This section outlined the foresight methodology employed to achieve the research objectives. The study utilized a mixed-method approach, combining both quantitative and qualitative designs. As a foresight methodology framework, we used the Political, Economic, Social, Technological, Environmental, and Legal (PESTEL) analysis for uncertainty analysis and scenario development [16]. Through the PESTEL framework, the key drivers that are likely to bring about change were identified using this information relating to Kenya’s preparedness for vaccine and biotherapeutics manufacture. By splitting the study into two different sections we were able to explore the topic in much more detail to extract informed insights from multiple angles. The PESTEL dimensions of sustainable vaccine and biotherapeutics manufacturing in Kenya are illustrated below, highlighting its role in shaping the nation’s healthcare future (Figure 1).

Figure 1. Proposed future foresight design under PESTEL dimensions.

Foresight Methodology design offers a structured approach to predicting future trends and scenarios by examining key influencing drivers of change for manufacturing.

The derived secondary data was from a systematic literature review, and the PESTEL framework was used to select the twelve Change Drivers. Insights were collected from stakeholders using purposive sampling. The data were collected from 50 professional experts, including health policymakers, pharmaceutical industry experts, and regulatory specialists, through Google Forms. Appendix 1 presents the distribution of expert opinions, and the sample questionnaire is given in Appendix 2.

5.2.1. Systematic Literature Review Procedure

The twelve PESTEL drivers were derived from a structured literature review aimed at identifying political, economic, social, technological, environmental, and legal factors associated with vaccine and biotherapeutics manufacturing readiness. Searches were conducted in Google Scholar, Web of Science, PubMed (MEDLINE), ScienceDirect, Scopus, and supplemented by institutional and policy sources from WHO [17], Africa CDC, the Medicines Patent Pool, and relevant Kenyan health-sector policy documents. The search covered publications from 2014 to 2025 and used combinations of the following terms: “biotherapeutics manufacturing,” “vaccine manufacturing,” “local pharmaceutical production,” “biomanufacturing readiness,” “regulatory preparedness,” “supply chain resilience,” “biosafety,” “technology transfer,” “public trust,” “intellectual property,” “Africa,” “Kenya,” and “low- and middle-income countries.”

Eligible records included peer-reviewed articles, technical reports, policy papers, or regulatory guidance documents written in English that directly addressed at least one readiness issue pertinent to vaccine or biotherapeutics manufacturing, such as infrastructure, financing, regulation, technology transfer, research and development capacity, workforce, supply chains, public acceptance, ethics, environmental management, or intellectual property. Exclusion criteria comprised commentaries unrelated to manufacturing readiness, documents without accessible full text, duplicates, and papers focused solely on clinical efficacy without implications for manufacturing or system readiness. Titles and abstracts were initially screened, followed by full-text review of potentially relevant records. The final synthesis included 42 unique sources mapped to the twelve PESTEL drivers presented in Table 1. These drivers were subsequently refined through expert review prior to scoring.

5.2.2. Expert (Respondent) Recruitment and Stakeholder Sample

In this study, the experts (respondents) were recruited purposively through stakeholder mapping of institutions involved in vaccine and biotherapeutics policy, production, research, regulation, procurement, and health-sector planning. Eligible respondents were adult professionals with at least five years of relevant experience, current or recent involvement in vaccine, pharmaceutical, or biotherapeutics policy or implementation, and sufficient familiarity with Kenya’s health manufacturing ecosystem to score the drivers. The final analytical sample comprised 50 completed questionnaires.

The respondent’s distribution was as follows: Policymaking/Public Health Programmes (n = 14; 28%), academia/research (n = 18; 36%), Pharmaceutical/Biomanufacturing Industry (n = 10; 20%), and Regulation/Quality Assurance (n = 8; 16%).

