Blog Details

Oncology is a medical specialty focused on the prevention, detection, and management of cancer. Cancer refers to a large group of diseases characterized by uncontrolled growth and spread of abnormal cells in the body. 

Cancer is a leading cause of death worldwide, with around 10 million cancer deaths in 2020. In India, over 1.1 million new cancer cases are diagnosed every year, and cancer deaths exceed 0.7 million annually. The most prevalent cancer types in India are breast, cervical, oral, and lung cancers. Other common cancers include colorectal, stomach, liver, prostate, and esophageal cancers. 

The high cancer burden in India can be attributed to population ageing, changing lifestyles, and risk factors like tobacco usage, unhealthy diet, physical inactivity, environmental pollutants, and infections. Lack of awareness, late diagnosis, and inadequate access to treatment facilities further compound the issue. However, early detection and timely treatment can significantly improve outcomes in most cancers.

Oncologists play a critical role across the cancer care continuum – from raising awareness to screening, diagnosis, treatment, palliative care, and survivorship care. The field of oncology has seen major advances in recent years, with improvements in surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, and personalized medicine. However, ensuring equitable and affordable access to quality cancer care remains a public health challenge in India and other developing countries.

Oncology Drug Market

The oncology drug market is experiencing rapid growth globally and in India. The global oncology drug market was valued at $139 billion in 2021 and is projected to reach $393 billion by 2028, growing at a CAGR of 15.1%.

Key factors driving this growth include:

– Rising cancer prevalence: Cancer cases are increasing globally due to population growth, ageing, and lifestyle changes. In 2020, there were 19.3 million new cancer cases and 10 million cancer deaths worldwide This rising prevalence is fueling demand for new and effective oncology drugs.

– Higher drug prices: The average cost for cancer drugs has dramatically increased, from around $10,000 per year in the early 2000s to over $150,000 per year currently for new targeted therapies and immunotherapies. Higher prices, often due to the high costs of drug development, are contributing to market growth.

– Advances in therapies: Innovation in oncology drug development is enabling more personalized, targeted, and effective treatments. Immunotherapies, antibody-drug conjugates, cell therapies, and combination therapies are transforming cancer care and driving the need for new drugs.

– Increased access: Oncology drug access is improving in developing countries due to rising incomes, healthcare modernization, and enhanced insurance coverage. This is expanding the global oncology market size.

The Indian oncology drug market is similarly experiencing rapid expansion. The market is projected to grow from $1.7 billion in 2021 to $3.9 billion by 2026, exhibiting a CAGR of 17%. Key growth factors in India include rising cancer prevalence, improved diagnostics, greater health insurance penetration, and increased healthcare spending. Domestic manufacturers are also launching more affordable biosimilars and generics to make cancer drugs more accessible in India. With its large population and increasing cancer burden, India represents a key growth opportunity for oncology drug companies.

Top Oncology Drug Manufacturers in India

India has emerged as a leading hub for oncology drug manufacturing, with several major players operating in this space. Here are some of the top oncology drug manufacturers and exporters in India:

Ellia Cytocare

• Specializes in oncology and generics 
• 90+ oncology drugs including oral solids, injectables and biologics
• Key drugs: Lenalidomide, Thalidomide, Bortezomib, Sorafenib, Tamoxifen 
• Oncology formulations facility in India with a capacity of 200 million units per year

Sun Pharma

• Leading Indian pharmaceutical company headquartered in Mumbai
• Key oncology drugs: Docetaxel, Paclitaxel, Gemcitabine, Oxaliplatin, Irinotecan, Lenalidomide
• Also manufactures generic versions of major cancer drugs that have gone off-patent
• Operates large oncology manufacturing facilities meeting international quality standards

Dr Reddy’s Laboratories 

• Hyderabad-based pharmaceutical company with a strong oncology portfolio
• Biosimilars of major biological cancer drugs like Rituximab, Trastuzumab, Bevacizumab 
• Also makes generic small molecule oncology drugs like Imatinib, Capecitabine
• Major exporter of affordable generic oncology drugs globally

Cipla

• Mumbai-headquartered pharma company, known for HIV and respiratory drugs
• Key cancer drugs: Lenalidomide, Abiraterone acetate, Temozolomide, Erlotinib
• Focus on improving access and affordability of cancer treatment in India
• Exporting oncology products to Africa and other emerging markets

