Oncology Precision Medicine: Challenges and Opportunities for Biopharmaceutical Companies

With a growing shift towards tailored therapies for cancer treatment, personalized medicine emerges as a groundbreaking solution. Cancer has been a major cause of concern among healthcare professionals and patients at the global level. As per the report of the American Cancer Society, in 2022, an estimated 1.9 million new cases of cancer have been diagnosed, and 609,360 deaths have occurred due to cancer worldwide. Personalized medicine enables researchers to gain better understanding about individual patient molecular profiles and help them to determine mutation at single gene level. With the introduction of high throughput screening technologies, including artificial intelligence, next-generation sequencing, and big data analytics, precision oncology witnessed success in the treatment of cancer patients. The individualized treatment approach has proven useful in navigating the complexities associated with cancer cell interactions with the surrounding microenvironment. Additionally, personalized medicine has revolutionized the diagnosing and treatment of cancer particularly those that remain unnoticed at early stage.

Considering the significance such as target efficiency of precision medicines, the oncology precision medicine market player shifted from one-size fit all treatment approach to precision medicines. However, to make personalized oncology treatment a reality for patients, there is a requirement to shape the biopharmaceutical drug development process and business model. Additionally, advanced regulatory frameworks, innovative technologies, and economic structures are required to ensure that patients can access specific therapies (1). According to the Roots Analysis, the global oncology precision medicine market size is estimated to grow from USD 130 billion in 2023 to USD 364 billion by 2035, representing a CAGR of 8.93% during the forecast period 2023-2035.

Major Challenges in the Oncology Precision Medicine

Though personalized oncology treatment has witnessed massive strides in treating patients, the domain also faces several challenges. Therefore, to make personalized medicine treatment of cancer a reality for the patient, it is vital to re-evaluate the drug development process and biopharmaceutical business model. Examples of the major challenges faced by the players in the oncology precision medicine market include:

. Tumor Heterogeneity

The tumor heterogeneity is one of the major challenges faced by the researchers during precision medicine trials for cancer treatment. The genetic profiling of tissue from a single tumor lesion may not accurately show the system disease due to substantial heterogeneity between tumors in the organ of origin and metastatic sites in certain patients. Similarly, the precision drugs targeting the molecular aberrations of one lesion may not show effective results in metastatic tumor lesions. Further, tumor molecular profiles continue to evolve, specifically under targeted treatments, making biopsies tests time-consuming. In such instances, circulating tumor DNA analysis emerges as a sought-after and non-invasive alternative for detecting driver mutations.

. Challenges in Addressing Mechanism of Resistance

The primary aim of precision medicine and cancer immunotherapy is to stimulate the immune response to attack tumor cells. Given the complex interactions between the immune system and tumors, addressing the mechanism of resistance can be challenging. However, the main challenge lies in creating a balance between autoimmunity and the ability of the immune system to recognize non-self molecules. Resistance to precision medicine in oncology treatment is categorized as primary (failure to respond against tumor) and secondary (relapse after successful treatment). In many cases, the immune system often fails in recognizing tumor cells as non-self substance and may develop resistance to them.

Several approaches have been taken by the oncology precision medicine market players for optimizing immune response and reducing resistance to cancer immunotherapies. These approaches include the development of biomarkers to assist with patient selection, monitoring treatment, alteration of tumor microenvironment, and training healthcare practitioners regarding the potential for delayed immune response with different types of treatments. A combination therapy approach has been followed that involves combining two therapies having the potential to target distinct immune checkpoints to kill tumor cells (2).

Data Integration and Analysis

The development of precision medicine relies heavily on complex data such as clinical trial information, proteomics, and genomics. However, analyzing and integrating the vast amount of data sets from different sources may pose a significant challenge for the researchers. In order to streamline the development of precision medicines for oncology treatment, there is a requirement for robust analytical tools and advanced computational approaches to derive data from various resources accurately.

. Pricing Structure

Precision medicines and targeted therapies are highly expensive in comparison to conventional drugs and existing treatment options. The pricing model for precision medicine may be challenging for commercial insurers, which have higher turnover and a limited coverage window than national health insurance programs.

