Bioprocessing remains a strong growth driver for life science tools, bodes well for Repligen
While current sentiment is at “an all-time low” in the gene therapy market, Repligen Corporation (RGEN) is well-positioned to take advantage of its base-business revenue growth, according to analysts at Leerink Partners. The firm on Thursday issued an “outperform” rating for the Waltham, Massachusetts-headquartered life sciences company focused on bioprocessing technology.
In a Sept. 11 report, Leerink analysts flagged the fact that investors are worried about potential headwinds from cuts to adeno associated virus-based in vivo gene therapy programs in the wake of patient deaths tied to Sarepta Therapeutics’ Elevidys and other recent cancellations.
“We analyzed Biomedtracker clinical trials data to see if there are truly meaningful program cuts to AAV-related in-vivo gene therapies but found only a handful of program cuts,” the analysts wrote. “Despite the recent setbacks, many core AAV-based gene therapy programs remain active, and success with just a few could flip the sentiment to positive overnight. Importantly, we did not find evidence of recent large-scale exits from AAV development at Novartis, Biogen, or other major gene therapy players.”
For Repligen, the analysts said the implications “appear manageable” and that it is “highly unlikely that the existing revenue base is meaningfully eroded” given the “historical resilience of late-stage/commercial ramp in RGEN’s top 20 25 accounts.”
The report also addressed questions about alternating tangential flow (ATF) competition for Repligen, which the analysts concluded also appear to be “overblown” with potential threats from competitors Cytiva and Meissner described as “limited to not materializing” — while noting that there are “long adoption curves for new products in bioprocessing” and calling out Repligen’s “entrenched 500+ site installed base for ATF.”
The report addressed a “second major controversy” for Repligen related to its flagship ATF technology, which the analysts said has been the subject of debate over both market sizing and competitive threats.
“Earlier in the year, management commented that ATF could represent a $15M+ annual revenue opportunity for a single blockbuster biologic,” the analysts wrote. “While we agree that the $15M+ number appears to still overstate the opportunity for most ‘blockbuster’ drugs, we acknowledge that higher level modeling often understates the true number of ATFs deployed per program, the multi-site distribution of manufacturing, and the consumable intensity of perfusion campaigns.”
Manufacturing, bioprocessing recovery
The majority of Repligen’s manufacturing sites are in the U.S., with key facilities in Estonia, France, Germany, Ireland, the Netherlands, and Sweden, according to the company. Repligen customers are primarily biopharma drug developers and contract development and manufacturing organizations (CDMOs), with focus areas in filtration and fluid management, chromatography, process analytics, and proteins.
“Though it is hard to say when the sentiment for gene therapy turns, our analysis suggests that these issues are largely overblown for RGEN,” the analysts concluded. “There is little evidence of material AAV clinical program cuts and rising ATF competition.”
On a medium-term basis, the report sees Repligen’s order trajectory as consistent with the broader bioprocessing recovery. The analysts noted that bioprocessing has been the strongest growth driver across life science tools, outpacing all other end markets.
“In 2Q25, Thermo Fisher (TMO, OP) reported bioproduction revenue growth of 18% year over year with book-to-bill above 1x, a clear sign of continued recovery momentum,” according to the analysts. “Similarly, Merck KGaA (MKKGY, Not Rated) reported ongoing strength across its bioprocessing franchise.”
In late July, Repligen announced it entered a strategic partnership with Germany-based Novasign to integrate machine learning and modeling workflows into its filtration platforms. As part of the agreement, Repligen will invest in Novasign to help scale its operations.
The partnership will embed Novasign’s digital modeling capabilities into Repligen’s tangential flow filtration (TFF) systems, enabling process analytical technology (PAT) and future advanced AI-based process control. The goal is to accelerate development timelines, reduce costs, and enable real-time predictive control via digital twins, according to the companies.
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Greg Slabodkin
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As Editor in Chief, Greg oversees all aspects of planning, managing and producing the content for Pharma Manufacturing’s print magazines, website, digital products, and in-person events, as well as the daily operations of its editorial team.
For more than 20 years, Greg has covered the healthcare, life sciences, and medical device industries for several trade publications. He is the recipient of a Post-Newsweek Business Information Editorial Excellence Award for his news reporting and a Gold Award for Best Case Study from the American Society of Healthcare Publication Editors. In addition, Greg is a Healthcare Fellow from the Society for Advancing Business Editing and Writing.
When not covering the pharma manufacturing industry, he is an avid Buffalo Bills football fan, likes to kayak and plays guitar.