Lupin’s India business has consistently outperformed the Indian pharma market (IPM) as the business continues to expand its presence in chronic and fast-growing therapies. At revenues of INR 60,042 Mn, the business accounts for 38% of Lupin’s total revenue and delivers high profitability and value to the company. With its high quality, affordable drugs and strong customer engagement, Lupin is a preferred partner for medical practitioners in India.
Lupin has been ranked sixth in the Indian Pharmaceutical Market (IPM) (MAT March 2022). In FY22, Lupin’s branded generics sales increased by 15.2% and achieved a five-year CAGR of 10.5% compared to 10.1% for the market. We have improved our market share from 3.46% in FY17 to 3.52% in FY22.
Lupin’s India Region Formulations (IRF) business is dominated by the chronic segment, accounting for 64.7% of total revenue. Lupin retains its fourth position in the high-growth chronic segment among its peers.
The top five therapy areas in India – Cardiology, Anti-diabetes, Respiratory, Anti-infective and Gastrointestinal – account for 76% of sales. As leaders in the Anti-TB segment, we also maintain second place in the Respiratory segment and third position in the Anti-diabetes and Cardiology segments.
In Anti-diabetes segment, Lupin had growth of 7.5%, compared to 7.2% in IPM and an increase in market share from 8.69% in FY21 to 8.72% in FY22. With a growth rate of 12.5%, the Cardiac segment outpaced IPM growth of 10.5%, and it increased market share from 6.77% in FY21 to 6.9% in FY22. Lupin now has nine brands in the Top 300 brands category of the IPM.
Lupin is committed to enhancing engagement with doctors and improving patient outcomes by expanding its field force and optimizing its portfolio across therapeutic divisions. During FY22, we launched three new divisions under IRF to increase focus on Diabetes care, Central Nervous System segment and Injectables market. In addition, we continue to introduce unique scientific platforms through which we partner with leading universities around the world and expert faculties in order to share the latest medical developments and enable upskilling for doctors practicing specific areas of specialization.
Through digital and technology-based patient support programs, Lupin continues to enhance customer engagement, create disease awareness, and drive therapy adherence. Some notable initiatives include:
According to the World Health Organization (WHO), India accounts for one-fifth of the total number of deaths resulting from stroke and ischemic heart disease. In most cases, consistently high heartbeat indicates a larger underlying health condition. For the purpose of bringing attention to this critical health parameter and ensuring that medical professionals are aware of its importance, we have published a book entitled ‘Heart Rate, a missing link?’ in which 114 eminent cardiologists have contributed. In order to increase the awareness of this issue, we created a new Guinness World Record™ title by creating the “Largest book sentence” having 4,921 copies of the book to display the title ‘Heart Rate, Is it a Missing Link?’
In India, coronary heart disease remains the leading cause of death for women, yet awareness of the disease remains abysmally low. Lupin launched the Shakti Campaign on Women’s Day in March 2022, in order to raise awareness about heart health among women and to encourage them to lead healthy lives.
Among the services offered by the Humrahi Patient Education Program are insulin pen education, insulin storage tips, diet counselling and exercise suggestions. Humrahi is currently covering 20 cities physically and pan India virtually, Humrahi has engaged more than 4,000 HCPs and touch the lives of over 1,50,000 patients through its services.
Lupin’s Joint Airways Initiative (JAI) is India’s first digital educator that educates patients on proper inhalation techniques and offers a wide range of value-added services that enable them to breathe easier.
Recent studies estimate that almost 43% of Indians suffer from mild to severe forms of depression. With the ‘Say Yes to Life’ initiative, we seek to raise awareness about mental health and demonstrate the importance of optimal mental health as a key contributor to a healthy and balanced life. In addition to partnering with Shaan, the renowned singer, we also organized a series of patient outreach initiatives in partnership with eminent psychiatrists across the country.
Lupin has developed exclusive digital assets such as LegalRx to assist physicians with their medical-legal issues, SciFlix for knowledge upgradation of young PG Pulmonologists, and multiple webinars and eCMEs to facilitate the Doctors’ training and development. Lupin possesses a number of innovative assets, such as ANYA (health chatbot) which is now available across five therapeutic areas including diabetes, heart diseases, respiratory diseases, Tuberculosis and the newly launched recently launched Women’s Health category.
