Here’s How to Make a Go-to-Market Strategy in Biotech

Setting up a go-to-market (GTM) strategy consists of creating a concrete plan for introducing a new product or service to the market. GTM is typically one of the earliest steps you make when building your biotech company and is, ideally, based on strong market research. An amazing GTM should help you better manage complex regulatory environments, R&D investments, and stakeholder expectations. With these considerations in mind, let’s take a look at some tips on how to build and refine an evidence-based GTM strategy for your biotech company.

1. Learn About Your Industry

Biotechnology is the umbrella term for fairly different industries. As you probably know, building medical devices is quite different from building products for agricultural use. Given that each segment has specific characteristics and challenges, you (as in ‘the company’ will want to become well-versed in identifying them.

If, for example, are building biopharmaceutical products, you may need to prepare a GTM that could work well for products such as monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapies. You may even want to take a good look at recent improvements in specific areas and whether your company can make a contribution. One example of a recent trend in biopharmacy is the increased use of therapies based on monoclonal antibodies and biosimilars.

Another thing to care about is the implementation of strong Quality Management Systems adapted to your situation, such as regular audits, rigorous testing protocols, and adherence to Good Manufacturing Practices. By doing so, you should ensure that your biotech operates at the highest standards.

Your GTM strategy may need to be adapted to current trends. For example, if you work in the field of genetics, it’s likely you will not ignore the potential for CRISPR technology for personalized medicine and targeted therapies. Other trends that may be of relevance to you include the use of AI in predicting drug compounds or the use of bioprinting technology to create bioartificial organs.

While you may not always be able to correctly identify all the important challenges, there are a few areas that typically need to be carefully inspected when designing your GTM strategy. One such area is compliance, as there are important costs associated with demonstrating the safety of your products. For example, you may need to conduct extensive clinical trials to demonstrate product safety and efficacy, which would include trials with both direct expenses (e.g., conducting the trial) and indirect expenses (e.g., managing the data and preparing the regulatory submissions).

2. Get Ready to Meet Regulatory Demands

If you are building powerful products, you have to be ready to navigate complex regulatory systems. Your GTM strategy will need to prepare you for the oversight of multiple regulatory bodies, each with its own set of requirements and standards.

Here are some regulatory institutions you may need to familiarize yourself with:

• FDA (Food and Drug Administration): In the United States, the FDA oversees the safety and efficacy of drugs, biologics, and medical devices. The FDA’s approval process involves preclinical and clinical testing phases
• EMA (European Medicines Agency): In the European Union, the EMA plays a similar role to the FDA, evaluating medicinal products for human and veterinary use.
• EPA (Environmental Protection Agency) and USDA (U.S. Department of Agriculture): These agencies regulate genetically engineered plants, animals, and microorganisms.
• WHO (World Health Organization): On a global scale, the WHO sets standards and provides guidance on the development and evaluation of biotech products, helping harmonize regulatory practices worldwide​.

The regulatory approval process for biotech products typically involves several phases and your GTM plan may need to include sections that are specifically designed to prepare you for each phase, including preclinical testing, investigational new drug application, clinical trials (Phase 1, 2, and 3) and final submission.

To meet regulatory demands, it can be a good idea to engage frequently with regulatory bodies during your development timeline, scheduling regular consultations to align expectations and address potential issues proactively. When planning key roles in your team, consider including regulatory affairs professionals who can navigate complex requirements and streamline the approval process. Leverage data analytics and digital tools to continuously monitor regulatory changes and optimize your compliance strategies. These considerations should be reflected in your GTM strategy by establishing clear regulatory milestones, ensuring compliance readiness, and maintaining flexibility to adapt to regulatory updates.

3. Prepare to Meet the Demands of Your Target Market with Specific Goals

By the time you have finished conducting comprehensive market research, you should have a strong understanding of your customer needs and preferences. Sometimes you will want to adapt the GTM strategy to specific subgroups. If you need to perform  market segmentation, consider the following options:

• Demographic Segmentation: This classifies consumers based on attributes like age, gender, income level, education, and geographic location. For example, if you are developing a new diagnostic tool, you may have to focus on specific age groups or geographic areas with higher incidences of certain diseases​.
• Behavioral Segmentation: This classifies consumers based on their behavior regarding products or services, such as usage frequency, brand loyalty, and benefits sought. This approach helps in creating targeted marketing campaigns that address specific behaviors and needs​.
• Firmographic Segmentation: For business-to-business (B2B) marketing, firmographic segmentation classifies companies based on attributes like industry, size, and location. This is particularly relevant for biotech companies selling to other businesses, such as hospitals or research institutions​.

Based on your segmentation, you can adopt various marketing strategies to reach your target market. For example, mass marketing would typically be suitablefor products with broad appeal; this strategy involves a single campaign targeting the entire market. Differentiated marketing, on the other hand, is what you do when you want different campaigns for different segments. Another option is niche marketing, a strategy that you adopt when you wish to focus all efforts on a specific, underserved segment of the market. Finally, you can also adapt your strategy to micromarketing, which consists of targeting a very narrow segment with highly specific characteristics​.

