New Drug Launches Will Drive Rapid Growth in the US and EU Pancreatic Cancer Market from 2012 -2017, According to New Report

Publisher estimates that the value of the pancreatic cancer market in the US and 5EU (France, Germany, Italy, Spain, and the UK) in 2012 was $529m. This market is defined as sales of branded drugs and major generic regimens commonly prescribed for pancreatic cancer patients across the six major markets (6MM). Just over half of these sales, $275m (52%), were generated in the US, while sales in the 5EU were estimated at $254m (48%).

By 2017, the end of the forecast period, Publisher projects pancreatic cancer sales to rise to $1.63 billion in the US and 5EU, at a high Compound Annual Growth Rate (CAGR) of 25.2%. Publisher expects the proportion of sales from the US to increase to 72%, with market share in the 5EU decreasing to 28% by 2017. The overall rapid increase in the market size across the 6MM is attributed to the launch of Celgene’s Abraxane in 2013 in the US and 2014 in Europe, and the incorporation of five pipeline agents into US clinical practice by the end of the forecast period. Publisher forecasts sales of Abraxane to rise significantly, from $21m in 2012 to $954m in 2017, at a CAGR of 115%; sales of Abraxane will represent nearly 60% of the pancreatic cancer market by the end of the forecast period.

Major drivers of the pancreatic cancer market in the US and 5EU during the forecast period include the following:

• The greatest driver of the pancreatic cancer market across the 6MM will be the strong and rapid adoption of premium-priced Abraxane in place of generic chemotherapy regimens, such as FOLFIRINOX (5-flourouracil [5-FU]/leucovorin/irinotecan/oxaliplatin) and gemcitabine monotherapy. Publisher forecasts particularly strong growth in the US, the largest market for pancreatic cancer therapeutics, and the market where Abraxane is priced the highest.
• Of the five new pipeline agents that will be launched during the forecast period, NewLink Genetics Corporation’s algenpantucel-L is expected to garner the highest sales, and is expected to launch in both the resectable and unresectable locally-advanced settings. Other drugs with significant forecast sales by 2017 include Threshold Pharmaceuticals/Merck’s TH-302, and Merrimack Pharmaceuticals’ MM-398.
• The incidence of pancreatic cancer is increasing across the 6MM, resulting in further treatment opportunities for premium-priced therapeutics.

Barriers to the growth of the pancreatic cancer market in the US and 5EU during the forecast period include the following:

• The patent expiry of Roche’s Xeloda will be a barrier to growth for the pancreatic cancer market. Xeloda is prescribed off-label across the 6MM as an oral alternative to 5-FU. Due to cost-containment pressure, Publisher expects rapid generic erosion of the brand’s market share following its patent expiry.
• In the 5EU, Publisher expects it to become increasingly challenging for companies to successfully gain reimbursement for premium-priced therapies for pancreatic cancer unless they offer major efficacy advantages over the current standards of care. Without reimbursement coverage by national health services, the uptake of branded therapies could be significantly depressed.
• Cost-consciousness in the EU due to the economic crisis will limit the pricing of newly-launched therapies for pancreatic cancer. Even the US market, which historically has had few constraints in terms of pricing, is facing pressure from healthcare authorities, physicians, and patients for the improved cost-effectiveness of drugs that are approved by the Food and Drug Administration (FDA).

Celgene’s Abraxane Will Become the Dominant Brand Across the Pancreatic Cancer Market

Celgene’s Abraxane was approved in the US and Europe in 2013 and 2014, respectively, for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. The first-line metastatic setting is the most commercially lucrative due to the high proportion of pancreatic cancer patients diagnosed with advanced disease. Key opinion leaders (KOLs interviewed by Publisher reported the rapid adoption of Abraxane into clinical practice and expect the drug to also be prescribed off-label for unresectable, locally-advanced patients and for second-line metastatic patients who have not received the drug in the first line. As the new standard of care for the widest range of metastatic patients — namely, patients with good or average performance status — Publisher expects GemAbrax (gemcitabine/Abraxane) to become a backbone regimen for future clinical trials of targeted agents, ensuring that Abraxane sales will be maintained, even if future pipeline agents demonstrate an efficacy benefit. Finally, with a Phase III trial of GemAbrax having been initiated in the resectable setting, Publisher anticipates that Abraxane will become fully-entrenched throughout the major segments in the pancreatic cancer market well beyond the forecast period of this report.