By taking a holistic approach, we aim to continue to build a digital eco-system that improves patient health outcomes.
Our OTC business, LupinLife Consumer Healthcare, is on a consistent growth path supported by a well-positioned brand portfolio, strong marketing levers and robust retailing. The business started in 2017 with one brand and has delivered double digit growth year on year. In FY22 the business recorded a healthy growth of 17%, despite the pandemic. Our strategic focus is to build consumer relevance, enable agile execution and demonstrate strong operational excellence. Here’s how some of our top OTC products performed:
Our flagship brand Softovac® led the way, recording growth of 19% YoY. Softovac® doubled in size over the past four years, and currently holds category leadership with 46% market share (IMS MAT March 2022 – Bulk Laxatives). Currently, Softovac ranks #1 in the powder laxative category (IMS).
In its second year of transitioning to our consumer healthcare business, Aptivate® continued to deliver strong performance as evidenced by its 34% growth. Aptivate has established itself as No. 1 ayurvedic appetite stimulant with the highest growth in the category (IMS).
This year, we launched BeOne®, an Ayurvedic supplement specially developed to take care of daily energy and immunity needs.
Lupin’s India business is poised for sustainable growth. As part of our ongoing efforts, we continue to focus on business imperatives, process improvement, and driving engagement with all our stakeholders including doctors, patients, distribution channels, and consumers. As a result of our expertise in brand building as well as our focus on gaining market leadership in key therapeutic areas, we are poised to continue driving the business towards new milestones and a better future.
The United States continues to be a key market for Lupin. Our strategy to grow the U.S. business is predicated on developing a pipeline of high-entry barrier generic products across a variety of therapeutic areas and increasing our focus on value-accretive complex products across the inhalation, injectable and biosimilar segments.
Patent expirations in the U.S. are expected to be nearly USD 140 Bn through 2026 per the latest Global Use of Medicines report by IQVIA. Biolosimilars are expected to result in USD 46 Bn of this amount as market dynamics mature and major products face genericization.
As the pandemic continued into FY22, we remained focused on delivering high quality products to customers and patients across the U.S. We maintained our ranking as the third largest company in the U.S. in terms of prescriptions dispensed, increasing by 9.7% compared with the previous fiscal period, on an extended unit basis.
In FY22, U.S. sales contributed INR 57,556 Mn to the company’s revenue accounting for 36% of overall sales. While seasonal product demand was low due to masking, social distancing and other precautions, we maintained and increased share across our inline portfolio especially on key products like generic Albuterol, Lisinopril and Lisinopril/HCTZ. In addition to this in-line growth, Lupin also had 9 product launches in FY22 with launch of authorized generic Brovana (arformoterol) being the most notable one.
Out of our total portfolio in the U.S. market, more than 25 product families have a market share greater than 50%. Some of these products include:
• Lanthanum Carbonate
• Levetiracetem ER
• Lisinopril HCTZ
As the third largest producer of medicines by TRx for the United States, Lupin holds substantial share across the market, including greater than 10% in the following therapy areas for FY22:
During the fiscal year, significant focus and efforts were centered around operational efficiencies and effectiveness. The U.S. Generics team underwent an Integrated Business Planning implementation focusing on integration of activities from R&D through commercialization.
We continued our efforts during the fiscal year to develop a patient education platform for our inhalation products focused on proper use. Albuterol was the first product added to platform with other products to be added in FY23 and beyond. In addition, we worked with several customers on driving pull-through of Albuterol in the channel.
During the year, we filed 19 ANDAs, with three Exclusive Filings and in three NCE-1 we address a market size of USD 14.2 Bn (per MAT Mar 2022 IQVIA). Our filings were across dosage forms including injectable, inhalation, liquids and OSDs. During this fiscal period, we also settled 15 U.S. patent litigations.
Our Specialty women’s health business continued to be impacted by the COVID-19 pandemic during FY22, with fewer in person physician visits. In February 2022, we received supplemental New Drug Application (sNDA) approval to expand the use of Solosec® (secnidazole) in the treatment of Bacterial Vaginosis (BV) for female patients 12 years of age and older and in the treatment of trichomoniasis for all patients 12 years of age and older. During H2 of FY22, we pivoted our Specialty strategy to optimize the financial performance of the segment. This included streamlining our internal resourcing, and entering into a partnership with Exeltis for in-person promotion of Solosec®. This partnership expanded the reach of Solosec®, allowing more healthcare providers to be aware of its benefits and increase access for women with BV and Trichomoniasis patients.