Impact-Uncertainty Analysis was used as a foresight technique to prioritize the 12 drivers. Each respondent evaluated every driver on two dimensions: (i) expected impact on Kenya’s readiness for vaccine and biotherapeutics manufacturing by 2040, and (ii) uncertainty regarding the evolution and influence of the driver on implementation. Both dimensions were rated on a 1 - 5 scale. For impact, 1 indicated negligible impact, 2 low impact, 3 moderate impact, 4 high impact, and 5 very high or transformative impact. For uncertainty, 1 represented very predictable or settled, 2 low uncertainty, 3 moderate uncertainty, 4 high uncertainty, and 5 very high uncertainty. Mean impact and mean uncertainty scores were calculated for each driver and plotted as (I, U) coordinates.

To interpret the scores, tendency levels were classified as low (1.00 - 2.49), moderate (2.50 - 3.99), and high (4.00 - 5.00) for impact, and as very low (1.00 - 1.99), low (2.00 - 2.60), moderate (2.61 - 3.40), high (3.41 - 4.20), and very high (4.21 - 5.00) for uncertainty. The Google Form was reviewed for completeness prior to analysis; incomplete responses for any impact or uncertainty item were excluded from the calculation of driver-level means. A consistency check was performed by comparing the mean scores with the direct influence ranking to ensure that the scenario axes reflected drivers that were both substantively important and systemically influential.

Combining Impact-Uncertainty and Influence Results

Scenario-axis selection was based on a two-stage process. First, the impact-uncertainty matrix was used to identify drivers with the highest potential effect on readiness. Second, the direct influence analysis identified which drivers exerted the strongest systemic influence on other PESTEL factors. SO1 and TO2 were chosen as the scenario axes due to their highest impact scores (4.115 and 4.155, respectively) and their ranking as the most influential drivers. SO1 represents the demand and trust axis, reflecting whether society and health professionals accept locally manufactured vaccines and biotherapeutics. TO2 represents the supply and capability axis, indicating whether Kenya possesses robust research and development capacity, manufacturing infrastructure, quality systems, and a skilled technical workforce. Legal and intellectual property factors exhibited higher uncertainty but were considered enabling or constraining conditions rather than primary axes, as their effects are mediated through policy and technical implementation.

Future scenario building is a strategic planning tool that enables stakeholders to envision and prepare for potential future developments [18]. In the context of vaccine and biotherapeutics manufacturing, scenario building provides insights into possible pathways, challenges, and transformative impacts of establishing and scaling local production capabilities in Kenya’s healthcare system.

Figure 2. Frames for future scenarios of vaccines and biotherapeutics manufacturing.

The illustration above shows how the study employed a scenario-based approach to understand the key drivers of change for successful vaccine and biotherapeutics manufacturing in Kenya. It was the analysis of the current state, projecting forward the potential impacts into the future and a planning process (detailed storytelling) [19] (Figure 2). Predictive or forecasting, exploratory innovation, and integrated implementation through targeted interventions to ensure effective integration were among the aspects of the study indicated in Table 1.

The PESTEL analysis approach identified the drivers of change with the greatest impact and highest uncertainty in this study. It focused on two critical areas—impact and uncertainty—for scenario analysis. According to [20], scenarios were constructed based on these two key elements. “Impact” measured the significance of each driver and challenge, while “Uncertainty” assessed the likelihood of various scenarios influencing the future readiness of Kenya for vaccine and biotherapeutics manufacturing.

Table 1.PESTEL Dimensions for Kenya for vaccine and biotherapeutics manufacturing.

Table 2 indicates drivers of change elicited from the systematic literature review and using expert opinion from the stakeholder mapping meeting conducted with healthcare policy makers, biopharmaceutical experts, and regulatory analysts.

This section analyzes the outcomes for each driver, focusing on two critical dimensions: impact and uncertainty. The aim is to identify the drivers with the greatest levels of both impact and uncertainty. An impact-uncertainty analysis approach was utilized to pinpoint the key drivers of change that are likely to have a significant influence and present the potential for uncertain occurrences in the future.

