Biologics Market Size, Share, and Trends 2024 to 2034

Biologics Market Size and Companies

The global biologics market was estimated at US$ 348.03 billion in 2022 and it is expected to hit over US$ 620.31 billion by 2032 with a noteworthy CAGR of 6% from 2023 to 2032.

Key Takeaways

• North America contributed more than 44.37% in 2022.
• Asia Pacific region is projected to expand at the CAGR of 11.0% during the forecast period.
• By source, the microbial segment dominated the market with a share of 58.23% in 2022.
• By manufacturing, the in-house segment dominated the market with 84.87% share in 2022.
• By product, the monoclonal antibodies segment accounted for a share of 66.42% in 2022.

Growth Factors

Biologic is a substance made from live creatures or containing living organism components. Biologic medications are a general class of biotechnology derived pharmaceuticals originating from humans, microorganisms, and animals. Proteins that influence the activity of other proteins and cellular processes, genes that control the creation of critical proteins, modified human hormones, and cells that create substances that suppress or activate immune system components may all be found in biologic products. As biologic medications alter the way natural biologic intracellular and cellular processes work, they are sometimes referred to as biologic response modifiers.

The rise in the frequency and diagnosis of chronic diseases has demanded the availability of sophisticated diagnostics and treatment medications, which has fueled the worldwide biologics market. Biologics are drugs that have been genetically modified to target a particular portion of the immune system that causes inflammation. With the emergence of coronavirus diseases, governments in various countries are also taking steps to boost the healthcare industry and secure the supply of biologics. In addition, researchers and scientists are studying species and expression systems in order to improve the productivity of biological products. In addition, a number of pharmaceutical companies are conducting research and development to increase the efficacy of oral medications for arthritis.

Due to the fall in small molecule medication research and development productivity, biologics are expected to grow dramatically in the future years. The pharmaceutical companies are working on a variety of biologic medications in order to maintain their market dominance. When oral medications for Crohn’s diseases and rheumatoid arthritis improve in effectiveness, more moderate patients are predicted to move to branded and new therapies. In addition, new compounds offer therapeutic options for patients who have previously failed to respond to conventional treatments, and they frequently display higher protection and efficacy.

Biologics Market Scope

As processing capacity improves, biopharmaceutical production capacity is likely to rise. Another example of these innovations in the employment of single use technologies is the production and manufacturing of biopharmaceuticals. Furthermore, biologists are working on developing more efficient creatures and speech processes. The development of cell lines and reagents that improve the efficacy of biological products is predicted to drive revenue growth.

The prevalence of prevalent chronic disorders as well as some countries’ comprehensive healthcare finance plans are expected to play a key role in the growth of the global biologics market. Over the projection period, improvements in the healthcare organizations together with reforms in numerous nations are projected to reflect well for the biologics market. In addition, developments in the anti-inflammatory biologics industry are expected to grow during the forecast period.

The adoption of novel biological procedures by pharmaceutical corporate giants in order to speed up their manufacturing processes is expected to result in a wide range of drug versions. The biologics industry is predicted to grow in demand due to technological advancements and less health risks.

Manufacturing is one of the most essential steps in the biologics production process, accounting for a significant portion of the worldwide biologics industry. As it represents the sector’s outsourcing and in-house operations, the mode of production is an important element to investigate. Rather than acquiring or outsourcing services, businesses choose to create their own. As a result, the percentage of biologics produced in-house has increased. Businesses are putting money into their own bioprocessing equipment.

Biologics Market Dynamics

Market Drivers

Development of drugs for arthritis

The medical industry has a significant emphasis on the development of novel drugs and treatments. Drugs for treating rheumatic arthritis has gained a major attention in the industry, as arthritis has become one of the rapidly spreading chronic condition. According to an estimation, by 2040, 78.4 million adults will have doctor-diagnosed arthritis.

While conventional drugs such as painkillers and DMARDs are widely prescribed to control arthritis pain, they have not shown adequate results for the same. This factor brings a demand for efficient medicine for arthritis. Biologics are derived from living organisms and target specific components of the immune system that are involved in inflammatory processes. As biologics have started gaining acceptance among healthcare professionals, there has been an increase in their adoption for arthritis treatment. Moreover, the ongoing commitment towards the development of arthritis treatment promotes the growth of the market by acting as a driving factor.

Rising research and development activities

Research and development activities in the pharmaceutical and biotechnology industries lead to the discovery and development of new and innovative range of therapeutic options for numerous medical conditions that contain a wide range of biologics. Biologics can be designed to target specific molecular pathways and receptors, making them more precise and personalized in their therapeutic approach.

Additionally, research and development activities are being done for developing biosimilars, that are similar to the approved biologics drugs. Multiple research laboratories demand biologics for the comparison purpose during the development of biosimilars. All these elements associated with research and development activities act as a driver for the growth of the biologics market.

Market Restraints

Integration of biosimilars in the industry

Biosimilars are highly approved materials that are similar to biologics. Biosimilars are typically introduced at lower prices as compared to biologics, the rapidly expiring patents of biologics open a wide set of opportunities for biosimilars. The integration of biosimilars in the industry can lead to a reduction in the market share for biologics. The reduced profit margins for biologics are observed to shift the focus towards biosimilars. This element acts as a major restraint for the market.

