Biologics Market Statistics:  Analysis of Global Market: Information By Source, By Manufacturing, By Regional Analysis and Forecast Till 2030. The Global Biologics Market Size is expected to earn a whopping revenue figure of USD 505.9 billion by 2030, with an exceptional growth rate (CAGR) of 4.4% from the early revenue figures of USD 343.4 billion in 2021.

Market Overview

The market for biologics is developing rapidly as a result of corporations investing heavily in production facility upgrades. Biologics can be utilized in numerous ways to treat chronic diseases, which is projected to contribute to market expansion. These products are derived from a variety of organisms, such as bacteria, mammals, and transgenic plants and animals. The high proportion of microbial-based biologic manufacturing can be attributed to how simple it is to obtain microbial cell lines and how flexible and inexpensive it is to cultivate them. Numerous products, including monoclonal antibodies (MAbs), vaccines, recombinant proteins, antisense, RNAi, and molecular treatment, are available in the biologics market. MAbs are believed to hold the largest market share due to their effectiveness in a variety of therapeutic applications, including illness treatment and clinical research. On the basis of how MAbs are utilized in many areas of life science, these molecules are categorized as diagnostics, therapeutics, and protein purification, among others.

Market Drivers for the Global Biologics Market – 

The market for biologics is shaped by the commercial success obtained by biologics due to developments in biomedical sciences.

Previously, only a small handful of companies could handle the entire process of producing biologics. There are currently a large number of companies on the market that produce biologics, therefore this has evolved significantly over the past decade. In this discipline, new products such as nanobodies, rDNA, synthetic vaccines, fusion proteins, soluble receptors, immunoconjugates, and immunotherapeutics have been developed. Biologics have altered the treatment of diseases and provided researchers with several opportunities to investigate hybrid structures that mix biologics with well-defined chemical entities. Rapid advancements in biotechnology have contributed to the enormous success of biologics. Antibodies, coagulation proteins, fusion proteins, growth factors, interferon, liposomes, vaccines, cell/tissue treatments, enzymes, hormones, interleukins, and peptides are examples of biologics. Because biologics can interact with difficult-to-reach sites that small molecules have been able to avoid, this field is of interest to businesses. Additionally, the commercial potential of biologics appears to be quite promising, as these substances appear to be more beneficial to the economy as a whole than tiny molecules. In addition, the rate of loss of efficacy for biologics is lower than that of small molecules, making them easier to administer.

The most recent developments in the biomedical sciences are propelling the biologics market forward.

Biotechnology and biomedical science procedures are always improving, which has facilitated the production of biologics to treat a variety of chronic illnesses. With these modifications, scientists intended to gain a deeper understanding of how cell lines are created, how proteins are discovered and expressed, and how they may be utilized for engineering. Recently, several biotechnology techniques for producing self-adjuvant antigen-adjuvant fusion protein subunit vaccines have been discovered. Characterized platforms of new adjuvants are believed to aid in the creation of new vaccines. In addition, the usage of Nanosystems has increased in recent years because they help alleviate the delivery issues associated with the use of mRNA therapies to treat diseases.

Findings indicate that the FDA's emphasis on mandated upgrades presents both challenges and possibilities for companies producing and transferring production methods for biologics. The introduction of single-use and modular technologies, as well as the continuous processing strategy, assisted the sector in modernizing its outdated practices and mitigating the risks associated with making significant modifications to current systems. The usage of bioink, which enables the placement of biologics and other cells in a regulated pattern to create living tissues and organs, has also impacted the present rise of biologics. 

Continual conferences and workshops are also propelling the industry for the future and growth of biologics. For instance, in December 2015, the New Horizons in Biologics & Bioprocessing conference was held. There, individuals discussed enhancements, modifications, new developments, the current trend in biologics development, and additional aspects of bioprocessing and biologics development. Therefore, biomedical progress is essential to the expansion of biologics.

Restraints in the growth of the Global Biologics Market –

The development of biosimilars and the unexpected effects of biologics on the immune system, which can lead to infections, can be the most significant impediment to the market's expansion.

In recent years, the number of biologics whose patents have expired has increased. This has prompted a move toward the creation of biosimilars. Given a large number of biosimilars at various stages of development, the market for biologics is likely to experience a slowdown in the near future. Currently, over 160 biosimilars are in various phases of development. These biosimilars are comparable to the soon-to-be-patent-free best-selling biologics Remicade, Humira, Herceptin, Avastin, Rituxan/MabThera, and Enbrel. In recent years, the European Medicines Agency has approved biosimilars for infliximab. Due to the success of biosimilars, the growth of the biologics market is projected to decelerate during the next few years.

Biological therapy has altered the treatment of a number of chronic diseases. However, it is believed that these medications have unexpected effects on the immune system, which can lead to severe infections. Those who use biologics that inhibit the immune system from performing certain of its functions are more susceptible to opportunistic infections. This could make it more difficult for people to utilize biologic therapy, which would be detrimental to profits. Biologics that increase the risk of infectious disorders include MAbs, T and B cells, Antithymocyte Globulin (ATG), drugs that interfere with T-cell co-stimulation signals, and anticytokine treatments. 

Biologic response modifiers are also believed to increase the risk of serious and opportunistic infections, particularly mycobacterial and viral infections, in patients. Also, it is believed that these products play a vital part in the development of autoimmune disorders or tumours, which could moderate the market's growth to some extent.