6.2.1. Mean of Drivers of Change Corresponding with Impact

Table 2 outlines average values and the tendencies per essay of each driver effect. “Among all drivers, T02 was the most powerful, with a mean score of 4.1550.” Just behind it was “S01,” which achieved a mean score of 4.115. Both “E01” and “E02” closely followed each other, attaining a mean score of 3.770 and 3.550, respectively. Conversely, “P01” was identified as the driver with the least impact, reflected by its lower mean score of 3.080.

Table 2.Mean of drivers on impact.

6.2.2. Mean of Drivers of Change Corresponding with Level of Uncertainty

Table 3 presents the mean values and tendencies pertaining to the uncertainty associated with each driver. “L01” was identified as having the highest level of uncertainty, with a mean score of 2.3050, followed by “L02” at 2.2400. “E02” also showed a notable level of uncertainty, scoring 2.1150. On the other end of the spectrum, the drivers with the lowest degree of uncertainty were “T02” and “P02” which had a mean score of 1.8250 in both cases.

Table 3.Mean of drivers on uncertainty.

6.2.3. Analysis

Above is an illustration of the Impact-Uncertainty Analysis, highlighting that the robustness of biopharmaceutical manufacturing infrastructure and societal acceptance of locally produced vaccines play a crucial role in realizing Kenya’s readiness for vaccine and biotherapeutics manufacturing (Figure 3). These key drivers of change are essential for building a future healthcare strategy that incorporates vaccine and biotherapeutics production as a sustainable solution.

Figure 3.Impact-uncertainty analysis.

“Direct Influence Graph,” shows that “S01” and “T02” have the strongest influence on the manufacturing and vaccine and biotherapeutics production solutions (Figure 4). Other drivers of change have a relatively strong influence on the key drivers of change such as “P01”, “E01”, and “S02”.

Figure 4.Direct influence graph.

The figure below (Figure 5) demonstrates that “S01” and “T02” (Levels of societal acceptance of locally produced vaccines and the robustness of biopharmaceutical manufacturing infrastructure) are the highest-ranked drivers of change. These factors are crucial in shaping and building future scenarios for Kenya’s readiness for vaccine and biotherapeutics manufacturing.

Figure 5.Rank of drivers of change by influence.

The illustration below (Figure 6) shows future Scenarios for vaccine and biotherapeutics manufacturing in Kenya by 2040; indicting aspects under each scenario from scenario 1 to 4.

Figure 6.Future scenarios for vaccine and biotherapeutics manufacturing in Kenya by 2040.

Scenario 1: Successful vaccine and biotherapeutics manufacturing

Under this scenario the high acceptability by society together with a well-established biomedical infrastructural underpinning has seen Kenya successfully adopt the manufacturing of vaccine and biotherapeutics. Stakeholders such as government agencies, healthcare institutions, and private investors play an active role in local production, ensuring they have a robust supply chain for local healthcare providers, while decreasing reliance on imports [64].

Supported by institutions and with regulatory alignment, BioVax can scale its production to deliver vaccine in line with domestic demand, placing Kenya as a regional centre for biopharmaceutical manufacture. Advanced bioprocessing technologies improve efficiency by making production and distribution cost-effective. In investment, cold chain logistics and quality assurance systems help ensure compliance with international standards, thereby promoting international partnerships and creating the possibility of exporting [16].

However, for adoption to happen, the locally produced vaccines must be widely trusted. The trust inspired through targeted public awareness campaigns and transparency in regulatory processes, and the sustainable uptake of vaccines after the pandemic will pave the way for the success of vaccination programmes. Moreover, working with BioVax provides an inspiration for novel research from research institutes, which will improve the production process of next-generation vaccines for being responsive to local disease pressures. This illustrates the transformative potential of Kenya’s developing vaccine and biotherapeutics production sector. With a focus on infrastructure investments, policy support, and public engagement, Kenya can become self-sufficient in vaccine production, improve healthcare resilience, and play a role in global health security. Adopting this route is in line with the objectives of Vision 2030 and contributes to making Kenya a leader in pharmaceuticals in Africa.