High development cost

Biologic developers or manufacturers face challenges due to the high capital investment required for the development of biologics, the development of biologics is a lengthy and time-consuming process. It can take years from the initial investment to the market approval. This extended timeline increases the overall costs as it requires continuous clinical trials, research-based activities and manufacturing practices. This factor can limit manufacturers from entering into the business which hampers the growth of the market. Thereby, considered a restraint for the market.

Market Opportunity

Rising demand for personalized medicine

Personalized medicine often depends on the targeted therapies, such therapies are designed to address specific molecular targets in the human body. Personalized medicine also relies heavily on the identification of biomarkers. Biologics play a major role in the development of diagnostic tools such as biomarkers. This can help in diagnosing diseases. With personalized medicine, there is an increasing demand for customized treatments to meet specific needs of an individual. Biologics can be modified and engineered to fit these requirements which leads to more effective and patient-centric treatment options. Thus, the demand for personalized medicine is observed to create opportunities for the market.

Market Challenge

Regulatory hurdles

The biologics market is expanding, many players are investing in research and development on an international level. Whereas the lack of harmonization among regulatory agencies from different countries may create a challenge for the growth of the market. Moreover, certain uncertainties in the regulatory framework pose a challenge for the market. As biologics continue to advance, regulatory agencies may face uncertainty in defining appropriate regulatory pathways. All these factors including scientific and technological challenges hamper the growth of the market by limiting the entry of manufacturers as well as researchers.

Source Insights

In 2022, the microbial segment dominated the biologics market. Due to the vast number of pharmaceuticals produced by these products, microbial expression systems had the highest revenue generation. E. coli and yeast are commonly included in microbial expression systems.

The mammalian segment is predicted to develop at the quickest rate in the future years. Platelet derived growth factor, recombinant insulin, and recombinant interferon is some of the products that have been generated using these expression systems.

Product Insights

In 2022, the monoclonal antibodies (MABs) segment dominated the biologics market. Due to the increased use of this class of pharmaceuticals in several therapeutic areas, monoclonal antibodies dominated the market with the biggest revenue share. Monoclonal antibodies allow sick cells to be targeted without hurting good cells.  

The vaccines segment, on the other hand, is predicted to develop at the quickest rate in the future years. Due to its use as a prophylactic measure in infectious disorders, vaccines are expected to expand at the fastest rate in the next years.

Disease Insights

In 2022, the oncology segment dominated the biologics market. This is attributed to the increased incidence of cancer combined with the presence of many research and development programs.  

The cardiovascular diseases segment, on the other hand, is predicted to develop at the quickest rate in the future years. This is attributed to the rising prevalence of heart and blood vessel diseases.

Region Insights

North America dominated the biologics market in 2022. This is due to the presence of a number of well-established players in this region. Furthermore, a larger revenue share is attributable to higher demand for disease treatment items.

Asia-Pacific, on the other hand, is expected to develop at the fastest rate during the forecast period. The regional contract manufacturers have made a upsurge of large expenditures in order to get a foothold in the capital intensive business.

Key Developments

• Moderna Inc., announced in August 2021 that it had completed the rolling submission process for its Biologics License Application to the FDA for full licensure of the Moderna COVID-19 vaccine for active immunization to prevent COVID-19 in people aged 18 and up.
• Pfizer Inc. and BioNTech SE declared in August 2021 that they had started a supplemental Biologics License Application with the FDA for the approval of a booster dose of COMIRNATY to prevent COVID-19 in people aged 16 and up.
• As India’s biggest biosimilar maker increases its production to generate value to stakeholders ahead of an anticipated initial pubic offering, Biocon Biologics is in talks with ADQ, the Abu Dhabi government’s wealth fund, to advance capital.
• A South Korean business, Samsung Biologics has committed to work with Eli Lilly & Company on the development of a virus neutralizing antibody for the COVID-19 virus.
• In 2020, WuXi Biologics completed purchase of Bayer’s drug product manufacturing facility in Germany. WuXi Biologics’ first medication production facility in Europe was expected to increase the company’s commercial manufacturing capabilities.
• In October 2020, Cadila Pharmaceuticals released two similar biologics known as NuPTH and Cadalimab in the Indian market to increase its geographical reach.

Biologics Market Companies

• Eli Lilly & Company
• Samsung Biologics
• F Hoffman La Roche
• Celltrion Addgene
• Amgen
• Abbvie Inc.
• Sanofi
• Pfizer Inc.
• Merck & Co. Inc
• Novo Nordisk A/S

Segments Covered in the Report

By Source

• Microbial
• Mammalian
• Others

By Product

• Monoclonal Antibodies
  • Human mABs
  • Humanized mABs
  • Chimeric mABs
  • Murine mABs
• Vaccines
• RecombinantProteins
• Antisense, RNAi & molecular therapy
• Cell Based Therapies
  • Stem Cell Therapy
  • CAR-T Cell Therapy
  • Tissue Engineering
• Others

By Indication

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

By Manufacturing

• Outsourced
• In-house

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Geography

• North America
• U.S.
• Canada
• Europe
• U.K.
• Germany
• France
• Asia-Pacific
• China
• India
• Japan
• South Korea
• Malaysia
• Philippines
• Latin America
• Brazil
• Rest of Latin America
• Middle East & Africa (MEA)
• GCC
• North Africa
• South Africa
• Rest of the Middle East & Africa