Next Generation Drug Conjugates Market: Distribution by Type of Targeting Ligand, Type of Payload, Type of Therapy, Route of Administration, Target Disease Indication and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

The global market for the next generation drug conjugates is expected to grow at a compounded annual growth rate (CAGR) of more than 20% during the forecast period. The next generation drug conjugates, owing to their non-immunogenic nature, better clinical profile, structural stability, limited side effects, targeted delivery of payload, deeper cellular penetration, and permeability, have emerged as the viable targeted therapeutics for rare disease indications, including cancers. Over the last decade, the standard cost of medical care for rare disease indications has increased exponentially. Specifically, in the US, close to USD 1 trillion was spent for medical care for rare diseases in 2020. Further, the average cost incurred by a patient suffering from a rare disease condition was USD 60,248 in 2020, which if taken into account is twice the average cost incurred by any general patient. The incremental rise in medicare cost, coupled with the rising burden of rare disease indications globally, prompted the stakeholders to look for alternatives to the conventional therapies, and next generation drug conjugates have emerged as a promising treatment option.

Owing to the structural similarity with antibody drug conjugates (ADCs), and various advantages related to clinical efficacy and stability over ADCs, the next generation drug conjugates have emerged as its direct viable alternative. Similar to ADCs, the next generation drug conjugates utilize a targeting ligand, a linker and a payload for the targeted delivery. However, unlike ADCs, which use antibody as the targeting ligand, the next generation drug conjugates utilize various non-antibody-based targeting ligands, such as peptides, amino sugar, lipid, and small molecule as their targeting agent. Further, in place of drug, it utilizes oligonucleotide, antisense oligonucleotide, si-RNA, drug, and radionuclide as their payload. 

As a result of various synergistic combinations with the targeting ligand and payload, various types of next generation drug conjugates, such as peptide drug conjugate, peptide receptor radionuclide therapy (peptide radionuclide conjugate), GalNac conjugates, peptide oligonucleotide conjugate, si-RNA conjugate, small molecule-drug conjugate (SMDC), ligand conjugated anti sense medicine (LICA), and peptide conjugated phosphorodiamidate morpholino oligomers (PPMO) have emerged in the domain of targeted therapeutics. The success of these next generation drug conjugates can be attributed to their clinical effectiveness, and its ability to target wide range of therapeutic modalities, including solid tumors, multiple myeloma, metabolic disorders, and hematological disorders. Till date, six next generation drug conjugates have been approved by the USFDA for therapeutic purposes, which include Lutathera® and Pluvicto®, peptide receptor radionuclide therapy, developed by Advanced Accelerator Applications, and Givlaari®, Oxlumo®, Leqvio® and Amvuttra® (GalNac conjugates) developed by Alnylam Pharmaceuticals.

With the ongoing pace of innovation in this field, encouraging clinical trial results, accelerated approvals, and the continuous efforts of both industry and non-industry players, the next generation drug conjugates market is likely to witness significant growth during the forecast period.

Key Market Insights

The Next Generation Drug Conjugates Market: Focus on GalNac Conjugate, Peptide Drug Conjugate, Peptide Oligonucleotide Conjugate, RNAi Conjugate, Peptide Receptor Radionuclide Therapy, Small Molecule-Drug Conjugate (SMDC), and Other Conjugates - Distribution by Type of Targeting Ligand (Amino Sugar, Lipid, Peptide, Small Molecule and Virus-like Particles), Type of Payload (Peptide, Small Molecule, Oligonucleotide and Radionuclide), Type of Therapy (Monotherapy and Combination Therapy), Route of Administration (Intravenous, Subcutaneous and Others), Mechanism of Action (sequence-specific target binding, radiation induced cytotoxicity, cancer-specific surface target mediated cytotoxicity, drug induced cytotoxicity, receptor mediated internalization and cytotoxicity and others) and Key Target Indications (Gastroenteropancreatic Neuroendocrine Tumors, Prostate Cancer, Leptomeningeal Carcinomatosis caused by Breast Cancer Brain Metastases, Hereditary Transthyretin Amyloidosis, Atherosclerotic Cardiovascular Diseases, Severe Hypertriglyceridemia, Hereditary Angioedema, Acute Hepatic Porphyria, Primary Hyperoxaluria, Heterozygous Familial Hypercholesterolemia, Hemophilia, Low-Risk Myelodysplastic Syndrome, Myelofibrosis, Alpha-1 Antitrypsin Deficiency Liver Disease and Familial Chylomicronemia Syndrome) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities in the next generation drug conjugates market, during the given forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the next generation drug conjugates market are briefly discussed below. 