Scenario 2: Low vaccine and biotherapeutics manufacturing

In this specific scenario, strong biomedical infrastructure does exist in Kenya but the manufacturing for vaccines and biotherapeutics is not adopted owing to regulatory issues and low societal acceptance. The public perception about the safety, efficacy and reliability of domestically produced vaccines is unfavorable, which may impede mass acceptance and progression towards self-sufficiency [16].

Misinformation or a lack of adequate public awareness around BioVax’s production capabilities can breed a lack of trust in BioVax, and lead to resistance from healthcare providers and the general population. In addition, hesitation from international drug companies and import-dependent stakeholders may pose additional challenges as they try to preserve existing market interests. [BW 39] Regulatory bottlenecks and slow policy implementation may slow adoption even more, making investments in local manufacturing less attractive [65].

The complexity of making and disseminating vaccines might also dissuade widespread use. Healthcare institutions may become hesitant because of limited technical know-how, lack of proper workforce training, and compliance issues with global standards. Additionally, financial limitations and perceived high costs may dissuade government and private sector interest in scaling up local vaccine production [66].

Overcoming these barriers, however, would necessitate a multi-faceted approach of comprehensive public education campaigns, transparent regulatory processes, and other incentives to instill confidence in domestic vaccine production. Eradication of any reaching misconceptions and collaboration between the government, industry and healthcare providers will secure success in the long term.

Scenario 3: Chaotic Change in Vaccine and Biotherapeutics Manufacturing

This scenario represents a future with high societal acceptance but low robustness in research, development, and manufacturing capabilities. The trigger is strong public, political, and health-sector demand for locally manufactured vaccines and biotherapeutics, even though the production ecosystem is technically immature. Supportive narratives, procurement pressure and public trust create momentum, but the capability base (qualified facilities, validated processes, trained workforce, quality systems, regulatory readiness, and reliable supply chains) remains insufficient.

The pathway is therefore unstable: BioVax and partners may move quickly into pilot production, technology transfer, or fill-and-finish activities, while upstream process development, GMP validation, cold-chain integration, raw-material sourcing, and post-market surveillance lag behind. This mismatch can lead to implementation delays, higher costs, repeated regulatory queries, dependence on imported inputs, and an uneven distribution between urban and underserved areas.

The likely outcome is a chaotic transition rather than full manufacturing readiness. Kenya may retain strong demand for local products but remain dependent on imports in the short to medium term, with a risk that delays or quality concerns damage public confidence. The strategic response is a phased manufacturing roadmap: prioritize technology-transfer milestones, GMP certification, workforce development, transparent regulatory review, realistic procurement commitments, and public reporting of progress so that high acceptance is converted into credible production capability.

Scenario 4: Rejection of Vaccine and Biotherapeutics Manufacturing

This scenario represents the low-acceptance and low-capability quadrant. The trigger is a combination of weak public and professional trust in locally manufactured vaccines and biotherapeutics, slow infrastructure development, uncertain financing, and fragmented policy or regulatory implementation. In this setting, neither demand-side confidence nor supply-side capability is strong enough to sustain a viable domestic manufacturing programme.

The pathway is stagnation: misinformation, safety concerns, limited awareness of quality assurance systems, and preference for imported products reduce demand, while investors and technology partners hesitate because production facilities, research and development systems, regulatory capacity, and procurement guarantees are not yet mature. Skilled personnel may move to better-established markets, and local activities may remain limited to planning, packaging, importation, or small-scale pilots rather than scaled production.

The outcome is rejection or prolonged non-adoption of local vaccine and biotherapeutics manufacturing. Kenya would continue to rely heavily on imported vaccines and biotherapeutics, losing opportunities for pandemic preparedness, regional market participation, skills development, and health security resilience. Avoiding this scenario requires early trust-building, transparent communication on safety and quality, demonstration batches, independent regulatory oversight, sustainable financing, and partnerships that demonstrate measurable progress from readiness planning to actual manufacturing capability.

