Bio-Techne's New USP Deal on mAb and Gene Therapy May Boost Its Stock

Bio-Techne Corp. TECH has recently entered into a distribution agreement with the U.S. Pharmacopeia (“USP”) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards with its analytical solutions, including the Maurice system. The collaboration aims to support monoclonal antibody and gene therapy development around the world.

According to the president of Bio-Techne’s Protein Sciences segment, the development marks a significant milestone in advancing the company’s efforts to provide innovative tools and solutions to the scientific community. 

Predicting TECH Stock Movement After This News

Since the June 24 announcement, Bio-Techne shares dipped 0.1%, closing at $51.84 in Friday’s session. On a promising note, the partnership highlights the company’s commitment to supporting advancements in biotherapeutic development while maintaining the highest standards of quality and patient safety. Despite exceptional growth, gene therapy faces challenges in the development and commercialization processes, including low yields, scalability hurdles, high costs and analytical complexities. USP reference standards offer well-characterized benchmarks for analytical testing, ensuring accuracy, reliability, and regulatory compliance in product development and quality control. Accordingly, we expect the latest development to positively boost the market sentiment toward TECH stock.

Bio-Techne has a market capitalization of $8.13 billion. The company’s earnings yield of 3.6% compares favorably to the industry’s -28.4% yield. In the trailing four quarters, it delivered an average earnings surprise of 6.7%.  

More on Bio-Techne’s Newest Addition

More than 160 antibody therapies against nearly 100 targets and a range of diseases have been approved globally. Maintaining consistent mAb quality is essential for their efficacy. As mAb patent protections expire and biosimilar versions of these therapies become available, the need for consistency is becoming increasingly important. This leads to a greater need for manufacturers to thoroughly test critical quality attributes throughout mAb development and manufacturing processes to demonstrate product safety and effectiveness.

Both USP mAbs and AAV reference standards provide stringent materials that can be used with Bio-Techne's leading analytical instruments, such as the MauriceFlex system. By combining these standards with the company's rapid, easy-to-use and multi-functional analytics, therapy manufacturers can achieve reliable, efficient and integrated characterization for purity, charge, size and identity applications for complex biologics, from development through product release. Addressing biotherapeutics quality challenges is essential, and both USP and Bio-Techne have a long history of developing solutions to support mAbs and are applying their know-how to solving analytical challenges in AAV-based gene therapies.

Industry Prospects Favoring TECH

Per a research report, the global monoclonal antibody therapeutics market was valued at $222.6 billion in 2023 and is expected to grow at a compound annual rate of 14.5% through 2029. Advancements in biotechnology and genetic engineering are crucial in driving the market’s growth. With ongoing R&D efforts, monoclonal antibodies are being explored for a wider range of diseases beyond their traditional applications, creating growth opportunities in this market. 

More Updates From TECH’s Protein Sciences Arm

In March, Bio-Techne announced that it had begun shipping the Leo System, powered by Simple Western Technology. Leo builds on the capabilities of the existing Simple Western platforms by significantly improving sample throughput and enhancing the reproducibility of protein quantitation.

TECH Stock Price Performance

In the past three months, TECH shares have declined 11.6% compared with the industry’s fall of 2.7%.  

TECH’s Zacks Rank and Key Picks

Bio-Techne currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Phibro Animal Health PAHC, Boston Scientific BSX, and Hims & Hers Health HIMS. While Phibro Animal Health sports a Zacks Rank #1 (Strong Buy), Boston Scientific and Hims & Hers Health each carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Phibro Animal Health’s fiscal 2025 earnings per share have jumped 5.2% to $2.04 in the past 30 days. Shares of the company have rallied 50.6% in the past year compared with the industry’s 14.3% growth. Its earnings yield of 7.9% compares comfortably with the industry’s 0.2% yield. PAHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 30.6%.

Estimates for Boston Scientific’s 2025 earnings per share have remained constant at $2.91 in the past 90 days. Shares of the company have surged 39.4% in the past year compared with the industry’s growth of 14.3%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.8%. In the last reported quarter, it delivered an earnings surprise of 11.9%.

Hims & Hers Health shares have surged 130.6% in the past year. Estimates for the company’s 2025 earnings per share have jumped 17.7% to 73 cents in the past 30 days. HIMS’ earnings beat estimates twice in the trailing four quarters, matched in one and missed on another occasion, the average surprise being 19.6%. In the last reported quarter, it posted an earnings surprise of 66.7%.

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This article originally published on Zacks Investment Research (zacks.com).

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