Enabling Innovation: Oncology Market Outlook 2020 (2023)

about the pastOver the past 50 years, outcomes for people diagnosed with cancer have changed. In 1970, about half of the cancer patients in the United States were still alive five years later. For patients diagnosed in 2009, the figure was closer to 70%.1Journal of the National Cancer Institute; Surveillance, Epidemiology, and Outcomes Program; see also Hannah Ritchie's data visualization, Cancer Deaths Are Falling; Five-Year Survival Rates Are Rising”, Our World in Data, February 2019 4, ourworldindata.org ; Cancer facts and figures 2020, American Cancer Society, cancer.org.This shift in outcomes has been achieved through a combination of public health interventions (such as smoking education), improved healthcare (such as early detection), and new drug therapies. This triad has transformed some diagnoses that were once considered incurable into chronic conditions. For example, the mortality rate in most patients currently diagnosed with multiple myeloma or prostate cancer is related to diseases other than cancer. Additionally, oncology therapies accounted for $143 billion in branded drug sales in 2019, accounting for about 20% of global drug sales.2 Product Sales, EvaluatePharma® July 2020, Evaluate Ltd.Analysts agree that global oncology therapy sales are expected to reach $250 billion by 2024, with a strong compound annual growth rate (CAGR) of 12%.

However, there is still a lot to do. The five-year survival rate for pancreatic cancer, glioblastoma and non-small cell lung cancer (NSCLC, the most common form of lung cancer) remains below 50 percent in treated patients. These three cancers account for more than 250,000 new diagnoses each year in the United States alone.3 Cancer Statistical Facts, Surveillance, Epidemiology, and End Results (SEER) Program, National Cancer Institute, seer.cancer.gov.Despite considerable, justified excitement about the use of PD-(L)14 Refers to PD-1 and PD-L1 therapies.In NSCLC, the response rate remains below 50%.

In addition, we found significant differences in results between regions. Five-year survival rates for non-Hodgkin's lymphoma (NHL) vary - 63% in Northern Europe to 50% in Eastern Europe - and 10-year survival rates for breast cancer - new EUROCARE 5 results show - 76% in Northern and Eastern Europe accounted for 65%.5 Has cancer care improved in Europe since the 1990s? : Latest results of the EUROCARE-5 study, European Cancer Congress, Vienna, Austria, 25-29. September 2015, eurocare.it.Although China still lags behind developed markets, performance has improved significantly; for example, the five-year overall survival rate for all cancers diagnosed in 2013 was estimated to be around 40%, compared to five years. The annual survival rate is about 30%.6Peter Baade et al., „Changes in cancer Survival in China 2003-15: A pooled Analysis of 17 population-based cancer registers“, The Lancet, mei 2018, Band 6, Nr. 5, Nr. 555- 67 Seiten, thelancet.com.Still, there is ample opportunity for China to bring further innovation to the 4 million patients diagnosed each year (see box “China's 4 million new patients each year, a major unmet need”).

Innovations in oncology are gaining momentum. While about eight years elapsed between the first treatment of HER2-positive patients in 1999 and the next treatment, the first PARP inhibitor hit the market in 2013 and the next was less than two years away. The next wave of innovation for patients is happening at an ever faster pace around the world. Dynamism and innovation are expected in immuno-oncology treatments, with more than 550 active cell and gene therapy agents in clinical development.

We examine the current state of the global oncology drug market to determine where to invest, where unmet need is greatest and where competition is fiercest. Our analysis also uncovers five disruptive trends that could change the strategic priorities of oncology pharmaceutical leaders - and potentially even the face of the oncology market itself.

