Plasma Trivia 🧩
In the United States, the current split between patients using intravenous immunoglobulin (IVIG) versus subcutaneous immunoglobulin (SCIG) for immunoglobulin replacement therapy is approximately:
A) 80% IVIG / 20% SCIG
B) 65% IVIG / 35% SCIG
C) 50% IVIG / 50% SCIG
D) 35% IVIG / 65% SCIG
Answer below.
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PLASMA MARKET WATCH
as of end of day Wednesday, March 25th, 2026
THE WEEK IN PLASMA
ADMA Biologics plunged 39.20% after short seller Culper Research released a report on March 24 alleging the company engaged in channel stuffing to inflate revenue growth. Meanwhile, Grifols jumped after announcing on March 24 that its board approved exploring a US IPO for its biopharma subsidiary, aiming to raise up to $5 billion by selling up to 20% of the division.
WHAT IT MEANS
ADMA's collapse reflects plasma industry vulnerability to inventory management allegations, with Culper claiming the company's reported 20% growth should have been a 3% decline without alleged channel stuffing. CSL's modest 0.96% gain amid broader selling demonstrates defensive positioning, with investors rotating into established players during market stress. Grifols' IPO announcement highlights the structural value of fully integrated US plasma operations, creating what would be the first self-sufficient plasma company covering collection through distribution without foreign inputs.
WHAT TO WATCH
ADMA's response statement on March 25 calling the allegations misleading sets up a credibility test for management's accounting practices. Grifols' IPO progress will depend on market conditions and regulatory approvals, with the potential $5 billion raise representing a significant test of US investor appetite for plasma pure-plays.
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MAIN TOPIC
The conventional read on plasma's supply picture in 2026 is broadly optimistic. Collection volumes have recovered from pandemic lows. Demand for intravenous immunoglobulin (IVIG) and other plasma-derived therapies continues to outpace available supply in most therapeutic categories.
What that read misses is a structural shift happening one layer below the public company disclosures, and a regulatory bottleneck forming quietly at its center.
The Shift in Collection
The large public operators have, to varying degrees, stepped back from aggressive U.S. center expansion.
CSL's FY2024 annual report shows 349 plasma collection centers across its global network, with strategic language now centered on throughput-per-center improvement through its RIKA plasmapheresis automation rollout. Grifols, managing a leveraged balance sheet through what it calls a "controlled growth" phase, has explicitly guided toward increasing collections per existing center rather than new U.S. openings. BioLife, Takeda's collection arm, is actively rationalizing its network, closing centers in Wyoming and West Virginia in recent months under a companywide "optimization" program.
ADMA Biologics (NASDAQ: ADMA) went further still. In December 2025, ADMA divested three collection centers for $12 million while simultaneously disclosing that approximately 85% of the raw material for its flagship product ASCENIV is now sourced from third-party collectors across a network of 280-plus centers.
That figure is the clearest single data point illustrating where the industry's collection growth responsibility has migrated: away from large vertically integrated manufacturers and toward a distributed ecosystem of smaller, independent operators working under long-term supply contracts.
Those operators are the ones opening new centers. And opening a new center is not simply a real estate and staffing exercise. It is a regulatory one.
How Licensing Actually Works
Under 21 CFR Part 640, Subpart G, source plasma may only ship in interstate commerce if the collecting establishment holds an active, unsuspended U.S. biologics license issued by CBER. Obtaining that license for a new center requires a prior approval supplement to an existing Biologics License Application (BLA) and an on-site pre-license inspection by trained CBER field investigators before any commercial shipments can begin.
Per the FDA's Compliance Program Guidance Manual, those inspections must be conducted by investigators who have completed specialized blood banking and plasmapheresis training. That makes them a credentialed, specific function, not a generic reviewer pool.
It is worth understanding precisely how this licensing pathway works, because the structure is unique to this industry. The first center an operator opens requires an original Biologics License Application (BLA). Every subsequent center is filed as a Prior Approval Supplement to that existing license, a less complex submission by design since the operator's core manufacturing and quality framework is already on file with FDA.
That distinction might suggest a faster path to approval for operators building out their networks. It does not provide one.
The Prescription Drug User Fee Act (PDUFA), the federal law that authorizes FDA to collect industry fees and sets enforceable review timelines for drug and biologic applications, does establish a 10-month standard review goal for prior approval supplements. But that framework includes a specific carve-out that most investors and analysts overlook. PDUFA explicitly exempts whole blood and blood components from its user fee and performance commitment structure. Source plasma collected for fractionation sits in that exempted category, meaning the supplements plasma operators file for each new center are not subject to the same accountability framework that governs novel drug and biologic reviews.
This exemption is not an inference. CBER's own SOPP 8401.2 states explicitly that non-PDUFA supplements are reviewed "adhering to performance goal timeframes as resources permit." That phrase is doing significant work. It means there is no statutory performance clock binding FDA to complete a pre-license inspection or issue an approval decision on a new source plasma collection center within any defined timeframe. No PDUFA date. No mandatory notice of delay. No legal remedy for an operator waiting on a scheduling decision.
For operators whose revenue from a new center is gated entirely on that approval, the timeline is a material business risk with no public reporting mechanism and no accountability framework.
The Baseline
Kamada Ltd. (NASDAQ: KMDA) offers the most granular publicly available window into what that timeline looks like in practice.
In September 2024, Kamada opened a new plasma collection center in Houston, Texas, disclosing it intended to submit a BLA supplement to the FDA in the first half of 2025. Kamada's own public guidance stated the company anticipated approval decisions "within 9-12 months of submissions." The Houston center received FDA approval in August 2025, following an on-site inspection in Q2 2025, tracking closely to the disclosed timeline.
