Drug Launch Dilemma: To Launch or Not to Launch.

Launching a new drug in the pharmaceutical industry is an exciting yet daunting prospect. It's tempting for companies to rapidly expand their product portfolios in response to competitive pressures, faster growth expectations and market opportunities. However, this eagerness can lead companies to manage more products than they can effectively handle, leading to stretched resources and diluted focus.

In this "Perspective Pill" article, we will explore essential strategies for a successful drug launch and discuss common pitfalls that companies should avoid.

Reasons for Launching a New Drug

In the rapidly evolving pharmaceutical industry, launching a new drug is a strategic decision driven by multiple compelling reasons. Companies often embark on this challenging journey to address unmet medical needs, expand their market presence, and enhance healthcare outcomes.

Each launch aims to tap into unique market opportunities. These initiatives not only promise substantial financial returns but also have the potential to significantly improve the market presence and growth.

Here are the key reasons, the "Dos" for launching a new drug:

1. Meeting Market Needs and Expectations:

Successful drug launches target unmet market needs and are often aimed at smaller patient populations with complex requirements. Pharmaceutical companies focus on drugs that fulfil these needs to establish a strong market presence.

Cipla 's launch of generic Remdesivir under the brand name Cipremi during the COVID-19 pandemic is a prime example of meeting urgent market needs. Cipla expedited the development and distribution in response to the critical demand for COVID-19 treatments, helping to address a significant health crisis.

2. Maximizing Revenue Potential:

Drugs that meet market expectations tend to perform well financially over their lifecycle, making the initial launch phase crucial for setting a positive revenue trajectory.

SUN PHARMA 's launch of Ilumya, a drug for the treatment of psoriasis, was strategically planned to enter a competitive but lucrative market segment. The drug was positioned to maximise revenue potential by tapping into a growing demand for advanced therapeutics in dermatology.

3. Innovation and Competitive Edge:

Launching new drugs allows companies to stay competitive and innovative, particularly in fields like oncology and immunology where rapid advancements are common.

Biocon introduced Ogivri, a biosimilar to Herceptin, which is used in the treatment of breast and gastric cancer. This launch not only showcased Biocon’s capability in complex biosimilar production but also provided a competitive edge in both domestic and international markets.

4. Regulatory Incentives:

Companies are motivated to develop and launch drugs that might receive regulatory incentives like FDA priority review, which can speed up the approval process for drugs that address significant health issues.

Dr. Reddy's Laboratories capitalised on regulatory incentives for orphan drugs with the launch of a generic version of Sapropterin Dihydrochloride Tablets, used to treat phenylketonuria, a rare genetic disorder. This move allowed them to enjoy benefits such as market exclusivity.

5. Strategic Market Expansion:

Launching new drugs can be a strategic move to expand into new markets, especially in regions like China, which are rapidly growing in pharmaceutical sales.

Lupin has expanded strategically into key markets like the USA and Japan by launching specialized products in the cardiovascular and anti-diabetic segments. These strategic launches have helped Lupin establish a strong presence in these lucrative markets.

6. Fulfilling Investor Expectations:

Pharmaceutical companies often launch new drugs to meet the expectations of investors and to drive the company's stock performance, particularly when significant research and development investments have been made.

Glenmark Pharmaceuticals launched Favipiravir under the brand name FabiFlu for the treatment of mild to moderate COVID-19. This was India’s first oral Favipiravir-approved medication. The launch was strategic to fulfil investor expectations by responding quickly to a pandemic-induced market opportunity, significantly boosting the company’s stock prices during the initial phase of the launch.

7. Access to Capital and Growth Opportunities:

Small and medium-sized companies often pursue drug launches to capitalize on favourable business cycles and venture capital funding, which can be particularly accessible during periods of economic growth. This access to capital enables them to invest in the commercialization of new drugs and potentially scale their operations.

Glenmark Life Sciences has effectively utilised periods of economic growth and accessible venture capital to fund its expansion and development of new products. A notable instance is their investment in novel molecules, which has been supported by robust funding strategies, allowing the company to scale operations and extend its global presence.