Oncology is the largest drug therapy area in the world and is highly competitive

Advances in oncology have significantly improved patient outcomes (Figure 1). But with the heavy investment in oncology research and development, both academia and industry, experts agree that much more needs to be done. Oncology is a priority area announced by the top ten pharmaceutical companies, with an estimated 1,700 clinical compounds in development (approximately one-third of the global clinical pipeline across all therapeutic areas).7 compounds in clinical development (phase I-III), excluding reformulated and biosimilars, Pharmaprojects, 2019, pharmaintelligence.informa.com.For NSCLC, approximately 100 active phase III trials in the US represent approximately 75,000 patients. For ALL, about 25 studies required the enrollment of more than 32,000 patients into clinical trials - more than the number of people who were newly diagnosed in one year.8 Retrieved from Clinicaltrials.gov, October 24, 2019. Include interventional trials with one of the following enrollment statuses: enrolling, active, not enrolling, or invited to enroll.

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In addition to extensive organic R&D by Big Pharma and numerous clinical-stage biotechs, we've also seen a spate of multi-billion dollar oncology acquisitions (e.g., Pfizer's $11 billion acquisition of Array BioPharma in 2019) and partnerships (including a $3 billion acquisition observed collaboration between AbbVie and Genmab on bispecific antibodies). Enthusiasm for oncology goals has resulted in a high contract premium. Over the past five years, the average oncology acquisition premium has been about 100% for deals valued at more than $5 billion.

However, if past trends repeat themselves, a fraction of these assets will shape future markets (Exhibit 2). The current success rate (from first human trial to commercial launch) in oncology is approximately 13%, with an average development time of 9.5 years.9 McKinsey based on an analysis of success rates of oncology development programs excluding reformulations and biosimilars from 2008 to 2018; Time to market based on median time to win based on oncology development programs excluding reformulations from 2010 to 2018. Formulations and biosimilars; see Pharma Projects, 2019, pharmaintelligence.informa.com.Post-launch results also vary wildly: Seven products valued at more than $5 billion accounted for 39% of sales in 2019, and more than half of products launched in the last five years are self-administered record a decline in sales at their peak. Generate over $500 million per year10 Product Sales Estimate, EvaluatePharma® July 2020, Evaluate Ltd.(Appendix 3). While the clinical pipeline is full of promising prospects, it is likely that only a small portion has sufficiently transformative benefit-risk profiles to drive ROI.

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(Video) Global Oncology Opportunities & Trends 2025: Key Markets, Indications and Products

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The oncology market encompasses many different indications

Although oncology is often grouped together as a single therapeutic area, it encompasses more than 20 different indications, with five of these indications accounting for the majority of current sales. In 2019, breast cancer, multiple myeloma, NSCLC, prostate cancer and NHL generated $90 billion in revenue (68% of the market). This number is expected to increase to US$141 billion (64% of the market) by 2024, primarily due to increasing sales of NSCLC PD(L)1.11Produktechattingen，EvaluatePharma® Juli 2020，Evaluate Ltd.While each of these five indications has significant morbidity and unmet need, sales correlate better with the presence of a handful of breakthrough therapies (Figure 4).

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In the commercial environment, most large pharmaceutical companies focus on synergistic subsets of indications with overlapping focuses and key opinion leader relationships. However, in a research and development setting, scientists do not know where new treatments work beyond their hypothesis. We therefore see that most players are exploring a broader range of indications by applying more “targeting” – the more indications they address, the more likely their approach is to result in a blockbuster product (Figure 5).

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Oncology growth, strategic focus area status and potential focus areas are influenced by four overarching trends by indication and indication group:

• Growth potential in mature markets.In the short term, manufacturers are expected to continue their high market growth by expanding the geographic coverage and areas of application of these therapies, for example by switching to previous treatments in addition to surgery. While there remains an unmet need (in many cases, the five-year survival rate for patients with metastatic disease is less than 50%), standard of care has set a high bar and requires truly transformative therapies to gain approval and use. The main indications are multiple myeloma, HER2 and ER+ breast cancer, prostate cancer, renal cell carcinoma and lung cancer mediated by anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR).
• The patient's treatment effect continued to be poor.This indication group is the holy grail of oncology research and development and is characterized by poor patient outcomes (less than 15% five-year survival rate) and very high patient numbers (more than 30,000 new patients per year in the US). Currently, only limited therapies are available for these indications or response rates to existing therapies are poor. Therefore, any effective therapy would offer an opportunity to change the standard of care, reshape cancer at the therapeutic level, and be extremely attractive from a commercial perspective. The main indications are colorectal cancer, hepatocellular carcinoma, pancreatic cancer, non-ALK and non-EGFR NSCLC.
• There are large patient populations with unmet needs.A large group of cancers with significant unmet needs (five-year survival rates less than 30% in most cases) and sizeable patient populations—typically 5,000 to 30,000 new patients diagnosed in the US each year (Figure 6). Despite the relatively small unmet need for developing effective therapies, it is commercially attractive. In the absence of more innovative therapies, chemotherapy remains the standard of care for most patients. Key indications include soft tissue sarcomas, gastrointestinal stromal tumors and triple negative breast, small cell lung, ovarian, uterine and esophageal cancers.
• niche cancer.Manufacturers have the opportunity to respond to a large number of less common cancers that affect fewer than 5,000 people each year. While the unmet need for certain indications, e.g. B. glioblastoma, is very high, the smaller patient population requires a new approach to the development and commercialization of effective therapies. This approach could include site-independent approvals to group many niche cancer types or orphan drug approvals to allow rapid market entry. The main indications are T-cell carcinoma, thyroid carcinoma, glioma and glioblastoma.

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Disruptive trends are expected to impact oncology in the years to come

Despite the pharmaceutical industry's track record in oncology, there are still significant unmet needs that need to be addressed. Five trends that could revolutionize the already changing innovation landscape in oncology.

New cell and gene therapies

The last five years have been marked by a growing enthusiasm for new therapies, including cell therapies, viral vectors, RNA therapies and stem cell therapies. In oncology, two chimeric antigen receptor T-cell (CAR-T) therapies, Kymriah and Yescarta, have been approved for the treatment of acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL) with unprecedented efficacy. While CAR-T sales are currently modest, hundreds of compounds are being tested and sales are projected to exceed $6 billion by 2024.12Vanessa M. Hubbard-Lucey, Jun Tang and Jia Xin Yu, "A Global Pipeline of Cancer Cell Therapies", Nature, 30 May 2019, nature.com.However, cell and gene therapies are wreaking havoc on current healthcare approaches as manufacturing and supply chain processes become more complex, particularly for autologous therapies. These therapies also have longer lead times and more sophisticated treatment regimens, and - since many have the potential for one-time cures - more complex market access considerations. asDepartment of Cell and Gene TherapyTo fulfill their promise, they willA fundamental change is requiredIn healthcare paradigms and business models, including delivery systems with economic incentives and access models that achieve and reward long-term benefits.

precision medicine

Precision medicine – getting the right drug to the right patient at the right time – is advancing at a rapid pace. Oncology is at the forefront of this trend: more than 160 tumor biomarkers were approved in 2019, and more than 90% of crucial research focused on molecular targets.13 Table of Pharmacogenomic Biomarkers in Drug Labeling, Food and Drug Administration, December 2019 update, fda.gov.As more therapies target subpopulations, driving the adoption of biomarker testing and patient mapping and discovery will be a key competitive advantage. For example, in addition to the three most common mutations in NSCLC (mutations associated with the ALK and KRAS genes and the EGFR protein), there are also a large number of less common mutations, each accounting for less than 3% of patients.14Dara L. Aisner et al., “Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: experiences from the Lung Cancer Mutation Consortium”, Journal of Thoracic Oncology, Vol. 10, No. 5, No. 768 – May 2015. 77, Japan Trade Organization . Tissue; Ethan Cerami et al., "Prospects for kinase fusions in cancer", Nature Communications, 10 September 2014, vol. 5, nature.com; Julie M. Batten et al., "ROS1 rearrangement defines unique molecular classes of lung cancer", Journal of Clinical Oncology, 10 March 2012, Vol. 30, No. 8, 863-70, ascopubs.org.Ways to increase test uptake can include working with test providers and governments, and promoting physician education. Once tested in patients, different approaches can improve treatment acceptance. This includes identifying prescribing potential based on electronic health records and engaging key stakeholders, such as patient advocacy groups, to better understand patient-physician relationships. journey in between. Additionally, as pharmaceutical companies develop therapies for smaller patient populations, exploring new clinical trials and business models will be crucial to ensure costs are reasonable for the potential patient population.