High Unmet Need in Pancreatic Cancer Will Remain Unfulfilled Without Predictive Biomarker-Driven Targeted Therapies

Due to the poor survival outcomes of patients across the pancreatic cancer spectrum, this indication has historically always been identified as one with some of the highest unmet need in oncology. Despite the approval of Abraxane, KOLs noted that this high unmet need is still prominent. Based on KOL insight, Publisher has identified a high unmet need for efficacious treatment options for patients across the disease spectrum, including drugs that can improve cure rates in the adjuvant setting, and novel treatments that can provide a major improvement in efficacy to extend survival well over a year in the metastatic setting. Although the approval of Abraxane in combination with gemcitabine has been welcomed by KOLs, they are not satisfied with the overall survival (OS) benefit of two months compared with gemcitabine monotherapy, and called for novel, predictive, biomarker-driven targeted therapies in order to substantially extend survival. The pancreatic cancer setting is playing catch-up with other oncology indications in regards to such strategies; it is apparent that pancreatic cancer is awaiting its own Zelboraf (vemurafenib) or Xalkori (crizotinib) - namely, a drug that can be used to treat carefully selected patient populations and personalize treatment options for these patients.

Without any of the late-stage pipeline agents being developed with such a strategy in mind, Publisher expects these unmet needs to remain unfulfilled by the end of the forecast period.

Pipeline Agents for First-Line Metastatic Disease Will Struggle to Compete with Abraxane

With the launch of Abraxane, the first-line metastatic setting has become more competitive. This is particularly the case for patients with good performance status, a setting where FOLFIRINOX or GemAbrax is primarily utilized. KOLs see Threshold Pharmaceuticals/Merck’s hypoxia-targeted chemotherapy, TH-302, as the most exciting pipeline drug in the first-line setting; however, the drug is being investigated in combination with gemcitabine, a backbone that has now been superseded by GemAbrax. Even if a survival improvement is obtained with TH-302/gemcitabine over gemcitabine alone, KOLs contend that TH-302 will struggle to gain uptake without head-to head-studies compared with GemAbrax.

Pipeline Drugs for Niche Patient Populations Are Expected to Garner Rapid Uptake

The late-stage pipeline for pancreatic cancer consists of six agents that are in Phase III of development. Of these, only NewLink Genetics’ algenpantucel-L is being investigated in the early-stage resectable setting. Based on KOL insight and clinical data, Publisher expects algenpantucel-L/gemcitabine to demonstrate an OS advantage over gemcitabine alone, although the efficacy advantage is not anticipated to be a drastic improvement.

The lack of treatment options for pancreatic cancer patients is, however, expected to facilitate the rapid uptake of this immunotherapy. Other niche settings in pancreatic cancer include the second- and third-line gemcitabine pretreated patient populations. Publisher anticipates these segments to be the settings in which the pipeline drugs could demonstrate the greatest impact on efficacy, as there are no standard-of-care regimens for these patient populations. Therefore, if a stellar efficacy benefit is observed, pipeline agents such as Merrimack Pharmaceuticals’ MM-398 and Immunomedics’ 90Y-clivatuzumab tetraxetan have the potential to gain rapid uptake for the treatment of GemAbrax-refractory pancreatic cancer.

Strong Early-Stage Pipeline is Indicative of Remaining High Commercial Opportunities in Pancreatic Cancer

Publisher has identified a strong early-stage pipeline for pancreatic cancer. Innovative strategies include immunotherapies, janus kinase/signal transducer and activator of transcription (JAK/STAT) inhibition, mitogen-activated protein kinase/ phosphatidylinositol-4,5-bisphosphate 3-kinase (MAPK/PI3K) pathway inhibitors, cancer stem cell-targeting agents, and poly (ADP-ribose) polymerase (PARP) inhibitors. Strikingly, in comparison with the late-stage setting, Big Pharma is playing a much stronger role in the investigation of these strategies.

Companies such as GlaxoSmithKline (GSK), Novartis, Roche, AbbVie, and AstraZeneca are involved in investigating drugs in early-stage clinical studies in pancreatic cancer patients. Publisher anticipates a high commercial reward for the developers of drugs that are able to fulfill some of the remaining high unmet need across the patient segments in pancreatic cancer. In particular, Publisher expects the developers of efficacious immunotherapies or novel, predictive, biomarker-driven targeted therapies to be able to command premium prices in the US.

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