8. Strategic Use of External Vendors:

Companies often collaborate with external vendors to compensate for limited internal capabilities. These partnerships allow them to access specialized services, such as manufacturing and patient services, which are crucial for the successful launch and commercialization of new drugs.

Zydus Group has frequently partnered with external vendors to enhance its drug development and manufacturing capabilities. These partnerships have been crucial in the launch of their COVID-19 vaccine, ZyCoV-D, enabling the company to leverage external expertise and infrastructure.

9. Flexibility and Agile Management:

Small and medium-sized companies can often react more flexibly and swiftly to market changes than their larger counterparts. This agility allows them to adjust their strategies effectively throughout the drug launch process, catering to evolving market demands and regulatory environments.

Laurus Labs Limited has demonstrated exceptional agility in responding to market needs, particularly with the rapid development and launch of antiviral drugs for COVID-19. Their flexible management practices have allowed them to swiftly adapt to evolving health crises and regulatory landscapes.

10. Focused Therapeutic Areas:

These companies frequently operate in niche markets or focus on speciality and rare disease segments where in-depth knowledge and a targeted approach can lead to successful product launches. This specialization often results in higher efficacy in meeting the specific needs of underserved patient populations.

NATCO Pharma focuses on niche markets such as cancer and hepatitis C, where they have developed specialized treatments that meet the specific needs of these patient populations. Their targeted approach has led to the successful launch of several high-impact drugs in underserved therapeutic categories.

BONUS - Know Your Strength:

Understanding and capitalizing on your organizational strengths is crucial in the drug launch process. Whether it's a robust R&D department capable of pioneering innovations, a powerful distribution network, a creative concept selling sales team, a fully-owned manufacturing unit or specialized knowledge in a particular therapeutic area, recognizing these assets can guide the strategic direction of a launch. Tailoring your approach to leverage these strengths can significantly enhance the likelihood of a successful market entry, ensuring that the drug not only meets the medical needs but does so in a way that aligns with your company’s core competencies.

诺和诺德 has long been recognized for its extensive expertise in diabetes treatment. Leveraging its profound knowledge and specialized research and development in the field of endocrinology, Novo Nordisk successfully launched Ozempic (Semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes. Ozempic was developed based on the strength of Novo Nordisk's deep understanding of diabetic pathophysiology and its innovative capabilities in biopharmaceuticals.

The launch was strategically planned to utilize the company's existing relationships with healthcare professionals and institutions specializing in diabetes care, ensuring a receptive initial audience and smoother market entry. Novo Nordisk's established reputation in diabetes care also helped facilitate trust and acceptance among patients and providers.

By aligning its product development and launch strategy with its organizational strengths, Novo Nordisk not only reinforced its leadership position in diabetes care but also ensured that the new product effectively met the needs of patients, thereby maximizing both clinical and commercial success.

Common Pitfalls to Avoid in Drug Launches

While the strategies for a successful drug launch are critical, equally important are the pitfalls to avoid. Here are some key "Don'ts" to keep in mind while planning to launch a drug:

1. Don't Overlook Regulatory Compliance:

Adhering to regulatory compliance is a cornerstone of successful pharmaceutical operations, yet it is a detail some companies might overlook in their rush to market.

Ranbaxy faced significant challenges due to non-compliance with FDA regulatory standards, leading to heavy fines and a loss of reputation. This underscores the importance of adhering strictly to regulatory guidelines in every market.

2. Avoid Insufficient Market Research:

A common mistake made by pharma firms is to launch drugs in an already crowded market without a comprehensive analysis of market saturation and patient demographics. This resulted in poor market penetration and financial losses.

One of the good examples is, that Wockhardt Ltd. encountered setbacks when some of its key drugs failed to meet the expected market demand, partly due to an insufficient understanding of the competitive landscape and patient demographics.

3. Don't Neglect Post-Launch Monitoring and Support:

The period following a drug's market entry is just as crucial as the launch itself. Effective post-launch monitoring and patient support systems are essential components of a successful drug lifecycle management strategy. Neglecting these aspects can lead to significant setbacks, such as unaddressed side effects that may compromise patient safety and ultimately affect the drug’s reputation and market performance.

Glenmark Pharmaceuticals learned the hard way that post-launch drug monitoring and patient support are crucial after encountering issues with side effects that were not adequately addressed, affecting their product's market standing.