Current Market Landscape: Next Generation Drug Conjugates Revolutionizing the Treatment for Cancer and Rare Diseases

The next generation drug conjugates market landscape is concentrated with the presence of over 30 large, mid-sized and small players engaged in the development of next generation drug conjugates. Currently, over 200 next generation drug conjugates are either approved or being evaluated in various stages of clinical research; of these, more than 50% of the drug candidates are in preclinical / discovery phase.

It is worth highlighting that close to 40% and 30% of the drug candidates are being investigated for the treatment of oncological and rare diseases, respectively, in different phases of development. These drug candidates have emerged as a promising targeted therapy. Further, over 260 clinical trials focused on various next generation drug conjugates, such as small molecule-drug conjugates (SMDC), peptide drug conjugates, GalNac conjugates, and others have been conducted since 2018, indicating the substantial efforts made by researchers engaged in this industry.

Peptide Drug Conjugate, Next Generation of Targeted Therapeutics in Clinical Trial as Anticancer Agents

Breakthrough in the pharmaceutical industry in the last few years has led to the development of various new types of drug modalities. Next Generation Drug Conjugates are one of the many new drug modalities, which have surfaced as targeted therapies for rare disorders and oncological disorders. Interestingly, owing to their structure and mechanism of action, peptide drug conjugate have emerged as a possible alternative to the antibody drug conjugates. Pepaxto, developed by Oncopeptides was the first anticancer peptide drug conjugate to receive accelerated approval from the FDA for the treatment of relapsed or refractory multiple myeloma in February 2021. However, the drug was withdrawn from the US market in October 2021 due to unfavorable results in a phase III clinical trial.

In American Society of Clinical Oncology (ASCO) 2023 annual meeting, clinical trial results of two peptide drug conjugate were presented, which include preliminary results from phase I clinical trials of Cybrexa Therapeutics / Exelixis’ CBX-12 and Theratechnologies’ TH1902. Additionally, there are about 10 peptide drug conjugate candidates, which are being evaluated either as monotherapy or combination therapy in active clinical trials. Further, it is worth highlighting that UK based Bicycle Therapeutics is leading the development of this novel drug class. In February 2023, Bicycle Therapeutics presented results from phase I portion of an ongoing phase I/II clinical trial of BT8009 under development for the treatment of heavily pre-treated urothelial, lung and breast cancer patients. In January 2023. the company received fast track designation from the FDA for BT8009 as a monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer. As the peptide drug conjugates move along the clinical development trajectory, we expect the market to grow at a favorable CAGR during the forecast period.

Peptide Receptor Radionuclide Therapy, Generating Interest in the Pharmaceutical Industry

Peptide receptor radionuclide therapy (PRRT) candidates comprise of an antigen targeting peptide conjugated to a radioisotope / radionuclide through a linker. Novartis is currently the market leader in PRRT therapy (peptide radionuclide conjugate) market with two marketed products - Lutathera and Pluvicto. Pluvicto, received FDA and EMA approval for the treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer patients who have already been treated with other anticancer treatments in March 2022 and December 2022, respectively. Novartis recorded sales worth USD 271 million for Pluvicto in FY 2022, even though there was a supply shortage reported for the drug in the US.

With its continuous focus on research on PRRT therapy (peptide radionuclide conjugates) market, Novartis signed a collaboration agreement with Bicycle Therapeutics in March 2023 for the development of bicycle radio-conjugates, which are peptide receptor radionuclide therapy using bicyclic peptides. Later in May 2023, Bayer entered into a similar collaboration with Bicycle Therapeutics for development of peptide radioconjugates targeting cancer. There have been more such partnerships and collaborations in this emerging segment of the drug conjugates market. Looking at the successful uptake of the approved PRRT therapy candidates and the rising interest of big pharma in the PRRT therapy market, this segment will continue to witness significant market growth during the forecast period.

