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Investment Ideas 2022: Explore three key themes dominating markets where investors might uncover potential opportunities. Read More

   

LIFE SCIENCES: ENTERING A GOLDEN ERA OF INNOVATION

September 2, 2022  |  9 Minute Read


Amit Sinha

CIO of Goldman Sachs Life Sciences

Amit Sinha

Josh Richardson, M.D.

Life Sciences Investing

Josh Richardson, M.D.

Kevin Xu

Life Sciences Investing

Kevin Xu


 

Key Takeaways

  • Life Sciences is currently the largest sector within the healthcare industry and has continued to expand rapidly, with heightened demand for therapeutics driven by aging demographics and the rising prevalence of chronic disease.

  • Breakthroughs across scientific disciplines have enabled new therapeutic candidates to be developed more quickly, efficiently and precisely. Innovation is increasingly occurring at small biotech startups rather than large pharma companies.

  • As drug development evolves, we believe new approaches to financing and capital formation will be needed. The scalability of modern discovery platforms may allow for greater opportunity, but also requires significantly more capital.

 


Healthcare is an integral part of the global economy that impacts every individual. The largest segment of the healthcare sector is Life Sciences (LS), which applies the study of living organisms and life processes towards the development of novel medicines and related technologies. The COVID-19 pandemic highlighted the importance and impact of the innovation and structural changes that are driving LS growth globally. We believe the current landscape provides opportunities to drive research forward in critical LS areas and explore new avenues for streamlining drug development and approval processes.

 

 

Life Sciences Comprises the Majority of Healthcare Venture Funding and Has Grown to a $2tn+ Market

 

Source: PitchBook. As of December 31, 2021. Statista. As of February 28, 2021. Grand View Research. As of March 1, 2022.

 

In our view, the foundation for LS innovation is supported by several key drivers, underpinned by decades of strong investment from both the private and public sectors. Tailwinds from sustained growth in funding and research are leading to a proliferation of scientific publications and new patents, with breakthroughs across disciplines including genetics, immunology, and cell biology. In parallel, technological advancements, such as the use of artificial intelligence (AI), are leading to faster drug development timelines and the creation of more personalized therapeutics. Advancements in the understanding of disease and a convergence of innovation across many scientific disciplines are enabling the development of new drug platforms that create novel ways to treat disease and solve patients’ unmet needs. Separately, regulatory bodies are creating policies to better leverage new technology and create new approval pathways, with a concerted effort in many geographies to support domestic LS innovation and development.

 

As the drug development process is evolving so are company formation timelines, creating a need for new financing models and capital solutions. In the next decade, 15 of the top-selling drugs in 2020 will lose patent exclusivity, resulting in a loss of $100bn+ in sales for large pharma companies.1As such, large pharma is reevaluating its long-standing strategy of developing most drugs in-house, and increasingly looking to smaller biotech companies as a way to acquire innovative drugs to replenish pipelines. However, small biotechs often have limited access to financing to efficiently progress through clinical trials while remaining private and independent. Going forward, we believe the next decade will see an acceleration of some of the critical trends that have shaped pharma strategies and pipelines historically. This will create challenges for incumbents, but opportunities for innovative new companies and technologies to come to the forefront.

 

 

Innovation is Unlocking an Emerging Model for Drug Development

 

Source: Goldman Sachs Asset Management. For illustrative purposes only.

 

Accelerating Life Sciences Product Development

Drug development is the most resource- and time-intensive segment of LS, historically requiring about 9 years (Investigational New Drug to approval) and $1-2bn to advance a single drug to approval.2 These long development timelines are the result of a traditionally rigid regulatory structure that was developed to ensure the safety and efficacy of products for human use. The drug development process continues to benefit from advancements in tools, diagnostics, technology, and regulation. As a result, we expect timelines to compress and the process to become more cost-efficient in the coming years.

 

 

Illustrative Drug Development Process

 

Source: Goldman Sachs Asset Management. For illustrative purposes only.

 

New applications of AI and machine learning (ML), adaptation of modular drug design, and improvements in clinical trial design and operations are creating a paradigm shift from a traditional model of drug discovery to an emerging model of rational drug design. This more engineering-based approach to drug development is enabling faster scalability, increased probability of success, accelerated timelines, and reduced cost.

 

Improved computing power and advancements in AI/ML techniques have made it possible to glean insights from an exponentially growing set of healthcare data. As techniques become more sophisticated, AI/ML has the potential to increase efficiency and reduce costs at many stages of drug development. One recent application is protein structure prediction, which is expected to have groundbreaking implications for science and medicine given the pivotal role that protein structure has for enabling drug discovery efforts and the arduous experimental approaches that are often needed to obtain protein structure.3 Many other examples of the value of AI/ML in drug discovery continue to emerge, with novel insights being derived for faster target identification and prioritization, more accurate identification of disease-relevant phenotypes, streamlined compound design and optimization, and precise predictions from high content imaging and digital pathology.

