Commercial Roadmap for the Launch: What can Biopharmaceuticals do to Increase the Odds of Success?

The Pharma and Biotech Healthcare market has been an ever-changing industry in terms of the type of biopharmaceutical products innovated and launched, evolving from management of chronic diseases in the 1990s to the expansive marketing of generic drugs, to now moving onto personalized therapies. To increase the success rate of biopharmaceutical product launch, one has to keep in mind to meet drug commercial and clinical parameters i.e. the biopharmaceutical product launch should add value to payers, patients, and physicians. However, to define the partnership and see its effect, the company needs to build a roadmap where pharma commercial planning and biopharmaceutical product launch assessment starts earlier, at least 36 months prior to the biopharmaceutical product launch. Planning and launch assessment are critical for the successful commercialization strategy of biopharmaceutical products.

A comprehensive and integrated biopharmaceutical product launch roadmap outlines specific plans for each function – regulatory, medical affairs, distribution, payer engagement, marketing and promotions, sales, and patient impact – as well as major milestones for each function in terms of launching a biopharmaceutical product quickly and effectively. Early healthcare market research, access, and valuable insights from stakeholders should advise clinical teams prior to Phase II and Phase III studies, as it takes a lot of data to map out biopharmaceutical product launch milestones in the biopharmaceutical industry.

Before a critical path product launch, planning is very crucial to avoid resource and time demolition. A few factors to consider for the product commercialization strategy of biopharmaceutical products are understanding the patient burden and niche segment population, benchmarking pricing and managing pharmaceutical market access, drug commercial partner identification, biopharmaceutical products value drivers, and analyzing competitors, among others. 

Understanding patient burden and niche segment population

Defining patient population for a particular asset is crucial from the clinical, payer, and pharma commercial perspectives. Understanding patient groups aids strategic decision-making and scenario planning by guiding opportunity and risk trade-offs, along with managing competitive advantage in the dynamic treatment market.

Essentially, any biopharmaceutical products or service is customized to improve revenue generation and the same is true for the healthcare industry. Not only is effective patient segmentation helpful for an organization from a regulatory and pharma commercial standpoint, but it also makes a convincing case for durable life cycle management strategies. When organizations are able to understand mutually exclusive patient pools and homogenous patient pools with the requirement of a similar therapy approach, it creates an opportunity to understand the available as well as addressable biopharmaceutical industry for the therapy in question.

With patient population identification, one can formulate the most effective roadmap for price points, biopharmaceutical products differentiation, and life cycle management. Thus, assessing, understanding, and leveraging insights around patient populations helps companies gather momentum for effective sales performance, remain relevant in the market, and earn profitable revenue through the effective valuation of the therapy.

Pricing and Market Access (P&MA)

P&MA is a major factor impacting biopharmaceutical product launch, commercialization, and shows a direct relation with the patient population. It is essential to identify the price and value from the beginning to provide the best valuation for the therapy in respect to avoid revenue loss.

Over the years, increased attention toward value-based healthcare delivery has challenged healthcare stakeholders-manufacturers, payers, government, providers, and consumers­­‑to envision a better go to market model pharma for the delivery of biopharmaceuticals for the time to come. To provide sustainable high-quality healthcare with cost-effective price tags, companies are being pushed to provide outcome-driven evidence for their price tag.

Understanding certain parameters to manage pricing is very important in the biopharma vertical, such as the size of the patient pool, competition in clinical efficacy, unmet need, niche patient demographics, diagnostic accuracy, and morbidity/mortality rates, among others. For instance, pricing a drug that caters to a rare disease state with no treatment and high mortality will be very different from the pricing of a pharmaceutical drug with a large patient size, manageable symptoms, negligible disease progression, and high competition between therapeutic classes. Positioning therapy among these variables and assessing pharmaceutical market access can point organizations toward the right formulary tier.

Product Value Drivers

Factors like unmet needs, biopharmaceutical product differentiation within and among pharmaceutical drug classes, therapeutic value, patient preference, and compliance, may have a major impact on biopharmaceutical product sales. Value drivers of any therapy need due consideration, right from the start of the developmental pipeline. If the healthcare market need for a biopharmaceutical product is high and also has high product differentiation, the biopharmaceutical product picks up the market in a short period of time after launch and generates high revenue. On the other hand, if the biopharmaceutical product has a low healthcare market need and low product differentiation, the revenue generation may be slow with low peak sales.

Additionally, it is very important to develop clinical trial designs that include endpoints relevant for effective pharmaceutical market access. Having relevant endpoints not only helps leverage the value of the pharmaceutical drugs from a payer perspective, but it also helps overcome clinical trial costs and drive revenue generation.