The study aimed to assess Kenya’s readiness for vaccine and biotherapeutics manufacturing by BioVax, identifying key drivers of change influencing local production. A systematic literature review highlighted twelve critical factors, including regulatory frameworks, infrastructure capacity, financial investment, research and development capabilities, global partnerships, intellectual property considerations, public trust, supply chain robustness, workforce expertise, and ethical concerns such as equitable vaccine access and pricing. Stakeholders and experts ranked these drivers using impact-uncertainty and Cross Impact analysis methodologies.

The combined impact-uncertainty and direct influence analyses identified SO1 and TO2 as the primary scenario axes: public and professional acceptance of locally manufactured vaccines and biotherapeutics, and the robustness of research, development and manufacturing capabilities. Regulatory preparedness, investment, legal and intellectual property factors remain critical enablers, but the scenario logic shows that Kenya’s readiness will depend most directly on whether technical manufacturing capability develops in parallel with public and professional trust. This interpretation aligns the conclusion with the selection rule applied in Sections 6.2.3 and 7.

Using SO1 and TO2 as the organizing axes, the study constructed four potential future scenarios: Successful Production, Low Production, Chaotic Change, and Rejection of Adoption. Opportunities include technology development, regional market expansion, skilled job creation and improved health security. However, policy bottlenecks, funding gaps, weak R&D capability, supply-chain vulnerability and public skepticism must be managed deliberately. These findings provide a roadmap for strengthening Kenya’s vaccine and biotherapeutics manufacturing readiness while keeping policy claims proportionate to the evidence generated through expert elicitation and scenario planning.

Analysis of the implications of these two key drivers of change highlighted several policy gaps that must be addressed to enhance Kenya’s readiness for vaccine and biotherapeutics manufacturing.

First, is the public willingness to get locally produced vaccines is still low due to lack of awareness and trust. Vaccine hesitancy in Kenya is due to fears about vaccines safety, efficacy, and a lack of Regulatory oversight. It requires extensive public education campaigns to instill confidence in local manufacturing, and the virtue of self-reliance in vaccine production. Furthermore, other ethical considerations such as equitable distribution of vaccines, transparent pricing models, and accessibility for marginalized communities need to be prioritized to drive fair, and sustainable adoption. Furthermore, the awareness strategies should take into account cultural perceptions of biotechnology and traditional healthcare practices to increase acceptance.

Second, the viability of local vaccine manufacture is contingent upon the robustness of infrastructure and regulatory frameworks. Poor production capacity, fragility of supply chains, and a lack of expertise in biomanufacturing make scalability a challenge. Rural and underserved areas present real barriers to the distribution of vaccine and limit access and impact. But having holes in regulatory oversight slows approvals and creates uncertainty for investors. Addressing these challenges requires strengthening Kenya’s pharmaceutical regulatory framework, investing in research and development, and promoting public-private partnerships. By making strategic investments in infrastructure and skilled workforce development, BioVax is going to be able to efficiently scale programmatic production of vaccines and biotherapeutics while improving national health security and self-sufficiency.

8.3.1. Improving Public Confidence and Acceptance of Locally Made Vaccines

i. Public Awareness Campaigns: Initiate nationwide awareness campaigns on the safety, efficacy, and benefits of locally produced vaccines. Nip myths in the but by using social media, traditional media, and community outreach programs.

ii. Community Engagement: It is important to work with community leaders, healthcare professionals and civil society organizations to build trust. Hold public forums, workshops and vaccination drives, so people can experience local vaccines firsthand.

iii. Stakeholder Education: Create specific interventions for healthcare workers, policymakers, and the general public about how local vaccine manufacturing can enhance health security and bring down dependence on imports.

iv. Openness and Confidence building: To inform the public about safety and quality standards followed in national vaccine manufacturing, share success stories, research grants and regulatory developments.