4. Avoid Poor Pricing Strategies:

Developing an effective pricing strategy is crucial for the successful launch of any new drug. When pricing does not align with market expectations, especially in highly competitive segments, it can lead to significant challenges. Such misalignments can stem from setting prices too high, making it difficult to gain market penetration, or too low, potentially devaluing the drug's perceived effectiveness or quality.

CADILA HEALTHCARE LTD faced challenges with some of its product launches due to pricing strategies that did not align well with market expectations, particularly in highly competitive segments.

5. Don't Underestimate the Importance of Effective Communication:

Effective communication with a proper Pharmaceutical Marketing Mix is a cornerstone of any successful product launch. Miscommunications can lead to significant misunderstandings among healthcare providers and patients regarding the benefits and uses of new healthcare products. When the intended message about a drug's effectiveness, usage, or potential side effects is not conveyed, it can severely impact patient outcomes and trust in the product.

Piramal Enterprises Limited - Investor Relations faced communication challenges during the launch of new healthcare products.

6. Don't Launch Solely Based on Competitor's Performance:

Often, companies rush to launch a product merely because a competitor's product is doing well. A case in point is several Indian pharma companies that entered the anti-diabetic market following the initial success of metformin, without a clear differentiation strategy. This resulted in a saturated market with low profit margins due to a lack of differentiation.

Even when the Sitagliptin molecule went off-patent, more than 200 brands were launched in India. Similarly, for dapagliflozin, over 80 brands were launched within a short time in 2021 and the count hit 156 brands in 2022. For vildagliptin, too, around 150 brands were launched in 2020, and the total stood at over 200 in 2022.

7. Don't Launch Just Because a Few HCPs Have Requested:

When considering the launch of a new pharmaceutical product, companies must base their decisions on comprehensive market research rather than the requests of a few healthcare professionals (HCPs).

While insights from HCPs are invaluable, relying solely on their input without broader validation can lead to skewed perceptions of demand and potential market size. This approach might cause pharmaceutical companies to launch products that do not align with the wider needs and conditions of the market, ultimately affecting the product's acceptance and success.

Hence, while the recommendations of HCPs are an important piece of the puzzle, they must be complemented by extensive data analysis and market testing to ensure that the launch will meet a genuine and sufficient market demand.

8. Don't Launch Merely Expecting a Sudden Rise in Sales:

Launching a new product with the expectation of immediate sales surges can be a risky strategy if not backed by a solid foundation. Often, companies are tempted by promising market trends and the potential for quick financial gains, leading them to expedite product launches.

However, such decisions can backfire if the launch isn't supported by thorough market research, HCP/ patient education, and a robust marketing strategy. Without these critical elements, a new drug may fail to reach its target audience effectively, or potential users might not understand its value or application, resulting in sales that fall far short of expectations.

Launch Labyrinth Solved

These lists of "Dos and Don'ts" underscore the importance of a well-rounded and strategic approach to drug launches, where mere immediate gains or incomplete strategies lead to longer-term challenges. These lessons are crucial for pharmaceutical companies aiming for successful market entries and sustainable growth. Avoiding these pitfalls can help ensure the successful launch and sustained market presence of new pharmaceutical products.

In conclusion, the journey of launching a new pharmaceutical product is fraught with challenges yet rich with opportunity. As we have seen through various insights and practical examples, success is most attainable when companies adopt a holistic and strategic approach to product launches. By integrating robust planning, precise market analysis, and effective communication, pharmaceutical companies can not only meet but exceed the expectations set before them. Let these lessons inspire and guide us as we continue to innovate and push the boundaries of what is possible in healthcare. Together, we can transform potential hurdles into stepping stones for success, improving patient outcomes and contributing to a healthier future for all.

Disclaimer: Please note that the insights and examples provided in the above write-up are based on secondary research, personal understanding, and experiences. They are intended to offer perspectives and not definitive advice. As a decision-maker, you are encouraged to consider these insights as part of a broader decision-making process. It is important to conduct your own thorough research, consult with experts, and consider all relevant factors specific to your circumstances before making any strategic decisions regarding pharmaceutical launches.