Direct Answer
74 SEC filers are classified under the Standard Industrial Classification code that describes the gene therapy industry, and their latest annual reports show $92.6 billion of combined revenue and a median operating margin of -274.6%. Investors should still evaluate its revenue model, industry-specific KPIs, valuation framework and the risks that can change the group's economics.
Industry Overview
Gene therapy companies develop treatments that deliver functional genes into patients, usually with viral vectors, to treat inherited diseases. Approved products have very high prices, and manufacturing, durability and safety are the main questions. The first numbers to compare across companies here are patients treated and sales, durability of effect and manufacturing capacity and yield.
Key Industry Metrics
- Patients treated and sales: Number of patients dosed and revenue booked. Prices per patient are very high, so a small count can mean large sales, and timing can be lumpy.
- Durability of effect: How long benefit lasts after a single dose. Longer effect supports high prices and payer contracts, while waning benefit raises doubts about value.
- Manufacturing capacity and yield: How much vector can be produced and the share meeting quality standards. Shortfalls limit patients treated and raise cost.
- Cash runway: Months of spending covered by cash on hand. Small patient populations mean limited revenue, so runway determines how long programs can continue.
- Pipeline stage: Where candidates sit from early to late trials. Later stages are closer to approval, and a single success may support multiple indications.
Primary Macro Drivers
- Regulatory approvals: Each approval for a new disease or patient group opens a market, so regulatory decisions set expected sales and launch timing.
- Payer coverage and outcome-based contracts: Because treatments cost a lot once, payers use outcome-based or installment deals, which decide how many patients are treated and how revenue is recognized.
- Manufacturing progress: Viral vector production is hard to scale, so improved yields lower cost of goods and let more patients be treated.
- Funding: Companies with no product sales depend on investors, so funding conditions set how many programs continue.
Major Risks
- Safety events: Serious side effects such as liver injury can lead to trial holds or restricted labels; watch safety updates and regulator communications.
- Small patient populations: Rare disease populations are small, so sales per therapy are limited and patient finding is slow; watch patients treated and diagnosis rates.
- High cost of manufacturing: Complex production keeps cost of goods high, which holds down gross margin even at high prices; watch manufacturing yield and capacity.
- Funding constraints: Little cash forces cuts or dilutive offerings; watch cash runway and operating spend.
Industry Characteristics
| Characteristic | Profile |
|---|---|
| Cyclicality | Mixed |
| Capital Intensity | Medium |
| Regulatory Intensity | High |
| Industry Maturity | Emerging |
| Geographic Importance | U.S. / Global |
Gene Therapy Filers in the SEC Record
74 companies with annual reports in the dataset are classified by the SEC in the Standard Industrial Classification code 2836. Their latest fiscal years end between 2022 and 2026, and together they reported $92.6 billion of revenue. Median revenue growth over the prior year was 14.0%. Median operating margin was -274.6% and median net margin -212.3%. Median total liabilities were 39% of total assets, and 17 of 74 reported a profit in their latest year.
| Company | Revenue | Growth | Operating margin | Net margin | Year |
|---|---|---|---|---|---|
| Amgen Inc | $36.8 billion | 10.0% | 24.7% | 21.0% | FY 2025 |
| Gilead Sciences, Inc. | $29.4 billion | 2.4% | 34.0% | 28.9% | FY 2025 |
| Biogen Inc. | $9.9 billion | 2.2% | n/a | 13.1% | FY 2025 |
| Neurocrine Biosciences Inc | $2.9 billion | 21.4% | 21.6% | 16.7% | FY 2025 |
| Exelixis, Inc. | $2.3 billion | 7.0% | 37.6% | 33.7% | FY 2026 |
| Moderna, Inc. | $1.9 billion | -39.9% | -158.1% | -145.2% | FY 2025 |
| Halozyme Therapeutics, Inc. | $1.4 billion | 37.6% | 33.6% | 22.7% | FY 2025 |
| Bio-Techne Corp | $1.2 billion | 5.2% | 8.4% | 6.0% | FY 2025 |
The 8 largest of 74 by revenue. Source: each company's own annual report as filed with the SEC (XBRL data), figures in U.S. dollars. A company's SIC code reflects its main business as the SEC records it, so it can differ from how an index provider or analyst classifies the company, and a diversified group appears under only one code.
Where to Go Next
The Gene Therapy guide describes how the industry earns money, what to measure and what can go wrong. To see how it compares, read the neighbouring industries in the same sector, then apply the same checks to a specific company.
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Frequently Asked Questions
What are the main KPIs for the Gene Therapy industry?
Key performance indicators for the Gene Therapy industry include: Patients treated and sales, Durability of effect, Manufacturing capacity and yield, Cash runway, Pipeline stage. Which matter most depends on the company's model, so compare them across several companies rather than relying on one.
How cyclical is the Gene Therapy industry?
The Gene Therapy industry exhibits mixed cyclicality characteristics. Some segments move with the broader economy while others maintain more stable demand, making stock selection within the group particularly important.
What are the biggest risks in the Gene Therapy industry?
The primary risks for Gene Therapy companies include: Safety events, Small patient populations, High cost of manufacturing, Funding constraints. Investors should assess each company's exposure to these factors and its track record of navigating them.