GalNAc Conjugates of Oligonucleotide Therapeutics Allow Targeted Delivery; Multiple Drug Conjugate Approvals are Anticipated in the Short-term

Over the past decade, oligonucleotide therapeutics have emerged as a promising therapeutic modality. Within these, the GalNAc conjugates have recently emerged as a breakthrough therapy for various rare disorders. GalNAc conjugates comprise of N-acetylgalactosamine (GalNAc) sugar molecule conjugated to an oligonucleotide. Given the affinity of GalNAc molecules to attach with the asialoglycoprotein receptor (ASGPR) of the liver cells, the GalNAc conjugated oligonucleotide therapy emerged as the dominant strategy for delivering therapeutic modality through the liver cells.

Ionis, Alnylam, Dicerna, and Suzhou Ribo Life Science are the key players involved in the development of GalNAc-conjugated oligonucleotide therapies. Amongst these players, Alnylam Pharmaceuticals has emerged as the market leader with four marketed products: Givlaari, Oxlumo, Leqvio, and Amvuttra. However, it is worth mentioning that the recent acquisition of Dicerna by Novo Nordisk in November 2021 and Ionis' collaboration with pharma giant AstraZeneca in April 2023 have increased interest among stakeholders and big pharma players in this domain. With at least 12 drug candidates from Ionis, Dicerna, and Alnylam, anticipated to receive approval in the coming years, and a robust pipeline of 21 drug candidates by Suzhou Ribo Life Sciences, it is anticipated that the segment will continue to witness significant market growth during the forecasted period.

Key Trends in the Next Generation Drug Conjugates Market

A number of stakeholders are forging alliances with other industry / non-industry players. In fact, over 75 strategic partnerships related to next generation drug conjugates, have been signed since 2018. Close to 45% of the partnerships inked in this domain are product development and commercialization agreements, indicating the efforts of stakeholders in development and commercialization of these next generation drug conjugates. It is worth highlighting that, owing to the recent increase in activity in this domain, many big pharma players have shown keen interest in entering this domain. For instance, companies such as Novartis, AstraZeneca, Janssen and others have forged strategic partnerships with these next generation drug conjugate developers, in order to gain entry into this domain. 

With the ongoing research efforts for the development of next generation drug conjugates, and growing contribution of big pharma players, we believe that the next generation drug conjugates market is likely to evolve at a rapid pace, over the forecast period. 

Next Generation Drug Conjugates Market Size: North America to Hold the Largest Market Share

Driven by the increasing number of R&D activities and growing demand for effective therapies for rare and oncological disorders, the next generation drug conjugates market is anticipated to witness an annualized growth rate (CAGR) of over more than 20%, during the period 2023-2035. Specifically, in terms of type of conjugates, the global market for next generation drug conjugates is anticipated to be driven by the GalNac Conjugates. Likewise, in terms of therapeutic area, the market is anticipated to be dominated by the conjugates targeting rare and oncological disorders.

In addition to it, more than 70% market share is captured by the players based in North America, of which ~60% are based in the US. This is followed by Asia-Pacific where a number of developers are engaged in the development of next generation drug conjugates. Interestingly, within Asia-Pacific, China has emerged as the leading country where majority of the next generation drug conjugate developers are based.

The recent accelerated approvals of various next generation drug conjugates, such as peptide drug conjugates, GalNac conjugates, and conjugates utilizing peptide radionuclide therapy (peptide radionuclide conjugate), along with the grant of orphan and breakthrough designations by the regulatory authorities, such as the USFDA and the EMA, has increased the overall interest and confidence of the pharmaceutical industry in these novel targeted therapies. All the above factors will contribute to a healthy market growth of the next generation drug conjugates market during the forecast period.

Leading Next Generation Drug Conjugate Developers 

Examples of key players engaged in next generation drug conjugate development (which have also been captured in this report, arranged in alphabetical order) include Advanced Accelerator Applications, Alnylam Pharmaceuticals, Arrowhead Pharmaceuticals, Cellectar Biosciences, Dicerna Pharmaceuticals, Ionis Pharmaceuticals, Shenzhen Ascentawits Pharmaceuticals Sirnaomics, Silence Therapeutics, and Suzhou Ribo Life Science. This market report includes an easily searchable excel database of all the next generation drug conjugate companies worldwide.

