected to grow to USD 7 billion in 2030 at a CAGR of 5%.

Segmental Analysis

The global biologics market share is segmented on the basis of source and manufacturing. 

The by-source segmentation is further divided into mammalian and microbial, where the microbial segment owes the major share of the market.

By Source

• Mammalian

The mammalian segment accounts for a market value of USD 123 billion in 2021 and is expected to grow to USD 182 billion by 2030, at an expected CAGR of 4%. One of the main things driving this segment is the improvement of technologies for making mammalian cell lines. For example, to make accurate models for mammalian cell culture and to solve the problems with making MABs, a technique based on multistep nonlinear particle swarm optimization was created. This technique finds kinetic parameters that cannot be tested in the lab, which is why the microbial segment is a dominant one in terms of revenue generation.

• Microbial

The microbial segmentation accounts for a market value of USD 199 billion in 2021 and is expected to grow to USD 296 billion by 2030 at a CAGR of 5%. This is mostly because microbial populations are easy to find and can be used as recombinant cell factories to make protein products, like recombinant insulin. Platelet-derived growth factor, granulocyte-macrophage colony-stimulating factor, and recombinant interferon are all types of growth factors. Also, the flexibility and low cost of growing microbial cell lines, especially E. coli, have led many market players to use them to build their robust biologics pipeline.

The manufacturing segmentation is further divided into in-house and outsourced, where the in-house segment wins the race of revenue generation.

By Manufacturing

• In-house

The in-house segmentation in the said market domain has a market share of USD 156 billion in 2021 and growing to USD 198 billion by 2030 at a CAGR of 3%. Some parts of production, like scaling up, formulation, and product and process development, are easier to control when biologics are made in-house. This is expected to boost the growth of the segment. Many companies work with CMOs to develop cell lines and then make biologics in-house. This is expected to help generate revenue in this segment.

• Outsourced

The outsourced segment accounts for a market value of USD 32 billion in 2021 and is expected to grow to USD 42 billion in 2030 at a CAGR of 3%. By outsourcing the production of biologics, pharmaceutical companies can save money and no longer have to buy expensive equipment. This is likely to boost the segment growth in the years to come.

Impact of covid-19

As the world moves into lockdown to halt the transmission of the COVID-19 virus, the uncertainty and constraints are hindering markets. Countries such as China, Italy, Australia, the United Kingdom, Canada, and the United States, among others, are the most affected. Thus, this may impact the global mining industry.

The ongoing spread and different responses to the COVID-19 are predicted to delay the existing mining projects. COVID-19's effect on the mining sector may take an extended period. For example, in Italy, one of the worst affected countries outside of China, the national lockdown has delayed various ongoing mining projects in-country. Alta Zinc suspended the manufacture of its flagship project, the Orno Mine Project, in the Lombardy region of Northern Italy.

Due to COVID-19-related regulations, major mining companies such as Rio Tinto and Anglo American, among others, have declared plans to scale back or close their operations. Following Mongolian government limitations, Rio Tinto's Oyu Tolgoi project in Mongolia ceased non-essential operations. Due to the Peruvian Government's proclamation of a 15-day quarantine to restrict the spread of COVID-19, Anglo American is temporarily demobilizing the majority of its extensive construction team at its Qullaveco copper mine in Peru. Hence, due to the lockdown in various countries, the consumption of mining chemicals is expected to decrease during 2020, which is likely to impact the market studied.

Recent Developments

• In March 2022, The European Medicines Agency approved Bristol Myers Squibb's request to use Opdivo (nivolumab) with chemotherapy as a neoadjuvant treatment for non-small cell lung cancer that can be removed.
• In January 2022, Merck KGaA presented its new technological advancements for the electronics industry at the CES show and discussed on how it can be assistive in the biologics department.
• In February 2022, Novartis India Limited signed an exclusive sales and distribution agreement with Dr. Reddy's Laboratories to make more of its medicines available in India.
• In May 2022, Novo Nordisk and Flagship Pioneering announced that they would work together to make a portfolio of medicines that would change the world.