How to Start A Hormone Replacement Therapy (HRT) Company (Step-by-Step Guide)

Starting a Hormone Replacement Therapy (HRT) company is one of the most exciting opportunities in healthcare right now. Why? Demand is booming—and the market is still underserved.

More people than ever are seeking HRT to help manage symptoms of hormone imbalance. From aging men and women to younger adults managing chronic fatigue, low libido, or mood disorders, interest is growing across all demographics.

A steady market increase, with some expecting the HRT market to nearly double by 2033, signals expanded use of HRT for menopause, andropause, and other hormone conditions, due to greater patient and clinician awareness as well as improved access. Between 2018 and 2022, usage of hormone therapies increased substantially across both male and female populations, especially among adults in their 30s to 50s.

What is Hormone Replacement Therapy (HRT)?

Hormone Replacement Therapy (HRT) is a medical treatment that replenishes hormones the body no longer produces in sufficient amounts. While testosterone replacement is a form of HRT often prescribed to men, HRT also includes estrogen and progesterone therapies commonly prescribed to women—especially during perimenopause and menopause.

HRT can help manage symptoms like:

• Low sex drive

• Fatigue and low energy

• Mood swings or depression

• Weight gain and muscle loss

• Brain fog and sleep issues

• Hot flashes or night sweats

• Vaginal dryness or erectile dysfunction

Your HRT business can serve men, women, or both depending on your niche, brand, and expertise.

What Type of HRT Company Should You Start?

We’ll run through the pros and cons of the different types of business models you might consider when starting an HRT company.

Start a Telehealth HRT Brand

Pros:

• Fully virtual with low overhead

• Fast time to market

• Nationwide reach

• Discreet and convenient for sensitive health concerns

• Can partner with a white-label telehealth provider to manage clinician visits, labs, fulfillment, and compliance

Cons:

• Digital marketing is essential for customer acquisition

• Some patients may prefer in-person consults or lab draws

Start a Brick-and-Mortar HRT Clinic

Pros:

• Appeals to patients who prefer face-to-face interactions

• May allow faster lab turnaround or in-office procedures

• Great for building strong community presence

Cons:

• High fixed costs (rent, staff, equipment)

• Limited to a local audience

• Slower time to market

Start a Hybrid HRT Practice

Pros:

• Combines the best of both models

• Lets you scale with telehealth while building local loyalty

• Provides flexibility for complex or sensitive cases

Cons:

• Involves managing both digital and in-person infrastructure

• More operational complexity

How Much Can You Earn with an HRT Company?

HRT businesses can be highly profitable thanks to:

• High demand

• Recurring revenue (subscriptions)

• Strong margins on specialty medications

• High LTV (lifetime value) when cross-selling

Key revenue drivers:

• Are you targeting a valuable niche like aging executives or perimenopausal women?

• Are you cross-selling GLP-1s, ED meds, or supplements?

• Are you using a subscription model to stabilize cash flow?

• Are you outsourcing or managing your own clinicians and support?

These are all things to keep in mind if you want to build a company that drive revenue and exceeds ROI targets.

HRT Market Growth (2019–2025)

Data aggregated from multiple sources including:

PharmiWeb, Strategic Market Research, Million Insights, NovaOne Advisor, Market.us, Fortune Business Insights, Fact.MR, Grand View Research, and Future Market Insights.

These sources provide historical data, market forecasts, and CAGR figures for the global hormone replacement therapy (HRT) market from 2019–2025 and beyond.

Legal & Compliance Considerations for HRT

While not all HRT medications are controlled substances, testosterone is a Schedule III controlled drug and DEA compliance is required.

Must-dos:

• Partner with state-licensed prescribers (MDs or NPs)

• Comply with the Ryan Haight Act (some states require in-person visits)

• Use DEA-registered pharmacies for controlled HRT meds

• Ensure HIPAA compliance

• Know each state’s telehealth laws

• Avoid non-compliant advertising—especially for sensitive health topics

• Consult with experienced legal counsel to ensure compliance with applicable laws and regulations.