There might be instances where therapy is in a disadvantaged position due to low unmet needs, low biopharmaceutical product differentiation, or high drug class competition. Here, market access pharma strategizing becomes all the more important, wherein companies might need to improve on marketing and promotional aspects to drive sales, rely on the sales force to improve drug prescriptions, and develop overall awareness of the therapy on the ground.

Competition in the Healthcare Market

Competitor identification is crucial, as direct or indirect branded/generic competitors can greatly impact the initial uptake and overall positioning of therapies in the relevant therapy market. A biopharmaceutical product with little/no competition in the healthcare market with good clinical evidence may be able to gain good positioning in the healthcare market, as opposed to therapy with high competition through a saturated treatment landscape, and comparable clinical evidence. Even if therapy has greater clinical efficacy and safety in comparison to other branded pharmaceutical drugs in the market, effective tools need to be applied to ensure successful launch and uptake, which is not mandatory for therapy with no market competition despite having mediocre clinical efficacy and safety.

Still, this case may vary for different therapeutic areas. Some parameters may drive uptake in a competition-dense treatment landscape for certain therapies, and pharmaceutical companies should pay attention to those to differentiate their products and leverage competitive advantage. Such parameters include treatment cost for the patient population, targeted patient sub-segment, level of unmet need, clinical efficacy differentiation between the therapy classes, being a first-in-class or best-in-class therapeutic, along with personalization of therapy for patients.

Thus, it becomes imperative for organizations to develop accurate competitive insights, identify the right market and enhance commercial roadmap by assessing risks, fixing appropriate pricing, and developing and marketing innovative therapies.

Dive deep into Competitive Intelligence to Stay Ahead of Competitors

Managing post-approval Marketing

Marketing within the pharma sector is highly complex, with the end audience being either GPs or specialists working within the therapeutic area of the drug product. Possessing a team with sufficient scientific understanding of benefits vs. risks to communicate with individuals who are very well-informed and have decades of diagnostic and/or treatment experience.

Moreover, considering the increase in personalized medicines and efforts to improve patient compliance, many therapies are being developed that do not require physician or nurse involvement for therapy administration. However, even considering patient ease of administration, there remains a requirement for patient education and awareness, which is a necessary step in ensuring effective treatment.

Thus, pharmaceutical companies now have to keep smarter sales reps and MSLs in their armory, so that they are capable of engaging with payers that are looking for the most cost-effective treatment, with prescribers who need the reassurance of a high level of clinical efficacy and safety, and with patients to develop a better understanding of therapeutic benefits and correct administration. Additionally, pharmaceutical companies are being driven to offer complimentary diagnostics and support services to ensure biopharmaceutical product differentiation and drive uptake within relevant patient populations. Not only this, companies need to invest in building a responsive network of distribution due to the nature of personalized therapies that cannot be stocked and are tailored to each patient. 

Commercial Partnerships

Traditional pharma commercialization strategies included launching drugs in one country/region and a very slow geography expansion. Most of the specialty drugs were available only in developed economies, and sometimes, within selective countries. Over time, healthcare access in emerging economies has improved with many pharmaceutical companies expanding geographical boundaries to launch therapies across multiple geographies. Managing multi-country launches without partnership may be viable for some large corporations, however, these companies also prefer partnering with local companies who have a better understanding and awareness around the local landscape and market characteristics. This becomes even more important for companies with single lead candidates or those who have a conservative pipeline so that expenses can be managed for future developmental projects through royalty earnings and less responsibility and reduced stake in marketing success.

Such collaborations also provide the acquisition of a credible and expert partner who may have a better understanding of the region’s dynamic landscape and can provide effective launch and marketing strategies. This provides manufacturer companies a way to capitalize on their R&D expenditure and develop robust pipelines for future success in the market.

Conclusion

Biopharma companies face various challenges at the successful product launch and, therefore, these biopharmaceutical companies must work hard to build a comprehensive biopharmaceutical product launch roadmap that consists of ample data, incorporates the right technology tools & strategies, and accounts for the inherent uncertainty associated with launching the biopharmaceutical products. While the individual components of a roadmap will look similar for both big and emerging biopharma companies, emerging firms need to do much more foundational work related to pharmaceutical market access strategy, operational processes, and technology than their big pharma counterparts. This foundational work can be easy to overlook amid the competing pressures of successful product launches. However, laying the proper groundwork for a critical path product launch is crucial to ensuring long-term success.