As we move ahead, our focus is in driving our transition from our legacy of high volume oral solid dose medications, to a P&L which is robustly anchored in high-barrier complex generics.
We have exciting filings and launches coming up throughout the next fiscal year. We are steadily progressing towards our next major inhalation product introduction with Tiotropium, as well as making progress on other pipeline programs. Our respiratory R&D team has advanced the Ellipta device and product platform, which is projected to be a major part of future plans across U.S. and other developed markets. With the TTP partnership, we are also making progress on the Respimat device and product platform.
Further, we are making inroads in long acting injectables with filing of our first product soon and moving two other long-acting injectable products into the clinic.
On the Women’s Health front, we completed a substantial funding partnership, which will enable us to bring forward our IUD and Implant programs, both of which are accelerating well through to clinical development.
Our focus remains on driving the transition to a complex generics player, ensuring that we bring more differentiated products to market and launch them with excellence.
With an estimated value of USD 335 Bn, the pharmaceutical market in Europe, Middle East, and Africa (EMEA) accounts for 26% of the global market. At INR 13,592 Mn, the EMEA region accounts for 8.6% of Lupin’s sales.
NaMuscla® is our flagship product in the Specialty segment in the region. It is prescribed for the treatment of myotonia in adults suffering from non-dystrophic myotonic disorders (NDM), a severe neuromuscular disease that has debilitating effects.
The pharmaceutical market in Europe is valued at USD 309 Bn, with the generic business representing more than USD 63 Bn. With major pharmaceutical brand patents set to expire soon, the European pharmaceutical market is expected to grow significantly.
In FY22, Lupin’s business in Europe recorded a decline by 1.7% with sales of INR 6,761 Mn as a consequence of low demand due to the pandemic in the first quarter of the financial year.
In FY22, we continued to focus on portfolio expansion and expansion of NaMuscla® beyond the U.K., Germany, and France.
Hormosan Pharma Gmbh, our German subsidiary, continues to expand into specialty care while focusing on two primary segments, Pain management and Neurology. Hormosan’s pain therapy portfolio is fully complementary to its medicinal cannabis product, which offers a unique opportunity to grow the business with optimal investment. In FY22, Hormosan continued to put effort into regaining its momentum in other therapy areas including women’s health and HIV following the easing of pandemic related restrictions.
The pharmaceutical market in Europe is valued at U.S.$ 309 Billion, with the generic business representing more than U.S.$ 63 Bn.
In U.K., we continue to maintain our leadership position in the ARV segment. We also received positive approval and reimbursement from NICE and SMC for Namuscla, a rare accomplishment for a repurposed medicine. Additionally, we also launched Luforbec®, our first branded generic product in the respiratory segment. This launch represents the first step towards building a significant presence in the respiratory segment in the U.K. and European markets.
The South African pharmaceutical market is valued at USD 3.8 Bn. While the market declined by 0.8% YoY, Pharma Dynamics, Lupin’s South African subsidiary, registered a growth of 6.2%, with sales of ZAR 1,375 Mn driven by sustained growth in key pharma segments, including Cardiovascular (CVS) and Central Nervous System (CNS), as well as the OTC franchise.
Pharma Dynamics continues to comply with the government’s Broad-Based Black Economic Empowerment (BBBEE) policy that aims to increase the economic participation of the black population in the economy. In addition to providing us with the opportunity to engage with key stakeholders in the industry, our compliance gives us preferred status when compared to our non-compliant peers.
In FY22, we have continued to work with the South African Health Products Regulatory Authority (SAHPRA) and we have received 21 product approvals. This year we introduced 18 new products as well as 3 line extensions to the South African market.
Lupin’s South African subsidiary, registered a growth of 6.2%, with sales of ZAR 1,375 Mn driven by sustained growth in key pharma segments.
Despite challenges, Pharma Dynamics remains the largest CVS company in South Arica with a value share of 14.8%. In unit terms, we currently have 19 products ranked as the top product in South Africa, and 24 products in the second position.
