Beyond borders: EY biotechnology report 2022
The 32nd edition of our Beyond borders report offers a chance to take stock of the US and European biotechnology (biotech) industry’s impressive performance during a period of intense global disruption. When we last published our Beyond borders overview five years ago, we noted the growing geopolitical complexities set to impact biotech. Titling our 2017 report, “Staying the course,” we observed that the industry would have to navigate a business environment in which, increasingly, “uncertainty is the only certainty.” From the perspective of 2022, we can affirm that biotech has indeed successfully stayed the course, despite the upheavals that have affected global business since the last edition of this report.
Beyond borders 5-year difference
In 2017, looming challenges included the impact of the UK’s Brexit vote and the intensifying US debate over the future of health care at the outset of the Trump administration in the US. Five years on, there is no question that biotech has not only survived but has thrived throughout these and subsequent disruptions — most notably the worldwide turbulence caused by the COVID-19 pandemic since early 2020. We can quantify the industry’s success in staying on track throughout this period: in 2021, the last full calendar year, the industry’s revenues were 55% higher than 2016 (as we noted in our previous report); biotech market capitalization had risen 84%; financing levels had surged 116%, with huge increases in the industry’s levels of venture capital (VC) investment and the biotech IPO market; and annual drug approvals were up 80% compared with 2016.
Yet in 2022, biotech must contend with an operating environment arguably even more uncertain than in 2017. The unforeseeable geopolitical situation in Eastern Europe will play out on a global business landscape still adjusting to the impact of the pandemic. In the wake of the past two years, biotech (as with other industries) is facing new tests, including supply chain disruption; intensifying competition for talent; challenges to established commercial models; and rising pressure to demonstrate a commitment to addressing environmental, social and governance (ESG) issues — from access and affordability to clinical trial diversity (all explored in detail in this report). Amid global macroeconomic changes, including resurgent worldwide inflation and the ever-present risk of an economic recession, the financial environment for biotech has significantly shifted in the opening months of 2022, with valuations plunging and the IPO window closing.
Taken together, these developments leave biotech navigating uncharted waters in 2022. Yet the fundamentals of the industry remain strong. Biotech’s growing R&D investments support a rich late-stage clinical pipeline that promises to remain a key driver for the US$1.4 trillion global biopharmaceutical (biopharma) industry.¹ While some biotechs may struggle with reduced access to the public markets, the sector as a whole will continue to flourish. Above all, the past five years have delivered an irrefutable lesson in the resilience of biotech: despite these challenges, we can be confident that the industry will continue to stay the course.
Authors

Arda Ural, PhD
Americas Industry Markets Leader
Principal, Health Sciences & Wellness
Ernst & Young LLP