What Tech Do You Need to Launch Your HRT Brand?

The right tech is essential wether your building out a virutal HRT brand or brick-and-mortar HRT clinic. Here are some of the most important layers of your tech stack::

• A conversion-optimized website (try Webflow or WordPress)

• Clinical intake forms with logic for screening

• EHR system to manage patient records

• SMS/email automation for appointment reminders, education, renewals

• Secure patient messaging platform

Pro Tip: Work with a white-label provider like OpenLoop to shortcut setup time and reduce tech and compliance overhead.

Build Your HRT Brand Strategically

As Meredith Hill said:

HRT isn’t one-size-fits-all. Define your target audience clearly. Who do you understand best? Who are you passionate about helping?

Some segments to consider:

• Men 35–60 managing low testosterone

• Women 40–55 navigating perimenopause

• Postmenopausal Women 56+ with common use cases for bone health, cognitive ability protection, and long-term quality of life improvements.

• Individuals interested in biohacking or maximizing their fitness

• LGBTQ+ communities looking for gender-affirming care

Also: consider avoiding boxing yourself in with testosterone or hormone heavy branding if you plan to add-on other products like GLP-1s, ED meds, or hair restoration later.

Go-To-Market Strategy for an HRT Company

Core Channels:

• SEO Content: Write helpful, educational content for terms like “Symptoms of low estrogen,” “How to know if I need HRT,” etc.

• Google Ads: Capture people actively searching for HRT help.

• Meta Ads (Facebook/Instagram): Great for storytelling,  testimonials, and brand building.

• Email/SMS Nurture: Many people need time to decide on HRT. Educate them over time and win the long game.

• Referral Programs: Reward existing patients for sharing with friends for a passive and low customer acquisition cost growth channel.

• Influencer/Creator Partnerships: Especially in women’s wellness or longevity.

Choosing a White-Label Telehealth Partner for HRT

If you’re going the virtual route or want to launch fast, partner with a trusted white-label telehealth provider. Here’s what to look for:

• Do they offer both men’s and women’s HRT?

• Can they support GLP-1s, ED meds, and hair loss treatments too?

• Do they have a large clinician network in all 50 states?

• Are they DEA-compliant for testosterone prescriptions?

• Do they offer 24/7 customer and patient support?

• Can they scale with your business?

Recommended: OpenLoop Health

HRT Startup Launch Checklist

Strategy & Planning

• Choose your model: Telehealth, Clinic, Hybrid

• Pick your niche and define your patient personas

• Perform keyword research and competitor analysis

• Plan your brand and long-term roadmap

Legal & Compliance

• Register your LLC/S-Corp

• Obtain NPI, licenses (or partner with those who have them)

• Ensure DEA & Ryan Haight Act compliance (for testosterone)

• Use HIPAA-compliant tech and vendors

 Clinical & Pharmacy Setup

• Decide: In-house vs. white-label providers

• Vet telehealth partners for reviews and scale

• Choose pharmacy fulfillment model (compounded vs. commercial)

Technology

• Launch a professional website

• Add HIPAA-compliant intake forms and workflows

• Set up an EHR, payments, and patient communication

Marketing

• Create educational content (blogs, videos, social)

• Launch Google and Meta ads

• Build email/SMS nurture sequences

• Run a referral or loyalty program

Operations & Finance

• Set pricing (bundled or à la carte)

• Forecast CAC, LTV, and breakeven

• Offer subscription plans for steady cash flow

• Plan for upsells like GLP-1s or wellness labs

Launch Your HRT Brand Faster with OpenLoop

OpenLoop is the leading white-label telehealth platform for HRT, with 20,000+ licensed clinicians and 500,000+ monthly patient visits.

From prescription compliance to EHR and fulfillment—we handle the back-end so you can focus on branding and growth.

Let’s build your HRT company together. Contact us today!

*This content is intended for general informational purposes only and should not be construed as legal advice. For guidance on your specific situation, please consult a licensed attorney.