The Outlook for Contract Research Organizations (CROs), que controlam a maioria dos serviços de desenvolvimento clínico gastos em Biopharma , permanece robusto. De fato, espera-se que os gastos em serviços específicos do local continuem a crescer a uma taxa de dígito médio. O crescimento em serviços especializados de fornecedores provavelmente ultrapassará outras áreas, com alguns segmentos de tecnologia clínica vendo aumentos anuais de receita na alta faixa de dígitos únicos ou de dois dígitos. Os serviços CRO do CRO manterão a maior parte dos gastos terceirizados do desenvolvimento clínico, com crescimento de meio dígito, apenas ligeiramente abaixo das taxas históricas que apoiaram retornos constantes dos acionistas nos últimos cinco anos.
ao mesmo tempo, o mercado está evoluindo. Os patrocinadores estão alterando modelos de fornecimento e fazendo investimentos em mudança de modelo em tecnologia, ciência de dados e Inteligência Artificial (Ai). Os próprios CROs estão visando investimentos em tecnologia clínica e pressionando a consolidação da indústria, adquirindo entidades menores e redes de sites. Os patrocinadores registram insatisfação com o desempenho do CRO, citando consistência limitada em velocidade e qualidade, falta da tecnologia mais recente e atrasada na implementação do estudo descentralizado, entre outros fatores. Embora os CROs nem sempre se preparem para o sucesso, os patrocinadores impõem suas próprias restrições ao desempenho por meio de estruturas difíceis de governança e processos e, muitas vezes, deixando os CROs fora de decisões críticas de projeto e planejamento de ensaios. Esses fatores abrem oportunidades para titulares inovadores e novos participantes para ganhar participação e possivelmente desenvolver ofertas disruptivas.
CROs also face customer-related challenges. Sponsors register dissatisfaction with CRO performance, citing limited consistency in speed and quality, a lack of the latest technology, and lagging decentralized trial implementation, among other factors. While CROs do not always set themselves up for success, sponsors impose their own constraints on performance through difficult governance and process frameworks and often by leaving CROs out of critical trial design and planning decisions. These factors open opportunities for innovative incumbents and new entrants to win share and possibly develop disruptive offerings.
There are opportunities for innovative CRO incumbents and new entrants to win share and possibly develop disruptive offerings.
No topo dessas questões imediatas, três tendências de longo prazo têm o potencial de remodelar a indústria nos próximos cinco a dez anos:
- Rousing funções e necessidades de pacientes e locais de estudo = MONTOLENTES = Garanta a atenção das equipes de gerenciamento de CRO hoje em relação às decisões de estratégia e investimento. As empresas prospectivas podem se posicionar para acelerar o crescimento investindo em capacidades que solidificarão sua posição e garantirão relevância sustentada no médio a longo prazo. Todos os jogadores, exceto os maiores e com melhor resistência, provavelmente precisarão fazer escolhas estratégicas sobre como concentrar esforços e investimentos. A grande decisão será entre espalhar o investimento nas três tendências para acompanhar em cada área e dobrar em uma área (como tecnologia e IA) enquanto adota uma abordagem de luz de investimento para os outros.
- Increased adoption of advanced technologies and AI
- Sponsors changing sourcing strategies
The potential impact of the coming changes is strong enough to warrant the attention of CRO management teams making strategy and investment decisions today. Forward-looking companies can position themselves to accelerate growth by investing in capabilities that will solidify their standing and ensure sustained relevance in the medium to long term. All but the largest and best-resourced players will likely need to make strategic choices about how to focus efforts and investment. The big decision will be between spreading investment across all three trends to keep up in each area and doubling down in one area (such as technology and AI) while taking an investment-light approach to the others.
Aqui está como vemos as três tendências se desenrolando e os desafios que cada um apresenta para os CROs. Os exemplos incluem custos crescentes de teste, startups lentas e baixa matrícula de pacientes, que diminuem a entrada do mercado. O ônus dos investigadores e indivíduos é alto, e os incentivos para participar de pesquisas clínicas permanecem baixas. À medida que os principais estudos do Covid-19 se abrem, o número geral de matrículas dos pacientes está retornando aos níveis que eles estavam há dez anos e devem permanecer essencialmente planos até 2028. (Consulte o Anexo 1.) Desenvolvimentos em Medicina de Precisão, Novas Modalidades, Maior Complexidade do Estudo e Limitada Infraestrutura Global de Justiça | Resposta, é provável que o paradigma atual baseado no local mude para uma abordagem mais centrada no paciente que será moldada pelos seguintes fatores:
Shifting Roles and Needs of Patients and Trial Sites
The traditional site-based model for clinical trials will evolve as sponsors and participants try to address longstanding issues that threaten to worsen over time. Examples include rising trial costs, sluggish startups, and low patient enrollment, which slows market entry. The burden on investigators and subjects is high, and the incentives to participate in clinical research remain low. As major COVID-19 studies wind down, overall patient enrollment numbers are returning to the levels they were at ten years ago and are projected to remain essentially flat through 2028. (See Exhibit 1.) Developments in precision medicine, new modalities, increased study complexity, and limited global trial infrastructure exacerbate these issues.