4. Develop a Value Proposition

A value proposition succinctly communicates what makes your product or service worth attention. To craft an effective value proposition, start by thinking about how to best address your target customers and their needs. Gather insights through interviews, surveys, and market research to understand the specific problems your customers face and what they value most in a solution.

Your value proposition should clearly differentiate your product from others in the market. Consider the following:

Unique Selling Points (USPs): Identify what your product does better than anyone else. This could be superior performance, cost-effectiveness, or unique technological innovations.

Testability: Ensure your value proposition is testable and backed by data. For instance, if your biotech product promises higher accuracy or faster results, provide evidence to support these claims​.

Focus on the benefits your product offers rather than just the features. Clearly explain how your product solves a problem or improves the life of your customer. Highlight specific benefits such as improved patient outcomes, cost savings, or ease of use. Avoid hype and superlatives; instead, use concrete benefits supported by data​. Consider customizing your value proposition to address the needs of different stakeholders, such as consumers, healthcare providers, and investors. Each group may, at least to some extent, value different aspects of your product​.

Your value proposition should be short, clear, and compelling. It should answer the following questions:

1. What product are you offering?
2. Who should buy your product?
3. How does your product improve the customer’s life?
4. Why should the customer choose your product over competitors?

Keep the statement to two or three short sentences that convey the core benefits and differentiators of your product​.

5. Prepare for Product Development and Launch Strategy

Product lifecycle management (PLM) encompasses all stages from initial development through market introduction, growth, maturity, and eventual decline. Effective PLM ensures that every phase of the product’s life is optimized for efficiency, compliance, and market readiness. Things to consider:

• Initial Development: This phase involves extensive R&D. Innovative biotechs often leverage advanced technologies such as AI and machine learning (ML) to enhance their research capabilities and accelerate drug discovery and development​.
• Clinical Trials: Conducting clinical trials is how you gather data on safety and efficacy. These trials are typically divided into three phases, each designed to answer specific research questions about the new product.
• Intellectual Property (IP), Patent Application & Trademarks, and Copyrights: You want to do your best to securepatents, copyrights, and trademarks to safeguard innovations and R&D investments. Effective IP protection not only prevents unauthorized use but also enhances the product’s market value and attractiveness to investors. Biotech companies must file patents to protect their inventions, including new drugs, diagnostic tools, and biotechnological processes. Trademarks and copyrights are used to protect brand names, logos, and proprietary content.

A successful product launch requires a strategic approach that includes thorough market research, stakeholder engagement, and continuous performance monitoring. Your GTM plan should prepare you for:

• Stakeholder Engagement: Engage with key stakeholders early in the development process. This includes healthcare providers, patients, regulatory bodies, and payers. Building strong relationships with these stakeholders can facilitate smoother market entry and broader acceptance​. Start by identifying all potential stakeholders, including patients, healthcare providers, regulatory bodies, payers, and advocacy groups. Understand their roles, interests, and levels of influence on your project. For example, stakeholders in the biotechnology ecosystem can range from scientists and regulatory bodies to competitors and patient advocacy groups. Prioritize stakeholders based on their impact and influence. High-priority stakeholders are those who can significantly affect the project’s success, such as regulatory agencies and key opinion leaders in the medical field.
• Marketing and Promotion: Develop a comprehensive plan that includes digital and traditional channels. Utilize omnichannel strategies to create awareness and drive engagement
• Monitoring and Adaptation: Post-launch, continuously monitor product performance and market feedback. Use this data to make necessary adjustments to your marketing strategies and product offerings.

6. Prepare for Using AI and ML

As you might suspect, leveraging advanced technology is key to driving innovation and improving efficiency in the biotech industry. AI and ML enable companies to automate complex tasks, analyze vast datasets, and generate new insights at an unprecedented pace. For instance, AI is being used to speed up drug discovery by screening biomarkers and analyzing scientific literature to identify novel compounds. Companies like Insilico Medicine and XtalPi are leading the way in AI-driven drug discovery, significantly reducing development times and costs​.

The integration of big data and advanced analytics allows biotech firms to interpret large volumes of biological data, leading to faster innovation. This data-driven approach is particularly valuable in areas like genomics, where companies use analytics to understand genetic variations and develop personalized medicine. ​

Cloud computing and Software as a Service (SaaS) solutions provide scalable and cost-effective platforms for data storage, analysis, and sharing. Cloud-based solutions enhance data security, improve compliance, and facilitate real-time collaboration across geographically dispersed teams.

To incorporate AI and ML into the GTM plan, consider making the best of these technologies early in drug discovery and development to accelerate innovation and reduce costs. For example, where it applies, the GTM plan should highlight the use of big data analytics for interpreting large biological datasets; this is particularly the case in genomics for developing personalized medicine.

What Does a GTM Look Like?

