2021 global life sciences outlook

2020 also saw exponential growth in connectivity through greater use of digital tools, faster (5G) networks, and cloud computing. New ways of collaborating reduce the time, distance, and cost of communications. Deals are often consummated remotely. Companies are also re-evaluating the need and role of work campuses, looking for new ways to maintain culture and drive client innovation. And as new ways of working can tax mental and physical health, life sciences and medtech companies are expanding mental health resources and promoting well-being. Behavioral health needs of workers will be critical to helping them thrive—and for acquiring new talent.

In the future, it is essential to find ways to keep the workforce feeling emotionally connected no matter how or where they work. One of the biggest challenges for life sciences and medtech companies will be fostering a sense of belonging among employees and ensuring that innovation is not lost in a purely virtual environment by deploying better remote collaboration and tools.

Accelerated digitization: New points of care, new roles for pharma and medtech—One of the effects of the pandemic was the rapid adoption of virtual care, which enables sharing of data and insights across the complete circle of care—from disease prevention to treatment to monitoring. This shift in health care delivery is likely to provide a better understanding of the role and effectiveness of pharmacology in treatment.

However, tracking of quality measures for virtual health and training physicians in web-side manner remains challenging. These quality measures are critical to pharmaceutical companies and for building data on health improvement and outcomes. Eased regulations during the pandemic increased adoption of telemedicine in many countries, but reimbursement and regulatory policies postpandemic will be key to permanent uptake and growth. While eased regulations in some countries such as the United States, Canada, China, and Singapore are likely to remain, more work is needed in other countries.

New digital health initiatives have the support and funding of governments, and tech companies are playing a major role in helping the move toward digital-first. The home is a hub of connectivity and emerging as a clinical point-of-care. Home testing and point-of-care testing are undergoing a revolution, and medtech companies can expect continued competition from consumer tech.

During the pandemic, startups and incumbents expanded home delivery of medicines, even drone delivery. Other consumer companies are bolstering health care services—digital pharmacies are adding telemedicine, and retail pharmacies are creating super health care centers. Pharmacies are administering COVID-19 vaccines, and in the future, the pharmacist may be a recognized care provider, prescribing acute medications and managing chronic diseases.

New customer-centric commercial model: Meeting physicians where they are, on their terms, and through more meaningful interactions—When hospitals and doctors’ offices barred in-person sales visits to minimize virus spread, virtual visits with sales reps soared. Today, some doctors say they will stick to video calls with reps, but others miss in-person visits. A hybrid, more supportive, commercial model is evolving that is a mix of both.

Reps who succeed in future will be those who understand the science, who are interested in patients, and who are capable of having meaningful discussions with health care professionals (HCPs). The post-COVID-19 opportunity is for the industry to rethink how to engage with physicians and how to drive value through digital channels and products on demand. Sales and medical affairs teams can benefit from coaching in empathy and virtual interactions. The mega medical congresses of the past are expected to make way for more virtual, focused, and hybrid physical/digital events.

New types of collaborations and clinical trials reshaping research and development—Accelerated digital transformation during the pandemic saw agile teams, speed to market, release of the minimum viable product, and senior management aligned with the process changes required for increased speed to market. The rapid development of novel vaccines for COVID-19 demonstrates that a new type of streamlining and efficiency is indeed possible. Biopharma companies are adopting various strategies for innovating clinical trials to shorten timelines, including new trial designs and new technologies such as artificial intelligence.

New collaborations with academia, biotech, platform companies, and data providers were already happening before COVID-19, but the pandemic accelerated time, attention, and capital to these types of collaborations by the sector.

Trial design and execution have also undergone changes. Pandemic trials have proven that big studies need not necessarily be multiyear affairs. Regulators are becoming more flexible about clinical trial design and the speed of trials. With support from regulatory bodies, there is a trend toward more decentralized, patient-centric trials in the long term, and they offer many advantages. More trials will be hybrid trials going forward, a combination of in-person and virtual visits.

Planning and resources are key to the success of these new models, especially to address the needs of the vulnerable or marginalized populations. Biopharma companies should work collaboratively and transparently within the health care ecosystem and with data startups to unlock the data necessary to inform transformative approaches.

