U.S.
The life sciences and healthcare industries have remained a major focus for government enforcers in the Trump administration. Agencies have continued to closely examine medical device and pharmaceuticals markets with a strong focus on innovation effects and potential entry.[1] That analysis is often challenging, as these markets are characterized by regulatory requirements, scarce and highly specialized human capital, complex intellectual property coverage, long and expensive product development cycles, development and manufacturing overlaps among product lines, and narrowly specialized products—not to mention potentially lifesaving impacts for patients.
Influenced in part by the Trump administration’s focus on healthcare costs[2] and in part by longstanding bipartisan emphasis on antitrust in healthcare industries, the federal agencies have also remained active in markets concerning the provision of care and its payment. As in other areas, state governments have sought to fill perceived gaps in federal enforcement through legislation, raising concerns about potential preemption and inconsistent rules across jurisdictions. In the coming year, we expect agency investigatory activity in life sciences to mature into further enforcement.
The Federal Trade Commission (FTC) challenged two mergers in life sciences in 2025: GTCR/Surmodics and Edwards/JenaValve. In the former, GTCR, a private equity firm with a majority stake in Biocoat (the second largest provider of hydrophilic coatings in the United States), sought to acquire Surmodics (the largest provider). The Biden administration had identified roll-up acquisitions from private equity buyers as high priority for enforcement,[3] but the Trump administration FTC’s complaint ignored that aspect of the case and alleged straightforwardly that the combined firm would have a greater than 50 percent share of the relevant market.[4]
The case is interesting for its settlement dynamics, in light of the agencies’ reversal of the Biden-era aversion to settlement in merger enforcement, and as another victory for merger defendants “litigating the fix.” The parties proposed to divest coating lines in response to the complaint, but the FTC argued that divestiture of a full standalone business unit was needed and that the proposed buyer (Integer) was inadequate due to prior failure to enter.
Nonetheless, GTCR ultimately executed the proposed remedy, and the court found the parties made a strong showing that the divestiture would resolve the FTC’s concerns and thus denied the FTC’s request for a preliminary injunction. FTC Chair Andrew Ferguson expressed displeasure before the decision that the parties had put the agency in an “annoying position” and vowed to evaluate ways to avoid similar situations going forward—though no concrete steps have yet been publicly announced.
The FTC also sued to enjoin Edwards Lifesciences’s acquisition of JenaValve on the grounds that it would eliminate head-to-head competition between the only two transcatheter aortic valve replacement devices for aortic-regurgitation patients (TAVR-AR devices) that have reached the clinical trials stage. The FTC claimed that the combined company would be incentivized to delay or discontinue one of the devices, reducing innovation and limiting patient choice. Edwards, on the other hand, argued the combination would bring a TAVR-AR device to the market faster. In January 2026, a court granted the FTC’s motion for a preliminary injunction, and the parties announced that they would abandon the deal. The FTC’s win here provides judicial validation for its potential competition theory of harm,[5] at least in markets where entry and innovation face substantial regulatory barriers.
In August 2025, the U.S. Department of Justice (DOJ) secured a settlement in a home health and hospice merger between United Health and Amedisys.[6] The Biden administration’s DOJ, along with the attorneys general of certain states, sued to block the merger in November 2024. In a clear showing of greater willingness settle merger cases, the Trump administration’s DOJ (together with the state attorneys general) announced a settlement in August that would divest over 100 facilities across 19 states. Reflecting continued concern for labor markets in the Trump administration, described further in our Labor Markets Preview, the deal also required divestiture of 1,800 employment contracts.