Ashwin Singhania
Life Sciences Strategy
Principal, EY-Parthenon,
Ernst & Young LLP
The year in review
Biotech performed exceptionally well in 2021, not in spite of but because of the COVID-19 crisis. The pandemic continues to disrupt health care delivery and is projected to result in a cumulative reduction in global medicine spending of US$175 billion over the next seven years compared with the pre-pandemic outlook.² Yet the vaccines and antivirals biotech has innovated to address COVID-19 have delivered a significant top-line surge, with biotech revenues hitting US$216.7 billion in 2021 — a dramatic 35% annual increase from 2020 (see Figure 1).
Figure 1. US and EU public company revenues, 2000–21
BioNTech and Moderna only joined the ranks of the commercial leaders in 2020, yet they are generating revenues greater than any other biotech in the world, barring long-standing industry leaders Amgen and Gilead. This dramatic rise underscores the extent to which the COVID-19 market dominated the biotech story in 2021. Moreover, this explosive growth is not going to disappear overnight — on the contrary, projections indicate that spending on vaccines and therapeutics targeting the coronavirus will more than double by 2026 (see Figure 2).
Figure 2. Projected cumulative spending on COVID-19 vaccines and therapeutics (2021–26)
Though vaccines will continue to dominate this space, drugs will take a growing share of the market. Multiple biotechs are already addressing this opportunity, including leading industry players Regeneron and Gilead. Regeneron’s REGEN-COV treatment brought the company 89% revenue growth in 2021, while Gilead recorded 11% growth on the strength of its Veklury (remdesivir) product. Both featured among the top biotech revenue growth stories of 2021, as did Vir Biotechnology, a new entrant in the commercial leader group in 2021. Vir’s Xevudy (sotrovimab) monoclonal antibody (mAb) treatment for COVID-19 reached US$1.1 billion in revenues on the strength of its profit-sharing arrangement with its partner GlaxoSmithKline.
Of course, despite the commercial significance of COVID-19 in 2021, biotech innovation extends far beyond this market. Indeed, regardless of regulatory delays caused by the ongoing challenges at the Food and Drug Administration (FDA) with inspection delays caused by the pandemic, 2021 saw 63 new products approved (50 new molecular entities and 13 biological license applications) (see Figure 3). This exceeded 2020’s total, even excluding the emergency use authorizations that brought certain COVID-19 products to market.
Figure 3. FDA product approvals, 2011–21
These approvals should be only the start of a wave of new innovations reaching the market. Biotech’s pipelines are full: over 6,000 drugs are in active development, with emerging biotechs accounting for a record 65% of them. This total includes around 800 next-generation biotherapeutics, with notable R&D activity in CAR T cell and NK cell therapies, gene editing and RNA therapeutics.
Moreover, the Big Pharma leaders need access to these biotech innovations, with loss of exclusivity threatening to erode an estimated US$252 billion from industry revenues by 2026. Replacing these revenues will depend heavily on biotech pipelines, particularly in the development of new modalities. (An analysis of the leading pharma group’s exposure to patent expirations, and the importance of new modalities for closing the resulting “growth gaps,” can be found in the 2022 EY M&A Firepower report.) These new modalities include the mRNA platforms that achieved significant commercial success in 2021, as well as next-generation antibodies and cell and gene therapies. Further into the future, these innovations will synergize with other novel technologies, including next-generation neural nets with sequencing tools, bioinformatics and AI-powered analytics (for more discussion of the potential of bioconvergence, see our guest perspective, “Bioconvergence: A multidisciplinary approach to advance human health,” by Belén Garijo of Merck Group).
The health of biotech’s R&D engine is cause for optimism, as is the normalization of health care delivery as COVID-19 recedes. After more than two years of pandemic disruption, this normalization should bring a rebound in product demand. However, there are signs that the aftermath of the pandemic will also leave biotech with significant challenges.
Among these challenges is a decisive shift in investor sentiment, which began in the last quarter of 2021. Over the past decade, and particularly during the pandemic, biotech has enjoyed soaring valuations. By early 2022, these valuations had plunged dramatically (see Figure 4). As Barbara Ryan, an Ernst & Young LLP senior advisor described it, “We are clearly living through an innovation renaissance, and the fundamentals of the industry are quite strong. But from a stock market perspective, we are living through the deepest and longest correction that we’ve seen in the biotech indexes since their inception.”
... from a stock market perspective, we are living through the deepest and longest correction that we've seen in the biotech indexes since their inception.
Figure 4. US and European biotech market capitalization relative to leading indices, January 2020–April 2022
Among the casualties of this return to pre-pandemic valuations is the biotech IPO market, which saw unprecedented levels of activity in 2020 and 2021, but slowed significantly in the first quarter of 2022. Biotech financing is notoriously cyclical, and after growing from US$53.4 billion in 2016 to well over double that total in the record financing years of 2020 and 2021, the industry can now expect a significant reset. In 2021, innovation capital (defined as the amount of capital raised by companies with revenues of less than US$500 million) reached an all-time high of US$104.7 billion. By comparison, the average over the previous 15 years was US$34.3 billion (see Figure 5). These smaller companies now face a more arduous path to the capital markets.
Figure 5. Innovation capital in the US and Europe, 2006–21
For some biotechs, reduced access to capital will mean navigating existential challenges. For many others, this shift will increase the desirability of exiting via acquisition, and it may galvanize M&A activity in the sector. Though a high number of deals were signed in 2021, most were minor plays, and the overall dealmaking value declined by 46% (see Figure 6). High valuations and the array of possible funding options available to companies in the sector have slowed M&A activity.
As valuations sink and financing becomes more challenging, a buyer’s market may emerge, with Big Pharma CEOs potentially reconsidering targets that in the past proved too expensive to justify acquiring. De-risked, late-stage biotech assets that fit naturally into a company’s strategic pipeline will naturally be an M&A priority for these companies. Alternatively, leading companies may seek to pursue strategic alliances rather than outright acquisitions, continuing a notable trend in recent years (see Databook). Our guest perspective from Terry Rosen of Arcus Biosciences, “Novel combination therapies — the path to differentiation in oncology ,” provides more discussion showing how partnership models may work effectively in the sector. While an M&A rebound seems probable, there is little evidence of it so far in 2022.
Figure 6. US and European M&As, 2005–21
Negotiating the uncertainties around both dealmaking and the broader shifts in the business landscape will not be the only challenge biotechs face in 2022. The pandemic has undoubtedly reshaped the industry in multiple ways, as emphasized in our discussions with industry stakeholders. Thomas Wozniewski, Global Manufacturing & Supply Officer of Takeda, writes: “COVID-19 has required diverse ways of working for all of us,” he says. Adding, “The industry has learned from it substantially.” (See his guest perspective, “Staying curious to make our supply chains better”). Among the lessons learned is the need for more effective use of digital technologies and data across the industry. As Chris Picariello, President of Johnson & Johnson Innovation notes, “One positive impact from the past few years has been the accelerated convergence of health, technology and data.” (See his guest perspective, “Partnering for an innovative and sustainable future”). Below, we discuss the shifts the industry is now experiencing in the wake of the pandemic and the ways that digital transformation can help address existing challenges and open new opportunities. We explore several aspects of this ongoing evolution, including:
- The impact of the pandemic on the industry’s commercial models, which have accelerated their adoption of digital and omnichannel approaches while face-to-face access to clinicians has been challenging (see "How biotech can improve its commercial launch capabilities")
- The rethinking supply chain strategies in the wake of ongoing disruption to global networks and the expected response of global policymakers to this perceived threat, which may include localization requirements and other significant reforms (see “How will Biotech and its stakeholders secure future supply chain resilience?”)
- The escalating challenges around attracting and retaining the necessary talent in an increasingly hypercompetitive labor market (see “How should biotechs close the emerging talent gaps?”)
- The heightened awareness of ESG issues among investors and the wider public — and the growing imperative for biotechs to address issues such as access to medicine (see “How Biotechs can add societal value by expanding access”) and lack of diversity in clinical trials (see “How can Biotech benefit from improving clinical trial diversity?”)
The business of biotech will not return to its pre-pandemic “old normal.” Companies will need to adapt to many new challenges in the rapidly evolving business environment. Yet, as 2021 demonstrated, there are also huge potential opportunities for biotech as it faces the future.
Guest perspective

Belén Garijo
Chair of the Executive Board and Chief Executive Officer, Merck Group
Guest perspective

Terry Rosen, PhD
Chief Executive Officer, Arcus Biosciences
Guest perspective

Chris Picariello
President, Johnson & Johnson Innovation – JJDC, Inc. (JJDC)
Guest perspective

Thomas Wozniewski
Global Manufacturing & Supply Officer, Takeda Pharmaceutical Company Ltd.