Natco Pharma 

• Hyderabad-based company focused on oncology and hepatology 
• Manufactures generic Capecitabine, Lenalidomide, Sorafenib, Imatinib, etc
• First to launch generic versions of many patented cancer drugs in India
• Known for supplying affordable drugs for chronic diseases

Cadila Healthcare

• Ahmedabad-headquartered pharma company with diverse portfolio
• Oncology focuses on Lymphoma, Breast Cancer and Lung Cancer drugs
• Key products: Rituximab biosimilar, Anastrozole, Capecitabine, Letrozole
• Investing in increasing oncology drug manufacturing capacity

Manufacturing and R&D

India has emerged as a major hub for oncology drug manufacturing and research & development. The country has a large pool of skilled professionals and relatively lower costs which make it an attractive destination for pharma companies to set up manufacturing facilities and R&D centers.

Overview of Manufacturing Facilities

Many leading Indian pharma companies have state-of-the-art manufacturing facilities dedicated to producing oncology APIs and formulations. Companies like Ellia Cytocare, Sun Pharma, Dr. Reddy’s, Lupin, Cipla, Cadila Healthcare etc. have multiple manufacturing sites spread across the country that cater to domestic as well as export markets. 

These facilities adhere to stringent global regulatory standards and are approved by regulators in the US, Europe, Canada etc. They utilize advanced technology and automation to ensure the quality and safety of oncology drugs. The infrastructure, expertise and regulatory track record have helped Indian firms partner with MNCs for contract manufacturing.

Investment in R&D

Indian pharma companies are steadily increasing their investment in R&D to develop innovative drugs and drug delivery systems for cancer treatment. According to a report by Cygnus, the Indian pharma sector spent around US$ 2.5 billion on R&D in 2020, a massive increase of over US$ 0.8 billion in 2015.

Several companies have established dedicated R&D centres focusing on oncology research. For instance, Sun Pharma has an R&D centre in Mumbai dedicated to oncology product development. Lupin and Biocon also have exclusive research facilities for developing biosimilars and novel biologics for cancer.

New Drug Development

Years of sustained R&D is enabling Indian companies to launch differentiated products and new mechanisms of action for cancer treatment. A notable example is Biocon’s recent launch of two monoclonal antibodies – Itolizumab and Qintabio. 

Other India-originated oncology drugs include Cipla’s Abraxane (nanoparticle albumin-bound paclitaxel) and Lupin’s Nulojix (belatacept) – both first-to-market generic versions. Aurobindo Pharma, Natco Pharma, and Hetero Drugs are among other companies at the forefront of developing oncology drugs.

With strategic partnerships, clinical expertise and a focus on innovation, India’s pharma sector is poised to play an even greater role in expanding access to high-quality and affordable oncology treatment globally.

Partnerships and Collaborations

Indian oncology drug manufacturers have actively pursued partnerships and collaborations as a key strategy for growth and expansion. Strategic partnerships allow companies to access new markets, enhance R&D capabilities, share expertise, and accelerate drug development.

Global Partnerships

Partnering with multinational pharmaceutical companies provides Indian firms access to global regulatory expertise, vast distribution networks, and cutting-edge research. 

• Sun Pharma has partnered with AstraZeneca and Merck to distribute and manufacture oncology drugs in emerging markets. 

• Dr Reddy’s Labs has partnered with Fujifilm and Merck for clinical trials and commercialization of drugs globally.

• Cipla has partnered with Roche to expand access to cancer drugs in India and other emerging markets.

Academic Collaborations

Partnerships with leading academic and research institutes help develop R&D capabilities.

• Biocon has partnered with top Indian research centres like IISc Bangalore for immunology research. 

• Piramal Pharma partners with AIIMS Delhi for early-stage oncology research.

• Zydus Cadila funds academic research chairs at institutes like IIT Bombay to drive innovation.

Joint Ventures

Joint ventures allow the pooling of resources and sharing of risks and rewards of drug development.

• Lupin has a JV with Yoshindo in Japan to develop and commercialize oncology drugs for the Japanese market.

• Aurobindo Pharma has a JV with China’s Halo Pharma to access the Chinese oncology market. 

• Glenmark has JVs with Sanofi and Merck to develop biological and novel oncology drugs for global markets.

