The biopharmaceutical landscape is rapidly expanding at a CAGR of 12.5%, with its market value set to rise from USD 333.09 billion in 2022 to USD 856.1 billion by 2030. Biologics are spearheading this growth, and developments in AI are enabling rapid innovations in personalized medicine, transforming care for diseases like cancers, autoimmune disorders, and diabetes.

Why It Matters

The shift from traditional small molecule drugs towards biologics over the last decade marks a pivotal evolution in drug development. Biologics, encompassing therapies like monoclonal antibodies and antibody drug conjugates, are redefining treatment strategies, providing new groundbreaking options for patients battling complex conditions.

State of Play

Biologics have become central to the pharmaceutical industry’s drive for innovation. A significant increase in FDA approvals underscores their expanding role in modern medicine.

• In 2023 alone, biologics accounted for a massive 48% of all FDA approvals, reflecting their critical role in current medicine.
• Among these approvals were groundbreaking achievements, including the first CRISPR–Cas9 cell therapy and a multitude of new antibody-based drugs, with a considerable number aimed at combating cancer.

AI Aids Biologic

The complexity and high costs of designing and manufacturing biologics are being driven down by cutting-edge technologies like large language models and artificial intelligence (AI).

• AstraZeneca’s collaboration with U.S. AI biologics firm Absci aims to harness zero-shot generative AI models for pioneering antibody therapeutics, marking an ambitious leap toward innovative drug discovery.
• Adagene combines computational biology and artificial intelligence to create novel antibodies, overcoming safety and efficacy issues in cancer therapy.
• Evaxion Biotech uses AI to simulate the human immune system and generate predictive models to identify and develop personalized immunotherapies for patients.

By the Numbers

• Samsung Biologics showcased impressive growth in 2023, announcing a 23% increase in year-over-year earnings, achieving record revenues of $2.8 billion, and operating profits reaching $750 million across its biologics and biosimilars operations. The company has recently expanded its manufacturing agreements, securing contracts to produce biosimilar treatments across various therapeutic areas with 14 of the top 20 global pharmaceutical firms.
• AbbVie’s $223 million investment to enhance its biologics production facilities in Singapore signifies the pressing demand for greater global manufacturing capacity, reflecting the sector’s expansion efforts.
• Lonza’s announcement of record sales, primarily driven by biopharmaceuticals, further highlights biologics’ financial success and crucial contribution to the pharmaceutical industry, indicating a strong growth trend within the sector.
• Biocon Biologics’ merger with Viatris Biosimilars, valued at $3 billion, accelerates their push into the biosimilars market.

The Bottom Line

The biopharmaceutical and biologics landscape is set for remarkable growth, led by AI, enabling better drug design and maximizing manufacturing efficiency. This progress, underscored by a surge in FDA approvals and strategic industry collaborations, promises to enhance patient care significantly, heralding a new era of personalized medicine and significant investment opportunities.

Biosimilars Explained

A biosimilar is a biologic medication whose marketing approval is based on demonstrating a high degree of similarity to an FDA-approved reference biologic. A biosimilar and its reference biologic are associated with identical treatment advantages and risks. To learn the science, manufacturing technology, and regulatory requirements, check out our on-demand Biosimilars Primer microcourse.