8.3.2. Strengthening Vaccine Manufacturing Infrastructure and Regulatory Frameworks

i. Investment in Manufacturing Facilities: Additional investments in expanding and modernizing vaccine production plants routinely around the world to satisfy national and local desires. Public-private partnerships have better funding and expertise, so pave the way for them.

ii. Strengthening Regulations: Codify vaccine clearances that satisfy safety norms and levels consistent with global standards. Enhance regulatory agencies’ capacity for swifter, more effective oversight.

iii. Capacity Building and Training: Create programs to train scientists, healthcare workers, and biopharmaceutical professionals to build local expertise.

iv. Support for Research and Development: Target greater federal investment in R&D to promote crushing vaccine and biotherapeutics innovation.

v. Collaborate with universities, research institutions and Industry players.

vi. Regular assessments: Develop continuous monitoring use cases to evaluate progress towards vaccine development milestones, public uptake rates and regulatory efficiency, identifying barriers and enablers to sustainable vaccine sector growth and self-sufficiency in Kenya.

Full capacity of Kenya in vaccine and biotherapeutics manufacturing rests on overcoming key challenges related to unlocking infrastructure investment, public confidence, regulatory frameworks, and technological progress. Table 4 outlines the key implementation strategies for achieving self-sufficiency in vaccine production and strengthening the biopharmaceutical sector.

Further studies need to determine Kenya’s readiness for vaccine manufacturing which can highlight the relative advantage by establishing the areas of bioprocessing, automation, policies, and investment opportunities. Societal perceptions, supply chain challenges, and cost-benefit analyses are key areas. Insights will inform long-term strategies to boost healthcare security and establish Kenya as Africa’s biotherapeutics hub.

Table 4. Policy recommendations and implementation strategies.

The findings should be interpreted with three limitations. First, driver prioritization relied on expert judgment, so results may reflect the knowledge, institutional positions, and expectations of the sampled stakeholders. Second, the analysis focused on Kenya and BioVax’s operating context; while the scenarios may be informative for other African manufacturing initiatives, they should not be generalized without considering local policy, market, and regulatory conditions. Third, the scenarios assess readiness pathways and strategic preparedness, not demonstrated manufacturing feasibility. Actual feasibility will require separate technical validation, GMP qualification, technology-transfer performance, product-specific regulatory review, cost modeling, and market-access assessment.

1) Name/Organization (Optional):

2) Stakeholder Category (Select one):

ResearcherAcademicRegulatorGovernment Agency RepresentativeInvestorNGO RepresentativePharmaceutical/Biotech CompanyQuality Control/Standards BodyOther

3)How would you rate Kenya’s readiness for vaccine and Biotherapeutics manufacturing?

Select one.

Response type: Single choice

ExcellentGoodAveragePoor

4)What do you consider the main challenge(s) in vaccine manufacturing and commercialization in Kenya? (Select all that apply)

Regulatory barriersLimited funding/investmentLack of skilled workforceMarket demand and acceptanceCompetitive pricing against imported productsSupply chain/logistics issuesLimited research and innovation capacityOther (Please specify): __________________________

5)What strategies should be prioritized to strengthen Kenya’s vaccine manufacturing sector? (Select up to 3)

Strengthening regulatory frameworksGovernment incentives e.g. Advanced Purchase AgreementsIncreasing investment and funding opportunitiesEnhancing research and innovation partnershipsDeveloping a skilled workforce through training programsImproving infrastructure and supply chainsOther (Please specify): __________________________

6)Are you currently involved in partnerships related to vaccine or biotherapeutics manufacturing?

Select one.

Response type: Single choice

YesNo

7)If yes, what type of partnership(s) are you engaged in? (Select all that apply)

Pre-clinical research collaborationsClinical Trials/Bridging studiesRegulatory and policy engagementInvestment and funding partnershipsTechnology transfer and licensing agreementsManufacturing and production partnerships

8)What support or resources do you believe are most critical for fostering successful partnerships in the sector?

9)Would you be interested in participating in future stakeholder workshops or collaborations withBioVax?

Select one.

Response type: Single choice

YesNo

10)What areas do you think KenyaBioVaxcan improve in?

Response type: Long answer

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11)Any additional comments or recommendations?

Response type: Long answer

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