Strategic partnerships have been crucial for growth in the oncology segment for Indian pharma companies. Collaborations provide access to new technologies, expedite drug development, and enable expansion into global markets.

Regulations and Approvals

The development and commercialization of oncology drugs in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare. 

Overview of Regulatory Landscape

• CDSCO is responsible for approval of new drugs, clinical trials, import and registration of oncology drugs in India. 

• The New Drugs and Clinical Trials Rules, 2019 provide the regulatory framework for clinical research and approval of new drugs.

• Oncology drugs must undergo rigorous clinical trials to establish safety and efficacy before approval. The clinical trial approval process is complex and involves multiple agencies.

• Post-marketing surveillance is mandated to monitor the adverse effects of approved oncology drugs. Pharmacovigilance regulations require manufacturers to report adverse events.

Drug Approval Process

• Approval of new oncology drugs follows a multi-stage process involving preclinical studies, clinical trials (Phase I to Phase III), and regulatory submission.

• Manufacturers must submit data on drug chemistry, manufacturing, controls, preclinical pharmacology, toxicology, and clinical safety and efficacy. 

• CDSCO reviews the application and may approve marketing authorization if satisfied with the safety, efficacy and risk-benefit profile. 

• The entire process can take 6-10 years from discovery to approval. Fast-track options are available for drugs addressing unmet needs.

Recent Regulatory Changes

• CDSCO has taken steps to expedite and streamline the drug approval process through reforms such as a reduction in review time and waivers for local trials.

• The New Drugs and Clinical Trials Rules, 2019 introduced provisions for accelerated review of breakthrough drugs, conditional approvals, and relaxed local trial requirements.

• Increased harmonization with international standards like the US FDA and EMA guidelines is enabling synchronized global drug development.

• Despite improvements, challenges remain in the regulation of clinical research, delays in trial approvals, and lack of expertise in evaluating biologics and biosimilars.

Access and Affordability

India has taken several steps to improve access and affordability of oncology drugs for patients.

Drug Pricing Controls

The Indian government regulates drug prices through the National Pharmaceutical Pricing Authority (NPPA). The NPPA has the power to cap the prices of medicines and ensure affordable and accessible cancer treatment. 

In 2019, the NPPA capped the prices of 42 anti-cancer drugs, cutting prices by up to 85%. These regulations have helped make many essential cancer drugs more affordable to patients.

Insurance Coverage 

Insurance coverage for cancer treatment has expanded in recent years. All health insurance policies are mandated to cover cancer treatment costs.

The government-sponsored health insurance scheme, Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY), provides a cover of Rs 5 lakhs for cancer treatment and other serious illnesses. Over 10 crore poor families are eligible for this scheme.

Many private insurers also offer policies tailored specifically for cancer coverage. The scope of coverage has increased from mainly hospitalization to covering other costs like chemotherapy, radiotherapy and cancer drugs. 

Increased insurance coverage has helped reduce the burden of treatment costs for cancer patients in India.

Improving Access

The government aims to establish at least one oncology facility equipped with surgical, medical and radiation cancer treatment in every district through its National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS). 

Cancer services are being expanded to tier 2 and tier 3 cities beyond the major metros. Charitable hospitals and NGOs are also pitching in to provide subsidized cancer treatment and drugs to economically disadvantaged patients.

Telemedicine and mobile clinics are helping take cancer care to remote areas. Doctors are also being trained in community health centres to diagnose and treat common cancers.

While more needs to be done, these efforts are steadily improving access to cancer treatment across India.

Export and Global Expansion

The oncology drug market in India has huge potential for export and global expansion. Indian manufacturers are increasingly looking beyond the domestic market and expanding their global footprint through exports as well as partnerships and operations abroad.

Export Markets

The major export markets for Indian oncology drugs include Asia Pacific, Africa, Latin America, and Middle East regions. The general expertise of Indian firms, cost competitiveness, good manufacturing capabilities and focus on emerging markets have enabled exports to grow rapidly. Indian manufacturers are deepening their presence in existing markets while also entering new high-growth markets for exports.

Some of the top destinations for exports of oncology drugs from India are:

– African Countries

– Asia-Pacific

– CIS Countries

– Latin America Countries

– Middle East Countries

International Partnerships 

Indian companies are collaborating with global pharma firms and institutes to co-develop novel drugs, conduct clinical trials and register products abroad to drive international expansion. Partnerships also enable technology transfer and access to newer drug delivery mechanisms.