The antitrust agencies have in the last few years gathered extensive information about the pharmaceuticals industry. The FTC released interim reports from a 6(b) study on pharmacy benefits managers (PBMs) in July 2024 and January 2025. FTC Chair Ferguson stated a commitment to releasing a final report but has not yet done so. This year, per an Executive Order concerning drug pricing, the agencies jointly held three listening sessions covering a wide range of issues in the development, regulatory approval, and distribution of pharmaceuticals. The agencies were receptive to complainants, with the director for the Bureau of Competition describing the industry as “rife with misaligned incentives, dominant oligopolies, and market structures that are opaque by design.” The issues raised in these sessions will form the basis of a report of recommendations to the President, which we expect will guide agency enforcement in life sciences in this administration.[7]
The administration’s handling of an inherited enforcement action against PBMs is of particular interest. In September 2024, the FTC filed an administrative complaint against Caremark Rx, Express Scripts, OptumRx, and their affiliated group purchasing organizations. The FTC alleged that the PBMs created and maintained an anticompetitive system of rebates that drove higher list prices and higher patient costs for insulin and other drugs by using their power to favor certain high-priced drugs and to threaten manufacturers with formulary exclusion. The case remains active, with the FTC denying a motion to stay discovery in December 2025.
However, the Trump administration has proven willing to settle litigations initiated under the Biden administration, such as the United Health case described above,[8] and PBM defendants have reached a settlement in at least one state challenge related to PBM pricing and reimbursement policies. This at least raises the possibility that the administration may seek to leverage findings from the FTC and DOJ listening sessions, and the still unfinished FTC 6(b) study, to strike a deal to end the FTC’s PBM suit as well.
AI regulation has dominated headlines, but questions of the appropriate balance between state and federal authority have also arisen in legislation targeting the life sciences and healthcare industries. In 2019, California passed AB 824, which created a presumption that settlements whereby a brand compensated a generics manufacturer to withhold its drug from the market were anticompetitive and unlawful. Early in 2025, a federal court entered a permanent injunction against the law, finding that it violated the dormant commerce clause except as to agreements completed or entered within California. Both sides are appealing the ruling. In July 2025, a federal court temporarily blocked Arkansas Bill 624, which would prevent PBMs from owning pharmacies within the state, on the same basis. A December 2025 suit by the Texas Attorney General alleging that Epic has monopolized the electronic health records health industry under Texas law further underscores increasingly assertive state-level enforcement in this area.
Promoting innovation in life sciences and reducing healthcare costs are major Trump administration policy priorities that have strengthened the antitrust agencies’ focus on those markets. While the willingness of agency leadership to settle is evident in life sciences cases, the agencies have also shown a willingness to litigate where it deems settlement impossible or inadequate. The extensive information gathering efforts carried forward from the prior administration and initiated by the new one over the past year are likely to direct increased enforcement in the year ahead.
Europe and the UK
Across the Atlantic, both UK and European authorities continue to pay close attention to competition in the life sciences sector. With the EC continuing to focus on the pharmaceutical industry, and with key legal tests of its enforcement approach expected this year, there is continued scope for aggressive antitrust enforcement in the EU, which is only likely to strengthen if the EC’s decisions receive further judicial approval.
Notably, in November 2025 the French Autorité de la Concurrence fined Doctolib approximately €4.6 million (US $5.4 million) for abuse of a dominant position, including for: i) the historic acquisition of a competitor in the supply of digital medical services, Mon Docteur, finding that Doctolib’s strategic rationale for the transaction was the “elimination of a competitor”; ii) imposing exclusivity obligations on doctors; and iii) bundling together its digital booking services and its teleconsultation platform. Doctolib is appealing the decision before the Paris Court of Appeal.
This investigation and the fines in relation to the historic Mon Docteur acquisition reflect a broader European desire to review below-threshold mergers. A number of authorities[9] have either obtained or are pushing for new “call-in” powers to enable the review of below-threshold mergers that can be applied in innovation-driven transactions—including where the target is pre-revenue (as seen most notably in the Illumina/Grail case). European Commission (EC) officials have made clear in public comments that investigating below threshold mergers in the pharmaceutical space remains a priority, highlighting its ongoing engagement with national competition authorities to identify transactions that would merit a referral to the EC for an EU-wide review.