Current Opportunities in the Global Biologics Market – 

Increased utilization of biologics products generates enormous market prospects.

During the projected period, the market for biologics is anticipated to expand by approximately 4.4% annually. Depending on how the items are currently utilized and how they are anticipated to grow in the future, some categories are anticipated to grow in a lucrative manner. Compared to other market sectors, the market penetration of MAbs is rather high. This substantial share can be explained by the variety of products in this category and the fact that market participants continue to spend money to enhance the efficacy of MAbs in various disease-treating modalities. On the other hand, it is anticipated that vaccinations will generate more revenue in the coming years as more funds are allocated to their improvement. In addition, there are partnerships and current research programmes that aim to create biological products such as recombinant proteins, antisense, RNAi, and molecular treatment, which have created an abundance of options.

Segmentation of the Global Biologics Market –

The global market for biologics is split by source and by manufacture.

The segmentation by the source is further subdivided into mammalian and microbial, with the microbial sector holding the largest market share.

Mammalian – 

The market value of the Mammalian category is projected to increase to USD 181.8 billion by 2030, at a CAGR of 4.4%, from its current level of USD 123.4 billion in 2021. The development of technology for producing mammalian cell lines is one of the primary factors driving this market. A technique based on multistep nonlinear particle swarm optimization was developed, for instance, to generate accurate models for mammalian cell culture and to overcome the challenges associated with generating MABs. This technique identifies kinetic factors that cannot be examined in a laboratory, which is why the microbiological section is the largest revenue generator.

Microbial – 

The Microbial market sector is valued at USD 199.2 billion in 2021 and is projected to reach USD 296 billion by 2030, expanding at a CAGR of 4.5%. This is mostly due to the fact that microbial populations are readily accessible and may be employed as recombinant cell factories to produce protein products such as recombinant insulin. Growth factors include platelet-derived growth factor, granulocyte-macrophage colony-stimulating factor, and recombinant interferon. In addition, the adaptability and low cost of cultivating microbial cell lines, particularly E. coli, have prompted numerous industry participants to utilize them to construct a robust biologics pipeline.

The segmentation by manufacturing is further subdivided into in-house and outsourced, with the in-house category winning the revenue generation race.

In-house – 

The market share of in-house segmentation in the aforementioned market domain is projected to reach USD 198.1 billion by 2030, a 2.7% CAGR. Some aspects of production, such as scaling up, formulation, and product and process development, are easier to regulate when biologics are manufactured in-house. This is anticipated to stimulate segment expansion. Numerous businesses collaborate with CMOs to develop cell lines and subsequently manufacture biologics internally. This is anticipated to aid in generating revenue for this area.

Outsourced – 

In 2021, the outsourced market sector is estimated to be worth USD 32.22 billion and is projected to reach USD 42.4 billion by 2030 at a CAGR of 3.1%. By outsourcing biologics production, pharmaceutical companies can save money and avoid purchasing costly equipment. This is likely to contribute to the segment's growth in the next years.

Regional Analysis of the Global Biologics Market – 

The Global Biologics Market is mainly divided into four regions, namely North America, Europe, Asia-Pacific, and Latin America, out of which the North American region has dominance over the global biologics market. 

North America – 

The North American market is estimated to increase at a CAGR of 3.8% from USD 246.9 billion in 2021 to USD 345.3 billion in 2030, representing the largest market share. The reason for the region's dominance is the exceptional growth rate of its healthcare institutions.

Europe – 

Europe is the second-leading region in the worldwide biologics market, with a market size of USD 56.9 billion in 2021 and expected to reach USD 85.4 billion by 2030 at a CAGR of 4.6%.

Asia-Pacific – 

Asia-Pacific comes third in this ranking, although its growth rate is the highest of all regions on the list. It has a market worth of USD 27.5 billion in 2021 and is projected to reach USD 56.5 billion by 2030, a phenomenal CAGR of 8.3%.

Latin America –

Latin America has the smallest market share, with a market value of USD 4.5 billion in 2021, and is projected to reach USD 6.9 billion by 2030, expanding at a CAGR of 4.8%.

Competition in the Global Biologics Market – 

The major competitors in the global biologics market are – Bristol-Myers Squibb Company, Merck KGaA, Novartis AG, Novo Nordisk A/S, Pfizer Inc., Johnson & Johnson Services Inc., Hoffmann La Roche Ltd, etc. 

Recent Developments by major competitors – 

• In March 2022, the European Medicines Agency approved Bristol Myers Squibb's proposal to use Opdivo (nivolumab) in combination with chemotherapy as a neoadjuvant treatment for resectable non-small cell lung cancer.
• In January 2022, Merck KGaA exhibited its latest technology developments for the electronics industry at CES and explained how it could be beneficial to the biologics division.
• In February 2022, Novartis India Limited entered into an exclusive sales and distribution arrangement with Dr. Reddy's Laboratories to expand the availability of its medications in India.
• In May 2022, Novo Nordisk and Flagship Pioneering announced that they would collaborate to develop a range of revolutionary pharmaceuticals.

Segmentation of the Global Biologics Market –

By Source – 

• Mammalian
• Microbial

By Manufacturing –

• In-house
• Outsourced

By Region – 

• North America
• Europe
• Asia-Pacific
• Latin America