Some major international partnerships by Indian oncology drug makers:

• – Aurobindo Pharma partnered with Clinical Network Services in Australia for clinical trials and product registrations.

• – Dr Reddy’s Laboratories partnered with Italy-based pharma firm Euticals for the development, licensing and supply of cancer drugs globally. 

• – Cipla joined hands with Roche, Eisai, Pfizer and other companies for distribution and marketing of oncology products in various regions.

Global Clinical Trials

India has emerged as a key regional hub for clinical trials due to its diverse patient pool, specialized sites, skilled manpower and cost efficiency. Oncology drugs form a major chunk of global clinical trials being conducted in India.

Indian firms are undertaking clinical trials across various geographies to establish the safety and efficacy of their oncology drugs as per international regulatory guidelines. This enables them to file for approvals and launch innovative drugs in regulated markets.

Some Indian companies conducting global clinical trials: 

• Sun Pharma has undertaken multiple clinical trials of novel oncology drugs across sites in the US, Europe, Australia and Asia. 

• Lupin recently completed a Phase 3 clinical trial of its breast cancer biosimilar drug across countries including the US, Europe, Asia and Latin America.

• Biocon is conducting global trials of its novel monoclonal antibody Itolizumab for cancer indications.

By leveraging India’s capabilities in clinical research and trials, oncology drug makers can establish product differentiation and position their drugs competitively in global markets.

Challenges

The oncology drug manufacturing industry in India faces several key challenges:

Pricing Pressure

• There is increasing pressure from regulatory authorities and patient rights groups to lower the prices of cancer drugs in India. Most new cancer drugs are very expensive, sometimes costing over $100,000 per patient for a full course of treatment.

• With rising cancer rates and increasing demand, there are concerns about access and affordability of cutting-edge cancer therapies in India. The government is pushing companies to cut prices to make drugs more affordable.

• However, companies argue they need to recover high R&D costs, especially for targeted therapies and immunotherapy drugs which take years of research and trials to develop. They warn lower prices will affect future R&D investments.

• There is a need to strike a balance between profitability for companies and ensuring access for patients who often pay out-of-pocket for cancer treatment. Innovative pricing models are required.

Competition 

• The oncology market is highly competitive with both domestic companies and multinationals competing for market share.

• Indian companies face pricing competition from low-cost generics produced by other Indian firms. However, they lack the resources for cutting-edge R&D being done by global majors.

• At the same time, multinational innovator companies face competition from Indian generic drug makers who produce low-priced copies of their patented drugs after exclusivity expires.

• Heavy competitive intensity creates pressure on profit margins and market share for all players. Companies need strategies to differentiate themselves.

Regulatory Environment

• Oncology drug makers in India face a complex regulatory framework involving drug approvals, clinical trials regulation, quality compliance and price controls.

• Navigating changing regulations and policies around issues like compulsory licensing, data exclusivity and patent enforcement is challenging for companies. 

• Delays and uncertainties in regulatory approvals impact launch timelines and access to the latest drugs for Indian patients.

• Companies need significant investments and expertise in regulatory affairs to ensure full compliance and accelerate new drug approvals. Robust quality systems are required.

• The government is working to streamline regulations and reduce approval timelines through initiatives like the Oncology Drug Advisory Committee. However, concerns remain around the evolving regulatory landscape.

Future Outlook

The oncology drug market in India is projected for robust growth in the coming years, driven by rising cancer prevalence, increasing healthcare expenditure, and improving access and affordability.

Market Growth Projections

• The Indian oncology drug market is projected to grow at a CAGR of 12-15% from 2022 to 2027, reaching over $3.5 billion by 2027. 

• New targeted therapies and immuno-oncology drugs will drive growth, with the biologics segment projected to grow at over 15% annually.

• Higher disposable incomes, better insurance coverage and government schemes will also boost market growth. Over 65% of cancer patients now have health insurance.

• Rising cancer cases, with over 1.1 million new cases per year, will propel demand for oncology medicines. The cancer burden is significant and rising.

Innovation Landscape

• Indian pharma companies are ramping up R&D investments to develop innovative drugs, particularly biosimilars of patented biologics. 