Recent Developments in Next Generation Drug Conjugates Market

• Several recent developments have taken place in the field of next generation drug conjugates market, some of which have been outlined below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we have outlined in our analysis.
• In April 2023, Novartis entered into a licensing agreement with 3B Pharmaceuticals. 3B Pharmaceuticals is German based company, involved in the development of peptide receptor radionuclide therapy (PRRT) candidates targeting fibroblast activation protein (FAP) receptors. 
• In March 2023, Japan based PeptiDream announced its second strategic collaboration with a US based RayzeBio for the development of peptide-radioisotope (RI) conjugate against Glypican-3 (“GPC3”) expressed in liver cancers. 
• In March 2023, Ionis Pharmaceutical announced that the USFDA has accepted the New Drug Application (NDA) for its investigational antisense medicine Eplontersen for the patients suffering with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). When approved, Eplontersen will become the second drug after Alnylam’s Amvuttra® (vutrisiran) for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). 

Scope of the Report

The market report presents an in-depth analysis of the various firms / organizations that are engaged in this market, across different segments.

The market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market report includes:

• An executive summary of the insights captured during our research, offering a high-level view of the current state of the next generation drug conjugates market and its likely evolution in the mid-to-long term.
• A brief introduction to the next generation drug conjugates, highlighting their historical background, as well as information on their structure, advantages, and the pharmacokinetic properties of these next generation drug conjugates.
• A detailed assessment of the market landscape of more than 200 next generation drug conjugates / next generation targeted therapeutics that are either approved or being evaluated in different stages of development (clinical or pre-clinical), based on several relevant parameters, such as type of conjugate (GalNac conjugate, peptide drug conjugate, peptide oligonucleotide conjugate, RNAi conjugate, peptide radionuclide conjugate, small molecule drug conjugate, and other conjugates), type of targeting ligand (amino sugar, lipid, peptide, small molecule and virus-like particles), type of payload, type of biological target, mechanism of action (sequence-specific target binding, radiation induced cytotoxicity, cancer-specific surface target mediated cytotoxicity, drug induced cytotoxicity, receptor mediated internalization and cytotoxicity and others), stage of development (preclinical, clinical and approved), phase of development (approved, phase III, phase II, phase I, preclinical and discovery), type of therapy (monotherapy and combination therapy), route of administration (intravenous, subcutaneous and others), target disease indication (muscular dystrophy, lung cancer, hepatitis, breast cancer, nonalcoholic steatohepatitis, prostate cancer, ovarian cancer, hypertension and hypertriglycedermia), therapeutic area (cardiovascular disorders, genetic disorders, hepatic disorders, metabolic disorders, musculoskeletal disorders, oncological disorders, respiratory disorders, renal disorders, and other disorders) and target population (children, adults and older adults). In addition, the chapter features information on various next generation drug conjugate developers, based on their year of establishment, company size, location of headquarters and most active players (in terms of number of drug candidates).
• Elaborate profiles of leading next generation drug conjugate companies (shortlisted based on number of drug candidates in pipeline that have been approved / commercialized or being evaluated in phase III clinical trials) and their respective product portfolios. Each profile features a brief overview of the company, product portfolio, an overview of the drug candidates which are either approved or are in phase III of clinical development, along with recent developments, and an informed future outlook of the company.
• An in-depth analysis of completed, ongoing, and planned clinical trials of various next generation drug conjugates, based on several relevant parameters, such as trial registration year, trial phase, trial status, enrolled patient population, type of sponsor, age group, most active industry players, leading drug candidate, primary purpose, therapeutic area and key geographical regions.
• An in-depth analysis of partnerships that have been established between various stakeholders since 2018, covering acquisitions, research and development agreements, product development and commercialization agreements, platform / technology licensing agreement, service agreement, clinical trial agreement, joint venture and others. 
• A study of the various grants that have been awarded to research institutes engaged in conducting research related to next generation drug conjugates, since 2018, based on various important parameters, such as year of grant award, amount awarded, funding institute center, support period, type of grant application, purpose of grant award, activity code, study section involved, popular NIH departments (based on number of grants awarded), prominent program officers, leading recipient organizations and key regions.
• A detailed analysis of more than 400 peer-reviewed, scientific articles focused on next generation drug conjugates that have been published since 2018, based on year of publication, type of publication, type of conjugate, target indication, copyright holders and focus area. The chapter also highlights the leading publishers and key journals (in terms of number of articles published and impact factor). 
• An in-depth analysis of next generation drug conjugates that failed to progress to later stages of development, based on various relevant parameters, such as trial status of discontinuation, trial phase of discontinuation, average trial year, type of therapy, target indication and reason for drug failure.
• An insightful success protocol analysis of recently approved and commercialized next generation drug conjugates, based on several relevant parameters, such as dosing frequency, drug efficacy, drug exclusivity, drug designation, fatality rate, geographical reach, intra-class competition, line of treatment, prevalence, price, type of therapy, and existing competition among developers.

