Biologics Market Size to Hit USD 204.50 Billion by 2034 | Boasting a 5.3% CAGR

According to latest report by Statifacts, the global Biologics market size was exhibited at USD 122.01 billion in 2024 and is projected to hit around USD 204.50 billion by 2034, growing at a CAGR of 5.3% during the forecast period 2024 to 2034.

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Rising burden of cancer, genetic diseases, and autoimmune diseases coupled with the approval of several disease-modifying therapies of these conditions are driving market growth. The development of personalized medicine and companion diagnostics further fuels growth of the market. These advancements allow for more targeted and effective treatments, which in turn increases the demand for biologic products.

As per Globocan, the incidence of cancer is projected to rise from 19.3 million in 2020 to 24.6 million in 2030. Moreover, autoimmune diseases are experiencing an annual increase in prevalence ranging from 3% to 9%. Additionally, there is a growing prevalence of neurological conditions such as Alzheimer's disease and Parkinson's disease. It is anticipated that the prevalence of Alzheimer's disease will reach 78 million in 2030 and by 2050, it will rise to 139 million. The development of disease-modifying therapies such as monoclonal antibodies for these conditions is driving the biologics industry.For instance, in January 2023, FDA approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer's disease. It reduces amyloid-β plaques and moderately slows mild cognitive decline in patients with early Alzheimer's disease.

In recent years, novel products such as gene therapy, RNAi therapies, mRNA-based vaccines have already been commercialized successfully. For instance, Pfizer's Comirnaty, an mRNA-based vaccine for Covid-19, which became the top-selling biologic in 2021 This achievement has paved the way for the development of mRNA-based vaccines targeting other diseases such as RSV and flu. For instance, in September 2022, Pfizer commenced phase 3 trials for its mRNA-base flu vaccine. These advancements highlight the expanding opportunities for mRNA-based vaccines in the medical field.

The approval of biosimilars is a key factor restraining the biologics market. 40 biosimilars have been approved by the U.S. FDA as of 2022. Due to the lower cost of biosimilars, governments encourage prescription and dispensing of biosimilars to reduce overall healthcare spending. For instance, biosimilars led to a saving of USD 7 billion in 2021, in the U.S.

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Biologics Outlook: Advanced research promises to bolster the future of medicine

Over the past decade, biologics have accounted for one-third of new medicine approvals

"Biologics" refer to a wide range of medicinal products such as blood or blood components, tissue, somatic cells, vaccines, recombinant therapeutic proteins, gene therapy manufactured from/comprising of living cells that are used as therapeutics to treat diseases. While chemical drugs are produced through chemical synthesis and mostly taken orally (as small molecules are easily absorbed in the body), biologics are made through complex biological processes and are mostly injected because proteins, which are large molecule substances, degrade in the stomach if administered orally. Due to their different molecular structure, chemical drugs are sometimes referred to as "small molecule" and biologics as "large molecule." These products have higher manufacturing costs, and therefore, higher drug prices.

First Generation versus Second Generation Biologics

Depending on the development period and the cell line used for the production, these products can be categorized into first generation and second generation biologics. First-generation biologics include insulins, growth hormones, and vaccines made from living cells, such as bacteria, yeast, and mold. Their cell culture and mass production are relatively easier, as they are produced using microbial cell lines.

Second-generation biologics are monoclonal antibodies and fusion proteins that are generated from animal cells in culture. These require relatively longer manufacturing processes, high costs, and high technology, because they can only be made with animal cells derived from mammals. Difference while using microbial and mammalian cell lines is that the latter require a post-translational protein modification system.

How AI impact the Biologics Market

Artificial Intelligence (AI) has emerged as a transformative force across industries, including the biologics market. Biologics, which include complex biomolecules such as monoclonal antibodies, vaccines, and cell and gene therapies, require intricate processes for development, production, and quality control. AI brings significant advancements in the following areas:

1. Drug Discovery and Development

• Target Identification: AI algorithms analyze biological data to identify potential therapeutic targets more efficiently. This reduces the time required for initial research.

• Molecular Design: AI-driven simulations predict the behavior of biologics, aiding in the design of molecules with optimized efficacy and safety profiles.

• Clinical Trial Optimization: AI helps in patient stratification, trial site selection, and predicting trial outcomes, leading to faster and more successful clinical trials.

2. Process Optimization

• Bioprocessing: AI-powered predictive analytics optimize upstream and downstream manufacturing processes, ensuring higher yields and lower costs.

• Automation: AI enables real-time monitoring and control of biomanufacturing, reducing human error and improving reproducibility.

• Supply Chain Management: AI enhances supply chain efficiency by forecasting demand, optimizing inventory, and minimizing waste.

3. Personalized Medicine

• AI processes large datasets of genomic and proteomic information to develop personalized biologic therapies tailored to individual patients.

• It assists in biomarker discovery, enabling targeted treatments with higher success rates.

4. Quality Assurance and Compliance

• Data Analytics: AI monitors production data to detect anomalies, ensuring consistent product quality and adherence to regulatory standards.

• Predictive Maintenance: AI models predict equipment failures, reducing downtime and ensuring uninterrupted production.

5. Market Trends and Strategy

• AI analyzes market data to identify trends, helping companies anticipate demand for specific biologic products.

• It supports pricing strategies and competitive intelligence.

6. Improving Accessibility

• By reducing the time and cost associated with biologic drug development, AI contributes to making these treatments more accessible to patients worldwide.

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Key Companies & Market Share Insights

Key strategies employed by key players include emphasizing R&D, launching new products, and strategic partnerships to expand their presence in different regions. For instance, in January 2023, the U.S. FDA approved Lecanemab through its accelerated approval pathway, specifically for the treatment of Alzheimer's Disease.

Furthermore, there is a significant focus on the establishment of new biologic manufacturing facilities by companies. In March 2023, Novartis revealed its division Sandoz's plan to invest approximately USD 400 million in the development of a biologics manufacturing facility located in Slovenia. Similarly, in March 2023, Eli Lilly announced its plan to invest an additional USD 500 million for the expansion of its existing 500,000 sq. ft. biologics manufacturing facility in Limerick. Notably, in January 2022, the company had initially announced an investment of USD 500 million for the development of the same facility. Some of the prominent players in the global biologics market include:

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
• Johnson & Johnson Services Inc.

Global Biologics Market Report Segmentation

By Type

• Monoclonal Antibodies
• Vaccines
• Recombinant Proteins
• Antisense
• RNAi

By Application

• Infectious Diseases
• Oncology
• Immunology
• Autoimmune Diseases

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• Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled

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