• Novel drug delivery mechanisms, like antibody-drug conjugates (ADCs), are also being explored by companies to improve efficacy and safety.

• Research collaborations with global biopharma companies are increasing to access new technologies and conduct clinical trials faster.

• Academic partnerships and government funding programs are supporting pre-clinical and clinical research at Indian research institutes.

Opportunities

• Export markets offer significant growth opportunities for Indian oncology drug manufacturers. 

• The US, Europe and Japan are key target markets, where Indian drugs can compete on cost-effectiveness.

• Emerging markets like Africa and Latin America also present untapped opportunities for exports and local partnerships.

• Indian companies can leverage strengths in process chemistry, generics manufacturing and biosimilars to gain global market share.

– Contract manufacturing partnerships with MNCs allow knowledge and tech transfers to Indian firms, boosting their capabilities.

– Digital health startups providing personalized medicine and AI-based solutions also offer collaboration opportunities.

Conclusion

The landscape of oncology drug manufacturers and suppliers in India is dynamic and promising, driven by both domestic and global factors. Despite facing challenges such as pricing pressures, competition, and a complex regulatory environment, Indian pharmaceutical companies have demonstrated resilience and innovation in meeting the growing demand for cancer treatment. With a strong focus on research and development, strategic partnerships, and expanding access to affordable healthcare, India is poised to continue its significant contribution to the global oncology drug market. As the country advances in technology, regulatory efficiency, and international collaboration, it holds immense potential to further improve cancer care outcomes not only domestically but also across borders, ultimately making a meaningful impact on the fight against cancer worldwide.

FAQs 

1. What is oncology drug manufacturing?

   – Oncology drug manufacturing involves the production of medications used in the prevention, diagnosis, and treatment of cancer. These drugs can include chemotherapy agents, targeted therapies, immunotherapies, and supportive medications.

2. Why is India considered a hub for oncology drug manufacturing?

   – India has emerged as a leading hub for oncology drug manufacturing due to factors such as a skilled workforce, relatively lower production costs, advanced manufacturing facilities meeting global standards, and a robust regulatory framework.

3. What are some of the top oncology drug manufacturers in India?

   – Some of the top oncology drug manufacturers in India include Ellia Cytocare, Sun Pharma, Dr Reddy’s Laboratories, Cipla, Natco Pharma, and Cadila Healthcare, among others.

4. What types of oncology drugs are manufactured in India?

   – Indian pharmaceutical companies manufacture a wide range of oncology drugs, including chemotherapy agents, targeted therapies, immunotherapies, biosimilars, and supportive medications for various types of cancers.

5. How does India ensure the quality of oncology drugs manufactured in the country?

   – Oncology drug manufacturers in India adhere to stringent quality standards set by regulatory authorities such as the Central Drugs Standard Control Organization (CDSCO). Manufacturing facilities are regularly inspected, and drugs undergo rigorous testing to ensure safety, efficacy, and compliance with regulatory requirements.

6. What role does research and development (R&D) play in Indian oncology drug manufacturing?

   – Indian pharmaceutical companies invest significantly in R&D to develop innovative oncology drugs and drug delivery systems. Research collaborations with academic institutions and partnerships with global pharmaceutical companies help drive innovation in the field of oncology drug development.

7. How does India regulate the approval and manufacturing of oncology drugs?

   – The approval and manufacturing of oncology drugs in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare. Oncology drugs must undergo rigorous clinical trials and meet regulatory standards before they are approved for marketing and distribution.

8. What are some of the challenges faced by the oncology drug manufacturing industry in India?

   – Challenges faced by the oncology drug manufacturing industry in India include pricing pressure, intense competition, navigating complex regulatory frameworks, and ensuring access and affordability of cancer medications for patients.

9. How does India contribute to the global oncology drug market?

   – India contributes to the global oncology drug market through exports of high-quality and affordable medications, participation in global clinical trials, and partnerships with international pharmaceutical companies for research, development, and distribution of oncology drugs worldwide.

10. What are the future outlook and opportunities for oncology drug manufacturing in India?

   – The future outlook for oncology drug manufacturing in India is promising, with projections of robust growth driven by rising cancer prevalence, increasing healthcare expenditure, and innovations in drug development. Opportunities exist for expansion into export markets, collaboration with global partners, and leveraging digital health technologies for personalized medicine.