The EC has also concluded several high-profile investigations in the pharmaceutical sector in recent years, targeting allegations of cartel behavior (Alchem) and abusive conduct including combinations of disparagement, abusive regulatory practices, and excessive pricing (Teva Copaxone and Vifor Pharma). The EC is currently pursuing Zoetis for acquiring and subsequently terminating the development of a competing R&D project and, in September 2025, undertook dawn raids at Sanofi over potential exclusionary practices that may amount to anticompetitive disparagement in the seasonal influenza vaccine space. Issues of disparagement and the alleged abuse of the regulatory process are before the European Courts in Teva’s Copaxone appeal, the outcome of which will likely shape the approach to current and future investigations.
In the UK, the Competition and Markets Authority (CMA) has continued to defend its three landmark excessive pricing decisions in Liothyronine, Hydrocortisone, and Phenytoin II. The companies’ appeals in Liothyronine were dismissed by the Court of Appeal earlier this year with the CMA’s fines broadly being upheld, while the Court of Appeal is scheduled to hear the companies’ appeals in Phenytoin II and Hydrocortisone in Q1 and summer 2026, respectively. Both of these appeals focus heavily on the Competition Appeals Tribunal’s (CAT) novel approach to the test for excessive pricing, which substantially departs from the excessive pricing test laid down by the Court of Appeal in Phenytoin I. The cases also seek to challenge legal shortcomings, including the manner in which the CAT applied its novel test in practice, and the CAT’s failure to take into account its own findings of fact when applying the legal test for excessive pricing and, in the alternative, assessing the appropriateness of any fines.
While the CMA’s merger control enforcement has, in the context of innovation theories of harm, been primarily directed towards AI mergers, the CMA continues to monitor activity in the life sciences space and has tools to enable it to call in mergers involving pre-revenue targets. Nevertheless, on the direction of the UK Government, the CMA has pivoted to a more permissive, growth friendly approach to merger control, with a stated intention to play a more limited supporting role on global transactions where UK issues would be expected to be addressed as part of a global and/or European remedies package. In practice, therefore, dealmakers should anticipate engagement with the CMA to be less aggressive than in recent years. The CMA is slowly adopting a more permissive approach to behavioral remedies as well, which is of particular significance for life sciences deals where divestiture remedies are often not viable.
[1] Wilson Sonsini partners Michelle Hale and Matt McDonald have published a recent article detailing the treatment of potential competition in life sciences mergers.
[2] As one major example, the Trump administration issued in May 2025 an Executive Order directing most-favored pricing for prescription drugs. Antitrust agencies around the world are likely to closely scrutinize how firms comply with this order and investigate any possible collusion.
[3] Former Commissioners Rebecca Kelly Slaughter and Alvaro Bedoya issued a concurring statement on the GTCR/Surmodics complaint solely to highlight it as a problematic private equity roll-up, which they asserted was a “widespread and problematic playbook in our economy.”
[4] The Trump administration’s FTC has continued to litigate a roll-up case against USAP brought under the Biden administration that involves anesthesia services in Texas. The Biden administration’s FTC settled with a second defendant in January 2025, and then-Commissioner Ferguson’s concurring statement suggests that the Trump administration takes a neutral view of private equity involvement, neither targeting nor shying away from such cases.
[5] In 2023, Sanofi and Mazi had abandoned a transaction in face of a similar challenge but prior to an injunction ruling.
[6] Wilson Sonsini represented BrightSpring, a divestiture buyer in this case.
[7] The FTC has continued to challenge improper listings in the Orange Book as a competition violation. In May 2025, the agency renewed challenges to more than 200 patents.
[8] See also, for instance, the discussion of the RealPage litigation in our Algorithmic Pricing Preview. The administration has also shown willingness to resolve medication pricing disputes through dealmaking rather than litigation in other contexts, such as the settlement filed along with the complaint in a CVS pharmacy insulin overcharge case under the False Claims Act.
[9] Cyprus, Denmark, Hungary, Ireland, Italy, Latvia, Lithuania, Norway, Slovenia, and Sweden all have the power to call in below-threshold mergers with the Belgian, Dutch, Finnish, Czech, Greek, German, and French competition authorities all actively pursuing call-in powers.