Kamada then opened its San Antonio center in March 2025 as its third Texas facility, disclosing it would submit approval applications to the FDA in the second half of 2025, again citing the 9-12 month anticipated window. That places the expected approval somewhere in mid-to-late 2026, with $8-10 million in annual normal source plasma revenue contingent on it.
The Houston approval navigated FDA's pre-license inspection process under pre-2025 staffing conditions. The San Antonio submission landed in a materially different environment.
CBER's Staffing Picture
CBER lost 194 net staff in FY2025, the largest single-year headcount decline in the center's history. That staffing exposure is structurally different from other FDA centers. At CDER, approximately 70% of staff are funded through user fees and thus insulated from appropriations-driven cuts. At CBER, only approximately 49% of the workforce is user-fee funded, per FDA's FY2025 budget data. The remaining majority are appropriated-fund positions, precisely the category most exposed to the DOGE-era workforce reductions that swept HHS beginning in early 2025.
Whether those reductions affected the specific pool of trained blood establishment investigators has not been publicly disclosed by FDA. That silence is notable, because it is exactly the function on which smaller operators building new centers depend.
In April 2025, a former senior CBER official told BMO Capital Markets analysts that the impact of FDA staffing cuts on review capacity was expected to materialize as early as 2026 and 2027. That warning was directed at novel drug and biologic reviews, where PDUFA protections at least create an accountability structure. For blood establishment pre-license inspections, no equivalent protection exists.
What Investors Should Be Watching
There is no publicly available data on current FDA wait times for blood establishment pre-license inspections. There is no PDUFA-equivalent reporting requirement. There is no FDA performance dashboard for this function.
To be clear about what is and is not known: we are not aware of any documented delay at any specific plasma center to date. What exists is a convergence of verifiable facts worth tracking closely.
The collection growth edge has shifted toward smaller operators. Those operators face a hard regulatory gate with no statutory deadline. The CBER workforce managing that gate is at its lowest staffing level in years, with no public accounting of how that reduction has affected the specific inspection functions on which those operators depend. And the submissions now sitting in that queue, including Kamada's San Antonio center, were filed into a staffing environment that no longer resembles the one that approved Houston.
That gap between what the timeline was and what it may now be is not yet visible in any public data. That is precisely what makes it worth watching.
TOP 5 HEADLINES
Here's your plasma news roundup for the week of March 17–25, 2026 🩸
Grifols Parkinson's Research Uses Plasma Biomarkers to Detect Disease a Decade Early March 17, 2026 | 🇩🇰 Denmark / 🇪🇸 Spain | Grifols shared early data from its Chronos-PD program at the AD/PD 2026 conference in Copenhagen, showing molecular changes tied to Parkinson's disease can appear in blood plasma up to 12 years before symptoms emerge. The research is coming out of Alkahest, a Grifols subsidiary, leveraging a biobank of over 100 million plasma samples collected over 15 years. It's proof-of-concept stage, but it's a compelling demonstration of plasma's potential beyond traditional therapeutic uses.
Regina Grifols Clinic Found Violating Mandatory Donation Timing Rules March 20, 2026 | 🇨🇦 Canada | CBC's investigation widened further when Health Canada found that Grifols' Regina location had allowed donors to give plasma again before the required 48-hour waiting period had elapsed. After CBC News asked both Grifols and Health Canada to respond to the recent deaths, the company posted a policy change on its website saying that beginning March 9, a person needs at least 48 hours between consecutive donations. The Regina clinic remained open while the company implements what it calls corrective actions.
Grifols Unveils Plan to Spin Off U.S. Biopharma Unit in Nasdaq IPO Worth Up to $5B March 24–25, 2026 | 🇪🇸 Spain / 🇺🇸 USA | Grifols announced it is preparing to float up to 20% of its U.S. Biopharma business on Nasdaq, aiming to raise as much as $5 billion to pay down debt and fund strategic growth while retaining majority ownership. The sale of a minority stake would reinforce Grifols' self-sufficiency vision, making it the only U.S. player in the sector that does not depend on other markets. The move comes as the company tries to rebuild investor confidence after a turbulent couple of years marked by a short-seller attack and a failed Brookfield buyout attempt.
PPTA Publishes Policy Brief on Strengthening Global Plasma Supply — March 25, 2026 | 🌍 Global | The Plasma Protein Therapeutics Association published a new policy paper today making the case that government policy is the critical lever for fixing chronic plasma supply shortfalls worldwide, ahead of its International Plasma Protein Congress coming up April 28–29 in Milan. The paper arrives as the EU's immunoglobulin shortage remains ongoing, with current shortages expected to last at least until June 2026, a timeline that has already been pushed back since the first shortage notification in 2024.
Trivia Answer 🧩
C. Approximately 50% IVIG and 50% SCIG. While IVIG historically dominated, subcutaneous immunoglobulin has grown steadily since the FDA approved the first SCIG product in 2006. The split has now reached rough parity in the U.S., driven by SCIG's appeal for home self-administration, flexible scheduling, and the avoidance of IV access, making it particularly attractive for patients on long-term replacement therapy.
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Disclaimer: Liters is an independent research and analysis publication covering the plasma industry, published by Liters Inc. Liters Inc. also operates Bell Chime Capital, an investment platform focused on plasma-backed assets, so topics covered may occasionally overlap with areas of investment interest. Liters is not promotional and does not solicit capital or provide investment advice.