CRB《Horizons：生命科学 2026》报告：400余家药企在监管不确定与成本上升中调整管线与产能投资

Life sciences manufacturers are continuing to invest in their product pipelines and manufacturing capabilities while exploring how advanced technologies can improve efficiency and support growth. At the same time, these investments are taking place amid regulatory uncertainty, geopolitical pressures, and rising costs.

Those are among the key findings of CRB’s Horizons: Life Sciences 2026 report, which draws on insights from more than 400 life sciences companies.

The report found that more companies are “starting, increasing or expanding their pipelines across every modality.” To support this, facility investments are focused not only on capacity, but also on flexibility, location, access to skilled workers, and reliable supply chains. Life sciences companies are also evaluating how emerging technologies like artificial intelligence (AI) and automation can fit into their new or existing workflows.

“Our findings show an industry that is remarkably willing to move forward despite some significant headwinds tied to the supply chain and the rising costs of getting therapies to patients quickly and safely,” said Peter Walters, CRB fellow for advanced Therapies at CRB and a co-author of the report. “Companies are investing in facilities, expanding into new modalities, adopting advanced technologies and developing new workforce strategies. The organizations that succeed will be the ones that can stay agile while building for the long term.”

Facility investments expand beyond established hubs

A key trend highlighted in the CRB report is where manufacturers are choosing to build new facilities, with 98% of respondents saying proximity to biopharma hubs is influencing facility location decisions.

Capital investments remain concentrated within mature corridors, according to the report, specifically North America’s east coast and the British Isles, which continue to attract large-scale projects. At the same time, multinational companies are diversifying their footprints into new regions, bringing manufacturing infrastructure and expertise that could encourage other businesses to follow, including smaller companies.

In the U.S., investment is also moving into nontraditional biopharma states such as Texas and Alabama. According to the report, companies are increasingly attracted to these regions due to their infrastructure availability and financial incentives, rather than if they have established talent pools. 

However, workforce availability remains a key consideration when establishing new facilities. Approximately 78% of respondents cited access to a skilled workforce as a top factor when choosing a new facility location. But what constitutes a skilled workforce is beginning to change as manufacturers introduce more advanced technologies, including automation and AI, into their processes. 

“Contrary to some reporting, we do not expect AI technologies to reduce the need for workers, but instead shift those needs,” according to the report. “These technologies may reduce some operator headcounts but exponentially multiply the need for highly technical mechatronics, maintenance and engineers.”

Differences in how companies are approaching investment is also highlighted. Large enterprises are leveraging mature operations, risk analysis capabilities, and financial resources to invest in automated facilities and digital infrastructure. Smaller and mid-size companies, meanwhile, are focusing capital expenditures on updated infrastructure, workforce availability, and baseline manufacturing efficiency as they work toward commercialization.

Those differences also shape how companies assess risk, with larger organizations being able to evaluate investments across multiple facilities and projects, while smaller companies may have fewer options for spreading costs or responding to setbacks. 

Despite regulatory and geopolitical uncertainty, including trade policy changes, tariffs and supply chain risks, companies are continuing to expand and diversify pipelines, with particularly strong momentum in peptides, cell and gene therapies, and antibody-drug conjugates (ADCs). 

Technology investments come with cost and complexity

CRB’s report also highlights the growing role of advanced technologies in facility planning as companies look for ways to support growth while managing production costs.

Approximately 68% of respondents expect AI, robotics, and automation to decrease their cost of goods. Automation is also the leading priority for modernizing existing facilities. 

But any potential savings must be weighed against upfront costs and the resources required to implement new systems.

“You’ve got not only the CapEx value of that automated system or that advanced technology, but then you’ve got the labor investment to create that system,” Walters said.

Not only do automation and robotics require significant spending, but these new technologies must also be evaluated and tested before being incorporated into existing operations and procedures. These steps can add time and cost, particularly when a project involves changes to a validated production environment.

Larger companies may be better positioned to absorb these costs and deploy new systems across their operations. However, smaller manufacturers with more limited capital often need to prioritize immediate infrastructure needs and production efficiency before making larger technology investments.

Facility design was highlighted in the report as another consideration for companies as they plan out their production needs. Respondents ranked flexibility as the third most important factor influencing new facility design after capital investment and efficiency and utilization in manufacturing. 

Rather than designing every space around a specific piece of equipment or process, manufacturers may leave room for future changes in production requirements. 

“Instead of designing around one specific bioreactor model, you create a space that can accommodate 10 different bioreactor models,” Walters said. “And that way, if a system goes to evolve and change in the future, you’re not having to change the infrastructure, you’re just moving something in and moving something out.” 

The report described a “defensive design inside the shell” approach, noting that leaving space unbuilt can provide options for future expansion and adaptation.

“Many owners will vastly underestimate the long-term value of leaving unbuilt shell space to allow facilities to grow and adapt,” according to the report. “Instead of viewing it as lower-value upfront cost, think of it as an investment that can pay off in multiple ways, offering a degree of flexibility that our survey respondents are often seeking years down the road.”

Companies upgrading facilities can also use any downtime to introduce digital technologies.

“An investment in digitalization, for example, is easier to justify when a facility shutdown is already in the plans,” according to the report.

AI adoption faces a trust gap in regulated manufacturing

While manufacturers see potential in AI and other advanced technologies, the report highlights a gap between expectations and adoption, particularly in regulated production environments.

Although advanced technologies are expected to reduce costs, confidence in AI drops for downstream current Good Manufacturing Practice (cGMP) settings. Concerns about accuracy, validation, and quality oversight are slowing implementation, with 43% of respondents saying they have no formal plans to use AI in cGMP. Additionally, fewer than 10% said they are scaling AI across clinical or commercial cGMP applications.

For now, administrative tasks were spotlighted as a leading area for AI adoption, potentially reaching 90% of respondents in the next three years. Meanwhile, large language models can help draft documents from regulatory filings, standard operating procedures (SOPs) and past deviations, with human review helping limit validation requirements. 

By comparison, only about a quarter of life sciences companies are currently testing AI in cGMP settings, though CRB projects adoption could reach 70% across a range of applications within three years.

The report said that live AI implementations should keep humans in the loop and accumulate robust audit trails so they can clear regulatory inspection when companies are truly confident to launch. 

“The tasks that are more routine, well-defined, repetitive, those can get handed over to machines and machine learning systems,” said Walters. “Key core decision-making capabilities probably still need to be in the hands of a competent human being who can oversee and make decisions on the fly.”