Shortening development and review timelines, thinking more like a regulator—As the pandemic progressed, the US Food & Drug Administration (FDA) reviewed over 2,300 emergency use authorization (EUA) requests and provided EUAs to more than 600 products, enabling therapies to be available to patients faster. The European Medicines Agency (EMA) uses the rolling review for vaccines, one of their expedited regulatory tools for emergencies that also includes rapid scientific advice, accelerated marketing authorizations, and compassionate use programs. Developers were allowed to use platforms approved in other areas, such as mRNA, for new development, provided they had the data to support it.

Vaccines forced a global population health perspective, and the approach has been very collaborative between regulatory agencies and industry. Cross-agency scientific resources enabled shorter review timelines for COVID-19 drugs and treatments.

With the desire to shorten new drug development and review timelines, regulators are expected to feel the added pressure starting in 2021. Novel strategies and technologies, including real-world evidence, platform trials, remote clinical trial monitoring, and advanced analytics can help organizations succeed in the new regulatory environment, compress timelines, and accelerate insights. Also, run-on clinical trials may be here to stay, but compliance with good manufacturing processes (GMP), which had been relaxed during the pandemic, may return.

Regulators take a risk-based approach in everything they do and thinking like a regulator is key. The best way to understand what a regulator wants is to study inspections and processes from the regulator’s perspective, analyzing risks and benefits carefully. COVID-19 EUAs could be a great tool for assessing how the US FDA thinks, even if a specific product is not in a company’s space. Stakeholders should review the US FDA's Investigations Operations Manual, updated in 2020.

Cross-border reliance intensifies the need for supply chain visibility and reshoring options—COVID-19 shined a light on cross-border reliance—in trade, manufacturing, and distribution. Currently, over 80% of pharmaceutical ingredients come from India and China, and the United States is increasingly relying on China and India for active pharmaceutical ingredients (APIs). To decrease foreign dependencies, there is a growing trend for bringing production back onshore, or reshoring. In 2021, a significant amount of investment is expected to continue in reshoring, especially for capacity shortfalls.

Because of the urgency of the COVID-19 pandemic, manufacturing for the COVID-19 vaccine was done at risk, i.e., before it is known whether the vaccine works or not. It is unclear whether this paradigm, or any part of it, could carry forward without these extraordinary circumstances and funding guarantees. Competitors are collaborating to boost vaccine demands amid supply constraints and changes in manufacturing and supply chain are driving the need for new partnerships. Companies should collaborate with others to ensure the consistent delivery of product into the market.

The success of the Pfizer-BioNTech and Moderna mRNA-based COVID-19 vaccines is paving the way for more innovation to come. If mRNA can be used, not just for vaccines, but for cancer cells, it may be one of the most exciting therapies since the polio vaccine. Viral vector and mRNA medicines are hard to manufacture, and manufacturing processes need to improve. A lot of pharma companies will need to leverage their partners instead of manufacturing the products themselves.

Advancing humanity: Environment, social, and governance (ESG) imperatives—Being a good corporate citizen is about leading with purpose, and the impacts a company’s operations have as a whole on ESG concerns. The pandemic made household names of life sciences companies, large and small, and some of these companies are now among the top 20 fastest-growing brands. With the sector on its front foot,how can companies build more trust and drive more growth for good?

In the midst of a crisis, priorities typically shift. But research shows that COVID-19 has not made people any less concerned about global climate change. Major companies continue to make pledges to reduce or eliminate their carbon footprints. The best way to reach and maintain sustainability may be a collective, timely, and strategic focus on our human and societal values.

When it comes to equity, the pandemic has exposed many inequities in our systems, our human frailties, but also, our collective strengths. The sector’s focus for 2021 should be on access, reach, and equity for all. Health equity requires meeting people where they are with the necessary resources to maintain or improve health outcomes. Diverse patients account for less than 10% of patients enrolled in clinical trials. It is important that a study population is representative of the population that may ultimately use a drug or therapeutic.

Life sciences companies are stepping up, allocating significant investments to reduce inequities in health, employment, and gender. These initiatives go beyond philanthropy and aim to accelerate meaningful change and demonstrable results. The private sector has a critical role to play in addressing ESG needs. Success today and in the future will depend on creating collective value for all stakeholders in a way that is transparent and sustainable.

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