Value-based pricing models are one way to deal with the reimbursement issues. These novel models of pricing will rely significantly on patient selection, and marketers are expected to develop algorithms for identifying the individuals who are most inclined to respond to certain precision medications.

Growing Opportunities in Oncology Precision Medicine Industry

Despite significant challenges, the field of oncology in precision medicine is set to experience growth over the next decade. The growth can be attributed to the rising opportunities and industrial trends that address the concerns associated with the development of personalized treatment. In this context, here are the top 3 trends that facilitate the use of personalized medicine in oncology (3).

1. Telemedicine

Telemedicine refers to the digital technologies that encourage early diagnosing and treatment of patients anywhere across the globe using internet networks. This digital technology has made its way in cancer diagnosing, increasing clinical trial accessibility to develop tailored therapies.

2. Precision Oncology for Lung Cancer Treatment

Precision medicine has made its way in the treatment of lung cancer owing to the increasing patient outcomes. With breakthrough technologies, researchers will be able to analyze histological subtypes of lung cancer, often known as non-small cell lung cancer, and develop tailored treatments to target different forms of cancer. The non-small cell lung cancer treatment approaches include osimertinib for EGFR mutants, ALK-positive mutations, and adagrasib for resistant KRAS mutations. Furthermore, melanoma targets has been developed for BRAF mutations and these targets have been evolved into responsive immunotherapy approaches including ipilimumab and immune checkpoint inhibitors nivolumab as they has potential to eradicate the inefficient of cytotoxic T cells to target foreign antigens presence of cancer cells.

3. AI Integration for Real Time Feedback

Artificial intelligence has already been a cornerstone technology for the development of personalized medicine. The growing shift towards real-time disease progression tracking has necessitated the integration of artificial intelligence and big data analytic tools. The real time monitoring enables clinician’s early detections, variation corrections and ensures development of personalized treatment. Further, continuous integration of AI and big data technologies also enhances the quality of treatment using accurate dosages of precision medicine, making targeted treatment more accessible for the patients.

Recent Development in the Oncology Precision Medicine Industry

It is interesting to note here that several recent developments have taken place in the oncology precision medicine market. The ongoing research activities emphasize the development of tailored solutions to develop advanced drugs to treat different forms of cancer.

• In September 2023, Exscientia and Merck entered into a licensing agreement offering its AI-powered precision drug design and discovery-driven technologies. Additionally, the licensing agreement enables Merck to emphasize developing drug design for neuroinflammatory and oncological disorders.
• In August 2023, IDEAYA Biosciences announced the clearance from the FDA of an investigational new drug (IND) application of GSK101 (IDE705). GlaxoSmithKline has sponsored this clinical trial to treat cancer patients with BRCA, homologous recombination, and homologous recombination deficiency mutations.
• In April 2023, Tango Therapeutics received the IND clearance for TNG260 (a CoREST complex (Co-repressor of Repressor Element-1 Silencing Transcription) from the FDA to treat STK11-mutant cancers (4).

Concluding Remarks 

Notably, precision medicines in oncology have a bright future owing to their significance, such as tailored approach and target specificity. Despite the challenges above, oncology precision medicine market players are increasing their research activities to bring innovation and advanced technologies into the drug discovery and development process. Additionally, data analytic technologies are increasingly integrated into the drug development process for accurate analysis of data. The goal is that precision oncology will allow for the personalization of cancer treatments. Still, it will additionally enhance general wellness as new genetic and molecular discoveries improve our knowledge of disease causes.

References

1. Roots Analysis. Oncology Precision Medicine Market. RootsAnalysis.com. (Assessed April 24,2024)
2. Health It Analytics. Top 3 Challenges of Integrating Precision Medicine With Routine Care. HealthITAnalytics.com. (Assessed April 24, 2024).
3. Technology Network. Challenges and Opportunities in Oncology Precision Medicine. TechnologyNetworks.com (Assessed Aprile 24, 2024).
4. PR NEWSWIRE (Roots Analysis). Oncology Precision Medicine Market. prenewswire.com. (Assessed April 24, 2024).