 

Companies engage a broad system of stakeholders that changes over the course of development—ranging from academic and research organizations in early development, to regulatory bodies and payers (i.e., insurers) that play a critical role in the approval and commercialization of drugs. To that end, advancements in the drug development process are complemented by an evolving regulatory environment, which is enabling greater flexibility. Recent regulatory modifications have more clearly defined situations where the clinical development process can be modified to better meet patient needs, ethical considerations, or specific requirements of the disease or drug modality. In the U.S., which produces the most biotech patents worldwide, the FDA has introduced new policies that are providing support for access to innovation and novel therapies.4 The result has been that annual FDA approvals doubled in the decade from 2010 to 2020.5 Similar initiatives are being undertaken by regulators in other regions, including the EMA (Europe) and NHMP (China).

 

 

"Advancements in the drug development process are complemented by an evolving regulatory environment, which is enabling greater flexibility."

 

 

Regulatory Flexibility In Clinical Trial Design...

 

  • Breakthrough designation, priority review, and accelerated approval pathway to reduce approval timelines for drugs addressing unmet needs

  • Concurrent clinical trials / adaptive design to modify trial timelines

  • Real-world evidence (RWE) to reduce trial costs and time

 

Example: Oncology products approved using the accelerated approval pathway are brought to market 4.7 years faster than traditionally approved oncology therapies.4

 

 

… More Customized Approaches Are Accelerating Drug Development

 

Priority Review

Designation for drugs that show significant improvements in safety or efficacy; directs FDA resources to shorten decision timeline to 6 months

 

Fast Track

Process designed to facilitate development, expedite review of drugs to treat conditions with an unmet medical need, to get drugs to patients faster

 

Accelerated Approval

For drugs that require an extended period to measure intended effects, approval can be granted based on surrogate endpoints in some cases

 

Breakthrough Therapy

Ability to gain approval based on preliminary clinical evidence if data indicates drug may provide substantial improvement over available therapy

 

 

Use of Policies in Novel Drug Development

 

Life Sciences charts_web

Source: US Food and Drug Administration. As of December 31, 2021.

 

 

Innovations in the Science of Life Sciences

Drug development is becoming increasingly interdisciplinary, with breakthroughs across key disciplines such as genetics, immunology, cell biology, and AI converging to create new modalities and drug platforms. Over the last ten years, the emergence of CRISPR-based gene editing has created an ability to precisely edit and manipulate genes, to correct genetic mutations, potentially treating genetic diseases at the source. A greater understanding of immunology has enabled more targeted therapies that use a patient’s own immune system to fight disease. Immune checkpoint inhibitors (i.e., drugs that block signals used by cancer cells to evade the immune system, allowing the body to recognize and kill cancer cells) are now widely used to treat a range of cancers. Engineered immunotherapies created with bi-specific antibodies and T-cell engagers (i.e., modalities that direct the immune system to target and kill cancer cells) are creating more targeted cancer therapies that greatly increase the standard of care over traditional chemotherapy and radiation approaches. Advancements in cell biology offer a complex, context-dependent ability to treat disease, with potential applications in regenerative medicine. The rapid growth in AI capabilities provide a powerful tool, not only for improved computational screening, but also for the identification of novel targets and design of new drugs. Collectively, the integration of discoveries, insights, and technologies across disciplines yields a more targeted, innovative, and effective way to treat disease through new drug platforms.

 

 

The Convergence of Breakthroughs is Creating New Drug Development Platforms with Robust Potential

 

Source: Goldman Sachs Asset Management. FDA (FDA Policies, Use of Policies).For illustrative purposes only.

 

Structural Changes Lead to New Opportunities

Scientific breakthroughs and improved regulatory frameworks are leading to structural changes that are shifting how LS innovation takes place. The evolution of life sciences startups can often mirror the drug development process, with companies experiencing different risks, opportunities, and financing needs as they reach new milestones and phases of development. As drug development processes evolve, the timeline of company formation and maturation is shifting too.

 

Smaller biotechs are often more specialized, agile, and closer to key sources of innovation (e.g., universities) than large pharma, making them better suited to advance novel therapies from concept to clinical trials. The cost of launching an LS startup and developing new IP has fallen as technology and processes have improved—similar to how cloud computing, no-code programs, and SaaS products have reduced the cost to launch a tech startup. While it is now cheaper to launch a new company and establish an initial proof of concept, it is more capital-intensive than ever to navigate clinical trial design and operations, as well as the ever-changing regulatory approval process.

