Differentiating-Oncology-Research-Pipeline-in-Today’s-Competitive-Era

Visit our latest blog here for our latest discussion around how real world data is powering advancements in Cancer R&D.

By Ciox CEO Paul Roma, Chief Digital Officer Florian Quarre, and VP of Life Sciences Julie Krommenhoek

Big pharma is increasingly doubling down on bets to develop new blockbuster cancer drugs.  Currently, approximately 700 organizations have one or more oncology drugs in late-stage development, and 14 of the world’s largest pharmaceutical companies are focusing at least one-third of their late-stage R&D activity on oncology.

Strong-late-stage-pipeline

Fig: Strong late-stage pipeline of oncology with 710 molecules in 2017, which is up by 60% in a decade from 434 molecules in 2007

With cancer treatments advancing and new innovative treatment types being introduced at warp speed, it’s no wonder oncology continues to remain the most dominant therapy segment, with annual cancer spending rising to $133 billion in 2017. Spend on cancer drugs in the U.S. has doubled since 2012 and reached almost $50 billion in 2017.

Oncology will be the fastest growing therapy area, with 12.7% of CAGR during the 2016-2022 period and sales reaching an estimated $192.2 billion in 2022. Interestingly, spending on cancer medicines is heavily concentrated, with the top 35 drugs accounting for 80% of the total expenditure, signaling a critical need to demonstrate superior effectiveness and gaining rapid traction for early pipeline expansion.

Global-Oncology-treatment-spending

Competition set to grow in the near future

The rapid growth in spending in oncology in recent years is resulting in an increase in R&D expenditures to discover novel cancer drugs.

Pharma witnessed a peak in R&D expenditure, the highest ever since 1980, by spending over 19.8% of their revenues, which adds up to a total spend of over $157 billion in 2016. Oncology as a therapy area enjoys the largest share of R&D investments in Pharma, as compared to other therapeutic areas, with around 4,500 cancer molecules (one-third of the total molecules) under development.

Clinical trial success rate has also significantly increased in oncology:

  • Phase I oncology trials had a 23% chance of success in 2012, which increased to a 66% chance of success in 2016.
  • Phase III oncology trials had a 40% chance of success in 2012, which increased to a 73% chance of success in 2016.

FDA approvals for NMEs in oncology

Year Total NME Approvals Oncology NME Approvals % of Oncology NMEs
2014 41 7 17%
2015 45 14 31%
2016 22 6 27%
2017 46 13 28%
2018 59 17 29%

Novel therapies being launched

Advances in cancer treatment are occurring rapidly, with more patients surviving cancer than ever before. Patients are receiving the benefits of oncology experts utilizing the most innovative, life-extending therapies that are getting approvals and indication expansions in record time.

With the advent of new immunotherapies and CAR-T / gene therapies, oncology is witnessing an unprecedented era of treatment and care.

Single-vs-Multiple-Indications

Immunotherapy: Immunotherapies gained traction because of their potential to significantly increase a cancer patient’s remission and survival. Currently, over 300 immuno-oncology therapies are in various stages of development, with trials being conducted across 27 different tumor types.

CAR-T / gene therapy: CAR-T, also known as “cancer’s newest miracle cure” has been gaining considerable momentum from pharma companies. In Aug 2017, Kymriah of Novartis became the first CAR-T to be approved by the FDA, followed by Gilead / Kite’s Yescarta in Oct 2017. In May 2018, Kymriah received second approval to treat appropriate r/r patients with large B-cell lymphoma.

New therapies such as Immunotherapy and CAR-T have the potential to treat multiple onsets and a broad array of cancer types. Development of I/O will lead to an increase in the number of oncology products catering to multiple indications, and a consequent decrease in the number of oncology products catering to a single indication only.