Roche Holding AG
Rank 19 in 2016
Roche lands at 10th, rising 9 places since the 2016 Index and 2 places compared with 2014. Roche focuses on access to cancer care and improvements in performance can in part be attributed to the inclusion of cancer in scope.
Rises 17 places to 2nd due to a refreshed access-to-medicine strategy governed by board members, and an innovative global access programme aimed at access to HIV diagnostics.
Holds steady at 4th through ensuring third-party compliance with its standards, and rewards for sales agents are not solely based sales targets.
Rises 5 places to 14th but places in third quartile as it lacks a clear process for the development of access plans for its late-stage projects.
Rises 12 places to 8th due to an improvement in the range of pro-
ducts that have equitable pricing strategies, extended to further countries.
Falls 6 places to 17th. Overtaken by peers in IP sharing, with no current engagement in licensing.
Rises 10 places to 9th with multiple capacity building initiatives with a focus on cancer control.
Rises one place to 11th. Engages in three structured donation programmes focused on cancer, including for trastuzumab (Herceptin®).
Improve access plans for R&D projects during development. Roche can improve its process to develop access plans by expanding this process to all projects for diseases in scope. Currently, Roche considers access in an ad hoc manner and utilises a general market access approach for its R&D projects without tailored access plans for diseases and countries in scope. Considering the unique barriers to access that affect those living in low- and middle-income countries, Roche can help ensure more patients globally can access products as soon as possible following market approval.
Build on strong capacity building initiatives. Breast cancer has the highest incidence of all cancers in countries in scope. Roche's Partnership to Improve Breast Cancer in Kenya is focused on increasing awareness and screening, improving diagnosis and treatment, and training healthcare professionals. This initiative meets all good practice standards. It is working in line with Kenya's national strategies to improve non-communicable disease (NCD) care, including breast cancer. Roche can identify other countries with national strategies for NCD or cancer control and partner to improve breast cancer care.
Expand access through increasing supply. Roche can identify generic medicine manufacturing partners for the non-exclusive voluntary licensing of products for high-burden diseases. Products could include rituximab (MabThera®) listed on the 2017 WHO Model List of Essential Medicines (WHO EML) for diffuse large B-cell lymphoma, chronic lymphocytic leukaemia, and follicular lymphoma. This can be facilitated through the newly expanded Medicines Patent Pool (MPP) mandate to include patented medicines on the WHO EML in its patent pooling and voluntary licensing strategy.
Focus expertise in diagnostic devices to address more priority R&D product gaps. Roche has an extensive portfolio of diagnostic devices and the largest number of diagnostic candidates in the pipeline. It can use its expertise to expand its diagnostic development to address more identified priority R&D product gaps in priority areas where it is currently active or has been active (HIV, viral hepatitis B and C and tuberculosis) as well as expanding its arsenal of diagnostic tests for specific pathogens, such as those responsible for diarrhoeal diseases, including V. cholerae and Shigella species.
Change since 2016
- Refreshed its access-to-medicine strategy with clear targets through its Access Planning Framework, which focuses on ensuring availability by working on awareness, diagnosis, healthcare capacity and funding.
- Partnered with the government of Niger State, Nigeria to provide high-quality drugs and free treatment for breast cancer patients and build capacity for prevention and care.
- Joined Access Accelerated with multiple initiatives focused on cancer care. It has also committed to measure impact and share results publicly via Access Observatory.
- Participates in Brazil's Partnerships for Productive Development to transfer production of biologic products, and provides training as part of the transfer.
- Launched in August 2016, a five-year partnership with the Kenya Ministry of Health in order to improve care and treatment for breast cancer.
- Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform
Pipeline and Portfolio
for diseases and countries in scope
Comparatively large pipeline: 100 R&D projects for diseases in scope (89 medicines; 11 diagnostics).
Clinical candidates: 82, including a novel inhibitor for the treatment of influenza and five Phase I medicines for the treatment of hepatitis B virus.
Regulatory approvals: 7, including atezolizumab (Tecentriq®) for the treatment of bladder and lung cancers.
R&D focus: non-communicable diseases (cancer and diabetes mellitus) and communicable diseases (viral hepatitis B).
Access provisions: for 2 projects, one of which has an equitable pricing commitment and the other with registration and supply strategies.
Comparatively large portfolio: 123 products for diseases in scope (90 diagnostics; 20 medicines; 13 platform technologies).
Portfolio focus: non-communicable diseases (cancer and ischaemic heart disease) and communicable diseases (viral hepatitis B and C and HIV/AIDS).
Essential medicines: 65% of Roche's medicines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 55% of Roche's medicines have first-line indications for diseases in scope.
Two business units: Pharmaceuticals and Diagnostics. Its pharmaceutical business has five therapeutic areas (oncology; infectious diseases; immunology; ophthalmology; and neuroscience). Its diagnostics business has four business units (Centralised and Point of Care Solutions, Diabetes Care, Molecular Diagnostics and Tissue Diagnostics).
M&A news: Activity includes the 2018 acquisition of Ignyta, a biotechnology company focused on oncology therapeutics; merger with Foundation Medicine, which develops and markets genomic analysis diagnostics for cancer.
Presence in emerging markets: In 2018, Roche reports sales in 77 countries in scope; 11 less than in the 2014 Index. It reports that more than 25% of its sales in 2017 came from Asia and Latin America.
*Figure excludes 11 projects that do not fall into the listed phases of development: e.g., technical lifecycle projects, diagnostics, platform technologies, vector control products, investigator sponsored trials and Phase IV projects.
**Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
***See Appendix IV for definition.