As a result of the current macro-economic and geopolitical challenges, a major challenge for FY23 will be to stem the deterioration in prices and work with inflation. Our strong market position in key therapeutic areas will continue to drive growth in this region.
The year FY23 is poised to be a significant one for Lupin’s European business, as we prepare to expand our respiratory franchise for Luforbec® metered dose inhaler (MDI) and focus on the continued expansion of NaMuscla®.
With a market size of USD 257 Billion, the APAC region accounts for more than 20% of the global pharmaceutical market. Lupin is present directly in major markets of Australia and Philippines. In markets of Japan and South Korea we operate through our local business partners. The APAC region accounts for 5% of Lupin’s global sales. In FY22, we recorded a growth rate of 27.8% in the region, while the market grew at 5.5%.
The APAC region accounts for 5% of Lupin’s
Lupin continues to cater to the market by supplying existing products, APIs, and select new products, through a licensing agreement with Kyowa Pharmaceutical Industry Co. Limited. In addition, we are also committed to our partnership with Yoshindo and Nichi-Iko for a biosimilar Etanercept that was launched in Japan in H2 FY20. We will continue to selectively introduce complex generics to the Japanese market, partnering to maximize value for the company.
We will continue to selectively introduce complex generics to the Japanese market, partnering to maximize value for the company.
In 2022, the Australian pharmaceutical market is valued at USD 13.6 Bn with a growth rate of 5.5%. The generics segment in Australia has experienced consolidation in recent times and is growing at a faster rate of 7.5% due to Government support.
Generic Health, Lupin’s Australian subsidiary, ranks fourth in the region among generic players and supplies generic prescriptions and OTC medicines to pharmacies and hospitals. Generic Health had entered into a definitive agreement to acquire 100% of shares of Southern Cross Pharma Pty Ltd (SCP) in December 2021 and the acquisition was completed in February 2022. SCP is incorporated in Melbourne, Australia, and is engaged in developing, registering, and distributing generic products. As a part of the acquisition, Generic Health will now offer over 60 registered products with sales exceeding AUD 30 Mn (approximately USD 22 Mn). As a result, Lupin’s value proposition and market share in the Australia will significantly increase. The combined revenues of Generic Health and SCP (post acquisition) were AUD 74 Mn, which corresponds to a strong closing in FY22.
Acquired Southern Cross Pharma to enhance Lupin’s value proposition in the Australian Market.
The pharmaceutical market in the Philippines is valued at USD 4.9 Billion, with a growth rate of 15.1% in 2022 following a decline of 5% in 2021. Lupin’s subsidiary in the Philippines, Multicare Pharmaceuticals Philippines Inc., is a premium branded generics company with strong presence in the rheumatology, gastrointestinal and diabetes segments. Within the reference market, we are ranked second among branded generic companies. With new strategies in place, Multicare demonstrated strong resilience against the COVID outbreak and ended the year with a total revenue of PHP 1,881 Mn, recording a 35% increase – twice the growth recorded by the pharmaceutical market in Philippines.
The pharmaceutical market in the Philippines is
valued at U.S.$ 4.9 Billion, with a growth rate of
15.1% in 2022.
With China’s growing commitment to affordable and accessible healthcare, Lupin is committed to serving the healthcare needs of the Chinese population by providing high quality generics and complex generic drugs.
Lupin successfully closed its first China partnership deal with Shenzhen Foncoo Pharmaceutical Co. Ltd. The Company also closed another strategic partnership with Yabao Pharmaceuticals Co. Inc. by leveraging its pediatric portfolio and catering to the growing needs of patients in China.
Data Source: IQVIA Global MIDAS MAT Dec 2021 & Philippines IQVIA local Data Feb, 2022.
Lupin successfully closed its first China
partnership deal with Shenzhen Foncoo
Pharmaceutical Co. Ltd.
At USD 50 Bn, the pharmaceutical market in the LATAM region grew by 17.6% in FY22, driven by the private market and innovations in select therapeutic areas. In FY22, our LATAM business recorded 5% sales growth compared to the prior year and contributed 4% to our overall revenues.