Now that you know what to include in a GTM strategy, let’s take a look at a GTM example, to get a sense of how you can structure the plan which will guide the near future of your biotech company.

Executive Summary

This GTM strategy outlines the approach for launching a new therapy targeting a specific condition. The plan includes market research insights, regulatory strategies, marketing segmentation, value proposition development, product development stages, and the integration of advanced technologies like AI and ML.

1. Market Research and Industry Analysis

• Industry Understanding: Conduct comprehensive research to understand the biopharmaceutical ecosystem, focusing on the market for [intervention] and trends such as biosimilars and personalized medicine.
• Competitive Analysis: Identify key competitors, analyze their products, pricing strategies, market share, and positioning.
• Regulatory Environment: Study the regulatory requirements of the FDA, EMA, and other relevant bodies to understand approval pathways and compliance needs.

2. Regulatory Strategy

• Early Engagement: Schedule regular meetings with regulatory bodies (e.g., FDA, EMA) to discuss development plans and seek guidance on clinical trial designs.
• Regulatory Experts: Hire experienced regulatory affairs professionals to navigate the approval process and ensure compliance with all regulatory requirements.
• Compliance Monitoring: Implement data analytics tools to monitor regulatory changes and adapt compliance strategies accordingly.

3. Market Segmentation

• Demographic Segmentation: Target specific age groups and geographic regions with higher incidences of [condition].
• Behavioral Segmentation: Focus on patients with a history of [e.g., using biologics and those seeking advanced therapies].
• Firmographic Segmentation: Engage with hospitals, specialty clinics, and healthcare providers that specialize in treating [condition].

4. Value Proposition Development

• Unique Selling Points (USPs): Highlight the superior efficacy and safety profile of the new [intervention] compared to existing treatments.
• Benefits Communication: Emphasize benefits such as [e.g., improved patient outcomes, reduced side effects, and ease of administration].
• Stakeholder-Specific Messaging: Tailor value propositions for different stakeholders, including patients, healthcare providers, and payers.

5. Product Development and Launch Strategy

• R&D and Clinical Trials: Leverage AI and ML to enhance drug discovery, optimize clinical trial designs, and accelerate data analysis.
• Intellectual Property Protection: Secure patents and trademarks for the new therapy to protect R&D investments and market positioning.
• Stakeholder Engagement: Build strong relationships with key opinion leaders, healthcare providers, and patient advocacy groups to support the launch.
• Marketing and Promotion: Develop a comprehensive marketing plan that includes digital campaigns, educational webinars, and collaborations with healthcare professionals.
• Monitoring and Adaptation: Continuously monitor market feedback and product performance post-launch to make necessary adjustments.

6. Integration of AI and ML

• Early Adoption: Utilize AI and ML in the initial stages of drug discovery to identify potential compounds and predict their efficacy.
• Data Analytics: Apply big data analytics to interpret large biological datasets to support personalized medicine approaches.
• Cloud Computing: Implement cloud-based solutions for data storage, analysis, and sharing, ensuring data security and compliance while facilitating real-time collaboration.

Timeline

1. Months 1-3: Conduct market research, engage with regulatory bodies, and hire regulatory experts.
2. Months 4-6: Develop detailed market segmentation, craft value propositions, and begin R&D using AI and ML.
3. Months 7-12: Initiate clinical trials, secure intellectual property protections, and develop marketing materials.
4. Months 13-18: Engage stakeholders, launch marketing campaigns, and prepare for regulatory submissions.
5. Months 19-24: Obtain regulatory approvals, launch the product, and monitor market performance.

Budget

• Market Research and Analysis: [Cost]
• Regulatory Compliance and Expertise: [Cost]
• Marketing and Promotion: [Cost]
• R&D and Clinical Trials: [Cost]
• Technology Integration (AI, ML, Cloud): [Cost]

Metrics for Success

• Regulatory Approval Timeline: Achieve approval within [timeline].
• Market Penetration: Capture [percentage] of the target market within the first year of launch.
• Patient Outcomes: Demonstrate a [percentage] improvement in patient outcomes compared to existing treatments.
• Revenue Targets: Generate [price] in sales within the first year.

By making use of these detailed steps and strategies, the GTM plan should look like a clear and comprehensive roadmap for launching the product.

Bottom Line: Embrace the Biotech Roller Coaster!

Developing a GTM strategy for your biotech is mostly about taking an evidence-based approach that includes understanding industry-specific challenges, meeting regulatory demands, and targeting market segments effectively. A robust GTM plan should typically incorporate early engagement with regulatory bodies to align expectations and ensure compliance, invest in regulatory expertise to navigate complex requirements and leverage advanced technologies like AI and machine learning for innovation and efficiency. It should also include strong quality management systems, strategic market segmentation, and a compelling value proposition tailored to various stakeholders.

Not that hard, right? Well, except for the occasional regulatory hiccup that might feel like deciphering an ancient alien language or the frantic last-minute scramble when you realize your key data scientist decided to join a llama farming commune in the Andes. But hey, nothing says innovation like a little chaos, right?