In response, the current site-based paradigm is likely to shift towards a more patient-centric approach that will be shaped by the following factors:
- Modelos de participação mais ágeis para expandir o envolvimento do paciente
- Attempts to optimize patient participation and retention by improving patient-trial matching and reducing trial complexity for the patient
- Better-equipped sites that can avoid bottlenecks and enhance trial impact
- An increase in scalable, cost-effective solutions built for speeding up trails and bringing new treatments to market faster
We are already seeing one concrete shift: the rise of the so-called patient-centered “trial-in-a-box” model pushed by the American Medical Association and National Institutes of Health, among others, which involves finding patients first, then setting up trial sites around them. (See Exhibit 2.) Patients are identified from various real-world data sets (such as electronic medical records, insurance, and social media) using advanced analytics and processing tools. Sites employ patient-centric approaches, including wearable tech, mobile apps, and remote monitoring, to improve convenience and retention. Investigators leverage telemedicine and home nursing services to deliver patient care remotely where possible, while still leveraging traditional site-based services (such as labs and imaging centers) when a remote option is not yet viable.
We expect this model to become more prominent. But establishing any new paradigm as a widespread reality requires developing and implementing an integrated set of solutions on a global scale across the following areas:
- Data and analytics, including global patient recruitment databases and real-time integration of electronic medical records and molecular data
- Infrastructure (such as clinical facilities) and integration with imaging, labs, and pharmacies
- Tecnologia e sistemas, incluindo sistemas de captura de dados, plataformas de engajamento de pacientes e novos locais de coleta de terminais mais próximos do paciente
- Trial enablement, which should include implementing standardized site onboarding and training and securing clinical coordinators and staff
The shift to more patient-centered models could lead to the disruption of current value pools that amount to some $4 billion and potential new value pools that could total about $8 billion. The drivers of disruption include efficiencies gained from optimized endpoint collection, automated data collection, integration with other facilities, and site setup. New value will result from accelerating time to market (for sponsors) through faster patient recruitment, improved retention, optimized trial design, and new site setup. There is also additional upside potential with expansion into new geographies with integrated patient data.
Current players must take steps to safeguard against value erosion through stronger integration of clinical operations tech platforms, for example. CROs are well positioned to use advanced technology and patient-centric methods to enhance efficiency, convenience, and retention in any new model. The likely owners and orchestrators of the new solutions will be large sponsors (following an in-house approach), site networks, site management organizations, integrated research organizations, and possibly site- and patient-focused tech players. Many of these organizations have already taken steps toward more patient-centered trials.
Aumentado Adoção de tecnologias avançadas e AI
Further disruption of current CRO value pools, such as clinical monitoring, project management, and patient recruitment, is likely through widening adoption of digital technology and AI. The disruption could amount to some $18 billion, or 40% of the total current value for CROs. (See Exhibit 3.)
Much of that disruption will probably come about through shifts from labor-intensive manual to tech-enabled automated solutions in outsourced services. In the process, value may shift from large CROs to smaller contract organizations, tech startups, and sponsors, fostering a more fragmented and competitive market landscape. There is also an opportunity for nimble CROs to defend their turf and capture new sources of value and competitive advantage.
Digital technology and AI will open access to new value pools for CROs—particularly with respect to AI—through three pathways:
- Deploy for productivity improvement. Enterprise-wide productivity improvements will generate about $3 billion in value for CROs. Many companies are already beginning to transform their medical writing functions with generative AI (GenAI), boosting efficiency with accelerated document generation across the clinical study lifecycle.
- Reshape existing operations. Radical speed and quality improvements should lead to an estimated $9 billion in value. For example, many companies are already starting to stand up “clinical control towers” to optimize trial execution using advanced analytics.