Accelerate the development schedule

As more pharmaceutical companies move into the field of oncology, competition for important targets has intensified. We estimate that nearly 80% of new clinical drugs target one marketed therapy or four or more clinical competitors.15 Pharmaceutical Articles | Informa December 2017. McKinsey analysis based on number of new assets tracked by MOA (based on primary objective), excluding new assets for which MOA was not disclosed; see Pharmaprojects, 2017, pharmaintelligence.informa.com.Increasing competition has shortened development cycles, with competing therapies entering the market soon after their initial commercial launch. To thrive in this environment, new development paradigms must be explored, including a greater emphasis on prior studies (as 54% of breakthrough asset approvals are based on Phase I or Phase II studies).16 Based on assets with breakthrough designations approved between 2013 and 2019, Breakthrough Therapies, Friends of Cancer Research, updated June 2020, focr.org.), site-independent approvals (e.g. Keytruda for MSI-H or dMMR mutations and Vitrakvi for NTRK mutations) and examining real-world evidence for the expansion of specific treatment indications (e.g. Ibrance for male breast cancer or ongoing Opdivo Study ATTRACTION-2). carried out).

Immuno-oncological combination therapy

Companies have increased investment in collaborative immuno-oncology research, with more than 200 mechanisms currently being investigated as joint PD-(L)1 or CTLA-4 partners, and immuno-oncology assets are estimated to account for about half of the top 10 the far However, widespread use of combination therapies complicates study design, especially when no combination partners are currently approved or the additional costs of a combination partner have to be covered for the clinical trial. At launch, these combination therapies are expected to result in higher treatment costs and may require new models to collaborate with payers and demonstrate cost-effectiveness.

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new listing model

The changing development landscape requires pharmaceutical companies to fundamentally rethink how they deliver medicines to physicians and patients. Treatment modalities have become complex and patient numbers have declined. For example, in NSCLC there are several oncogenic driver mutations such as ROS1, BRAF, NTRK, EGFR, HER2 and MET, each with their own targeted therapy. At the same time, larger and more sophisticated decision-making tools and associated advanced analysis algorithms help prescribers determine the right treatment for a given patient. In addition to identifying the right treatment, pharmaceutical companies are increasingly offering “white glove” services to assist patients with difficult treatment plans. This is particularly relevant for new cell therapies.FDA approval of CAR-T is expected to increaseFrom two in 2019 to 24 in 2024. These new treatments face challenges in both manufacturing and commercialization. Most assets, including all marketed CAR-Ts and approximately 75% of treatments in development, are autologous, meaning they require costly single-batch production methods. At the same time, only a handful of sites have the appropriate infrastructure and are CAR-T certified, requiring a high-touch business model to bring these emerging therapies to patients, providers, and payers.

Overall, we believe that the oncology therapeutic area will continue to have meaningful and transformative potential for patient outcomes. Significant unmet needs remain in many indications in the United States and worldwide. The potential for innovation is enormous, both in terms of the number of new drugs being tested and investments in the pharmaceutical industry. Precision medicine and new treatments, including cell therapy, have tremendous potential to transform patients' lives. To realize this potential, however, pharmaceutical companies must innovate in ways to shorten development timelines, develop combination therapies, and—crucially—find effective ways to bring those therapies to market.