One of the key objectives of this market report was to estimate the current market size and the future growth potential of the next generation drug conjugates over the forecast period. Based on several parameters, such as target consumer segments, region-specific adoption rates, and expected prices of such products, we have developed informed estimates of the likely evolution of the next generation drug conjugates market over the forecast period 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of conjugate (peptide receptor radionuclide therapy, ligand mediated RNAi conjugates, ligand conjugates anti sense medicine and peptide drug conjugates), key target indications (gastroenteropancreatic neuroendocrine tumors, prostate cancer, leptomeningeal carcinomatosis caused by breast cancer brain metastases, hereditary transthyretin amyloidosis, atherosclerotic cardiovascular diseases, severe hypertriglyceridemia, hereditary angioedema, acute hepatic porphyria, primary hyperoxaluria, heterozygous familial hypercholesterolemia, hemophilia, low-risk myelodysplastic syndrome, myelofibrosis, alpha-1 antitrypsin deficiency liver disease and familial chylomicronemia syndrome), and key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and secondary research. Financial figures mentioned in this report are in USD, unless otherwise specified. 

Frequently Asked Questions

Question 1: What are next generation drug conjugates?

Answer: Next generation drug conjugates are conjugates that use non-antibody-based targeting ligand for targeted therapy. These conjugates use GalNAc, small molecules, peptides, and radionuclides as their targeting ligands.

Question 2: What is GalNAc used for?

Answer: N-Acetylgalactosamine or more popularly known as the GalNac, is an amino sugar derivative of galactose. Conjugation of GalNac as a targeting ligand has emerged as dominant strategy for delivering therapeutic modalities, such as si-RNA, oligonucleotide, antisense oligonucleotide and others to the hepatocytes. Interestingly, ligand conjugated anti sense medicine and ligand mediated RNAi conjugates have emerged as the popular next generation drug conjugates in this industry.

Question 3: What are GalNAc oligonucleotide conjugates?

Answer: GalNac oligonucleotide conjugates, or more popularly known as the GalNAc conjugates, are the next generation drug conjugates, which use GalNac as their targeting ligand and oligonucleotide as their payload for targeted therapy. Owing to their clinical proficiency, structural stability, and tissue penetration, they have emerged as a popular next generation drug conjugate among the industry stakeholders.

Question 4: What are the advantages of peptide drug conjugates?

Answer: Owing to the various advantages offered by the peptides, such as limited immunogenicity within the body, better clinical profile, lesser side effects, structural stability, and ease of administration through subcutaneous administration; peptides have been successfully used to target various cell receptors for targeted therapy.

Question 5: What is peptide receptor radionuclide therapy?

Answer: Peptide receptor radionuclide therapy is a type of next generation drug conjugate, which uses peptide as the targeting ligand, and radionuclide as their cytotoxic payload, to provide targeted therapy. Lutathera® by Advanced Accelerator Applications was the first peptide receptor radionuclide therapy to be approved by the USFDA and the EMA for the treatment of neuroendocrine tumor.

Question 6: What is the likely market growth rate (CAGR) for the next generation drug conjugates market?

Answer: The market size for next generation drug conjugates market is projected to grow at an annualized rate (CAGR) of ~20%, during the forecast period 2023-2035.

Question 7: Who are the leading companies in the next generation drug conjugates market?

Answer: Some of the leading companies engaged in the next generation drug conjugates development (which have also been captured in this market report, arranged in alphabetical order) include Advanced Accelerator Applications, Alnylam Pharmaceuticals, Arrowhead Pharmaceuticals, Cellectar Biosciences, Dicerna Pharmaceuticals, Ionis Pharmaceuticals, Shenzhen Ascentawits Pharmaceuticals Sirnaomics, Silence Therapeutics, and Suzhou Ribo Life Science.