- Invent new revenue streams. New services and business models are expected to generate $7 billion to $10 billion in new value. One example is the ecosystem integrator or orchestrator model, under which CROs with the necessary capabilities bring together other participants with distinctive offerings that improve the clinical trial process with more complete end-to-end services. Participants could include data providers, technology partners, and site networks that leverage digital twins of patients based on data from various sources to simulate trial outcomes em silico. Neste exemplo, o CRO orquestra as regras de participação e troca de valor no ecossistema. Atualmente, menos de 5% das empresas de serviços de desenvolvimento clínico estão investindo em novos fluxos de receita. Esta é a desconexão mais significativa entre a configuração de prioridade de hoje e o potencial de amanhã. O primeiro se baseou em fornecedores de terceirização de serviço completo, ou de ponta a ponta, devido a limitações de recursos, enquanto este tendeu a provedores de serviços funcionais para um maior controle e o que eles esperam ser melhor desempenho. Será mais fácil para os CROs grandes competir com fornecedores mais especializados à medida que a diferenciação de qualidade se dissipa. Os CROs de ponta a ponta também podem esperar se beneficiar do crescente foco dos patrocinadores na eficiência operacional. Os patrocinadores podem até consolidar fornecedores para melhorar a eficiência, reduzindo a capacidade necessária para a bordo de muitos fornecedores diferentes para um estudo específico, por exemplo. (See Exhibit 4.) These value pools include more than $15 billion in near adjacencies that build directly off core CRO services, such as pharmacometrics, real-world evidence and data, clinical technology, and bioanalytics, and another $15 billion or more in medium adjacencies with synergies to existing clinical development services, such as translational research, medical affairs, and formulation Desenvolvimento. Eles também devem investir nos esforços de vendas e marketing para explorar todo o potencial de informações, colaboração e informações orientadas a dados que permitem estratégias de marketing e vendas mais direcionadas e personalizadas.
To succeed in these new models, CROs must prioritize productivity and growth while systematically upskilling their workforces, controlling costs, developing strategic relationships, and ensuring responsible AI use. Less than 5% of clinical development services companies are currently investing in new revenue streams. This is the most significant disconnect between today’s priority setting and tomorrow’s potential.
Sponsors Changing Sourcing Strategies
Customers of the clinical development services outsourcing market have historically been bifurcated between biotech and large pharmaceutical companies. The former has relied on full-service, or end-to-end, outsourcing vendors because of resource limitations, while the latter has tended toward functional service providers for greater control and what they hope will be better performance.
In the future, though, end-to-end CROs will likely gain the upper hand, benefiting from the maturation of many clinical development services. It will be easier for large CROs to compete with more specialized vendors as quality differentiation dissipates. End-to-end CROs can also expect to benefit from sponsors’ rising focus on operational efficiency. Sponsors may even consolidate vendors to improve efficiency by reducing the capacity required to onboard many different vendors for a particular study, for example.
End-to-end CROs can capitalize further by extending their core offerings into high-value adjacent service areas, unlocking an additional $50 billion or more in incremental value pools across pharma service verticals. (See Exhibit 4.) These value pools include more than $15 billion in near adjacencies that build directly off core CRO services, such as pharmacometrics, real-world evidence and data, clinical technology, and bioanalytics, and another $15 billion or more in medium adjacencies with synergies to existing clinical development services, such as translational research, medical affairs, and formulation development.
To fully leverage these opportunities, end-to-end CROs must adopt a customer-centric commercial model. They must also invest in sales and marketing efforts to exploit the full potential of cross-selling, collaboration, and data-driven insights that allow for more targeted and personalized marketing and sales strategies.
Mesmo em um mercado atraente para CROs, a maioria das empresas terá que fazer escolhas. Somente as maiores e mais bem resgatadas podem proteger os pools de valor existentes e capitalizar novos. Fazer ambos exigirá investir em geral em locais e pacientes, tecnologias avançadas e expansão da IA e portfólio. Outros CROs precisarão decidir onde estão as melhores oportunidades em um mercado em evolução, e a execução bem -sucedida provavelmente exigirá alterações em seus modelos operacionais. Os patrocinadores também se beneficiarão de fazer sua parte, aproveitando os CROs como parceiros estratégicos nos vários estágios do desenvolvimento clínico, incluindo os estágios de design e planejamento.
O mercado já está mudando. Os CROs que desejam manter ou adquirir posições de liderança devem se mover rapidamente. Inscreva -se
