The global market for biologics contract manufacturing is forecast to grow substantially over the next decade as pharmaceutical and biotechnology companies seek additional production capacity and specialized manufacturing expertise. According to a new report from DataM Intelligence, the market was valued at $29.67 billion in 2025 and is projected to reach $110.05 billion by 2035, representing a compound annual growth rate (CAGR) of 14% from 2026 through 2035.

The report attributes the projected expansion to rising demand for biologic medicines, increased investment in biopharmaceutical research and development, and greater reliance on contract development and manufacturing organizations (CDMOs). As drug developers advance increasingly complex therapies, outsourcing partners are expanding their facilities, technologies, and service offerings to support development and commercial production.

Monoclonal antibodies remain a major driver of demand, accounting for 44.3% of the market by product type in 2024, according to the report. Other segments include recombinant proteins, cell and gene therapies, vaccines, and additional biologic products. Demand for these products is encouraging manufacturers to invest in scalable production systems and capabilities suited to a range of therapeutic modalities.

Manufacturing providers are broadening their offerings to accommodate more complex molecules, including bispecific and multispecific antibodies and antibody-drug conjugates (ADCs). In October 2026, Catalent introduced a U.S. program intended to manufacture complex biologics from gene sequence through drug substance production in 10 months, reflecting industry efforts to shorten development timelines.

Single-use bioreactors and modular manufacturing systems are also gaining traction. These technologies can offer greater production flexibility, reduce equipment cleaning requirements, and facilitate changeovers between products. In July 2026, Bora Biologics expanded its U.S. commercial manufacturing platform through the addition of a Rockville, Maryland, facility, bringing its installed single-use drug substance capacity to 20,000 liters across two FDA-registered facilities.

Manufacturers are also investing in domestic production to strengthen supply chain resilience and provide customers with access to commercial-scale capacity. Samsung Biologics completed its acquisition of GSK’s Rockville facility in March 2026, adding 60,000 liters of drug substance capacity and establishing its first U.S. manufacturing presence.

Long-term manufacturing agreements are another feature of the evolving market. These arrangements can help drug developers secure capacity as products move from clinical development toward commercialization. In July 2026, Lonza expanded a strategic collaboration with a U.S. biopharmaceutical company, adding two commercial biologics programs and options for two additional programs.

CDMOs are increasingly combining multiple stages of biologics production under one service offering. These services can include process development, drug substance manufacturing, analytical testing, sterile filling, and final product preparation, helping drug developers coordinate manufacturing activities across development phases.

In June 2026, Recipharm announced an investment in its U.S. sterile manufacturing operations to expand fill-and-finish capabilities for biologics and advanced therapies. Such investments reflect the need for manufacturing partners that can support both clinical supply and commercial production.

Despite favorable growth prospects, biologics manufacturing remains technically demanding. Complex processes, stringent regulatory expectations, and the need for consistent product quality can create operational challenges for both drug developers and their outsourcing partners. CDMOs must maintain robust quality systems while scaling production and accommodating different product requirements.

North America accounted for 46.3% of the biologics contract manufacturing market in 2024, according to DataM Intelligence. The region benefits from an established biotechnology sector, substantial pharmaceutical research and development activity, and an extensive network of contract manufacturing providers. Asia-Pacific is projected to record the highest CAGR during the forecast period. Investment in biopharmaceutical infrastructure, expanding manufacturing capacity, and broader access to biologic medicines are expected to support regional growth.

As biologics pipelines continue to develop and commercial demand increases, capacity expansion, strategic partnerships, and geographic diversification are expected to remain central to the sector. Providers that combine scalable manufacturing platforms, regulatory expertise, and reliable supply networks will be positioned to support drug developers seeking to bring complex biologic therapies to market.

For more information, visit www.datamintelligence.com.