Request for Proposals

Loop-mediated Isothermal Amplification (LAMP) technology, manufacturing and market access assessment.

Location: Remote

Type of assignment: Consultancy / Independent Contractor

BACKGROUND 

The Medicines Patent Pool (MPP) was established by Unitaid in 2010 as a public health organization with a mandate to accelerate access to affordable and quality-assured HIV treatments in developing countries through an innovative voluntary licensing (VL) and patent pooling mechanism. It negotiates intellectual property (IP) licensing agreements with patent holders to allow generic manufacture and supply of medicines in low and middle-income countries (LMICs). Through its innovative business model, MPP partners with industry, governments, civil society, international organizations, patient groups and other stakeholders. To date, MPP has signed agreements with 20 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, three oral antiviral treatments for COVID-19 and 15 COVID-19 technologies. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation and SDC. More information at https://medicinespatentpool.org/

The World Health Organization (WHO) Health Technology Access Programme (HTAP) advances global health security and equitable access to health products by expanding regional innovation and manufacturing capacity. HTAP selects priority technologies and coordinates partners to share know-how, support technology transfer and to make health products available for communities that need them.  HTAP fosters partnerships to facilitate know-how sharing and technology transfer.  WHO HTAP (HTAP; previously the COVID-19 Technology Access Pool [CTAP]) in partnership with MPP has secured 7 transparent, non-exclusive global licenses involving 16 technologies that span diagnostics, vaccines and R&D tools. Under HTAP, the scope of MPP’s support has expanded to technology transfer for diagnostics as demonstrated by the in-licensing agreement with SDB Biosensor Inc., and technology transfer support and out-licensing agreement with Codix Bio for rapid diagnostic test technology. Following a recent assessment of medical devices technologies submitted to HTAP, the Loop-mediated Isothermal Amplification (LAMP) technology was identified as a potential technology to support geo-diversified manufacturing. Preliminary analysis has highlighted the applicability of the LAMP technology to different pathogens including in response to health emergencies. 

OBJECTIVE 

The objective of the assessment is to provide a comprehensive evidence base on the LAMP technology innovation, intellectual property landscape, market access (procurement, supply and use of LAMP products) and manufacturing landscape. The assessment outputs will inform MPP and WHO HTAP towards understanding of the LAMP technology development, manufacturing and market access landscape, and guide tailored MPP/ WHO HTAP technology transfer mechanisms needed to enable increased manufacturing capabilities in LMICs. 

REQUIRED PROFILE:  

• Individual/Team’s expertise in Diagnostics [including R&D or product development], Health systems, Market Access, Global Health 
• Project management and customer service skills; Excellent communication skills, including professional/ scientific writing and the ability to synthesise scientific information for scientific and non-scientific audiences.  

Proposals will be assessed according to the following criteria:  

• Breadth, depth and relevance of data and information to be collected;  
• Cost of the budget proposal; 
• Timelines;  
• Prior experience of the team assigned to the project;   
• Firm track record in customer satisfaction;  
• Note: prior experience working with MPP is a value-add.  

SCOPE OF WORK:  

MPP and WHO HTAP are seeking a highly experienced consultancy firm/team/ individual to assess the technology development, manufacturing and market access landscape of the Loop-mediated Isothermal Amplification (LAMP) technology covering the detailed thematic areas listed below with a focus on LMICs. 

1. Technology innovation landscape: Mapping of the global research, innovation and product development landscape for LAMP technology including: 

1. 1. Global Mapping of the technology pipeline and products: Overview of research, innovation, and product development in LAMP technology (human medicine and veterinary medicine), focusing on products in development and clinical evaluation that target epidemic and pandemic-prone diseases1 and diseases prioritised by MPP2 (human medicine). Overview of Market-authorised products based on LAMP technology (human medicine). 
   2. Adoption Trends: Use of LAMP technology across life sciences markets, with a focus on the diagnostics market landscape.
   3. Technology Funding: List of leading funding entities supporting LAMP development and scale-up.
   4. Competitive Technologies: Alternative or emerging technologies that may compete with or replace LAMP, including key players, market readiness, and maturity.

2. Intellectual property landscape: Provide an overview of the human medicine related LAMP technology intellectual property landscape and summary of technology developers – including IP filing trends, start-ups, IP related mergers & acquisitions, academic developers, SMEs, diagnostics firms (with a focus on entities that are recipients of public or philanthropic funding). 

3. Manufacturing landscape:  

1. Assessing the global LAMP manufacturing landscape by region, scope of manufacturing capabilities, installed capacity, current volume, product compliance & certifications, market share and focus (e.g., global procurement vs. regional markets), and historical supply performance.  
2. Assessment of LAMP supply chain (reagents, instruments, accessories), and other critical/non-critical components.
3. Landscape of regional incentives or existing barriers or delays to include or exclude LAMP technology-based products in regional manufacturing. 

4.Health system readiness and use enablers (Human Medicine):  

1. An overview of the infrastructure and health facility requirements for the use of LAMP diagnostic products, including the equipment, maintenance, and operational (including training) considerations for the health workforce.
2. Information related to global, regional and national guidelines for the procurement and use of diagnostics based on LAMP technology. 
3. Summary of the barriers and enablers that may affect adoption and use in health facilities, e.g., workforce requirements, storage facilities, cold-chain, laboratory facilities, uptake and end-user use, etc.  

5. Market access dynamics:  

1. Global and regional market demand for existing market-authorised LAMP diagnostics by disease area, including pricing trends and distribution models. For products in development, provide data related to modelled demand estimates.
2. Information related to barriers to access, such as pricing, supply chain vulnerabilities, market penetration in LMICs, and cost-effectiveness analyses, to understand the potential value of addressing these barriers through increasing LAMP products manufacturing capacity in LMICs. 

The information mentioned above represents an example and does not represent an exhaustive list of data required for the assessment.  

TIMELINES OF THE PROJECT: 

We expect to have an inception meeting within a week of initiating the contract, with the firm/team providing a methodology, work plan, stakeholder mapping and data sources that will guide the report. We expect the first draft of the required outputs to be delivered by November 23rd November 2025. MPP/ WHO HTAP will, then, provide its feedback to support the development of the final report that is expected by end of January 2026. Therefore, the time available for the consultants to implement the assessment is around 8-10 weeks.    

EXPECTED DELIVERABLES: 

• The detailed data collected and the submission of analytical data, and supporting
• A report on findings per thematic area 
• Any other presentations, as required by MPP.  

SUBMISSION OF PROPOSALS: 

Interested applicants/team who meet the requirements are requested to send their proposal in English including: 

• Statement of interest with an overall description of the approach proposed to respond to the expectations of this RFP, including the necessary requirements (proof of qualifications and skillset etc.) 
• Proposed methodology to assess the products and technologies as described in this RFP.
• Supporting evidence of conducting similar activities in the diagnostic space 
• Timeline with an estimated number of days necessary to deliver the assignment.
• Financial proposal in USD including a budget justification for all costs associated with this project 

to recruitment@medicinespatentpool.org mentioning “RFP – LAMP technology and market access assessment” in the email subject by  3rd November 12 PM (noon) CET.  If you need additional information, please reach out to Cheleka Mpande at cmpande@medicinespatentpool.org.  

All applicants must adhere to the MPP Conflict of Interest Policy and the Code of Ethics.  

MPP will review the proposal after the application closing date. Please kindly note that only shortlisted applicants will be contacted.