 

Traditional financing models for LS have not yet adapted to the changing landscape. Not only have the number of LS startups increased, but the shift to more platform-based companies has resulted in increased capital requirements beyond the capacity of traditional sources. LS companies in the early research stage rely heavily on government or philanthropic capital that is generally not seeking a financial return (e.g., grants) to help establish a viable idea. The falling costs of launching a startup enable this initial funding to take a company further than before. Early-stage LS venture firms have been integral in supporting company formation around early ideas, with annual investment more than tripling to $18bn in the decade through 2020.6 Traditionally, LS venture firms funded companies for long periods through initial clinical trials when scientific and clinical risk remained high. However, while upfront costs have gone down, longer term capital requirements have intensified. Simultaneously, VC financing has been insufficient to meet the needs of LS startups. As a result, we believe that private growth capital provides a unique solution to companies that have a different growth curve.

 

 

Lifecycle of Life Sciences Companies is Tied to Drug Development Stages

 

Source: Goldman Sachs Asset Management. For illustrative purposes only.

 

Drug development at small companies is often facilitated through partnerships with large pharma companies, whose operational capabilities are more conducive to clinical trials, drug manufacturing, and distribution rather than drug development. The more recent focus of developing platform technologies with non-binary outcomes, as opposed to single assets, also means that biotech companies can produce diversified product lines while scaling more quickly than in the past. Large pharma companies, who are increasingly facing loss of exclusivity on top-selling drugs, look to these products developed by smaller companies to replenish existing and future drug pipelines. 

 

The Growth Gap

For companies that choose to remain independent, the increased capital needs of clinical development have led them to go public earlier in their development. Between 2014 and 2021, the percentage of biotech companies going public in pre-clinical or phase 1 stage surged from 12% to 59%.7 While biotech/pharma companies account for less than 10% of VC deals annually, the industry has consistently accounted for at least 25% of VC-backed IPOs, reflecting the need for companies to tap public markets.8

 

Many LS companies today still have high levels of scientific, clinical and regulatory risk at the time of IPO, often with binary options for success. This risk can be difficult to price in public markets, with many investors preferring opportunities at the late-clinical or commercial phase when scientific and regulatory risk has largely been minimized. To that end, the median returns 12-months post IPO declined from 59% in 2014 to -11% in 2020/21. Additionally, the daily volatility of public markets can lead LS companies to trade with broad market conditions, rather than based on the development of the underlying technology. These issues are particularly pertinent when additional financing is needed to support further clinical development, as is often the case for many early-stage companies entering public markets today. As a result, public markets are often a sub-optimal financing option for financing throughout clinical trials. 

 

 

"As the drug discovery and development process is evolving, so are company formation timelines, creating a need for new financing models and capital solutions."

 

Traditional VCs continue to support robust idea and company formation; however, these companies require substantial capital beyond this stage to fund definitive experiments to de-risk and scale the platform and develop associated therapeutics. With the increasing number of companies being formed and decreasing ability to access public equity capital, we expect this to result in an opportunity set of high quality private companies that require private capital to scale. 

 

 

Private Growth Capital Gap & Drug Development Life Cycle

 

Source: Goldman Sachs Asset Management. For illustrative purposes only.

 

A New Era Ahead

As macro-trends drive demand for better healthcare, we believe that innovations in tools, technologies, and processes for treating disease, combined with a supportive regulatory environment, has created a golden age for LS that will enable faster, better innovation globally. While significant advancements have been made in recent years, we believe we are still in the early stages of a multi-decade era of unprecedented growth. As funding for research, a growing workforce, and better global drug development infrastructure continues to enable greater supply of novel ideas, new financing models will be needed to support company formation and development. This is presenting an opportunity for private market investors with the requisite expertise and network to capitalize on a timely opportunity to advance the future of healthcare innovation through investment in LS.

 

 

 

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1 “The Top 15 Blockbuster Patent Expirations Coming This Decade.” Higgins-Dunn, Noah. Fierce Pharma, July 12, 2021.

2 “Research and Development in the Pharmaceutical Industry.” Congressional Budget Office, April 2021.

Callaway, “It will change everything”. AI makes gigantic leap in solving protein structures, Nature, 588, December 2020..

"Understanding the History and Use of the Accelerated Approval Pathway," Avalere. January 4, 2022.

5 U.S. Food and Drug Administration.

6 PitchBook. As of March 30, 2022.

7Goldman Sachs.

8 Pitchbook.

 

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