5 Critical Steps for Entering the Life Sciences Market

Market Research and Regulatory Analysis

Robust market research is necessary before a company can enter the life science market. New life science companies or companies looking to enter new markets should conduct comprehensive market research for greater insight into demand, competition, and trends.

According to an article by LifeSciences Intellipedia, market research provides new companies insight into their customers and preferences, allowing for informed decision-making as companies enter the market and tailor their products.

One of the primary components of understanding market dynamics is market segmentation. Executives in the life sciences space should analyze and break down the markets into various demographics, behaviors, and needs. In healthcare, market segmentation could depend on the conditions of the patients companies intend to serve.

Beyond analyzing the market demographics, market segmentation also acknowledges what specific customers need and prefer.

For example, a company looking to launch a continuous glucose monitor (CGM) may consider medical device connectivity, how patients share information with their healthcare providers, and the average age of CGM users to understand how it can modify the product to best suit consumer’s needs.

“A successful launch is about understanding the needs and wants of a market, including those who pay for it and what they value,” Jeff Ford, principal at Deloitte Consulting, told PharmaNewsIntelligence earlier this year.

In addition to market segmentation, companies should consider the competitive landscape where they are trying to launch products. They may ask themselves whether the market is saturated and what opportunities or gaps exist. Understanding these factors can help organizations craft a unique approach to market entry, which may improve the existing business model or enhance profitability.

During the market research process, stakeholders may also take the opportunity to assess market entry feasibility. Understanding factors like the market size, growth potential, and product demand can help during the product launch.

Companies may also conduct a cost analysis and feasibility study to comprehensively understand how a new product or company will fit into the market share.

Market research may help inform data management strategies, research and development, quality control, chemical inventory management, and collaborations.

Beyond market research, regulatory analysis is vital to successful market entry. Companies should consider regulatory requirements, which may differ between medical device manufacturers and pharmaceutical companies. A comprehensive understanding of approval processes, compliance standards, and legal considerations can help pre-emptively prevent potential complications.

Companies may also consider connecting with regulatory authorities early to understand the regulatory process and gather information on best practices. This connection can also help them conduct a risk assessment, identify potential regulatory risks or challenges that may impact market entry, and develop strategies to mitigate them.

Thorough market research and regulatory analysis provide the foundation for informed decision-making, helping companies understand the nuances of the target market and make strategic choices for successful market entry in the life sciences industry.

Selecting an Entry Strategy

Market entry strategies are critical to launching or entering any part of the global market. Market entry strategies may include licensing, partnerships, or direct exporting.

The appropriate market entry strategy begins with strategic considerations. The company should assess its business goals to ensure its market entry strategy appropriately aligns with the business model. The organization should also evaluate its available resources, including capabilities, staff, technology, etc.

Upon assessing the strategic considerations, experts may consider the following market entry strategies.

• Licensing agreements: One potential market entry strategy that can help ease new life sciences companies into the market is partnering with local companies through  to help with product distribution or development. This allows companies to leverage technology, intellectual property, and new products without investing too much into reaching the local market. According to an article published in Biotechnology Healthcare, “Licensing also may afford an aggressive strategy for identifying and providing lead products for the pharmaceutical licensee and the biotech early-stage company acting as the licensor.” In a 2023 Deloitte report on pharma licensing, experts highlight four primary factors to consider when licensing: when to partner, identifying the right partner, preparing offering materials, and deal negotiation skills.
• Partnerships and collaborations: Partnerships and collaborations with manufacturers, distributors, research institutions, and other life sciences companies can allow the company to share the risk associated with entering the market and expedite market entry. Newer startups may partner with more established entities to access more expansive resources.
• Exporting: Exporting strategies such as direct or indirect exporting can be another market entry strategy. If a company has the resources to manage a global supply chain, it may opt for direct exporting, while others who don’t have the capacity may consider indirect approaches.
• Mergers and acquisitions: Acquiring local companies can help entrants into new markets understand and pursue local market access strategies. This strategy provides immediate market access, an established customer base, and operational capabilities.
• Strategic alliances: Another market entry strategy can be developing strategic alliances with local companies or manufacturers to reach a broader market and understand local healthcare systems. These strategic alliances may also help companies when developing their commercial strategy.

Other factors to consider during the entry strategy are market maturity, competitive landscape, regulatory compliance, intellectual property protection, risk tolerance, adaptability, and sustainability.

Product Adaptation and Regulatory Compliance

The next step of the market entry process focuses on adaptability and regulatory compliance. While a company may develop a product with widespread applications, successful market entry acknowledges how different markets in other countries or locations may require slightly different approaches.

Market localization is critical for the continued success of a product. Companies should use their market research, clinical trial data, and real-world evidence to understand how the products must be adapted for different markets.

In addition, regulatory compliance is critical in every stage of the market entry process. Companies should consider how global differences in regulation might require changes in product formulation.

At this stage, researchers may consider conducting case studies or clinical trials to understand the local applications of the product. Additionally, many regulatory organizations may require local clinical trial evidence before regulatory approval.

Connecting with regulatory bodies, such as the United States Food and Drug Administration (FDA) in America, the European Medicines Agency in Europe, the National Medical Product Administration in China, and the Central Drugs Standard Control Organization in India, is vital.

Companies should also assess local packaging guidelines and develop new packaging that caters to the regulations and local market. Other considerations may include establishing quality assurance systems and supply chain oversight strategies.

Building Strategic Partnerships

Strategic partnerships play a pivotal role in successful market entry by leveraging local expertise, sharing risks, and enhancing the overall capabilities of a life sciences company. Building and nurturing these partnerships requires careful planning, due diligence, and a commitment to fostering relationships based on mutual trust and shared objectives.

“Corporate alliance deals structured as licensing transactions, co-development agreements, joint ventures, or sales and marketing alliances play an integral role in many growth strategies for biopharmaceutical companies,” noted experts in Biotechnology Healthcare.

According to an article by Ernst and Young, strategic partnerships are another avenue for offsetting risks.

Business leaders should assess local companies and their market presence or reputation to identify a strategic partner. Local strategic partners can help biotech or biopharma companies understand local regulatory environments, the payer space, and reimbursement strategies.

Executing Marketing and Distribution

Biopharmaceutical companies and startups looking to enter the life sciences market should also consider localized marketing strategies tailored to the local community.

A company may consider tailoring its messaging to target specific patient demographics. They may also choose a particular digital channel such as online advertising, social media, or more that reach specific audiences.

Finally, companies should consider their distribution protocols by selecting local distribution partners that align with the company’s mission and optimize these standards.

Executing effective marketing and distribution strategies involves a deep understanding of the local market, cultural nuances, and regulatory requirements. It requires a dynamic and adaptive approach, incorporating traditional and digital channels to reach and engage the target audience effectively. Continuous monitoring, feedback analysis, and adjustments are essential to optimize marketing efforts and enhance market penetration.