Brazil and Mexico, the two largest markets in the region, accounted for 63% of the LATAM market in size and recorded a growth of 13% in FY22. The region also includes exports from India. As a result of signing distribution agreements with key players in Chile, Peru and Colombia, we have now expanded our presence into these markets. Additionally, the region entered into an out-licensing agreement with Biomm for sales of Peg-Filgrastim in Brazil.
The pharmaceutical market in the LATAM region grew
by 17.6% in FY22, driven by the private market
and innovations in select therapeutic areas.
With a market size of USD 10.7 Bn, Mexico is the second largest pharmaceutical market in Latin America. Despite pandemic-driven macroeconomic headwinds, the market registered strong growth of 13% in 2021.
Laboratorios Grin (Lab Grin), Lupin’s subsidiary in Mexico, reported a 15% increase in sales, while continuing to rank second in the ophthalmic reference market (by units). This growth is essentially coming from the private Branded channel fueled by a strong innovative pipeline.
Lab Grin’s portfolio includes 50 ophthalmic products and ten primary care products. We are continually seeking opportunities to introduce innovative products to the ophthalmic market. By leveraging our global product pipeline, we plan to expand beyond the ophthalmic segment by launching products in the respiratory and CNS segments. We are committed to transforming Lab Grin’s portfolio into one that consists of innovative and branded generics products across therapy areas.
With a market size of USD 24 Bn, the Brazilian pharmaceutical industry is the largest in the LATAM region, accounting for 44% of the region’s salesThe Brazilian pharmaceutical market in 2021 reported a growth rate of 12.3%, driven by the volume growth of essential medicines as well as the recovery of key therapy areas. Price pressures and higher input costs adversely affected profitability.Data Source: IQVIA Global MIDAS MAT Dec 2021 & BRA and MEX IQVIA local Data Feb, 2022
MedQuimica, Lupin’s Brazilian subsidiary, is now ranked 8th in terms of value and the 6th largest in terms of volume (in reference market), commanding a 3.92% market share and increasing by 11% compared to the last year.
We are well-positioned to emerge stronger in the coming quarters with our efficient manufacturing platform and an optimal commercial structure.
We remain focused on increasing our presence in Growth Markets; increasing market share in the existing markets by launching a combination of in-house and in-licensed products, biosimilars and injectables, and entering new markets by building suitable partnerships, exploring acquisitions opportunities or identifying and launching products/offerings catering to local existing unmet/growing patient needs.
The COVID-19 pandemic continued to affect business across countries in FY22 and we are still witnessing the impact of post-COVID effects on the market demand for antibiotic pharmaceutical products. The demand for oral cephalosporin antibiotics has declined across markets in the last two years though we expect it to bounce back in FY23.
The market has also witnessed huge Increases in the cost of key raw materials, intermediates, energy and other utilities, and this is contributing to an increase in the cost of manufacture of products across the API industry. The price of Penicillin-G, for example, the raw material used to manufacture certain cephalosporin antibiotics, has increased exponentially and the end market has not yet been able to absorb this increase.
These are new market realities and Lupin has reoriented its market approach with the current market environment. We have leaned on our experience in process chemistry including fermentation technology and refocused our efforts to mitigate the impact of headwinds in the market place and manage the situation optimally. Most importantly, our client base remained strong during these challenging times.
API contributed about 6% percent of the total sales of the firm with sales of INR 9,904 Mn.
We are developing a robust portfolio of new API products to meet the needs of numerous therapies. Introducing new products to different markets will pave the way for sustainable growth of API business over the next five years.
API contributed about 6% percent of the total
sales of the firm with sales of INR 9,904 Mn.
Further, the Indian government has launched a noteworthy initiative under the Production-Linked Incentive (PLI) scheme to achieve broader self-reliance in the API sector and reduce reliance on imports for key products. We have set in motion a series of initiatives in response to this important initiative, which includes the expansion of our API production capacities and the introduction of new products in our portfolio.
By leveraging our extensive experience in API research and formulation development, our value-added formulation P2P business focuses on the development of new molecules and combinations which are tailored to meet the needs of the market. In FY22, the P2P business has commercialized 2 new and novel formulations in the cardiovascular segment and received approval of 1 product in gastrointestinal therapy.
As part of our Global Institutional Business (GIB), we partner with global and national public health organizations to coordinate the fight against tuberculosis and HIV.
For many years, Lupin has been leading the fight against Tuberculosis and providing affordable, high-quality medicines to underserved communities. We are one of the very few vertically integrated companies engaged in the manufacture and supply of key first line anti-TB drugs. Today, our products are available in more than 50 countries across Africa, Latin America, CIS, and Asia. As a result of our relentless commitment to the fight against TB, we are one of the world’s largest suppliers of first-line anti-TB drugs.
The development of new drugs for treating multidrug-resistant tuberculosis (MDR-TB) is underway. Backward integration enables us to manufacture vital APIs in-house. This ensures reliable supplies and availability of APIs, enabling patient access to quality-assured medications at affordable prices.
The pandemic has significantly impacted TB eradication programs across TB burdened nations, resulting in a significant decrease in TB notification rates. Globally, TB notification rates dropped by 18% worldwide during the peak of COVID-19 period in 2020, with high burden countries such as India experiencing a drop of almost 41%. The intense focus of various countries on the management of COVID-19 diverted the focus of public health infrastructure towards pandemic-affected individuals. According to the Global TB report 2021, the impact of COVID-related disruptions on TB incidence is likely to persist for much longer periods unless rigorous efforts are undertaken by respective stakeholders and governments to reactivate and intensify TB eradication programs. It is expected that this scenario will continue to improve through FY23.
There has been an increased focus on the prevention of TB in high-risk individuals, such as those living with HIV or having close contact with TB patients. The preventive TB regimen uses a fermentation-based product called Rifapentine. Lupin’s fermentation expertise, combined with our large API/formulation manufacturing capabilities, gives us a strong head start for growth. In our efforts to maximize access, we are looking to register our formulations with the national drug regulatory authority in more than 20 high disease burden countries to support the fight towards eradication of TB.
We are excited about our association with international and national public health organizations in the treatment of HIV patients in low and middleincome countries.
As with TB, we are backwardly integrated to manufacture new anti-retroviral (ARV) drugs and offer high quality medications at affordable prices, while mitigating the risk of disruption in supply. We have received product approval from the US FDA and WHOPQ for a few key ARV products and have begun commercial supplies. Lupin is well-poised to be able to garner significant market share in the ARV segment in the access countries as we have the fundamental requisites of being backward integrated and of having large manufacturing capacities to meet global demand. In FY22, we received the approval under the PEPFAR route of US FDA for our TLD, the key first-line drug used currently in the management of HIV/AIDS.. To date, we are having more than 120 regulatory dossier submissions globally for our ARV medicines of which 30 approvals have already been received.
The past year has enhanced the need for a greater focus on purpose - where the actions businesses take are for the benefit of all stakeholders – employees, customers, regulators and society – in addition to shareholders.
In line with our vision of providing affordable medicines for our global communities, we continued to develop and launch generics and biosimilars that provide critical savings throughout the healthcare system.
With heightened pricing pressure due to higher competitive intensity and consolidation of buying groups, product differentiation has become more and more important. The way to growth is via exclusive or low competition launches especially in unbranded generic markets. In accordance, Lupin is purposefully scaling up Inhalation, Injectables and Biosimilars across our footprint of global businesses.
The pharma industry is facing rising costs across various line items. High input prices of APIs, key starting materials and excipients, rising packaging, logistics and utility costs have impinged on margins. Accordingly, the industry is witnessing product discontinuations due to margin compression, especially in competitive markets like the U.S.
For generic companies, efficient manufacturing at scale is a must to be globally competitive. Pharmaceutical manufacturing is evolving with these changing market dynamics with newer initiatives such as continuous manufacturing to produce quality products with continuous monitoring. Single-use bioreactors are being preferred in certain cases as they eliminate need for cleaning and validation between separate production stages. Such technologies help eliminate downtime, lower energy requirements, and are less labour intensive, reducing probability of product defects.
COVID-19 exemplified the susceptibility of pharmaceutical supply chains to large demand shifts and supply shocks caused by geopolitical tensions, and sole-sourced suppliers. Due to the emerging geo-political issues, the pharmaceutical industry supply chain has been impacted due to delay and disruption in the movement of goods because of their dependency on China for APIs and excipients. Accordingly, companies have made supply chain resilience as one of the near-term priorities, and enhanced efforts to detect vulnerability in their supply chain and collaborate with suppliers to improve planning and build competencies.